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<|newrecord|> nctId: NCT06276413 id: REBRA id: REBRA type: REGISTRY domain: REBRA briefTitle: REgistRy BRAnch goRE EndopRosthEsis acronym: REBRA overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2030-12-31 date: 2024-02-26 date: 2024-02-26 name: University Hospital Padova class: OTHER briefSummary: Multicenter registry on patients treated by the new Gore thoracic branched endoprosthesis conditions: Aortic Aneurysm, Thoracic conditions: Aortic Dissection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: GORE TAG Thoracic Branch Endoprosthesis measure: early mortality measure: device stability measure: technical success measure: early major adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vascular and Endovascular Clinic - Padova University city: Padova zip: 35020 country: Italy name: Michele Piazza, Pr role: CONTACT phone: 3498644688 email: michele.piazza@unipd.it lat: 45.40797 lon: 11.88586 hasResults: False
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<|newrecord|> nctId: NCT06276400 id: 4-24-0023:1 briefTitle: LPFC Organization in Emotion-Duration Difference Estimation overallStatus: RECRUITING date: 2024-01-29 date: 2028-03-31 date: 2028-03-31 date: 2024-02-26 date: 2024-03-05 name: University of California, Santa Barbara class: OTHER briefSummary: To support optimal behavior in daily life, goals and responses following emotional events should ideally incorporate not only the valence and intensity of prior emotional episodes but also their temporal features, such as the relative duration of positive vs. negative attributes. However, how specific brain regions contribute to the integration of temporal and emotional information and promote goal-directed response remains unknown.
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The goal of this study is to examine how specific brain regions track both emotional and temporal information of dynamic emotional events to inform other related brain regions to guide goal-oriented and context-appropriate actions. The investigators will scan healthy human participants using functional MRI (fMRI) while they view emotional image sequences and track the associated emotional and temporal (duration) information, and act accordingly. The investigators will employ multivariate patterns analysis and pattern similarity analysis to identify brain regions that represent (can decode) emotion, time, and their combined signals, as well as brain regions that represent the associated action goal. In addition, to infer the causal contributions of these brain regions in forming task-relevant representations (emotion, time, and action goal), the same participants will be recruited to receive transcranial magnetic stimulation (TMS) in these regions. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a basic science study in which all participants will participate in all task conditions within each experiment (repeated-measures design). primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Participants will typically be unaware of the conditions presented, though because these involve manipulations of stimuli or task demands, they may be aware of the manipulation. This is not expected to impact the primary outcome measures (e.g., BOLD signal activation patterns). count: 50 type: ESTIMATED name: Emotion valence name: Time name: TMS Stimulation measure: Multivariate BOLD metrics measure: Behavioral response sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: University of California, Santa Barbara status: RECRUITING city: Santa Barbara state: California zip: 93106 country: United States lat: 34.42083 lon: -119.69819 hasResults: False
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<|newrecord|> nctId: NCT06276387 id: K23AT011768-01 type: NIH link: https://reporter.nih.gov/quickSearch/K23AT011768-01 id: K23AT011768 type: NIH link: https://reporter.nih.gov/quickSearch/K23AT011768 briefTitle: Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis acronym: DREAMER overallStatus: RECRUITING date: 2024-01-26 date: 2025-12 date: 2025-12 date: 2024-02-26 date: 2024-02-26 name: University of California, San Francisco class: OTHER name: National Center for Complementary and Integrative Health (NCCIH) briefSummary: This clinical trial will test a mindfulness program in individuals with rheumatoid arthritis (RA). The main goals of this pilot study are to:
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* Assess patient satisfaction with a mindfulness course
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* Identify barriers to participation in, or completion of, a mindfulness course
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* Gather initial information to understand how a mindfulness course impacts RA symptoms
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Participants will:
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* Complete online questionnaires
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* Attend two in-person study visits, involving a brief joint exam and blood draw
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* Roughly half the participants will have the chance to participate in an 8-week online mindfulness course
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* Roughly half the participants will be invited to participate in an online focus group following completion of the mindfulness course
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Researchers will compare those in the mindfulness course with those receiving standard care in preparation for a larger future study to see how mindfulness impacts stress and inflammation in individuals with RA. conditions: Arthritis, Rheumatoid studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to participate in a mindfulness-based stress reduction (MBSR) course or treatment as usual (TAU). Randomization will be done using a program-tracking system. primaryPurpose: OTHER masking: DOUBLE maskingDescription: Physicians completing joint exams to assess clinical disease activity, including the principal investigator, will be blinded to participant assignment. It will not be possible for participants to be blinded to treatment condition. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Mindfulness Program measure: Patient Satisfaction as Assessed by CSQ-8, Adapted for DREAMER Study measure: MBSR Course Attendance (Intervention Adherence) measure: Percent of Study Completers (Study Retention) measure: Clinical Disease Activity Index (CDAI) measure: Disease Activity Score in 28 Joints (DAS-28) measure: Modified Rheumatoid Arthritis Disease Activity Index, 5-item (RADAI-5) measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference, 4-Item Scale measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue, 4-Item Scale measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mindfulness, 13-item Scale measure: Perceived Stress Scale, 10-item measure: Brief Resilience Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Osher Center for Integrative Health status: RECRUITING city: San Francisco state: California zip: 94115 country: United States lat: 37.77493 lon: -122.41942 hasResults: False
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<|newrecord|> nctId: NCT06276374 id: SMC 2023-12-107 briefTitle: Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-11-30 date: 2027-12-31 date: 2024-02-26 date: 2024-02-26 name: Woo-Keun Seo class: OTHER briefSummary: To compare the safety of dual antiplatelet therapy with aspirin and clopidogrel and single antiplatelet therapy administered from 30 days to 12 months following carotid artery stenting on clinically significant bleeding and its prevention effects on net clinical events including combined cardiovascular and cerebrovascular accidents and major bleeding events in patients with carotid artery disease who are at high bleeding risk. conditions: Carotid Artery Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1556 type: ESTIMATED name: Patients who are scheduled to undergo carotid artery stenting measure: Clinically significant bleeding measure: Combined cardiovascular and cerebrovascular accidents sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06276361 id: ROV-QUAR-2023-01 briefTitle: Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia acronym: QUARTZ overallStatus: RECRUITING date: 2023-09-26 date: 2026-05 date: 2026-05 date: 2024-02-26 date: 2024-03-12 name: Rovi Pharmaceuticals Laboratories class: INDUSTRY briefSummary: This is a single ascending dose phase 1 study to evaluate the pharmacokinetics (PK), safety, and tolerability of a single intramuscular (IM) injection of quarterly Risperidone (QUAR) for different formulations and dose strengths in participants with schizophrenia. conditions: Schizophrenia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Oral risperidone; QUAR F1/2, Dose 1 - Gluteal name: Oral risperidone; QUAR F1/2, Dose 2 - Gluteal name: Oral risperidone; QUAR F1/2, Dose 3 - Gluteal name: Oral risperidone; QUAR F1/2, Dose 3 - Deltoids measure: λz measure: t1/2 measure: Tmax measure: Cmax measure: Cmin measure: Clast measure: AUC0-t measure: AUCinf measure: AUCextrap measure: Vd/F measure: Cl/F sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Investigational Site status: RECRUITING city: Amman country: Jordan lat: 31.95522 lon: 35.94503 hasResults: False
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<|newrecord|> nctId: NCT06276348 id: 20226892 briefTitle: Newborn Genomic Sequencing Pilot Study overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-13 date: 2024-02-28 date: 2024-09 date: 2024-02-26 date: 2024-03-04 name: Rady Pediatric Genomics & Systems Medicine Institute class: OTHER briefSummary: The goal of this clinical trial is to test a new method for newborn screening using whole genome sequencing, called BeginNGS. Newborns who are not suspected of having genetic diseases and who are admitted to the NICU at Rady Children's Hospital, San Diego, will be enrolled. The main questions this study aims to answer are:
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* What is the diagnostic yield of diagnostic whole genome sequencing (DWGS) in this population?
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* What is the diagnostic sensitivity and specificity of BeginNGS and whole exome sequencing (WES) as compared to DWGS?
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* What are the potential issues related to implementing DWGS in this population?
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Enrolled newborns will have a blood sample taken and will receive three tests:
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* DWGS
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* BeginNGS
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* WES conditions: Genetic Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single group, multiple interventions. All enrollees receive all interventions. primaryPurpose: SCREENING masking: NONE count: 120 type: ACTUAL name: Whole genome sequencing name: BeginNGS test name: WES measure: Proportion of enrolled infants who are diagnosed with a genetic disease by DWGS. measure: Proportion of enrolled infants who are identified with a genetic disease by BeginNGS. measure: Proportion of enrolled infants who are identified with a genetic disease by WES. measure: Proportion of enrolled infants who have a positive standard NBS test. measure: Proportion of parents approached who agree to participate in the study. measure: Parental reasons for refusal. measure: Time from sample arriving in lab to return of DWGS results. measure: Time from birth to return of DWGS results. measure: Results of confirmatory testing if BeginNGS or WES identifies a diagnostic finding not reported by DWGS. sex: ALL minimumAge: 1 Day maximumAge: 10 Days stdAges: CHILD facility: Rady Children's Hospital San Diego city: San Diego state: California zip: 92123 country: United States lat: 32.71533 lon: -117.15726 hasResults: False
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<|newrecord|> nctId: NCT06276335 id: IRAS:322440 briefTitle: Influence of Timing of Implant Placement on Early Healing Molecular Events overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-05-30 date: 2024-02-23 date: 2024-03-08 name: Queen Mary University of London class: OTHER name: University of Zurich briefSummary: Dental implants have been on the market for several years and they are routinely used to replace single/multiple missing teeth with a high success rate. However, there is still a limited number of studies comparing the influence of timing of implant placement on wound healing. In addition, there is no data available on the signaling pathways and the expression of healing biomarkers involved in the early stages of osseointegration after immediate implant placement (IP) or delayed implant placement (DP).
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The primary objective of this study is to describe changes in the expression of inflammatory, angiogenesis and osseous biomarkers of saliva at 1, 3, 7, 15 and 30 days and of PICF at 3, 7, 15 and 30 days after immediate implant placement (IP) compared with delayed placement (DP). conditions: Dental Implant conditions: Healing Wound conditions: Biomarkers conditions: Saliva studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Immediate implant placement and guided bone regeneration (Test) name: Late implant placement and guided bone regeneration (Control) measure: Changes in the expression of inflammatory, angiogenesis and osseous biomarkers of PICF and saliva measure: Blood flow changes measure: Soft tissue volume changes measure: Peri-implant bone level measure: Full mouth plaque score (FMPS) measure: Full mouth bleeding score (FMBS) measure: Probing pocket depth (PPD) measure: Gingival recession (REC) measure: Clinical attachment level (CAL) measure: Suppuration measure: Patient satisfaction at 6 months after loading measure: Changes in the pink esthetic score (PES) measure: Changes in the white esthetic score (WES) measure: Changes in the papilla fill index (PFI) measure: Implant survival sex: ALL minimumAge: 25 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre for Oral Clinical Research city: London zip: E1 2AD country: United Kingdom name: Nikolaos Donos, DDS MS PhD role: CONTACT phone: +44(0)2078823063 email: BHNT.Clinicaloralresearchcentre@nhs.net name: Vandana Luthra, Dr role: CONTACT phone: +44(0)2078826348 email: BHNT.Clinicaloralresearchcentre@nhs.net name: Nikolaos Donos, DDS MS PhD role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06276322 id: HU-FTR-SZK-01 briefTitle: Assessment of All Spine Segments ın Individuals With Low Back Pain overallStatus: RECRUITING date: 2023-12-01 date: 2024-03-20 date: 2024-12-31 date: 2024-02-23 date: 2024-03-07 name: Hacettepe University class: OTHER briefSummary: The aim of the study is to evaluate the kinematics of all spine segments in 3 planes and compare them with asymptomatic controls using wearable technology while performing functional tasks that patients with chronic low back pain often describe as painful in their daily lives. conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Low back pain group and healthy group primaryPurpose: OTHER masking: NONE count: 46 type: ESTIMATED name: Low back pain group name: Healthy group measure: Evaluation of the kinematics of the all spine during walking measure: Evaluation of the kinematics of the all spine during Bending Forward and Lifting Objects measure: Evaluation of the kinematics of the all spine during Standing from Sitting measure: Evaluation of the kinematics of the all spine during Climbing Step measure: Spine Normal Joint Movement evaluation measure: Pain intensity: Visual Analog Scale measure: Oswestry Disability Index measure: Fear of movement: Tampa Kinesiophobia Scale sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Hacettepe university status: RECRUITING city: Ankara state: Altındağ zip: 06050 country: Turkey name: Sümeyye Zehra Güler, MSc role: CONTACT phone: 5079320390 phoneExt: +90 email: zhrkzlk1906@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06276309 id: NECC2401 briefTitle: Protein Molecular Characteristics and Prognosis of Cervical Neuroendocrine Tumors overallStatus: RECRUITING date: 2024-02-01 date: 2024-06-30 date: 2024-06-30 date: 2024-02-23 date: 2024-02-23 name: Fujian Maternity and Child Health Hospital class: OTHER briefSummary: The clinical diagnosis and treatment data of 300 cases of cervical neuroendocrine tumors were collected, including age, preoperative biopsy pathology results, postoperative histopathological results, TCT results, and colposcopy biopsy pathology results. At the same time, paraffin tissue specimens (remaining specimens after pathological diagnosis) from 100 cases of cervical neuroendocrine tumors from multiple centers across the country were collected to establish a cervical neuroendocrine tumor data follow-up database. Protein concentration and omics analysis were performed on the data results, to evaluate the molecular characteristics and prognosis of cervical neuroendocrine tumor proteins, and to preliminarily explore its clinical application value. conditions: Neuroendocrine Neoplasm conditions: China conditions: Women conditions: Cervical Cancer conditions: Cervical Lesion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED measure: mortality rate measure: Disease-free survival sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Maternity and Child Health Hospital status: RECRUITING city: Fuzhou state: Fujian zip: 350001 country: China name: Binhua Dong role: CONTACT phone: +8687558732 email: dbh18-jy@126.com lat: 26.06139 lon: 119.30611 facility: Fujian Provincial Hospital status: RECRUITING city: Fuzhou state: Fujian country: China name: Dongjie Chen role: CONTACT lat: 26.06139 lon: 119.30611 facility: Ningde Mindong Hospital status: RECRUITING city: Ningde state: Fujian country: China name: Fang Xie role: CONTACT lat: 26.66167 lon: 119.52278 facility: Putian City first Hospital status: RECRUITING city: Putian state: Fujian country: China name: Yi Chen role: CONTACT lat: 25.43944 lon: 119.01028 facility: The Second Affiliated Hospital of Fujian Medical University status: RECRUITING city: Quanzhou state: Fujian country: China name: Luhong Li role: CONTACT lat: 24.91389 lon: 118.58583 facility: Zhangzhou affiliated Hospital of Fujian Medical University status: RECRUITING city: Zhangzhou state: Fujian zip: 363000 country: China name: Feifeng Shi, M.D role: CONTACT lat: 24.51333 lon: 117.65556 facility: Maternal and Child Health Hospital of Hubei Province status: RECRUITING city: Wuhan state: Hubei country: China name: Hongning Cai, M.D role: CONTACT phone: +8615926224867 lat: 30.58333 lon: 114.26667 facility: Xiangya Hospital, Central South University status: RECRUITING city: Changsha state: Hunan country: China name: Yu Zhang role: CONTACT lat: 28.19874 lon: 112.97087 facility: Jiangxi maternal and Child Health Hospital status: RECRUITING city: Nanchang state: Jiangxi country: China name: Ling Li role: CONTACT lat: 28.68396 lon: 115.85306 hasResults: False
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<|newrecord|> nctId: NCT06276296 id: 0001 briefTitle: Heart Rate Variability After Ablation overallStatus: RECRUITING date: 2023-03-01 date: 2024-08-31 date: 2024-10-01 date: 2024-02-23 date: 2024-02-23 name: Charles University, Czech Republic class: OTHER name: Vascular surgery, University hospital Královské Vinohrady, Prague briefSummary: Pulsed-field catheter ablation is a promising new treatment method for patients with atrial fibrillation. The mechanism of cell damage here is different from that of classic catheter ablation, in which the ganglion plexuses around the pulmonary veins are also damaged and thus changes in the autonomic nervous system occur. The aim of the work is to find out, using heart rate variability, whether the autonomic system is less affected during pulsed field ablation than in classic radiofrequency ablation. conditions: Atrial Fibrillation studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Holter EKG - 1 day before ablation name: Radiofrequency ablation name: Pulsed field ablation name: Holter EKG - 1 month after ablation measure: Mean RR interval (ms) measure: SDNN (ms) measure: RMSSD (ms) measure: pNN50 (%) measure: peak frequency (Hz) measure: power (ms2) measure: LF/HF ratio measure: SD1 (ms) measure: SD2 (ms) measure: SD2/SD1 measure: ApEn measure: Correlation dimension sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady status: RECRUITING city: Prague zip: 10034 country: Czechia name: Jana Vesela, Ing.,Ph.D. role: CONTACT phone: +420267162714 email: janca.zd@gmail.com name: Pavel Osmancik, MD,Ph.D. role: CONTACT phone: +420267162714 email: pavel.osmancik@fmail.com lat: 50.08804 lon: 14.42076 hasResults: False
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<|newrecord|> nctId: NCT06276283 id: DZ2022E0006 briefTitle: DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29) overallStatus: RECRUITING date: 2023-02-15 date: 2025-05-31 date: 2026-02-28 date: 2024-02-23 date: 2024-02-23 name: Dizal Pharmaceuticals class: INDUSTRY briefSummary: This study tests a combination therapy (i.e., DZD9008 plus bevacizumab) in patients with advanced NSCLC harboring EGFR mutations who have progressed on or after standard of care, which aims to understand whether the combination therapy is safe, how well the combination therapy works, and how the body will process DZD9008 when used in combination with bevacizumab. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: DZD9008 plus Bevacizumab measure: Part A: 1) Dose Limiting Toxicity (DLT); 2) Treatment-Emergent Adverse Events (TEAEs); TEAEs ≥CTCAE grade 3; and Serious Adverse Events (SAEs). Part B: 1) TEAEs; TEAEs ≥CTCAE grade 3; and SAEs. measure: Part A: 1) Tumor response per RECIST 1.1 and 2) Plasma concentration of DZD9008 and its metabolite. Part B:1) Tumor response per RECIST 1.1; 2) Intracranial tumor response per RECISIT 1.1; 3) Plasma concentration of DZD9008 and its metabolite. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200030 country: China name: Lu, Dr role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06276270 id: PT-MUC-1_05-21 briefTitle: Multi-centre, Open-label, First-in-man Study With Mucopad HA overallStatus: RECRUITING date: 2023-12-12 date: 2024-12-31 date: 2024-12-31 date: 2024-02-23 date: 2024-02-23 name: Contipro Pharma a.s. class: OTHER briefSummary: The device´s intended use is to treat defects and/or lesions of the oral mucosa, e.g. oral mucositis.To prove safety of the device in terms of clinical results. conditions: Oral Mucositis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Mucopad HA measure: Resolution of mucositis symptoms since completion of radiotherapy measure: - Pain management (VAS scale) measure: Development of xerostomy measure: Subjective evaluation on scale 1-5 of the treatment by investigator/ patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Masarykův onkologický ústav, Klinika radiační onkologie status: RECRUITING city: Brno state: Česká Republika zip: 56401 country: Czechia name: Tomáš Novotný role: CONTACT phone: +420543131103 email: novotny@mou.cz lat: 49.19522 lon: 16.60796 facility: FN Hradec Králové Klinika onkologie a radioterapie status: RECRUITING city: Hradec Králové state: Česká Republika zip: 56401 country: Czechia name: Milan Vošmik role: CONTACT phone: +420495832316 email: milan.vosmik@fnhk.cz lat: 50.20923 lon: 15.83277 facility: Fakultní nemocnice Ostrava, Klinika onkologická status: RECRUITING city: Ostrava state: Česká Republika zip: 56401 country: Czechia name: Jana Jackaninová role: CONTACT phone: +420597371111 email: jana.jackaninova@fno.cz lat: 49.83465 lon: 18.28204 facility: Etická komise FN Bulovka status: RECRUITING city: Praha state: Česká Republika zip: 56401 country: Czechia name: Petra Holečková role: CONTACT phone: +420266084516 email: petra.holeckova@bulovka.cz lat: 50.08804 lon: 14.42076 facility: Fakultní Thomayerova nemocnice Onkologická klinika 1.LF UK a FTN status: RECRUITING city: Praha state: Česká Republika zip: 56401 country: Czechia name: Radka Lohynská role: CONTACT phone: +420261083890 email: radka.lohynska@ftn.cz lat: 50.08804 lon: 14.42076 hasResults: False
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<|newrecord|> nctId: NCT06276257 id: 2024-7301 briefTitle: Paravertebral Block for Mastectomy With Immediate Reconstruction overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-07 date: 2025-12 date: 2024-02-23 date: 2024-02-23 name: CHU de Quebec-Universite Laval class: OTHER briefSummary: Following a mastectomy, patients may develop chronic pain, called post-mastectomy pain syndrome (PMPS). This syndrome manifests itself as complex neuropathic pain that seems linked to nerve damage suffered either during surgery, during healing or by nervous system dysfunction. However, the exact pathophysiology remains unknown. Typically, the pain is located on the ipsilateral side of the surgery and projects to the anterior thorax to the lateral thorax and may affect the proximal part of the arm. This pain persists for more than three months following the procedure and has the characteristics of neuropathic pain: burning sensation, tingling, electric shock, hyperalgesia, etc. The prevalence of PMDS varies between 2% and 78%; this disparity comes from the fact that there are no clear criteria in the literature for making the diagnosis. One of the risk factors for developing PMDS is the presence of acute pain immediately postoperatively.
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The main objective of this study is to compare two analgesic modalities, namely BPV (study modality) and usual analgesia (control modality), in patients undergoing total mastectomy with immediate reconstruction under general anesthesia with the aim of to evaluate their functional pain score at 24, 48 and 72 hours following the surgical procedure. conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Paravertebral block name: Usual analgesia measure: Evaluation of postoperative pain using the BPI measure: Total use of opioids received intraoperatively. measure: Use of non-opioid analgesia intraoperatively measure: Total dose of opioids received in the PACU measure: Time before first opioid measure: Total opioids consumed in the 48 hours following surgery measure: Chronic pain sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06276244 id: NM040-GUP19002 briefTitle: Trial Readiness and Endpoint Assessment in Congenital and Childhood Myotonic Dystrophy acronym: GUP19002 overallStatus: ACTIVE_NOT_RECRUITING date: 2020-07-08 date: 2024-04 date: 2024-04 date: 2024-02-23 date: 2024-02-23 name: Fondazione Serena Onlus - Centro Clinico NeMO Milano class: OTHER name: Bambino Gesù Hospital and Research Institute name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS name: IRCCS Istituto delle Scienze Neurologiche di Bologna name: IRCCS Fondazione Stella Maris name: IRCCS Istituto Neurologico Mondino, Pavia, Italy name: Azienda Ospedaliera Città della Salute e della Scienza di Torino name: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta name: Istituto Giannina Gaslini briefSummary: Children with congenital myotonic dystrophy (CDM) present at birth with respiratory insufficiency, talipes equinovarus, feeding difficulties and hypotonia. There is a 30% mortality rate in the first year of life. Children with childhood onset myotonic dystrophy present with symptoms later on but soon develop behavioural difficulties and learning difficulties and are at risk for autistic features and gastrointestinal symptoms. The ability to conduct a therapeutic trial in children with CDM or ChDM is directly limited by the lack of available data regarding appropriate clinical endpoints and biomarkers. Whereas there is an active Italian collaboration recruiting adults with DM1 to study muscle and multisystem aspects in this population, there is no active network in Italy involved in the pediatric population with DM1. Though the underlying mechanism is the same in adult DM1, in CDM and ChDM there are specific challenges to the pediatric population. The aim of this project is to coordinate the Italian Child Neurologist actively involved with CDM and ChDM in a common effort of standardizing protocols and procedures to be applied in the care of these patients. Specific aims are to collect functional measures and clinical information over time to define clinically meaningful endpoints and outcome measures in preparation for international therapeutic clinical trials. This project will contribute to the ongoing international study in CDM by recruiting additional patients from all over Italy and will extend the investigations to the childhood onset forms as an additional add-on pilot study in view of potential treatment options. The investigators expect that the Italian network, with Telethon support, will provide the necessary backbone for trial readiness in the pediatric population both at the national and international levels. conditions: CDM conditions: ChDM studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Physical function measure: Physical function measure: Cognitive-behavioral and Quality of Life measure: Cognitive-behavioral and Quality of Life measure: Biomarkers measure: Biomarkers sex: ALL maximumAge: 17 Years stdAges: CHILD facility: Fondazione Serena Onlus - Centro Clinico NeMO Milano city: Milan zip: 20162 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06276231 id: SalbuEase briefTitle: Nebulized Salbutamol in Acute Renal Colic overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-03-01 date: 2026-05-01 date: 2024-02-23 date: 2024-03-19 name: Oman Medical Speciality Board class: OTHER_GOV briefSummary: A Prospective, double blinded, Randomized efficacy and safety trial of Nebulized Salbutamol in acute renal colic.
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Research Summary:
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INTRODUCTION: Pain is a common reason for individuals to seek health care, especially emergency care. Salbutamol has an effect for smooth muscle relaxation of the ureters. The administration of Salbuatmol has been shown to be safe and effective in the treatment of asthma exacerbation, but there have been no studies evaluating the use of neublized salbutamol for the treatment of acute renal colic pain in the emergency department.
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METHOD: This is a double blinded randomized clinical controlled trial. Two hundred renal colic patients presenting to the emergency department will be randomized to intervention (10 mg nebulized salbutamol) and (10 ml neublized Normal saline) case groups. Both the groups will get the standard treatment (IM diclofenac 75mg) added to the intervention. Their pain before and after intervention will be measured by Numerical Rating scale (NRS pain score). Patient and attending physician will be blinded throughout the study. The Secondry outcomes are safety, need for rescue medications and time to discharge.
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AIM: The aim of this study is to compare analgesic effects of Nebulized Salbutamol versus Placebo in adult patients with renal colic.
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PRIMARY OJECTIVES: Analgesic effects of Nebulized Salbutamol on the Numerical Rating scale (NRS).
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SECONDARY OBJECTIVES: Adverse Events, the need of rescue pain medications and time to discharge.
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PATEINT POPULATION: Adults (from age 18 to 60 years) who presents to emergency department (ED) at Armed force Hospital with acute flank pain suggestive of renal colic
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INTERVENTION: Single dose of Nebulized Salbutamol 10mg.
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CLINICAL MEASURMENT: Numerical pain Analog Scale will be assessed at 0,15,30, 45 and 60 minutes after intervention. Number and dosage of rescue medication, any reported events by patient or attending physician will be documented.
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OUTCOME: Decrease in pain measures by NRS pain score after Nebulized Salbutamol is given, tolerability and safety evaluation. conditions: Renal Colic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 214 type: ESTIMATED name: Salbutamol name: 0.9% Normal Saline name: Diclofenac Injection measure: Pain reduction at 60 minutes measure: Adverse Event/Side Effects measure: Need of Rescue medications measure: Pain reduction rate. measure: ED revisits sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06276218 id: PSU briefTitle: Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study overallStatus: RECRUITING date: 2022-02-01 date: 2024-02-15 date: 2024-02-16 date: 2024-02-23 date: 2024-02-23 name: Prince of Songkla University class: OTHER briefSummary: A randomized control trial was conducted to compare the outcomes of conservative management for closed midshaft clavicular fractures using self-adjustable clavicular brace and standard clavicular brace. conditions: Clavicle Fracture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Clavicular brace measure: DASH measure: Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prince of Songkla University status: RECRUITING city: Songkla state: Hatyai zip: 90110 country: Thailand name: Thanachai Klongsangsorn role: CONTACT phone: +66991964733 email: poom_thanachai@hotmail.com lat: 7.19882 lon: 100.5951 hasResults: False
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<|newrecord|> nctId: NCT06276205 id: 1037/RC/KEMU briefTitle: Vitamin D & Levothyroxine Combination Versus Levothyroxine on Lipid Profile in Hypothyroidism acronym: ViDaLLiT overallStatus: RECRUITING date: 2024-03-01 date: 2024-09-30 date: 2024-09-30 date: 2024-02-23 date: 2024-02-23 name: King Edward Medical University class: OTHER briefSummary: The goal of this clinical trial is to study the improvement of lipid levels in hypothyroid individuals after staring treatment.
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The main question it aims to answer is:
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• whether adding Vitamin D to standard therapy has any additional benefits
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Participants will be given Vitamin D in replacement doses according to their pre-existing Vitamin D level in addition to levothyroxine.
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Researchers will compare them with another group receiving only levothyroxine to see how much lipids improve in them conditions: Hypothyroidism Primary conditions: Lipid Disorder conditions: Dyslipidemias studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Vitamin D name: Levothyroxin measure: Decline in Total Cholesterol measure: Decline in LDL sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: King Edward Medical University status: RECRUITING city: Lahore state: Punjab zip: 54000 country: Pakistan name: AP Endocrinology role: CONTACT phone: +923004683473 email: sidrah.lodhi@gmail.com lat: 31.558 lon: 74.35071 hasResults: False
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<|newrecord|> nctId: NCT06276192 id: 2023-01882-01 briefTitle: Digital Physiotherapy Treatment for Patients With Subacromial Pain Compared to Usual Physiotherapy in Primary Care acronym: diSAID overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2026-03-26 date: 2028-03-26 date: 2024-02-23 date: 2024-02-23 name: Region Östergötland class: OTHER name: Linkoeping University briefSummary: The goal of this clinical trial is to test a digital treatment for patients with subacromial pain using the digital Shoulder Aid (diSAID) strategy. The participants in this study will be randomly assigned to digital treatment (diSAID) or to receive the treatment that is currently available in primary care, i.e. continue according to usual practice.
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The main question this clinical trial aims to answer are:
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- Can the diSAID improve shoulder function and reduce pain for patients with subacromial pain in primary care? conditions: Subacromial Pain Syndrome conditions: Shoulder Pain conditions: Rotator Cuff Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Non-Inferiority Randomised Controlled Trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Digital Physiotherapy (diSAID) name: Traditional Physiotherapy measure: Mean change in shoulder function and pain after 12 weeks using The Shoulder Pain and Disability Index (SPADI) measure: Mean change in shoulder pain intensity at rest, arm activity and at night measured by numeric rating scale (NRS) measure: Mean change in pain Self-Efficacy measure: Mean change of self-reported rating of improvement measure: Mean change of health-related quality of life measure: Patients treatment expectancies measure: Patients self-reported rating of pain sensitivity measure: Costs and cost-effectiveness direct and indirect measure: Impact on the environment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anna Petersson city: Linköping zip: SE 58191 country: Sweden name: Anna Petersson, PhD student role: CONTACT phone: +46101031053 email: anna.h.petersson@regionostergotland.se name: Teresa Holmgren, PhD role: CONTACT phone: +46101034158 email: Teresa.Holmgren@regionostergotland.se name: Hanna Björnsson Hallgren, Associate Prof role: PRINCIPAL_INVESTIGATOR name: Jenny Samuelsson, PhD role: SUB_INVESTIGATOR lat: 58.41086 lon: 15.62157 hasResults: False
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<|newrecord|> nctId: NCT06276179 id: KFSIRB200-97 briefTitle: Epidural Oxycodone for Pain Management for Lower Limb Amputation overallStatus: RECRUITING date: 2024-02-24 date: 2024-08-01 date: 2024-08-01 date: 2024-02-23 date: 2024-02-28 name: Kafrelsheikh University class: OTHER briefSummary: The aim of this study is to evaluate the effect of epidural oxycodone for pain management after lower limb amputation. conditions: Epidural conditions: Oxycodone conditions: Pain conditions: Lower Limb Amputation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Oxycodone name: Bupivacaine measure: Acute postoperative pain scores measure: Time to the first request for the rescue analgesia measure: Postoperative morphine consumption measure: Incidence of phantom limb pain measure: Adverse effects sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kafrelsheikh University status: RECRUITING city: Kafr Ash Shaykh state: Kafrelsheikh zip: 33516 country: Egypt name: Gamal H Shams, MD role: CONTACT phone: 00201095927971 email: gamal.shams2@gmail.com name: Ahmed A Ghareeb, MD role: PRINCIPAL_INVESTIGATOR name: Mohamed H Osman, MD role: PRINCIPAL_INVESTIGATOR name: Heba F Dawood, MD role: PRINCIPAL_INVESTIGATOR name: Mohamed M Kotb, MD role: PRINCIPAL_INVESTIGATOR lat: 31.11174 lon: 30.93991 hasResults: False
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<|newrecord|> nctId: NCT06276166 id: 72374215 briefTitle: Trajectory of Frailty and Cognitive Dysfunction in Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-06-30 date: 2026-12-31 date: 2024-02-23 date: 2024-03-07 name: Zheng Li class: OTHER briefSummary: To explore the heterogeneity of the development trend of frailty and cognitive function of older adults. conditions: Frailty conditions: Cognitive Dysfunction conditions: Community-dwelling Older Adults studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 934 type: ESTIMATED name: No intervention measure: Frailty measure: Cognitive function measure: Health status and life style measure: Activities of daily life (ADLs) measure: Anxiety measure: Apathy measure: Perceived social support measure: Social network sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06276153 id: CRGGCext briefTitle: Construction of Multicenter Retrospective Registry Cohort Database for Gallbladder Cancer acronym: CRGGCext overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-02-28 date: 2029-02-28 date: 2024-02-23 date: 2024-02-28 name: RenJi Hospital class: OTHER briefSummary: The aim of the study is to establishing a standardized clinical information database for patients with malignant tumors of gallbaldder. Based on the database, real-world clinical research on the diagnosis and treatment of biliary tract tumors is about to be carried out, and a high-standard cohort research foundation is laid for precision therapy. conditions: Biliary Tract Diseases conditions: Gallbladder Cancer conditions: Gallbladder Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 5000 type: ESTIMATED name: no interventions measure: overall survival measure: progression-free survival sex: ALL minimumAge: 18 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06276140 id: 4/23/2-4661/2-9 briefTitle: Iron-deficiency Anaemia and Its Impact on Recovery After Colorectal Cancer Surgery acronym: ID-COLO overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-01 date: 2026-01 date: 2024-02-23 date: 2024-02-28 name: Oncology Institute of Vojvodina class: OTHER_GOV name: University of Bern briefSummary: The aim of this prospective, observational cohort study is to assess the impact of iron deficiency anaemia on the incidence of perioperative complications and the quality of recovery after surgery in patients undergoing colorectal cancer surgery. The main questions the study aims to answer are:
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* whether the presence of preoperative iron deficiency anaemia leads to a poorer quality of postoperative recovery in patients undergoing colorectal cancer surgery
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* whether different combinations of complete blood count parameters (red blood cell indices) could be suitable diagnostic tools for the detection of iron deficiency in the latent stage (without laboratory-confirmed anaemia) in colorectal cancer patients.
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Blood samples for laboratory analyses will be collected from each study patient admitted to the surgical ward one day prior to elective surgery and on the first postoperative day during the stay in the intensive care unit. The pre-operative laboratory analyses include a complete blood count and serum iron status parameters (iron concentration, ferritin concentration, TIBC, UIBC and TSAT). Laboratory parameters analysed on the first postoperative day include complete blood count, serum concentration of electrolytes (Na, K, Ca, Cl, Mg), serum concentration of urea and creatinine, parameters of haemostasis (aPTT, PT, INR), serum concentration of C-reactive protein and procalcitonin.
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Data about overall morbidity, intraoperative complications, quality of postoperative recovery, red blood cell transfusion rate, all-cause infection rate, antibiotic usage, as well as length of hospital stay will be collected.
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The researchers will compare the group of patients with iron deficiency anaemia, the group of patients with iron deficiency in the latent stage and the control group to determine whether patients with iron deficiency have a higher incidence of perioperative complications and impaired recovery after surgery. The researchers will investigate whether iron deficiency can be detected at an early stage, when anaemia is not yet present, by calculating various red blood cell indices. conditions: Iron Deficiencies conditions: Iron Deficiency Anaemia conditions: Postoperative Complications conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Laboratory analyses for the detection of iron deficiency anaemia measure: Overall morbidity measure: Prevalence of absolute iron deficiency, functional iron deficiency and iron deficiency anaemia in the study population measure: Red blood cell transfusion rate measure: All-cause infection rate measure: Days of antibiotic use measure: Number of different antibiotics administered measure: Length of Intensive care unit-stay measure: Length of hospital-stay measure: Intraoperative complications measure: Quality of postoperative recovery measure: Reoperation measure: Estimated total iron-deficit measure: Serum ferritin level measure: Values of different erythrocyte indices sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06276127 id: MERC301123 briefTitle: Oral Bisoprolol Vs IV Diltiazem in Atrial Fibrillation or Flutter With Rapid Ventricular Rate. acronym: BisoAF overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-06 date: 2024-02-23 date: 2024-03-05 name: Oman Medical Speciality Board class: OTHER_GOV briefSummary: INTRODUCTION: The study focuses on comparing the effectiveness of oral Bisoprolol, a beta-1 adrenergic receptor blocker, against intravenous Diltiazem, a calcium channel blocker, in treating rapid atrial fibrillation or flutter with rapid ventricular response in an emergency setting. This research aims to fill the gap in empirical evidence regarding the use of oral Bisoprolol for these conditions, potentially offering a convenient, evidence-based alternative for patient management in emergency departments where established protocols are lacking.
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METHOD: This study is a randomized controlled trial targeting patients who present to the emergency room with symptomatic atrial fibrillation or flutter and rapid ventricular response requiring intervention. Participants will be split into two groups and undergo continuous monitoring of vital signs and regular electrocardiograms to ensure safety and document any adverse effects. The primary focus is on patient safety while evaluating the efficacy of the treatments.
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AIM: Evaluate the efficacy and safety of oral bisoprolol in treating atrial fibrillation or atrial flutter with rapid ventricular response in an emergency department setting.
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PRIMARY OJECTIVES: The primary efficacy outcome will be evaluated by achieving a HR\<110 beats per minute or a decrease ≥20% of baseline HR at 60 minutes. The primary safety outcome measures are HR \< 60 bpm and SBP \< 95 mm Hg.
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