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Baseline data collection for each participant will be obtained, and the study will be analyzed using descriptive statistics, a paired t-test and independent t-test. The statistical significance level will be set at P=0.05. conditions: Musculoskeletal Disorders conditions: Stress Management conditions: Perceived Stress conditions: Reported Stress conditions: Perceived Pain conditions: Reported Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The experimental group will receive the Barre stretching intervention. The control group will not receive any intervention. primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 63 type: ESTIMATED name: Barre Stretching Intervention measure: Self-Reported Stress (Perceived Stress Scale) measure: Self-Reported Pain (Numerical Pain Rating Scale/Visual Analog Scale) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Idaho State University city: Pocatello state: Idaho zip: 83209 country: United States name: Crystal Kanderis Lane, MS role: CONTACT phone: 208-282-4209 email: crystalkanderisla@isu.edu name: Leciel Bono, PhD(s) role: CONTACT phone: (208)282-3076 email: lecielbono@isu.edu lat: 42.8713 lon: -112.44553 hasResults: False
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<|newrecord|> nctId: NCT06279169 id: 2023-BRT-SBF-113355 briefTitle: The Effect of Heart Sound and White Noise on Pain and Physiological Parameters During Hepatitis B Vaccine Injection overallStatus: RECRUITING date: 2024-04-24 date: 2025-08-29 date: 2025-08-29 date: 2024-02-26 date: 2024-04-26 name: Bartın Unıversity class: OTHER briefSummary: It can cause physiological and behavioral changes in infants such as pain, tachycardia, hypoxemia, increased blood pressure, grimacing, prolonged crying, and irritability. Vaccination is an important part of neonatal nursing care. Newborns express their pain nonverbally and behaviorally. Therefore, any pain assessment is based on the ability of others to recognize pain symptoms. This randomized controlled trial was planned to evaluate the effect of heart sound and white noise on pain and physiological parameters during intramuscular injection of hepatitis B vaccine in newborns. This randomized controlled study used parallel trial design. conditions: Pain, Acute conditions: Newborn; Vitality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 99 type: ESTIMATED name: Heart Sound name: White Noise measure: The Newborn Infant Pain Scale (NIPS) measure: oxygen saturation measure: heart rate measure: Crying Time sex: ALL minimumAge: 2 Days maximumAge: 28 Days stdAges: CHILD facility: Bartın University status: RECRUITING city: Bartın country: Turkey name: Fatma Dinç, Asst.Prof. role: CONTACT phone: +9005383555685 email: fatmadinc@bartin.edu.tr name: Aylin Kurt, Asst.Prof. role: CONTACT phone: +9005382087211 email: aylinkurt67@gmail.com lat: 41.63583 lon: 32.3375 hasResults: False
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<|newrecord|> nctId: NCT06279156 id: MTU-EC-IM-0-014/65 briefTitle: Optimal Frequency of Total Body Water Measurements by Bioelectrical Impedance Analysis to Prevent Intradialytic Hypotension overallStatus: COMPLETED date: 2022-06-01 date: 2023-02-28 date: 2023-02-28 date: 2024-02-26 date: 2024-03-06 name: Thammasat University Hospital class: OTHER briefSummary: The goal of this clinical trial was to compare the efficiencies of bioelectrical impedance analysis (BIA) measurement frequency in preventing intradialytic hypotension in end-stage renal disease (ESRD) patients undergoing regular hemodialysis. The main question aimed to answer about the optimum frequency of BIA measurements to prevent intradialytic hypotension.
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Participants underwent BIA measurements to determine their appropriate dry weight, and factors affecting intradialytic hypotension.
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Researchers compared the efficiencies of BIA measurements between the every-1-month group and the every-2-month group to prevent intradialytic hypotension. conditions: Intradialytic Hypotension conditions: End Stage Renal Disease on Dialysis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 94 type: ACTUAL name: Bioelectrical Impedance Analysis (BIA) measure: incidence rate ratio of intra-dialytic hypotension of every-1-month BIA to every-2-month BIA measure: factors affecting intra-dialytic hypotension sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thammasat University Hospital city: Pathum Thani zip: 12120 country: Thailand lat: 14.01346 lon: 100.53049 hasResults: False
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<|newrecord|> nctId: NCT06279143 id: dOCT-pBCC briefTitle: The Diagnostic Accuracy of Advanced Imaging in Identifying Suspected Skin Cancer (Basal Cell Carcinoma) Around the Eyes acronym: dOCT-pBCC overallStatus: RECRUITING date: 2024-04-04 date: 2026-08-31 date: 2026-11-30 date: 2024-02-26 date: 2024-04-25 name: Vejle Hospital class: OTHER briefSummary: The purpose is to investigate the diagnostic value (sensitivity and specificity) of dermal-Optical Coherence Tomography (D-OCT, VivoSight Dx), in patients with clinically suspected BCC lesions inside the periocular region and compare these results to previous reports using D-OCT in diagnosing lesions outside the periocular area.
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The Hypotheses:
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* The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is comparable to previous reports on BCC lesions outside the periocular region when the standard D-OCT probe is used.
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* The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is increased when the customised D-OCT probe is used.
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* The sensitivity and specificity of D-OCT in diagnosing periocular BCC is comparable to punch biopsy when both standard and the customised D-OCT probes are used.
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* D-OCT with the 10 and 20-millimeter standoff is capable of subtyping periocular BCC.
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* The inter-observer variation in diagnosing and sub-typing periocular BCC decreases with increasing experience in the scanning procedure.
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* The number of scans to correctly interpret D-OCT decreases with increasing experience in the scanning procedure.
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* Delineation of periocular BCC tumour extension is possible using both D-OCT probes conditions: BCC - Basal Cell Carcinoma conditions: BCC conditions: Skin Diseases conditions: Eyelid Tumor conditions: Eyelid Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 210 type: ESTIMATED measure: Diagnostic accuracy of D-OCT in diagnosing BCC inside the periocular region, compared to previous reports on lesions outside the periocular region measure: Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for diagnosing BCC measure: Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for subtyping BCC measure: Observer agreement in identifying presence/absence of BCC lesions, using D-OCT measure: Observer agreement in classifying BCC lesions into subtypes, using D-OCT measure: Observer agreement in mapping BCC lesions prior to surgery, using D-OCT measure: Quantification of learning curve in correctly diagnosing BCC over time with increasing experience with D-OCT measure: Quantification of learning curve in correctly identifying BCC subtypes over time with increasing experience with D-OCT measure: Quantification of skills in correctly demarcating BCC over time with increasing experience with D-OCT measure: Accuracy of D-OCT in delineation of periocular BCC extension prior to surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital status: RECRUITING city: Vejle state: Region Of Southern Danmark zip: 7100 country: Denmark name: Sveina B Karlsdóttir, MD role: CONTACT phone: 53420448 phoneExt: 0045 email: sveina@outlook.dk name: Susanne Støvring role: CONTACT phone: 79406461 phoneExt: 0045 email: susanne.stoevring@rsyd.dk lat: 55.70927 lon: 9.5357 hasResults: False
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<|newrecord|> nctId: NCT06279130 id: N23NEO briefTitle: Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations acronym: NEOASIS overallStatus: RECRUITING date: 2024-01-29 date: 2029-01-29 date: 2034-01-29 date: 2024-02-26 date: 2024-02-26 name: The Netherlands Cancer Institute class: OTHER name: Agenus Inc. briefSummary: In this study, the efficacy of botensilimab and balstilimab in mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR) tumors will be assessed. conditions: Resectable MMR-deficient Solid Tumors conditions: Resectable MMR-proficient Solid Tumors studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Basket, open-label primaryPurpose: TREATMENT masking: NONE count: 92 type: ESTIMATED name: botensilimab name: balstilimab measure: Major pathological response rate measure: Pathological response rates measure: Event free survival measure: Disease free survival measure: Overall survival measure: Radiological response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Netherlands Cancer Institute status: RECRUITING city: Amsterdam state: Noord-Holland zip: 1066 CX country: Netherlands name: Marieke van de Belt, MsC role: CONTACT name: Myriam Chalabi, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 hasResults: False
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<|newrecord|> nctId: NCT06279117 id: 2023/9/8 briefTitle: The Effect of Therapeutic Touch on Exam Anxiety overallStatus: RECRUITING date: 2024-01-15 date: 2024-02-23 date: 2024-03-10 date: 2024-02-26 date: 2024-02-26 name: Dokuz Eylul University class: OTHER briefSummary: Aim: This study was planned to determine the effect of therapeutic touch applied to nursing students on test anxiety.
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Method: Students who met the inclusion criteria were divided into therapeutic touch and control groups using the randomization method. After the groups were determined, the students filled out the Introductory Information Form and the State Exam Anxiety Scale. 30 minutes before the exam, therapeutic touch was applied to each of the students, who were divided into groups, for 20 minutes. No application was made to the control group, and they were told to wait in the classroom where the group was waiting as they wished.Immediately after the application was completed, the scale was re-applied to both groups. conditions: Test Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled clinical trial primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: therapeutic touch measure: Text Anxiety measure: Text Anxiety sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Gizem Göktuna status: RECRUITING city: İzmir zip: 35000 country: Turkey name: Gizem Göktuna role: CONTACT phone: +905448303393 email: gizemgoktuna@gmail.com lat: 38.41273 lon: 27.13838 hasResults: False
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<|newrecord|> nctId: NCT06279104 id: 2023-TJ-OCCC briefTitle: A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-05-01 date: 2025-05-01 date: 2024-02-26 date: 2024-02-26 name: Tongji Hospital class: OTHER name: Wuhan Union Hospital, China name: Henan Cancer Hospital name: Qilu Hospital of Shandong University name: Hubei Cancer Hospital name: Anhui Provincial Cancer Hospital name: Peking University Cancer Hospital & Institute name: Hunan Province Tumor Hospital name: First Affiliated Hospital of Suzhou Medical College name: Shandong Tumor Hospital name: Chongqing University Cancer Hospital name: First Affiliated Hospital of Zhongshan Medical University name: Peking University Shenzhen Hospital briefSummary: The goal of this observational study is to learn about the treatment effectiveness of physician's choice of chemotherapy and the immune checkpoint inhibitor (ICI)-based therapy in patients with relapsed/refractory ovarian clear cell carcinoma (OCCC), and compare the treatment response with the phase II, single-arm clinical trial INOVA to investigate the efficacy of combinational therapy of sintilimab plus bevacizumab. The main questions it aims to answer are:
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* What is the efficacy of physician's choice of chemotherapy in relapsed/refractory OCCC patients in the real world?
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* Is ICI-based therapy more effective than physician's choice of chemotherapy in real-world for relapsed/refractory OCCC patients?
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* Dose the combinational regimens of sintilimab plus bevacizumab in Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma (INOVA) trial more effective than physician's choice of chemotherapy?
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Participants will be respectively retrieved and extracted de-identified, longitudinal electronic health records (EHR)-derived data. conditions: Ovarian Clear Cell Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: physician's choice of chemotherapy name: immune checkpoint inhibitor based therapy measure: tumor response rate measure: progression-free survival (PFS) measure: time to response (TTR) measure: duration of response (DOR) measure: disease control rate (DCR) sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06279091 id: A0104023PP briefTitle: Correlation of Children and Parental Anxiety and Effectiveness of Breathing Exercises on Anxiety Reduction overallStatus: ACTIVE_NOT_RECRUITING date: 2023-05-23 date: 2023-11-05 date: 2024-05-23 date: 2024-02-26 date: 2024-02-26 name: Mansoura University class: OTHER briefSummary: The purpose of this study to evaluate the correlation between children and parental dental anxiety as well as to evaluate the effectiveness of breathing exercises on anxiety reduction. conditions: Dental Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Selected children will be divided randomly into 3 groups:
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Control group (Group I). Diaphragmatic Breathing group (Group II). Bubble Blower Breathing group (Group III). primaryPurpose: OTHER masking: NONE count: 90 type: ESTIMATED name: Diaphragmatic Breathing name: Bubble Blower Breathing name: Tell Show Do measure: scale of dental anxiety by Corah Dental Anxiety Scale (CDAS) measure: scale of dental anxiety by Facial Image Scale (FIS) measure: scale of dental anxiety by Venham Clinical Anxiety Scale (VCAS) measure: scale of dental anxiety by Pulse Oximeter sex: ALL minimumAge: 5 Years maximumAge: 8 Years stdAges: CHILD facility: Mansura University city: Mansoura state: Dakahlia zip: 35511 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False
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<|newrecord|> nctId: NCT06279078 id: AJOUIRB-DB-2023-446 briefTitle: Long-term Effect of Steroid on Metabolic Diseases in Asthmatics overallStatus: RECRUITING date: 2023-12-30 date: 2024-12-30 date: 2025-06-30 date: 2024-02-26 date: 2024-02-26 name: Ajou University School of Medicine class: OTHER name: AstraZeneca briefSummary: The goal of this retrospective/observational study is to compare the clinical outcomes between the high-cumulative-dose group and the low- cumulative-dose group of oral/inhaled corticosteroid in the long-term management of asthma patients. The main hypothesis are:
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i. High cumulative dose of corticosteroid is related to the prevalence of osteoporosis/osteoporosis in the long-term management of adult asthma.
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ii. High cumulative dose of corticosteroid can affect populations that have a high-risk of osteoporosis (females over 50 years of age).
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iii. High cumulative dose of corticosteroid is related to the prevalence of diabetes mellitus, hypertension, and hyperlipidemia in the long-term management of adult asthma.
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iv. High cumulative dose of corticosteroid affects bone metabolism-related diagnostic tests and laboratory values and the prescription rate of bone metabolism-related medications. conditions: Asthma conditions: Osteoporosis, Osteopenia conditions: Osteoporosis Risk conditions: Osteoporotic Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20000 type: ESTIMATED name: Corticosteroid measure: Prevalence of osteoporosis/osteopenia measure: Bone mineral density (BMD) score measure: Total alkaline phosphatase measure: Corrected calcium measure: Serum phosphate measure: Serum albumin measure: prevalence of steroid related comorbidities(Diabetes Mellitus, Hypertension, Hyperlipidemia, etc.) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ajou University Medical Center status: RECRUITING city: Suwon state: Gyeonggi zip: 16499 country: Korea, Republic of name: Hyun-Seob Jeon, M.D. role: CONTACT phone: +82-31-219-4612 email: googlingpenguin@gmail.com name: Hae-Sim Park, M.D., Ph.D. role: CONTACT phone: +82-31-219-4779 email: hspark@ajou.ac.kr lat: 37.29111 lon: 127.00889 hasResults: False
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<|newrecord|> nctId: NCT06279065 id: 373/23-EP briefTitle: Investigation of the Influence of the Human Microbiome on the Pathogenesis and Recurrence Probability in Giant Cell Arteritis acronym: GCA-Biom overallStatus: RECRUITING date: 2024-02-18 date: 2026-02-18 date: 2028-02 date: 2024-02-26 date: 2024-02-26 name: University of Bonn class: OTHER briefSummary: The longitudinal observational study aims to assess the impact of the microbiome especially the gut-microbiome in the emergence and course of giant cell arteritis (GCA) patients. At diagnosis and 6 month follow up we will analyze the oral, blood and gut microbiome from GCA patients and healthy controls. Thereby identified potential candidate commensal will be further analyzed for possible interactions and influence on the immune system. conditions: Giant Cell Arteritis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Analysis of blood and microbiome samples (stool, oral lavage) measure: Significant differences in the composition of the microbiome measure: Influence of the microbiome on therapy response e.g. increased probability of recurrence with accumulation of specific microbiome species measure: potential association of microbiom composition with application of immune modulating drugs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn status: RECRUITING city: Bonn state: North Rhine-Westphalia zip: 53127 country: Germany name: Valentin S. Schäfer, Dr. med. role: CONTACT phone: +49 228 287-17000 email: rheumatologie@ukbonn.de lat: 50.73438 lon: 7.09549 facility: University Hospital Bonn status: RECRUITING city: Bonn zip: 53127 country: Germany name: Valentin Schäfer, MD role: CONTACT phone: +28 287 17000 email: rheumatologie@ukbonn.de name: Maike Adamson role: CONTACT phone: +28 287 17000 email: rheumatologie@ukbonn.de lat: 50.73438 lon: 7.09549 hasResults: False
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<|newrecord|> nctId: NCT06279052 id: RC31/23/0535 briefTitle: Adolescent Projections During Transition in Prader-Willi Syndrome acronym: APT-WILL overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-01 date: 2024-12-01 date: 2024-02-26 date: 2024-02-28 name: University Hospital, Toulouse class: OTHER briefSummary: Single-center, cross-sectional qualitative study seeking to collect the experience of adolescence and the transition to adulthood of people affected by Prader-Willi syndrome in a population. To do this, the present will carry out a qualitative study with a reflexive thematic analysis of the data collected through semi-structured interviews using an interview guide. conditions: Prader-Willi Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Phone interview measure: Experience of the disease and aspirations regarding the future sex: ALL minimumAge: 15 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: CHU de Toulouse city: Toulouse country: France name: Grégoire BENVEGNU role: CONTACT email: benvegnu.g@chu-toulouse.fr name: Dalil Benkanoun role: CONTACT email: dalil.benkanoun@hotmail.fr lat: 43.60426 lon: 1.44367 hasResults: False
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<|newrecord|> nctId: NCT06279039 id: KY20230116-06 briefTitle: Clinical Observation of Exosomes in Patients After Q-switched Laser Surgery overallStatus: RECRUITING date: 2022-09-01 date: 2024-08-31 date: 2024-12-31 date: 2024-02-26 date: 2024-02-26 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: the goal of this half-face controlled study is to evaluate the effect of exosome-containing liquid dressings on the recovery of patients after Nd:YAG laser 532 treatment. conditions: Exosome conditions: Skin Regeneration conditions: Laser studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 38 type: ESTIMATED name: Exosome liquid dressing measure: Global Aesthetic Improvement Scale score measure: Dermatology Quality of life index measure: post-inflammatory hyperpigmentation sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Jie Dai status: RECRUITING city: Nanjing state: Jiangsu zip: 210006 country: China name: jie dai role: CONTACT phone: 02552271117 email: karry_dj@126.com lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06279026 id: PG-006-5 briefTitle: UTAA17 Injection in the Treatment of Relapsed/Refractory Multiple Myeloma overallStatus: RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2027-07-01 date: 2024-02-26 date: 2024-02-26 name: PersonGen BioTherapeutics (Suzhou) Co., Ltd. class: INDUSTRY name: Second Affiliated Hospital of Soochow University briefSummary: The clinical trial was designed as a single-arm, open-label clinical study, with the main purpose of exploring the safety, pharmacokinetics, and best recommended dose (RP2D) of the UTAA17 injection in the treatment of relapsed or refractory multiple myeloma (r/r MM) subjects, and also the efficacy will be observed. Eligible subjects will accept the infusion of UTAA17 injection after pretreatment, and their blood will be collected before and after infusion for evaluation of pharmacokinetics, immunogenicity and safety. This study plans to evaluate efficacy using the revised Evaluation of Efficacy in multiple myeloma -IMWG criteria (2016), which will be evaluated at 4w, 2m, 3m, 6m, and 6 to 24m (at a frequency of Q3m) after cell reinfusion, in addition to the baseline period. Efficacy evaluation continues until one of the following occurs: subject disease progression (PD), acceptance of a new antitumor therapy, death, occurrence of intolerable toxicity, investigator decision, or patient decision to withdraw. conditions: Relapsed/Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: UTAA17 injection primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: UTAA17 Injection measure: DLT measure: RP2D sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Soochow University status: RECRUITING city: Suzhou state: Jiangsu zip: 215000 country: China name: Huimin Meng, doctor role: CONTACT phone: +86-18015580390 email: huimin.meng@persongen.com.cn lat: 31.30408 lon: 120.59538 hasResults: False
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<|newrecord|> nctId: NCT06279013 id: NRG-CC012CD id: NCI-2023-10831 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: NRG-CC012CD type: OTHER domain: NRG Oncology id: NRG-CC012CD type: OTHER domain: DCP id: NRG-CC012CD type: OTHER domain: CTEP id: R01CA279472 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA279472 briefTitle: Comparing Telephone Symptom Monitoring Interventions for Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment overallStatus: NOT_YET_RECRUITING date: 2024-06-16 date: 2027-02-01 date: 2028-05-01 date: 2024-02-26 date: 2024-02-28 name: NRG Oncology class: OTHER name: National Cancer Institute (NCI) briefSummary: In this clinical trial, symptom monitoring (interactive voice response \[IVR\] is compared to automated telephone symptom management \[ATSM\] and telephone interpersonal counseling \[TIPC\]) for reducing symptom burden and psychological distress (depressive and anxiety symptoms) among people receiving oral anti-cancer treatment. Symptoms are the number one driver of treatment interruptions and unscheduled health services use. To reduce the risk of these events, symptom monitoring and management are necessary. However, these services are not implemented routinely, especially in the community oncology settings. Further, depressive and anxiety symptoms are a key barrier to enacting symptom self-management strategies. IVR is a form of symptom monitoring where patients, when called, enter their symptom ratings over the phone. Their symptom summary is sent to their provider, and patients may be advised to reach out to their oncology provider, based on their symptoms. The ATSM intervention combines IVR assessments with a Symptom Management and Survivorship educational handbook with self-management strategies. Patients receiving ATSM enter their symptom ratings over the phone and have their symptoms reported to their provider, but patients are also directed to the handbook for strategies to manage elevated symptoms. Patients receiving ATSM who report being anxious, discouraged, or sad will also receive TIPC, which targets psychological distress and its connection to social support and interpersonal communication. Information gathered from this study may help researchers learn more about the best ways to manage patient symptoms and improve patient outcomes. conditions: Hematopoietic and Lymphoid System Neoplasm conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cluster randomized primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Interviewers will be blinded to the study arm; IVR is automated. whoMasked: OUTCOMES_ASSESSOR count: 516 type: ESTIMATED name: Counseling name: Health Education name: Interview name: Medical Chart Review name: Monitoring name: Questionnaire Administration measure: Symptom Severity/Toxicity Index measure: Incidence of Unscheduled Health Services Usage measure: Practice personnel time to address weekly interactive voice response (IVR) symptom reports measure: Treatment fidelity measure: Cost measure: Patient financial burden sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06279000 id: CTU 22/025 briefTitle: Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery acronym: COLCAT overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2027-09-30 date: 2028-09-30 date: 2024-02-26 date: 2024-02-28 name: Cantonal Hospital of St. Gallen class: OTHER briefSummary: Perioperative myocardial injury/infarction (PMI) and major adverse cardiovascular events (MACE) are common causes of morbidity and mortality in patients at increased cardiovascular risk undergoing non-cardiac surgery.
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However, research in recent years has yielded limited preventive and therapeutic measures for PMI/MACE. Recent studies in patients with chronic and acute coronary artery disease have shown that colchicine administration can reduce the risk of cardiovascular events.
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These encouraging results in non-surgical patients ask for a similar investigation in patients undergoing major non-cardiac surgery. The aim of the proposed study is to investigate the effects of perioperative colchicine administration on the incidence of PMI/MACE. conditions: Cardiovascular Diseases conditions: Cardiovascular Complication conditions: Perioperative Complication conditions: Myocardial Infarction studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized, triple-blinded, placebo-controlled, multicenter primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Patients, anaesthesia providers and all other health care workers involved in the treatment and the study personal will be blinded to the group allocation by provision of equal looking study drugs (verum and placebo), which are repacked for blinding. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 880 type: ESTIMATED name: Colchicine name: Placebo measure: Perioperative Myocardial Injury/Infarction measure: Major Adverse Cardiovascular Events measure: New onset Atrial fibrillation measure: postoperative high sensitive cardiac Troponin T concentrations measure: long term cardiovascular outcome measure: Gastrointestinal adverse events sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06278987 id: ANES-2024-32661 briefTitle: Comparison of Cryoablation of Pericapsular Nerve Group (PENG) to Fascia Iliaca Catheter in Patients With a Hip Fracture overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2026-12-01 date: 2024-02-26 date: 2024-03-19 name: University of Minnesota class: OTHER briefSummary: The purpose of this study is to determine if patients with hip fractures who undergo cryoablation of the PENG have improved pain control 30 days from surgery when compared to those who have a fascia iliaca catheter. conditions: Hip Fractures studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized prospective controlled trial. This will be single blinded trial. Randomization will be 1:1 primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: PENG block and cryoablation name: fascia iliaca compartment block measure: Maximum pain score on Post-operative day 30 measure: Opioid use measure: functional pain scores measure: number of patients using opioids measure: Length of Hospital Stay measure: Time to first ambulation measure: Number of patients returned home by Post Operative Day 30 sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06278974 id: PDSFGOCLMC-2023-001 briefTitle: Comparing Myopia Treatments in Youth: Defocus Spectacles, Glasses, and Ortho-K overallStatus: RECRUITING date: 2023-11-10 date: 2025-05-01 date: 2025-05-01 date: 2024-02-26 date: 2024-02-26 name: He Eye Hospital class: OTHER briefSummary: The research project titled "A Comparative Study on the Clinical Efficacy, Quality of Life, and Cost of Use of Peripheral Defocus Spectacles, Frame Glasses, and Orthokeratology Lenses in Myopic Children and Adolescents" aims to evaluate different non-surgical myopia correction methods in children. It focuses on assessing the impact of peripheral defocus spectacles, frame glasses, and orthokeratology lenses on the quality of life, clinical effectiveness, and costs associated with each method. The study is a prospective cohort study involving 300 children aged 13-17 years with myopia ranging from -1.00D to -6.00D. It aims to compare the psychological, social, and educational aspects of these correction methods, alongside their costs and clinical outcomes over a period of one year. conditions: Myopia conditions: Cost-effectiveness Analysis conditions: Quality of Life studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Improvement in Quality of Life Scores measure: Cost-Effectiveness Analysis measure: Clinical Effectiveness Analysis sex: ALL minimumAge: 13 Years maximumAge: 17 Years stdAges: CHILD facility: HeEyeHospital status: RECRUITING city: Shenyang state: Liaoning zip: 110000 country: China name: Lan Hu, Master role: CONTACT phone: 15940406919 email: hulan@hsyk.com.cn lat: 41.79222 lon: 123.43278 hasResults: False
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<|newrecord|> nctId: NCT06278961 id: IRB 2021-4329 briefTitle: Families Filming Infants Learning Movement acronym: FILM overallStatus: RECRUITING date: 2021-01-28 date: 2024-09-30 date: 2024-09-30 date: 2024-02-26 date: 2024-02-26 name: Ann & Robert H Lurie Children's Hospital of Chicago class: OTHER name: Northwestern University name: IRCCS Fondazione Stella Maris name: University of Melbourne name: University of Sydney briefSummary: The study objective is to improve accuracy in the early detection of neurodevelopmental impairment, especially CP, by evaluating the timepoint (in weeks post term age) that the Prechtl GMA is most useful for prediction of neurodevelopmental impairment at two years of age in children with and without medical complexity. The study team plans to recruit 100 healthy, term-born infants and 250 infants at risk of developing CP for a total of 350 enrolled infants. conditions: Infant Development conditions: Cerebral Palsy conditions: Motor Disorders conditions: Neurological Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 350 type: ESTIMATED name: Observational measure: Fidgety Movements in healthy, term born infants measure: Fidgety Movements in children with a range of medical complexities measure: Fidgety Movements and two-year Neurodevelopmental outcomes in health, term born infants measure: Fidgety Movements and two-year Neurodevelopmental outcomes in children with a range of medical complexities sex: ALL minimumAge: 10 Weeks maximumAge: 20 Weeks stdAges: CHILD facility: Feinberg School of Physical Therapy and Human Movement Sciences status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Ryan Millman, B.S. role: CONTACT phone: 847-530-2319 email: ryan.millman@northwestern.edu lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06278948 id: LRP23023-depigmenting cream briefTitle: Efficacy and Tolerability of Test Product Versus Cysteamine 5% in Treatment of Facial Epidermal Melasma overallStatus: RECRUITING date: 2023-10-06 date: 2024-06 date: 2024-06 date: 2024-02-26 date: 2024-02-26 name: Cosmetique Active International class: INDUSTRY briefSummary: This interventional, randomized, investigator blinded, controlled study conducted in one centre consists in a 4-month evaluation period within the same season avoiding sunny season on 140 subjects with facial epidermal melasma. conditions: Melasma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: Group TP name: Group CYS measure: change in mMASI scoring measure: change in Investigator's Global Assessment (IGA) measure: change in Subject Global Assessment of Improvement (SGAI) sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: MS Clinical Research Pvt. Ltd status: RECRUITING city: Bangalore country: India lat: 12.97194 lon: 77.59369 hasResults: False
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<|newrecord|> nctId: NCT06278935 id: APP-24-00887 briefTitle: Lifestyle Tailored Offloading for Diabetic Foot Ulcers overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-02-26 date: 2024-04-02 name: University of Southern California class: OTHER briefSummary: The goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care. The main questions it aims to answer are to determine the acceptability and feasibility of taking a tailored lifestyle-focused approach as part of comprehensive diabetic foot ulcer management. Patient participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention. conditions: Diabetic Foot Ulcer conditions: Diabetic Foot studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Lifestyle-based intervention by a occupational therapist measure: Participant satisfaction measure: Diabetes distress measure: Factors affecting offloading treatment measure: DFU-related outcomes sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06278922 id: STUDY00001149 id: R01AA031010 type: NIH link: https://reporter.nih.gov/quickSearch/R01AA031010 briefTitle: Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2028-09-30 date: 2028-09-30 date: 2024-02-26 date: 2024-02-26 name: University of Massachusetts, Worcester class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: The U.S. Deaf community - a group of more than 500,000 Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking and twice the rate of trauma exposure compared to the general population. Although there are several treatments for alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) in hearing populations, none have been developed for or tested with Deaf clients. To address these barriers, the study team developed Signs of Safety, a Deaf-accessible therapy toolkit for treating AUD and PTSD. Their aims are to conduct a nationwide, virtual clinical trial to compare (1) Signs of Safety with (2) treatment as usual and (3) a no treatment control, to collect data on clinical outcomes, and to explore potential mediators and moderators of outcome. conditions: PTSD conditions: Alcohol; Use, Problem studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The PI and all Co-Is will be masked to study condition. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 144 type: ESTIMATED name: Seeking Safety + Signs of Safety toolkit name: Treatment as usual measure: Change from Baseline Percent Drinking Days Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback measure: Change from Baseline Percent Drinking Days Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback measure: Change from Baseline Percent Drinking Days Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback measure: Change from Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback measure: Change from Baseline Percent Binge Drinking Days Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback measure: Change from Baseline Percent Binge Drinking Days Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback measure: Change from Baseline Number of Drinks Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback measure: Change from Baseline Number of Drinks Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback measure: Change from Baseline Number of Drinks Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback measure: Change from Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Measured by the PCL-5 measure: Change from Baseline Past 30-day PTSD Severity to Three-month Follow-up as Measured by the PCL-5 measure: Change from Baseline Past 30-day PTSD Severity to Six-month Follow-up as Measured by the PCL-5 measure: Change from Baseline Diagnostic and Statistical Manual (DSM)-5 diagnostic criteria for Alcohol Use Disorder to Immediate Post-Treatment as measured by the DSM-5 AUD Assessment Tool measure: Change from Baseline Percent Days of Drug Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana measure: Change from Baseline Number of Instances of Drug Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana measure: Change from Baseline Percent Days of Marijuana Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana measure: Change from Baseline Number of Instances of Marijuana Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana measure: Change from Baseline Percent Days of Tobacco Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana measure: Change from Baseline Number of Instances of Tobacco Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana measure: Change from Baseline Substance-related Problems at Immediate Post-Treatment as Measured by the Short Inventory of Problems Revised (SIPS-R) measure: Change from Baseline Alcohol Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R) measure: Change from Baseline Drug Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R) measure: Change from Baseline Marijuana Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R) measure: Change from Baseline Tobacco Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R) measure: Change from Baseline Psychosocial Functioning at Immediate Post-Treatment as Measured by the Outcome Questionnaire (OQ-30.2) for Adults sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-16 uploadDate: 2024-02-16T10:27 filename: Prot_SAP_000.pdf size: 2163767 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-08-21 uploadDate: 2024-02-16T10:29 filename: ICF_001.pdf size: 85664 hasResults: False
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<|newrecord|> nctId: NCT06278909 id: 6036699 briefTitle: Trigeminal Nerve Stimulation in Treatment-resistant Generalized Anxiety Disorder: a Feasibility Study overallStatus: RECRUITING date: 2024-01-18 date: 2025-01-30 date: 2025-06-30 date: 2024-02-26 date: 2024-03-26 name: Dr. Rafael Freire class: OTHER briefSummary: This is a feasibility study for trigeminal nerve stimulation (TNS) in patients with treatment-resistant generalized anxiety disorder (TR-GAD). Ten participants will receive TNS for 8 weeks as an augmentation strategy to pharmacological treatment for generalized anxiety disorder (GAD).
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* The primary objective is to ascertain if TNS is a safe and well-tolerated treatment for patients with TR-GAD.
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* The secondary objective will be to monitor changes in GAD symptom severity throughout the study.
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Results from this study will inform a randomized controlled trial to be conducted in the future. conditions: Generalized Anxiety Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a traditional feasibility study, which evaluates preliminary safety and effectiveness information. It does not meet the definition of a "device feasibility" study. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Trigeminal Nerve Stimulation measure: Incidence of treatment-emergent adverse events measure: Incidence of treatment-emergent side effects measured with the NSEC measure: Response to treatment defined by CGI-I score below 3 measure: Remission defined by CGI-S score below 3 measure: Change in anxiety severity measured by CGI-S measure: Change of anxiety symptoms measured with GAD-7 measure: Change of anxiety symptoms measured with PSWQ measure: Change of anxiety symptoms measured with BAI sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kingston Health Sciences Centre status: RECRUITING city: Kingston state: Ontario country: Canada name: Yan Deng role: CONTACT phone: +1-613-548-7839 email: yan.deng@queensu.ca name: Rafael Freire, MD PhD role: PRINCIPAL_INVESTIGATOR name: Elisa Brietzke, MD PhD role: SUB_INVESTIGATOR name: Claudio Soares, MD PhD role: SUB_INVESTIGATOR lat: 44.22976 lon: -76.48101 hasResults: False
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<|newrecord|> nctId: NCT06278896 id: 23-684-END briefTitle: Early Neutropenic Fever De-escalation of Antibiotics Study acronym: END overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2028-03-01 date: 2024-02-26 date: 2024-02-26 name: Brigham and Women's Hospital class: OTHER name: Dana-Farber Cancer Institute briefSummary: This is a randomized, open label clinical trial among individuals with hematologic conditions. The trial aims to evaluate the safety and clinical outcomes of de-escalating antibiotic therapy among stable individuals diagnosed with neutropenic fever, in which no bacterial infection has been identified. conditions: Hematologic Malignancy conditions: Febrile Neutropenia conditions: Antibiotic Stewardship studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 260 type: ESTIMATED name: Cessation of antibiotics measure: Mortality, transfer to the ICU, septic shock, culture-confirmed bacteremia measure: Antibiotic utilization measure: Mortality post F&N measure: Drug resistance measure: Clostridium difficile infection measure: Candidiasis measure: Adverse Events measure: Allergic Reactions measure: Bacteremia measure: Neutropenia measure: Length of stay measure: Readmissions measure: Fever sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06278883 id: Pro00115007 id: R01HG011794 type: NIH link: https://reporter.nih.gov/quickSearch/R01HG011794 briefTitle: Genomic Medicine Risk Assessment Care for Everyone - Implementation Phase acronym: GRACE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-06-30 date: 2025-06-30 date: 2024-02-26 date: 2024-03-27 name: Duke University class: OTHER name: National Human Genome Research Institute (NHGRI) briefSummary: The "Genomic medicine Risk Assessment Care for Everyone" (GRACE)" intervention project will develop a scalable end-to-end solution for risk assessment and management that meets the needs of those populations living in low resource settings. The long-term goal is to increase access to and uptake of risk-informed evidence-based guidelines that will improve population health through better patient outcomes, higher quality of life, and decreased costs. The three primary aims are:
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Aim 1: Develop a scalable implementation framework that guides each unique clinical setting, including low resource settings, in deploying GRACE effectively for the needs of their patients and providers.
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Aim 2: Facilitate the potential for genomic medicine to promote population health by broadening access to and uptake of genomic risk assessment by the general population through a pragmatic implementation-effectiveness trial of GRACE.
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Aim 3: Reduce health disparities related to genomic medicine by allowing individual adaption of GRACE to suit their level of resources, education, and access within a pragmatic implementation-effectiveness trial.
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Three sets of participants will be engaged: patients (n=750), providers (n=25), and family members of "probands" (i.e., patients that have a genetic change that increases risk, n\~500).
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Patient participants will be asked to complete a baseline survey, enter their family health history information into MeTree (a family health history web-based platform) and complete a survey about their experience using the platform. Subsequent study procedures will depend on: 1) the results of their MeTree risk evaluation, 2) their acceptance/declination of genetic testing (for those categorized as needing testing by MeTree), and 3) the results of the test (for those accepting testing).
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Provider participants will be providers who are the primary care physicians treating one or more patients enrolled in the patient participant group. Providers will be notified on a patient by patient basis once the patient participant under their care has complete the risk assessment process and the risk report is available from MeTree. At study completion, provider participants will be asked to complete a survey about their demographics, practice, and experiences with the study.
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Blood relatives of the probands who are identified by the proband as open to engaging with the study will be contacted and offered genetic counseling and genetic testing. conditions: Cardiovascular Diseases conditions: Cancer conditions: Liver Diseases conditions: Hyperthermia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Everyone who consents is enrolled in the risk assessment pipeline. primaryPurpose: SCREENING masking: NONE count: 750 type: ESTIMATED name: Disease Risk Assessment measure: Reach of genomic risk assessment measure: Utility of genomic risk assessment measure: Uptake of genetic counseling risk recommendations by the participant measure: Uptake of genetic testing recommendations by the provider sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UF Health Callahan city: Callahan state: Florida zip: 32011 country: United States lat: 30.56218 lon: -81.83066 facility: UF Health Murray Hill city: Jacksonville state: Florida zip: 32205 country: United States lat: 30.33218 lon: -81.65565 facility: UF Health Normandy city: Jacksonville state: Florida zip: 32221 country: United States lat: 30.33218 lon: -81.65565 facility: UF Health Kernan Square city: Jacksonville state: Florida zip: 32246 country: United States lat: 30.33218 lon: -81.65565 facility: UF Health Augustine Oaks city: Jacksonville state: Florida zip: 32258 country: United States lat: 30.33218 lon: -81.65565 hasResults: False
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<|newrecord|> nctId: NCT06278870 id: SYSKY-2023-431-02 briefTitle: Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial overallStatus: RECRUITING date: 2023-09-06 date: 2031-06-30 date: 2031-06-30 date: 2024-02-26 date: 2024-02-26 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: The goal of this multicentre, randomized, double-blind controlled, phase III clinical trial is to compare the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab (THP) for newly diagnosed recurrent/metastatic Human epidermal growth factor receptor 2 (HER2) positive advanced breast cancer, and to explore the impact of biomarkers on clinical efficacy and safety. The main questions it aims to answer are:
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* Analyse the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of THP.
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* Explore the impact of biomarkers on clinical efficacy and safety of the combination of disitamab vedotin in combination with pyrotinib treatment.
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Participants in the experimental group will receive disitamab vedotin in combination with pyrotinib for 6-8 cycles (each cycle lasting 28 days), followed by maintenance treatment with trastuzumab in combination with pyrotinib. Participants in the control group will receive paclitaxel in combination with trastuzumab and pertuzumab for 6-8 cycles (each cycle lasting 21 days), followed by maintenance treatment with trastuzumab and pertuzumab.
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Researchers will compare disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab to see if disitamab vedotin in combination with pyrotinib could be a new option for first-line treatment of HER2-positive metastatic breast cancer. conditions: HER2-positive Metastatic Breast Cancer conditions: First-line Treatment studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 312 type: ESTIMATED name: disitamab vedotin name: Pyrotinib name: trastuzumab name: Pertuzumab name: taxane drug measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Disease control rate (DCR) measure: Objective Response Rate (ORR) measure: Clinical Benefit rate (CBR) measure: Adverse Events (Based on CTCAE 5.0 standards) measure: Quality of Life (QoL) by Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) measure: Exploration of biomarkers sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen Memorial Hospital,Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Herui Yao, PhD role: CONTACT phone: +86 13500018020 email: yaoherui@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06278857 id: QCGC-001/2023 briefTitle: SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr) acronym: SATELLITE overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-30 date: 2028-06-30 date: 2024-02-26 date: 2024-02-26 name: Queensland Centre for Gynaecological Cancer class: OTHER_GOV name: GlaxoSmithKline Research & Development Limited briefSummary: The main goal of this clinical trial is to evaluate dostarlimab, an immunotherapy drug, as a potential alternative to surgery for early-stage endometrial cancer with Mismatch Repair deficiency, a genetic cause for 20-30% of cases. The study aims to establish dostarlimab's efficacy and safety in early-stage endometrial cancer, exploring its potential as a non surgical option for those unsuitable or unwilling to undergo major surgery, allowing for fertility preservation or addressing specific health conditions.
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Participants will have seven dostarlimab sessions over 12 months. The treatment plan involves four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks.
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This research is a promising step toward a new, less invasive treatment choice for patients with specific genetic traits. It expands the range of care options for endometrial cancer. conditions: Endometrial Cancer Stage I conditions: Mmr Deficiency conditions: Endometrioid Endometrial Adenocarcinoma conditions: Immune-related Adverse Event studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a non-randomised, prospective, pilot, open-label, single arm study. Participation in this trial involves seven dostarlimab sessions over 12 months, with a treatment protocol of four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Dostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI] measure: Determine the absence endometrial cancer following protocol treatment regimen of dostarlimab. measure: Determine the safety and tolerability of dostarlimab in participants with early-stage MMR deficient endometrioid endometrial adenocarcinoma. measure: TEAEs/irAEIs Leading to Study Drug Discontinuation measure: TEAEs/irAEIs Leading to Study Withdrawal measure: Clinically Significant Changes in Haematology measure: Clinically Significant Changes in Clinical Chemistry measure: Clinically Significant Changes in Thyroid Function measure: Abnormal Vital Signs measure: Abnormal Electrocardiogram (ECG) Parameters measure: Clinically Significant Abnormal Physical Examination measure: Concomitant Medications measure: Study Feasibility Outcome: Recruitment Rate measure: Study Feasibility Outcome: Rationale for Treatment Discontinuation measure: Study Feasibility Outcome: Study Withdrawal Rate measure: Study Feasibility Outcome: Incidence of Immune-Related Adverse Events (irAEs) measure: Study Feasibility Outcome: Number of Cycles of dostarlimab Completed measure: Qualitative Evaluation by Semi-Structured Interview to gather valuable consumer feedback to inform future clinical research programs. measure: Participant Burden Assessment measure: Participant Burden Assessment - Adverse Events measure: Evaluation of Fertility Outcomes/Pregnancy Plans for WOCBP compare to their pre-treatment reproductive plans. measure: Correlate clinical efficacy (pCR) with irAEs. measure: Fertility outcome within the fertility preservation population - pregnancy rates measure: Fertility outcome within the fertility preservation population - pregnancy loss rates measure: Fertility outcome within the fertility preservation population - live birth rates measure: Fertility outcome within the fertility preservation population - rates of maternal and fetal complications/abnormalities sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Westmead Hospital city: Sydney state: New South Wales zip: 2145 country: Australia name: Sara Baniahmadi role: CONTACT phone: 07 3346 5073 email: s.baniahmadi@uq.edu.au name: Alison Brand, Professor role: PRINCIPAL_INVESTIGATOR lat: -33.86785 lon: 151.20732 facility: Royal Brisbane and Women's Hospital city: Brisbane state: Queensland zip: 4029 country: Australia name: Sara Baniahmadi role: CONTACT phone: 07 3346 5073 email: s.baniahmadi@uq.edu.au name: Vanessa Behan role: CONTACT phone: 07 3346 5590 email: v.behan@uq.edu.au name: Jeffrey Goh, Associate Professor role: PRINCIPAL_INVESTIGATOR lat: -27.46794 lon: 153.02809 facility: Peter MacCallum Cancer Centre city: Melbourne state: Victoria zip: 3000 country: Australia name: Sara Baniahmadi role: CONTACT phone: 07 3346 5073 email: s.baniahmadi@uq.edu.au name: Linda Mileshkin, Professor role: PRINCIPAL_INVESTIGATOR lat: -37.814 lon: 144.96332 hasResults: False
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<|newrecord|> nctId: NCT06278844 id: 3020 briefTitle: Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication acronym: ESCPAND overallStatus: RECRUITING date: 2023-12-12 date: 2026-09 date: 2027-12 date: 2024-02-26 date: 2024-02-26 name: University Hospital, Antwerp class: OTHER briefSummary: This randomized controlled trial aims to investigate the impact of conduction system pacing in comparison to right ventricular apical pacing on exercise capacity, as measured by peak oxygen uptake (VO2peak), in heart failure patients with indication for pacing but no compelling indication for cardiac resynchronization therapy (CRT). The mechanisms of exercise intolerance in heart failure patients influenced by conduction system pacing will be assessed. conditions: Heart Failure With Reduced Ejection Fraction conditions: Heart Failure With Preserved Ejection Fraction conditions: Heart Conduction Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 75 type: ESTIMATED name: Conduction system pacing name: Right ventricular apical pacing measure: Exercise capacity measure: Exercise capacity measure: Echocardiographic parameters (Ejection Fraction) measure: QRS width measure: Biomarker, N-terminal pro B-type natriuretic peptide levels measure: Health-related quality of life scores sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitair Ziekenhuis Antwerpen status: RECRUITING city: Edegem state: Antwerp zip: 2650 country: Belgium name: Faro Verelst role: CONTACT phone: 038213538 email: faro.verelst@uza.be lat: 51.15662 lon: 4.44504 hasResults: False
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<|newrecord|> nctId: NCT06278831 id: 2023-02645 briefTitle: Efficacy of Structured SOcial COnsultation and Support in Reducing the FINancial Burden of Radiotherapy acronym: SOCOFIN-1 overallStatus: RECRUITING date: 2023-07-08 date: 2024-05-31 date: 2024-10-15 date: 2024-02-26 date: 2024-02-26 name: University Medical Center Goettingen class: OTHER briefSummary: Objectives:
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* Assess the extent of financial burden of patients undergoing radiotherapy
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* Identify clinical and socio-economical factors correlated with the occurrence and extent of financial toxicity
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* Design a structured social consultation to reduce financial burden induced by radiotherapy
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