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<|newrecord|> nctId: NCT06262919 id: CDRB436I1401 briefTitle: Special Drug Use-results Surveillance of Tafinlar/Mekinist overallStatus: RECRUITING date: 2024-02-09 date: 2031-12-31 date: 2031-12-31 date: 2024-02-16 date: 2024-03-22 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: This is a prospective, multicenter, single-arm, non-interventional and observational J-PMS conducted by the central registration system and operated in Electronic data capture. conditions: BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: Tafinlar/Mekinist measure: [Pediatric patients] Number of patients and incidence of adverse events/adverse reactions with respect to skeletal and sexual maturation measure: [Adult patients] overall response rate (ORR) measure: [Pediatric patients] Incidence proportion of ORR measure: [Pediatric and adult patients] Incidence proportion of PFS measure: [Pediatric patients] Number of patients with changes in height and body weight and sexual maturation sex: ALL minimumAge: 6 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Novartis Investigative Site status: RECRUITING city: Kobe state: Hyogo zip: 650-0011 country: Japan lat: 34.6913 lon: 135.183 facility: Novartis Investigative Site status: RECRUITING city: Akita zip: 010-8543 country: Japan lat: 39.71667 lon: 140.10826 facility: Novartis Investigative Site status: RECRUITING city: Osaka zip: 534-0021 country: Japan lat: 34.69374 lon: 135.50218 facility: Novartis Investigative Site status: RECRUITING city: Osaka zip: 550-0015 country: Japan lat: 34.69374 lon: 135.50218 hasResults: False
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<|newrecord|> nctId: NCT06262906 id: BA-VCAP-01 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-02-16 date: 2024-04-25 name: [Redacted] hasResults: False
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<|newrecord|> nctId: NCT06262893 id: Shoulder nerve blocks briefTitle: Effect of Dexamethasone Adjuvant in Combined Supraclavicular Block and Suprascapular Block Versus Interscalene Block in Patients Undergoing Shoulder Arthroscopy overallStatus: NOT_YET_RECRUITING date: 2024-02-25 date: 2025-12 date: 2026-01 date: 2024-02-16 date: 2024-02-16 name: Assiut University class: OTHER briefSummary: In this study the investigators aim to compare the effect of the suprascapular- supraclavicular nerve block in association with dexamethasone to that of the interscalene brachial plexus block on analgesic effect during arthroscopic shoulder surgery, as postoperative pain scores ,postoperative consumption of analgesic rescue medications and diaphragmatic excursion assessment. conditions: Shoulder Arthroscopy Blocks conditions: Dexamethasone studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Shoulder arthroscopy blocks measure: Postoperative analgesia by visual analog scale (VAS). measure: Diaphragmatic excursion sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Assiut University city: Assiut country: Egypt name: Assiut University role: CONTACT lat: 27.18096 lon: 31.18368 hasResults: False
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<|newrecord|> nctId: NCT06262880 id: BIO-2305 briefTitle: Dietary Supplementation on Gastrointestinal Barrier Function overallStatus: RECRUITING date: 2024-02-06 date: 2024-12-20 date: 2025-02-06 date: 2024-02-16 date: 2024-03-08 name: Brightseed class: INDUSTRY briefSummary: The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels on parameters of gastrointestinal (GI) health in otherwise generally healthy adults with risk factors (high BMI and waist circumference) for increased GI permeability. The primary hypothesis is that supplementation with plant derived phenolics will improve gut health compared to placebo. conditions: Intestinal Permeability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 126 type: ESTIMATED name: plant derived phenolics name: Microcrystaline cellulose (MCC) measure: 0-2 h urine 13C Mannitol excretion measure: 2 to 8 h urine 13C Mannitol measure: 0 to 2 h urine LMR measure: 2 to 8 h urine LMR measure: Blood Biomarkers measure: Blood Biomarkers measure: Blood Biomarkers measure: Fecal Biomarkers measure: Fecal Biomarkers measure: Inflammatory Biomarkers (Blood) measure: Inflammatory Biomarkers (Blood) measure: Inflammatory Biomarkers (Blood) measure: Inflammatory Biomarkers (Blood) measure: 7-day recall of gastrointestinal symptoms measure: 7-day recall of gastrointestinal symptoms measure: Stool frequency measure: Stool consistency measure: Body Weight sex: ALL minimumAge: 30 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Biofortis status: RECRUITING city: Addison state: Illinois zip: 60101 country: United States name: Chad Cook role: CONTACT lat: 41.9317 lon: -87.98896 hasResults: False
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<|newrecord|> nctId: NCT06262867 id: ReadySetFood briefTitle: Early Allergen System Experience acronym: EASE overallStatus: NOT_YET_RECRUITING date: 2024-03-07 date: 2026-09-01 date: 2026-09-01 date: 2024-02-16 date: 2024-02-20 name: Prollergy dba Ready Set Food class: OTHER name: ObvioHealth briefSummary: Multiple clinical trials have demonstrated that early allergen introduction, feeding babies common food allergens before six months, decreases children's risk of developing a food allergy. Despite successful food allergy introduction trials showing that food allergies can be prevented, early introduction in the required amount can be challenging for parents. In some studies, less than 20% of parents introduce peanuts before their child is six months old, and few feed them regularly after introduction. Ready. Set. Food! is a direct-to-consumer product that offers a convenient supplement with a daily dose regimen that can be added to breastmilk, formula, or food to make early allergen introduction easy. The formulation includes cow's milk, egg, and peanut, representing the majority of childhood food allergies, and the protein levels are based on doses found to be effective in clinical trials. Over 200,000 infants have used Ready. Set. Food!.
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This study investigates the effectiveness of introducing common allergens to infants with the goal of preventing food allergies. The study will enroll 1,100 infants stratified by their risk of developing a food allergy who are assigned to either receive Ready. Set. Food! supplements or follow standard allergen introduction practices recommended by their pediatrician.
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The goal of this study is to assess how Ready. Set. Food! allergen introduction supplements improve the experience of parents introducing allergens, decrease healthcare costs related to food allergies, and decrease food allergy prevalence. conditions: Food Allergy in Infants studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1110 type: ESTIMATED name: Ready. Set. Food! Stage 1 Mix ins measure: The proportion of caregivers who are adherent with the evidence-based guidance for cow's milk, egg, and peanut during the 6 - month period measure: Frequency of caregiver-reported allergy or food introduction-related adverse events (AEs) after introduction of cow's milk, egg, and peanut measure: Frequency of caregiver-reported serious adverse events (SAEs) after introduction of cow's milk, egg, and peanut measure: Frequency of caregiver-reported special interest adverse events (FPIES and anaphylaxis) after introduction to cow's milk, egg, and peanut by 12 months of age measure: The proportion of caregivers who are satisfied with introduction of egg, cow's milk, and peanut measure: The total allergy-related healthcare costs measure: The proportion of participants with food allergy to cow's milk, egg, or peanut measure: The proportion of participants with a suspected food allergy sex: ALL minimumAge: 2 Months maximumAge: 5 Months stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06262854 id: AOU Careggi Firenze briefTitle: Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study acronym: BIG D-FOOT overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-05-31 date: 2024-02-16 date: 2024-02-16 name: Azienda Ospedaliero-Universitaria Careggi class: OTHER briefSummary: This study is designed as a double-blind, placebo-controlled, parallel series randomized trial aimed at verifying the effiicacy and safety of a local calcium-sulphate bio-absorbable antibiotic delivery (tobramicina+vancomicina) versus placebo (calcium-sulphate matrix without antibiotics) in patients with diabetic foot osteomyelitis treated with surgical procedures. conditions: Diabete Mellitus conditions: Foot Ulcer conditions: Osteomyelitis - Foot conditions: Surgical Procedure, Unspecified studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Granules of calcium sulphate with and without antibiotics are identical and undistinguishable. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Calcium-sulphate granules with tobramicina+vancomicina measure: The composite primary endpoint of this study will be the incidence osteomyelitis recurrence or new osteomyelitis in adjacent sites or tissue infection at the site of osteomyelitis. measure: Proportion of healed patients measure: Proportion of osteomyelitis recurrence measure: Proportion of post-surgical tissue infection measure: Proportion of wound recurrence measure: Proportion of patients undergoing major amputation measure: Proportion of patients undergoing new surgical intervention measure: Ulcer time-to-healing measure: Osteomyelitis time-to-recurrence measure: Any serious adverse events measure: Any non serious adverse events measure: Proportion of post-surgical dehiscence measure: Direct medical costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06262841 id: Murat Kaan Erdem briefTitle: Post-Surgical Morbidity and Bone Healing of Impacted Lower Third Molars: Piezosurgery vs. Conventional Instruments overallStatus: COMPLETED date: 2022-11-01 date: 2023-04-01 date: 2023-04-01 date: 2024-02-16 date: 2024-02-16 name: Ankara University class: OTHER briefSummary: The aim of this study is to compare piezosurgery and conventional surgery in impacted third molar surgery and to determine its effect on postoperative outcomes and quality of life. conditions: Impacted Third Molar Tooth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 21 type: ACTUAL name: Piezosurgery name: Conventional burs measure: Change in Oral Health-related Quality of Life measure: Change in pain measure: Change in Mouth opening measure: Operation time measure: Change in facial swelling sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Ankara University Faculty of Dentistry city: Ankara state: Çankaya zip: 06510 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06262828 id: UW 24-064 briefTitle: HEARTWISE - P-CARDIAC for Chinese: Population-based Study acronym: HEARTWISE overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-01-31 date: 2027-04-30 date: 2024-02-16 date: 2024-02-16 name: The University of Hong Kong class: OTHER briefSummary: Cardiovascular disease (CVD) is one of the prominent diseases that affect many people. One cost-effective solution is to identify people at higher risk of CVD by CVD risk prediction model. China-PAR, TRS-2P, and SMART2 are common risk prediction models for prevention. However, these risk scores were mostly based on the routinely self-check health information and multivariable regression without time-varying consideration. Investigators developed a Machine Learning (ML) based risk prediction model, Personalized CARdiovascular DIsease risk Assessment for Chinese (P-CARDIAC) among a predominantly Chinese population in Hong Kong to estimates the 10 years of secondary recurrent CVD risk for the high-risk individuals. The study objective is to evaluate the accuracy of the P-CARDIAC performance in practice among a large-scale Hong Kong population in medicine specialist outpatient clinic (SOPC) and cardiac clinic. The results will reassure cardiologists that the P-CARDIAC risk score is sensitive to the heart disease symptoms. Investigators anticipate that the results may help to facilitate P-CARDIAC in clinical setting and provide more practical information with the development of P-CARDIAC. conditions: Cardiovascular Diseases conditions: CVD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED measure: The relationship between P-CARDIAC risk score and heart disease related symptoms measure: P-CARDIAC risk thresholds determination sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: School of Nursing, The University of Hong Kong city: Hong Kong country: Hong Kong name: Sze Ling Celine Chui, PhD role: CONTACT phone: (852) 3917 6629 email: [email protected] lat: 22.27832 lon: 114.17469 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-10-31 uploadDate: 2024-01-31T01:00 filename: Prot_SAP_000.pdf size: 294821 hasResults: False
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<|newrecord|> nctId: NCT06262815 id: 2023-06806-01 briefTitle: The Utility of Treatment With Nasogastric Tube Placement for Small Bowel Obstruction acronym: NGTUBE-OBS overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-02-16 name: Daniel Wilhelms class: OTHER name: Linkoeping University briefSummary: Small bowel obstruction (SBO) occurs when the normal movements of the small bowel is obstructed, most commonly due to adhesion related to previous abdominal surgery. This may cause strangulation of the small bowel with reduced blood flow which is a surgical emergency requiring prompt treatment in the operating room. If there are no signs of strangulation or ischemia of the bowel at the time of diagnosis, international guidelines recommend initial treatment with intravenous fluids and nasogastric tube placement. However, there is emerging debate regarding non-selective treatment with nasogastric tube placement in patients with SBO. This management started around 1930 as a means to reduce pain in patients with SBO, in conjunction with other additions to management, like intravenous fluids. However the effect and utility of routine nasogastric tube placement have not been prospectively evaluated. There are a total of three retrospective observational studies in the past decade with a total of 759 patients where 292 (36%) were managed without a nasogastric tube. There was no difference in the rates of conservative treatment failure (requiring surgery), complications (vomiting, pneumonia) or mortality between patients receiving a nasogastric tube and those who didn't. However, the retrospective design of these studies limits their validity. Furthermore, nasogastric tube placement has been shown to be one of the more painful interventions patients may experience in-hospital. This calls into question the patient benefit of routine nasogastric tube placement in patients with SBO and further studies are needed to discern the utility of this intervention.
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Definitive treatment for SBO is surgical adhesiolysis but there is debate regarding the timing of surgery, particularly in older adults. A large proportion of patients may be managed conservatively with oral contrast and repeated radiological evaluation and the obstruction will resolve in many patients within 24 to 48 hours. This timeframe is dependent on factors related to the disease itself as well as patient related factors like previous surgery and comorbidities. Older patients are at high risk for complications but current available data is insufficient to inform practice in this population. Frailty, a state of increased vulnerability and susceptibility to adverse events, has been shown to be an independent prognosticator in older adults in the Emergency Department(ED) and suggested as a potential measure to risk stratify older adults with SBO. However to the authors knowledge there is no available data on frailty in older adults with SBO and only one prospective observational trial looking at older adults with SBO. Despite SBO being one of the most common surgical emergencies in older adults.
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To investigate the potential benefit of nasogastric tube placement in patients with SBO and the ability of frailty to prognosticate outcomes in older adults better evidence is needed. conditions: Small Bowel Obstruction conditions: Frailty conditions: Nasogastric Tube studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Nasogastric tube placement name: Clinical Frailty Scale measure: Pain at Emergency Department discharge measure: Nausea at Emergency Department discharge measure: Hospital Length of Stay measure: Mortality measure: Admission for Small bowel obstruction measure: Emergency Surgery measure: Emergency Department Length of Stay sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sahlgrenska Universitetssjukhuset status: RECRUITING city: Göteborg country: Sweden name: Nina Bardhi, MD role: CONTACT lat: 57.70716 lon: 11.96679 facility: Östra sjukhuset status: RECRUITING city: Göteborg country: Sweden name: Mathias Jerkfelt, MD role: CONTACT lat: 57.70716 lon: 11.96679 facility: Skånes Universitetssjukhus status: ACTIVE_NOT_RECRUITING city: Lund country: Sweden lat: 55.70584 lon: 13.19321 facility: Skånes Universitetssjukhus status: ACTIVE_NOT_RECRUITING city: Malmö country: Sweden lat: 55.60587 lon: 13.00073 facility: Lasarett i Motala status: RECRUITING city: Motala country: Sweden name: Jens Wretborn, PhD role: CONTACT phone: +46101033000 email: [email protected] lat: 58.53706 lon: 15.03649 facility: Vrinnevisjukhuset status: RECRUITING city: Norrköping country: Sweden name: Sigrid Wallden, MD role: CONTACT lat: 58.59419 lon: 16.1826 facility: Sundsvalls sjukhus status: RECRUITING city: Sundsvall country: Sweden name: Robert Schytzer, MD role: CONTACT lat: 62.39129 lon: 17.3063 facility: Akutmottagningen US Östergötland status: RECRUITING city: Linköping state: Östergötland zip: 58185 country: Sweden name: Jens Wretborn, PhD role: CONTACT phone: +46101033000 email: [email protected] name: Alaa Hussein, MD role: CONTACT phone: +46101033000 email: [email protected] lat: 58.41086 lon: 15.62157 hasResults: False
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<|newrecord|> nctId: NCT06262802 id: 123123 briefTitle: Volumetric Changes in Large Cystic Lesions Using Active Decompression and Distraction Sugosteogenesis vs Passive Decompression overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-09-01 date: 2025-03-01 date: 2024-02-16 date: 2024-02-16 name: Radwa Hydar Ragab class: OTHER briefSummary: Null hypothesis active decompression and distraction sugosteogenesis is not faster than passive decompression in volume reduction of large cystic lesions conditions: Odontogenic Cysts studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DEVICE_FEASIBILITY masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 10 type: ESTIMATED name: Active decompression measure: Volume change sex: ALL minimumAge: 12 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06262789 id: 49RC23_0011 briefTitle: RAT-HEMATO : Return to Work After Malignant Hemopathy acronym: RAT-HEMATO overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2027-04-01 date: 2027-04-01 date: 2024-02-16 date: 2024-02-16 name: University Hospital, Angers class: OTHER_GOV briefSummary: Return to work (RTW) of patients after cancer treatment has been a topic of growing interest for the past two decades. Advances in cancer care have led to better patient survival, with some cancers considered as chronic or even cured diseases. The return of patients to their "pre-cancer life" can thus become an objective. Indeed, RTW after cancer is associated with improved quality of life for patients in several studies (improved financial status, improved social contacts, return of functional abilities and improved self-esteem). However, many difficulties can interfere with RTW. Many factors have been identified: disease, treatment, patient and occupational factors. The feeling of "return-to-work self-efficacy" is one of the main psychological determinants and its interest has been recently demonstrated in oncology. It corresponds to a cognitive mechanism based on expectations and/or beliefs of an individual about being able to carry out the actions required to achieve a goal, in this case RTW. The majority of studies on RTW concerns solid cancer and are retrospective. Very few studies have focused on hematological malignancies, whose prognosis was, until recently, worse. Moreover, very few interventional studies exist. There is therefore a significant need for prospective studies with appropriate methodological tools to reliably assess the benefit of interventional measures on RTW. The investigators propose to conduct a prospective, comparative, randomized, multicenter study evaluating the impact of an early RTW-consultation in patients who have been treated for a hematological malignancy. The investigators hypothesize that this consultation will improve patients' RTW rates and RTW quality. conditions: Leukemia conditions: Lymphoma conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 264 type: ESTIMATED name: "Return-to-work after cancer" consultation measure: Return-to-work rate at 1 year (percentage) measure: Cumulative incidence of return-to-work at 1 year measure: Change or not of the professional situation in the 2 arms measure: Factors influencing return to work measure: Quality of life (SF-12 score) evolution measure: Anxiety and depression (HAD scale) evolution measure: Return-to-work self-efficacy (RTW-SE-11 scale) evolution measure: Self-assessment of the benefit of the "return-to-work after cancer" consultation sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Angers University hospital city: Angers country: France name: PAILLASSA Jérome, MD role: CONTACT phone: 02.41.35.45.24 phoneExt: +33 email: [email protected] lat: 47.46667 lon: -0.55 facility: Brest University Hospital, Morvan Site city: Brest country: France name: Marie-Anne Couturier, MD role: CONTACT phone: 02.98.22.30.37 email: [email protected] lat: 48.3903 lon: -4.48628 facility: Caen University hospital city: Caen country: France name: Ghandi Laurent DAMAJ, MD role: CONTACT phone: 02.31.27.21.40 phoneExt: +33 email: [email protected] lat: 49.18585 lon: -0.35912 facility: Rennes University Hospital, Pontchaillou site city: Rennes country: France name: Roch HOUOT, MD role: CONTACT phone: 02.99.28.42.91 phoneExt: +33 email: [email protected] lat: 48.11198 lon: -1.67429 facility: Centre Henri Becquerel city: Rouen country: France name: Stéphane LEPRETRE, MD role: CONTACT phone: 02.32.08.22.23 phoneExt: +33 email: [email protected] lat: 49.44313 lon: 1.09932 facility: Rouen University Hospital city: Rouen country: France name: Laetitia ROLLIN, MD role: CONTACT phone: 02.32.88.82.69 email: [email protected] lat: 49.44313 lon: 1.09932 facility: Tours University Hospital, Bretonneau Site city: Tours country: France name: Emmanuel GYAN role: CONTACT phone: 02.47.47.38.11 email: [email protected] lat: 47.38333 lon: 0.68333 hasResults: False
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<|newrecord|> nctId: NCT06262776 id: SIRZOSTER1.01 briefTitle: Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients acronym: SIR ZOSTER overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-06 date: 2026-11 date: 2024-02-16 date: 2024-02-16 name: Central Adelaide Local Health Network Incorporated class: OTHER_GOV name: National Health and Medical Research Council, Australia name: University of Adelaide name: Royal Prince Alfred Hospital, Sydney, Australia briefSummary: The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between kidney transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are:
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1. Are there differences in vaccination immunological responses in kidney transplant patients on different immunosuppression regimens?
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2. Are there differences in vaccination immunological responses between kidney transplant patients and their healthy co-habitants? Participants will all receive a 2-dose course of SHINGRIX recombinant Zoster vaccination, and have immunological responses measured and compared at 5 timepoints between 1 week to 1 year post-vaccination. conditions: Immunosuppression conditions: Vaccine Response Impaired studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Recombinant zoster vaccine adjuvanted (SHINGRIX) measure: Functional T cell memory measure: Frequency of virus specific T cells measure: Magnitude of antibody response measure: Concentration of post-vaccination circulating cytokines measure: Frequency of polyfunctional T cells measure: Magnitude of vaccine-induced cross-protective antiviral responses measure: Frequency of virus-specific T stem cell memory compared to baseline measure: Incidence of shingles measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 measure: Tolerability of vaccination regimen as assessed by EQ-5D sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06262763 id: HILT for SIJP briefTitle: High-intensity Laser Therapy for Sacroiliac Joint Pain acronym: Girls overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-03 date: 2023-04-28 date: 2024-03-28 date: 2024-02-16 date: 2024-02-16 name: Kafrelsheikh University class: OTHER briefSummary: Effect of high intensity laser on sacroiliac joint pain conditions: Sacroiliac Joint Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ACTUAL name: Laser Therapy name: Traditional exercises name: Placebo laser measure: Pain intensity measure: Pressure pain threshold measure: Functional disability sex: FEMALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Kafr Al-Sheikh University city: Kafr Ash Shaykh country: Egypt lat: 31.11174 lon: 30.93991 hasResults: False
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<|newrecord|> nctId: NCT06262750 id: 00375/23 briefTitle: Evaluation of Safety and Efficacy of Anticoagulation Treatment in Patients With Splanchnic Vein Thrombosis: SAPIENT Study acronym: SAPIENT overallStatus: RECRUITING date: 2023-12-01 date: 2023-12-01 date: 2025-11-01 date: 2024-02-16 date: 2024-02-16 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Prospective single-centre, observational study with medical products. Patients with a medical history of SVT will be observed for at least 24 months after inclusion. The study will begin when the patient is referred to our centre for SVT and will end at the 24-month follow-up or at the occurrence of a study outcome event, or in case of Death OBJECTIVE: To prospectively define the incidence of recurrent thrombosis and bleeding events during anticoagulant therapy in patients with diagnosed SVT, regardless of whether they will be hospitalized or treated as outpatients conditions: Splanchnic Vein Thrombosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 170 type: ESTIMATED measure: Incidenze of bleedings events measure: Incidence of venous and arterial thromboembolic events measure: Rate of progress /stable /regressive measure: incidence of liver related events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UOC Servizio e DH Ematologia status: RECRUITING city: Rome zip: 00168 country: Italy name: Valerio De Stefano role: CONTACT name: Rossella Talerico role: SUB_INVESTIGATOR name: Silvia Betti role: SUB_INVESTIGATOR name: Francesco Santopaolo role: SUB_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06262737 id: RBHP 2023 CHIAMBARETTA id: 2023-A01121-44 type: REGISTRY domain: ANSM briefTitle: Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol acronym: PISO overallStatus: RECRUITING date: 2023-09-30 date: 2024-10-01 date: 2025-10-01 date: 2024-02-16 date: 2024-02-16 name: University Hospital, Clermont-Ferrand class: OTHER briefSummary: The purpose of this study is to assess the sensation of ocular dry eye symptom after an intravitreal injection of anti-VEGF. conditions: Macular Degeneration conditions: Diabetic Macular Edema conditions: Retinal Vein Occlusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: OSDI measure: OSDI measure: HM measure: AM measure: NIBUT 1 measure: NIBUT 2 measure: Interferometry sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Clermont-Ferrand status: RECRUITING city: Clermont-Ferrand zip: 63000 country: France lat: 45.77966 lon: 3.08628 hasResults: False
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<|newrecord|> nctId: NCT06262724 id: Perforator Flaps briefTitle: Breast Reshaping Following Massive Weight Loss overallStatus: COMPLETED date: 2021-08-01 date: 2023-08-01 date: 2024-01-01 date: 2024-02-16 date: 2024-02-26 name: Ain Shams University class: OTHER briefSummary: Reliability of Chest Wall Perforator Flaps for Breast Reshaping following Massive Weight Loss conditions: Breast Ptosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All patients were subjected to the same intervention. primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: Breast auto-augmentation measure: Measurement of breast volume by sono-mammography measure: Sternal notch to nipple distance measure: Nipple to inframammary fold distance measure: Measure of nipple-to-nipple distance sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Faculty of Medicine, Ain Shams University city: Cairo state: Abbasia zip: 11591 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06262711 id: 321917 briefTitle: Effects of Vitamin C on Skeletal Muscle acronym: VICS overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-03 date: 2025-03 date: 2024-02-16 date: 2024-02-16 name: University of East Anglia class: OTHER name: The Norfolk and Norwich University Hospitals NHS Foundation Trust name: The Quadram Institute Clinical Research Facility briefSummary: As part of the ageing process muscles become weaker. One of the reasons for this is that mitochondria, the 'engines' that provide energy to fuel muscles, age and work less efficiently. Mitochondria are found in almost all cells in the human body. Mitochondria take in nutrients that are provided from food and break these down to create energy-rich compounds to fuel many different processes in the body. Muscles are loaded with mitochondria because they require a lot of energy. Mitochondria naturally produce small compounds called oxidants that can damage muscle cells and can cause inflammation. The cells in the body have a natural defence system to protect against oxidants, but when mitochondria age and become less efficient, the amount of oxidants that they produce can increase. These oxidants can damage muscles and the mitochondria themselves. Antioxidants, such as vitamin C, may help protect muscles from the damage caused by oxidants, and may help mitochondria work more efficiently. In this study, the investigators will explore whether vitamin C can help mitochondria work more efficiently, which may improve muscle strength, and help older people to remain mobile and independent for longer. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Crossover Assignment primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Double blind masking whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 16 type: ESTIMATED name: Vitamin C name: Placebo measure: Difference in skeletal muscle mitochondrial function between vitamin C and placebo groups. measure: Difference in skeletal muscle phosphomonoester to phosphodiester ratio (PME/PDE) between vitamin C and placebo groups. measure: Difference in knee extension strength between vitamin C and placebo groups. measure: Difference in hand grip strength between vitamin C and placebo groups. measure: Difference in Short Physical Performance Battery (SPPB) score between vitamin C and placebo groups. measure: Difference in plasma vitamin C between vitamin C and placebo groups. measure: Difference in serum hs-CRP between vitamin C and placebo groups. measure: Difference in serum IL-6 between vitamin C and placebo groups. measure: Difference in serum TNF-α between vitamin C and placebo groups. measure: Difference in plasma P1NP between vitamin C and placebo groups. measure: Difference in plasma CTX between vitamin C and placebo groups. sex: FEMALE minimumAge: 65 Years stdAges: OLDER_ADULT facility: University of East Anglia city: Norwich state: Norfolk zip: NR4 7TJ country: United Kingdom lat: 52.62783 lon: 1.29834 hasResults: False
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<|newrecord|> nctId: NCT06262698 id: 81825902.903/148 briefTitle: The Effect of HBM-Based Education on Nursing Students acronym: HBM overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2024-12-31 date: 2025-06-30 date: 2024-02-16 date: 2024-02-16 name: Kafkas University class: OTHER briefSummary: The purpose of the study is to investigate the effect of HBM-based education on CAM knowledge, attitudes, and health beliefs related to medication use among nursing students through a randomized controlled trial.
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Research hypotheses:
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Hypothesis 01: There is no effect of HBM-based education on CAM knowledge level among nursing students.
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Hypothesis 1: There is an effect of HBM-based education on CAM knowledge level among nursing students.
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Hypothesis 02: There is no effect of HBM-based education on CAM attitude level among nursing students.
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Hypothesis 2: There is an effect of HBM-based education on CAM attitude level among nursing students.
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Hypothesis 03: There is no effect of HBM-based education on health beliefs related to medication use among nursing students.
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Hypothesis 3: There is an effect of HBM-based education on health beliefs related to medication use among nursing students. conditions: Nursing conditions: Evidence-Based Nursing studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The experimental group will receive six weeks of HBM-based training. primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Participants were assigned to groups using the "simple randomization method". Participants were not informed of which group they were in. Automated computer-based randomization resulted in the implementation of the experiment with the scheduling scenario and confidential allocation of participants to one of the four intervention branches. The researcher was blind to all conditions until the participants started the computer program and the intervention began. Participants were also unaware of whether the group they were assigned to was an experimental or a control condition. In addition, researchers coding and analyzing data will be blind to randomization and interventions. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Experiment group name: Pre-post test measure: The TCM Attitude Scale (CACMAS) The GETAT Attitude Scale (CACMAS): The scale, developed by McFadden et al. (2010), consists of 27 items rated on a 7-point Likert scale. Its Turkish validity and reliability were established by Köse et al. (2018). measure: The Medication Health Belief Scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Kafkas University Faculty of Health Sciences city: Kars zip: 36500 country: Turkey name: Gönül GÖKÇAY, Asist. Prof. role: CONTACT phone: 05447915549 email: [email protected] lat: 40.59825 lon: 43.08548 hasResults: False
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<|newrecord|> nctId: NCT06262685 id: 2023-509418-12-00 briefTitle: Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins acronym: PREVESTATGx overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2025-02-10 date: 2025-03-04 date: 2024-02-16 date: 2024-02-16 name: Instituto de Investigación Hospital Universitario La Paz class: OTHER name: Instituto de Salud Carlos III briefSummary: This is a Phase IV multicentre adaptive single-blinded randomized clinical trial if preemptively genotyping populations at risk of cardiovascular disease susceptible of receiving high or moderate doses of statin therapy is efficacious, cost-efficacious, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol conditions: Cardiovascular Diseases conditions: Dyslipidemias conditions: Statin Adverse Reaction conditions: Pharmacogenic Myopathy studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase IV, multicentre, controlled, randomized, parallel and single-blind adaptive clinical trial nested within the iPHARMGx master protocol study primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Subjects will remain blinded to arm assigned because pharmacogenetic phenotype and statin/dose-guidance will only be exclusively accesible to the attending physician whoMasked: PARTICIPANT count: 216 type: ESTIMATED name: Preemptive pharmacogenetic atorvastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic simvastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic pitavastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic rosuvastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic pravastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic lovastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic fluvastatin dose based on CPIC guidelines name: Standard of Care (SoC) dosing of atorvastatin name: Standard of Care (SoC) dosing of simvastatin name: Standard of Care (SoC) dosing of pitavastatin name: Standard of Care (SoC) dosing of rosuvastatin name: Standard of Care (SoC) dosing of prasavastatin name: Standard of Care (SoC) dosing of lovastatin name: Standard of Care (SoC) dosing of fluvastatin measure: Incidence of clinically relevant statin-associated musculoskeletal events measure: Low density lipoprotein cholesterol (LDLc) serum concentration baseline reduction rate measure: Baseline change in statin therapy prescription measure: Cost of a statin preemptive pharmacogenetic prescription scheme measure: Novel prognostic and predictive genetic biomarkers of statin-related adverse events and efficacy identification measure: Death from cardiovascular causes, nonfatal myocardial infarction or hospitalization for unstable angina or resuscitated cardiac arrest measure: Difference in percentage in the eight-item Morisky Medication Adherence Scale (MMAS-8) questionnaire score between intervention and control arm measure: SAMS intensity reduction of a statin preemptive pharmacogenetic prescription scheme sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital La Paz city: Madrid state: Comunidad De Madrid zip: 28046 country: Spain name: Stefan Mark Stewart Balbás, MD role: CONTACT lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06262672 id: PR0319R01 briefTitle: Evaluation of Some Parameters in University Students During the COVİD-19 Epidemic Process overallStatus: COMPLETED date: 2021-05-20 date: 2021-11-20 date: 2021-11-20 date: 2024-02-16 date: 2024-02-28 name: Kırklareli University class: OTHER briefSummary: The physical and mental effects of the COVID-19 pandemic have been examined by many researchers, but this study aims to evaluate in every aspect how university students who had to receive education with the distance education model due to the pandemic went through this process. Data regarding people's positive and negative habits from anthropometric characteristics and sleep quality, which is one of the sub-dimensions of healthy lifestyle behaviors, were evaluated, and the relationship between these parameters was examined in detail. conditions: Health Behavior conditions: Sleep conditions: Body Weight studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 236 type: ACTUAL name: Evaluation form measure: Health Promotion Life-Style Profile (HPLP-II) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Anthropometric Measurements sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kirklareli University city: Kirklareli state: Kayalı zip: 39000 country: Turkey lat: 41.73508 lon: 27.22521 hasResults: False
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<|newrecord|> nctId: NCT06262659 id: 2023-142 briefTitle: The Effect of Ultrasonography on Blood Flow,Vessel Diameter,and Depth Measurements in Dialysis Patients With Fistula overallStatus: RECRUITING date: 2024-03-08 date: 2024-06-10 date: 2024-09-10 date: 2024-02-16 date: 2024-03-12 name: Kudret Atakan Tekin class: OTHER briefSummary: Arteriovenous fistulas (AVF) are considered essential and the primary vascular access for end-stage renal disease patients to receive hemodialysis (HD) treatment. The maturation failure rate of AVFs is approximately 23%. The aim of our study is to compare intraoperative fistula flow and measurements of vascular structures' diameters with postoperative fistula maturation, following the completion of the fistula operation, to reveal the relationship between them. Providing insights into the need for intraoperative intervention and/or postoperative fistula management based on these measurements is intended to contribute to the literature by offering predictions and perspectives. conditions: Arteriovenous Fistula studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 66 type: ESTIMATED name: Doppler Ultrasonography Assessment measure: intraoperative Arteriovenous Fistula Flow Measurement sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kudret Atakan Tekin status: RECRUITING city: Merkez state: Çorum country: Turkey name: Kudret Atakan Tekin role: CONTACT phone: 05424912184 email: [email protected] hasResults: False
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<|newrecord|> nctId: NCT06262646 id: NTEC-2023-677 briefTitle: Video-conferencing FACT for Young Children With Special Needs overallStatus: RECRUITING date: 2024-02-01 date: 2025-01-31 date: 2026-01-31 date: 2024-02-16 date: 2024-02-16 name: Chinese University of Hong Kong class: OTHER name: Hong Kong Christian Service name: Hong Kong Federation of Youth Groups name: Hong Kong Young Women's Christian Association name: Yang Memorial Methodist Social Service name: Hong Kong Sheng Kung Hui Welfare Council briefSummary: Objective: This RCT evaluates the efficacy of Focused Acceptance and Commitment Therapy (FACT) delivered via videoconferencing for parents of special needs children, targeting reducing parental stress (primary outcome), symptoms of depression and anxiety, as well as psychological flexibility.
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Background: Parental caregiving for children with special needs is associated with significant stress, potentially impairing parental and familial functioning. Acceptance and Commitment Therapy (ACT) has shown promise in bolstering mental health across diverse populations. Preliminary findings from a feasibility trial (NCT05803252) suggest the potential of FACT in this context.
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Methods: Expanding upon prior research, this definitive RCT compares FACT to standard parenting advice, correcting for earlier limitations through increased sample size and rigorous methodology. Assessments will be conducted at baseline, post-intervention (4-8 weeks), and 6-month follow-up.
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Results: The study anticipates that FACT will demonstrate superior outcomes in promoting well-being among parents compared to parenting advice alone.
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Conclusion: By leveraging videoconferencing for therapy delivery, the RCT aims to improve access to mental health interventions and emphasize the importance of psychological health among parents of special needs children. This could foster greater recognition and proactive management of mental health within this population. conditions: Autism Spectrum Disorder conditions: Attention Deficit Hyperactivity Disorder conditions: Specific Learning Disorder conditions: Communication Disorders conditions: Motor Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two-arm Randomised Controlled Trial (RCT) with a repeated-measures parallel-group design primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Eligible parents consenting to participate will be randomly assigned to either the FACT or Control Group in a 1:1 ratio, using the permuted block size of 6 through sequentially numbered, opaque and sealed envelopes with number cards (1=intervention, 2=control). A separate set of random numbers, concealed from the research team and RAs, will be generated by a statistician. Clerical staff uninvolved in the project will administer the randomisation. The research assistant (RA-1), blinded to subject selection, will open the envelopes only after informed consent and baseline assessments are completed. The research assistant (RA-2) is also blinded to group assignments and will conduct assessments/evaluations. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 253 type: ESTIMATED name: Focused Acceptance and Commitment Therapy name: Control Group measure: Parenting stress measure: Parental depressive symptoms measure: Parental anxiety symptoms measure: Parental Psychological Flexibility measure: ACT Core Process Utilization sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Chinese University of Hong Kong status: RECRUITING city: Hong Kong country: Hong Kong name: Pui Tik YAU role: CONTACT phone: (852) 3943-9915 email: [email protected] lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06262633 id: CRE-2023.079 briefTitle: A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer overallStatus: RECRUITING date: 2024-03-15 date: 2026-04-30 date: 2026-06-30 date: 2024-02-16 date: 2024-03-19 name: Chinese University of Hong Kong class: OTHER briefSummary: This study is to investigate the efficacy of Targeted Microwave Ablation (TMA) under MRI-Ultrasound fusion and organ-based tracking (OBT) navigation in localized prostate cancer (PCa) in a multi-centre trial. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 103 type: ESTIMATED name: Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation measure: The oncological control of prostate cancer measure: Cancer detection on biopsy of each ablated MRI visible lesion measure: Cancer detection on biopsy of each ablated MRI invisible lesion measure: Gleason 4 or 5 cancer detected on biopsy of ablated area measure: Out-of-field recurrence: Any cancer outside treated area on systematic biopsy measure: Common Terminology Criteria for Adverse Events (CTCAE) v5.0 measure: PSA change measure: Urinary Symptoms after treatment measure: Sexual side effects after treatment measure: Continence side effects after treatment measure: Common Terminology Criteria for Adverse Events (CTCAE) rectal toxicity measure: Quality of life measured by ED-5Q-5Lquestionnaire measure: Quality of life in patients with prostate cancer measured by EPIC-26 measure: Quality of life measured by QLQ-C30, sex: MALE minimumAge: 45 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peter Ka-Fung CHIU status: RECRUITING city: Sha Tin country: Hong Kong name: Peter Ka-Fung CHIU, PhD,MBChB role: CONTACT phone: 35052625 email: [email protected] lat: 22.38333 lon: 114.18333 hasResults: False
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<|newrecord|> nctId: NCT06262620 id: 2022-NHLHCRF-LX-01-0201-06 briefTitle: The Comparisonof Mediastinal/Hilar Lymph Node Biopsies by EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB overallStatus: NOT_YET_RECRUITING date: 2024-02-18 date: 2026-02-18 date: 2026-02-18 date: 2024-02-16 date: 2024-02-16 name: China-Japan Friendship Hospital class: OTHER briefSummary: The goal of this prospective, multi-centre, randomised controlled clinical study is to compare the diagnostic efficacy and safety of the three biopsy techniques (EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB) in mediastinal/hilar lymph node biopsies.
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Participants will divided into EBUS-TBNA group, EBUS-TBCB group, and EBUS-TBFB group at a 1:1:1 ratio by using central, computerized random sequence, and then undertake EBUS-TBNA, EBUS-TBCB, or EBUS-TBFB according to the group.
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Researchers will compare the adequacy of sampling by the three biopsy techniques, their sample quality, diagnostic rate, and incidence of each adverse events. conditions: Lymphadenopathy Hilar conditions: Lymphadenopathy Mediastinal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 723 type: ESTIMATED name: EBUS-TBNA name: EBUS-TBCB name: EBUS-TBFB measure: Dignostic rate of EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB measure: Incidence rate of adverse events measure: the adequacy of sample acquisition measure: the quality of sample acquisition sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06262607 id: CLE400-NP-201 briefTitle: A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia Paresthetica overallStatus: RECRUITING date: 2024-01-29 date: 2024-12-31 date: 2025-01-15 date: 2024-02-16 date: 2024-04-17 name: Clexio Biosciences Ltd. class: INDUSTRY briefSummary: This is a Phase 2, randomized, double-blind, vehicle-controlled study to assess the efficacy and safety of CLE-400 topical gel for the treatment of chronic pruritus in adult subjects with Notalgia Paresthetica (NP). conditions: Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP) studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 40 subjects, 2 arms, parallel primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: double whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: CLE-400 name: Vehicle measure: Percent change from baseline in weekly mean of the daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 4. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical site 11 status: RECRUITING city: Bryant state: Arkansas zip: 72022 country: United States lat: 34.59593 lon: -92.48905 facility: Clinical site 01 status: RECRUITING city: Coral Gables state: Florida zip: 33134 country: United States lat: 25.72149 lon: -80.26838 facility: Clinical Site 10 status: RECRUITING city: North Miami Beach state: Florida zip: 33116 country: United States lat: 25.93315 lon: -80.16255 facility: Clinical Site 02 status: RECRUITING city: Indianapolis state: Indiana zip: 46250 country: United States lat: 39.76838 lon: -86.15804 facility: Clinical Site 23 status: RECRUITING city: Methuen state: Massachusetts zip: 01844 country: United States lat: 42.7262 lon: -71.19089 facility: Clinical Site 09 status: RECRUITING city: Dublin state: Ohio zip: 43016 country: United States lat: 40.09923 lon: -83.11408 facility: Clinical site 16 status: RECRUITING city: Houston state: Texas zip: 77004 country: United States lat: 29.76328 lon: -95.36327 facility: Clinical Site 06 status: RECRUITING city: San Antonio state: Texas zip: 78213 country: United States lat: 29.42412 lon: -98.49363 hasResults: False
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<|newrecord|> nctId: NCT06262594 id: L'ÉTOILE briefTitle: Lemborexant Treatment of Insomnia Linked to Epilepsy acronym: L'ÉTOILE overallStatus: NOT_YET_RECRUITING date: 2024-02-08 date: 2025-02-08 date: 2026-02-08 date: 2024-02-16 date: 2024-02-16 name: University of Manitoba class: OTHER name: Duke University briefSummary: The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy. conditions: Epilepsy conditions: Sleep studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 26 type: ESTIMATED name: Lemborexant measure: WASO sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06262581 id: 2021-FXY-471 briefTitle: Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery overallStatus: RECRUITING date: 2023-09-23 date: 2024-11-30 date: 2025-12-31 date: 2024-02-16 date: 2024-02-16 name: Sun Yat-sen University class: OTHER briefSummary: According to the cancer statistics in 2020, colorectal cancer (CRC) remains a major public health issue worldwide, representing the third common cancer (10%) and second leading cause of death (9.4%) with 5-year survival rate approaching 65%. Meanwhile, 28.8% of the newly diagnosed cases and 30.3% of the CRC-related death occurs in China. Among all the CRC, stage I-III account for 75%. For the standard management for non-late stage(stage I-III) CRC patients, surgery including the primary site and local lymph nodes dissection has been the most important one. But for the high-risk stage II and locally-advanced stage III CRC, neoadjuvant or adjuvant therapy such as chemotherapy and radiotherapy plays a vital role in preventing the residual cancer cells to relapse and spread to distant sites after surgery. For the past decades, immunotherapy like anti-PD-1 and anti-CTLA4 checkpoint inhibitor achieves great process in solid tumor treatment especially for late-stage CRC. And Pembrolizumab and Nivolumab has been proved for dMMR/MSI-H late-stage-CRC by FDA. Combination of Ipilimumab and Nivolumab has achieved great success among the early-stage-CRC in NICHE study. The investigators here to carry out a phase II clinical trial to explore the safety and effect of single anti-PD-1 (Tisleizumab-BGB-A317 ) neoadjuvant treatment for non-late stage CRC patients. conditions: DMMR Colorectal Cancer conditions: Anti PD-1 conditions: Immunotherapy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Tisleizumab(BGB-A317) measure: pathological complete regression rate measure: CR rate measure: Major Pathological Response rate measure: Disease free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen University Cancer Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Gong C Chen, Prof role: CONTACT phone: +862087343584 email: [email protected] name: Zhi-zhong Pan, Prof role: SUB_INVESTIGATOR name: Xiao-jun Wu, Prof role: SUB_INVESTIGATOR name: Zhen-hai Lu, Prof role: SUB_INVESTIGATOR name: Pei-rong Ding, Prof role: SUB_INVESTIGATOR name: Li-ren Li, Prof role: SUB_INVESTIGATOR name: Fu-long Wang, M.D. role: SUB_INVESTIGATOR name: Rong-xin Zhang, M.D. role: SUB_INVESTIGATOR name: Jian-hong Peng, M.D. role: SUB_INVESTIGATOR name: Jun-zhong Lin, M.D. role: SUB_INVESTIGATOR name: Ling-heng Kong, M.D. role: SUB_INVESTIGATOR name: Cong Li, M.D. role: SUB_INVESTIGATOR name: Wu Jiang, M.D. role: SUB_INVESTIGATOR name: Wen-hua Fan, M.D. role: SUB_INVESTIGATOR name: Wen-hao Zhou, M.D. role: SUB_INVESTIGATOR name: Jing-hua Tang, M.D. role: SUB_INVESTIGATOR name: Yuan Li, M.D. role: SUB_INVESTIGATOR name: Miaoqing Wu role: SUB_INVESTIGATOR name: Di Cao role: SUB_INVESTIGATOR name: Yi-fan Liu role: SUB_INVESTIGATOR name: Da Kang role: SUB_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06262568 id: Soh-Med-23-03-18MS briefTitle: Effect of Guidelines on Nurses' Awareness Toward HRP and Maternal Near Miss Cases overallStatus: RECRUITING date: 2023-04-01 date: 2024-03-01 date: 2024-06-01 date: 2024-02-16 date: 2024-02-16 name: Sohag University class: OTHER briefSummary: The current study will evaluate the impact of awareness of maternity nurses toward instructional guidelines and evaluate the knowledge, practice and attitude of nurses toward high risk pregnancy and maternal near miss cases before and after education. conditions: High Risk Pregnancy and Maternal Near Miss Cases studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 71 type: ESTIMATED name: assess the nurse knowledge and practices. measure: Evaluate the outcome of instructional guidelines on maternity nurses' awareness toward high-risk pregnancy and Maternal Near Miss Cases by questionnaire before and after training sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Sohag University hospitals status: RECRUITING city: Sohag country: Egypt name: ghona Abd EL-Nasser, Professor role: CONTACT phone: 01123067894 email: [email protected] lat: 26.55695 lon: 31.69478 hasResults: False
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<|newrecord|> nctId: NCT06262555 id: TYGH111061 briefTitle: Novel Light Delivery Method for Performing Transbronchial Photodynamic Therapy for Peripheral Lung Cancer overallStatus: RECRUITING date: 2024-03 date: 2024-06-30 date: 2024-12-31 date: 2024-02-16 date: 2024-02-16 name: Taoyuan General Hospital class: OTHER_GOV briefSummary: This research aims to develop an innovative photodynamic therapy (PDT) for peripheral lung tumors. Current treatments involve surgery, chemotherapy, and radiation. Photodynamic therapy, using light and photosensitizing drugs, is promising but has limitations. Our team proposes using Lipiodol, a contrast agent, instilled into the trachea via bronchoscopy, surrounding the tumor. Preliminary pig model trials showed safety. Clinical trials, building on a U.S. study (NCT02916745), commenced in October 2021, treating three cases. Initial results suggest safety, but efficacy requires further investigation. Based on ongoing trials, we propose a phase I trial with multiple light treatments from different directions and an additional dose after 48 hours to assess safety and efficacy. This study will guide future clinical trials for optimal PDT dosage. conditions: Lung Cancer conditions: Lung Cancer Metastatic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 3 type: ESTIMATED name: Transbronchial PDT peripheral lung tumor ablation measure: Technical Feasibility measure: Technical Safety measure: Tumor remission rate sex: ALL minimumAge: 20 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taoyuan General Hospital, Ministry of Health and Welfare status: RECRUITING city: Taoyuan City zip: 320 country: Taiwan name: Yei-San Hsieh, MD role: CONTACT phone: +886-975061108 email: [email protected] name: Yei-San Hsieh, Dr. role: PRINCIPAL_INVESTIGATOR name: Hwi-Lu Chang, Dr. role: SUB_INVESTIGATOR lat: 24.95233 lon: 121.20193 hasResults: False
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<|newrecord|> nctId: NCT06262542 id: 111016 briefTitle: Efficacy and Safety of Chinese Herb Medicine-Moxibustion Therapy on Chemotherapy-Induced Leukopenia overallStatus: RECRUITING date: 2024-03-13 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-04-12 name: Taichung Armed Forces General Hospital class: OTHER_GOV briefSummary: Cancer is the second leading cause of death globally, with an estimated 9.6 million deaths in 2018, accounting for one-sixth of total deaths. The economic burden of cancer continues to rise globally, causing significant physiological, psychological, and economic pressures on individuals, families, communities, and healthcare systems. The toxic effects of chemotherapy, such as nausea, vomiting, decreased blood cells, fatigue, etc., can impair patients' function, activities, and quality of life. Chemotherapy-induced leukopenia (CIL), particularly low white blood cell counts (48.9%), is a major concern for cancer patients.
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Current conventional treatments primarily involve colony-stimulating factors (G-CSF and GM-CSF) to accelerate neutrophil recovery and regulate granulocyte production. However, G-CSF is costly and adds financial burden, and its use is restricted to cases meeting specific criteria. Additionally, rapid changes in patients' symptoms, weakness, and poor appetite may lead to swift deterioration of their condition, making it challenging to predict and prevent. Moreover, G-CSF has frequent side effects, including skin rash, liver function abnormalities, nausea, vomiting, fever, headache, fatigue, palpitations, and increased levels of ALP, LDH, and uric acid, with bone pain being the most common.
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Traditional Chinese Medicine (TCM) has been a long-standing medical practice in Eastern societies and is a legally recognized healthcare option in Taiwan, covered by national health insurance. TCM includes acupuncture, moxibustion, and Chinese herbal medicine, all of which have been researched for their potential in addressing chemotherapy-induced leukopenia. conditions: Cancer, Chemotherapy-induced Leukopenia, Chinese Herb Medicine-moxibustion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: moxibustion and Chinese herbal medicine group measure: Track the number of white blood cells sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taichung Armed Force General Hospital status: RECRUITING city: Taichung state: Taiping zip: 411228 country: Taiwan name: ming huei cheng role: CONTACT phone: 0921059072 email: [email protected] lat: 24.1469 lon: 120.6839 hasResults: False
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<|newrecord|> nctId: NCT06262529 id: 22-AOI-06 briefTitle: Neurocognitive Impairment After Ischemic Stroke acronym: COG-TRA-Y MRI overallStatus: RECRUITING date: 2024-02-09 date: 2025-02-09 date: 2027-02-09 date: 2024-02-16 date: 2024-02-16 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Affecting more than 150,000 patients in France, stroke is a major public health issue and a leading cause of disability worldwide. In western countries, 80-85% of strokes are of ischemic subtype. This study will focus on young adults, aged 18-45, with a diagnosis of ischemic stroke.
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Studies assessing post-stroke cognition in young patients reported an alarming prevalence of cognitive impairment, affecting about 60% of stroke survivors between 4 and 12 months after the acute event. However, longitudinal data on neurocognitive trajectories (i.e., the evolution of cognitive impairment over time) in young patients with ischemic stroke are lacking. Collecting such data requires an exhaustive neuropsychological assessment and several functional evaluations, at different times, for the same patient.
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Repeated neurocognitive study of young patients with ischemic stroke will enable: a description of the prevalence of impaired global cognitive efficiency, an analysis of the specific neurocognitive domains affected, and the tracing of trajectories of recovery from cognitive impairment over time, in terms of global cognitive efficiency and as a function of specific neurocognitive domains (memory, executive, attentional, social cognition, instrumental functions, fatigability, etc.).
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Up to date, the clinic-radiological predictors and associated factors of neurocognitive impairment after ischemic stroke in young patients have not been studied. Ischemic stroke causes acute brain lesions of the gray matter (GM) and white matter (WM). Numerous studies suggest that cognitive health may be more closely linked to the integrity of WM than to GM. Magnetic resonance imaging (MRI), and in particular diffusion tensor imaging (DTI) sequences, analyze WM bundles. By using fiber tracking algorithms image analysis enable the WM fiber bundle reconstruction and allow quantifying the volume of lesions (pre-existing and ischemic stroke-induced) in the WM tract.
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The aim of this study is to study whether the extension of pre-existing and acute white matter lesions is associated with poorer cognitive recovery after ischemic stroke, both in terms of global cognitive performance and impairment in specific neurocognitive domains. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 16 type: ESTIMATED name: Cerebral MRI measure: evolution of neurocognitive disorders (trajectories of global cognitive efficiency) over 1 year after stroke sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: cannes Hospital status: NOT_YET_RECRUITING city: Cannes zip: 06600 country: France name: sylvain LACHAUD role: CONTACT email: [email protected] name: Sylvain Lachaud role: PRINCIPAL_INVESTIGATOR lat: 43.55135 lon: 7.01275 facility: Nice University Hospital status: RECRUITING city: Nice zip: 06000 country: France name: Marina Passalboni role: CONTACT phone: 04 92 03 27 90 email: [email protected] name: barbara CASOLLA role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 hasResults: False
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<|newrecord|> nctId: NCT06262516 id: CASE2824 briefTitle: Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-01-01 date: 2029-01-01 date: 2024-02-16 date: 2024-02-16 name: Case Comprehensive Cancer Center class: OTHER briefSummary: The goal of this study is to conduct the first randomized-controlled trial to determine the oncologic efficacy of lymph node dissection in participants with upper tract urothelial cell carcinoma. The main questions it aims to answer are:
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* To determine oncologic outcomes, specifically 2-year recurrence-free survival
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* To determine other oncologic outcomes including treatment-free, cancer-specific and overall survival
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* To determine time to recurrence and recurrence patterns
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* To determine use of adjuvant therapies
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* To determine perioperative complications
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Participants will undergo nephroureterectomy with or without lymph node dissection. Researchers will compare these two groups to determine the oncologic efficacy of performing lymph node dissection. conditions: Urothelial Carcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is designed as a 1:1 two armed randomized-controlled trial. primaryPurpose: TREATMENT masking: NONE count: 94 type: ESTIMATED name: Nephroureterectomy name: Lymph Node Dissection measure: Recurrence-free survival measure: Treatment-free survival measure: Cancer-specific survival measure: Overall Survival measure: Time to recurrence measure: Use of adjuvant therapies measure: Perioperative complications sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic Glickman Urological and Kidney Institute city: Cleveland state: Ohio zip: 44195 country: United States name: Mohamed Eltemamy, MD role: CONTACT phone: 216-444-5888 email: [email protected] lat: 41.4995 lon: -81.69541 hasResults: False
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<|newrecord|> nctId: NCT06262503 id: P.T.REC/012/004810 briefTitle: the Influence of Virtual Reality Approach on Phantom Pain in Trans Tibial Amputation overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-01 date: 2024-02 date: 2024-03 date: 2024-02-16 date: 2024-02-20 name: Cairo University class: OTHER briefSummary: 1. To investigate the effect of Virtual reality (VR) on phantom limb pain in trans tibial amputation.
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2. To investigate the effect of Virtual reality (VR) on lower limb Function in trans tibial amputation.
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A sample size of 60 will be randomly allocated to two groups(30 in each group) , by using computer-generated random number list method. Control group will receive conventional physiotherapy(TENS- Phantom exercises and mirroring exercise) for reducing phantom pain in trans -tibial amputation and the experimental group will receive conventional physiotherapy(TENS- Phantom exercises and mirroring exercise) and Virtual Reality for reducing phantom pain in trans -tibial amputation . conditions: Phantom Pain Following Amputation of Lower Limb studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group1:conventional physiotherapy for phantom Pain Group2:conventional physiotherapy and Virtual Reality for phantom Pain primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Virtual Reality name: Transcutaneous Electrical Nerve Stimulation (TENS) name: Mirroring Therapy name: Phantom Exercises measure: Pain Intensity Level measure: Lower Extremity Functional sex: ALL minimumAge: 18 Months maximumAge: 75 Months stdAges: CHILD facility: Faculty of Physical therapy, Cairo university city: Giza zip: 12613 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False
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<|newrecord|> nctId: NCT06262490 id: P.T.REC/012/004765 briefTitle: Impact of Pelvic Floor Rehabilitation Combined With Ultrasound Therapy on Osteomyoarticular Symptoms in Chronic Perineal Pain overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-01 date: 2024-09-01 date: 2024-02-16 date: 2024-02-16 name: Cairo University class: OTHER briefSummary: The purpose of the study is to find out the effect of pelvic floor rehab combined with ultrasound have effect in chronic perineal pain subjects associated with osteomyoarticular symptoms . conditions: Chronic Perineal Pain conditions: Pelvic Floor Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Traditional ultrasound therapy name: Pelvic floor rehabilitation measure: Assessment of osteomyoarticular symptoms measure: Assessment of perineal pain intensity measure: Assessment of pelvic floor muscle strength measure: Assessment of pelvic floor muscle tightness measure: Assessment of lumbar spine mobility sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Cairo University city: Giza country: Egypt name: Aya T- Allah M. Nabil, PhD student role: CONTACT phone: 01063028038 email: [email protected] name: Salwa M. El Badry role: CONTACT name: Amel M. Yousef, Prof. role: PRINCIPAL_INVESTIGATOR name: Hazem S. Al-Ashmawy, Ass. Prof role: PRINCIPAL_INVESTIGATOR lat: 30.00808 lon: 31.21093 hasResults: False
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<|newrecord|> nctId: NCT06262477 id: NL-TCZ-12280 briefTitle: A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants overallStatus: RECRUITING date: 2024-01-02 date: 2024-11-30 date: 2024-11-30 date: 2024-02-16 date: 2024-02-16 name: Biogen class: INDUSTRY briefSummary: The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants. The secondary objective of the study is to evaluate PK over time, clinical safety, pharmacodynamic (PD) profiles and immunogenicity of BIIB800 and Actemra. conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: BIIB800 name: Actemra measure: Maximum Serum Concentration (Cmax) of Tocilizumab measure: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tocilizumab measure: Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab measure: Time to Reach Cmax (Tmax) of BIIB800 and Tocilizumab measure: Apparent Total Body Clearance (CL/F) of BIIB800 and Tocilizumab measure: Apparent Terminal Half-Life (t1/2) of BIIB800 and Tocilizumab measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Area Under the Effect-Time Curve (AUE) of Soluble Interleukin-6-Receptor (sIL-6R) measure: Maximum Observed Effect (Emax) of sIL-6R measure: Time to Emax (tEmax) of sIL-6R measure: AUE of High Sensitive C-Reactive Protein (hsCRP) measure: Minimum Observed Effect Emin of hsCRP measure: Time to Emin (tEmin) of hsCRP measure: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAbs) measure: Number of Participants With ADA Titers sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Fortrea Clinical Research Unit Inc. status: RECRUITING city: Madison state: Wisconsin zip: 53704 country: United States role: CONTACT phone: 608-210-5574 email: [email protected] name: Sarah Russell, MD role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False
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<|newrecord|> nctId: NCT06262464 id: 17.361/ 07.12.2023 briefTitle: An OCD Prevention Programme for at Risk Adults acronym: ØCD overallStatus: RECRUITING date: 2024-02-09 date: 2024-03-29 date: 2024-04-01 date: 2024-02-16 date: 2024-03-18 name: Babes-Bolyai University class: OTHER name: Romanian National Authority for Scientific Research briefSummary: The main purpose of this randomised clinical trial is to test the efficacy of a prevention program for adult who are at risk of developing OCD, thus constituting a form of tertiary prevention. conditions: Obsessive-Compulsive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Prevention measure: Change from baseline in OCD symptoms on the OCI-R after the intervention measure: Change from baseline in depressive symptoms on the PHQ-9 after the intervention measure: Change from baseline in anxiety symptoms on the GAD-7 after the intervention measure: Change from baseline in experiential avoidance on the EAQ after the intervention measure: Change from baseline in cognitive distortions on the OBQ-44 after the intervention measure: Change from baseline in uncertainty intolerance on the IUS after the intervention measure: Change from baseline in resilience on the RSA after the intervention measure: Change from baseline in life quality on the WHOQOL-BREF after the intervention measure: Change from baseline in irrationality on the ATQ after the intervention measure: Change from baseline in global health on the GHQ-12 after the intervention sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Babes-Bolyai University, Faculty of Psychology and Educational Sciences, Department of Clinical Psychology and Psychotherapy status: RECRUITING city: Cluj-Napoca zip: 400015 country: Romania name: Roxana AI Cardos, PhD Student role: CONTACT phone: 0040751477323 email: [email protected] lat: 46.76667 lon: 23.6 hasResults: False
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<|newrecord|> nctId: NCT06262451 id: 20-30182 id: 5R24AI118629 type: NIH link: https://reporter.nih.gov/quickSearch/5R24AI118629 briefTitle: Fecal Microbiota Transplant National Registry overallStatus: RECRUITING date: 2023-10-20 date: 2032-10 date: 2032-10 date: 2024-02-16 date: 2024-02-16 name: University of California, San Francisco class: OTHER name: National Institute of Allergy and Infectious Diseases (NIAID) briefSummary: A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness. Neonates will not be enrolled at any site for this study. The study data will derive from patient and donors past and present medical records, research records, and records about phone calls made as part of this research. The patient data will also be used from the records on visits. conditions: Fecal Microbiota Transplant studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10 type: ESTIMATED measure: To assess short-term and long-term safety of FMT and other gut-related-microbiota products measure: To characterize effectiveness of FMT and other gut-related-microbiota products. measure: To gather information on FMT practice in North America measure: To promote scientific investigation. measure: To aid practitioners and sponsors in satisfying regulatory requirements sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Francisco status: RECRUITING city: San Francisco state: California zip: 94115 country: United States name: Rachael Leigh Delacruz role: CONTACT phone: 415-514-8087 email: [email protected] lat: 37.77493 lon: -122.41942 hasResults: False
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<|newrecord|> nctId: NCT06262438 id: MH22CAQ id: 2022-002886-14 type: EUDRACT_NUMBER id: 2023-505000-27 type: OTHER domain: EU CT Number briefTitle: CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients acronym: CHIP-AML22/Q overallStatus: RECRUITING date: 2024-02-06 date: 2028-06 date: 2032-06 date: 2024-02-16 date: 2024-02-16 name: Princess Maxima Center for Pediatric Oncology class: OTHER name: Daiichi Sankyo briefSummary: The CHIP-AML22 Master protocol has the overall aim of increasing the cure rate in newly diagnosed pediatric de novo AML patients, while avoiding unnecessary toxicity. The linked Quizartinib trial (CHIP-AML22/Quizartinib) is a phase II, single arm, open label, study on the safety, efficacy, pharmacokinetics and pharmacodynamics of quizartinib in combination with chemotherapy and as single-agent after high dose therapy in newly diagnosed pediatric AML patients with a FLT3-ITD mutation and NPM1 wild-type. conditions: Acute Myeloid Leukemia in Children studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Given the rarity of pediatric subjects with newly diagnosed Acute Myeloid Leukemia (AML) with FLT3-ITD mutations and the slow enrollment in historical studies, it is not feasible to enroll a sufficient number of subjects for an adequately powered randomized study. Therefore, a standard oncology Phase 2 response-rate design has been chosen. One of the exploratory objectives planned is to compare the outcome of patients treated in this study to the outcome of patients treated in the NOPHO-DBH AML-2012 study as historical control. primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Quizartinib name: Etoposide name: Dexrazoxane name: Mitoxantrone name: Cytarabine name: Methotrexate name: Daunorubicin name: Fludarabine name: allo-SCT measure: Primary objective (efficacy) measure: Primary objective (safety) measure: Secondary objectives (efficacy_1) measure: Secondary objectives (efficacy_2) measure: Secondary objectives (efficacy_3) measure: Secondary objectives (efficacy_4) measure: Secondary objectives (efficacy_5) measure: Secondary objectives (efficacy_6) measure: Secondary objectives (efficacy_7) measure: Secondary objectives (efficacy_8) measure: Secondary objectives (efficacy_9) measure: Secondary objectives (safety) - Adverse Events, Laboratory Abnormalities and cumulative incidence of non-relapse mortality measure: Pharmacokinetics (PK_1) measure: Pharmacokinetics (PK_2) measure: Pharmacokinetics (PK_3) measure: Pharmacokinetics (PK_4) measure: Palatability of quizartinib formulations sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Princess Máxima Center for pediatric oncology status: RECRUITING city: Utrecht zip: 3584 CS country: Netherlands name: Gertjan Kaspers, Prof. Dr. role: CONTACT name: Bianca Goemans, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 52.09083 lon: 5.12222 hasResults: False
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<|newrecord|> nctId: NCT06262425 id: ALC001NR004 briefTitle: rTMS Over S1 Enhance Motor Learning in Healthy People overallStatus: RECRUITING date: 2024-01-20 date: 2025-06-15 date: 2025-09-15 date: 2024-02-16 date: 2024-02-20 name: Neuron, Spain class: OTHER briefSummary: The purpose of this study is to compare the effectiveness of different repetitive Transcranial Magnetic Stimulation protocols for enhancing motor learning in healthy peolple. conditions: Transcranial Magnetic Stimulation conditions: Motor Learning studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 95 type: ESTIMATED name: repetitive Transcranial Magnetic Stimulation over primary somatosensory cortex name: repetitive Transcranial Magnetic Stimulation over primary motor cortex name: sham repetitive Transcranial Magnetic Stimulation measure: Change in accuracy measure: Change in reaction time speed measure: Change in pegs placed in 30 seconds sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neuron status: RECRUITING city: Madrid zip: 28045 country: Spain name: Alfredo Lerín Calvo, PhD Student role: CONTACT phone: +34620187457 email: [email protected] lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06262412 id: 2023-02193-01 briefTitle: Internet-delivered Cognitive-behaviour Therapy for Child and Adolescent Body Dysmorphic Disorder overallStatus: RECRUITING date: 2024-02-19 date: 2026-04-30 date: 2026-10-31 date: 2024-02-16 date: 2024-02-26 name: Karolinska Institutet class: OTHER name: Region Stockholm name: Vastra Gotaland Region name: Region Skane briefSummary: The purpose of this trial is to evaluate the clinical efficacy, the cost-effectiveness and the 6-month durability of a therapist-guided, Internet-delivered cognitive-behavior therapy programme for children and adolescents with body dysmorphic disorder. conditions: Body Dysmorphic Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multisite parallel-group randomised controlled superiority trial. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: All study personnel who can be blind to study aims/hypotheses and group allocation, will be blind. Assessors conducting post-treatment and follow-up assessments will be external to the research team and blind to study aims/hypotheses and treatment allocation for the full duration of the trial (up to the 6-month follow-up). The assessors will not receive any information about the study design, objectives or treatment conditions in order to maximise the blinding integrity. At each follow-up assessment, participants will be reminded by their assessor to not reveal details about their treatment. whoMasked: OUTCOMES_ASSESSOR count: 154 type: ESTIMATED name: Internet-delivered cognitive-behaviour therapy (ICBT) name: Internet-delivered relaxation treatment (IRT) measure: Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version (BDD-YBOCS-A) measure: Treatment response and full or partial remission measure: Clinical Global Impression - Severity (CGI-S) measure: Clinical Global Impression - Improvement (CGI-I) measure: Children's Global Assessment Scale (CGAS) measure: Appearance Anxiety Index (AAI) measure: Short Mood and Feeling Questionnaire - child version and parent version (SMFQ) + additional suicide item (only child/adolescent) measure: Generalized Anxiety Disorder - 7 item scale (GAD-7) measure: Deliberate Self-Harm Inventory - Youth version (DSHI-Y-7) measure: CRAFFT (acronym for the key words Car, Relax, Alone, Forget, Friends and Trouble) measure: Work and Social Adjustment Scale - youth (WSAS-Y) and parent version (WSAS-P) measure: Child Health Utility 9D (CHU9D) measure: Trimbos/iMTA Questionnaire for Costs associated with Psychiatric Illness (TiC-P) measure: Working Alliance Inventory - child (WAI-C) and parent version (WAI-P) measure: Client Satisfaction Questionnaire (CSQ-8) measure: Treatment Credibility and Expectancy Scale (TCES) measure: Patient Exposure/Relaxation Adherence Scale (PEAS/PRAS) measure: Treatment preference measure: Areas of concern and cosmetic procedures measure: School absenteeism measure: Concurrent interventions measure: BASS platform usage data measure: Completed modules measure: Adverse events questionnaire sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: BUP OCD och relaterade tillstånd status: RECRUITING city: Stockholm zip: 113 30 country: Sweden name: Anita Birovecz, MSc role: CONTACT phone: +46 70 275 61 25 email: [email protected] lat: 59.33258 lon: 18.0649 hasResults: False
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<|newrecord|> nctId: NCT06262399 id: ITL-2002-CL-999 id: 2022-003778-22 type: EUDRACT_NUMBER briefTitle: Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2040-04 date: 2040-04 date: 2024-02-16 date: 2024-02-16 name: Intellia Therapeutics class: INDUSTRY briefSummary: This is a follow-up study of subjects who received NTLA-2002 in a previous clinical trial as an observational evaluation of the long-term effects of the investigational therapy. conditions: Hereditary Angioedema studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Incidence of treatment-related Adverse Events (AEs); incidence of treatment-related Serious Adverse Events (SAEs); incidence of treatment-related Adverse Events of Special Interest (AESIs) defined per protocol measure: To evaluate the long-term efficacy of NTLA-2002 in previously treated subjects measure: Change from baseline in consumption of on-demand HAE medications for reported HAE attacks measure: Change from baseline in healthcare utilization for HAE attacks measure: Change from baseline in QoL parameters as measured by the MOXIE Angioedema-QoL instrument. measure: Change from baseline in QoL parameters as measured by the EQ-5D-5L instrument. measure: Change from baseline in QoL parameters as measured by the WPAI:GH instrument. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Centre National de Reference - Grenoble city: Grenoble country: France lat: 45.16667 lon: 5.71667 facility: Hôpital Claude Huriez city: Lille country: France lat: 50.63297 lon: 3.05858 facility: New Zealand Clinical Research city: Auckland country: New Zealand lat: -36.84853 lon: 174.76349 facility: Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital city: Cambridge country: United Kingdom lat: 52.2 lon: 0.11667 hasResults: False
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<|newrecord|> nctId: NCT06262386 id: 202202172B0 briefTitle: Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial overallStatus: RECRUITING date: 2023-08-01 date: 2028-07-31 date: 2028-07-31 date: 2024-02-16 date: 2024-02-16 name: Chang Gung Memorial Hospital class: OTHER name: National Science and Technology Council briefSummary: For patients with lung cancer who have undergone tumor resection, early relapse significantly impacts survival. However, there are currently no reliable screening or imaging tools available to identify patients at risk of early relapse. To address this clinical challenge, many studies have focused on understanding the clinicopathologic characteristics associated with an increased risk of early relapse. Despite these efforts, we can identify patients at risk but cannot pinpoint which individuals will actually experience early relapse. Studies on adjuvant therapy have shown improved survival in cases of more advanced disease but have not demonstrated a reduction in early relapse rates.
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In our preliminary analysis of previous study data, we observed that patients with a smaller reduction in circulating tumor cells (CTCs) within the first three days after surgery, followed by an increase on the third-day post-operation, are more likely to experience early relapse during regular monitoring. This pattern may be indicative of minimal residual disease. By combining trends in circulating tumor cell variations with pathologic characteristics, we aim to select patients for adjuvant therapy who are at high risk of developing early relapse.
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The objective of our study is to employ screening based on circulating tumor cell dynamics and pathologic features to identify patients likely to experience early relapse and to assess the effectiveness of adjuvant therapy in these cases. conditions: Lung Cancer conditions: Relapse/Recurrence studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 358 type: ESTIMATED name: Cisplatin based chemottherapy measure: Accuracy of proposed relapse prediction model measure: early relapse rate measure: Overall surveival sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ching-Yang Wu status: RECRUITING city: Taoyuan City zip: 333 country: Taiwan name: Ching-Yang Wu role: CONTACT phone: +886975368204 email: [email protected] name: Jason CH Hsieh role: CONTACT phone: +886975366137 email: [email protected] name: Jui-Ying Fu role: SUB_INVESTIGATOR name: Ching-Feng Wu role: SUB_INVESTIGATOR lat: 24.95233 lon: 121.20193 hasResults: False
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<|newrecord|> nctId: NCT06262373 id: 221321 briefTitle: Angular Pregnancy - Ultrasound Definition and Correlation With Clinical Outcomes overallStatus: COMPLETED date: 2017-10-01 date: 2019-10-01 date: 2019-10-01 date: 2024-02-16 date: 2024-02-16 name: King's College Hospital NHS Trust class: OTHER briefSummary: The aim of this study is to establish clinically meaningful ultrasound-based diagnostic criteria for AP. To this end, the investigators will prospectively collect clinical and ultrasound data from early intrauterine pregnancies and correlate this data with pregnancy outcomes (particularly with risk of miscarriage), to establish whether there are any diagnostic criteria that can be used to make the diagnosis, facilitate increased surveillance of at risk pregnancies and reassure those with normally located pregnancies. The collected data will be used to correlate incidence of angular pregnancy and clinical variables such as maternal age, uterine fibroids, assisted conception, multiple pregnancy, ethnicity, previous uterine and adnexal surgery. conditions: Miscarriage in First Trimester studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 236 type: ACTUAL name: Ultrasound measure: Primary measure: Secondary measure: Secondary sex: FEMALE minimumAge: 16 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: King's College Hospital city: London zip: SE5 9RS country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06262360 id: P2023457 briefTitle: Changes in Pulmonary Ventilation Distribution Assessed by Electrical Impedance Tomography in Healthy Children Under General Anesthesia acronym: EIT_ped overallStatus: RECRUITING date: 2024-02-16 date: 2024-06-30 date: 2024-09-30 date: 2024-02-16 date: 2024-02-21 name: Queen Fabiola Children's University Hospital class: OTHER briefSummary: The incidence of atelectasis is high in patients undergoing general anesthesia. This may cause oxygenation impairment and further contribute to post-operative pulmonary complications. As important airway management devices for general anesthesia, few studies have compared the impact of laryngeal mask airway and spontaneous breathing on atelectasis. Through the study, the distribution of the pulmonary ventilation of children undergoing an elective and standard procedure in our center (H.U.D.E.R.F.) will be studied using electric impedance tomography.
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Children from 1 year-old to 6-year-old, ASA physical status I or II who will undergo elective circumcisions under general anesthesia associated with regional anesthesia (Penile Block10) at the One Day Clinic of H.U.D.E.R.F. (Hôpital des Enfants Reine Fabiola - Brussels - Belgium).
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Patients will be allocated to three different group in a ration of 1:1:1.
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* Group 1: spontaneous mask ventilation (20 patients).
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* Group 2: spontaneous laryngeal mask (LMA) ventilation (20 patients).
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* Group 3: spontaneous-pressure support LMA ventilation (LMA SV-PS) (20 patients).
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* Standard monitoring for the inductions of the anesthesia will include non-invasive blood pressure (NIBP), pulse oximetry (SpO2), Electrocardiogram (ECG), End-Tidal CO2 (EtCO2), End Tidal Sevoflurane concentration (EtSev %), inspired fraction of oxygen (FiO2), body temperature (rectal thermometer).
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Induction is based as well on the local routine protocols using an inhalation induction of the patient with Sevoflurane (Fet of 6-8%) and a recommended FiO2 from 80-90% maximum until the stabilization of the induction. Then the FiO2 will be decreased at least under 40% and Sevoflurane adapted to the need of the deepness of the anesthesia (both at the discretion of the anesthesiologist in charge of the patient).
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Depending on the randomization, the patient will undergo the surgery either with spontaneous face mask ventilation (group 1), LMA spontaneous ventilation (group 2), or LMA SV-PS (group 3) (during which the pressure support will be adapted at the discretion of the anesthesiologist but with a tidal volume included in the range of 6-10ml/kg).
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Electrical impedance tomography measurements:
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The effects of the spontaneous breathing (mask ventilation or LMA) or the pressure support ventilation (LMA SV-PS) on atelectasis formations and the distribution of the ventilation will be assessed using electrical impedance tomography.
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The device used during the study will be the "PulmoVista 500"; it will be provided by Dräger (Lübeck, Germany) free of charge and without any obligation or results/conclusions requested by Dräger. The device is approved CE (European regulation) and will be used in the conditions for which it has been designed.
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A reusable belt with 16 evenly spaced electrodes will be placed around the chest of each patient included in the study between the 4th and 6th ribs as recommended by Dräger.
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The EIT measurements will be taken of 4 different moments:
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T1: Before induction of the anesthesia in the preoperatory waiting room (and at least 30 min after the premedication).
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T2: After the induction of anesthesia (GA and penile block), just before the beginning of the surgical procedure.
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T3: After the end of the surgical procedure, just before discontinuing the general anesthesia.
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T4: Before the discharge of the PACU. conditions: Anesthesia, Pediatric studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: General anesthesia with mask ventilation name: General anesthesia and spontaneous laryngeal mask ventilation name: General anesthesia with spontaneous laryngeal mask ventilation with pressure support measure: Variation of poorly ventilated pulmonary zones sex: ALL minimumAge: 1 Year maximumAge: 6 Years stdAges: CHILD facility: H.U.B - Hôpital Universitaire des Enfants Reine Fabiola status: RECRUITING city: Brussels zip: 1020 country: Belgium name: Denis Schmartz, MD role: CONTACT phone: +3225553919 email: [email protected] lat: 50.85045 lon: 4.34878 hasResults: False
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<|newrecord|> nctId: NCT06262347 id: 2024-0115 id: UG1DA013732 type: NIH link: https://reporter.nih.gov/quickSearch/UG1DA013732 briefTitle: Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD acronym: TOME overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-20 date: 2025-06-20 date: 2024-02-16 date: 2024-02-20 name: T. John Winhusen, PhD class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) name: National Institute on Drug Abuse (NIDA) briefSummary: The primary objective of this study is to evaluate the ability of TOME to increase Medication for Opioid Use Disorder (MOUD) and opioid-overdose knowledge in pregnant and postpartum persons. conditions: Opioid Use Disorder conditions: Pregnancy Related conditions: Substance Use conditions: Drug Abuse conditions: Drug Abuse in Pregnancy conditions: Drug Addiction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is an intent-to-treat, two-arm, open-label, randomized controlled trial. primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME) name: Control measure: Medication for Opioid Use Disorder (MOUD) knowledge score measure: Opioid Overdose knowledge score measure: Medication for Opioid Use Disorder (MOUD) Internalized Stigma measure: Drug Self-efficacy sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06262334 id: Pro00133917 id: K23MD016123 type: NIH link: https://reporter.nih.gov/quickSearch/K23MD016123 briefTitle: Evaluating the Fade to Fitness Program: A Barbershop-based Program for Black Men overallStatus: RECRUITING date: 2024-03-20 date: 2024-06-15 date: 2024-06-15 date: 2024-02-16 date: 2024-03-26 name: University of South Carolina class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The Fade to Fitness Program is a targeted intervention designed to improve the holistic health and quality of life among Black men. This comprehensive initiative focuses on four key health behaviors: Physical Activity, Healthy Eating, Stress Management, and Depression Management.
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It is grounded in psychological and social theories like Self-Determination Theory, Motivational Interviewing, and Social Cognitive Theory. The program emphasizes the importance of making informed choices, feeling competent and connected, and learning through observation and modeling. Facilitators play a pivotal role, leading group discussions, providing support, and fostering an inclusive atmosphere.
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The program is structured into weekly sessions that tackle each health behavior, interspersed with off weeks; for community engagement, especially in barbershops, to discuss health topics and promote a healthier lifestyle. conditions: Health Related Quality of Life studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: The Fade to Fitness Program measure: Number of men who are eligible/eligible. measure: Length of time needed to enroll 15 men measure: Facilitator-assessed attendance in intervention measure: Number of men who express interest in the study measure: Attrition in intervention measure: Acceptability, appropriateness, demand, implementation, practicality, and integration of the intervention measure: Change in weight measure: Change in body mass index measure: Change in moderate-to-vigorous physical activity measure: Global Health - Mental 2a measure: Global Health - Physical 2a measure: Perceived Stress Scale measure: Emotional Distress - Depression - Short Form 4a measure: Healthy Eating Subscale of the Health Promotion Lifestyle Profile II measure: Instrumental Support- Short Form 4a measure: Informational Support - Short Form 4a measure: Emotional Support - Short Form 4a measure: Companionship - Short Form 4a measure: Motivation and Attitudes Towards Changing Health (MATCH) measure: NIH Self-Efficacy Measure measure: Subjective Social Norms of Health Behavior measure: Valuing Questionnaire measure: Diet sex: MALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of South Carolina status: RECRUITING city: Columbia state: South Carolina zip: 29208 country: United States name: Guillermo M Wippold, PhD role: CONTACT phone: 803-216-1051 email: [email protected] name: Guillermo M Wippold, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.00071 lon: -81.03481 hasResults: False
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