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Adults with insomnia will be randomized to an ACT-I or waitlist group. Both the ACT-I treatment and waiting period span 7 weeks. Assessments take place at baseline (pre), after 4 weeks (mid), and after 8 weeks (post), followed by a 3- and 6-month follow-up for the ACT-I group.
The main questions this RCT aims to answer are:
* Is ACT-I superior to a waitlist control group in improving insomnia severity (primary outcome) in addition to sleep diary measures, anxiety, depression, general mental health, and sleep-related quality of life (secondary outcomes)?
* How do networks of insomnia symptoms or potential treatment processes (i.e., psychological (in)flexibility, sleep-related arousal, dysfunctional cognitions, and sleep-related safety behaviors) develop during and following ACT-I? conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Acceptance and Commitment Therapy for insomnia (ACT-I) measure: Insomnia severity measure: Insomnia severity measure: Insomnia severity measure: Insomnia severity measure: General well-being measure: General well-being measure: General well-being measure: General well-being measure: Sleep-related quality of life measure: Sleep-related quality of life measure: Sleep-related quality of life measure: Sleep-related quality of life measure: Anxiety symptoms measure: Anxiety symptoms measure: Anxiety symptoms measure: Anxiety symptoms measure: Depression symptoms measure: Depression symptoms measure: Depression symptoms measure: Depression symptoms measure: Sleep diary: total sleep time measure: Sleep diary: total sleep time measure: Sleep diary: total sleep time measure: Sleep diary: total sleep time measure: Sleep diary: sleep onset latency measure: Sleep diary: sleep onset latency measure: Sleep diary: sleep onset latency measure: Sleep diary: sleep onset latency measure: Sleep diary: wake after sleep onset measure: Sleep diary: wake after sleep onset measure: Sleep diary: wake after sleep onset measure: Sleep diary: wake after sleep onset measure: Sleep diary: sleep efficiency measure: Sleep diary: sleep efficiency measure: Sleep diary: sleep efficiency measure: Sleep diary: sleep efficiency measure: Psychological flexibility measure: Psychological flexibility measure: Psychological flexibility measure: Psychological flexibility measure: Psychological inflexibility measure: Psychological inflexibility measure: Psychological inflexibility measure: Psychological inflexibility measure: Sleep-related arousal measure: Sleep-related arousal measure: Sleep-related arousal measure: Sleep-related arousal measure: Dysfunctional sleep-related cognitions measure: Dysfunctional sleep-related cognitions measure: Dysfunctional sleep-related cognitions measure: Dysfunctional sleep-related cognitions measure: Sleep-related safety behaviors measure: Sleep-related safety behaviors measure: Sleep-related safety behaviors measure: Sleep-related safety behaviors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Amsterdam city: Amsterdam state: Noord-Holland zip: 1018 WS country: Netherlands name: Mathilde I Looman, MSc role: CONTACT phone: (0)20 525 6810 phoneExt: +31 email: m.i.looman@uva.nl lat: 52.37403 lon: 4.88969 hasResults: False
<\|newrecord\|> nctId: NCT06336538 id: CASE1124 briefTitle: Abbreviated MBCT for Depression in Older African American/Black Breast Cancer Survivors overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-01-31 date: 2025-01-31 date: 2024-03-28 date: 2024-03-29 name: Case Comprehensive Cancer Center class: OTHER briefSummary: The purpose of this research study is to develop and test an intervention designed to improve mood and reduce symptoms of depression. conditions: Breast Cancer conditions: Breast Cancer Female conditions: Breast Cancer Stage I conditions: Breast Cancer Stage II conditions: Breast Cancer Stage III conditions: Mild Depression conditions: Moderate Depression studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Investigator will first conduct focus groups with older (≥65 years old) African American/Black (AA/B) breast cancer survivors (BCS) with elevated depressive symptoms. They will collect participant perspectives on barriers and facilitators to participation in MBI clinical trials, as well as how to adapt this intervention, called Mindfulness-Based Cognitive Therapy-Brief (MBCT-Brief), to increase cultural relevancy for older AA/B BCS with elevated depressive symptoms. They will then conduct a single arm clinical trial that incorporates the results of the qualitative data analysis to establish feasibility and acceptability of MBCT-Brief. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 31 type: ESTIMATED name: MBCT measure: Mean participant attendance rate measure: Acceptability rate using CSQ(Client Satisfaction Questionnaire-8) measure: Change in fear of recurrence as assessed using FCRI(Fear of Cancer Recurrence Inventory) scores measure: Change in trait mindfulness as assessed using FFMQ-15(Five Facet of Mindfulness Scale Short Form) scores measure: Change in Quality of life as assessed using ICS-2(Impact of Cancer Scale version 2) scores measure: Change in depressive symptoms as assessed using PROMIS-D(Patient Reported Outcomes Measurement Information System-Depression) scores sex: FEMALE minimumAge: 65 Years stdAges: OLDER_ADULT facility: Cleveland Clinic Department of Wellness and Preventive Medicine city: Cleveland state: Ohio zip: 44106 country: United States name: Jacob Hill, ND role: CONTACT lat: 41.4995 lon: -81.69541 hasResults: False
<\|newrecord\|> nctId: NCT06336525 id: 2023P001895 id: R01HL164462 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL164462 briefTitle: Adult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-01-31 date: 2027-01-31 date: 2024-03-28 date: 2024-04-22 name: Brigham and Women's Hospital class: OTHER name: University of Alabama at Birmingham name: Emory University name: University of Pennsylvania name: University of Massachusetts, Worcester name: The University of Texas Health Science Center at San Antonio name: Beth Israel Deaconess Medical Center name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: Rural communities in the southern U.S. suffer a disproportionate burden of morbidity and mortality from cardiometabolic disease, with traditional risk factors explaining only a modest proportion of the excess burden of disease. There is considerable evidence that multiple dimensions of sleep health, including sleep duration, efficiency, timing, and regularity, as well as the disorders sleep apnea and insomnia, affect cardiometabolic disease risk. However, there is currently a lack of systematically developed sleep data in rural populations. The RURAL Sleep Study is an ancillary study to a recently initiated longitudinal epidemiology study in rural Appalachia and Mississippi Delta (the RURAL Study). The RURAL Sleep Study will add measures of sleep health to the complex individual, social and environmental factors and health outcome measures being evaluated by the RURAL Study, by incorporating minimally burdensome measures of multiple dimensions of sleep health. The results are expected to inform health care providers, public health officials, and the general public of the prevalence, risk factors, and consequences of impaired sleep health in these rural communities, providing a critical basis for prevention, recognition, and management of sleep disorders and improvement of sleep and cardiometabolic health. conditions: Sleep Apnea conditions: Insomnia conditions: Sleep Deprivation conditions: Sleep Disorders, Circadian Rhythm conditions: Sleepiness, Excessive Daytime conditions: Fatigue studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 3680 type: ESTIMATED measure: Oxygen desaturation index measure: Insomnia Severity Index measure: Sleep Duration measure: Sleep Duration Regularity measure: Sleep Timing measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment Short Form 8a measure: Restless Legs Syndrome (RLS) measure: Chronotype measure: Sleep Timing Regularity measure: Global Sleep Quality measure: Oxygen desaturation index, 3% sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06336512 id: RC.28.1.2024 briefTitle: Trimester Sequential Estimation of Serum Zonulin as a Predictor of Gestational Diabetes Mellitus overallStatus: COMPLETED date: 2023-01-15 date: 2023-07-01 date: 2023-10-01 date: 2024-03-28 date: 2024-03-28 name: Benha University class: OTHER briefSummary: Gestational diabetes mellitus (GDM) is the development of glucose intolerance (GI) during pregnancy in a previously normoglycemic (NG) woman and associated with insulin resistance (IR). GDM is the most prevalent metabolic disorder during pregnancy and became a major public health problem for being usually diagnosed and detected after 24 gestational weeks (GW), while its complications can occur much earlier and this may explain its burden on maternal and fetal welfare. Human zonulin is a surrogate marker of intestinal permeability and can be utilized as biomarker for intestinal barrier function. Zonulin-mediated increase in intestinal permeability plays a role in the pathogenesis of insulin resistance, obesity, DM and metabolic syndrome. The increasing global prevalence of GDM with its associated risk of poor pregnancy and long-term risks for the mother and the offspring may lead to the production of new generation of diabetics. conditions: Gestational Diabetes studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Newly Pregnant Women with singleton fetus primaryPurpose: DIAGNOSTIC masking: NONE count: 70 type: ACTUAL name: ELISA measure: Estimation of Gestational DM sex: FEMALE minimumAge: 22 Years maximumAge: 50 Years stdAges: ADULT facility: Benha university city: Banhā state: El- Qalyobia zip: 13511 country: Egypt lat: 30.45906 lon: 31.17858 hasResults: False
<\|newrecord\|> nctId: NCT06336499 id: TREC2023-KY107 briefTitle: Risk Stratification of Orbital Tumors Based on MRl and Artificial Intelligence overallStatus: COMPLETED date: 2012-01-01 date: 2022-10-31 date: 2023-12-31 date: 2024-03-28 date: 2024-03-29 name: Beijing Tongren Hospital class: OTHER briefSummary: Orbital tumors can be categorized into benign and malignant tumors, and there are significant variations in their biological behavior, treatment, and prognosis. This study aims to enhance the accurate diagnosis and risk stratification of orbital tumors using artificial intelligence (AI) technology and multiparameter magnetic resonance imaging (MRI) data. It further explores the intrinsic relationship between MRI and the differential diagnosis of benign and malignant orbital tumors, as well as the pathological subtypes of malignant tumors and Ki-67 expression levels. This research aims to aid in guiding personalized diagnosis and treatment decision-making for patients with orbital tumors while promoting the practical application and incorporation of AI technology. conditions: Orbital Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 600 type: ACTUAL name: Multi-parametric MRI and image analysis by deep learning or machine learning algorithms measure: The area under the curve of Receiver Operating Characteristic of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and levels of Ki-67 expression in malignant ones. measure: The area under the Precision-Recall curve of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors. measure: Sensitivity of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors. measure: Specificity of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors. measure: Accuracy of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06336486 id: BalikesirU-FTR-BG-01 briefTitle: the Effectiveness of Intermittent Pneumatic Compression on Neuropathic Pain in Patients With Diabetic Polyneuropathy overallStatus: COMPLETED date: 2018-12-04 date: 2020-02-01 date: 2020-02-01 date: 2024-03-28 date: 2024-04-01 name: Busra Gunes class: OTHER briefSummary: In this study,the effectiveness of intermittent pneumatic compression therapy on neuropathic pain and quality of life in patients with neuropathic pain due to type 2 diabetes was investigated conditions: Diabetic Neuropathic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two groups with a conventional therapy control group primaryPurpose: TREATMENT masking: NONE count: 50 type: ACTUAL name: intermittent pneumatic compression +pregabalin group name: pregabalin group measure: The Leeds assessment of neuropathic symptoms and signs(LANSS) measure: Pain quality rating scale(PQAS) measure: Visual Analog Scale(VAS) measure: 36-Item Short Form Health Survey(SF-36) sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Balıkesir University city: Balıkesir state: Merkez zip: 10050 country: Turkey lat: 39.64917 lon: 27.88611 hasResults: False
<\|newrecord\|> nctId: NCT06336473 id: 2023-A02097-38 briefTitle: Evaluation of the Effects of Cross Linking on the Biomechanical Characteristics of Skin Samples From Patients With Classic or Hypermobile Ehlers-Danlos Syndrome acronym: SEDSKIN overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-07-31 date: 2024-03-28 date: 2024-03-28 name: GCS Ramsay Santé pour l'Enseignement et la Recherche class: OTHER briefSummary: The main aim of this study is to evaluate the effect of cross linking on the elasticity of skin samples from patients with non-vascular Ehlers-Danlos Syndrome (hEDS or cEDS). conditions: Ehlers-Danlos Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-center study performed on biopsied skin samples primaryPurpose: BASIC_SCIENCE masking: NONE count: 28 type: ESTIMATED name: skin biopsy measure: Young's modulus quantification measure: Collagen fibril diameter measurement measure: Collagen fibril D-period length measurement sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique Maussins-Nollet city: Paris zip: 75019 country: France lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06336460 id: 2023-537 briefTitle: PENG vs. FIC Blocks in Hip Fractures in the ED overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-04-01 date: 2024-03-28 date: 2024-03-28 name: Orange Park Medical Center class: OTHER briefSummary: This study is a prospective, randomized clinical trial assessing the efficacy of physician-performed ultrasound-guided pericapsular nerve group (PENG) block vs fascia iliaca compartment (FIC) block for pain control in acute hip fracture. conditions: Hip Fractures conditions: Nerve Block conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The research associate/outcome assessor will not have access to group assignment and will therefore be blinded to the type of block. Although the patient, their caregiver(s), and the clinician caring for the patient will not be directly informed of the group assignment, a note will be logged in the clinical record by the physician placing the block indicating the details of the block after this procedure has been completed. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Pericapsular Nerve Group (PENG) Block name: Fascia Iliaca Compartment (FIC) Block for Patients with Isolated Hip Fractures measure: Numeric pain score at 30 minutes measure: Numeric pain score at 60 minutes measure: Cumulative Morphine Milligram Equivalents in 24 hours after enrollment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06336447 id: STU00220295 briefTitle: VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain overallStatus: RECRUITING date: 2024-01-12 date: 2026-12-31 date: 2027-02-28 date: 2024-03-28 date: 2024-03-28 name: Northwestern University class: OTHER briefSummary: This study will examine the impact of virtual reality used in conjunction with sedation compared to sedation alone in patients undergoing watervcooled genicular nerve ablations for chronic knee pain.
The goals of the study is to determine the relative efficacy of virtual reality as a distraction modality when used as an adjuvant to procedural sedation compared to sedation alone for procedure related pain. To assess procedural satisfaction, and 1-month pain and functional outcomes.To explore whether virtual reality and lower procedure-related pain scores affect 1-month outcomes. And finally to determine whether demographic and clinical characteristics are associated with outcome measures. conditions: Pain, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trail. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcome assessor will be blinded to study randomization whoMasked: OUTCOMES_ASSESSOR count: 62 type: ESTIMATED name: Experimental: Group #1: Virtual Reality Headset name: Group 2 No Virtual Reality Headset measure: Procedural related pain measure: Procedure related satisfaction measure: Post procedure anxiety measure: Mean reduction in pain 1 month after procedure measure: Midazolam administered measure: Fentanyl administered sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern Medicine Pain Center status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Paul Fitzgerald role: CONTACT phone: 312-695-1064 email: p-fitzgerald2@northwestern.edu name: Jason Ross, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False
<\|newrecord\|> nctId: NCT06336434 id: IMPAACT 2040 briefTitle: CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy overallStatus: NOT_YET_RECRUITING date: 2024-09-24 date: 2026-12-24 date: 2026-12-24 date: 2024-03-28 date: 2024-03-28 name: National Institute of Allergy and Infectious Diseases (NIAID) class: NIH briefSummary: This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting injectable (LA) during pregnancy and postpartum among people with HIV-1 viral suppression and their infants. conditions: HIV-1-infection conditions: Pregnancy conditions: Postpartum studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: CAB LA 600mg name: RPV LA 900mg name: CAB LA 400mg name: RPV LA 600mg measure: PK trough of CAB LA measured in plasma in pregnancy and postpartum measure: Percentage of adults with at least one Grade 3 or higher adverse event in pregnancy and through 18 weeks postpartum measure: Percentage of adults with at least one serious adverse event in pregnancy and through 18 weeks postpartum measure: PK trough measured in plasma in pregnancy and postpartum measure: Percentage of adults with HIV-1 RNA less than 50 copies/mL at delivery measure: Percentage of adults with HIV-1 RNA less than 50 copies/mL at delivery using the standardized FDA snapshot algorithm measure: Percentage of adults with virologic escape (single measurement of greater than or equal to 200 copies/mL) from study entry through pregnancy and through 18 weeks postpartum measure: Percentage of adults with confirmed virologic failure through 18 weeks postpartum measure: Number of adults with HIV-1 resistance to CAB and/or RPV using IAS-USA in participants who experience confirmed virologic failure, assessed at entry and time of failure measure: Number of infants with HIV-1 infection measure: Percentage of infants at least one Grade 3 or higher adverse event through 18 weeks post-birth measure: Percentage of infants at least one serious adverse event through 18 weeks post-birth measure: Percentage of infants with a congenital anomaly consistent with the Metropolitan Atlanta Congenital Defects Program (MACDP) definition of defect measure: Percentage of deaths among infants measure: Percentage of adults with a spontaneous abortion (less than 20 weeks gestation) measure: Percentage of adults with a fetal demise/stillbirth (greater than or equal to 20 weeks gestation) measure: Percentage of neonatal deaths (within 28 days of life) among infants measure: Percentage of infants born small for gestational age (SGA) at < 10th percentile measure: Percentage of infants born with low birth weight < 2500 g measure: Percentage of infants born preterm < 37 weeks gestation measure: Percentage of adult-infant participant pairs with any adverse pregnancy outcome of spontaneous abortion, fetal demise/stillbirth, neonatal death, SGA, or preterm delivery measure: CAB and RPV plasma concentrations in infants exposed to CAB LA + RPV LA during pregnancy and via chest/breastfeeding measure: Percentage of adults who discontinued injections prior to receiving the full course of injections due to intolerability of injection measure: Frequency of CAB LA + RPV LA injections received measure: Percentage of adults willing to continue CAB LA + RPV LA postpartum and/or in future pregnancies sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Site 4601, University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program city: La Jolla state: California zip: 92093-0672 country: United States name: Megan Loughran, BA role: CONTACT phone: 858-534-9218 email: meloughran@health.ucsd.edu lat: 32.84727 lon: -117.2742 facility: Site 5048, University of Southern California LA city: Los Angeles state: California zip: 90033 country: United States name: Lourdes Topete role: CONTACT phone: 323-865-1585 email: ltopete@usc.edu lat: 34.05223 lon: -118.24368 facility: Site 5092, Johns Hopkins University, Baltimore city: Baltimore state: Maryland zip: 21287 country: United States name: Amanda Haines role: CONTACT phone: 443-287-8950 email: ahaines8@jhmi.edu lat: 39.29038 lon: -76.61219 facility: Site 5013, Jacobi Medical Center Bronx city: Bronx state: New York zip: 10461 country: United States name: Marlene Burey, NP role: CONTACT phone: 718-918-4783 email: marlene.burey@nychhc.org lat: 40.84985 lon: -73.86641 facility: Site 8051 - Wits RHI Shandukani Research Centre city: Johannesburg zip: 2001 country: South Africa name: Rorisang Komane, BNS role: CONTACT phone: +27-72-933-4002 email: rkomane@wrhi.ac.za lat: -26.20227 lon: 28.04363 facility: Site 8052, Soweto city: Johannesburg country: South Africa name: Ntatule Ndiweni role: CONTACT phone: +27-11-989-9748 email: ndiwenih@phru.co.za lat: -26.20227 lon: 28.04363 facility: Site 8950, FAMCRU CRS city: Parow zip: 7505 country: South Africa name: Jeanne de Jager, MSc role: CONTACT phone: +27-21-938-4290 email: jeannes@sun.ac.za lat: -33.89723 lon: 18.59992 facility: Site 30300, Umlazi Clinical Research Site city: Umlazi zip: 4066 country: South Africa name: Zukiswa Godlwana role: CONTACT phone: +27-31-2601998 email: zukiswa.godlwana@caprisa.org lat: -29.96572 lon: 30.88639 hasResults: False
<\|newrecord\|> nctId: NCT06336421 id: Şuletuvanç briefTitle: The Effect of Virtual Reality Application on Perceived Anxiety and Vital Signs in Primiparous overallStatus: COMPLETED date: 2022-11-01 date: 2023-06-15 date: 2024-03-22 date: 2024-03-28 date: 2024-03-28 name: Ataturk University class: OTHER briefSummary: Purpose: To determine the effect of virtual reality application on anxiety and vital signs perceived by primiparous women during cesarean section.The research was conducted in a randomized controlled experimental design.The population of the research consisted of primiparous pregnant women with a caesarean section indication in the Ataturk University Health Research and Application Center Gynecology Clinic Operating Room. conditions: Cesarean Section Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: statistics expert whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: Virtual Reality measure: Personal Information Form measure: State Anxiety Scale measure: Pregnant follow-up form sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Ayse Aydin city: Yakutiye state: Erzurum zip: 25000 country: Turkey lat: 39.89821 lon: 41.26916 hasResults: False
<\|newrecord\|> nctId: NCT06336408 id: B2023-370R briefTitle: The SLEEP-CARE Study overallStatus: RECRUITING date: 2024-02-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-28 date: 2024-03-28 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: Sleep disorder is common in ICU patients, such as reduced sleep time, fragmentation, and abnormal sleep rhythm. In 2023, American Thoracic Society released a research statement on sleep and circadian disruption(SCD) in ICU, which considered SCD is an important potential target for improving critical illness outcomes. Although polysomnography(PSG) is the gold standard of sleep measurement, subjective sleep evaluation tools are still used in most clinical studies related to sleep in ICU. This makes the sleep quality of ICU patients overestimated and difficult to reflect their true sleep conditions. And the answers to how and which outcomes different levels of sleep deprivation affect patient outcomes are still unclear and need to be further explored. conditions: Sleep Disturbance studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED measure: Compound outcome index measure: LOS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Hospital, Fudan University status: RECRUITING city: Shanghai country: China name: Jingjing Li, Master role: CONTACT phone: 13512106878 email: li.jingjing@zs-hospital.sh.cn lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06336395 id: 2019/00888 briefTitle: Ma-Spore ALL 2020 Study overallStatus: RECRUITING date: 2020-03-04 date: 2030-03 date: 2030-03 date: 2024-03-28 date: 2024-03-28 name: National University Hospital, Singapore class: OTHER briefSummary: The primary objective of this trial is to improve the overall survival rate of children and young adult with B-lineage acute lymphoblastic leukemia (B-ALL) in Singapore and Malaysia in the context of a multicenter cooperative trial using a risk-stratified therapy. conditions: B Lymphoblastic Leukemia studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 500 type: ESTIMATED name: Prednisolone name: Dexamethasone name: Vincristine name: Methotrexate name: L-Asparaginase name: Pegylated asparaginase name: Erwinase name: Dasatinib name: Imatinib name: Cyclophosphamide name: Cytarabine name: Mercaptopurine name: Thioguanine name: Rituximab name: Doxorubicin name: Fludarabine measure: Overall survival (OS) measure: Event free survival (EFS) measure: Cumulative incidence (CI) of relapse for all treated cohorts measure: Cumulative incidence (CI) of therapy-related mortality (TRM) for all treated subjects sex: ALL maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Subang Jaya Medical Centre status: RECRUITING city: Kuala Lumpur zip: 47500 country: Malaysia name: Hai Peng Lin role: CONTACT phone: +603 56391621 email: flslhp@gmail.com name: Lee Lee Chan, MBBS role: SUB_INVESTIGATOR lat: 3.1412 lon: 101.68653 facility: University Malaya Medical Centre status: RECRUITING city: Kuala Lumpur zip: 59100 country: Malaysia name: Hany Arrifin, MBBS role: CONTACT phone: +603 79492065 email: hany@ummc.edu.my lat: 3.1412 lon: 101.68653 facility: KK Women's and Children's Hospital status: RECRUITING city: Singapore zip: 229899 country: Singapore name: Ah Moy Tan, MBBS role: CONTACT phone: +65 63941039 email: tan.ah.moy01@singhealth.com.sg lat: 1.28967 lon: 103.85007 hasResults: False
<\|newrecord\|> nctId: NCT06336382 id: 23-0874 id: 1R21MH135148 type: NIH link: https://reporter.nih.gov/quickSearch/1R21MH135148 briefTitle: Tau Biomarkers in Late-onset Psychosis (LOP) overallStatus: RECRUITING date: 2024-02-16 date: 2026-12-31 date: 2027-06-30 date: 2024-03-28 date: 2024-03-28 name: Jeremy Koppel class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: Hallucinations or delusions that occur for the first time in older people with no acute medical problems or mood symptoms may be related to impending dementia. This study aims to confirm this hypothesis using novel blood biomarkers and Positron Emission Tomography (PET) imaging tracers, as well as non-invasive testing. conditions: Late Onset Schizophrenia conditions: Delusional Disorder (Late Onset) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 16 type: ESTIMATED name: Tau PET imaging scan measure: Quantification of neurofibrillary tangle pathology in subjects via PET [18F]PI-2620 radiotracer uptake. measure: Measurement of peripheral soluble tau pathology with tau plasma immunoassays. measure: Evaluation of sensorimotor gating integrity and it's association to tau PET ligand uptake. sex: ALL minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT facility: The Feinstein Institutes for Medical Research status: RECRUITING city: Manhasset state: New York zip: 11030 country: United States name: Erica Christen, MS role: CONTACT phone: 516-562-3492 email: EChriste@northwell.edu name: Michelle Gong, AS role: CONTACT phone: 516-562-3492 email: MGong@northwell.edu lat: 40.79788 lon: -73.69957 hasResults: False
<\|newrecord\|> nctId: NCT06336369 id: 1713/2023 briefTitle: Brown Adipose Tissue Activity in Gilbert's Syndrome overallStatus: RECRUITING date: 2024-03-06 date: 2027-01-15 date: 2027-01-15 date: 2024-03-28 date: 2024-03-28 name: Medical University of Vienna class: OTHER name: University of Vienna name: Griffith University briefSummary: The goal of this case-control study is to investigate energy metabolism and brown adipose tissue (BAT) activity in individuals with Gilbert's syndrome (GS) and controls. The main focus of the study is to analyze:
1. the link between bilirubin metabolism and metabolic health.
2. energy metabolism and body composition in individuals with Gilbert's syndrome and control subjects
3. brown adipose tissue activity in Gilbert's syndrome and healthy controls.
Participants will undergo the following investigations:
1. cold exposure
2. PET-CT imaging with 18-F-FDG
3. MRI imaging of liver, abdominal fat and muscle
4. blood sampling
5. indirect calorimetry
6. bioelectrical impedance analysis
7. infrared thermography
Researchers will compare individuals with GS and control subjects in terms of metabolic health, body composition and BAT activity. conditions: Gilbert Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: analyzing brown adipose tissue, body composition and metabolic health measure: cold-induced brown adipose tissue (BAT) activation sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Vienna status: RECRUITING city: Vienna zip: 1090 country: Austria name: Florian Kiefer, MD, PhD role: CONTACT phone: +43140400 phoneExt: 43120 email: florian.kiefer@meduniwien.ac.at lat: 48.20849 lon: 16.37208 hasResults: False
<\|newrecord\|> nctId: NCT06336356 id: D6970C00011 briefTitle: A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compared to Placebo in Participants With Uncontrolled Hypertension overallStatus: NOT_YET_RECRUITING date: 2024-05-13 date: 2024-11-05 date: 2024-11-05 date: 2024-03-28 date: 2024-03-28 name: AstraZeneca class: INDUSTRY briefSummary: The main purpose of this study is to assess the serum free cortisol response after ACTH stimulation test at baseline and at Week 8 in participants with uncontrolled hypertension. conditions: Uncontrolled Hypertension studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 45 type: ESTIMATED name: Baxdrostat name: Placebo measure: Individual Cortisol Level measure: Number of Participants with Abnormal Stimulated Cortisol sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06336343 id: STUDY-23-01698 briefTitle: Bimekizumab in Plaque Psoriasis overallStatus: RECRUITING date: 2024-03 date: 2025-10-31 date: 2025-10-31 date: 2024-03-28 date: 2024-03-28 name: Icahn School of Medicine at Mount Sinai class: OTHER name: UCB Pharma name: Psoriasis Treatment Center of Central New Jersey briefSummary: The purpose of this research study is to evaluate the effectiveness and safety of bimekizumab in individuals with moderate-to-severe psoriasis who have failed similar therapies. Bimekizumab improves psoriasis by suppressing a type of substance found in bodies called interleukins (specifically, interleukins 17a and 17F), which are known to increase inflammation. This study will look at the effectiveness of bimekizumab in psoriasis patients that have failed previous therapies that target interleukin IL-17A or 23. conditions: Plaque Psoriasis studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Bimekizumab measure: Body Surface Area (BSA) of < 1 measure: Psoriasis and Severity Index Score (PASI) of < 1 measure: Physician Global Assessment (PGA) of < 1 measure: Psoriasis and Severity Index Score (PASI) of < 2 measure: Physician Global Assessment (PGA) of < 2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Windsor Dermatology - Psoriasis Treatment Center of Central New Jersey status: RECRUITING city: East Windsor state: New Jersey zip: 08520 country: United States name: Elise Nelson role: CONTACT phone: 609-443-4500 name: Jerry Bagel role: PRINCIPAL_INVESTIGATOR lat: 40.268 lon: -74.54043 facility: Icahn School of Medicine at Mount Sinai status: RECRUITING city: New York state: New York zip: 10029 country: United States name: Giselle Singer role: CONTACT phone: 212-241-3288 name: Mark Lebwohl role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06336330 id: D1699R00050 briefTitle: Real-world Study on Dapagliflozin Usage in Patients With Heart Failure (HF) in Germany acronym: EvolutionHF-DE overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-09-30 date: 2026-09-30 date: 2024-03-28 date: 2024-03-28 name: AstraZeneca class: INDUSTRY briefSummary: Heart failure (HF) is a global, public health issue that affects more than 63 million people worldwide; this burden is expected to increase substantially as the population ages. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality; there is also an immense impact on patients' health-related quality of life (HRQoL). Dapagliflozin was recently granted approval for heart failure by the European Commission, regardless of ejection fraction and whether the patient has diabetes. Real-world observational data are necessary to describe dapagliflozin use in real-world settings in order to assess treatment patterns, HF symptoms and their impact on physical limitation, HRQoL and work productivity, as well as health care utilization of patients treated with dapagliflozin in this setting under local treatment standard conditions in Germany. conditions: Heart Diseases conditions: Cardiovascular Diseases conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: Time to discontinuation of dapagliflozin measure: Reasons for discontinuation of dapagliflozin measure: Dose changes of dapagliflozin measure: Number of patients with dapagliflozin treatment interruptions measure: Treatment switches from dapagliflozin to other SGLT2i measure: Time to other heart failure treatment discontinuation measure: Number of other heart failure treatment initiation measure: Number of other heart failure treatment dosage changes measure: Number of other heart failure treatment discontinuation measure: Number of glucose lowering medication initiation measure: Number of glucose lowering medication dosage changes measure: Number of glucose lowering medication discontinuation measure: Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score measure: Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire measure: Absolute change from baseline in Work Productivity and Activity Impairment (WPAI) score measure: The absolute change from baseline in occurrence of depressions in patients initiated on dapagliflozin for HF as captured by the Patient Health Questionnaire-9 (PHQ-9) measure: Healthcare resource utilisation - Number of hospitalisations since dapagliflozin initiation measure: Healthcare resource utilisation - Length of HF-related hospital stay since dapagliflozin initiation sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06336317 id: ELIMINATE-2024 briefTitle: Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE acronym: ELIMINATE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-12 date: 2027-12 date: 2024-03-28 date: 2024-03-28 name: Region Örebro County class: OTHER name: The Swedish Heart and Lung Association name: Örebro University, Sweden name: University of Cambridge briefSummary: The goal of this randomized, double-blind, placebo-controlled clinical trial is to investigate the immunological effects of influenza vaccination outside of the influenza season on arterial inflammation in patients with a recent acute myocardial infarction (AMI). The primary objective is to compare the effects of influenza vaccination to those of a placebo in reducing post-myocardial infarction coronary inflammation as measured by coronary computed tomography angiography (CCTA). The main questions it aims to answer are:
Does influenza vaccination reduce arterial inflammation as measured by CCTA at week 8 after percutaneous coronary intervention (PCI) in comparison to baseline? Does influenza vaccination modulate systemic inflammation as measured by blood biomarkers and in-vitro challenge tests at week 8 after PCI in comparison to baseline? Researchers will compare the effects of influenza vaccination with those of a placebo. conditions: Acute Myocardial Infarction conditions: Cardiovascular Diseases conditions: Inflammatory Response studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Influenza vaccine name: Placebo measure: The right coronary artery measure: The whole coronary tree measure: Ascending aorta measure: Interleukin 1 beta (IL-1β) measure: Tumor necrosis factor alpha (TNF-α) measure: Interleukin-2 receptor (IL-2r) measure: Interleukin Interleukin-6 (IL-6 ) measure: Ferritin measure: Troponin-I measure: N-terminal pro-B-type natriuretic peptide measure: Explorative endpoints measure: Explorative endpoints sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06336304 id: NXTPMCF-01 briefTitle: NXT Post-Market Clinical Follow-up overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-11 date: 2025-12 date: 2024-03-28 date: 2024-03-28 name: Laborie Medical Technologies Inc. class: INDUSTRY briefSummary: NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations conditions: Urinary Incontinence conditions: Urinary Obstruction conditions: Urinary Bladder, Overactive conditions: Urinary Bladder, Neurogenic conditions: Urinary Incontinence, Urge studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 180 type: ESTIMATED measure: Assess NXT system performance measure: Assess NXT system safety measure: Assess NXT system performance sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06336291 id: PH-L19TNFLOM-01/23 briefTitle: A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence acronym: GLIOSTELLA overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-03-28 date: 2024-03-28 name: Philogen S.p.A. class: INDUSTRY briefSummary: The trial aims to collect safety, efficacy, exposure, dose- response, pharmacokinetic and pharmacodynamic information of the combination of L19TNF and lomustine at different dose levels in patients with Glioblastoma at progression or recurrence conditions: Glioblastoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: L19TNF name: L19TNF name: L19TNF name: Lomustine name: Lomustine measure: Adverse Events measure: Serious Adverse Events measure: Unacceptable Toxicity measure: DILI assessment measure: Survival measure: Overall Survival measure: Progression Free Survival measure: Objective Response Rate measure: Disease Control Rate measure: Duration of Response measure: Time to reach maximum drug concentration [Tmax] measure: Terminal half-life [t1/2] measure: Area under the drug concentration-time curve, extrapolated to infinity [AUC] measure: Maximum drug concentration [Cmax] measure: Human anti-fusion protein antibodies (HAFA) levels against L19TNF sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06336278 id: 19/03/2024 briefTitle: Relationship Between Central Sensitization and Kinesiophobia in Knee Osteoarthritis overallStatus: COMPLETED date: 2022-10-01 date: 2023-10-01 date: 2023-12-01 date: 2024-03-28 date: 2024-04-22 name: Selda Sarıkaya class: OTHER briefSummary: Objective: The knee joint is one of most common locations in OA. In recent years, it has been accepted that there are different pain phenotypes and patient subgroups in knee OA and that central sensitization (CS) mechanisms are at the forefront in some patients. It is also known that fear of movement, known as kinesiophobia, develops in patients with chronic pain. The aim of this study is to investigate CS and kinesiophobia in patients with knee OA, their relationships with each other, and their effects on pain intensity, functional status, pain catastrophizing and depression.
Materials and Methods: Forty-two patients with knee OA and 42 healthy subjects participated in our study. Demographic data, body mass index, habits, comorbidities, medications of participants and disease duration and radiographic grade of knee OA patients were recorded. VAS was used to assess the severity of pain and WOMAC was used to assess pain and functional status in patients with OA. Algometer (pressure pain threshold measurement) and Central Sensitization Inventory were used to evaluate central sensitization in all participants. Pressure pain threshold (PPT) was measured at 3 different points: knee joint, cruris and forearm. The presence of kinesiophobia was assessed with the Tampa Scale af Kinesiophobia (TSK). Pain Catastrophizing Scale (PCS) and Beck Depression Inventory (BDI) were used to assess chronic pain related symptoms. conditions: Knee Osteoarthritis conditions: Central Sensitisation conditions: Kinesiophobia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 84 type: ACTUAL name: Pressure Algometer measure: Pain Pressure Treshold measure: Central Sensitization measure: Kinesiophobia measure: Pain Catastrophizing measure: Depression measure: Visuel Analog Scala measure: Western Ontario and McMaster Universitesies Osteoarthritis Index sex: ALL minimumAge: 45 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zonguldak Bulent Ecevit Universitiy city: Zonguldak zip: 67100 country: Turkey lat: 41.45139 lon: 31.79305 hasResults: False
<\|newrecord\|> nctId: NCT06336265 id: Diaphragm ultrasound briefTitle: Diaphragmatic Ultrasound to Predict the Therapeutic Effect of High-flow Nasal Cannula Oxygen Therapy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-03-28 name: Xingui Dai class: OTHER briefSummary: Follow-up was conducted for every patient requiring high-flow nasal cannula oxygen therapy in district 1 of the Intensive Care Department of Chenzhou NO.1 People's Hospital. Patients who met the inclusion criteria but did not meet the exclusion criteria were included for observation. Respiratory parameters, diaphragmatic activity, and variation rate of diaphragmatic thickness were recorded at the beginning of high-flow nasal cannula oxygen therapy, 1 hour after treatment, 3 hours after treatment, 6 hours after treatment, 9 hours after treatment, and 12 hours after treatment. Throughout the procedure, a panel of experts assessed whether the patient needed endotracheal intubation; If yes, the study was terminated; if no, high-flow nasal cannula oxygen therapy was continued, and observation and evaluation were continued until the end point of the study (12 hours after treatment). If patients or their family members do not want to continue to participate in the study during the study, they will be considered as withdrawal. If patients suffer from sudden malignant arrhythmia or cardiac arrest during the study, resulting in death or transfer to other hospitals or other departments during the study, patients will be excluded. Data from dropped and excluded patients were not included in the final statistical analysis. After the data of 269 patients were collected, the study was concluded, and the results and conclusions were derived by statistical analysis. conditions: Hypoxic Respiratory Failure studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 269 type: ESTIMATED name: Diaphragm ultrasound measure: Thickness and thickening fraction of Diaphragm measure: Diaphragmatic excursion measure: Respiratory rate measure: Incidence of tracheal intubation sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06336252 id: F-23059441 briefTitle: Technology Assisted Nudging to Increase Physical Activity Among Hospitalised Medical Patients acronym: SENS4ME overallStatus: RECRUITING date: 2024-04 date: 2025-12-20 date: 2026-06-20 date: 2024-03-28 date: 2024-03-28 name: Bispebjerg Hospital class: OTHER name: AAL name: Innovationsfonden briefSummary: Primary Objective To investigate if patients hospitalised for older adults with a decreased level of physical function, either related to a chronic condition e.g., COPD, Congestive heart failure, renal failure; infections; frailty and tendency of falling; orthopaedic surgery - after hip fracture will increase their time spent out of bed during hospitalisation and 3 months after discharge through visual feedback and motivational intervention about physical activities from a new mobile technology.
Hypothesis Patients hospitalised for medical disease will increase their physical activity level during hospitalisation and 3 months after discharge through visual feedback and motivational intervention from a new mobile technology. conditions: COPD conditions: Heart Failure conditions: Parkinson Disease conditions: Arthritis conditions: Old Age; Cachexia conditions: Stroke Sequelae studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1/1 allocation primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Primary outcome (accelerometer data) blinded for the investigator and assesor. whoMasked: OUTCOMES_ASSESSOR count: 162 type: ESTIMATED name: Digital nudging intervention target to change behavior measure: Time spent out of bed measured in minutes related to the total accelerometer wear time (minutes) measure: Readmission within 90 days measure: Length of stay (days) measure: Time spent lying down, sitting, standing, and walking measured in minutes related to the total accelerometer wear time (minutes) measure: Time spent out of bed in hospital in minutes related to the total accelerometer wear time (minutes) measure: Time spent out of bed after discharge in minutes related to the total accelerometer wear time (minutes) measure: Quality of life (EQ5D-5L) measure: - In-hospital fall incidents sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Christian Dall status: RECRUITING city: Copenhagen zip: 2400 country: Denmark name: Christian H Dall, PhD role: CONTACT phone: 00 45 28604402 email: christian.have.dall@regionh.dk name: Morten T Kristensen, Professor role: CONTACT phone: 0045 38635000 email: morten.tange.kristensen@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False
<\|newrecord\|> nctId: NCT06336239 id: KS2023097 briefTitle: PrevaLence of Albuminuria in Patients With CARdiovascular Disease and Type 2 Diabetes Mellitus in China: a National Cross-sectional Study acronym: PLACARD overallStatus: RECRUITING date: 2023-12-21 date: 2024-06-30 date: 2024-12-30 date: 2024-03-28 date: 2024-04-12 name: Beijing Anzhen Hospital class: OTHER briefSummary: The association between Cardiovascular Disease (CVD) and Chronic Kidney Disease (CKD) is well established. Traditional risk factors for CVD and CKD are similar, with type 2 diabetes mellitus (T2DM) being the most prevalent risk factor. However, CKD is underdiagnosed and undertreated in patients with CVD. Further understanding of the combination of CKD in CVD patients is important to formulate prevention and treatment strategies for CVD patients and high-risk groups, reduce adverse events in CVD patients, and prevent progression of CKD to End Stage Renal Disease (ESRD). conditions: Cardiovascular Disease conditions: Type 2 Diabetes Mellitus studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 3000 type: ESTIMATED measure: The prevalence of albuminuria measure: Lthe prevalence of microalbuminuria and macroalbuminuria evels of microalbuminuria and macroalbuminuria measure: The prevalence of microalbuminuria and macroalbuminuria measure: To evaluate the related influence factors of albuminuria and the treatment patterns of CKD patients and non-CKD patients in cardiology departments; measure: Evaluate the management of patients with type 2 diabetes mellitus and cardiovascular disease across different levels of cardiology departments in hospitals. measure: Exploratory Objective sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Sixth Hospital status: RECRUITING city: Beijing state: Beijing country: China name: Lei Dong role: CONTACT lat: 39.9075 lon: 116.39723 facility: Fangshan District First Hospital status: COMPLETED city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking University Third Hospital status: COMPLETED city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Chinese PLA Army Characteristic Medical Center status: COMPLETED city: Chongqing state: Chongqing country: China lat: 29.56278 lon: 106.55278 facility: Haidong City Second People's Hospital status: NOT_YET_RECRUITING city: Haidong state: Gansu country: China name: Haiyan Xu role: CONTACT facility: The First Affiliated Hospital of Sun Yat-sen University status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong country: China name: Chen Liu role: CONTACT lat: 23.11667 lon: 113.25 facility: First Hospital of Hebei Medical University status: RECRUITING city: Shijia Zhuang state: Hebei country: China name: Le Wang role: CONTACT phone: 18633889597 email: coronary2012@163.com lat: 34.17775 lon: 109.84894 facility: Ruyang County People's Hospita status: RECRUITING city: Luoyang state: Henan zip: 471201 country: China name: Yanna Song role: CONTACT name: Litao Wu role: PRINCIPAL_INVESTIGATOR lat: 34.68361 lon: 112.45361 facility: Luoyang Sixth People's Hospita status: COMPLETED city: Luoyang state: Henan country: China lat: 34.68361 lon: 112.45361 facility: Yongcheng People's Hospital status: COMPLETED city: Yongcheng state: Henan country: China facility: The First Affiliated Hospital of Zhengzhou University status: NOT_YET_RECRUITING city: Zhengzhou state: Henan country: China name: Zhanying Han role: CONTACT lat: 34.75778 lon: 113.64861 facility: Zhangjiagang Sixth People's Hospital status: COMPLETED city: Zhangjiagang state: Jiangsu country: China lat: 31.865 lon: 120.53889 facility: Shenyang Ninth People's Hospital status: RECRUITING city: Shenyang state: Liaoning country: China name: Peng Gao role: CONTACT phone: 18940223349 email: 35095369@qq.com lat: 41.79222 lon: 123.43278 facility: Shenyang Tenth People's Hospital status: ACTIVE_NOT_RECRUITING city: Shenyang state: Liaoning country: China lat: 41.79222 lon: 123.43278 facility: Jining First People's Hospital status: NOT_YET_RECRUITING city: Jining state: Shandong country: China name: Changjie Ren role: CONTACT lat: 35.405 lon: 116.58139 facility: Tai'an First People's Hospital status: COMPLETED city: Tai'an state: Shandong country: China lat: 36.18528 lon: 117.12 facility: Weihai Central Hospital status: NOT_YET_RECRUITING city: Weihai state: Shandong country: China name: Yufeng Wang role: CONTACT lat: 37.50914 lon: 122.11356 facility: Jing'an District Central Hospital of Shanghai status: COMPLETED city: Shanghai state: Shanghai country: China lat: 31.22222 lon: 121.45806 facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine status: NOT_YET_RECRUITING city: Shanghai state: Shanghai country: China name: Xin Chen, Phd role: CONTACT email: heartmedi@163.com name: Xin Chen, Phd role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: Zhongshan Hospital Fudan University Qingpu Branch status: RECRUITING city: Shanghai state: Shanghai country: China name: Zilong Wang role: CONTACT phone: 18116016189 email: qy1499@126.com lat: 31.22222 lon: 121.45806 facility: Qinyuan County People's Hospital status: COMPLETED city: Changzhi state: Shanxi country: China lat: 35.20889 lon: 111.73861 facility: Shanxi Bethune Hospital status: RECRUITING city: Taiyuan state: Shanxi country: China name: Yue Song role: CONTACT phone: 13657218603 email: song_yu_e@163.com lat: 37.86944 lon: 112.56028 facility: The First Affiliated Hospital of Xi'an Jiaotong University status: NOT_YET_RECRUITING city: XI Ail state: Shanxi country: China name: Zuyi Yuan role: CONTACT lat: 44.9 lon: 122.8 facility: The Fifth People's Hospital of Sichuan Province status: NOT_YET_RECRUITING city: Chendu state: Sichuan country: China name: Xiaojuan Zhang role: CONTACT facility: West China Hospital of Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China name: Yong Peng role: CONTACT lat: 30.66667 lon: 104.06667 facility: The First Affiliated Hospital of Xinjiang Medical University status: NOT_YET_RECRUITING city: Ürümqi state: Xinjiang country: China name: Xiang Ma role: CONTACT lat: 43.80096 lon: 87.60046 facility: Taizhou Central Hospital status: RECRUITING city: Taizhou state: Zhejiang country: China name: Haipeng Cai role: CONTACT phone: 13867622455 email: 1917483306@qq.com lat: 32.49069 lon: 119.90812 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-10-26 uploadDate: 2024-02-29T04:49 filename: Prot_000.pdf size: 711941 hasResults: False
<\|newrecord\|> nctId: NCT06336226 id: BB AVF one stage vs two stage briefTitle: Brachio Basilic Arterio Venous Fistula One Stage vs Two Stage overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-04 date: 2025-05 date: 2024-03-28 date: 2024-04-05 name: Assiut University class: OTHER briefSummary: The aim of this work was to compare primary failure rates and the primary functional patency of one-stage vs two stage brachiobasilic fistulas to compare the two surgical techniques . conditions: Arterio-venous Fistula studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: Brachio basilic arterio venous fistula one stage versus two stage measure: Comparative study between one stage brachio basilic arterio venous fistula versus two stage sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06336213 id: 20240306 briefTitle: Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients overallStatus: RECRUITING date: 2024-02-19 date: 2024-11-01 date: 2024-12-15 date: 2024-03-28 date: 2024-03-28 name: Petrovsky National Research Centre of Surgery class: OTHER briefSummary: According to the literature, presepsin was recommended not only as an effective indicator in the diagnosis of sepsis in intensive care units, but also as a reliable prognostic marker of postoperative inflammatory processes in cardiac surgery. Previous study carried out in Petrovsky NRCS related to biomarkers in cardiac surgery and presepsin in particular showed good sensitivity in infection complications prognosis. conditions: Aortic Aneurysm and Dissection conditions: Cardiac Valve Disease conditions: Thoracic Aortic Aneurysm conditions: Thoracic Aortic Dissection studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: Ampicillin-sulbactam measure: Infectious complications rate measure: Total amount of complicated patients measure: Mortality measure: Length of hospital stay measure: Length of ICU stay measure: Multiorgan failure sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Petrovsky Research National Centre of Surgery (Petrovsky NRCS) status: RECRUITING city: Moscow zip: 119991 country: Russian Federation name: Artem Gubko, Ph.D. role: CONTACT phone: +79684241490 email: gubko@artvig.ru name: Denis Guskov, Ph.D role: SUB_INVESTIGATOR name: Boris Akselrod, Ph.D role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 hasResults: False
<\|newrecord\|> nctId: NCT06336200 id: Karabuk-006 briefTitle: Knee Osteoarthritis and Kinesiophobia overallStatus: RECRUITING date: 2024-01-01 date: 2024-04-30 date: 2024-05-30 date: 2024-03-28 date: 2024-04-05 name: Karabuk University class: OTHER briefSummary: Kinesiophobia after total knee arthroplasty is an important parameter affecting recovery. However, the relationship between kinesiophobia and the factors it may cause is not clear. Therefore, this study aimed to examine the relationship between kinesiophobia, pain, fear of falling, mobility and proprioception in the early period after total knee arthroplasty. conditions: Knee Osteoarthritis conditions: Kinesiophobia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 56 type: ESTIMATED measure: Kinesiophobia measure: Severity of pain measure: Functional mobility measure: Proprioception measure: Fear of falling sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Pursaklar Public Hospital status: RECRUITING city: Ankara country: Turkey name: Musa Gunes, Msc role: CONTACT phone: 0 (370) 418 9081 email: musagunes@karabuk.edu.tr name: Fidan Yılmaz, Msc role: PRINCIPAL_INVESTIGATOR name: Emime Emirmahmutoğlu, Bachelors role: PRINCIPAL_INVESTIGATOR name: Buğrahan Şahin, MD role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06336187 id: UPO 2020 02 briefTitle: European Active Surveillance of Renal Cell Carcinoma Study (EASE RCC Study) acronym: EASE overallStatus: RECRUITING date: 2018-06-01 date: 2024-12 date: 2030-12 date: 2024-03-28 date: 2024-04-10 name: Azienda Ospedaliero Universitaria Maggiore della Carita class: OTHER name: Università degli Studi del Piemonte Orientale "Amedeo Avogadro" briefSummary: The goal of this observational, prospective, multi-national clinical study is to assess overall survival of patients who are diagnosed with incidental, histologically (biopsy) confirmed, \<4 cm Renal Cell Carcinoma (RCC) and are managed conservatively with active surveillance.
The primary endpoint is overall survival. The Secondary endpoints are tumor growth rate, progression rate, cancer-specific survival, progression-free survival, identification of clinical and pathological variables and molecular and genetic markers that correlate with growth rate and progression.
The main question it aims to answer is: patients with RCC (less than 4 cm) diagnosis can be managed with active surveillance instead treated with invasive curative procedure? For all participants a percutaneous biopsy of the renal mass will be arranged in all cases to histologically confirm the diagnosis of RCC (unless a diagnostic biopsy has been acquired in the previous 6 months). As a minimum, two samples will be used for diagnostic purposes while remaining core(s) will be preserved for molecular studies.
Then, all patients will be under active surveillance, which is defined as the initial monitoring of tumor size by serial abdominal imaging (US, CT, or MRI) Follow-up visits will be scheduled 3 (optional) and 6 months after diagnosis, every 6 months up to 3 years and yearly thereafter. A follow-up visit will also be carried out at the time of progression when it occurs. Follow-up visits will include medical history and physical examination (optional), and assessment of concurrent medications, blood and urine collection and storage if participating in translational activities, cross-sectional abdominal and chest imaging exams.
Follow-up percutaneous biopsies of the renal tumor are not mandatory, but can be performed when considered clinically important. conditions: Renal Cell Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: active surveillance name: molecular investigation measure: Overall Survival measure: Disease progression measure: Molecular pattern sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale Maggiore della Carità status: RECRUITING city: Novara zip: 28100 country: Italy name: Alessandro Volpe, MD role: CONTACT lat: 45.44694 lon: 8.62118 hasResults: False
<\|newrecord\|> nctId: NCT06336174 id: Anhui-SIA-cohort briefTitle: Cognitive Decline and Underlying Mechanisms in Symptomatic Intracranial Artery Stenosis Patients: A Cohort Study overallStatus: RECRUITING date: 2022-11-01 date: 2025-12-31 date: 2026-12-31 date: 2024-03-28 date: 2024-04-02 name: Anhui Medical University class: OTHER briefSummary: The purpose of this study is to explore the mechanism of cognitive impairment in patients with symptomatic intracranial atherosclerotic stenosis (ICAS), and further plans to explore the impact of different treatment options on cognitive function in symptomatic ICAS patients. conditions: Intracranial Atherosclerosis conditions: Cognitive Impairment conditions: Cerebrovascular Event studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin name: Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin measure: The changes in Memory measure: Occurrence of ischemic cerebrovascular events measure: MoCA (Montreal Cognitive Assessment) measure: MMSE (Mini Mental State Examination) measure: DST (Digital Span Test; Forward and Backward) measure: The Stroop Color Test measure: CTT (Color Trail Test) measure: CDT (Clock drawing test) measure: VFT (Verbal Fluency Test) measure: HAMD (Hamilton Depression Scale) measure: HAMA (Hamilton Anxiety Scale) measure: MRI measure- resting state MRI images measure: MRI measures-structural phase MRI images measure: MRI measures-3D pCASL images measure: Ultrasound measures-MCA-PI (middle cerebral artery-pulsatility index) measure: Ultrasound measures-IMT (intima-media thickness) measure: Blood Metabolomics measures-CRP (C-reactive protiein) measure: Blood Metabolomics measures-oxLDL(Oxidized low-density lipoprotein) measure: Blood Metabolomics measures-miRNA/microRNA sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Medical University status: RECRUITING city: Hefei state: Anhui zip: 230032 country: China name: Qiang Wei, PhD role: CONTACT phone: +8618788836237 email: qiangwei_914@126.com lat: 31.86389 lon: 117.28083 hasResults: False
<\|newrecord\|> nctId: NCT06336161 id: ESPB versus CEI briefTitle: Comparison Between Ultrasound-Guided Erector Spinae Plane Block Versus Ultrasound-Guided Caudal Injection overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-05-01 date: 2024-03-28 date: 2024-03-28 name: Al-Azhar University class: OTHER briefSummary: Patient-controlled analgesia is typically used to relieve postoperative pain. Patient-controlled analgesia, on the other hand, is prone to opioid-related side effects. Furthermore, standard postoperative analgesia has a limited analgesic impact. If postoperative lumbosacral spine pain is not successfully treated, it can progress to chronic pain, compromising patients' quality of life.
The methods of access for epidural injections are characterized as transforaminal, interlaminar, or caudal. Caudal epidural injections (CEI) are often utilized as a diagnostic or therapeutic tool in a range of lumbosacral-originating spinal pain problems, and they are especially useful in patients with complicated lumbar epidural access diseases, such as post laminectomy syndrome. It is regarded as a very simple treatment in the realm of interventional pain management, and it is also recognized to have a reduced risk of inadvertent Dural puncture than other epidural techniques conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Fentanyl measure: Measurement of Post-operative Pain sex: ALL minimumAge: 21 Years maximumAge: 60 Years stdAges: ADULT facility: Al-Azhar University hospitals city: Cairo country: Egypt name: Mohamed Khalil, Resident role: CONTACT phone: +201001297071 email: khalil.mohamed24mkh@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06336148 id: ACTM-838-01 briefTitle: A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-01 date: 2026-07 date: 2024-03-28 date: 2024-03-28 name: Actym Therapeutics, Inc. class: INDUSTRY briefSummary: This is a first in human (FIH) 2-part study using ACTM-838 in patients with advanced solid tumors resistant to standard of care treatment. Part 1a will evaluate dose escalation and Part 1b will evaluate dose expansion. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an Open label Single dose study. primaryPurpose: TREATMENT masking: NONE maskingDescription: Open label count: 35 type: ESTIMATED name: ACTM-838 measure: Incidence and severity of adverse events and serious adverse events - Part 1a and Part 1b measure: Proportion of participants experiencing dose limiting toxicities - Part 1a and 1b measure: Objective response rate (ORR) as defined as complete response (CR) or partial response (PR) - Part 1a and Part 1b measure: Confirmed ORR defined as confirmed CR or confirmed PR - Part 1b measure: Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1b measure: Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1b measure: Progression free survival (PFS) - Part 1b measure: Change in tumor markers - Part 1b measure: Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1b measure: Objective response rate (ORR) defined as complete response (CR) or partial response (PR) - Part 1a measure: Confirmed ORR defined as confirmed CR or confirmed PR - Part 1a measure: Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1a measure: Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1a measure: Progression free survival (PFS) - Part 1a measure: Change in tumor markers - Part 1a measure: Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1a measure: Tumor PD colonization as measured by ddPCR and payload delivery as measured by RNA detection - Part 1a sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200 city: Westmead state: New South Wales zip: 2145 country: Australia name: Mark Wong, Dr role: CONTACT phone: +61 2 9845 5200 email: mark.wong@sydney.edu.au lat: -33.80383 lon: 150.98768 facility: Southern Oncology Clinical Research Unit, Level 3, Mark Oliphant Building, 5 Laffer Drive, Site No: 202 city: Bedford Park state: South Australia zip: 5042 country: Australia name: Ganessan Kichenadasse, Dr role: CONTACT phone: +61 491 670 039 email: clinicaltrials@socru.org.au lat: -35.03333 lon: 138.56667 facility: Alfred Hospital, 55 Commercial Road, Site No: 201 city: Melbourne state: Victoria zip: 3004 country: Australia name: Andrew Haydon, Dr role: CONTACT phone: +61 3 9076 3129 email: andrew.haydon@monash.edu.au lat: -37.814 lon: 144.96332 hasResults: False
<\|newrecord\|> nctId: NCT06336135 id: 23-001 briefTitle: Reduction in Symptoms After Laser Therapy With Acorn aHFS overallStatus: ENROLLING_BY_INVITATION date: 2024-03-25 date: 2025-03 date: 2025-12 date: 2024-03-28 date: 2024-03-28 name: Acorn Biolabs Inc. class: INDUSTRY briefSummary: This study evaluates the severity and duration of symptoms experienced after laser therapy comparing four post-procedure topical products. Each product is applied to an individual region of interest (5 cm diameter) on the back or décolleté according to randomization code after laser therapy. The subject, blind to the product applied to each of 4 regions of interest, assesses eight symptoms daily for 14 days. Photography is performed daily. conditions: Skin Aging studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: autologous hair follicle derived secretome measure: Reduction in severity and duration of symptoms sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Rejuuv Medi Spa city: Markham state: Ontario zip: L3R0M3 country: Canada lat: 43.86682 lon: -79.2663 hasResults: False
<\|newrecord\|> nctId: NCT06336122 id: 83904_1 id: R01DK135885-01 type: NIH link: https://reporter.nih.gov/quickSearch/R01DK135885-01 briefTitle: OASIS: Peer Support for T2DM in Appalachia (Peer Participant) acronym: OASIS overallStatus: RECRUITING date: 2024-02-21 date: 2025-12-31 date: 2026-03-31 date: 2024-03-28 date: 2024-04-08 name: University of Kentucky class: OTHER name: Department of Health and Human Services name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The goal of this clinical trial is to compare the effects of peer coaching models in older adults with unmanaged type two diabetes. The main questions it aims to answer are:
Are peer coaching models effective at promoting Type 2 Diabetes Mellitus self-management?
If effective, which facets of the peer model are most effective? Peer coaches will Undergo peer coach training.
Reach out to peer participants on a weekly/biweekly time frame to discuss self-management and goal setting.
Retain records of contact, topics discussed, and general notes on interactions. Researchers will compare differences in the frequency of contact, as well as how peer coaches were matched to peer participants to see if efficacy of the intervention is altered between groups. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 76 type: ESTIMATED name: Peer Coach Training - Weekly name: Peer Coach Training - Biweekly measure: Number of participants with change in A1c measure: Diabetes Empowerment measure: Quality of Life Index measure: Social Support measure: Depression Scale measure: Problem Areas in Diabetes measure: Diabetes Self-Management measure: Acts of Daily Living measure: Social Network Scale sex: ALL minimumAge: 55 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barren River Area Development District status: RECRUITING city: Bowling Green state: Kentucky zip: 42101 country: United States name: Michelle Hines role: CONTACT phone: 270-306-4036 email: michelle@bradd.org lat: 36.99032 lon: -86.4436 facility: UK HealthCare status: RECRUITING city: Hazard state: Kentucky zip: 41701 country: United States name: Kay Douthitt, MD role: CONTACT email: key.douthitt@uky.edu lat: 37.24954 lon: -83.19323 hasResults: False
<\|newrecord\|> nctId: NCT06336109 id: N-20220063-3 briefTitle: Fragmented Sleep, Pain, and Biomechanics overallStatus: RECRUITING date: 2024-01-26 date: 2024-12-31 date: 2024-12-31 date: 2024-03-28 date: 2024-04-03 name: Aalborg University class: OTHER briefSummary: This interventional study aims to test the effects of sleep disruption on pain sensitivity and biomechanics in healthy individuals during experimental knee and shoulder pain. The main question the study aims to answer is:
1) Does sleep fragmentation increase experimental knee and shoulder pain and what are the underlying mechanisms?
Participants will receive two injections a) Hypertonic saline (painful) in the knee and b) hypertonic saline (painful) in the upper arm. conditions: Pain conditions: Healthy conditions: Sleep Disturbance studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: Hypertonic saline knee and shoulder injection measure: Knee Pain intensity (NRS 0-10) measure: Shoulder Pain intensity (NRS 0-10) measure: Pain sensitivity measure: The Pittsburgh Sleep Quality Index score measure: The Pain catastrophizing Scale score measure: The Hospital Anxiety and Depression Scale score measure: The Knee injury and Osteoarthritis Outcome Score measure: Rapid Assessment of Physical Activity score measure: Pain distribution by number of pixels marked on a body chart measure: Video-based motion capture measure: Quality of sleep (NRS 0-100) measure: Level of rest (NRS 0-100) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Aalborg University status: RECRUITING city: Aalborg state: Nordjylland zip: 9000 country: Denmark name: Kristian K Petersen, Dr. Med role: CONTACT phone: (+45) 31697510 email: kkp@hst.aau.dk name: Emma Hertel, M. Sc. role: CONTACT phone: (+45) 60887473 email: eh@hst.aau.dk lat: 57.048 lon: 9.9187 hasResults: False
<\|newrecord\|> nctId: NCT06336096 id: VX23-548-017 briefTitle: A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation and Strength of Suzetrigine overallStatus: RECRUITING date: 2024-03-28 date: 2024-10 date: 2024-10 date: 2024-03-28 date: 2024-04-26 name: Vertex Pharmaceuticals Incorporated class: INDUSTRY briefSummary: The purpose of this study is to evaluate the pharmacokinetics (PK) of suzetrigine (SUZ; VX-548) and its metabolite along with its safety and tolerability, in healthy participants. conditions: Pain studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 72 type: ESTIMATED name: Suzetrigine name: Suzetrigine measure: Part A: Maximum Observed Plasma Concentration (Cmax) of SUZ measure: Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of SUZ measure: Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of SUZ measure: Part B: Cmax of SUZ measure: Part B: AUC0-tlast of SUZ measure: Part B: AUC0-inf of SUZ measure: Part A: Cmax of SUZ Metabolite measure: Part A: AUC0-tlast of SUZ Metabolite measure: Part A: AUC0-inf of SUZ Metabolite measure: Part A: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Part B: Cmax of SUZ Metabolite measure: Part B: AUC0-tlast of SUZ Metabolite measure: Part B: AUC0-inf of SUZ Metabolite measure: Part B: Safety and Tolerability as Assessed by Number of Participants with AEs and SAEs measure: Part C: Cmax of SUZ and its Metabolite measure: Part C: AUC0-tlast of SUZ and its Metabolite measure: Part C: AUC0-inf of SUZ and its Metabolite measure: Part C: Safety and Tolerability as Assessed by Number of Participants with AEs and SAEs sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Celerion - Tempe status: RECRUITING city: Tempe state: Arizona zip: 85283 country: United States lat: 33.41477 lon: -111.90931 hasResults: False
<\|newrecord\|> nctId: NCT06336083 id: RC31/23/0618 briefTitle: Familial Form of Carotid Web: a Doppler Ultrasound Study acronym: Family-WEB overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-03-28 date: 2024-04-11 name: University Hospital, Toulouse class: OTHER briefSummary: There is no evidence of familial forms of carotid web. The aim of this study is to determine the prevalence of carotid web among relatives of patient with carotid web using carotid doppler ultrasound. conditions: Carotid Web studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 90 type: ESTIMATED name: Doppler ultrasound measure: Evaluation of the prevalence of carotid web by doppler ultrasound in first-degree relatives of patients with carotid web. measure: Description of the clinical characteristics of relatives with carotid web and their index case. measure: Description of the morphological characteristics of relatives with carotid web and their index case. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Toulouse, Purpan city: Toulouse zip: 31059 country: France name: Louis FONTAINE, MD role: CONTACT phone: 05 61 77 93 67 phoneExt: +33 email: fontaine.l@chu-toulouse.fr lat: 43.60426 lon: 1.44367 hasResults: False
<\|newrecord\|> nctId: NCT06336070 id: 2024-FIS-3251696 id: CIACIF/2022/368 type: OTHER_GRANT domain: Regional Ministry of Education, Universities and Employment - Generalitat Valenciana briefTitle: Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study acronym: POWER Health overallStatus: RECRUITING date: 2024-01-01 date: 2027-12-31 date: 2028-12-31 date: 2024-03-28 date: 2024-04-04 name: University of Valencia class: OTHER name: Generalitat Valenciana briefSummary: POWER Health is a randomized clinical trial with a two-arm parallel design whose objectives are 1) to study metabolic flexibility and autonomic function (both capacities that describe cardiovascular health) in a sample of postmenopausal oncological women vs postmenopausal untreated controls (CT); and 2) to analyze the impact of two different 8-week physical exercise supervised interventions: HIIT training vs strength training focused on muscle power, on both cardiovascular capacities in these populations. conditions: Breast Cancer Female conditions: Cardiometabolic Syndrome conditions: Metabolism Disorder, Lipid conditions: Autonomic Dysfunction conditions: Cardiovascular Diseases in Old Age studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: HIIT program (8 weeks) name: MPI program (8 weeks) measure: Fat oxidation during incremental test measure: Detrended Fluctuation Analysis measure: Weight measure: Height measure: Calf, waist and hip circumferences. measure: Lean mass measure: Fat-free mass measure: Visceral adipose tissue measure: Bone Mass measure: Fat mass measure: Blood Pressure measure: Oxygen Saturation measure: Sarcopenia measure: Physical activity and sedentariness measure: Lactate measure: Rating Perceived Exertion measure: Visual Analogue Scale of Pain measure: Cadence measure: Mechanical Power measure: Muscle Power 5STS measure: Basal metabolic rate measure: Respiratory exheange ratio at rest measure: Fat oxidation at rest measure: Carbohydrate oxidation at rest measure: Carbohydrate oxidation during incremental test measure: Energy expenditure during incremental test measure: FATmax intensity measure: VO2peak measure: Sample Entropy measure: SD1/SD2 ratio measure: The root mean square of successive differences between normal heartbeats (RMSSD) sex: FEMALE minimumAge: 35 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Physical Activity and Sport Sciences status: RECRUITING city: Valencia state: Comunidad Valenciana zip: 46010 country: Spain name: Cristina Blasco Lafarga, PhD role: CONTACT phone: 64372 phoneExt: 9638 email: m.cristina.blasco@uv.es name: Jordi Monferrer-Marín, Predoctoral student role: SUB_INVESTIGATOR name: Ainoa Roldán, PhD role: SUB_INVESTIGATOR name: Jørn Wulff Helge, PhD role: SUB_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False
<\|newrecord\|> nctId: NCT06336057 id: RC31/23/0408 briefTitle: Mentalizating in Adults Suffering From Narcolepsy Type 1. acronym: NARCOMENTAL overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-04 date: 2025-12 date: 2024-03-28 date: 2024-03-28 name: University Hospital, Toulouse class: OTHER briefSummary: The main objective is to examine the potential mentalization impairments affecting a population suffering from narcolepsy type 1. Indeed, the hypothesis of this research is that mentalization could be impaired in narcoleptic patients. conditions: Narcolepsy Type 1 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Mentalization measure: Comparison of mentalization abilities, in a population of patients with NT1 versus a control group. measure: Comparison and description of mentalization abilities in a population of patients versus controls. measure: Better characterization of the clinical impression of an altered subjective experience of the difficulties the patients are going through. measure: Determination of the existence of a correlation between the time of appearance of the first symptoms and the initiation of treatment and the level of mentalization in NT1 patients, or not. measure: Determination of the existence of a correlation between the age at the first symptoms of NT1 patients and mentalization abilities, or not. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre de compétence Narcolepsies et Hypersomnies rares, CHU de Toulouse, Hôpital Pierre-Paul Riquet city: Toulouse zip: 31059 country: France name: Rachel DEBS, Dr role: CONTACT phone: 05 61 77 94 88 email: debs.r@chu-toulouse.fr lat: 43.60426 lon: 1.44367 hasResults: False
<\|newrecord\|> nctId: NCT06336044 id: Taufiller/22 briefTitle: Pre-marketing Clinical Trial to Evaluate the Safety and Efficacy of the Filler of Hyaluronic Acid Recombinant Collagen overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2025-01 date: 2024-03-28 date: 2024-03-28 name: Taumedika s.r.l. class: INDUSTRY name: Nextrasearch S.r.l.s. briefSummary: Study to validate the safety and efficacy of the Hyaluronic Acid +Collagen filler 20 patients will undergo through 3 visits one to asses the health and apply the filler one after 4 weeks to check the results one after 16 weeks for the final check and results validation Safety assessed with analysis of the Adverse Events conditions: Wrinkle conditions: Scar conditions: Laxity; Skin studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 20 patients will undergo skin characterists measurments at time 0 at +4weeks and at +16 weeks primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Karisma measure: Safety: no adverse events measure: Efficacy: change of wrinkles and scars measure: Efficacy: change of wrinkles and scars measure: Efficacy: change of wrinkles and scars measure: Efficacy: change of wrinkles and scars measure: Duration of the efficacy sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06336031 id: 30002163 briefTitle: Impact of Blood Phobia on Fainting Susceptibility overallStatus: RECRUITING date: 2024-03-30 date: 2024-12 date: 2025-02 date: 2024-03-28 date: 2024-04-17 name: Simon Fraser University class: OTHER briefSummary: The primary purpose of this study is to characterize cardiovascular autonomic function to emotional stimuli (blood-injection-injury phobia \[needle phobia\]) during an orthostatic (upright) challenge in individuals with and without known needle phobia. It is well established that emotional stress can produce hypotensive (low blood pressure) reactions. Interestingly, these hypotensive reactions to venipuncture (even with minimal blood drawn), insulin injections, finger sticks for blood sugar monitoring, dental care, and vaccinations can affect up to a quarter of adults and appear to be uniquely associated with blood-injection-injury phobia rather than other phobias. These hypotensive reactions can ultimately lead to a vasovagal syncope (fainting) response, and lead to increased avoidance of medical and dental procedures as a result of this phobia. Ultimately, this has severe implications on public health and places additional strain on the Canadian healthcare system. Currently, there is limited understanding surrounding the initiation of this response. Additionally, a comprehensive profile of cardiovascular autonomic function during exposure to provoking stimuli during orthostatic stress has not been captured in the literature. We will test individuals with and without blood-injection-injury phobia using our standard approach while exposing them to emotional stimuli. conditions: Syncope, Vasovagal conditions: Blood, Injection, Injury Type Phobia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: blood-injection-injury (BII) phobia stimuli name: neutral stimuli measure: Orthostatic Tolerance sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Simon Fraser University status: RECRUITING city: Burnaby state: British Columbia zip: V5A 1S6 country: Canada name: Vera E Lucci, PhD role: CONTACT phone: 7787828560 email: vlucci@sfu.ca name: Victoria E Claydon, PhD role: PRINCIPAL_INVESTIGATOR lat: 49.26636 lon: -122.95263 hasResults: False
<\|newrecord\|> nctId: NCT06336018 id: NN7535-7703 id: U1111-1289-2466 type: OTHER domain: World Health Organization (WHO) briefTitle: A Research Study on Etavopivat in Participants With and Without Liver Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-29 date: 2025-07-04 date: 2025-07-04 date: 2024-03-28 date: 2024-03-28 name: Novo Nordisk A/S class: INDUSTRY briefSummary: The study investigates an investigational drug called etavopivat in participants with hepatic impairments and participants with normal hepatic function (matched controls). During the study, all participants will be given a single oral dose of etavopivat. All participants will take the etavopivat orally together with water. After dosing, the study will last for 7 to 9 days. conditions: Liver Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Etavopivat measure: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose (AUC0-inf, etavopivat) measure: Maximum observed etavopivat plasma concentration after a single dose (Cmax, etavopivat) measure: Area under the etavopivat plasma concentration-time curve from 0 hours to the last quantifiable concentration after a single dose (AUC0-last, etavopivat) measure: Time to maximum observed etavopivat plasma concentration after a single dose (tmax, etavopivat) measure: Terminal half-life for etavopivat after a single dose (t1/2, etavopivat) measure: Apparent plasma clearance of etavopivat after a single dose (CL/Fetavopivat) measure: Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values (Vz/Fetavopivat) measure: Number of adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Orlando Clinical Research Center city: Orlando state: Florida zip: 32806 country: United States lat: 28.53834 lon: -81.37924 facility: Amer. Rrsch Corp-TX Liver Inst city: San Antonio state: Texas zip: 78215 country: United States lat: 29.42412 lon: -98.49363 hasResults: False
<\|newrecord\|> nctId: NCT06336005 id: NN6022-7683 briefTitle: A Study to See How Safe a New Medicine (NNC6022-0001) is in Healthy People overallStatus: RECRUITING date: 2024-03-28 date: 2024-10-17 date: 2024-10-17 date: 2024-03-28 date: 2024-04-15 name: Novo Nordisk A/S class: INDUSTRY briefSummary: The study is testing a new study medicine, which is being tested as a potential medicine to treat cardiometabolic diseases.
The aim of this study is to see if the study medicine is safe, how it works in participants body, and what the body does to the study medicine.
Participants will either get NNC6022-0001 (the new study medicine) or placebo (a "dummy medicine" without the active ingredient). Which treatment participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.
The study will last for about 10 months in total. conditions: Healthy Volunteers conditions: Cardiometabolic Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Sponsor staff involved in the clinical trial is masked according to company standard procedures. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: NNC6022-0001 name: Placebo (NNC6022-0001) measure: Number of treatment emergent adverse events (TEAE) measure: AUC0-t, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose measure: AUC0-∞, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to infinity after a single dose measure: Cmax, SD; the maximum plasma concentration of NNC6022 0001 after a single dose measure: IL-1β, SD; ratio of <Timepoint> (time of the maximal plasma concentration of NNC6022 0001) to baseline sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: ICON - location Groningen status: RECRUITING city: Groningen zip: 9728 NZ country: Netherlands lat: 53.21917 lon: 6.56667 hasResults: False
<\|newrecord\|> nctId: NCT06335992 id: Dnr 2022-00831-01 briefTitle: Tissue Regeneration in Patients With Chronic Obstructive Pulmonary Disease After an Exercise Intervention. acronym: T-Rex overallStatus: RECRUITING date: 2022-09-01 date: 2025-02-28 date: 2025-04-30 date: 2024-03-28 date: 2024-03-28 name: Uppsala University class: OTHER name: Lund University briefSummary: The main objective of this project is to identify mechanisms for lung regeneration in patients with COPD induced by exercise training. The hypothesis is that adjusted exercise training improves disease outcome in these patients by decrease remodelling processes linked to oxidative stress, inflammatory and/or immunological pathways in the lung. Along the way, the investigator also expect to identify (or validate) biomarkers mirroring systemic processes such as reduced inflammation and ameliorating the epithelial barrier in these patients. These events may additionally act as potential targets for interventions.
Objectives (i) Evaluate biomarkers for regenerative processes, matrix turnover, stem cell activity and inflammatory patterns in lung tissue biopsies, blood- and urine samples correlated to vital lung parameters and physical capacity, before and after attending an exercise-training program.
(ii) Study the effects of exercise training on the pulmonary ventilation/perfusion ratio and quality of life.
(iii) Evaluate the relation between pathophysiology in the lung evaluated by CT scan, and systemic response measured by muscle biopsies and biomarkers in blood/urine.
(iv) Investigate in vitro cell behaviour and remodelling/regenerative processes altered in COPD patients upon exercise training (aim 1). conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Exercise regime measure: Pulmonary Function measure: Physical capacity measure: Inflammation markers measure: Level of emphysema measure: Maximal physical capacity ( Wmax) measure: COPD Assessment Test (CAT) sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lund University status: RECRUITING city: Lund country: Sweden name: Gunilla Westergren Thorsson, Phd role: CONTACT phone: +4646222 00 00 email: gunilla.westergren-thorsson@med.lu.se name: Caroline Ms Larsson, Phd role: CONTACT phone: +46736673026 email: caroline.larsson@med.lu.se lat: 55.70584 lon: 13.19321 facility: Uppsala University status: RECRUITING city: Uppsala country: Sweden name: Margareta Mrs Emtner, Phd role: CONTACT phone: +46737594481 email: margareta.emtner@medsci.uu.se name: Christer Mr Janson, Phd role: CONTACT phone: +46186114115 email: christer.janson@medsci.uu.se lat: 59.85882 lon: 17.63889 hasResults: False
<\|newrecord\|> nctId: NCT06335979 id: CPIT565B12101 id: 2023-510025-14-00 type: OTHER domain: EU CT briefTitle: An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE). overallStatus: NOT_YET_RECRUITING date: 2024-12-16 date: 2028-08-23 date: 2028-08-23 date: 2024-03-28 date: 2024-04-11 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE conditions: Systemic Lupus Erythematosus, SLE studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: PIT565 measure: Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) measure: Maximum Observed Blood Concentrations (Cmax) measure: Time to Reach Maximum Blood Concentrations (Tmax) measure: Presence/absence of Anti-drug Antibodies sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06335966 id: STUDY00025975 briefTitle: BEST-RPP Pilot: Screening for Esophageal Cancer in Rural Oregon Without an Endoscopy acronym: BEST-RPP overallStatus: RECRUITING date: 2024-01-25 date: 2025-01-30 date: 2025-01-30 date: 2024-03-28 date: 2024-03-28 name: OHSU Knight Cancer Institute class: OTHER name: Kuni Foundation name: Oregon Health and Science University briefSummary: Recent advancements in swallowable esophageal cell-collection devices (SECD) offer a safe, minimally invasive, accurate, and low-cost alternative to esophageal screening without the need for an upper endoscopy. The BEST-RPP study aims to evaluate the acceptability and feasibility of using this novel approach to screen for Barrett's Esophagus (BE) and Esophageal Carcinoma (EAC) in rural primary care clinic settings in Oregon. conditions: Esophageal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 110 type: ESTIMATED name: Screening with swallowable esophageal cell-collection devices (SECD) measure: Feasibility of the use of a SECD: Number of providers who indicate likelihood of using SECD measure: Feasibility of the use of SECD: Number of providers who indicate willingness to be trained and train clinic staff measure: Feasibility of the use of SECD: Number of referrals measure: Feasibility of the use of SECD: Number enrolled measure: Patient acceptability: Number of interested patients who schedule an appointment to be screened measure: Patient acceptability: Number of patients who come to their appointments measure: Patient acceptability: Number of patients interested in being screened via SECD at other care centers measure: Access: time to full diagnostic work up for patients with positive SECD results sex: MALE minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OHSU Knight Cancer Institute status: RECRUITING city: Portland state: Oregon zip: 97239 country: United States name: Laura Ferrara, MA role: CONTACT phone: 541-399-1139 name: Fouad Otaki, MD role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 hasResults: False
<\|newrecord\|> nctId: NCT06335953 id: IRB00418404 id: U54AG063546 type: NIH link: https://reporter.nih.gov/quickSearch/U54AG063546 briefTitle: ALIGN: Aligning Medications With What Matters Most (Demonstration) overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2025-04 date: 2025-04 date: 2024-03-28 date: 2024-04-22 name: Johns Hopkins University class: OTHER name: National Institute on Aging (NIA) briefSummary: The goal of this clinical trial is to test the effectiveness of a pharmacist-led, primary care-based de-prescribing intervention for people living with dementia (PLWD) and the person's care partners.
The intervention consists of the following strategies: 1) a de-prescribing educational brochure designed to activate the patient and care partner; 2) a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of the person's goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored de-prescribing recommendations designed to be useful and actionable for the PCP.
The investigators will compare the intervention group with the waitlist control group to see if there is a difference in the primary outcome, the proportion of patients who deprescribe at least one medication by 3 months. conditions: Polypharmacy conditions: Alzheimer's Disease and Related Dementias conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 280 type: ESTIMATED name: Pharmacist-led deprescribing intervention measure: Proportion of patients who stop one or more medications measure: Proportion of patients who start one or more new medications measure: Proportion of patients who stop one or more potentially inappropriate medication (PIM) measure: Total number of medications measure: Shared decision-making as assessed by CollaboRATE sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Johns Hopkins Bayview Medical Center city: Baltimore state: Maryland zip: 21224 country: United States name: Ariel Green, MD, MPH, PhD role: CONTACT phone: 410-550-6733 email: ariel@jhmi.edu lat: 39.29038 lon: -76.61219 hasResults: False
<\|newrecord\|> nctId: NCT06335940 id: 38RC23.0376 briefTitle: Admission for Respiratory Disease And VIdeo Regulation System acronym: ARAVIS-PED overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-07-31 date: 2024-10-18 date: 2024-03-28 date: 2024-04-02 name: University Hospital, Grenoble class: OTHER briefSummary: Pediatric dyspnea is a major health problem, accounting for up to 27% of admissions to emergency departments in winter. It is estimated that a significant number (13%) of patients presenting to emergency departments are outpatients, at a time when emergency departments are having to cope with an ever-increasing flow of patients.
Proper referral of patients calling the SAMU Centre-15 takes on its full meaning in this context, but regulating paediatric calls is more difficult. Indeed, the regulating doctor is most often in contact with the parents, who describe what they see and pass on their concerns, and it is difficult to have direct contact with patients who are often very young. Obtaining objective criteria such as saturation and respiratory rate is also a real challenge.
To overcome the complexity of medical regulation, a number of tools and aids have been developed, including visio or video-regulation (regulation via the camera on the caller's smartphone).
This device has been evaluated in a number of situations, enabling it to take its place in the daily practice of many doctors, but there is very little data concerning pediatric visio-regulation, particularly with regard to dyspnea.
To the best of the investigator knowledge, there is no prospective study looking at the impact of Video-Regulation on the outcome of patients requiring the advice of SAMU Centre-15 for pediatric dyspnea. conditions: Pediatric Respiratory Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 588 type: ESTIMATED name: Videoregulation measure: To determine in children under 10 years of age for whom a call to the SAMU38 for dyspnea is made, whether the use of Visio-Regulation reduces the percentage of emergency room admissions compared with standard telephone medical regulation. measure: Evaluate whether the use of video-regulation has an impact on the dispatcher's referral decision between ambulatory medicine and the emergency department. measure: Determine whether the use of video-regulation leads to an increase in call time with the regulating doctor measure: Evaluate parents' satisfaction with videoregulation compared with a standard call measure: Evaluate the number of rescue vectors (fire brigade, private ambulance) triggered but whose decision will ultimately be to "leave on the spot" after the rescue worker's assessment. measure: Evaluate whether the increased use of video-regulation is not associated with a higher rate of hospitalization in a conventional ward or intensive care unit sex: ALL maximumAge: 10 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06335927 id: GWK2023-001 briefTitle: HAIC Combined With Cadonilimab and Regorafenib as 2nd-line Treatment for ICC overallStatus: RECRUITING date: 2023-05-11 date: 2025-05-10 date: 2026-05-10 date: 2024-03-28 date: 2024-03-28 name: Fudan University class: OTHER briefSummary: This study is a single-arm Phase II clinical trial aiming to evaluate the safety and efficacy of HAIC combined with Cadonilimab and Regorafenib as second-line treatment for unresectable intrahepatic cholangiocarcinoma.
The study plans to enroll approximately 45 participants. All enrolled participants will receive continuous treatment: HAIC-Gemox: Gemcitabine 1000mg/m2 on Day 1 + Oxaliplatin 85mg/m2 on Day 1, every 3 weeks (Q3W), for up to 6 treatment cycles, Cadonilimab(6mg/kg, D2, Q3W) and Regorafenib (80mg QD, Q3W) until the investigator determines that there is no longer any clinical benefit (based on comprehensive assessment including RECIST v1.1 imaging evaluation and clinical condition), intolerable toxicity, initiation of new anti-tumor therapy, or meeting other criteria for treatment discontinuation, whichever occurs first. conditions: Intrahepatic Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: HAIC-GEMOX+Cadonilimab+Regorafenib measure: Objective Response Rate (ORR) measure: Hepatic Objective Response Rate (hORR) measure: Duration of Response (DoR) measure: Disease Control Rate (DCR) measure: Time to Response (TTR) measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) measure: Safety and tolerability sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Li Tan role: CONTACT phone: +8615800680751 lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06335914 id: dualPET-mPC id: CAPCR: 23-5595 type: OTHER domain: University Health Network briefTitle: Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2029-03-04 date: 2029-09-04 date: 2024-03-28 date: 2024-03-28 name: University Health Network, Toronto class: OTHER briefSummary: This study will use Prostate Specific Membrane Antigen (PSMA) and (18)F-Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging in patients with advanced prostate cancer to learn about tumor biology across disease stages and during treatment. This may help with treatment selection and potential response monitoring in the future. conditions: Advanced Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: Ga 68 PSMA-11 PET name: 18F-DCFPyL PET name: FDG PET measure: Proportion of patients with high volume mCSPC having PSMA avid disease measure: Proportion of patients with PSMA-/FDG+ discordant lesions sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Princess Margaret Cancer Centre city: Toronto state: Ontario zip: M5G 2M9 country: Canada name: Di (Maria) Jiang, M.D. role: CONTACT phone: 416-946-4501 phoneExt: 4807 email: di.jiang@uhn.ca name: Di (Maria) Jiang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06335901 id: xx20190901 briefTitle: Clinical Characteristics and Outcomes of Coronary Heart Disease overallStatus: COMPLETED date: 2020-02-01 date: 2022-01-31 date: 2022-04-30 date: 2024-03-28 date: 2024-03-29 name: Xinjiang Medical University class: OTHER briefSummary: This study evaluated and compared the prognostic value of different Baseline data and clinical variables to develop a risk ractor ediction model in patients with CHD. conditions: Coronary Heart Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20000 type: ACTUAL name: Drug:Standard therapy measure: Death （All-cause mortality、Cardiac mortality ） measure: Major adverse cardiovascular events sex: ALL minimumAge: 18 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Xinjiang Medical University city: Ürümqi state: Xinjiang zip: 630000 country: China lat: 43.80096 lon: 87.60046 hasResults: False
<\|newrecord\|> nctId: NCT06335888 id: CRAFT briefTitle: A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis acronym: CRAFT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2029-05 date: 2029-05 date: 2024-03-28 date: 2024-04-05 name: Insel Gruppe AG, University Hospital Bern class: OTHER name: Paul Scherrer Institut, Center for Proton Therapy briefSummary: The goal of this open-label clinical trial is to evaluate the efficacy of AzaFol-PET/CT in the diagnosis of GCA (giant cell arteritis), to compare AzaFol- with 2-\[18F\]FDG-PET/CT, and to assess the safety and tolerability of AzaFol in subjects with suspicion of GCA.
Participants will undergo AzaFol-PET/CT imaging at a single timepoint. conditions: Giant Cell Arteritis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Cross-over, randomized, open label, single-centre primaryPurpose: DIAGNOSTIC masking: NONE count: 70 type: ESTIMATED name: AzaFol name: FDG measure: Specificity of the GCA-diagnosis at the patient level measure: Lesion detection rate (visual analysis) measure: Lesion detection rate (semiquantitative analysis) measure: Sensitivity of the GCA-diagnosis at the patient level sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Rheumatology and Immunology, University Hospital Bern, Inselspital city: Bern zip: 3010 country: Switzerland name: Britta Maurer role: CONTACT lat: 46.94809 lon: 7.44744 hasResults: False
<\|newrecord\|> nctId: NCT06335875 id: HUM00227568 briefTitle: Brain Small Chain Fatty Acid Metabolism in Bipolar Disorder: Ketones acronym: BIPO overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-03 date: 2027-03 date: 2024-03-28 date: 2024-03-28 name: University of Michigan class: OTHER briefSummary: Small exploratory open-label pilot study to assess supplementation of a ketone ester (Juvenescence) combined with a 'ketogenic-mimicking diet' as a potential therapy for persons with bipolar disorder. conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Ketone Ester Beverage name: Low Glycemic Index Diet measure: Change in blood beta-hydroxybutyrate level measure: Change in blood glucose lability measure: Change in neural network stability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Domino's Farms city: Ann Arbor state: Michigan zip: 48105 country: United States lat: 42.27756 lon: -83.74088 facility: University Hospital city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 hasResults: False
<\|newrecord\|> nctId: NCT06335862 id: NL.84862.041.23 briefTitle: Primary Posterior Tracheopexy Prevents Tracheal Collapse acronym: PORTRAIT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-09-30 date: 2027-03-31 date: 2024-03-28 date: 2024-03-28 name: UMC Utrecht class: OTHER name: For Wis(h)dom Foundation name: Erasmus Medical Center name: Great Ormond Street Hospital for Children NHS Foundation Trust name: Karolinska University Hospital briefSummary: Introduction: Children born with a blind-ending gullet (oesophagus), or Oesophageal Atresia (OA), need to undergo surgical correction in the first week of life. OA is often accompanied by a weakened windpipe (trachea), known as tracheomalacia (TM). TM entails that the windpipe collapses during expiration. Severe TM can cause respiratory symptoms, including frequent respiratory tract infections and blue spells, that can potentially lead to life-threatening events. In some patients, major secondary surgical treatment may be indicated. This surgical procedure involves widening the trachea (using sutures) to prevent collapse, known as secondary posterior tracheopexy (SPT). Prior to performing this SPT, complications and negative consequences of TM may have already occurred. This may be prevented by performing this procedure during the primary OA correction, called a primary posterior tracheopexy (PPT). The aim of this trial is to determine if a PPT can decrease - or prevent - tracheal collapse in newborns with OA and TM, compared to a wait-and-see policy (no-PPT).
Methods: This is an international multicentre double-blind randomised controlled trial. Seventy eight children with OA type C will be included. Patients will be included after written parental informed consent. Half of the patients will be randomly allocated to the PPT-group and half to the no-PPT-group. The degree and location of TM are evaluated through preoperative, intraoperative and two postoperative videoscopic examinations of the trachea (tracheobronchoscopy). Whether TM symptoms occur is assessed during three routine follow-up consultations until the age of 6 months. The primary outcome is the degree of collapse of the tracheal wall during the intraoperative tracheobronchoscopy (after performing the PPT/no-PPT), measured in percentages.

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