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<|newrecord|> nctId: NCT06345586 id: 078066 briefTitle: Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-03 date: 2024-04-03 name: Chulalongkorn University class: OTHER briefSummary: The purpose of this study is to study the effect of Drospirenone on cervical mucus change by modified Insler score, pre-bariatric surgery and post-bariatric surgery conditions: Contraception studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Participants received Drospirenone will be assess for cervical mucus change by modified Insler score primaryPurpose: BASIC_SCIENCE masking: NONE count: 16 type: ESTIMATED name: Drospirenone measure: Cervical mucus by modified Insler score measure: Estrogen and progesterone levels versus time measure: Number of Participants With Treatment-Related Adverse Events sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Chulalongkorn University city: Bangkok zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False
<|newrecord|> nctId: NCT06345573 id: BASEC 2020-02922 briefTitle: Heart-brain-axis and Psychosocial Stress overallStatus: ACTIVE_NOT_RECRUITING date: 2021-10-11 date: 2023-11-20 date: 2024-11 date: 2024-04-03 date: 2024-04-08 name: University of Zurich class: OTHER briefSummary: The main study objective is to prospectively determine the influence of sex-related risk factors and psychosocial variables on neuronal stress responses and myocardial perfusion in a population of 64 female and male individuals 50-75 years of age and free of cardiovascular disease. conditions: Mental Stress conditions: Myocardial Ischemia conditions: Sex Role conditions: Gender studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 64 type: ACTUAL name: Mental stress measure: Amygdala-to-cerebellum ratio of glycolytic metabolic activities (SUV/SUV) measure: Difference between the rest and stress amygdala-to-cerebellum perfusion ratios (kBq/kBq) measure: Myocardial flow reserve (MFR, no unit) measure: Amygdala-to-vmPFC ratio of glycolytic metabolic activities (SUV/SUV) measure: Difference between the rest and stress amygdala-to-vmPFC perfusion ratios (kBq/kBq) measure: Myocardial blood flow (MBF) at rest (mL/g/min) measure: Myocardial blood flow (MBF) at stress (mL/g/min) measure: Heart-rate response (HRR, no unit) measure: Salivary cortisol (mol/L) measure: Noradrenaline (mL/min) measure: Adrenaline (mL/min) measure: Dopamine (mL/min) measure: Spleen metabolic activity (SUV) measure: Bone marrow metabolic activity (SUV) measure: Aorta metabolic activity (SUV) measure: Left ventricular ejection fraction (LVEF, %) measure: C-reactive protein (CRP, mg/L) measure: Interleukin-2 (IL-2, pg/mL) measure: Interleukin-4 (IL-4, pg/mL) measure: Interleukin-6 (IL-6, pg/mL) measure: Interleukin-8 (IL-8, pg/mL) measure: Interleukin-10 (IL-10, pg/mL) measure: Tumor necrosis factor (TNF, pg/mL) measure: Matrix metalloproteinase-9 (MMP9, pg/mL) measure: Monocyte Chemoattractant Protein-1 (MCP1, pg/mL) measure: Vascular Cell Adhesion Molecule (VCAM) measure: Gender score questionnaire measure: Rate-Pressure-Product (RPP, in beats per minute x mmHg) measure: vmPFC-to-cerebellum ratio of glycolytic metabolic activities (SUV/SUV) measure: Nail cortisol value (pg/mg) measure: General Anxiety Disorder (GAD-7) Questionnaire measure: Patient Health Questionnaire (PHQ-8) measure: Shortened Maastricht Exhaustion Questionnaire measure: Type D Personality (DS14) questionnaire measure: Wagnild & Young Score resilience questionnaire measure: Perceived Stress Scale (PSS-4) questionnaire measure: Jenkins Sleep Scale (JSS-4) measure: Trier Inventory for Chronic Stress (TICS) measure: Perceived stress measure: Left ventricular stroke volume (LVSV, mL) measure: Left ventricular end-systolic volume (LVESV, mL) measure: Left ventricular end-diastolic volume (LVEDV, mL) measure: Estradiol levels (pmol/L) measure: Progesterone levels (nmol/L) measure: Sex Hormone Binding Globulin (SHBG) levels (nmol/L) measure: Total testosterone levels (nmol/L) measure: Free testosterone levels (pmol/L) sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Zurich city: Zürich zip: 8091 country: Switzerland lat: 47.36667 lon: 8.54999 hasResults: False
<|newrecord|> nctId: NCT06345560 id: 077766 briefTitle: Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-03 date: 2024-04-03 name: Chulalongkorn University class: OTHER briefSummary: The purpose of this study is to investigate whether bariatric surgery affects Drospirenone only pills absorption conditions: Contraception studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pre-bariatric surgery pharmacokinetics study of Drospirenone compare with post-bariatric surgery primaryPurpose: BASIC_SCIENCE masking: NONE count: 16 type: ESTIMATED name: Drospirenone measure: Plasma concentration versus Time of Drospirenone measure: Number of Participants With Treatment-Related Adverse Events sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Chulalongkorn University city: Bangkok zip: 10330 country: Thailand name: Punyawee Utaipatanacheep role: CONTACT lat: 13.75398 lon: 100.50144 hasResults: False
<|newrecord|> nctId: NCT06345547 id: EDGE 003539 briefTitle: Muscle Mass Via UltraSound in Cirrhosis (MMUSCLE) acronym: MMUSCLE overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2026-05-02 date: 2027-05-31 date: 2024-04-03 date: 2024-04-03 name: University Hospital, Antwerp class: OTHER briefSummary: The goal of this observational cohort study is to learn about loss of muscle mass and muscle strength (sarcopenia) in patients with cirrhosis. The main question\[s\] it aims to answer are:
* what is the prevalence and development of sarcopenia in cirrhosis?
* what is the role of malnutrition? Participants will
* undergo a muscle ultrasound of the lower and upper limb muscles
* handgrip strength will be measured
* malnutrition screening and assessment
* complete a questionnaire to assess quality of life conditions: Sarcopenia conditions: Cirrhosis conditions: Malnutrition studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: ultrasound measure: Prevalence of sarcopenia: muscle mass measure: Prevalence of sarcopenia: muscle strength measure: Development of sarcopenia: changes in muscle mass measure: Development of sarcopenia: changes in muscle strength measure: Development of sarcopenia: changes in muscle quality measure: Decompensation events: MELD score • MELD evolution measure: Decompensation events: mortality • MELD evolution measure: Decompensation events: transplantation • MELD evolution measure: Malnutrition measure: Quality of life in cirrhosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Antwerp city: Edegem state: Antwerpen zip: 2650 country: Belgium name: Karolien Dams, MD role: CONTACT phone: +3238213635 phoneExt: 5175 email: [email protected] name: Jolien Derdeyn, MD role: CONTACT phone: +328213807 phoneExt: 3807 email: [email protected] name: Jolien Derdeyn, MD role: SUB_INVESTIGATOR name: Thomas Vanwolleghem, MD, Phd role: SUB_INVESTIGATOR name: Philippe Jorens, MD, PhD role: SUB_INVESTIGATOR name: Stany Perkisas, MD, PhD role: SUB_INVESTIGATOR name: Karolien Dams, MD role: PRINCIPAL_INVESTIGATOR lat: 51.15662 lon: 4.44504 hasResults: False
<|newrecord|> nctId: NCT06345534 id: ONZ-2023-0255 briefTitle: FAST-FORWARD vs HAI5 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2033-12-31 date: 2033-12-31 date: 2024-04-03 date: 2024-04-03 name: University Hospital, Ghent class: OTHER briefSummary: Randomized comparison between the FAST-FORWARD schedule and the HAI5 schedule for breast cancer radiotherapy in 5 fractions. conditions: Cancer, Breast studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients participating in the study will be randomized 1:1 between the FAST-FORWARD schedule and the HAI5 schedule. The first group is treated according to the FAST-FORWARD schedule, consisting of 5 radiation sessions on 5 consecutive working days (e.g. Monday to Friday). 2 rest days are allowed in the schedule, so that the treatment lasts a maximum of 7 days. The second group is treated according to the HAI5 schedule, developed by the radiotherapy department of Ghent University Hospital. In this schedule, at least 1 day of rest is scheduled between each treatment session, so the treatment is administered over 10-14 days. primaryPurpose: TREATMENT masking: NONE maskingDescription: Both healthcare provider and patient know the treatment count: 740 type: ESTIMATED name: Questionnaire measure: Early side effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitary Hospital city: Ghent zip: 9000 country: Belgium name: Liv Veldeman, MD, PhD role: CONTACT phone: 09 332 30 15 email: [email protected] name: Emma Van Damme, MD role: CONTACT phone: 09 332 19 53 email: [email protected] lat: 51.05 lon: 3.71667 hasResults: False
<|newrecord|> nctId: NCT06345521 id: 2022-1-4032-3 briefTitle: The Follow-up System of Pediatric Heart Failure and the Establishment of End-stage Heart Failure Registry overallStatus: RECRUITING date: 2022-01-01 date: 2024-06-22 date: 2024-12-31 date: 2024-04-03 date: 2024-04-03 name: China National Center for Cardiovascular Diseases class: OTHER_GOV name: Peking University First Hospital name: Beijing Children's Hospital briefSummary: Establish a follow-up management system for pediatric heart failure and a registration platform for end-stage heart failure conditions: Heart Failure conditions: Congenital conditions: End-stage Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: No intervention measure: the recurrence rate of heart failure measure: NT-proBNP level measure: Incidence rate of drug adverse reactions measure: Readmission rate for heart failure sex: ALL maximumAge: 14 Years stdAges: CHILD facility: Fuwai hospital status: RECRUITING city: Beijing country: China name: Shoujun Li, MD role: CONTACT phone: +86 13501071589 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06345508 id: 2024-12161 briefTitle: Early Detection of Liver Cancer by QUS acronym: QUS in HCC overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-06 date: 2029-12 date: 2024-04-03 date: 2024-04-12 name: Centre hospitalier de l'Université de Montréal (CHUM) class: OTHER name: Centre de Recherche du Centre Hospitalier de l'Université de Montréal name: Canadian Institutes of Health Research (CIHR) briefSummary: Worldwide, liver cancers are the third most common cause of cancer mortality. Even when liver cancer is suspected by blood tests, imaging is required to determine the location, size, and extent of disease. Medical societies therefore recommend surveillance with ultrasound every 6 months in at-risk patients. However, a key challenge to improving the survival is that ultrasound may miss half of early-stage liver cancers, thus diagnosis must rely on additional tests such as computed tomography (CT), magnetic resonance imaging (MRI), or biopsy. Hence, there is a clear need to improve the ability to detect liver cancers, especially with ultrasound. The investigator's team proposes novel ultrasound approaches to detect cancer nodules invisible on conventional ultrasound based on differences in mechanical and structural properties between liver and tumor. Improving detection is critical because liver cancer can be cured only if detected at an early stage, as shown by improvements in survival rates in patients enrolled in surveillance programs. The investigator's multi-disciplinary, national, and international team includes experts in clinical fields (hepatology, oncology, radiology, pathology), basic sciences (engineering, medical physics, machine learning, biostatistics), and patient partnership. The investirgator will apply the methodology of patient partner recruitment and collaborate with the Centre of Excellence on Partnership with Patients and the Public to select potential new collaborators. This will permit this project to be informed at every stage by patient and family perspectives, ensuring that the results of this project will be more robust, impactful, and aligned with the priorities, needs and experiences of those who live with liver cancer. The investigator submits a research proposal focused on advanced imaging techniques because imaging constitutes a foundation for surveillance, diagnosis, staging, treatment selection and assessment of treatment response in patients with liver cancer. conditions: Hepatocellular Carcinoma conditions: Liver Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 328 type: ESTIMATED name: Quantitative Ultrasound name: B-mode Ultrasound name: Magnetic Resonance Imaging name: Liver Biopsy measure: Compare the sensitivity of QUS + B-mode US vs B-mode US alone for lesion detection, using MRI as the reference standard for detection measure: Compare the specificity of QUS + B-mode US vs B-mode US alone for diagnosis of HCC, using MRI or biopsy as the composite reference standard for classification measure: Determine the lesion-to-liver contrast of investigational QUS techniques for detection of HCC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de l'Université de Montréal (CHUM) city: Montréal state: Quebec zip: H2X 0A9 country: Canada name: An Tang, MD, MSc role: CONTACT phone: 514-890-8000 phoneExt: 36400 email: [email protected] name: Casey Bourdeau Caporuscio, MSc role: CONTACT phone: 514-890-8000 phoneExt: 14756 email: [email protected] name: An Tang, MD, MSc role: PRINCIPAL_INVESTIGATOR lat: 45.50884 lon: -73.58781 hasResults: False
<|newrecord|> nctId: NCT06345495 id: 2023-0899 id: NCI-2024-02814 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2027-01-01 date: 2029-01-01 date: 2024-04-03 date: 2024-04-03 name: M.D. Anderson Cancer Center class: OTHER name: Incyte Corporation briefSummary: To learn if giving ruxolitinib and busulfan before a stem cell transplant can help to reduce spleen size and help the transplant to succeed. conditions: Splenomegaly conditions: Myelofibrosis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Ruxolitinib name: Allogeneic Stem Cell Transplantation name: Levetiracetam name: Eltrombopag name: Busulfan name: Romiplostim name: Fludarabine phosphate name: Cyclophosphamide name: Mesna name: Tacrolimus measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States lat: 29.76328 lon: -95.36327 hasResults: False
<|newrecord|> nctId: NCT06345482 id: MHB039A-A-101 briefTitle: A Study of MHB039A for Advanced Solid Tumor overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-04-01 date: 2029-06-01 date: 2024-04-03 date: 2024-04-03 name: Minghui Pharmaceutical (Hangzhou) Ltd class: INDUSTRY briefSummary: Phase I/II open label, multicenter study to evaluate the efficacy and safety of MHB039A in advanced malignant tumors. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 196 type: ESTIMATED name: MHB039A measure: Incidence of participants with adverse events (AE) measure: Number of participants with dose-limiting toxicity (DLT) measure: Maximum Plasma Concentration (Cmax) of MHB039A measure: The area under the plasma concentration-time curve (AUC) of MHB039A measure: To detectable anti-drug antibodies with treated subjects measure: Objective response rate (ORR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital city: Shanghai state: Shanghai zip: 200030 country: China name: Shun Lu, MD role: CONTACT phone: 13601813062 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
<|newrecord|> nctId: NCT06345469 id: O-PBM2 briefTitle: Cost Analysis of Therapies for Severe Anemia overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-05-01 date: 2024-04-03 date: 2024-04-03 name: Helios Klinik Gotha/Ohrdruf class: OTHER name: Marisa Eichner briefSummary: The goal of this observational study is to learn about the costs that occur when participants with severe anemia are treated with blood transfusions or with patient blood management (PBM). PBM means that the body of the participant is stimulated to produce new blood by itself rather than receiving it from a blood donor, and to reduce blood losses.
The main question the study aims to answer is: Do participants treated with transfusions incur the same treatment costs than participants treated with PBM? And how much costs are this in relation to the lives saved by the therapy of severe anemia? conditions: Severe Anemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 640 type: ESTIMATED name: Patient blood management (PBM) name: Allogeneic transfusion measure: cost-effectiveness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06345456 id: izmirkatip briefTitle: The Value of End-tidal Capnography in Gastrointestinal Bleeding overallStatus: COMPLETED date: 2020-06-01 date: 2021-01-01 date: 2021-01-01 date: 2024-04-03 date: 2024-04-08 name: Izmir Katip Celebi University class: OTHER briefSummary: Gastrointestinal bleeding is a condition that frequently presents to emergency departments and can be fatal if diagnosis and treatment are delayed. The working mechanism of end tidal capnography is simply to detect the respiratory carbon dioxide level.
In our study, the investigators aimed to determine the severity of gastrointestinal bleeding by using the Glaskow Blachford Score and AIMS65 score in cases presenting with gastrointestinal bleeding, to determine the end tidal carbon dioxide value by capnography in these cases and to determine its effectiveness in evaluating mortality and morbidity in gastrointestinal bleeding. conditions: Gastro Intestinal Bleeding studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 103 type: ACTUAL name: End-tidal capnography measure: The correlation between ETCO2 value and mortality in patients with gastrointestinal bleeding will be investigated. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Katip Çelebi Üniversitesi city: İzmir country: Turkey lat: 38.41273 lon: 27.13838 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2020-06-01 uploadDate: 2024-04-01T04:48 filename: SAP_000.pdf size: 281538 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2020-06-01 uploadDate: 2024-04-01T04:35 filename: ICF_001.pdf size: 418132 hasResults: False
<|newrecord|> nctId: NCT06345443 id: 23-005288 briefTitle: NRM on Vascular Perfusion in Heathy Adults acronym: NRM overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-12-31 date: 2026-05-31 date: 2024-04-03 date: 2024-04-03 name: Mayo Clinic class: OTHER briefSummary: The purpose of this study is to better understand the effects of nicotinamide riboside supplement in overall cardiovascular health in healthy adults. conditions: Vascular Stiffness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: The pharmacy will be responsible for randomization and dispensing appropriate randomized intervention. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Nicotinamide Riboside Malate name: Placebo measure: Reduction of Endothelial stiffness sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States name: Snigdha Panda, BS role: CONTACT phone: 507-538-5827 email: [email protected] name: Jennifer Soderlind role: CONTACT phone: 507-284-4799 email: [email protected] lat: 44.02163 lon: -92.4699 hasResults: False
<|newrecord|> nctId: NCT06345430 id: 2023-14 briefTitle: Wearable Technological Device Applied to Patients With Chronic Pain overallStatus: COMPLETED date: 2023-11-18 date: 2024-01-15 date: 2024-01-30 date: 2024-04-03 date: 2024-04-03 name: Hacettepe University class: OTHER briefSummary: Within the scope of this research, a single session of Wearable Technological Device (Exopulse Molli-Suit) will be applied to patients with chronic back and neck pain. The results will be evaluated acutely, after 24 hours, after 1 week and after 1 month. conditions: Neck Pain conditions: Low Back Pain conditions: Chronic Pain conditions: Musculoskeletal Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: Exopulse Molli-Suit (Wearable Technological Device) measure: Pain Severity measure: Sleep Qaulity measure: Disability Level measure: Repetitive Reach Test measure: Body Composition Analysis measure: Lifting object overhead test measure: Sustained Overhead Work Test measure: back performance test sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yasemin Özel Aslıyüce city: Yeni̇mahalle state: Ankara zip: 06100 country: Turkey hasResults: False
<|newrecord|> nctId: NCT06345417 id: O-PBM1 briefTitle: Outcomes of Patient Blood Management in Severely Anemic Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-05-01 date: 2024-04-03 date: 2024-04-03 name: Helios Klinik Gotha/Ohrdruf class: OTHER name: Helios Klinikum Erfurt briefSummary: The goal of this observational cohort study is to compare patients with very low red blood counts who receive different therapy. Its main question\[s\] it aims to answer are:
* Which group of patients dies more frequent: Patients who receive patient blood management only, patients who receive patient blood management and transfusions or patients who receive only transfusions?
* Among these groups: which group of patients has more complications during hospital stay? Patients will either receive patient blood management, which is the management of anemia, bleeding and coagulation problems, will receive transfusions, that is, blood from other people, or a mix of both. conditions: Severe Anemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20000 type: ESTIMATED name: Patient Blood Management (PBM) name: Allogeneic transfusion measure: Number of dead participants at the end of hospitalization (inhospital mortality) measure: Number of participants with surgical wound complications measure: Number of participants with a documented acute myocardial infarction measure: Number of participants suffering renal injury measure: Number of days spent in hospital (Length of stay in hospital) measure: Number of participants readmitted to the studied hospital measure: Number of participants with a documented transfusion reaction measure: Number of participants receiving an allogeneic transfusion measure: Number of participants treated in an intensive care ward measure: Number of participants with documented respiratory complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Helios Klinikum city: Erfurt state: Thuringia country: Germany name: Achim Spenner role: CONTACT phone: +49-361-7810 email: [email protected] lat: 50.9787 lon: 11.03283 facility: Helios Klinikum city: Gotha state: Thuringia zip: 99867 country: Germany name: Petra See role: CONTACT phone: +49-3621-220 0 email: [email protected] name: Kai D role: CONTACT phone: +49-3621-220 phoneExt: 5058 email: [email protected] lat: 50.94823 lon: 10.70193 hasResults: False
<|newrecord|> nctId: NCT06345404 id: CPI-818-003 briefTitle: Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Participants With Moderate to Severe AD overallStatus: RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-03 date: 2024-04-10 name: Corvus Pharmaceuticals, Inc. class: INDUSTRY briefSummary: Safety, tolerability, and preliminary efficacy of soquelitinib in participants with moderate to severe AD conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Sequential Dose Escalation primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Blinded Placebo-Controlled whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: Soquelitinib name: Placebo measure: Incidence of adverse events, changes in laboratory values, vital signs, and electrocardiograms measure: To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by percent change in Eczema and Severity Index (EASI) measure: To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by change in percent reaching validated Investigator Global Assessment (vIGA) of 0 or 1 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Corvus Clinical Trials Information status: RECRUITING city: Burlingame state: California zip: 94010 country: United States name: Liza Tom role: CONTACT phone: 650-900-4514 email: [email protected] name: Gabriel Luciano role: CONTACT phone: 6509004548 email: [email protected] lat: 37.5841 lon: -122.36608 hasResults: False
<|newrecord|> nctId: NCT06345391 id: PANACEA_CO-CREATION_2024 briefTitle: Co-creation of Pain Science Education for Children Living Beyond Cancer acronym: PANACEA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-09 date: 2024-04-03 date: 2024-04-03 name: Vrije Universiteit Brussel class: OTHER name: Universitair Ziekenhuis Brussel name: University Ghent name: University Hospital, Ghent name: University of Calgary briefSummary: A pain science education (PSE) intervention for children (8-12y) living beyond cancer (CBC) will be developed through a co-creational approach with CBC, their parents and pediatric oncology clinicians. The study will be guided by the Intervention Mapping Protocol. conditions: Children Living Beyond Cancer (i.e. Child Cancer Survivor) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 24 type: ESTIMATED name: Co-creation name: Concept Mapping measure: Satisfaction with the co-created intervention measure: Understandability of the co-created intervention measure: Empowerment with regard to the co-created intervention measure: Ownership of the intervention development sex: ALL minimumAge: 8 Years maximumAge: 12 Years stdAges: CHILD facility: Vrije Universiteit Brussel city: Jette state: Brussels zip: 1090 country: Belgium name: Emma Rheel, PhD role: CONTACT phone: +32496908353 email: [email protected] name: Kelly Ickmans, PhD role: CONTACT phone: +32498483347 email: [email protected] name: Sophie Pleysier, MSc role: SUB_INVESTIGATOR lat: 50.87309 lon: 4.33419 hasResults: False
<|newrecord|> nctId: NCT06345378 id: IRFMN_PapaGio briefTitle: Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Admissions of Patients Accessing the Emergency Department (ASST Papa Giovanni XXIII) overallStatus: ACTIVE_NOT_RECRUITING date: 2021-11-25 date: 2024-12 date: 2027-12 date: 2024-04-03 date: 2024-04-04 name: Mario Negri Institute for Pharmacological Research class: OTHER briefSummary: The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients. conditions: Quality of Care conditions: Evaluation conditions: Emergency Departments conditions: Appropriateness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1200 type: ESTIMATED measure: Algorithm creation measure: Algorithm validation measure: Algorithm application measure: Appropriateness estimation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST Papa Giovanni XXIII city: Bergamo state: BG zip: 24127 country: Italy lat: 45.69601 lon: 9.66721 hasResults: False
<|newrecord|> nctId: NCT06345365 id: 09 briefTitle: MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) overallStatus: RECRUITING date: 2024-01-18 date: 2026-12-31 date: 2028-12-31 date: 2024-04-03 date: 2024-04-10 name: Zhongnan Hospital class: OTHER name: Ruijin Hospital name: Shanxi Province Cancer Hospital name: The First Affiliated Hospital of Zhengzhou University name: Jingzhou Central Hospital name: Yichang Central People's Hospital name: Taihe Hospital name: The Central Hospital of Xiaogan name: Xianning Central Hospital name: The First People's Hospital of Jingzhou briefSummary: Investigator proposed to apply the new dosage form of mitoxantrone hydrochloride liposomes to the clinical treatment of AML, while combining with cytarabine and azacitidine to form the MA+AZA treatment regimen(Mitoxantrone liposome +Ara-Cytarabine+Azacitidine), which would provide an optimal induction treatment regimen for patients with primary AML by comparing with the traditional chemotherapy regimen, DA+AZA (Daunorubicin+Ara-Cytarabine+Azacitidine). conditions: Acute Myeloid Leukaemia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 154 type: ESTIMATED name: mitoxantrone liposome, Ara-Cytarabine and azacitidine name: Daunorubicin,Ara-Cytarabine, azacitidine measure: Complete remission rate measure: Incidence of adverse events measure: Compound CR rate measure: Objective remission rate measure: No remission rate measure: Event-free survival measure: Disease-free survival measure: Overall survival measure: Mortality rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Zhengzhou University status: NOT_YET_RECRUITING city: Zhengzhou state: Henan zip: 450052 country: China lat: 34.75778 lon: 113.64861 facility: The Central Hospital of Huanggang status: NOT_YET_RECRUITING city: Huanggang state: Hubei zip: 438000 country: China lat: 23.67704 lon: 116.99961 facility: The First People's Hospital of Jingzhou status: NOT_YET_RECRUITING city: Jingzhou state: Hubei zip: 434000 country: China lat: 30.35028 lon: 112.19028 facility: Jingzhou Central Hospital status: NOT_YET_RECRUITING city: Jingzhou state: Hubei zip: 434020 country: China lat: 30.35028 lon: 112.19028 facility: Shiyan Taihe Hospital status: NOT_YET_RECRUITING city: Shiyan state: Hubei zip: 442000 country: China lat: 32.6475 lon: 110.77806 facility: Zhongnan Hospital of Wuhan University status: RECRUITING city: Wuhan state: Hubei zip: 430071 country: China name: Zhou Fuling, director role: CONTACT phone: +86-02767813137 email: [email protected] lat: 30.58333 lon: 114.26667 facility: Xianning Central Hospital status: NOT_YET_RECRUITING city: Xianning state: Hubei zip: 437100 country: China lat: 29.84347 lon: 114.32201 facility: The Central Hospital of Xiaogan status: NOT_YET_RECRUITING city: Xiaogan state: Hubei zip: 432100 country: China lat: 30.92689 lon: 113.92221 facility: Yichang Central Hospital status: NOT_YET_RECRUITING city: Yichang state: Hubei zip: 443003 country: China lat: 30.71444 lon: 111.28472 facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine status: NOT_YET_RECRUITING city: Wuxi state: Jiangsu zip: 214028 country: China lat: 31.56887 lon: 120.28857 facility: Shanxi Cancer Hospital status: NOT_YET_RECRUITING city: Taiyuan state: Shanxi zip: 030009 country: China lat: 37.86944 lon: 112.56028 hasResults: False
<|newrecord|> nctId: NCT06345352 id: IRFMN_7520_PoliMI briefTitle: Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Admissions of Patients Accessing the Emergency Department (Fondazione IRCCS Ca' Granda Ospedale Maggione Policlinico) overallStatus: ACTIVE_NOT_RECRUITING date: 2020-09-15 date: 2024-12 date: 2027-12 date: 2024-04-03 date: 2024-04-04 name: Mario Negri Institute for Pharmacological Research class: OTHER briefSummary: The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients. conditions: Quality of Care conditions: Evaluation conditions: Emergency Department conditions: Appropriateness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1200 type: ESTIMATED measure: Algorithm creation measure: Algorithm validation measure: Algorithm application measure: Appropriateness estimation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano city: Milano state: MI zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
<|newrecord|> nctId: NCT06345339 id: M21-341 briefTitle: A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants overallStatus: RECRUITING date: 2024-04-26 date: 2028-06-03 date: 2028-06-03 date: 2024-04-03 date: 2024-04-29 name: AbbVie class: INDUSTRY briefSummary: This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone \[TSH\]) on synthetic T4 treatment. This study will also therefore evaluate the efficacy and safety of dose conversion from synthetic T4 therapy to Armour Thyroid therapy. conditions: Hypothyroidism studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 2800 type: ESTIMATED name: Armour Thyroid name: Levothyroxine measure: Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response measure: Number of Participants with Adverse Events (AEs) measure: Percentage of Participants who Achieve TSH Response measure: Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid measure: Frequency of Dose Titrations During the Double-Blind (DB) Period Among Participants who Achieved TSH Response at the End of the DB Period sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Diagnamics Inc. /ID# 262680 status: RECRUITING city: Encinitas state: California zip: 92024 country: United States lat: 33.03699 lon: -117.29198 facility: NorCal Medical Research /ID# 256512 status: RECRUITING city: Greenbrae state: California zip: 94904 country: United States lat: 37.94854 lon: -122.5247 facility: West Orange Endocrinology /ID# 256139 status: RECRUITING city: Ocoee state: Florida zip: 34761-4547 country: United States lat: 28.56917 lon: -81.54396 facility: Endocrine Research Solutions /ID# 256784 status: RECRUITING city: Roswell state: Georgia zip: 30076 country: United States name: Site Coordinator role: CONTACT phone: 678-878-4750 lat: 34.02316 lon: -84.36159 facility: West Broadway Clinic /ID# 256756 status: RECRUITING city: Council Bluffs state: Iowa zip: 51501-3822 country: United States lat: 41.26194 lon: -95.86083 facility: L-MARC Research Center /ID# 255733 status: RECRUITING city: Louisville state: Kentucky zip: 40213-1014 country: United States lat: 38.25424 lon: -85.75941 facility: Physician's East Endocrinology /ID# 256491 status: RECRUITING city: Greenville state: North Carolina zip: 27834 country: United States lat: 35.61266 lon: -77.36635 facility: Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751 status: RECRUITING city: Canton state: Ohio zip: 44718 country: United States lat: 40.79895 lon: -81.37845 facility: Lynn Institute of Norman /ID# 256785 status: RECRUITING city: Norman state: Oklahoma zip: 73072 country: United States lat: 35.22257 lon: -97.43948 facility: Lynn Institute of Oklahoma City /ID# 263141 status: RECRUITING city: Oklahoma City state: Oklahoma zip: 73112 country: United States lat: 35.46756 lon: -97.51643 facility: Texas Diabetes and Endocrinology - Central Austin /ID# 255728 status: RECRUITING city: Austin state: Texas zip: 78731 country: United States name: Site Coordinator role: CONTACT phone: 512-334-3505 lat: 30.26715 lon: -97.74306 facility: Texas Diabetes and Endocrinology - South Austin /ID# 255723 status: RECRUITING city: Austin state: Texas zip: 78749 country: United States lat: 30.26715 lon: -97.74306 facility: North TX Endocrine Center /ID# 255737 status: RECRUITING city: Dallas state: Texas zip: 75231 country: United States lat: 32.78306 lon: -96.80667 facility: Diabetes and Thyroid Center of Ft. Worth /ID# 256781 status: RECRUITING city: Fort Worth state: Texas zip: 76132 country: United States lat: 32.72541 lon: -97.32085 facility: Juno Research /ID# 259238 status: RECRUITING city: Houston state: Texas zip: 77040-5059 country: United States lat: 29.76328 lon: -95.36327 facility: Consano Clinical Research, LLC /ID# 256138 status: RECRUITING city: Shavano Park state: Texas zip: 78231 country: United States name: Site Coordinator role: CONTACT phone: 210.291.3797 lat: 29.58495 lon: -98.55252 facility: Texas Valley Clinical Research /ID# 261476 status: RECRUITING city: Weslaco state: Texas zip: 78596 country: United States lat: 26.15952 lon: -97.99084 hasResults: False
<|newrecord|> nctId: NCT06345326 id: E1-22-3155 briefTitle: Greater Occipital Nerve Block Versus Pulse Radiofrequency in Migraine acronym: GON-B/PRF overallStatus: RECRUITING date: 2023-01-15 date: 2024-03-30 date: 2024-04-30 date: 2024-04-03 date: 2024-04-03 name: Adiyaman University Research Hospital class: OTHER name: Ankara City Hospital Bilkent briefSummary: The aim of the study is to evaluate the clinical efficacy of the repeated greater occipital nerve(GON) blokcs with GON pulse radiofreaquency (PRF) conditions: Migraine studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective observational primaryPurpose: TREATMENT masking: NONE count: 68 type: ESTIMATED name: Greater occipital nerve block measure: NRS measure: Complications measure: the frequency of headhache sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara City Hospital Bilkent status: RECRUITING city: Ankara zip: 06680 country: Turkey name: Sukriye Dadali, MD role: CONTACT phone: +905333316636 email: [email protected] lat: 39.91987 lon: 32.85427 hasResults: False
<|newrecord|> nctId: NCT06345313 id: CIRCADIAN RHYTHM briefTitle: EFFECT OF CIRCADIAN RHYTHM ON INFLAMMATORY PARAMETERS IN UNILATERAL INGUINAL HERNIORRAHIES overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-09-15 date: 2024-10-15 date: 2024-04-03 date: 2024-04-03 name: Ankara City Hospital Bilkent class: OTHER briefSummary: To evaluate the inflammatory response of participants who will undergo unilateral inguinal hernia surgery at two different times of the day (08.00-12.00 during the day and 18.00-22.00 at night). The main question it aims to answer is; Is the inflammation response higher in participants who undergo surgery later in the day? Serum inflammatory parameters will be measured in both groups at the preoperative 1st hour and the postoperative 24th hour. conditions: Inflammatory Response studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: Day Group name: Night Group measure: Change of IL6 (interleukin) (ng/ml) measure: Quality of recovery from anesthesia according to difference in circadian rhythm measure: Change of NLR ( Neutrophil/ Lymphocyte Ratio ) measure: Change of PLR ( Platelet / Lymphocyte Ratio ) measure: Change of SII (Systemic immune-inflammation index ) measure: Change of CRP (C Reactive Protein) (mg/dl) measure: Change of Fibrinogen (mg) measure: Change of Sedimentation (mm/hour) measure: Change of Procalcitonin (µg/l) measure: Change of Ferritin (ml/ng) measure: Postoperative pain scores according to the difference in circadian rhythm sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Bilkent City Hospital city: Ankara state: Cankaya zip: 06800 country: Turkey name: Burcu Dikmen Demiryorgan role: CONTACT phone: +905067611029 email: [email protected] name: Fatma Kavak Akelma role: CONTACT phone: +905327079113 email: [email protected] lat: 39.91987 lon: 32.85427 hasResults: False
<|newrecord|> nctId: NCT06345300 id: NCC4309 briefTitle: NALIRIFOX in Combination With Camrelizumab for BRPC: a Prospective, Exploratory Study overallStatus: RECRUITING date: 2024-03-10 date: 2024-12-12 date: 2025-12-24 date: 2024-04-03 date: 2024-04-03 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER name: Jiangsu HengRui Medicine Co., Ltd. briefSummary: The aim of this study is to assess the efficacy and safety of Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab for patients with borderline resectable pancreatic cancer conditions: Borderline Resectable Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab name: Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate measure: R0 resection rate measure: Event free survival (EFS) measure: Overall survival (OS) measure: Objective Response Rate(ORR) measure: Disease Control Rate（DCR） measure: Safety and tolerability by incidence, severity and outcome of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences status: RECRUITING city: Beijin country: China name: Yongkun Sun role: CONTACT phone: 13141276041 email: [email protected] hasResults: False
<|newrecord|> nctId: NCT06345287 id: 24/018-4298 briefTitle: Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related HNSCC overallStatus: RECRUITING date: 2024-01-01 date: 2025-12-31 date: 2026-12-31 date: 2024-04-03 date: 2024-04-03 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: The aim of this study is to develop an adaptive radiation therapy plan for locally advanced head and neck squamous cell carcinoma receiving induction therapy containing immunotherapy and chemotherapy. The therapy plan is based on clinical remission, in order to reduce treatment-related toxic side effects without sacrificing clinical efficacy and improve the quality of life of patients. conditions: Head and Neck Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 133 type: ESTIMATED name: radical radiotherapy (60Gy) name: radical radiotherapy (66Gy) name: radical radiotherapy (70Gy) name: anti-PD-1 or PD-L1 antibody measure: Progression-free survival measure: Overall survival measure: Deep partial response measure: Local-Regional failure survival measure: Toxicity Adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC status: RECRUITING city: Beijing country: China name: Jingbo Wang, Doctor role: CONTACT phone: 15811166516 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06345274 id: SP0077172 id: K23DA050729 type: NIH link: https://reporter.nih.gov/quickSearch/K23DA050729 briefTitle: MBC2OTP Project (Measurement-Based Care Implementation in Community Opioid Treatment Programs) acronym: MBC2OTP overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-02 date: 2026-02 date: 2024-04-03 date: 2024-04-22 name: Northwestern University class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The goal of this clinical trial is to evaluate the effectiveness and implementation of measurement-based care, which involves the systematic use of client self-report data to inform and enhance treatment, in opioid treatment programs using a pilot hybrid effectiveness-implementation study design. The main questions this study aims to answer are: 1) is measurement based care effective for improving patient treatment attendance and opioid abstinence, and 2) can measurement based care be implemented with fidelity in opioid treatment programs? Participants in this study will be opioid treatment program leaders and treatment providers. Leaders and treatment providers will participate in measurement-based care implementation strategies such as training and consultation to help them use measurement-based care with their patients. There is no comparison group for this study, however researchers will compare effectiveness outcomes prior to and post measurement-based care implementation and will evaluate changes in measurement-based care use with fidelity post implementation. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 40 type: ESTIMATED name: Measurement Based Care Training and Monthly Consultation measure: Patient treatment attendance (effectiveness outcome) measure: Patient treatment attendance (effectiveness outcome) measure: Treatment provider measurement based care exposure (implementation outcome) measure: Patient opioid abstinence (effectiveness outcome) measure: Treatment provider measurement based care fidelity (implementation outcome) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Family Guidance Centers, Inc. city: Aurora state: Illinois zip: 60505 country: United States lat: 41.76058 lon: -88.32007 facility: Northwestern University Feinberg School of Medicine city: Chicago state: Illinois zip: 60611 country: United States name: Kelli Scott, PhD role: CONTACT lat: 41.85003 lon: -87.65005 facility: Family Guidance Centers, Inc. city: Chicago state: Illinois zip: 60654 country: United States name: Kelli Scott, PhD role: CONTACT lat: 41.85003 lon: -87.65005 facility: Family Guidance Centers, Inc. city: Des Plaines state: Illinois zip: 60016 country: United States lat: 42.03336 lon: -87.8834 facility: Family Guidance Centers, Inc. city: Joliet state: Illinois zip: 60435 country: United States lat: 41.52519 lon: -88.0834 hasResults: False
<|newrecord|> nctId: NCT06345261 id: 2024-872 briefTitle: Diphenhydramine in Catheter Related Bladder Discomfort overallStatus: ENROLLING_BY_INVITATION date: 2024-04-01 date: 2025-04-01 date: 2025-05-01 date: 2024-04-03 date: 2024-04-03 name: Cairo University class: OTHER briefSummary: Diphenhydramine has H1-antihistamine action, it also possesses anti-muscarinic properties. Thus, diphenhydramine might be able to reduce the problem of catheter related bladder discomfort by inhibiting smooth muscle spasm of the urinary bladder via its anti-muscarinic action . conditions: Catheter Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 104 type: ESTIMATED name: DiphenhydrAMINE 50 Mg/mL Injectable Solution name: Saline measure: incidence of catheter related bladder discomfort postoperative measure: visual analog scale (VAS) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo university city: Cairo zip: 11562 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<|newrecord|> nctId: NCT06345248 id: 2024-854 briefTitle: Laparoscopic-assisted Versus Ultrasonography-guided Transversus Abdominis Plane Block in Laparoscopic Sleeve Gastrectomy overallStatus: ENROLLING_BY_INVITATION date: 2024-04-01 date: 2025-04-01 date: 2025-05-01 date: 2024-04-03 date: 2024-04-03 name: Cairo University class: OTHER briefSummary: The transversus abdominis plane (TAP) block, whereby local anesthetic is injected between the internal oblique and transversus abdominis fascia to facilitate blockade of somatic afferents nerves, is an effective, non-narcotic adjunct incorporated into many ERAS protocols. We hypothesized that surgeon delivered LAP-TAPs would be non-inferior to anesthesia-delivered US-TAPs in terms of post-operative pain control conditions: Transversus Abdominis Plane studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 74 type: ESTIMATED name: US-TAP name: LAPTAP measure: morphine needed measure: first analgesic request time measure: patients' satisfaction measure: opioid-associated side effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo university city: Cairo zip: 11562 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<|newrecord|> nctId: NCT06345235 id: ID DEC-2023/07/X/NZ5/00141 briefTitle: New Biomarkers and Plasma Prothrombotic Potential in Cardiac Transthyretin Amyloidosis overallStatus: RECRUITING date: 2023-07-11 date: 2024-07-11 date: 2024-07-11 date: 2024-04-03 date: 2024-04-19 name: John Paul II Hospital, Krakow class: OTHER briefSummary: The development of cardiac amyloidosis is caused by the deposition of misfolded, insoluble proteins in the extracellular matrix of tissues. An important element of the clinical picture of the disease is the increased risk of thromboembolic complications, independent of the occurrence of atrial fibrillation, and the presence of intracardiac thrombi. The pathomechanism may be related to an increase in filling pressure or amyloid infiltration leading to myocardial damage and endothelial dysfunction, which may activate the prothrombotic inflammatory cascade, resulting in increased thrombogenic potential. Currently, there is limited published data on the potential role of new heart failure biomarkers in the assessment of ATTR cardiomyopathy, particularly in the assessment of asymptomatic carriers of pathogenic TTR variants. Moreover, there are few literature reports on the direct assessment of the coagulation system in this group of patients, and the pathomechanism of the increased thromboembolic risk is unexplored.
Purpose of the study: To assess the diagnostic value of biomarkers related to heart failure (growth differentiation factor-15 (GDF15), soluble suppression of tumorigenicity-2 (ST2), galectin-3), amyloidosis ( TTR, tissue inhibitor of metalloproteinase-1 (TIMP-1), matrix metalloproteinase-9 (MMP-9, matrix metalloproteinase-9), neurofilament light chain (NfL)) and the generation potential thrombin as a marker of the prothrombotic state in the course of ATTR.
Methods: This prospective, single-center study will include consecutive patients diagnosed with ATTR cardiomyopathy (GROUP 1, n=30), asymptomatic carriers of pathogenic TTR variants (GROUP 2, n=30), and a matched control group of healthy volunteers (GROUP 3 , n=20). Material for research was collected and secured from all study participants. After giving informed consent, all patients will be tested using the ELISA method from peripheral blood (enzyme-linked immunosorbent assay) GDF15, ST2, TTR, TIMP-1, MMP-9, galectin-3, NfL. The values of these biomarkers will be compared in subgroups and correlated with clinical data, laboratory test results, echocardiography including analysis of left ventricular global strain (GLS), and scintigraphy. Additionally, the prothrombotic potential of plasma will be tested in both groups of patients using the calibrated automatic thrombogram (CAT) method, in accordance with the protocol previously used in the laboratory Expected results: The project will provide information on the value of biomarkers in the assessment of ATTR cardiomyopathy, especially in the assessment of asymptomatic carriers of pathogenic TTR variants, which may translate into the creation of a diagnostic algorithm for early identification of the development of the disease. Moreover, it will allow us to determine whether patients with cardiac ATTR are characterized by a prothrombotic state, which has not yet been described in the literature and may have potential clinical implications. conditions: Transthyretin Amyloidosis studyType: OBSERVATIONAL observationalModel: FAMILY_BASED timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: blood test measure: Biomarkers measure: Thrombin as a marker measure: Biomarkers measure: Biomarkers measure: Biomarkers measure: Biomarkers measure: Biomarkers measure: Biomarkers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: John Paul II Hospital status: RECRUITING city: Kraków zip: 31-202 country: Poland name: Katarzyna Holcman, MD role: CONTACT phone: 608214249 phoneExt: 48 email: [email protected] name: Katarzyna Holcman, MD role: PRINCIPAL_INVESTIGATOR lat: 50.06143 lon: 19.93658 hasResults: False
<|newrecord|> nctId: NCT06345222 id: GETAT 23/05 briefTitle: Examining the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Knee Pain overallStatus: COMPLETED date: 2023-05-01 date: 2023-07-31 date: 2023-07-31 date: 2024-04-03 date: 2024-04-04 name: Bursa Yüksek İhtisas Education and Research Hospital class: OTHER_GOV briefSummary: 92 patients with a diagnosis of primary knee pain of unknown cause followed at the family medicine outpatient clinic and who met our exclusion criteria were invited to the study. When creating patient list, the examination of patients, interviews with patients, as well as their medical records and examinations were used. Patients were divided into two groups: prolotherapy (n=46) and control group (n=46) by simple randomization method. However, when the study started, 32 people in the prolotherapy group and 33 people in the control group of these patients participated in the study. Prior to the research, detailed information was provided about the research in the experimental and control groups and signed consent was obtained from all participants that they volunteered to participate in the research. 5% dectrose was applied to the prolotherapy group by injection method to the pain area. In the control group, existing medical treatments were continued and no injection procedure was performed. Before the research, all participants were evaluated with Case Report Form, Visual Analog Scale (VAS) and Quality of Life Scale Short Form (SF-36). The cases in the experimental and control groups were re-evaluated with the VAS and SF-36 scales at the first month. conditions: The Aim of This Research is to Investigate the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Chronic Knee Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Case control study primaryPurpose: TREATMENT masking: NONE count: 65 type: ACTUAL name: Prolotherapy measure: change in knee pain with prolotherapy application measure: change in quality of life sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bursa Yuksek Ihtisas Training and Research Hospital city: Bursa state: Türkiye zip: 16310 country: Turkey lat: 40.19559 lon: 29.06013 hasResults: False
<|newrecord|> nctId: NCT06345209 id: BM-D19 briefTitle: Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for Coronary Small Vessels overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2025-12 date: 2024-04-03 date: 2024-04-03 name: BrosMed Medical Co., Ltd class: INDUSTRY name: Chinese Academy of Medical Sciences, Fuwai Hospital briefSummary: To evaluate the safety and efficacy of a sirolimus-coated coronary balloon dilatation catheter for the treatment of small vessel lesions of primary coronary arteries. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 236 type: ESTIMATED name: Sirolimus-coated Coronary Balloon Dilatation Catheter name: Drug-coated Coronary Balloon Dilatation Catheter measure: Late luminal loss (LLL) measure: Device success rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06345196 id: BozokUni briefTitle: Motivational Interviewing Applied to Individuals With Diabetes overallStatus: RECRUITING date: 2024-04-15 date: 2024-05-15 date: 2024-10-15 date: 2024-04-03 date: 2024-04-03 name: Bozok University class: OTHER briefSummary: This study will be conducted using a randomized controlled trial design to evaluate the effect of online individual motivational interviewing on well-being, stress and difficulties in individuals with diabetes. The study will be conducted between March 2024 and March 2025 with individuals with Type 2 Diabetes who are followed up in Yozgat Bozok University Health Practice and Research Center Internal Medicine Polyclinic. The motivational interview group will receive a motivational interview once a week, lasting a maximum of 40 minutes, consisting of a total of four sessions. Chi-square (X2), t-test, repeated measures analysis of variance, Pearson correlation coefficient, partial eta-square and linear regression analysis will be used to evaluate the data. conditions: Motivational Interviewing conditions: Stress conditions: Well-Being, Psychological conditions: Diabetes Mellitus conditions: Type2diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 66 type: ESTIMATED name: motivational interview measure: Change in coping with stress measure: State of Well-Being Change measure: Changing Strength and Difficulties in Diabetes sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Akdağmadeni School of Health status: RECRUITING city: Yozgat country: Turkey name: Betül Bal role: CONTACT phone: 0 (354) 314 14 15 email: [email protected] lat: 39.82 lon: 34.80444 facility: Bozok University status: RECRUITING city: Yozgat country: Turkey name: Betül Bal role: CONTACT phone: 0 (354) 314 14 15 email: [email protected] lat: 39.82 lon: 34.80444 hasResults: False
<|newrecord|> nctId: NCT06345183 id: CA209-1275 briefTitle: Real-World Outcomes of Nivolumab+Ipilimumab and Pembrolizumab+Lenvatinib Among US Advanced Renal Cell Carcinoma (aRCC) Patients overallStatus: RECRUITING date: 2024-02-19 date: 2024-04-01 date: 2024-12-31 date: 2024-04-03 date: 2024-04-03 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: This observational study aims to describe demographic, clinical characteristics, treatment patterns outcomes of participants with advanced Renal Cell Carcinoma (aRCC) receiving either Nivolumab + Ipilimumab, or Pembrolizumab + Lenvatinib combination therapy conditions: Advanced Renal Cell Carcinoma (aRCC) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 350 type: ESTIMATED name: Nivolumab + Ipilimumab combination therapy name: Pembrolizumab + Lenvatinib combination therapy measure: Participant year of birth measure: Participant sex at birth measure: Participant primary payer measure: Participant race measure: Participant ethnicity measure: Participant U.S. state of residence measure: Participant initial Renal Cell Carcinoma (RCC) diagnoses measure: American Joint Committee on Cancer (AJCC) TNM stage measure: Participant advanced/metastatic Renal Cell Carcinoma (RCC) diagnosis measure: Participant renal cell carcinoma (RCC) histology results measure: Participant tumor grade measure: Participant biomarker or genetic testing method measure: Participant molecular and/or genetic mutations reported measure: Participant site of metastatic disease measure: Participant Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) measure: Participant Karnofsky score (KPS) measure: Participant comorbidities and/or chronic conditions measure: Participant blood test results measure: Participant Memorial Sloan Kettering Cancer Center (MSKCC) score measure: Participant International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) score measure: Participant smoking status measure: Participant COVID-19 status measure: Participant surgical history measure: Participant radiation treatment history measure: Participant treatment regimen received measure: Participant treatment initiation and discontinuation dates measure: Participant rationale for discontinuation of treatment measure: Participant radiation therapy prescribed measure: Participant total number of radiotherapy cycles measure: Participant initial dose and frequency/schedule of index therapy measure: Participant index treatment dose modifications measure: Participant rationale for dose modifications of index therapy measure: Participant date of dose modifications of index therapy measure: Participant last dose and frequency/schedule of index therapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cardinal Health status: RECRUITING city: Dublin state: Ohio zip: 43017 country: United States lat: 40.09923 lon: -83.11408 hasResults: False
<|newrecord|> nctId: NCT06345170 id: buhucgun05 briefTitle: Investigation the Effect of the Social-Communication Area Developmental Screening Test for Infants and Young Children Training Program Applied in Addition to the DIR/Floortime™ Therapy Program in Children With Developmental Risk overallStatus: RECRUITING date: 2023-01-03 date: 2024-04-10 date: 2024-04-10 date: 2024-04-03 date: 2024-04-03 name: Biruni University class: OTHER briefSummary: The term "developmental risk" is used as a general term for developmental delays observed in infancy and early childhood. Developmental delay refers to the delay in children reaching developmental milestones compared to their peers. The DIR/Floortime™ therapy program is an approach that uses play as a therapeutic tool, emphasising the importance of interaction involving affect and excitement in a child's development. DIR/Floortime™ therapy program aims to support the child's development with a family-centred perspective by evaluating the child and the family together. DIR/Floortime™ therapy program is known to contribute to the functional and emotional development of children and the development of parenting skills of caregivers. The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) is a parent-reported developmental screening test that aims to identify 'delays' in the social communication area skills of infants and children. The SCASI training program is a training program for children and parents developed on the basis of this screening test, which includes targeted activities to support the development process according to the child's developmental level. To the best of our knowledge, there is no study investigating the effect of the SCASI training program applied in addition to the DIR/Floortime™ therapy program in children with risky development. The aim of the study is to examine the effect of the SCASI training program applied in addition to the DIR/Floortime™ therapy program in children with risky development. A total of 34 children with developmental risk between the ages of 1 and 3 will included in the study. Participants will randomly divided into two groups: control group (n=17) in which the DIR/Floortime™ therapy program will be applied and intervention group (n=17) in which the SCASI training program will be applied in addition to the DIR/Floortime™ therapy program. The DIR/Floortime™ therapy program will be applied by the therapist in the clinic for 50 minutes, 2 days a week for 12 weeks, and the SCASI training program will be applied by the parents at home, 2 days a week, for an average of 30 minutes a day, for 12 weeks. Demographic and clinic informations, SCASI test, Age and Stages Questionnarie (ASQ), Age and Stages Questionnaires: Social-Emotional (ASQ-SE) and Brief Infant and Toddler Social Emotional Assessment (BITSEA) will be used as outcome measures in the study. conditions: Children With Developmental Risk studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 34 type: ESTIMATED name: The DIR/Floortime™ Therapy Program name: The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) Training Program measure: The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) measure: Age and Stages Questionnarie (ASQ) measure: Age and Stages Questionnaires: Social-Emotional (ASQ-SE) measure: Brief Infant and Toddler Social Emotional Assessment (BITSEA) sex: ALL minimumAge: 1 Year maximumAge: 3 Years stdAges: CHILD facility: Biruni University status: RECRUITING city: Istanbul zip: 34015 country: Turkey name: Hikmet Ucgun, PT, PhD role: CONTACT phone: +905321616271 email: [email protected] lat: 41.01384 lon: 28.94966 hasResults: False
<|newrecord|> nctId: NCT06345157 id: COMB157GIT02 briefTitle: ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-04-30 date: 2026-04-30 date: 2024-04-03 date: 2024-04-03 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: Study to evaluate the effectiveness of ofatumumab in Italian RRMS patients in the real-life setting. conditions: Multiple Sclerosis, Relapsing-Remitting studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Ofatumumab measure: Annualized relapse rate (ARR) measure: Proportion of patients with an improvement in SDMT (Symbol Digit Modality Test) measure: Fatigue Severity Scale [FSS] measure: Quality of life parameters assessed by EQ-5D-3L measure: Treatment satisfaction assessed by TSQM-9 measure: Expanded Disability Status Scale (EDSS) measure: Variation of NfL in plasma measure: Adverse Events (AEs) measure: Discontinuation rates due to AE and/or other reasons sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06345144 id: 202307211RINC briefTitle: Learning Experience of Undergraduate Nursing Students in Pediatric Oncology Ward overallStatus: RECRUITING date: 2023-08-22 date: 2024-03-29 date: 2024-03-29 date: 2024-04-03 date: 2024-04-03 name: National Taiwan University Hospital class: OTHER briefSummary: Clinical practices are crucial experiences for nursing students as they prepare themselves for future nursing work. Despite some research having been studied among Taiwanese nursing students in the past, there has been limited research into the experiences within pediatric oncology wards, where diseases are complex and frequently involve life-and-death issues. Therefore, the purpose of this study is to explore the experiences of undergraduate nursing students in pediatric oncology wards. conditions: Pediatric Cancer studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: RETROSPECTIVE count: 15 type: ESTIMATED measure: Explore the experiences of undergraduate nursing students practicing in pediatric oncology wards. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wei-En Li status: RECRUITING city: New Taipei City country: Taiwan name: Wei-En Li role: CONTACT lat: 25.01111 lon: 121.44583 hasResults: False
<|newrecord|> nctId: NCT06345131 id: KY20230829-06 briefTitle: Clinical Research Plan for the Safety and Accuracy of Ultrasound-guided Radial Artery Puncture Catheterization overallStatus: RECRUITING date: 2023-07-01 date: 2024-08 date: 2024-09 date: 2024-04-03 date: 2024-04-03 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: By observing the anatomical relationship and influencing factors of the radial artery through ultrasound, the optimal puncture location is selected, and puncture catheterization is guided to reduce the number of punctures, reduce complications, and improve safety and accuracy. conditions: Surgical Patients studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Non invasive blood pressure monitoring measure: Measure the transverse diameter of the radial artery at each anatomical point sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing First Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210006 country: China name: Liu Han, MD role: CONTACT phone: 18951670163 email: [email protected] lat: 32.06167 lon: 118.77778 typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2023-07-22 uploadDate: 2024-02-14T20:25 filename: Prot_ICF_000.pdf size: 166411 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2023-07-22 uploadDate: 2024-03-05T21:35 filename: SAP_001.pdf size: 300501 hasResults: False
<|newrecord|> nctId: NCT06345118 id: FallpreventT2DMelderly briefTitle: Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus acronym: FallT2DMOLD overallStatus: RECRUITING date: 2024-03-01 date: 2024-09-01 date: 2025-12-31 date: 2024-04-03 date: 2024-04-03 name: National Geriatric Hospital class: OTHER_GOV briefSummary: .This randomized controlled clinical trial aims to evaluate the effects of fall prevention in older adults with type 2 diabetes mellitus. The main questions it aims to answer are:
* Describe the current situation of falls, the risk of falls, and some related factors in elderly type 2 diabetic patients
* Evaluate the results of fall prevention and related factors in the study population.
Participants will be randomly divided into control and intervention groups. The intervention group will be trained to follow the Otago Training Program as the primary fall prevention method. On the other hand, the control group will receive the standard care following the treatment guidelines for type 2 diabetes mellitus and other comorbidities.
At the end of the intervention, the study will mainly compare the rate of fall incidents after 6 months of intervention as well as other physical performance tests. conditions: Diabetes Mellitus, Type 2 conditions: Fall conditions: Elderly Patient studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Otago exercise program measure: Physical performance 1 - Timed Up and Go (TUG) measure: Physical performance 2 -Berg Balance Scale (BBS) measure: Activities of Daily Living (ADLs) measure: Health-related Quality of Life measure: Functional Reach Test (FRT) measure: Instrumental Activities of Daily Living (IADLs) sex: ALL minimumAge: 60 Years maximumAge: 60 Years stdAges: ADULT facility: National Geriatric Hospital status: RECRUITING city: Hanoi zip: 100000 country: Vietnam name: Huyen TT Vu, PhD role: CONTACT phone: +84913531579 email: [email protected] lat: 21.0245 lon: 105.84117 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-10-11 uploadDate: 2024-03-13T14:07 filename: ICF_000.pdf size: 320767 hasResults: False
<|newrecord|> nctId: NCT06345105 id: AIeffectiveV4 briefTitle: Real Time Effective Withdrawal Time and Adenoma Detection Rate overallStatus: RECRUITING date: 2024-04-01 date: 2024-11-30 date: 2025-01-31 date: 2024-04-03 date: 2024-04-16 name: The University of Hong Kong class: OTHER briefSummary: The goal of this observational study is to assess the correlation between the artificial intelligence (AI) derived effective withdrawal time (EWT) during colonoscopy and endoscopists' baseline adenoma detection rate (ADR). The association between the AI derived EWT with ADR during the prospective colonoscopy series would also be determined. The colonoscopy video of participants will be monitored by the AI conditions: Colon Polyp conditions: Colon Adenoma conditions: Artificial Intelligence studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 198 type: ESTIMATED name: Endoscreener QC measure: Adenoma detection rates of the endoscopists measure: Adenoma detection rate measure: Polyp detection rate sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Queen Mary Hospital, the University of Hong Kong status: RECRUITING city: Hong Kong country: Hong Kong name: Thomas Ka Luen Lui role: CONTACT phone: +852 97360997 email: [email protected] lat: 22.27832 lon: 114.17469 hasResults: False
<|newrecord|> nctId: NCT06345092 id: Omfs.3-3-3 briefTitle: Comparison Between IPRF With Vit. C and IPRF Alone in Management of ID'Pain overallStatus: COMPLETED date: 2022-09-01 date: 2023-03-01 date: 2023-09-01 date: 2024-04-03 date: 2024-04-04 name: Cairo University class: OTHER briefSummary: Randomized clinical trial between 2groups,the study group to be injected in the TMJ with injectable platelet rich fibrin with vitamin C and the control group to be injected in the TMJ with injectable platelet rich fibrin alone in management of internal Temporomandibular joint derangement conditions: TMJ Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 40 type: ACTUAL name: Vitamin C name: Injectable platelet rich fibrin measure: Pain management measure: disc position using MRI measure: maximum mouth opening measure: lateral excursion sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Dentistry cairo university city: Cairo zip: +2 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<|newrecord|> nctId: NCT06345079 id: AG0219NET briefTitle: Cessation of Somatostatin Analogues After PRRT in Mid-Gut Neuroendocrine Tumours acronym: STOPNET overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-09 date: 2028-06 date: 2024-04-03 date: 2024-04-03 name: Australasian Gastro-Intestinal Trials Group class: NETWORK name: Canadian Cancer Trials Group briefSummary: Neuroendocrine tumours (NETs) are slow growing cancers, which commonly present as metastatic incurable disease. Some neuroendocrine tumours, termed functional NETs, overproduce hormones which result in a variety of symptoms. However, approximately 75% of NETs are considered non-functional meaning that they do not result in hormone overproduction. The main treatment for both functional and non-functional NETs is somatostatin analogues (SSA, a type of inhibitory hormone). These drugs slow tumour growth and reduce hormone production. Over time, the majority of patients will experience tumour growth despite treatment with SSA therapy. When this occurs, the addition of Peptide Receptor Radionuclide Therapy (PRRT, a type of targeted radiotherapy) in combination with ongoing SSA therapy is given. However, it is not known if continuing SSA therapy after commencement of PRRT is beneficial or not.
The aim of this study is to estimate the outcomes of patients with grade 1 and 2 well differentiated mid and hind-gut neuroendocrine tumours who have progressed on SSA therapy and receive subsequent PRRT with or without concurrent SSA. conditions: Neuroendocrine Tumors studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: Cessation of somatostatin analogues name: Continuation of somatostatin analogues measure: 20-month progression free survival rate after PRRT measure: Assess the barriers which would impede the feasibility of a subsequent phase 3 trial measure: Measure Quality of life using the European Organisation For Research And Treatment Of Cancer (EORTC) Core Quality of Life questionnaire (QLQ-C30) scales measure: Measure Quality of life using the EORTC QLQ-GINET21 scales measure: Cost-effectiveness of SSA therapy cessation measure: Psycho-oncological impacts of SSA therapy cessation: Decision Regret measure: Psycho-oncological impacts of SSA therapy cessation: Fear of Cancer Progression measure: Psycho-oncological impacts of SSA therapy cessation: Decisional Conflict measure: Time to commencement of subsequent therapy measure: Overall survival measure: Rates of SSA being recommenced over time measure: Exploratory analyses sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Brisbane Women's Hospital city: Brisbane state: Queensland zip: 4006 country: Australia name: Matthew Burge role: CONTACT phone: (07) 3636 8111 email: [email protected] name: Matthew Burge role: PRINCIPAL_INVESTIGATOR lat: -27.46794 lon: 153.02809 hasResults: False
<|newrecord|> nctId: NCT06345066 id: 18834 id: J3R-MC-YDAC type: OTHER domain: Eli Lilly And Company briefTitle: A Study of LY3841136 in Overweight and Obese Participants overallStatus: RECRUITING date: 2024-04-03 date: 2025-03 date: 2025-03 date: 2024-04-03 date: 2024-04-19 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatide in overweight and obese patients. The study will last up to approximately 42 weeks. conditions: Obesity conditions: Overweight studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Tirzepatide name: LY3841136 name: Placebo measure: Number of Participants With One or More Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration measure: Percent Change from Baseline in Body Weight measure: Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3841136 measure: Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of LY3841136 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fortrea CRU, Inc. status: RECRUITING city: Daytona Beach state: Florida zip: 32117 country: United States name: Hugh Coleman role: PRINCIPAL_INVESTIGATOR lat: 29.21081 lon: -81.02283 facility: Fortrea CRU, Inc. status: RECRUITING city: Dallas state: Texas zip: 75247 country: United States name: Archie Bowie role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: Fortrea CRU, Inc. status: RECRUITING city: Madison state: Wisconsin zip: 53704 country: United States name: Nicholas Siebers role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False
<|newrecord|> nctId: NCT06345053 id: 203428 briefTitle: Presence of PTSD and Emotion Dysregulation Among Inpatients With Substance Use Disorder overallStatus: RECRUITING date: 2021-05-01 date: 2024-10-01 date: 2025-10-01 date: 2024-04-03 date: 2024-04-03 name: Norwegian University of Science and Technology class: OTHER name: Møre og Romsdal Hospital Trust name: Oslo University Hospital briefSummary: There are high rates of co-occurring posttraumatic stress disorder (PTSD) among patients receiving treatment for substance use disorder (SUD). PTSD and SUD should be treated simultaneously, but adults in SUD treatment are often not assessed for PTSD nor offered PTSD-based interventions. One of the reasons for reluctance in offering trauma focused treatment is increased risk of drop out. PTSD and related emotion dysregulation are related to elevated psychological burden, higher dropout rates and increased risk of relapse. this is a feasibility study, where the plan is to integrate a combination of Dialectical Behaviour Therapy for Substance Use Disorder (DBT-SUD skills) a therapy targeting difficulties in emotion regulation and Narrative Exposure Therapy (NET) a trauma focused therapy, for patients with co-occurring PTSD symptoms into standard SUD treatment . The plan is to assess its potential benefits by assessing whether adding this combination to standard SUD treatment is relevant, feasible, acceptable, and safe. Treatment outcomes are 1) Prevalence of PTSD, suicidal behaviour, and self-harm, as well as the severity of difficulties in emotion regulation and emotional avoidance among patients (N approx. = 100) in inpatient treatment for SUD. 2) Change post-treatment and at 3 and 12 months follow up, from baseline in PTSD symptom severity, depressive symptoms, emotion regulation, emotion avoidance, and experience of shame. 3) Rates of dropout and relapse compared to previous rates.
This project can increase knowledge about psychological mechanisms in co-occurring PTSD and SUD and improve the quality of treatment for this vulnerable patient population. conditions: Post Traumatic Stress Disorder conditions: Substance Use Disorders conditions: Emotion Regulation conditions: Suicide conditions: Self-harm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a repeated measures follow-up feasibility study without control group. primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Narrative Exposure Therapy measure: The intervention is relevant - prevalence of PTSD /SUP PTSD. measure: The intervention is relevant - prevalence of traumatic experiences. measure: The intervention is relevant - The severitiy of difficulties in emotion regulation. measure: The intervention is feasible, accepted and safe - The dropout rate from treatment. measure: The intervention is safe - Suicide behaviour while in treatment. measure: The intervention is safe - Self-harm behaviour while in treatment. measure: The intervention is accepted - participation in DBT-SUD skills sessions. measure: The intervention is feasible and accepted - Objective experience of treatment. measure: The potential benefits of the intervention - Change in PTSD symptoms from base line to 3-and 12 month follow up. measure: The potential benefits of the intervention - Change in Difficulties in emotion regulation from baseline to 3- to 12- month follow up. measure: The potential benefits of the intervention - Relapse to alcohol abuse at 3- and 12-months follow up. measure: The potential benefits of the intervention - Relapse to substance abuse at 3- and 12-month follow up. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Molde Treatment Center, Møre and Romsdal Hospital Trust status: RECRUITING city: Molde state: Møre And Romsdal zip: 6410 country: Norway name: Edvard Breivik role: CONTACT phone: +4793032613 email: [email protected] name: Johanna Vigfusdottir role: CONTACT phone: +4746746154 email: [email protected] lat: 62.73752 lon: 7.15912 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-15 uploadDate: 2024-03-18T06:41 filename: Prot_SAP_000.pdf size: 766255 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-25 uploadDate: 2024-03-25T10:01 filename: ICF_001.pdf size: 621574 hasResults: False
<|newrecord|> nctId: NCT06345040 id: H-22067692 briefTitle: The Dialogue Study: A Virtual-reality Based Treatment for Eating Disorders overallStatus: RECRUITING date: 2024-02-26 date: 2025-12 date: 2026-06 date: 2024-04-03 date: 2024-04-03 name: Mental Health Services in the Capital Region, Denmark class: OTHER briefSummary: The Dialogue Study is a randomized, assessor-blinded parallel-groups superiority clinical trial fulfilling the CONSORT criteria for non-pharmacological treatment. The aim of the trial is to investigate the effect of a new virtual reality based psychotherapy for eating disorders. A total of 96 participants with a diagnosis of anorexia nervosa or bulimia nervosa will be allocated to either Virtual-reality therapy plus treatment as usual or treatment as usual. All participants will be assessed at baseline and 12- and 24 months post baseline. A stratified block-randomisation with concealed randomisation sequence will be conducted. Independent assessors blinded to the treatment will evaluate outcome. Analysis of outcome will be carried out with the intention to treat principles. conditions: Eating Disorders conditions: Anorexia Nervosa conditions: Bulimia Nervosa studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: Virtual-reality intervention name: TAU - specialized treatment measure: Eating disorder symptoms post treatment measured with the Eating Disorder Examination Questionnaire measure: Level of depressive symptoms post treatment measure: Motivation for change post treatment measure: Level of identification with the eating disorder and level of embodiment post treatment measure: Experience of the eating disorder voice post treatment measure: Beliefs about the power and benevolence of the eating disorder voice post treatment - engagement scale measure: Total score of eating disorder voice characteristics post treatment measure: Level of quality of life post treatment measure: Perceived difference in power between eating disorder voice and eating disorder patient post treatment measure: Level of acceptance of and action in relation to the eating disorder voice post treatment measure: Level of self-compassion post treatment measure: Level of body dissatisfaction post treatment measure: Level of perceived self-efficacy post treatment measure: Ability to regulate emotion post treatment measure: Level of executive functioning post treatment measure: Participant satisfaction measure: Presence of childhood traumas measure: Level of simulator sickness measure: Level of dysfunctional cognitive beliefs post treatment measure: Positive and negative aspects of eating disorders as perceived by the participant post treatment measure: Personal recovery post treatment measure: Presence of comorbidity measure: Cost effectiveness of the intervention measure: Level of cognitive (in)flexibility post treatment measure: Monitoring and reporting of adverse and unwanted events measure: Level of immersion in virtual reality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Copenhagen Research Center for Mental Health - CORE status: RECRUITING city: Hellerup state: Copenhagen zip: 2900 country: Denmark name: Nina K Hansen, MSc (Psych.) role: CONTACT phone: 21699487 phoneExt: +45 email: [email protected] name: Louise B Glenthøj, DMSc, PhD role: CONTACT phone: 21452889 phoneExt: +45 email: [email protected] name: Louise B Glenthøj, DMSc, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.73204 lon: 12.57093 hasResults: False
<|newrecord|> nctId: NCT06345027 id: H-53163 CASEY briefTitle: CHIMERIC ANTIGEN RECEPTOR TREATMENT TARGETING CD70 (SEVENTY) acronym: CASEY overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-05-01 date: 2042-04-01 date: 2024-04-03 date: 2024-04-03 name: Baylor College of Medicine class: OTHER briefSummary: This study is for patients that have lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease and the patients condition has come back or has not gone away after treatment, including the best treatment we know for these diseases.
Some patients with Lymphoma or T/NK-lymphoproliferative disease show signs of virus that is sometimes called Epstein Barr virus (EBV). This virus causes mononucleosis or glandular fever ("mono") before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's and non-Hodgkin Lymphoma. This suggests that the EBV plays a role in causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells infected by EBV are able to hide from the body's immune system and escape destruction.
T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. T cells have been used to treat patients with cancers. T cells, that have been trained to kill EBV infected cells can survive in blood and affect the tumor. We have treated over 80 people on studies using T cells to target these diseases. About half of those patients who had disease at the time they got the cells had responses including some patients with complete responses (meaning the cancer could no longer be detected).
We think that if T cells are able to last longer in the body, they may have a better chance of killing EBV and EBV infected tumor cells. Therefore, in this study we will add a new gene to the EBV T cells that can cause the cells to live longer called C7R. We know that T cells need substances called cytokines (substances such as proteins released by specific cells of the immune system) to survive and that the cells may not get enough cytokines after the cells are infused into the body. We have added the gene C7R that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time.
The purpose of this study is to find the largest safe dose of C7R-EBV T cells, and additionally to evaluate how long they can be detected in the blood and what affect they have on the cancer. conditions: Leukemia, Myeloid, Acute conditions: Leukemia, B-cell conditions: Leukemia, T-Cell conditions: Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Treatment Arm A measure: Dose limiting toxicity (DLT) rate measure: Overall Response Rate sex: ALL maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Texas Children's Hospital city: Houston state: Texas zip: 77030 country: United States name: Bilal Omer, MD role: CONTACT phone: 832-826-0860 email: [email protected] lat: 29.76328 lon: -95.36327 facility: The Methodist Hospital city: Houston state: Texas zip: 77030 country: United States name: Bilal Omer, MD role: CONTACT phone: 832-826-0860 email: [email protected] lat: 29.76328 lon: -95.36327 hasResults: False
<|newrecord|> nctId: NCT06345014 id: 23CP40803 briefTitle: The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome overallStatus: RECRUITING date: 2023-12-20 date: 2025-12-30 date: 2026-03-30 date: 2024-04-03 date: 2024-04-04 name: AJU Pharm Co., Ltd. class: INDUSTRY name: OM Pharma SA briefSummary: This study is planned to Evaluate the Efficacy and Safety of OM-89 in Patients with Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome conditions: Chronic Prostatitis conditions: Chronic Pelvic Pain Syndrome studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Once a subject voluntarily gives written consent to participate in this study, a screening test will be conducted to evaluate their eligibility. Subjects determined to be eligible to participate in the study on Visit 2 (baseline) will be enrolled, randomized 1:1 either to the test group (OM-89 \[Uro-Vaxom® Capsule\]) or the control group (placebo of OM-89) and administered the investigational product for 26 weeks.
In parallel, an alpha blocker (alfuzosin 10 mg) will be administered for the first 13 weeks as a background treatment, followed by the placebo of alfuzosin until Week 26. The efficacy and safety will be checked until Week 52 from the start of the treatment for all subjects. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Background treatment - Xatral® XL Tab. 10 mg (alfuzosin hydrochloride): With the treatment of the investigational product, it will be administered for the first 13 weeks (Administration of the placebo will be continued to maintain the treatment compliance and blinding for the rest 13 weeks).
After week 13, Background treatment will be blinded for subject only until end of treatment period(Week 26). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 332 type: ESTIMATED name: OM-89 [Uro-Vaxom® Capsule] name: OM-89 Placebo [Uro-Vaxom® Capsule Placebo] measure: NIH-CPSI total score measure: NIH-CPSI domain score measure: Subject and Investigator's Global Assessment sex: MALE minimumAge: 19 Years maximumAge: 55 Years stdAges: ADULT facility: AJU Pharm Co., Ltd. status: RECRUITING city: Seoul country: Korea, Republic of name: JUNGMIN LEE role: CONTACT phone: +82-02-2630-0700 email: [email protected] lat: 37.566 lon: 126.9784 hasResults: False
<|newrecord|> nctId: NCT06345001 id: 22261 briefTitle: A First-in-Human Study to Learn About How BAY3630942 is Distributed and Processed Inside the Body When Given After BAY3547922 and How Safe it is in People With Liver Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-08-12 date: 2024-08-30 date: 2024-04-03 date: 2024-04-29 name: Bayer class: INDUSTRY briefSummary: Researchers are studying a new potential treatment for liver cancer.
To do this, researchers have developed a protein, called a monoclonal antibody, which can find and attach itself to another protein present on the surface of liver cancer cells. This can help the new treatment to specifically target cancer cells in the liver.
In this study, researchers want to understand the distribution and processing of this monoclonal antibody in people with liver cancer.
Researchers will use the following two forms of monoclonal antibody as study interventions during this study:
* BAY3630942: This is the monoclonal antibody attached to a tracer. A tracer emits radiation that can help researchers track the monoclonal antibody in the body using imaging tests like PET/CT (positron emission tomography / computed tomography). All participants will receive a fixed dose of BAY3630942 during the study.
* BAY3547922: This is the monoclonal antibody without the tracer. Participants may receive different amounts of BAY3547922 during the study.
In this study, participants will not derive therapeutic benefit from receiving BAY3630942 or BAY3547922. However, this study may help researchers develop a new treatment for people with liver cancer and find a dose to be tested in future studies.