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A total of 120 participants will be enrolled, participants will be randomized 1:1 to receive a single dose of Recombinant COVID-19 vaccine (Sf9 Cell) (test group) or COVID-19 Vaccine (Vero Cell), Inactivated. conditions: COVID-19 conditions: SARS-CoV-2 Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 120 type: ACTUAL name: Recombinant COVID-19 Vaccine (Sf9 Cell) name: COVID-19 Vaccine (Vero Cell), Inactivated measure: Incidence of adverse drug reactions (ADRs) measure: Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 prototype strain measure: Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 Omicron variant measure: Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 prototype strain measure: Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 Omicron variant measure: GMT and GMI of specific neutralizing antibody against SARS-CoV-2 prototype strain measure: GMT and GMI of specific neutralizing antibody against SARS-CoV-2 omicron variant measure: GMT and GMI of IgG antibodies against SARS-CoV-2 S protein RBD sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: West China Hospital of Sichuan University city: Chengdu state: Sichuan country: China lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06381830 id: ASCT+CART briefTitle: Clinical Study of CAR-T Cell Therapy Following ASCT for R/R B-cell Non-Hodgkin's Lymphoma overallStatus: RECRUITING date: 2024-01-01 date: 2027-01-01 date: 2027-01-01 date: 2024-04-24 date: 2024-04-24 name: The First Affiliated Hospital of Soochow University class: OTHER name: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd name: Suzhou Hongci Hematology Hospital, Suzhou, China briefSummary: The study is designed to evaluate the efficacy and safety of chimeric antigen receptor T-cell therapy following autologous stem cell transplantation for relapsed/refractory B-cell Non-Hodgkin's lymphoma. conditions: Lymphoma, B-Cell conditions: Autologous Stem Cell Transplantation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Apheresis name: Autologous Stem Cell Transplantation name: CAR-T Cell Therapy measure: Overall Response Rate (ORR) measure: Progression-free Survival（PFS） measure: Duration of Response(DOR) measure: Complete Response Rate measure: Overall Survival（OS） measure: Adverse events profile sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Soochow University status: RECRUITING city: Suzhou state: Jiangsu zip: 215000 country: China name: Caixia Li, M.D. role: CONTACT phone: +86 512 67781856 email: [email protected] lat: 31.30408 lon: 120.59538 hasResults: False
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<|newrecord|> nctId: NCT06381817 id: 2024112 briefTitle: Haplo-cord HCT vs. Haplo-HCT for T-ALL Patients overallStatus: RECRUITING date: 2024-04-01 date: 2028-03-31 date: 2028-03-31 date: 2024-04-24 date: 2024-04-26 name: The First Affiliated Hospital of Soochow University class: OTHER name: Children's Hospital of Soochow University name: Ruijin Hospital name: Nanfang Hospital, Southern Medical University name: Fujian Medical University Union Hospital name: First Affiliated Hospital Xi'an Jiaotong University name: Wuhan Union Hospital, China name: Zhejiang University briefSummary: The goal of this clinical trial is to learn if haploidentical hematopoietic cell transplantation combined with an unrelated cord blood unit (haplo-cord HCT) works to treat acute T cell lymphoblastic leukemia (T-ALL). It will also learn about the safety of the transplantation. The main questions it aims to answer are:
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Dose co-infusion of cord blood in haploidentical hematopoietic cell transplantation (haplo-HCT) lower the rate of relapse? What medical problems do participants have when having haplo-cord HCT? Researchers will compare haplo-cord HCT to haplo-HCT to see if haplo-cord HCT works to treat T-ALL.
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Participants will be infused an unrelated cord blood unit at the same day of haploidentical graft infusion. conditions: Acute T Cell Lymphoblastic Leukemia conditions: Haploidentical Hematopoietic Stem Cell Transplantation conditions: Cord Blood studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 146 type: ESTIMATED name: Haplo-cord HCT name: Haplo-HCT measure: Progression-free survival measure: Overall survival measure: Cumulative incidence of relapse measure: Non-relapse mortality measure: Adverse events sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Soochow University status: RECRUITING city: Suzhou state: Jiangsu zip: 215000 country: China name: Yang XU role: CONTACT phone: 86+051267781850 email: [email protected] name: Yang Xu role: PRINCIPAL_INVESTIGATOR lat: 31.30408 lon: 120.59538 hasResults: False
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<|newrecord|> nctId: NCT06381804 id: 24YL9001 briefTitle: Effect of Shotblocker and Palm Stimulator overallStatus: RECRUITING date: 2024-04-19 date: 2024-05 date: 2024-05 date: 2024-04-24 date: 2024-04-24 name: Necmettin Erbakan University class: OTHER briefSummary: This study discusses the advancements in nursing, particularly focusing on intramuscular injections, their complications, and innovative non-pharmacological methods such as the Shotblocker and palm stimulator to reduce pain. These methods, based on the gate control theory, aim to minimize discomfort during injections by applying tactile stimulation, which has proven effective in various studies. conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: shotblocker name: palm stimulator measure: Visual analog scale (VAS) pain Scale score sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Necmettin Erbakan University status: RECRUITING city: Meram country: Turkey name: Gülden Basit role: CONTACT phone: (0 332) 320 40 29 email: [email protected] role: CONTACT phone: (0 332) 320 40 29 name: Merve Öz role: SUB_INVESTIGATOR lat: 37.82985 lon: 32.46777 hasResults: False
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<|newrecord|> nctId: NCT06381791 id: PRO00036811 briefTitle: CBD for Pain Following Orthopedic Shoulder Surgery acronym: CBD overallStatus: RECRUITING date: 2024-05-01 date: 2026-12-30 date: 2027-12-30 date: 2024-04-24 date: 2024-04-24 name: The Methodist Hospital Research Institute class: OTHER briefSummary: The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery.
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Researchers will compare Epidiolex to a placebo solution to see if Epidiolex lowers pain after shoulder surgery.
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Participants will:
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* track their pain and what medications they use every day in a provided pain diary. A researchers will call every seven days to check on the participant and diary.
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* Complete two short surveys. Once before surgery and once after.
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* Have bloodwork tested after surgery conditions: Shoulder Osteoarthritis conditions: Rotator Cuff Injuries studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is designed as a randomized, double-blinded controlled trial. Patients will be recruited in clinic preoperatively prior to their scheduled procedure. Patients and the treating physician/research study team will be blinded to the treatment arm. Patients will be randomized to either the test group, which will be prescribed Epidiolex (cannabidiol) postoperatively in addition to the standard pain regimen, or the control group, which will have a placebo provided in addition to the standard pain regimen. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Epidiolex name: Placebo oral solution measure: Primary - Pain Journal measure: Survey Data measure: Pain Disability Index (PDI) measure: Pain, Enjoyment, General Activity (PEG) Scale measure: Patient Health Questionnaire 4 (PHQ-4): The four-item patient health questionnaire for anxiety measure: Pittsburgh Sleep Quality Index (PSQI) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Houston Methodist Hospital status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Haley M Goble, MHA, CRCC role: CONTACT phone: 713-441-3930 email: [email protected] name: Patrick C McCulloch, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06381778 id: 112006-E briefTitle: Taiwan Registry of Hypertrophic Cardiomyopathy (THIC) Research Synopsis overallStatus: RECRUITING date: 2023-02-06 date: 2027-12-01 date: 2027-12-01 date: 2024-04-24 date: 2024-04-24 name: Far Eastern Memorial Hospital class: OTHER briefSummary: Hypertrophic cardiomyopathy (HCM) is hallmarked by the presence of left ventricular hypertrophy (LVH) and may present various symptoms including arrhythmia and heart failure. Mutations in the genes related to sarcomeric proteins and metabolic disorders are known causes of HCM. However, it remains required to further explore the prevalence of HCM in the context of Taiwanese' genetic background. Additionally, certain rare diseases that affect the heart, including Fabry disease, cardiac amyloidosis, may present LVH, which makes precise diagnosis among HCM and these diseases more challenging. In this TSOC multi-center registry, we aim to systematically evaluate the clinical, genetic, biochemical features,prevalence, and possible natural course of HCM and relevant rare diseases such as Fabry disease in Taiwan. In the meanwhile, we may also generate the specific "red-flag" signs of Fabry disease in Taiwan. conditions: Hypertrophic Cardiomyopathy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 2600 type: ESTIMATED measure: Death measure: CV death sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Far Eastern Memorial Hospital status: RECRUITING city: New Taipei City zip: 220 country: Taiwan name: Yen-Wen Wu, MD, PhD role: CONTACT phone: 886-2-8966-7000 phoneExt: 1090 email: [email protected] name: Yen-Wen Wu, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 25.01111 lon: 121.44583 hasResults: False
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<|newrecord|> nctId: NCT06381765 id: Serratus-Pectointercostal briefTitle: Serratus Plane Block and Pectointercostal Block overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2024-08-01 date: 2024-04-24 date: 2024-04-24 name: Cukurova University class: OTHER briefSummary: ASA I-II female patients aged over 18 who will undergoing breast reduction surgery will recruit to the study. Patients will divide into 2 groups. Deep serratus plane block will perform with 0,25 %bupivacaine 20 ml at the midaxillary 5. rib, bilaterally for Group I. At Group II, deep serratus plane block ( 0,25 %bupivacaine 20 ml) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally . General anesthesia with sevoflurane and remifentanil will perform to the all patients. Postoperative pain scores, morphine consumption and complications will record till the 24.th hours. conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Serratus plane bock and pectointercostal block measure: postoperative morphine consumption measure: postoperative visual analog scale scores sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06381752 id: CPMvsPT briefTitle: Value of Continuous Passive Motion in Rehabilitation After Total Knee Replacement overallStatus: COMPLETED date: 2019-06-25 date: 2020-03-31 date: 2020-03-31 date: 2024-04-24 date: 2024-04-24 name: Johannes Gutenberg University Mainz class: OTHER briefSummary: Immediate rehabilitation after total knee arthroplasty (TKA) differs in terms of volume, intensity but also type of treatment. Continuous passive motion after TKA is so far only investigated for replacing physiotherapy. This study is conducted to investigate CPM when it partially replaces group physiotherapy in terms of functional and patient-reported outcomes. conditions: Total Knee Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 175 type: ACTUAL name: Continuous passive motion name: standard rehabilitation measure: Staffelstein Score measure: Oxford Knee Score (OKS) measure: Range of motion (ROM) measure: Visual Analogue Scale (VAS) measure: Return to work sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitaetsmedizin der JGU Mainz city: Mainz state: Rheinland-Pfalz zip: 55131 country: Germany lat: 49.98419 lon: 8.2791 hasResults: False
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<|newrecord|> nctId: NCT06381739 id: M011 briefTitle: A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled Aerosol acronym: AeroVax overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-07 date: 2026-07 date: 2024-04-24 date: 2024-04-25 name: McMaster University class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: The goal of this clinical trial is to study the safety of a new inhaled vaccine to prevent COVID infection and learn about the immune responses that are made in the lungs and the blood after vaccination. Participants will be randomized (like the toss of a coin) to receive the experimental vaccine or a placebo (a look-alike solution that contains no vaccine).
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To be in the study participants will have to have already had three doses of a messenger ribonucleic acid (mRNA) COVID vaccine and be generally healthy. Participants are given a single dose of the vaccine by breathing in a fine mist that goes directly into the lungs.
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During follow-up participants will:
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* visit the clinic for checkups and blood tests at 2, 4 and 8 weeks after vaccination
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* report their symptoms for 24 weeks after getting the vaccine.
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In some participants, the researchers will collect cells from the lung 4 weeks after vaccination (a test known as a bronchoscopy). conditions: COVID-19 Infection studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 350 type: ESTIMATED name: ChAd-triCoV/Mac name: Control measure: Antigen specific T cell responses in blood. measure: Antigen specific T cell responses in bronchoalveolar lavage (BAL). measure: Any grade 3, 4, or 5 adverse events that are possibly or probably related to study vaccine. measure: Confirmed COVID infection by reverse transcriptase polymerase chain reaction (RT-PCR) measure: CD4 and CD8 T cell responses specific for the spike (S1), nucleoprotein (N) and polymerase (POL) SARS-CoV-2 antigens expressed by the vaccine, including those expressing memory T cell markers, in the peripheral blood. measure: Neutralizing and total antibody levels in BAL and blood measure: Any adverse events, including grade 1 or 2 or where relationship to vaccine/placebo administration or study procedures is judged not related or unlikely. measure: Tissue-resident memory surface marker expression airway T cells sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Health Sciences Centre city: Hamilton state: Ontario zip: L8S 4K1 country: Canada lat: 43.25011 lon: -79.84963 hasResults: False
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<|newrecord|> nctId: NCT06381726 id: Progetto AIRC IG-2022 ID 27184 briefTitle: Personalized Rendering of Motor System Functional Plasticity Potential to Improve Glioma Resection and Quality of Life overallStatus: RECRUITING date: 2024-03-07 date: 2028-02-28 date: 2028-02-28 date: 2024-04-24 date: 2024-04-24 name: University of Milan class: OTHER name: University of Turin, Italy briefSummary: Background Lower-grade-gliomas affect young patients, thus the longest progression-free-survival (PFS) with a high level quality of life is crucial. Surgery most significantly impacts on tumor natural history, postponing recurrence, improving symptoms, decreasing the need of adjuvant therapies, with extent of resection, gross-total and supra-total (GTR and STR), strongly associating with longest PFS. Achievement of GTR or STR depends on the degree of functional reorganization induced by glioma. Consequently, a successful treatment fostering neural circuit reorganization before surgery, would increase the chance of GRT/STR.
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Hypothesis The plastic potential of motor system suggests that reorganization of circuits controlling hand movements could be presurgically fostered in LGG patients by enhancing plasticity with up-front motor-rehabilitation and/or by decreasing tumor infiltration with up-front chemotherapy. Advanced neuroimaging allows to infer the neuroplasticity potential. Intraoperative assessment of the motor circuits functionality will validate reliability of preoperative analyses.
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Aims The project has 4 aims, investigating: A) the presurgical functional (FC) and structural (SC) connectomics of the hand-motor network to picture the spontaneous reorganization and the influence of clinical, imaging and histomolecular variables; B) the dynamic of FC and SC after tumor resection; C) changes in FC and SC maps after personalized upfront motor rehabilitation and/or chemotherapy; D) the effect of FC and SC upfront treatment on the achievement of GTR/STR preserving hand dexterity.
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Experimental Design Resting-state fMRI and diffusion-MRI will provide FC and SC maps pre- and post-surgery; personalized up-front motor rehabilitation and/or chemotherapy will be administered; Intraoperative brain mapping procedures will generate data to validate the maps.
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Expected Results
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1. Provide a tool to render the motor functional reorganization predictive of surgical outcome.
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2. Identify demographic, clinical and imaging variables associated with functional reorganization.
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3. Describe the gain induced by up-front treatment.
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4. Distinguish "patterns" predicting chance for GTR/STR from "patterns" suggesting need for up-front treatment.
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Impact On Cancer Results will increase the achievement of GTR/STR, preserving motor integrity, with dramatic impact on LGGs natural history. conditions: Glioma conditions: Glioma, Malignant studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients immediately candidate for resection will be assessed neurologically, neuropsychologically and by functional MRI. Extent of resection will be assessed on \<48hrs and 2-month MRI. Neurological and neuropsychological assessment will be performed during regular follow-up. Patients not requiring an adjuvant treatment according to tumor board meeting will be submitted to functional MRI at 4-8 and 12 months from surgery. Patients not immediately eligible for resection will be submitted to biopsy for histomolecular definition. Patients not requiring radiation therapy will be submitted to neurological, neuropsychological, and functional MRI evaluation. Upon clinical context, patients will undergo motor rehabilitation and/or chemotherapy. After 3-6 months, patients will undergo functional MRI and evaluated for surgery. Neurological and neuropsychological evaluation will be performed at treatment initiation, every month during treatment, at admission for surgery and 1 month after surgery. primaryPurpose: TREATMENT masking: NONE count: 400 type: ESTIMATED name: Resting State Functional Magnetic Resonance Imaging (rs-fMRI) name: Up-front Motor Rehabilitation name: Up-front Chemotherapy measure: Muscle power measure: Motor praxia measure: Comprehensive neuropsychological assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale Galeazzi Sant'Ambrogio status: RECRUITING city: Milan state: Lombardy zip: 20157 country: Italy name: Lorenzo Bello, MD role: CONTACT phone: 0039-340-217-1453 email: [email protected] lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06381713 id: ONZ-2024-0158 briefTitle: Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-12 date: 2027-12 date: 2024-04-24 date: 2024-04-24 name: University Ghent class: OTHER name: Research Foundation Flanders briefSummary: Achieving speech that is understandable and acceptable to others is the key outcome in cleft treatment. Therefore, speech therapy provided by a speech-language pathologist is necessary. This intervention is traditionally provided twice per week for 30 minutes for months or even years by first-line speech-language pathologists. Unfortunately, this low intensity intervention is based on a historical context rather than scientific evidence. This means that current speech therapy knows several shortcomings including poor outcomes, treatment fatigue and high costs related to year-long therapy. Because of these issues, the use of high intensity speech intervention is proposed. Even though solid proof-of-concepts exist for this model, it has not yet found its way into clinical practice.
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Before this intensity can be implemented and utilized in clinical practice, the effect of this novel program on a larger societal scale must be determined. This project will compare the effect of high intensity and low intensity speech intervention in children with a cleft palate in terms of speech, quality of life, and cost-utility as provided by first-line speech-language pathologists by conducting a large-scale randomized controlled trial. The final goal is to utilize this program in clinical practice and to create awareness of the benefits for children with a cleft palate among stakeholders. conditions: Cleft Palate Children conditions: Speech Therapy conditions: Speech Disorders in Children conditions: Cleft Lip and Palate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: High intensive combined phonetic-phonological intervention name: Low intensive combined phonetic-phonological intervention measure: Consonant proficiency measure: Incremental cost-utility ratio measure: Incremental cost-effectiveness ratio measure: Intelligibility in Context measure: Health-related quality of life measure: Speech Function measure: Speech Distress measure: Communication attitudes of children aged 4 and 5 years measure: Communication attitudes of children aged 6 years and older sex: ALL minimumAge: 4 Years maximumAge: 12 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06381700 id: DF CO2405/0014 (P) briefTitle: Effectiveness of MySmile App for Improving the Oral Health of Secondary School Children: overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-06 date: 2025-06 date: 2024-04-24 date: 2024-04-24 name: University of Malaya class: OTHER briefSummary: The goal of this cluster-randomised control trial is to assess the effectiveness of the MySmile app for improving oral health in secondary school children. The main questions it aims to answer are:
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1. Will the MySmile app be more effective in improving secondary school children's dental plaque and gingival health over and above the existing school dental service (SDS)?
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2. Will the MySmile app be more effective in improving secondary school children's oral health knowledge, attitudes, and behaviours over and above the existing SDS?
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3. Is the MySmile app easy to use by secondary school children?
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4. Is the MySmile app acceptable to use from the perspective of secondary school children?
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Participants in the intervention group will receive the SDS and MySmile app. The control group will receive SDS only. Therefore the researcher will compare between the intervention and control group in terms of dental plaque, gingival health, oral health knowledge, oral health attitudes and oral health behaviours. conditions: Oral Disease conditions: Gingival Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 303 type: ESTIMATED name: MySmile app name: Control measure: The mean decrement in plaque score will be assessed using the Plaque Control Record developed by O'Leary Drake and Naylor in 1972 measure: The mean increment in gingival health will be assessed using Gingival Index developed by Silness and Loe in 1963 measure: The mean increment of oral health knowledge, attitude and practice using validated questionnaires. sex: ALL minimumAge: 15 Years maximumAge: 17 Years stdAges: CHILD facility: Muhammad Hamidie bin Saari city: Kuala Lumpur state: Wilayah Persukutuan Kuala Lumpur zip: 50480 country: Malaysia name: Zamros Yuzadi Mohd Yusof, PHD role: CONTACT name: Zamros Yuzadi Mohd Yusof, PHD role: PRINCIPAL_INVESTIGATOR name: Marhazlinda Jamaludin, Master role: PRINCIPAL_INVESTIGATOR name: Unaizah Hanum Obaidellah, PHD role: PRINCIPAL_INVESTIGATOR name: Nazirah Ab Mumin, PHD role: PRINCIPAL_INVESTIGATOR lat: 3.1412 lon: 101.68653 hasResults: False
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<|newrecord|> nctId: NCT06381687 id: 2023-3118978 id: PID2022-141095NB-I00 type: OTHER_GRANT domain: Spanish Ministry of Science, Innovation and Universities briefTitle: A Movement and Music Programme in Early Childhood Education and Care (The MoviMusi Study Protocol) acronym: MOVIMUSI overallStatus: RECRUITING date: 2024-03-20 date: 2024-07-31 date: 2025-07-31 date: 2024-04-24 date: 2024-04-24 name: University of Valencia class: OTHER briefSummary: The early childhood education and care (ECEC) environment is an important setting for providing children with daily opportunities for movement and music, supporting holistic child development in the early years. To date, there are no studies evaluating the implementation of a holistic programme in the ECEC context in the areas of movement behaviour, motor, and musical skills. The main aim is to examine the impact over time of a holistic movement and music programme on correlates of movement behaviour, gross and fine motor skills, and musical skills in young children (1-3 years). The secondary aims are to examine the impact of the movement and music programme on the perceptions of the educational community, as well as the barriers and facilitators they perceive in the process of baseline assessment, construction, and implementation of the movement and music programme in their own ECEC community. This cluster-randomised controlled trial (intervention and control groups) with public ECEC centres will be performed over a 24-month period. Baseline measurements will be taken in the first year of the project, and the longitudinal evaluation of the implementation of the movement and music programme in the second year. educational community's perceptions about the barriers and facilitators associated with the correlates of movement behaviour will be taken into account, as will the results of the assessment of gross and fine motor and musical skills identified in the first year of the project, with a special focus on the structured and unstructured opportunities for movement and music both in the ECEC settings and at home. This research project aims to fill a knowledge gap during a period of childhood that has rarely been explored, either nationally or internationally (1-3 years), and to position movement and music teaching practices as key contexts in the curriculum development of infant and toddler education. conditions: Fundamental Motor Skills conditions: Physical Activity conditions: Music Intervention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The allocation of ECECs to the intervention versus control group will be randomised in a blinded procedure at the end of the first year, following the baseline assessment. Once ECEC centres meeting the selection criteria are identified, they will be randomised to one of the trial arms. primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 312 type: ESTIMATED name: A multi-component, multi-level programme (MoviMusi) measure: Physical activity measure: Sleep time measure: Motor skills measure: Musical skills measure: Sedentary time measure: For young children, the first secondary outcome measure is physical activity and sedentary time during unstructured and structured physical activity opportunities. measure: For young children, the second secondary outcome measure will be the play patterns during unstructured outdoor free play. measure: For ECEC educators, the first secondary outcome will be the perceived barriers and facilitators for the inclusion of movement and music as curricular practices in the ECEC institution. measure: For ECEC educators, the second secondary outcome will be the perceived impact of the implementation of the movement and music program. measure: For families, the first secondary outcome is the perceived barriers and facilitators to PA in young children. measure: For families, the second secondary outcome is the perceived barriers and facilitators to the inclusion of music at home. measure: For families, the third secondary outcome are the means of transport to ECEC settings and barriers to active comm measure: For families, the fourth secondary outcome is the habitual perceived PA and sedentary behaviour in the child's home environment. measure: For families, the fifth secondary outcome is the perceived barriers and facilitators to PA in young children. sex: ALL minimumAge: 14 Months maximumAge: 22 Months stdAges: CHILD facility: University of Valencia status: RECRUITING city: Valencia state: Comunidad Valenciana zip: 46021 country: Spain name: Vladimir Martínez-Bello, Ph.D. role: CONTACT phone: 34961625473 email: [email protected] name: María del Mar Bernabé-Villodre, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Herminia Vega-Perona, Ms.Sc. role: SUB_INVESTIGATOR name: José Díaz-Barahona, Ph.D. role: SUB_INVESTIGATOR name: Yolanda Cabrera García-Ochoa, Ph.D. role: SUB_INVESTIGATOR name: Sandra Molines-Borrás, Ph.D. role: SUB_INVESTIGATOR name: Felipe Gertrudix, Ph. D. role: SUB_INVESTIGATOR name: Juan Carlos Montoya-Rubio, Ph. D. role: SUB_INVESTIGATOR name: María Ángeles Fernández-Vilar, Ph. D. role: SUB_INVESTIGATOR name: José Manuel Azorín, Ph. D. role: SUB_INVESTIGATOR name: Nataliya Filenko, Ph. D. role: SUB_INVESTIGATOR name: Daniel Martínez-Bello, Ph.D. role: SUB_INVESTIGATOR name: Ángela Martínez, Ph.D. role: SUB_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False
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<|newrecord|> nctId: NCT06381674 id: OHSU: 25890 id: HT9425-23-1-0845 type: OTHER_GRANT domain: Department of Defense briefTitle: Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation acronym: SuBTyPE overallStatus: NOT_YET_RECRUITING date: 2024-05-13 date: 2028-09-30 date: 2028-09-30 date: 2024-04-24 date: 2024-04-24 name: Oregon Health and Science University class: OTHER name: United States Department of Defense briefSummary: Current clinical assessment tools are often not sensitive enough to detect and treat some subtle (yet troubling) problems after mTBI. In this study, the investigators will use wearable sensors to both assess and treat people with mTBI. Specifically, the investigators will provide immediate feedback, with visual and/or auditory, on movement quality during physical therapy. This immediate feedback on performance may improve outcomes as the investigators will measure multiple body segments including head movements simultaneously with balance and walking exercises. Such complex movements are needed for safe return to high level activity and military duty. The investigators will test this approach against a standard vestibular rehabilitation program. There are few potential risks to this study such as increasing symptoms and a small fall risk. Benefits include physical therapy for balance problems regardless of therapy with or without biofeedback. An indirect benefit is to have data on correct dosage of physical therapy. The investigators will also distinguish which concussion subtype profiles benefit most from physical therapy. This will help healthcare providers and patients by providing more information to help establish clinical guidelines and new tools for physical therapy. conditions: Mild Traumatic Brain Injury, Concussion conditions: Rehabilitation conditions: Balance Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There will be two groups in this study that will be randomized concurrently into two different rehabilitation programs. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Parties that will be masked include those collecting and analyzing data before and after rehabilitation (post-doctorate fellows, research assistants, and statistician). whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Vestibular therapy for mTBI augmented with audio and visual real-time biofeedback name: Vestibular therapy for mTBI measure: Patient Global Impression of Change (PGIC) measure: Concussion Clinical Profiles Screening (CP Screening) measure: Dizziness Handicap Index (DHI) measure: Quality of Life After Brain Injury (QOLIBRI) measure: The Patient Reported Outcomes Measurement Information System (PROMIS)-Satisfaction with Participation in Social Roles-Short Form 4a measure: Hospital Anxiety and Depression Scale (HADS) measure: Headache Impact Test (HIT-6) measure: Insomnia Severity Index (ISI) measure: Neck Disability Index (NDI) measure: Convergence Insufficiency Symptom Survey (CISS) measure: Vertigo Symptom Scale (VSS) measure: Concussion Symptom Subtypes Inventory (CSSI) measure: Automated Neuropsychological Assessment Metric (ANAM) measure: Dynamic Visual Acuity ( DVA-Clinical) measure: Ocular Motor Function Tests measure: Video Head Impulse Test (vHIT) measure: Functional Gait Assessment (FGA) measure: Complex Turning Course (CTC) measure: Modified Balance Error Scoring System (mBESS) measure: Modified Clinical Test for Sensory Integration on Balance (mCTSIB) measure: Instrumented One Minute Walk (Single and Dual Task) measure: Hybrid Assessment of Mobility (HAM-4) measure: Tandem Gait (Single and Dual Task) measure: Vestibular Ocular Motor Screening (VOMS) measure: Central Sensorimotor Integration Testing (CSMI) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Oregon Health & Science University city: Portland state: Oregon zip: 97239-3098 country: United States lat: 45.52345 lon: -122.67621 facility: Fort Sam Houston city: San Antonio state: Texas zip: 78234 country: United States lat: 29.42412 lon: -98.49363 facility: University of Utah city: Salt Lake City state: Utah zip: 84112 country: United States lat: 40.76078 lon: -111.89105 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Protocol and ICF date: 2024-02-13 uploadDate: 2024-03-07T11:25 filename: Prot_SAP_ICF_000.pdf size: 1554413 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan: Updated Statistical Analysis Document date: 2024-04-02 uploadDate: 2024-04-04T19:41 filename: SAP_001.pdf size: 112584 hasResults: False
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<|newrecord|> nctId: NCT06381661 id: APHP240385 briefTitle: Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Bayesian Basket Trial acronym: PALETTE overallStatus: NOT_YET_RECRUITING date: 2026-04-01 date: 2029-05-01 date: 2032-04-01 date: 2024-04-24 date: 2024-04-24 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context. conditions: Sepsis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomization will concern 3 specific domains (immunomodulation, coagulation, and corticosteroids); in each domain, patients will be randomly allocated between control (standard of care) and 1-4 experimental treatments using parallell arms primaryPurpose: TREATMENT masking: NONE count: 2000 type: ESTIMATED name: Tocilizumab name: Baricitinib name: Anakinra name: Hydrocortisone name: Hydrocortisone and fludrocortisone name: Heparin name: Low molecular weight heparin name: Recombinant humanThrombomodulin( rhTM) name: Sivelestat name: Fresh frozen plasma name: Usual care measure: All-cause mortality measure: Number of patients with persistent life-supportive therapies measure: Composite of the two primary outcomes measure: Overall Survival measure: Overall Survival measure: Overall Survival measure: Number of hospital free days measure: Number of hospital free days measure: Time to recover walking measure: Time to resume previous social and professional activities measure: Quality of life score for adults assessed by SF-36 measure: Quality of life score for adults assessed by EQ-5D-5L measure: Quality of life score for children assessed by FFS measure: Quality of life score for adults assessed by SF-36 measure: Quality of life score for adults assessed by EQ-5D-5L measure: Quality of life score for children assessed by FFS measure: Quality of life score for adults assessed by SF-36 measure: Quality of life score for adults assessed by EQ-5D-5L measure: Quality of life score for children assessed by FFS measure: Number of adverse events measure: Incidence of new sepsis episodes measure: Incidence of new sepsis episodes measure: Incidence of new sepsis episodes measure: Incidence of new unscheduled hospitalizations measure: Incidence of new unscheduled hospitalizations measure: Incidence of new unscheduled hospitalizations measure: Incidence of sequels in neurocognitive, neuromuscular; cardiovascular, respiratory, renal, metabolic, and immune systems sex: ALL minimumAge: 37 Weeks maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06381648 id: 23228/LyMIC briefTitle: Detecting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma (LyMIC) acronym: LyMIC overallStatus: RECRUITING date: 2023-04-15 date: 2026-06-18 date: 2026-06-18 date: 2024-04-24 date: 2024-04-25 name: City of Hope Medical Center class: OTHER briefSummary: Lymph node metastasis (LNM) is a major prognostic factor in intrahepatic cholangiocarcinoma (ICC), and accurate preoperative prediction of the presence or absence of LNM has significant clinical implications in determining treatment strategy. Despite this, there are currently no reliable biomarkers established to detect LNM in ICC.
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This study seeks to develop a liquid biopsy assay that can accurately detect LNM before treatment in ICC patients. conditions: Cholangiocarcinoma conditions: Cholangiocarcinoma, Intrahepatic conditions: Cholangiocarcinoma Resectable conditions: Cholangiocarcinoma; Liver studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED name: LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma) measure: Sensitivity measure: Specificity measure: Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center status: RECRUITING city: Duarte state: California zip: 91016 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: [email protected] name: Ajay Goel, PhD role: PRINCIPAL_INVESTIGATOR name: Takayuki Noma, MD role: SUB_INVESTIGATOR lat: 34.13945 lon: -117.97729 facility: Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University status: RECRUITING city: Hokkaido state: Sapporo zip: 060-8648 country: Japan name: Akinobu Taketomi, PhD role: CONTACT email: [email protected] name: Kazuki Wakizaka, PhD role: SUB_INVESTIGATOR name: Akinobu Taketomi, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.41104 lon: 142.88878 facility: Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University status: RECRUITING city: Fukuoka zip: 812-8582 country: Japan name: Masaki Mori, PhD role: CONTACT email: [email protected] name: Masaki Mori, PhD role: PRINCIPAL_INVESTIGATOR name: Takeo Toshima, PhD role: SUB_INVESTIGATOR lat: 33.6 lon: 130.41667 facility: Department of Surgery, Tokushima University status: RECRUITING city: Tokushima zip: 770-8503 country: Japan name: Mitsuo Shimada, PhD role: CONTACT email: [email protected] name: Yuma Wada, PhD role: SUB_INVESTIGATOR name: Takayuki Noma, MD role: SUB_INVESTIGATOR name: Yuji Morine, PhD role: SUB_INVESTIGATOR name: Tetsuya Ikemoto, PhD role: SUB_INVESTIGATOR name: Yu Saito, PhD role: SUB_INVESTIGATOR name: Mitsuo Shimada, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.06667 lon: 134.56667 hasResults: False
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<|newrecord|> nctId: NCT06381635 id: FD-BUE-REC: IRB000124920 briefTitle: Effect of Aloe Vera Gel and Manuka Honey on Radiation Induced Oral Mucositis overallStatus: RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2025-01-01 date: 2024-04-24 date: 2024-04-24 name: Ain Shams University class: OTHER briefSummary: The goal of this \[ type of study: Clinical trial\] is to test effectiveness of Aloe Vera Gel and Manuka Honey in management of Radiation Induced Mucositis in head and neck cancer patients.
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The main question \[s\] \] is to \[ learn about, test, compare etc.\] it aims to answer are:
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1. Is Aloe Vera Gel and Manuka Honey effective in management of Radiation Induced Mucositis?
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2. Does Aloe Vera Gel and Manuka Honey affect the level of TGFβ1 and EGF in saliva of patients with radiation induced mucositis? participants will be asked to apply Aloe Vera Gel and Manuka Honey or saline three times daily during radiotherapy and 6 months after radiotherapy. conditions: Radiation Mucositis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Manuka honey mixed with aloe vera gel measure: Change from World Health Organization Oral Toxicity Scale Grading of Oral Mucositis measure: the level of salivary transforming growth factor beta 1 measure: the level of salivary Epidermal Growth factor (EGF) sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ain shams University status: RECRUITING city: Cairo zip: 11565 country: Egypt name: hani wlliam, MD role: CONTACT phone: +20 0001000093885 email: [email protected] lat: 30.06263 lon: 31.24967 facility: Fatma E.Sayed status: RECRUITING city: Cairo country: Egypt name: Fatma E. Hassanein, PHD role: CONTACT phone: +201000093885 email: [email protected] name: Asma Abou Bakr role: CONTACT email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06381622 id: CTA no: 2023-510028-63-00 briefTitle: Combining Lidocaine and Ropivacaine for an Infraclavicular Brachial Plexus Nerve Block overallStatus: RECRUITING date: 2024-04-18 date: 2024-08-03 date: 2024-09-03 date: 2024-04-24 date: 2024-04-24 name: Nordsjaellands Hospital class: OTHER briefSummary: The aim of the study is to investigate how the combination of ropivacaine (a slow onset, long duration local anesthetic) with lidocaine (a rapid onset, shorter duration local anesthetic) affects the onset and duration of a lateral infraclavicular plexus brachialis (LIC) block in patients undergoing non-acute hand surgery. conditions: Nerve Block conditions: Anesthesia, Local conditions: Forearm Fracture conditions: Surgery conditions: Brachial Plexus Block studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: Ropivacaine 0.5% Injectable Solution name: Lidocaine epinephrine name: Ropivacaine 0.75% Injectable Solution measure: Total time to breakthrough pain measure: The onset of sensory block measure: Total duration of sensory blockade measure: Total duration of motor blockade measure: Degree of motor blockade measure: Pain intensity at pain breakthrough measure: Duration of maximum pain intensity after the blockade has ended measure: Occurence of adverse events (AE) and serious adverse events (SAE) measure: Failed blockade measure: The patient's experience of the treatment (patient satisfaction) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nordsjælland Hospital status: RECRUITING city: Hillerød zip: 3400 country: Denmark name: Lars H Lundstrøm, PhD role: CONTACT phone: 48296512 phoneExt: 45 email: [email protected] name: Christian Rothe, PhD role: CONTACT phone: 48297459 phoneExt: 45 email: [email protected] lat: 55.92791 lon: 12.30081 hasResults: False
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<|newrecord|> nctId: NCT06381609 id: 69HCL22_0901 briefTitle: Peer Support in Alcohol Dependence acronym: PEERSIAD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-11-01 date: 2027-11-01 date: 2024-04-24 date: 2024-04-24 name: Hospices Civils de Lyon class: OTHER briefSummary: Alcohol use disorder (AUD) affects between 4% and 6% of French adults, and requires appropriate medical treatment.
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However, 20-40% of patients with AUD are lost to follow-up at an early stage. Consequently, it is important for addiction departments to implement and evaluate innovative tools and interventions, including the involvement of peer support, to help patients remain in care, and to assess whether peer support has a positive impact on their clinical outcome.
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Addiction peer support specialists (APSSs) are individuals who have personally experienced addiction, and who have decided to use their experience to assist other people going through a similar situation, after completing a specific official graduation.
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Compared to other caregivers, APSSs may induce in patients a sense of identification which could improve the patient motivation to engage and remain in care.
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This is the main hypothesis and the main scientific objective of the PEERSIAD study, which will aim to confirm that accompanying patients with AUD using APSSs after alcohol detoxification, reduces the rate of lost-to-follow-up and improves the overall clinical outcome. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 626 type: ESTIMATED name: Quality life questionnaire AQoLS name: Quality life questionnaire Euroqol EQ-5D-5L name: Peer support consultations measure: Unplanned cessation of care at 6 months measure: Number of unfulfilled consultations measure: Euroqol-5D-5L questionnaire score measure: Difference in costs (in euros) measure: Number of AUD criteria according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) measure: Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score measure: average number of standard drinks declared per week measure: Alcohol Quality of Life Scale (AQoLS) score measure: State-Trait Anxiety Inventory (STAI-Y) score measure: Montgomery-Åsberg Depression Rating Scale (MADRS) score measure: Cannabis Use Disorders Identification Test - Revised (CUDIT-R) score measure: type of opioid use measure: frequency of opioid use measure: type of psychostimulant use measure: frequency of psychostimulant use measure: Fagerström test score measure: Health Care Satisfaction Questionnaire (HCSQ) score measure: Number of hospitalisations measure: Service organization description measure: Description of type of support and missions performed by Peer Support measure: Acceptability of Intervention Measure (AIM) score measure: AIM score measure: Adoption of intervention measure: Intervention fidelity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CH Le Vinatier city: Bron zip: 69500 country: France name: Monique GUENIN, MD-PhD role: CONTACT phone: +33 4 37 91 55 55 email: [email protected] name: Monique GUENIN, MD-PhD role: PRINCIPAL_INVESTIGATOR lat: 45.73333 lon: 4.91667 facility: Hôpital Beaujon city: Clichy zip: 92110 country: France name: Delphine MOISAN, MD-PhD role: CONTACT phone: +33 1 40 87 58 82 email: [email protected] name: Delphine MOISAN, MD-PhD role: PRINCIPAL_INVESTIGATOR lat: 48.90018 lon: 2.30952 facility: GH Nord, Hospices Civils de Lyon city: Lyon zip: 69004 country: France name: Benjamin ROLLAND, Professor role: CONTACT name: Benjamin ROLLAND, Professor role: PRINCIPAL_INVESTIGATOR name: François BAILLY, MD-PhD role: SUB_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: CHS St Anne city: Paris zip: 75014 country: France name: Clément VANSTEENE, MD-PhD role: CONTACT name: Clément role: CONTACT name: VANSTEENE, MD-PhD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Bichat Hospital city: Paris zip: 75018 country: France name: Pierre-Alexis GEOFFROY, MD-PhD role: CONTACT phone: +33 1 40 25 82 60 email: [email protected] name: Pierre-Alexis GEOFFROY, MD-PhD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06381596 id: 2023-1715 id: A536000 type: OTHER domain: UW- Madison id: SMPH/OPHTHAL&VIS SCI/GEN type: OTHER domain: UW- Madison id: Protocol Version 3/6/2024 type: OTHER domain: UW- Madison briefTitle: Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration acronym: FPF in AMD overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-24 date: 2024-04-24 name: University of Wisconsin, Madison class: OTHER briefSummary: The goal of this clinical trial is to learn if the areas of stressed cells in the retina correlate to areas of disease identified in standard imaging and whether the images are helpful to identify potential areas of concern before symptoms or disease occurs. The main question it aims to answer is:
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* to evaluate patterns of increased autofluorescence FPF in the setting of geographic atrophy
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Participants will undergo FPF imaging using the OcuMet Beacon system. conditions: Geographic Atrophy conditions: Age-Related Macular Degeneration studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: OcuMet Beacon measure: Limits of agreement between the fundus autofluorescence (FAF) area of GA images taken with the Heidelberg Spectralis to the flavoprotein fluorescence (FPF) area of GA with images taken with the OcuMet Beacon measure: Compare the cross-sectional associations between FPF intensity (average pixel intensity over a 5.5 mm-diameter region centered at the macula) to FAF area at the time of measurement measure: Compare the cross-sectional associations between best corrected visual acuity (BCVA - using Early Treatment Diabetic Retinopathy Study, greater number of letters read correctly equals better vision) to FAF area at the time of measurement sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophthalmology and Visual Sciences city: Madison state: Wisconsin zip: 53705 country: United States name: Amy Remm role: CONTACT phone: 608-262-3377 email: [email protected] name: Mihai Mititelu, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False
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<|newrecord|> nctId: NCT06381583 id: 23228/EMERALD briefTitle: A Liquid Biopsy for High-risk Pre-cancer Screening of Esophageal Adenocarcinoma acronym: EMERALD overallStatus: RECRUITING date: 2023-04-15 date: 2026-06-18 date: 2026-06-18 date: 2024-04-24 date: 2024-04-25 name: City of Hope Medical Center class: OTHER briefSummary: This study aims to develop a highly sensitive, specific, and cost-effective blood assay for the early detection of esophageal adenocarcinoma and its precursor lesions, using advanced machine learning and state-of-the-art biological analyses. conditions: Esophagus Cancer conditions: Esophageal Cancer Stage conditions: Esophageal Cancer conditions: Esophageal Neoplasms conditions: Esophagus Adenocarcinoma conditions: Esophagus, Barrett conditions: Barrett Esophagus conditions: Barrett Adenocarcinoma conditions: Barrett Epithelium conditions: Barretts Esophagus With Dysplasia conditions: Barrett's Esophagus Without Dysplasia conditions: Barretts Esophagus With High Grade Dysplasia conditions: Barretts Esophagus With Low Grade Dysplasia conditions: Barrett Esophagus, Long-Segment conditions: Barrett's Esophagus With Dysplasia, Unspecified conditions: Barrett's Esophagus With Esophagitis conditions: Gastroesophageal Reflux conditions: Reflux Disease conditions: Esophageal Adenocarcinoma conditions: Esophageal Dysplasia conditions: Esophageal Neoplasms Malignant studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia) measure: Sensitivity measure: Specificity measure: Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center status: RECRUITING city: Duarte state: California zip: 91016 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: [email protected] name: Ajay Goel, PhD role: PRINCIPAL_INVESTIGATOR name: Alessandro Mannucci, MD role: SUB_INVESTIGATOR lat: 34.13945 lon: -117.97729 hasResults: False
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<|newrecord|> nctId: NCT06381570 id: VICTORY/OZM-138 briefTitle: Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas acronym: VICTORY overallStatus: RECRUITING date: 2024-03-21 date: 2026-03-21 date: 2029-03-21 date: 2024-04-24 date: 2024-04-24 name: Daniel Morgenstern class: OTHER name: The Hospital for Sick Children briefSummary: This is a Pilot, multicenter, open-label study of patients less than or equal to 25 years, with recurrent or progressive LGG harboring a CRAF or BRAF alteration, including BRAF V600 mutations and KIAA1549: BRAF fusions. Patients with BRAF or CRAF alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories.
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The study will be conducted in two sequential phases:
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Phase A: A Feasibility (combination dose finding) phase, followed by Phase B: An Efficacy phase. The maximum tolerated dose (MTD)/Recommended Phase 2 Dose (RP2D) of the combination as determined in Phase A would be the dose used in Phase B. The patients on Phase A who were below the MTD/RP2D would be eligible for intra-patient dose escalation to MTD/RP2D subject to criteria outlined later conditions: Low-grade Glioma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 57 type: ESTIMATED name: Tovorafenib measure: MTD/RP2D measure: Safety and Tolerability measure: Overall response rate measure: Pharmacokinetics (Cmax vinblastine and tovorafenib) measure: Pharmacokinetics (AUC of vinblastine and tovorafenib) measure: Progression free survival measure: Duration of response measure: Clinical Benefit rate sex: ALL minimumAge: 0 Weeks maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: The Hospital for Sick Children status: RECRUITING city: Toronto state: Ontario zip: M5G 1X8 country: Canada name: Nirav Thacker role: CONTACT phone: 6137377600 phoneExt: 6525 email: [email protected] lat: 43.70011 lon: -79.4163 hasResults: False
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<|newrecord|> nctId: NCT06381557 id: YRPG-PMS-ZYJN-RCT-2022-01 briefTitle: Cancer-related Fatigue in Patients With Breast Cancer Treatment With Zhengyuan Capsules acronym: CRF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-03-01 date: 2027-03-01 date: 2024-04-24 date: 2024-04-24 name: Qiang Fu class: OTHER name: Yangtze River Pharmaceutical Group Co., Ltd. briefSummary: Traditional Chinese medicine（TCM） has achieved some meaningful results in improving the symptoms and quality of life of cancer patients, but many research results need to be further verified by clinical trials with larger samples and better design.This study aims to investigate effectiveness and safety of Zhengyuan Capsules for cancer-related fatigue in patients with breast cancer. conditions: Cancer-related Fatigue studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 240 type: ESTIMATED name: Zhengyuan Capsules name: Placebo contains 5%-10% Zhengyuan Capsule total mixed powder measure: Fatigue degree with the Brief Fatigue Inventory（BFI） measure: Fatigue degree the Revised Piper Fatigue Scale（PFS⁃R） measure: Fatigue degree with the MD Anderson Symptom Inventory（MDASI） measure: Change of patients' functional status with Karnofsky performance status (KPS) measure: Quality of Life Questionnaire-Breast Cancer Module 23（QLQ-BR23） measure: Adverse reaction rates, including the damage of liver and renal functions that reflected by increased alanine aminotransferase, aspartate aminotransferase and creatinine urea nitrogen respectively sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06381544 id: fbu_nurs_elmali_002 briefTitle: The Effect of Aromatherapy Use in Nursing Skills Training overallStatus: COMPLETED date: 2024-02-12 date: 2024-02-19 date: 2024-03-06 date: 2024-04-24 date: 2024-04-24 name: Fenerbahce University class: OTHER briefSummary: Nursing education is an education in which theory and practice are intertwined and requires the development of both cognitive and motor skills of students. The laboratory environment is a bridge between classroom learning and clinical practice. In order for students to transform the target behavior into a skill, it takes place in the laboratory on inanimate models under the supervision of the instructor. It has been assumed that there is a strong relationship between learning and anxiety; while a moderate level of anxiety is necessary for learning, a high level of anxiety causes a decrease in learning.
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Many studies have reported that students experience anxiety before their first clinical/practice experience. During skills training, it is observed that students are stressed, their hands are shaking, and they do not feel comfortable, especially before practices involving invasive interventions. This is a factor that makes learning skills training difficult. Therefore, it is important for the student to be comfortable, self-confident, and mentally open to learning during skill training. New applications and different techniques for skill training are important in this sense. It is reported that aromatherapy application has positive effects on reducing anxiety and increasing concentration.
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RESEARCH HYPOTHESES:
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H0: Aromatherapy has no effect on students' anxiety and learning levels during skill training.
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H1: Aromatherapy reduces the anxiety experienced by students during skills training.
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H2: Aromatherapy has a positive effect on students' learning nursing skills. conditions: Nursing Students studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 69 type: ACTUAL name: Aromatherapy application measure: Difference between skill learning of students in the aromatherapy group and the control group measure: Difference between anxiety levels of students in the aromatherapy group and the control group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fenerbahce University city: Istanbul state: Atasehir zip: 34758 country: Turkey lat: 41.01384 lon: 28.94966 facility: Fenerbahce University city: Ataşehir state: Istanbul zip: 34758 country: Turkey lat: 40.9833 lon: 29.1167 hasResults: False
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<|newrecord|> nctId: NCT06381531 id: 4410 briefTitle: Tracing Brain Tumors Through Deep Time acronym: TRACE overallStatus: NOT_YET_RECRUITING date: 2024-06-10 date: 2027-06-10 date: 2027-06-10 date: 2024-04-24 date: 2024-04-24 name: Tata Memorial Centre class: OTHER name: Indian Statistical Institute, Kolkata briefSummary: Brain tumors involve different age groups with a wide range of tumor types involving different anatomical compartments of the brain. The evolution of the brain in vertebrates, including the most recent homo species (including humans), has occurred through increasing structural complexity in more evolved species. In the retrospective study, we will investigate the location of the tumors and different structural aspects of skull anatomy in patients with brain tumors. The information will be compared with the anatomical evolution of the brain and skull in vertebrates to look for possible associations, which can provide insights into evolutionary biology. conditions: Brain Tumor conditions: Oncology studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 10000 type: ESTIMATED name: Imaging with CT and MRI measure: Age-based density maps of brain tumor location measure: Anthropometric analysis of skulls sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Tata Memorial Hospital city: Mumbai state: Maharashtra zip: 400012 country: India name: Dr Archya Dasgupta, MD role: CONTACT lat: 19.07283 lon: 72.88261 hasResults: False
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<|newrecord|> nctId: NCT06381518 id: Z2023165 briefTitle: Switching From Intravenous to Subcutaneous Infliximab in Adult Patients With Inflammatory Bowel Disease acronym: SHUFFLE overallStatus: ENROLLING_BY_INVITATION date: 2024-03-12 date: 2025-05-01 date: 2025-05-01 date: 2024-04-24 date: 2024-04-24 name: Zuyderland Medisch Centrum class: OTHER briefSummary: The aim of this study is to evaluate the IFX exposure (AUC), effectiveness, presence of ADAbs and treatment burden before and after switching from IV to SC IFX maintenance treatment in a real-world cohort of IBD patients with quiescent disease on IFX monotherapy and combination therapy of IFX and an immunomodulator.
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Methods: this is a prospective, single centre, open-label cohort study, conducted in Zuyderland Medical Centre in which 36 adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 of which 18 patients use an immunomodulator in addition to IFX (cohort 2). After the switch to SC CT-P13, patients are followed for 24 weeks.
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The study is subdivided into two phases: the IV IFX treatment phase before switching and the SC CT-P13 treatment phase after the switch. After enrolment, the subject receives a final dose of IV IFX according to their own maintenance schedule. Primary endpoints are the Area under the concentration-time curve (AUC) at steady state (1) before and after the switch to SC CT-P13 and (2) with or without concomitant immunomodulator during SC therapy. AUCs will be estimated using pharmacokinetic modelling in MwPharm. Besides IFX trough level, treatment related time expenditure, quality-of-life and patient satisfaction will be assessed before and after the switch. conditions: IBD conditions: Infliximab conditions: Crohn Disease conditions: Ulcerative Colitis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: This is a prospective, single centre, open-label cohort study, conducted in Zuyderland Medical Centre in which adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 and is designed to compare the pharmacokinetics of SC CT-P13 to IV IFX and relate this to the pharmacodynamics. primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Switch to SC CT-P13. measure: Area under the curve (AUC) at steady state measure: Quality of life score measure: Patient satisfaction measure: Time expenditure sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zuyderland Medical Centre city: Sittard country: Netherlands lat: 50.99833 lon: 5.86944 hasResults: False
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<|newrecord|> nctId: NCT06381505 id: STUDY02002103 briefTitle: RetracTOR/ Retractor for Image Guided Trans-Oral Surgery overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-12-31 date: 2025-12-31 date: 2024-04-24 date: 2024-04-26 name: Ryan J. Halter class: OTHER name: Dartmouth College briefSummary: This study aims to demonstrate that a polymer retractor functions the same as a standard metal retractor used during endoscopy and throat surgery. The retractor is the device that holds the mouth open so the surgeon can easily access the mouth and throat. For example, this study aims to confirm that the mouth is held open the same amount with a polymer retractor as it is with a metal retractor. Benchtop experiments have demonstrated that the metal and polymer retractor's function the same, and thus this study will use this in patients. conditions: Oral Cavity Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: Comparing intraoperative surgical working volume (SWV) of a radiolucent retractor (custom device) as compared to SWV of standard-of-care metal retractors. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dartmouth-Hitchcock Medical Center city: Lebanon state: New Hampshire zip: 03756 country: United States name: Joseph Paydarfar, MD role: CONTACT phone: 603-650-8123 email: [email protected] lat: 43.64229 lon: -72.25176 hasResults: False
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<|newrecord|> nctId: NCT06381492 id: 2024-0057 id: A536130 type: OTHER domain: UW- Madison id: SMPH/ORTHO&REHAB/PHYS THER type: OTHER domain: UW- Madison id: Protocol Version 11/20/2023 type: OTHER domain: UW- Madison briefTitle: Quantifying Patellar Tendon Microstructure Using DTI overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-04-24 date: 2024-04-24 name: University of Wisconsin, Madison class: OTHER briefSummary: The goal of this observational study is to understand how diffusion tensor imaging (DTI) relates to other traditional measures and knee function. The main question it aims to answer is:
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Will regions of known patellar tendon pathology present with smaller DTI scalar parameters, shorter fiber length, and lower fiber density compared to the contralateral tendon and healthy regions in the ipsilateral tendon.
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Participants will:
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* undergo MRI and ultrasound imaging
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* perform knee function test
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* complete questionnaires conditions: Patellar Tendinopathy conditions: Anterior Cruciate Ligament Reconstruction studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: MRI name: Ultrasound (US) measure: Compare scalar parameters of known patellar tendon pathology to the contralateral tendon measure: Compare DTI scalar parameters of known patellar tendon pathology to the healthy regions in the ipsilateral tendon sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Wisconsin - Madison city: Madison state: Wisconsin zip: 53705 country: United States name: Maria Flory role: CONTACT phone: 608-262-8652 email: [email protected] lat: 43.07305 lon: -89.40123 hasResults: False
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<|newrecord|> nctId: NCT06381479 id: B031 briefTitle: Exploring the Effects of Probiotics on Workplace Related Stress Symptoms overallStatus: RECRUITING date: 2024-04-19 date: 2024-12-31 date: 2025-03-31 date: 2024-04-24 date: 2024-04-29 name: National Taiwan Sport University class: OTHER name: Bened Biomedical Co., Ltd. briefSummary: There is still a lack of research to explore the interaction between high-pressure workers and probiotics to improve the intestinal microbiota, sleep, inflammation and anti-oxidation. A total of 120 subjects are expected to be recruited and divided into two groups of 60 subjects, receiving probiotics or placebo, and completing a 8-week trial period. conditions: Stress conditions: Sleep Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: probiotics name: placebo measure: Cortisol measure: Perceived Stress Scale (PSS) measure: Job Stress Scale measure: Overwork Survey measure: Insomnia Severity index (ISI) measure: The State Trait Anxiety Inventory (STAI) measure: Depression Anxiety Stress Scales (DASS-42) measure: The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16 measure: VAS-GI measure: Patient Global Impression scales of Improvement rated by patient, PGI-C measure: Serotonin measure: GABA measure: Norepinephrine measure: Immunoglobulin A, IgA measure: adrenocorticotropic hormone, ACTH measure: Total Antioxidant Capacity , TAC sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Graduate Institute of Sports Science, National Taiwan Sport University status: RECRUITING city: Taoyuan zip: 33301 country: Taiwan name: Chi-Chang Huang, PI role: CONTACT phone: +88633283201 phoneExt: 2409 email: [email protected] lat: 24.95233 lon: 121.20193 hasResults: False
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<|newrecord|> nctId: NCT06381466 id: D7250C00001 briefTitle: A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral AZD0233 Compared With Placebo in Healthy Adult Participants. overallStatus: RECRUITING date: 2024-04-01 date: 2025-03-20 date: 2025-03-20 date: 2024-04-24 date: 2024-04-24 name: AstraZeneca class: INDUSTRY name: Parexel briefSummary: The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of AZD0233 following single and multiple ascending dose (SAD and MAD) administration in healthy participants. conditions: Dilated Cardiomyopathy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 96 type: ESTIMATED name: AZD0233 name: AZD0233 Placebo measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs) measure: Maximum observed plasma (peak) drug concentration (Cmax) of AZD0233 measure: Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) of AZD0233 measure: Area under the concentration-time curve in the dose interval (AUCtau) of AZD0233 measure: Area under plasma concentration time-curve from zero to infinity (AUCinf) of AZD0233 measure: Time to reach peak or maximum observed concentration or response following drug administration (tmax) of AZD0233 measure: Terminal elimination half-life (t1/2) of AZD0233 measure: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD0233 measure: Apparent volume of distribution at steady state following extravascular administration (Vz/F) of AZD0233 measure: Terminal rate constant (λz) of AZD0233 measure: Accumulation ratio for Cmax (Rac Cmax) of AZD0233 measure: Accumulation ratio for AUC (Rac AUC) of AZD0233 measure: Renal clearance (CLR) of AZD0233 measure: Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)] of AZD0233 measure: Cumulative amount of unchanged drug excreted into urine (Aeinf) of AZD0233 measure: Percentage of dose excreted unchanged in urine from time t1 to t2 [Fe(t1-t2)] of AZD0233 sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Research Site status: RECRUITING city: Glendale state: California zip: 91206 country: United States lat: 34.14251 lon: -118.25508 hasResults: False
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<|newrecord|> nctId: NCT06381453 id: 23-5037 briefTitle: Belimumab in Autoimmune Hepatitis acronym: BELief overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2028-04-30 date: 2029-04-30 date: 2024-04-24 date: 2024-04-24 name: University Health Network, Toronto class: OTHER name: GlaxoSmithKline briefSummary: Background: Autoimmune hepatitis (AIH) is a rare chronic and lifelong liver disease. Untreated, disease progresses to end-stage cirrhosis and the focus of therapy is with immunosuppression. Current therapies are limited, not targeted, and associated with side effects that patients report reduce quality of life. AIH is believed to arise as a consequence of genetic \& environmental risks. Disease is characterised by impaired immunoregulation, that favours a chronic and relapsing hepatitis. As well as recognising an important role for cytotoxic T cells and regulatory T cells, it has become apparent that in AIH, as well as other related autoimmune conditions, that B-cells are important. AIH is characterised by a plasma cell rich interface hepatitis and elevated IgG concentrations. Furthermore B-cell lineages interact with regulatory T-cells. Off-label use of Rituximab, an anti-CD20 agent, has been described for patients with AIH. A number of other ways of effectively targeting B-cells in the treatment of related autoimmune diseases have also been developed, but there have been limited studies in people living with autoimmune hepatitis. Belimumab is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), also known as B-lymphocyte stimulator. It is approved in the Canada to treat systemic lupus erythematosus and lupus nephritis. It has not been studied before in AIH, but off-label reports are published. In an open-label clinical trial of people living with autoimmune hepatitis, the investigator will now formally study the effect of adding Belimumab to existing standard of care, with the goal being to evaluate treatment efficacy, the ability to reduce the burden of existing therapies whilst still controlling AIH disease, and to describe the tolerability \& safety of Belimumab in people with AIH. Study Design: Open label, multi-centre, Canadian clinical trial. Patient population: Patients with autoimmune hepatitis, excluding patients with decompensated liver disease, who either have active disease despite standard of care (Group A), or who are maintained with disease remission using standard of care therapy (Group B). 48 patients will be recruited. Intervention: Weekly sub-cutaneous Belimumab. Duration: 72 weeks with interim analysis after 24 patients have been treated for 24 weeks; target recruitment 48 patients. Evaluation: Safety, Serum liver tests, quality of life, exploratory immunologic biomarkers, optional liver biopsy or fine needle liver aspirate. Primary end-point: Group A: 50% or more of subjects have an ALT\<2x ULN \& corticosteroids at a dose of \</= 5mg of Prednisone (or equivalent); Group B: 50% or more of subjects able to maintain remission (normal ALT, normal IgG) on monotherapy with Belimumab. Conclusion: Using a combination of makers of treatment efficacy and safety the investigator will test the hypothesis that Belimumab should be further formally evaluated for people living with AIH. conditions: Autoimmune Hepatitis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Belimumab Auto-Injector [Benlysta] measure: To investigate the effect of treatment with Belimumab on AIH disease activity and corticosteroid use in the management of AIH measure: To investigate the effects of treatment with Belimumab on AIH disease activity and treatment burden measure: To measure the effects of treatment with Belimumab on AIH disease activity and treatment burden measure: To see the effects of treatment with Belimumab on AIH disease activity and treatment burden measure: To measure the effects of Belimumab on markers of AIH disease activity measure: To evaluate the effects of Belimumab on markers of AIH disease activity measure: To outline the effects of Belimumab on Patient Reported Outcomes (PRO) measure: To assess the effects of Belimumab on Patient Reported Outcomes (PRO) measure: To measure the effects of Belimumab on Patient Reported Outcomes (PRO) measure: To evaluate the safety of Belimumab in patients with autoimmune hepatitis measure: To assess the safety of Belimumab in patients with autoimmune hepatitis measure: Safety and Tolerability measure: To report the safety of Belimumab in patients with autoimmune hepatitis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06381440 id: PROGR-EX_MNESYS briefTitle: Traditional Versus Progressive Robot-assisted Gait Training in People With Multiple Sclerosis and Severe Gait Disability acronym: PROGR-EX overallStatus: RECRUITING date: 2023-11-15 date: 2024-11-30 date: 2024-11-30 date: 2024-04-24 date: 2024-04-24 name: University Hospital of Ferrara class: OTHER name: Universita di Verona name: Università degli Studi di Ferrara briefSummary: Multiple sclerosis (MS) is a demyelinating neurodegenerative disease. Qualitative alterations in walking function in MS people involve 75% of subjects with MS and are determined by reduced coordination, mobility, balance, and increased risk of falling. Robot assisted gait training (RAGT) devices seem effective in MS patients with severe motor disabilities, failing to show significant superiority when compared to intensive overground gait rehabilitation (OGT). This study aims to evaluate the effects of a low-intensity RAGT at progressively increasing intensity compared to conventional RAGT and OGT. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Control Trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Lokomat device (Hocoma AG, Volketswil, Switzerland). name: Conventional walking training measure: Walking function measure: Mobility measure: Walking endurance measure: Balance measure: Spasticity measure: Perceived quality of life measure: Perceived walking ability measure: Fatigue measure: Anxiety measure: Depression measure: Kinesiophobia measure: Adaptation to medical condition measure: Coping strategies measure: Muscle oxygen consumption measure: Hemodynamic cortical activation measure: Electrical brain activity measure: miRNA expression measure: Acceptability of robot intervention sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Neuroscience and Rehabilitation, University Hospital of Ferrara status: RECRUITING city: Ferrara state: Emilia Romagna zip: 44124 country: Italy name: Sofia Straudi, MD, PhD role: CONTACT phone: 0532236185 email: [email protected] name: Sofia Straudi, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Fabio Manfredini, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Nicola Lamberti, PhD role: SUB_INVESTIGATOR name: Andrea Baroni, PhD role: SUB_INVESTIGATOR name: Giulia Fregna, MSc role: SUB_INVESTIGATOR name: Michela Rimondini, PhD role: SUB_INVESTIGATOR name: Marialuisa Gandolfi, MD, PhD role: SUB_INVESTIGATOR name: Luigi Zerbinati, MD role: SUB_INVESTIGATOR lat: 44.83804 lon: 11.62057 hasResults: False
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<|newrecord|> nctId: NCT06381427 id: 01NVF22109 briefTitle: Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure acronym: PeriOP-CARE HF overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-08-31 date: 2027-03-01 date: 2024-04-24 date: 2024-04-24 name: University of Giessen class: OTHER name: Deutsche Luft und Raumfahrt briefSummary: Chronic heart failure affects up to three million people in Germany, with prevalence increasing with age. It is a leading cause of cardiovascular disease-related deaths. Patients with heart failure undergoing non-cardiac surgery face higher risks of complications and death compared to those with coronary artery disease. Despite guidelines recommending comprehensive preoperative evaluation, there is no systematic risk assessment structure in place, leading to inadequate perioperative care. This study aims to evaluate a multidisciplinary approach for high-risk patients aged 65 and above, regardless of prior heart failure diagnosis, to mitigate postoperative complications. The investigators measure the NTpro BNP before surgery and include patients with NTproBNP\> 450 in this study and randomize them either to the standard care group or the intervention group.The hypothesis is that standardized risk screening and multidimensional care (Intervention group) can reduce complications in these patients undergoing non-cardiac surgery. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1057 type: ESTIMATED name: Interdisciplinary decision-making for perioperative care measure: combined primary endpoint at 90 days post-operation : re-hospitalization,AKI, bacterial infection and cardiac decompensation measure: Incidence of acute kidney injury measure: Incidence of any, treatable, suspected, or confirmed bacterial infection measure: Incidence of cardiac decompensation measure: Incidence of re-hospitalization measure: Mortality measure: Incidence of myocardial infarction (STEMI, NSTEMI) measure: Incidence of Myocardial Injury after Non-Cardiac Surgery (MINS) measure: Quality of life assessed using PHQ-9 measure: Quality of life assessed using GAD-7 measure: Utilization of services and costs sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Justus Liebig University Giessen, University Hospital Giessen and Marburg city: Gießen zip: 35390 country: Germany name: Michael Sander, PhD role: CONTACT phone: +4964198544401 name: Birgit Aßmus, PHD role: CONTACT lat: 50.58727 lon: 8.67554 hasResults: False
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<|newrecord|> nctId: NCT06381414 id: ChildhoodEarlyOralAging briefTitle: Childhood Early Oral Aging Syndrome: Prevalence, Etiological Factors, and Consequences on Occlusion overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-31 date: 2024-12-20 date: 2024-04-24 date: 2024-04-24 name: University of Nove de Julho class: OTHER briefSummary: The Early Oral Aging Syndrome (EOAS) is a broad concept concerning changes in oral health caused by systemic diseases of different origins, which are related to the current lifestyle in the pediatric population. Enamel defects associated with intrinsic and extrinsic factors promote the acceleration of dental structure loss in an early manner, causing impairment of function, aesthetics, and quality of life. In this context, this study aims to identify the prevalence of early childhood tooth wear and its severity using the Early Childhood Oral Aging Syndrome (EOAS) index as a diagnostic and epidemiological survey instrument, considering current alterations found in the pediatric population and verifying possible factors associated with each severity level. Participants aged 3 to 6 years old, enrolled in the pediatric dentistry clinic of the University Nove de Julho, will be selected. Children with imperfect amelogenesis and dentinogenesis, genetic syndromes, and undergoing orthodontic treatment will be excluded from the research. A questionnaire on general health, sleep quality, nutrition, hygiene habits, and parafunctional habits will be administered. Subsequently, a clinical examination will be conducted using the new Early Childhood Oral Aging Syndrome (EOAS) index with scores ranging from 0 to 3 to assess dental wear and dental management, and scores I to III that should be used concomitantly in cases of enamel defects presence, in addition to measuring the Vertical Dimension of Occlusion (VDO). EOAS scores will be computed and statistically analyzed for deciduous dentition with a significance level of P\<0.05. conditions: Aging studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 183 type: ESTIMATED name: Observation measure: Assessment of Tooth Wear and Dental Management measure: Presence of Enamel Defects measure: Vertical Dimension of Occlusion sex: ALL minimumAge: 3 Years maximumAge: 6 Years stdAges: CHILD facility: Nove de Julho University city: São Paulo state: SP zip: 03155-000 country: Brazil lat: -23.5475 lon: -46.63611 hasResults: False
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<|newrecord|> nctId: NCT06381401 id: MS-492-2023 briefTitle: Bupivacaine 0.125% Versus Bupivacaine 0.25% in Superficial Cervical Plexus Block on Operative Field Visibility for Adults Undergoing Tympanomastoid Surgeries overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-06-28 date: 2024-07-05 date: 2024-04-24 date: 2024-04-24 name: Cairo University class: OTHER briefSummary: Bleeding is one of the most common complications in tympanomastoid surgery that could prolong the time of operation and also might lead to morbidity. Pain is also one of the most annoying complications of tympanomastoid surgeries. Thus, adequate surgical field visualization is utmost important. A bloodless field allows optimal exposure and identification of vital neurovascular structures. Even small bleeding, inconsequential for the patient's volume status, can create great technical difficulty in the confined space of the tympan, leading to prolonged surgery, incomplete procedures, and increased complications.
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To decrease bleeding, different interventions have been proposed, including reverse Trendelenburg position, the application of topical vasoconstrictors, regional anesthesia, laryngeal mask airways, different ventilation strategies, and - most importantly - controlled systemic hypotension, with target mean arterial pressures (MAP) generally between 60 and 70 mmHg. However, induced hypotension can lead to cerebral, renal and mesenteric hypoperfusion, organ damage, and other serious complications.
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The use of regional nerve blocks as an alternative to hypotensive anesthesia has gained popularity in recent years. The superficial cervical plexus block (SCPB) provides effective analgesia and reduces sympathetic activity, resulting in reduced bleeding and improved surgical conditions. The superficial cervical plexus (SCP) provides sensory innervation to the ear and surrounding structures, reducing pain perception during and after surgery.
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To our knowledge, this is the first randomized controlled clinical trial investigating the effect of combined general anesthesia with SCPB using 0.125% versus 0.25% bupivacaine during tympanomastoid surgery.
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This study aims to compare the efficacy of two different concentrations of bupivacaine 0.125% \& 0.25% in Superficial Cervical Plexus Block in patients undergoing tympanomastoid surgery on operative field visualization, intraoperative hemodynamic stability, and postoperative analgesia.
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We hypothesize that bupivacaine 0.125% would be non-inferior to bupivacaine 0.25% in achieving optimal surgical field visualization, hemodynamic stability, surgeon satisfaction and postoperative analgesia.
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This prospective randomized controlled double-blinded study will be carried out on 60 patients between 21 to 70 years, with ASA I-II and undergoing tympanomastoid surgery. They were equally divided into two groups: Group A: Patients received SCPB using 0.25% bupivacaine (5ml of bupivacaine 0.5% + 5ml normal saline). Group B: Patients received SCPB using 0.125% bupivacaine (2.5ml of bupivacaine 0.5% + 7.5ml normal saline). conditions: Surgical Field Visualization, Acute Postoperative Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: bupivacaine 0.25% name: bupivacaine 0.125% measure: The total consumption of IV glyceryl trinitrate (GTN) measure: Fentanyl consumption measure: Postoperative pain measure: Postoperative hospital stay sex: ALL minimumAge: 21 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06381388 id: NL86587.041.24 briefTitle: Interaction Between the Brain Hemispheres - Key to Motor Recovery After Stroke acronym: InterAct overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-12-31 date: 2028-06-30 date: 2024-04-24 date: 2024-04-24 name: Jord Vink class: OTHER briefSummary: Rationale: Acute stroke leaves many patients with functional deficits, of which upper extremity motor impairment is one of the most disabling. Evidence from imaging and electrophysiological studies converge on the idea that impaired motor function after stroke is associated with disrupted network activity in the brain. Non-invasive brain stimulation methods, like transcranial magnetic stimulation (TMS), can be used to restore disrupted network activity and have been shown to successfully facilitate recovery of motor function in patients with stroke. Application of continuous theta burst stimulation (cTBS), an inhibitory form of TMS, to the contralesional motor cortex has been shown to improve the recovery of motor function in patients with stroke. However, responsiveness to this treatment varies considerably between stroke patients and the mechanisms through which contralesional cTBS facilitates recovery of motor function remain unclear.
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Objective: To determine if contralesional cTBS normalizes interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex stroke patients with motor impairments. Age-matched healthy persons will serve as controls.
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Study design: A prospective, open-label within-subject intervention study
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Study population: 40 patients with first-ever ischemic stroke in one hemisphere and a unilateral paresis of the upper extremity, and 40 age-matched controls.
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Main endpoints: Primary endpoint: Interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex. Secondary endpoints: contralesional intracortical inhibition; effect of contralesional TMS interference on finger tapping frequency. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: cTBS measure: Interhemispheric inhibition (IHI) measure: Ipsilesional resting motor threshold (RMT) measure: Contralesional resting motor threshold (RMT) measure: TMS interference measure: Intracortical inhibition (ICI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: De Hoogstraat Revalidatie city: Utrecht country: Netherlands name: Anne Visser-Meily, MD, PhD role: CONTACT lat: 52.09083 lon: 5.12222 hasResults: False
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<|newrecord|> nctId: NCT06381375 id: 24-2-2024 briefTitle: Drug-drug Interactions With Anti-tuberculous Drugs overallStatus: RECRUITING date: 2024-04-30 date: 2024-12-01 date: 2025-02-15 date: 2024-04-24 date: 2024-04-24 name: Cairo University class: OTHER briefSummary: This study aims to assess the prevalence and the outcome of prescribing drugs known to have major drug-drug interactions with anti-tuberculous drugs among Kasr Alainy tuberculous patients. conditions: Drug-drug Interaction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Anti Tuberculosis Drug measure: Estimate the prevalence of prescribing drugs known to have major drug-drug interaction(s) with anti-tuberculous drugs among Kasr Alainy tuberculous patients measure: 2. Assess the outcome of prescribing drugs known to have major drug-drug interaction(s) with anti-tuberculous drugs among Kasr Alainy tuberculous patients (response to treatment and the prevalence of life-threatening events). sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Omnia Azmy Nabeh status: RECRUITING city: Cairo zip: 11562 country: Egypt name: Omnia Azmy Nabeh, MD role: CONTACT phone: 01066969673 email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06381362 id: IGOMIPS briefTitle: Italian Registry of Minimally Invasive Pancreatic Surgery acronym: IGOMIPS overallStatus: RECRUITING date: 2019-02-28 date: 2029-02-28 date: 2029-02-28 date: 2024-04-24 date: 2024-04-24 name: Associazione Italiana per lo Studio del Pancreas class: OTHER briefSummary: Assess the prevalence of minimally invasive pancreatic surgery in the country and its outcomes conditions: Pancreatic Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2300 type: ESTIMATED name: Minimally invasive pancreatic surgery measure: Postoperative short-term outcomes measure: Long-term oncological outcomes measure: Rate of cases that after a minimally invasive approach had to be converted to and open approach measure: Surgeon learning curve measure: Surgeon learning curve measure: Surgeon learning curve measure: Surgeon learning curve sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Giovanni Capretti status: RECRUITING city: Milan country: Italy name: Giovanni Capretti, Dr. role: CONTACT phone: +390282247646 email: [email protected] name: Alessandro Zerbi, Prof. role: PRINCIPAL_INVESTIGATOR name: Giovanni Capretti, Dr. role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06381349 id: GPOEM-GEMS briefTitle: Predicting Outcomes of GPOEM Using Gastric Electrical Mapping acronym: GPOEM-GEMS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-06-01 date: 2024-04-24 date: 2024-04-24 name: Chris Varghese class: OTHER briefSummary: Gastric peroral endoscopic myotomy (GPOEM) is a minimally-invasive procedure that involves dividing the pylorus, to enhance gastric emptying in gastroparesis patients. This is a single-arm, multi-centre, prospective observational study to determine the clinical utility of Gastric Alimetry in predicting GPOEM treatment outcomes. The investigators further aim to develop a clinical decision rule to inform patient selection. Gastric Alimetry will be conducted \<1 month prior to GPOEM. All subjects will then be followed up for 12 months. conditions: Gastroparesis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Gastric Alimetry test measure: Gastroparesis Cardinal Symptom Index (GCSI) measure: Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QoL) measure: EQ-5D scores measure: Patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) measure: Patient Health Questionnaire - 8 (PHQ-8) measure: Generalized Anxiety Disorder 7-item (GAD-7) measure: Perceived Stress Scale 4 (PSS-4) measure: Brief Illness Perception Questionnaire-Revised measure: Alimetry® Gut-Brain Wellbeing (AGBW) measure: Work Productivity and Activity Impairment (WPAI) measure: Change in Gastric Alimetry Phenotype sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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