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<\|newrecord\|> nctId: NCT06285929 id: 2013209-1 briefTitle: ACS Community Access to Resources Education and Support acronym: ACS CARES overallStatus: ENROLLING_BY_INVITATION date: 2023-09-01 date: 2025-08-31 date: 2025-12-31 date: 2024-02-29 date: 2024-02-29 name: American Cancer Society, Inc. class: OTHER name: University of Alabama at Birmingham briefSummary: The goal of this study is to evaluate the pilot phase of ACS Cares to identify key implementation outcomes and assess effectiveness of the program to improve distress, enhance communication, and reduce missed appointments and healthcare utilization. conditions: Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: ACS CARES Student Navigation measure: Measure the impact of ACS CARES on patient-reported outcomes: SDOH barriers measure: Measure the impact of ACS CARES on patient-reported outcomes: Information Needs measure: Measure the impact of ACS CARES on patient-reported outcomes: Distress needs measure: Measure the impact of ACS CARES on patient-reported outcomes: Satisfaction with program measure: Measure the impact of ACS CARES on patient-reported outcomes: Unmet needs measure: Measure the impact of ACS CARES on patient-reported outcomes: Patient-provider communication measure: Measure the impact of ACS CARES on patient-reported outcomes: clinical trials knowledge measure: Measure the impact of ACS CARES on patient-reported outcomes: Patient activation measure: Measure the impact of ACS CARES on patient-reported outcomes: Financial toxicity measure: Measure the impact of ACS CARES on patient-reported outcomes: Quality of life measure: Context, Training, and Process Measures: Service Penetrance and Process Measures: Service Penetrance measure: Sociodemographic differences between ACS CARES supported and non-ACS CAREs supported patients measure: Impact of ACS CARES on treatment adherence and healthcare measure: Context, Training, and Process Measures: Volunteer Satisfaction sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA Health city: Los Angeles state: California zip: 90024 country: United States lat: 34.05223 lon: -118.24368 facility: American Cancer Society city: Kennesaw state: Georgia zip: 30144 country: United States lat: 34.02343 lon: -84.61549 facility: University of Iowa Health Care city: Iowa City state: Iowa zip: 52242 country: United States lat: 41.66113 lon: -91.53017 facility: Medical University Hospital Authority, Hollings Cancer Center city: Charleston state: South Carolina zip: 29492 country: United States lat: 32.77657 lon: -79.93092 hasResults: False
<\|newrecord\|> nctId: NCT06285916 id: NORA520-PT-US-1a briefTitle: A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression acronym: NuMom overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-02 date: 2026-03 date: 2024-02-29 date: 2024-02-29 name: Gerbera Therapeutics, Inc. class: INDUSTRY briefSummary: The purpose of this research study is to test the study drug, NORA520, as a possible treatment for severe postpartum depression (PPD). The trial aims to determine:
* How well NORA520 is tolerated and what side effects it may cause
* If NORA520 reduces depressive symptoms in subjects with severe PPD
* The amount of NORA520 in the blood at various times after taking the study drug; this provides information that helps determine how often NORA520 should be taken
* In a subset of subjects, the amount of NORA520 in breastmilk at various times after taking it to determine if and how much NORA520 can pass into breastmilk Participate in this study will be randomly assigned to one of 3 different groups. All subjects will take the study drug for 3 days. conditions: Depression, Postpartum conditions: Postpartum Depression conditions: Post-partum Depression conditions: Postnatal Depression conditions: Post-Natal Depression studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: NORA520 Dose 1 name: NORA520 Dose 2 name: Placebo measure: Incidence, severity, and causality of AEs, SAEs, and AESIs measure: Change from baseline in HAM-D17 total score compared to placebo measure: Change from baseline in HAM-D17 total score measure: HAM-D17 response measure: HAM-D17 remission measure: Change from baseline in HAM-D17 subscale and individual item scores measure: Change from baseline in Clinical Global Impression - Severity (CGI-S) score measure: Clinical Global Impression - Improvement (CGI-I) scale positive response measure: Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score measure: Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score measure: Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score measure: Number of patients who start any new antidepressant or anti-anxiety medication sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Gerbera site city: Canoga Park state: California zip: 91304 country: United States lat: 34.20112 lon: -118.59814 facility: Gerbera sites city: Miami Gardens state: Florida zip: 33014 country: United States lat: 25.94298 lon: -80.24452 facility: Gerbera site city: Orlando state: Florida zip: 32807 country: United States lat: 28.53834 lon: -81.37924 facility: Gerbera site city: Saint Petersburg state: Florida zip: 33607 country: United States lat: 27.77086 lon: -82.67927 facility: Gerbera site city: League City state: Texas zip: 77573 country: United States lat: 29.50745 lon: -95.09493 facility: Gerbera site city: Richardson state: Texas zip: 75080 country: United States lat: 32.94818 lon: -96.72972 hasResults: False
<\|newrecord\|> nctId: NCT06285903 id: AUAREC20220002-11 briefTitle: Comparing the Hydrodynamic Piezoelectric Technique With Osseodensification for the Assessment of Internal Sinus Iift-ing acronym: RCT overallStatus: COMPLETED date: 2022-09-02 date: 2022-12-01 date: 2023-12-30 date: 2024-02-29 date: 2024-03-28 name: Al-Azhar University class: OTHER briefSummary: Successful osseointegration considered the cornerstone in implant stability which predict the highest implants success outcomes. Implant stability depend on many factors like the implant design, surgical technique, and bone density. Posterior maxilla considered as a challenging area in implant placement, this is due to less dense trabecular bone sur-rounded by a thin layer of cortical bone which result in suffering in implant stability. The aim of this study is to evaluate the bone density outcomes using bone densification technique and piezoelectric surgical technique in sinus lift to promote bone gain conditions: Bone Density, Low studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A total of 20 patients were randomly divided into two groups: Group1: patients received dental implant using osseodensification via Densah bur, Group2: patients received dental implant using hydrodynamic piezoelectric sinus lifting. The patients in both groups underwent bone grafting under sinus membrane. Modified bleeding index and probing depth were evaluated at 3, 6 and 12months intervals. An Osstell device was used to de-termine implant stability by recording the values of implant stability quotient (ISQ) im-mediately after implant placement and after 3 months. CBCT was performed before, af-ter 6 months and after 12 months to evaluate ridge height, bone density. Marginal bone loss was evaluated after 3 months via periapical radiograph, after 6 months and after 12 months via CBCT. primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: internal sinus lift surgery measure: Implant stability using the Osstell device by percentage measure: Modified sulcus bleeding index,Peri-implant pocket depth (PPD)by mm measure: Bone Densityby mm sex: ALL minimumAge: 35 Years maximumAge: 39 Years stdAges: ADULT facility: Alazhar university ,Assuit branch ,Egypt city: Assiut state: Assuit zip: 0000 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False
<\|newrecord\|> nctId: NCT06285890 id: 2023-1016 id: NCI-2024-01733 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Phase I Study of HC-7366 With Azacitidine and Venetoclax for Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2027-12-31 date: 2029-12-31 date: 2024-02-29 date: 2024-04-12 name: M.D. Anderson Cancer Center class: OTHER name: HiberCell, Inc. briefSummary: To find a recommended dose of HC-7366 that can be given in combination with azacitidine and venetoclax to patients with AML. The safety and effects of this drug combination will also be studied. conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: HC-7366 name: Azacitidine name: Venetoclax measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Abhishek Maiti, MD role: CONTACT phone: 346-725-0901 email: amaiti@mdanderson.org name: Abhishek Maiti, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06285877 id: 291120234382023 briefTitle: Effectiveness of the Use of the Nintendo Switch Combined With Conventional Therapy in People With Acquired Brain Injury overallStatus: RECRUITING date: 2024-02 date: 2024-02 date: 2025-01 date: 2024-02-29 date: 2024-02-29 name: Universidad Rey Juan Carlos class: OTHER briefSummary: Purpose: to observe the possible benefits produced by conventional therapy through virtual reality with the Nintendo Switch to try to improve motivation and increase the degree of care satisfaction. The aim is to improve postural control in both seated and standing positions and to maintain and improve cognitive capacity.
Material and methods: one group (experimental group) will receive a total of 8 one-hour sessions or 16 half-hour sessions, depending on their individual needs, for 8 weeks using the Nintendo Switch. The other group (control group) will continue to receive their conventional scheduled therapy.
Measures: Abilhand, MEC-Lobo, FIST, Fugl-Meyer, Berg Balance Scale and CSQ-8. conditions: Occupational Therapy conditions: Acquired Brain Injury conditions: Adults studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Control Group (CG), which received their usual sessions of conventional therapy sessions, and an Experimental Group (EG), which received therapy with Nintendo Switch plus their conventional therapy sessions. primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Conventional therapy sessions name: Conventional therapy sessions plus Nintendo Switch measure: Abilhand measure: MEC-Lobo measure: Function in Sitting Test (FIST) measure: Fugl-Meyer measure: Berg Balance Scale (BBS) measure: Client Satisfaction Questionnaire (CSQ-8) sex: ALL minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad Rey Juan Carlos status: RECRUITING city: Móstoles state: Madrid zip: 28933 country: Spain name: Isabel Quirosa Galan, MsC role: CONTACT phone: +34655551210 email: i.quirosa.2016@alumnos.urjc.es lat: 40.32234 lon: -3.86496 hasResults: False
<\|newrecord\|> nctId: NCT06285864 id: 122/2023 briefTitle: Sense to Act: An Interoceptive Sensibility Intervention for Musculoskeletal Pain overallStatus: RECRUITING date: 2024-02 date: 2024-06 date: 2024-12 date: 2024-02-29 date: 2024-03-01 name: Iscte-University Institute of Lisbon class: OTHER name: Foundation for Science and Technology (FCT) name: University of Évora briefSummary: The ability to be connected and act according to bodily information is fundamental in chronic pain adjustment. This study aims to test the feasibility of an intervention designed to improve interoceptive sensibility, i.e., the ability to sense, interpret, and regulate bodily sensations in chronic musculoskeletal pain patients. conditions: Musculoskeletal Pain conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants will be unaware of their assigned treatment. whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: Interoception-based intervention measure: Feasibility - Sessions' acceptability measure: Feasibility - Program acceptability, appropriateness, and feasibility measure: Feasibility - Recruitment, retention, and attendance rates measure: Feasibility - safety/unexpected events measure: Feasibility - Treatment Fidelity Check measure: Interoceptive sensibility measure: Psychological flexibility measure: Emotion regulation measure: Pain-related self-efficacy measure: Pain catastrophizing measure: Activity patterns measure: Affective distress (depression and anxiety) measure: Pain severity measure: Physical function and Vitality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Iscte - University Institute of Lisbon status: RECRUITING city: Lisbon zip: 1649-026 country: Portugal name: Inês Oliveira, MSc role: CONTACT phone: +351217903000 email: iamoa@iscte-iul.pt name: Sónia Bernardes, PhD role: CONTACT phone: +351217903000 email: sonia.bernardes@iscte-iul.pt name: Inês Oliveira, MSc role: PRINCIPAL_INVESTIGATOR lat: 38.71667 lon: -9.13333 facility: University of Évora status: RECRUITING city: Évora zip: 7004-516 country: Portugal name: Inês Oliveira, MSc role: CONTACT phone: +351266740800 email: iamoa@iscte-iul.pt name: Sónia Bernardes, PhD role: CONTACT phone: +351217903000 email: sonia.bernardes@iscte-iul.pt name: Inês Oliveira, MSc role: PRINCIPAL_INVESTIGATOR lat: 38.56667 lon: -7.9 hasResults: False
<\|newrecord\|> nctId: NCT06285851 id: 23-0825 briefTitle: A Novel Iron Supplement for Athletes: Phase I overallStatus: COMPLETED date: 2023-11-23 date: 2023-12-12 date: 2023-12-12 date: 2024-02-29 date: 2024-03-28 name: University of Calgary class: OTHER name: Lallemand Bio-Ingredients briefSummary: Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study is a pilot trial to assess the tolerability of a novel iron supplement prior to conducting a clinical trial on the efficacy of the developed novel iron supplement on iron status and performance. conditions: Constipation conditions: Diarrhea conditions: Cramp, Abdominal conditions: Bleeding Gastric studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 14 type: ACTUAL name: FeSC measure: GI Symptoms measure: Gastrointestinal symptoms measure: Supplement Tolerability and Preferences Questionnaire measure: Recovery sex: FEMALE minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: University of Calgary city: Calgary state: Alberta country: Canada lat: 51.05011 lon: -114.08529 hasResults: False
<\|newrecord\|> nctId: NCT06285838 id: 2020/2706 briefTitle: Impact of Measures Taken to Contain COVID-19 on Hospital Surgical Care Services and Clinical Outcomes overallStatus: COMPLETED date: 2020-07-17 date: 2023-11-30 date: 2024-01-20 date: 2024-02-29 date: 2024-02-29 name: Singapore Health Services class: OTHER briefSummary: Swift and decisive actions on the part of healthcare and hospital authorities are required to effectively contain the current COVID-19 pandemic. These measures firstly allow personnel and facilities leeway to provide surge capabilities to meet anticipated increased demands on the healthcare service. In addition, by deferring none urgent hospital visits, admissions and investigations, such measures support social distancing and aid attempts to control disease transmission. Deferring perceived non-urgent patient services may however lead to unintended delayed diagnoses and exacerbation of current patient conditions and lead to increased emergency admissions and surgeries.
A policy decision was made that essential surgical services pertaining to cancer and urgent cardiovascular surgery were allowed but that surgeons had the option to postpone what is assessed to be less urgent cases. Increasingly patients also postpone their surgeries or visits because of anxieties over the developing situation. Elective surgical services at the Outram Campus were thus significantly reduced from January 2020 as part of the measures to contain the COVID-19 outbreak.
The surgical philosophy during this period was that a judicious policy that allowed surgeons to proceed with surgery deemed critical but to postpone those deemed less so will at the system level, avoid poor outcomes for patients who required surgery and yet successfully re-allocate resources required to address the unfolding pandemic. conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 11000 type: ACTUAL measure: Impact of measures taken to contain COVID-19 on hospital surgical care services and clinical outcomes sex: ALL minimumAge: 21 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Singapore Health Services Pte ltd city: Singapore zip: 169856 country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False
<\|newrecord\|> nctId: NCT06285825 id: 2023-0864 id: NCI-2024-01736 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2026-08-22 date: 2028-08-22 date: 2024-02-29 date: 2024-03-13 name: M.D. Anderson Cancer Center class: OTHER name: Sobi, Inc. briefSummary: To look at the safety and effectiveness of emapalumab for the treatment of prolonged severe cytopenia in participants with LBCL who receive CART. conditions: Cytopenia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Emapalumab measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Paolo Strati, MD role: CONTACT phone: 713-745-1776 email: pstrati@mdanderson.org name: Paolo Strati, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06285812 id: 000003 briefTitle: Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children acronym: OTO-MATIC overallStatus: RECRUITING date: 2023-01-10 date: 2024-05-30 date: 2024-05-30 date: 2024-02-29 date: 2024-02-29 name: PhotoniCare, Inc. class: INDUSTRY name: TTi Health Research & Economics briefSummary: A pragmatic, mixed-method trial is to show the ability of OtoSight to change management of the pediatric patient presenting with ear pain in a way that improves patient outcomes and reduces costs. conditions: Otitis Media Acute studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 700 type: ESTIMATED name: OtoSight Middle Ear Scope measure: Change the clinician rate of antibiotic prescriptions measure: Change the number of antibiotic rounds per patient measure: Change costs associated with management of pediatric patients presenting with ear-related pain measure: Change in unnecessary antibiotic prescriptions measure: Change in prescription adherence measure: Change in antibiotic prescription rate when fluid not present measure: Improve patient outcomes measure: Change medical resource utilization measure: Change unnecessary medical intervention measure: Impact clinician confidence measure: Impact caregiver satisfaction measure: Change in Health-related Quality of Life (HQoL) sex: ALL minimumAge: 6 Months maximumAge: 17 Years stdAges: CHILD facility: Children's National Hospital status: NOT_YET_RECRUITING city: Washington state: District of Columbia zip: 20010 country: United States name: Bobbe Thomas role: CONTACT lat: 38.89511 lon: -77.03637 facility: Trillim Health status: RECRUITING city: Rochester state: New York zip: 14620 country: United States name: Shealynn Hilliard role: CONTACT lat: 43.15478 lon: -77.61556 facility: Cyn3rgy Research status: RECRUITING city: Gresham state: Oregon zip: 97030 country: United States name: Allie Calaman role: CONTACT lat: 45.49818 lon: -122.43148 facility: Carolina ENT status: RECRUITING city: Orangeburg state: South Carolina zip: 29118 country: United States name: Simone Ansley role: CONTACT lat: 33.49182 lon: -80.85565 hasResults: False
<\|newrecord\|> nctId: NCT06285799 id: IHAT_ID_2024 briefTitle: Safety and Effectiveness of Iron Hydroxide Adipate Tartrate (IHAT) in Iron Deficient Premenopausal Women overallStatus: RECRUITING date: 2024-03-05 date: 2025-12-01 date: 2025-12-31 date: 2024-02-29 date: 2024-04-19 name: Nemysis Ltd class: INDUSTRY name: RDC Clinical Pty Ltd briefSummary: This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Iron Hydroxide Adipate Tartrate (IHAT) at 2 different dose levels compared to placebo for increasing serum ferritin levels in iron deficient, but otherwise healthy premenopausal women over 12 weeks. conditions: Iron-deficiency studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 180 type: ESTIMATED name: Low Dose IHAT name: High Dose IHAT name: Carob Flour measure: Percentage of women recovering from iron deficiency at week 12 measure: Time to reach normalisation of ferritin levels measure: Change in iron status measure: Change in fatigue measure: Incidence and prevalence of gastrointestinal side effects measure: Iron deficiency symptoms sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RDC Clinical Pty Ltd status: RECRUITING city: Brisbane state: Queensland zip: 4006 country: Australia name: Amanda Rao, PhD role: CONTACT phone: +61 414 488 559 email: amanda@rdcglobal.com.au name: David Briskey, PhD role: CONTACT phone: +61 421 784 077 email: david@rdcglobal.com.au name: Amanda Rao, PhD role: PRINCIPAL_INVESTIGATOR lat: -27.46794 lon: 153.02809 hasResults: False
<\|newrecord\|> nctId: NCT06285786 id: REB 2023-109 briefTitle: Patient Handling Techniques and New Technology for Health Care Workers overallStatus: RECRUITING date: 2023-09-20 date: 2024-03-15 date: 2024-04-20 date: 2024-02-29 date: 2024-02-29 name: University of New Brunswick class: OTHER briefSummary: Patient handling is a major risk-factor for the development of musculoskeletal injuries in healthcare providers. To have a significant impact on injury reduction related to patient handling will require the incorporation of technology. This project is to investigate a piece of technology that has been designed to facilitate in-bed patient handling: The Vendlet.
The purpose of this research project is to assess the ability of the Vendlet system outfitted on a Span-America Medical Systems (SAMS) bed to reduce the physical load on healthcare providers performing patient handling tasks. This evidence-based outcomes will be used to support the mitigation of the Vendlet from the European market into the Canadian market. The SAMS bed is currently available in North America and has several adjustable features to support patient transfer activities.
The project will provide a biomechanical comparison of commonly used patient handling techniques performed using a SAMS bed outfitted with and without a Vendlet patient transfer device. This Vendlet technology has the potential to significantly reduce the musculoskeletal and joint strain of healthcare providers while handling patients. conditions: Work-related Injury studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: One single group of participants will be performing the same patient handling tasks:
1. During session 1 (Pre-Intervention) participants will not receive any instruction on how to perform the patient handling techniques on both beds.
2. During session 2 (Post-Intervention) participants will be asked to perform the patient handling techniques as seen during the intervention on both beds. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Participants will be masked of the proper technique/training during the pre-intervention session (with and without the use of technology). Specifically, on how to manually move the patient in both beds. count: 30 type: ESTIMATED name: Ergonomic Training on Patient Handling Techniques measure: Neuromuscular Activity - Average muscle activation measure: Neuromuscular Activity - Peak muscle activation measure: Motion Capture: To assess postural changes in patient handling technique. measure: Motion Capture: To assess cumulative load forces measure: Motion Capture: To assess joint angles measure: Foot Pressure Distribution: Peak pressure will be the outcome measure of interest to assess postural balance and stability of the participant performing the patient handling technique. measure: Foot Pressure Distribution: Contact area will be the outcome measure of interest to assess postural balance and stability of the participant performing the patient handling technique. measure: Bed Pressure Distribution: Average pressure distribution will be outcome measures to assess the safe placement of the patient. measure: Bed Pressure Distribution: Peak pressure distribution will be outcome measures to assess the safe placement of the patient. measure: Self Reported Questionnaires measure: Exit Survey measure: Rating of Perceived Exertion (RPE) sex: ALL minimumAge: 17 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Universite de Moncton status: RECRUITING city: Moncton state: New Brunswick zip: E1A 3E9 country: Canada name: Dre. Michelle Cardoso, PhD, Doctorate role: CONTACT phone: 506-470-3979 email: michelle.cardoso@umoncton.ca lat: 46.09454 lon: -64.7965 hasResults: False
<\|newrecord\|> nctId: NCT06285773 id: Medipol Hospital 36 briefTitle: Recto-intercostal Fascial Plane Block and Pecto-intercostal Fascial Plane Block for Cardiac Surgery overallStatus: RECRUITING date: 2024-02-25 date: 2024-10-20 date: 2024-11-10 date: 2024-02-29 date: 2024-02-29 name: Medipol University class: OTHER briefSummary: In cardiac surgeries performed with median sternotomy, mediastinal and thoracic tube placement sites are outside the area of effect of parasternal blocks, and sometimes the sternotomy incision extends below the T6 dermatome. Recto intercostal fascial plane block (RIFPB) has been defined as a complementary block for analgesia of this region. This study aims to evaluate the effectiveness of the combination of ultrasound-guided recto-intercostal fascial plane block and pectointercostal fascial block for postoperative analgesia management after open heart surgery (coronary artery bypass) with median sternotomy. conditions: Cardiac Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for open heart surgery (coronary artery bypass) with median sternotomy will be included in the study. Patients will be randomly divided into two groups (Group PR = PIFPB + RIFPB group, Group C = Control group) including 30 patients each, before entering the operating room. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Outcomes Assessor and participant were blinded to the study whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: RIFPB block name: Postoperative analgesia management name: PIFPB block measure: Global recovery scoring system / Quality of Recovery 15 questionairre measure: Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable") measure: The use of rescue analgesia measure: The use of rescue analgesia sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Medipol University Hospital status: RECRUITING city: Istanbul state: Bagcilar zip: 34070 country: Turkey name: Bahadir Ciftci, MD role: CONTACT phone: +905325034428 email: bciftci@medipol.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06285760 id: 135/23 briefTitle: Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY) acronym: SANDI overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-02 date: 2025-02 date: 2024-02-29 date: 2024-03-04 name: Puerta de Hierro University Hospital class: OTHER name: Hospital Clinic of Barcelona name: Hospital Central de la Defensa Gómez Ulla name: Hospital Vall d'Hebron name: Hospital Universitario Ramon y Cajal name: University Hospital of Girona Dr.Josep Trueta name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa briefSummary: The goal of this observational study is to assess the natriuretic effect of intravenous acetazolamide in patients admitted with heart failure and persistent congestion despite treatment with intravenous furosemide and sodium-glucose cotransporter type 2 (iSGLT2) inhibitors.
The main question it aims to answer is whether there is a difference in natriuresis 48 hours after acetazolamide association to medical treatment recommended by the guidelines (furosemide and ISGLT2). conditions: Heart Failure conditions: Persistent Congestion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 64 type: ESTIMATED name: Standarized diuretic therapy measure: Change in natriuresis 48 hours after acetazolamide measure: Increase in diuresis 48 hours after acetazolamide administration measure: Weight difference 48 hours after acetazolamide administration measure: Difference in congestion score 48 hours after acetazolamide administration. measure: Difference in ultrasound measurements 48 hours after acetazolamide administration. measure: Changes in renal function 48 hours after acetazolamide administration. measure: Ionic (potassium (mmol/L) changes measure: chloride (mmol/L) changes 48 hours after acetazolamide administration measure: bicarbonate (mmol/L) changes 48 hours after acetazolamide administration measure: Changes in blood pressure 48 hours after administration of acetazolamide sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Julia González González city: Madrid zip: 28222 country: Spain name: Julia González González role: CONTACT phone: 0034617453693 email: juliagfk@gmail.com lat: 40.4165 lon: -3.70256 hasResults: False
<\|newrecord\|> nctId: NCT06285747 id: 23-004117 id: NCI-2024-01191 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-004117 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: A Correlational Study: Breast Cancer-related Chest Wall Lymphedema, Quality of Life, and Shoulder Function overallStatus: RECRUITING date: 2023-07-28 date: 2025-08-01 date: 2025-08-01 date: 2024-02-29 date: 2024-02-29 name: Mayo Clinic class: OTHER briefSummary: This study evaluates how swelling in the chest following breast cancer treatment may affect patients' quality of life and shoulder function. conditions: Breast Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 85 type: ESTIMATED name: Non-Interventional Study measure: Chest wall lymphedema measure: Quality of life - Limb Lymphoedema Quality of Life (LymQOL) measure: Disability of the shoulder - Disabilities of the Arm, Shoulder and Hand (DASH) sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Kayla A. Van Der Weerd, PT, DPT role: CONTACT phone: 507-266-8721 email: VanDerWeerd.Kayla@mayo.edu name: Kayla A. Van Der Weerd, PT, DPT role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
<\|newrecord\|> nctId: NCT06285734 id: KYLL-202312-049 briefTitle: Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals With Abdominal Distention overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-01-07 date: 2025-01-07 date: 2024-02-29 date: 2024-02-29 name: Shandong University class: OTHER name: Qilu Hospital of Shandong University (Qingdao) name: Jinan Central Hospital name: Zaozhuang Municipal Hospital name: Binzhou Medical University name: Weihai Municipal Hospital name: Central Hospital of Zibo name: Weifang People's Hospital name: Qilu hospital of Shandong University Dezhou hospital name: Qihe Xian Renmin Hospital briefSummary: Abdominal distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO) and abnormal orocecal transit time (OCTT). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO and abnormalities in OCTT. In this study, the prevalence of SIBO and OCTT irregularities in individuals presenting with abdominal distention was ascertained through the implementation of the breath test. Furthermore, the correlation between abdominal distention and SIBO/OCTT was analysed to enhance the elucidation of the underlying etiology of abdominal distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal distention. conditions: Abdominal Distention studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 402 type: ESTIMATED name: Breath test measure: Positive rate of SIBO in patients with abdominal distension measure: Positive rate of abnormal OCTT in patients with abdominal distension measure: Correlation between clinical features of patients with abdominal distension and SIBO measure: Correlation between clinical features of patients with abdominal distension and OCTT sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06285721 id: DELTES briefTitle: Delirium Treatment With Transcranial Electrical Stimulation acronym: DELTES overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2027-01-31 date: 2027-03-31 date: 2024-02-29 date: 2024-02-29 name: A.J.C. Slooter class: OTHER name: Radboud University Medical Center name: HagaZiekenhuis briefSummary: The goal of this clinical trial is to investigate the effectiveness of standardized and personalized transcranial alternating current stimulation (tACS) in patients with postoperative delirium. To investigate this, will perform a double-blind, randomized, sham-controlled, multicenter trial.
To test the safety and feasibility of tACS in delirious patients, the first 30 patients will be randomized to receive either active or sham tACS treatment in a 1:1 ratio through a pilot study. For the main phase of the study, patients will be randomized, resulting in an overall 1:1:1 allocation to standardized tACS, personalized tACS or sham treatment.
Electroencephalogram (EEG) will be measured directly before and directly after the first stimulation session to assess whether tACS can reduce relative delta power. tACS or sham treatment will be given once daily for a maximum of 14 days, or until resolution of delirium or discharge (whichever comes first). During the treatment phase, presence and severity of delirium will be assessed daily. After the treatment phase, an additional EEG will be measured. Cognitive status will be assessed three months postoperative. conditions: Delirium studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 159 type: ESTIMATED name: transcranial alternating current stimulation (tACS) name: Sham transcranial alternating current stimulation (tACS) measure: Relative delta power measure: Duration of delirium measure: Severity of delirium measure: Length of hospital stay measure: Cognitive status three months post delirium measure: Subjective sensations during treatment measure: Average peak frequency measure: Phase Lag Index measure: Corrected Amplitude Envelope Correlation (AECc) measure: Relative power sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radboudumc city: Nijmegen state: Gelderland zip: 6525 GA country: Netherlands name: Indira Tendolkar, MD, PhD role: CONTACT lat: 51.8425 lon: 5.85278 facility: HagaZiekenhuis city: Den Haag state: Zuid-Holland zip: 2545 AA country: Netherlands name: Thomas H Ottens, MD, PhD role: CONTACT lat: 52.07667 lon: 4.29861 hasResults: False
<\|newrecord\|> nctId: NCT06285708 id: 2023B0193 briefTitle: Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD overallStatus: RECRUITING date: 2024-02 date: 2025-07 date: 2026-01 date: 2024-02-29 date: 2024-02-29 name: Ohio State University class: OTHER briefSummary: The long-term goal of this study is to reduce suicidal thoughts and behaviors among treatment-seeking individuals who also have posttraumatic stress disorder (PTSD). Prolonged exposure (PE) and crisis response plan (CRP) have demonstrated empirical support for reducing suicide attempts as compared to treatment as usual. However, no studies to date have assessed their effectiveness when used in combination. In light of this knowledge gap, the primary objective of this study will be to test the effectiveness of PE augmented with CRP as compared to PE with care as usual (self-guided treatment plan), an active comparator, for the reduction of suicide ideations and attempts for individuals with comorbid PTSD. conditions: PTSD conditions: Suicidal Ideation conditions: Suicide, Attempted conditions: Trauma, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Prolonged exposure measure: Beck Scale for Suicidal Ideation (SSI) measure: Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R) measure: PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) measure: Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Self-Rated Level 1 Cross-Cutting Symptom Measure measure: Interpersonal Needs Questionnaire (INQ) - Abbreviated measure: Beck Hopelessness Scale (BHS) - Abbreviated measure: Brief Suicide Cognitions Scale (SCS) measure: Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) measure: Monetary Choice Questionnaire (MCQ) measure: Behavioral Inhibition Scale (BIS) measure: Behavioral Activation Scale (BAS) measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Measures sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Ohio State University status: RECRUITING city: Columbus state: Ohio zip: 43210 country: United States name: Jaryd Hiser role: CONTACT phone: 614-814-0163 email: jaryd.hiser@osumc.edu name: Justin Baker, Ph.D. role: SUB_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False
<\|newrecord\|> nctId: NCT06285695 id: ILS241-I001 briefTitle: Clareon Toric Study (T2-T9) overallStatus: RECRUITING date: 2024-04-04 date: 2028-04 date: 2028-04 date: 2024-02-29 date: 2024-04-24 name: Alcon Research class: INDUSTRY briefSummary: The purpose of this post-market study is to describe the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs). conditions: Aphakia conditions: Corneal Astigmatism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Clareon Toric IOL name: Cataract surgery measure: Mean monocular best corrected distance visual acuity (BCDVA) measure: Mean monocular absolute residual refractive cylinder measure: Mean absolute IOL rotation from previous visit measure: Mean absolute IOL rotation from end of surgery supine baseline to each subsequent visit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gimbel Eye Centre status: RECRUITING city: Calgary state: Alberta zip: T3B 0M3 country: Canada lat: 51.05011 lon: -114.08529 facility: Uptown Eye Specialists status: RECRUITING city: Concord state: Ontario zip: L4K 2Z5 country: Canada lat: 43.80011 lon: -79.48291 facility: Prism Eye Institute status: RECRUITING city: Oakville state: Ontario zip: L6H 0J8 country: Canada lat: 43.45011 lon: -79.68292 facility: Laurentians Eye Institute status: RECRUITING city: Boisbriand state: Quebec zip: J7H 0E8 country: Canada lat: 45.61678 lon: -73.83249 facility: Bellevue status: RECRUITING city: Montréal state: Quebec zip: H1V 1G5 country: Canada lat: 45.50884 lon: -73.58781 facility: McGill University status: RECRUITING city: Montréal state: Quebec zip: R7A 3N2 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False
<\|newrecord\|> nctId: NCT06285682 id: ETH2324-2826 briefTitle: Bioavailability of Hydroxytyrosol in Healthy Adult Humans overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-03 date: 2024-03-30 date: 2024-05-01 date: 2024-02-29 date: 2024-02-29 name: Anglia Ruskin University class: OTHER name: Fattoria La Vialla name: Instituto Kurz briefSummary: Brief summary: There is current scientific interest in hydroxytyrosol due to its anti-inflammatory and antioxidant properties, efficient protection of vascular tissue and ability to neutralise free radicals via hydrogen donation. Recognised as the potent polyphenol within a commercially available olive-fruit water (OliPhenolia®), data from this research will determine the dose of OliPhenolia® required for the optimum absorption and metabolism of hydroxytyrosol. The primary aim of this research is to identify the dose of hydroxytyrosol (0.5, 1.0 or 1.5 mg∙kg-1) within OliPhenolia® that demonstrates the greatest area under the plasma concentration curve for hydroxytyrosol over a four-hour period. A secondary aim is to assess maximum concentration (CMAX) and time to maximum concentration (TMAX) of total hydroxytyrosol and secondary metabolites (Tyrosol, HT-3-glucoronide, HT-3-sulphate, 3,4-Dihydroxyphenylacetic Acid, Homovanillic Acid and Oleuropein) following consumption of 3 randomised doses of OliPhenolia® on separate occasions with healthy adult volunteers. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants are randomly assigned a dose of olive-derived hydroxytyrosol in a double-blind manner. Following a ≥3 day wash out participants then cross-over to an alternate dose. This process is then repeated for the third and final dose. primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: Volume of nutritional supplement is provided in a double-blinded manner. Both participants and research testers will be masked from knowing the specifics of the volume allocation. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 8 type: ACTUAL name: OliPhenolia®) measure: Hydroxytyrosol bioavailability measure: Bioavailability of hydroxytyrosol metabolites. measure: Hydroxytyrosol CMax measure: Hydroxytyrosol TMAX measure: CMAX of hydroxytyrosol secondary metabolites measure: TMAX of hydroxytyrosol secondary metabolites sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cambridge Centre for Sport and Exercise Sciences, Anglia Ruskin University city: Cambridge zip: CB5 8DZ country: United Kingdom lat: 52.2 lon: 0.11667 hasResults: False
<\|newrecord\|> nctId: NCT06285669 id: KA18/35 briefTitle: Effects of Kinesiotaping on Respiratory Muscles in Very Preterm Infants overallStatus: COMPLETED date: 2018-01-01 date: 2020-06-30 date: 2020-06-30 date: 2024-02-29 date: 2024-02-29 name: Ondokuz Mayıs University class: OTHER briefSummary: This study aimed to evaluate the effects of kinesio taping on blood gas parameters, respiratory rate, heart rate, oxygen saturation, and pressure limits in preterm infants with RDS who are on NIV. It is hypothesized that the application of kinesio taping to the chest area of preterm infants may improve respiratory functions and oxygenation at the alveolar level, leading to decreased work of breathing, reduced respiratory rate, and improved neonatal stability by promoting respiratory mechanics and enhancing chest expansion. conditions: Preterm conditions: Premature conditions: Infant, Newborn, Diseases conditions: Respiratory Distress Syndrome conditions: Neonatal Respiratory Distress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Kinesio-Taping Application primaryPurpose: TREATMENT masking: NONE count: 26 type: ACTUAL name: kinesiotaping application measure: Level of pH sex: ALL minimumAge: 1 Month maximumAge: 4 Months stdAges: CHILD facility: Nilay Çömük Balci city: Samsun state: Atakum zip: 55139 country: Turkey lat: 41.27976 lon: 36.3361 hasResults: False
<\|newrecord\|> nctId: NCT06285656 id: ASH-KG briefTitle: Femoral Blood Gas and Prediction of Postoperative Bleeding overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-10-01 date: 2024-10-03 date: 2024-02-29 date: 2024-02-29 name: Ankara City Hospital Bilkent class: OTHER briefSummary: Postoperative bleeding is still an important concern after major abdominal surgery. Postoperative bleeding is the most important determinant of morbidity and death. It results in longer hospital stays, the necessity for extra radiological tests, interventional radiology treatments, and the possibility of reoperation. Early detection of postoperative bleeding reduces morbidity and mortality with appropriate intervention.Simultaneous arterial and venous blood gas measurements can be used to quickly identify the degree of bleeding and the need for replacement in serious trauma patients brought to the emergency room.Lactate levels, venous oxygen saturation, and the differential in partial pressure of carbon dioxide between arterial and venous blood can all be used to indicate the requirement for replacement, as demonstrated in several studies. The purpose of this study is to evaluate lactate levels, venous oxygen saturation, and arterial-venous partial pressure of carbon dioxide difference in blood gas analysis in order to assess the severity of bleeding in patients undergoing major abdominal surgery as early as possible and perform replacement as soon as possible. conditions: Postoperative Hemorrhage conditions: Blood Transfusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Eritrocyte replacement measure: Postoperative Hemmorhagea sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06285643 id: ASK-PD5-CS201 briefTitle: A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD) acronym: REGENERATE-PD overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-11-30 date: 2027-11-30 date: 2024-02-29 date: 2024-02-29 name: Asklepios Biopharmaceutical, Inc. class: INDUSTRY name: Bayer briefSummary: The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 87 type: ESTIMATED name: AAV2-GDNF Gene therapy name: Control Surgery measure: Motor symptoms-MDS-UPDRS parts 2 and 3 measure: PD Motor Diary Non-Motor symptoms-MDS-UPDRS part1 measure: PDQ39 Levodopa Equivalent Daily Dose measure: Change from baseline in the MDS-UPDRS parts 2 and 3, and the PD Motor Diary measure: Change from baseline in the MDS-UPDRS part 1 and PDQ-39 measure: Change in Levodopa equivalent daily dose sex: ALL minimumAge: 45 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06285630 id: Alba101 id: 2023-05299-01 type: OTHER domain: Ethix briefTitle: The Development and Health of the Intestinal Flora During the First Year of Life acronym: PREVENT overallStatus: ENROLLING_BY_INVITATION date: 2024-02-26 date: 2024-10-30 date: 2024-12-20 date: 2024-02-29 date: 2024-02-29 name: Alba Health AB class: INDUSTRY name: Universiteit Antwerpen name: Uppsala University name: Copenhagen Studies on Asthma in Childhood briefSummary: In this research study (PREVENT 1), Alba Health, in collaboration with academic institutions (Uppsala University, COPSAC and University of Antwerp) is investigating the association between the developing gut microbiota (collection of microbes present in the human gut) in the first year of life and lifestyle, wellbeing and health in a Swedish population. The study is the first of its kind in a Swedish population to collect and associate microbiome composition to an extensive family history and health questionnaire, stool colour and crying type, building on learnings from previous studies performed in other countries, such as the HELMI and COPSAC studies (HELMI - Finnish Health and Early Life Microbiota cohort from the University of Helsinki in Finland; COPSAC - Copenhagen Prospective Studies on Asthma in Childhood in Denmark).
The PREVENT 1 study is an observational research study led by Alba Health involving 300 families in Sweden with children between 0 and 12 months of age at the time of the study's start. After providing informed consent, the participating families will be asked to provide three stool samples from their child (the sample collection is not invasive and does not cause discomfort) and will be asked to answer questionnaires on lifestyle, well-being and family health. The participating families will not be asked to change their lifestyle beyond sample and data collection.
From the collected stool samples, we will extract microbial DNA and subject this to deep metagenomic sequence analysis. The study will only analyze microbial DNA, any human related material will be discarded. The stool samples will be destroyed within one month of sequencing (maximum 3 months from collection). The data will be stored according to GDPR and Swedish law, with informed consent in Sweden and with appropriate security measures. All research will be carried out in Sweden. conditions: Healthy conditions: Microbial Colonization studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Observational, no intervation will be made measure: Microbiome composition of infants in variable age ranges measure: Is the composition associated with and gastrointestinal issues sex: ALL minimumAge: 3 Months maximumAge: 12 Months stdAges: CHILD facility: Alba Health AB city: Stockholm country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False
<\|newrecord\|> nctId: NCT06285617 id: 2022GDRC016 briefTitle: Short-Term Versus 6-Week Prednisone in The Treatment of Subacute Thyroiditis acronym: SAT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-31 date: 2025-04-30 date: 2024-02-29 date: 2024-02-29 name: Xinqiao Hospital of Chongqing class: OTHER briefSummary: The goal of this clinical trial is to compare the efficacy and safety of short-term versus 6-week prednisone in the treatment of moderate-to-severe subacute thyroiditis. The main questions it aims to answer are: Does the short-term medication regimen reduce glucocorticoid side effects while achieving similar efficacy as the guideline treatment group? Patients with moderate-to-severe symptoms were randomly assigned to receive either 30 mg/day prednisone for 1 week, followed by 1 week of nonsteroidal anti-inflammatory drugs, or the conventional 6-week prednisone therapy in the control group. conditions: Subacute Thyroiditis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prednisone primaryPurpose: TREATMENT masking: NONE count: 600 type: ESTIMATED name: 1-week predisone+1-week celecoxib name: 6-weeks predisone measure: The difference in efficacy between the two groups at the completion. measure: Thyroid function measure: Total cholesterol (TC) measure: Triglycerides (TG) measure: Systolic blood pressure (SBP) measure: Diastolic blood pressure (DBP) measure: Parathyroid hormone (PTH) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06285604 id: IRB-20230398-R briefTitle: Effect Evaluation of Different Blood Products Infusion on Neonatal Anemia overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-09-30 date: 2025-12-31 date: 2024-02-29 date: 2024-02-29 name: Women's Hospital School Of Medicine Zhejiang University class: OTHER briefSummary: The goal of this observational study is to evaluate the clinical efficacy of the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells, and to study the changes of inflammatory response before and after the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells in anemic neonates. The main questions it aims to answer are:
* Objective evaluation of the advantages and disadvantages of transfusion of different blood products in the treatment of neonatal anemia from the clinical efficacy.
* To provide objective basis for clinical rational use of blood in the selection of blood products.
Participants will be transfused with fresh irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells respectively according to relevant clinical and laboratory indicators. conditions: Neonatal Anemia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Blood transfusion measure: Clinical efficacy of different red blood cell products transfusion in anemic neonates measure: The changes of inflammatory response before and after transfusion in anemic neonates sex: ALL minimumAge: 1 Day maximumAge: 1 Year stdAges: CHILD facility: Women's Hospital School of Medicine Zhejiang University city: Hangzhou state: Zhejiang zip: 310006 country: China lat: 30.29365 lon: 120.16142 hasResults: False
<\|newrecord\|> nctId: NCT06285591 id: 2023-1801 briefTitle: Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors overallStatus: RECRUITING date: 2023-11-10 date: 2025-03-31 date: 2025-03-31 date: 2024-02-29 date: 2024-02-29 name: West China Hospital class: OTHER briefSummary: Radiation therapy is a common treatment modality in the management of head and neck malignancies. However, head and neck tumors often have some adverse reactions when receiving radiation therapy, such as dry mouth, change of taste, oral mucositis, etc. Among them, the incidence of oral mucositis is more than 90%, and the incidence of oral mucositis of degree 3 or more than degree 3 is more than 50%. Severe oral mucositis seriously affects the quality of survival of patients. Lactobacillus Reuteri is a natural flora of the human body that can be found in the gastrointestinal tract, skin, etc. Among them, Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can be isolated from healthy mammals as well as poultry, and are common Lactobacillus strains marketed for the production of oral probiotics, which are commonly used in infant formulas, among others. In oral inflammatory diseases, it has been reported in the literature that Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can reduce gingival and periodontal inflammation, mainly through the mechanisms of modulating the host inflammatory response and displacing pathogenic bacteria. In terms of safety, oral Lactobacillus Reuteri has good stability, very low pathogenic potential, and is not toxic to humans. Therefore, this study is a placebo-controlled, multi-center, open, randomized controlled clinical study to evaluate the efficacy of Lactobacillus Reuteri for the prevention of radioactive oral mucosal reactions in intensity-modulated radiotherapy for head and neck tumors, including nasopharyngeal carcinoma. conditions: Oral Mucositis (Ulcerative) Due to Radiation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 130 type: ESTIMATED name: Lactobacillus Reuteri Tablets name: Placebo-containing tablets name: Radiotherapy measure: The incidence of Severe Oral mucositis (WHO grade ≥3) measure: The time to onset of Severe Oral mucositis (WHO grade ≥3) measure: The duration of Severe Oral mucositis (WHO grade ≥3) measure: Taste function measure: Xerostomia summated xerostomia inventory (SXI) measure: Functional assessment of cancer therapy-head and neck (FACT- H&N) quality of life questionnaire measure: Adverse events measure: Oral activities scores measure: Mouth and throat soreness (MTS) scores sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital, Sichuan University status: RECRUITING city: Chengdu state: Sichuan zip: 610041 country: China name: Xingchen Peng, PhD role: CONTACT phone: +86 18980606753 email: pxx2014@163.com lat: 30.66667 lon: 104.06667 hasResults: False
<\|newrecord\|> nctId: NCT06285578 id: MOST 107-2410-H-277-003 briefTitle: Effects of Probiotic and HIIT in Obese Women overallStatus: COMPLETED date: 2018-10-01 date: 2019-01-31 date: 2019-03-01 date: 2024-02-29 date: 2024-02-29 name: University of Taipei class: OTHER briefSummary: The aim of this study is to investigate whether there are the additive effects when implementing both high-intensity interval training (HIIT) and probiotics simultaneously on improving cardiorespiratory endurance and metabolism in middle-aged women. conditions: Cardiorespiratory Fitness conditions: Metabolism conditions: Anthropometry studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 47 type: ACTUAL name: Probiotics supplementation name: HIIT training name: Placebo supplementation measure: Height measure: Body weight measure: Body mass index (BMI) measure: Body fat percentage measure: Waist circumference measure: Hip circumference measure: Maximum oxygen uptake (VO2max) measure: Time to exhaustion (TTE) measure: Running economy (RE) measure: Fasting blood glucose (FBG) measure: Total cholesterol (TC) measure: Triglyceride (TG) measure: High-density lipoprotein cholesterol (HDL-C) measure: Low-density lipoprotein cholesterol (LDL-C) measure: Muscle mass measure: Fat mass measure: Bone mineral density (BMD) measure: Caloric intake sex: FEMALE minimumAge: 35 Years maximumAge: 55 Years stdAges: ADULT facility: University of Taipei city: Taipei country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
<\|newrecord\|> nctId: NCT06285565 id: CE390/2023 briefTitle: A Nurse-led Coaching Programme With Telemonitoring in Heart Failure acronym: INTERCOACH overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-05-01 date: 2025-05-01 date: 2024-02-29 date: 2024-02-29 name: Alberto Dal Molin class: OTHER name: Azienda Ospedaliero Universitaria Maggiore della Carita briefSummary: The goal of this pilot interventional study is to assess the feasibility and acceptability of a supportive intervention for patients affected by heart failure. The main questions it aims to answer are:
* Are implementation strategies effective in facilitating participant fidelity?
* What factors contribute to patients' satisfaction with the designed intervention, and how can these be optimized for improved patient experience and adherence?
* Are the methods and tools established the most appropriate to ensure the completeness of the data collection?
Participants will follow a combined intervention consisting of:
1. pre-discharge educational meeting;
2. telephone nurse-led coaching sessions;
3. home telemonitoring of vital signs.
In the main trial, researchers will compare data from the intervention group with a control group to assess whether it reduces hospitalization rates and improves self-care capabilities conditions: Heart Failure conditions: Telemonitoring conditions: Hospitalizations conditions: Feasibility conditions: Mentoring studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A parallel, open-label randomized controlled feasibility study primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The assessors will collect clinical outcomes by telephone and will be blinded to the group assignment whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Nurse-led telephone coaching intervention with home telemonitoring of vital signs measure: Recruitment rate measure: Retention rate measure: Adherence to the coaching intervention measure: Adherence to telemonitoring program measure: Completeness of data collection measure: 90- and 180-day all-cause hospital readmissions measure: 90- and 180-day heart failure-related hospital readmissions measure: 90- and 180-day Emergency Departments visits measure: 90- and 180-day General Practioner visits measure: 90- and 180-day oupatient visits measure: Self-care capacity (Self-Care of Heart Failure Index ) measure: Self Care - Self-Efficacy Scale measure: Quality of life (SF-12 scale) measure: Anxiety (Hamilton Anxiety Scale ) measure: Depression (Geriatric Depression Scale) measure: Heart Failure Somatic Perception Scale v.3 (HFSPS) measure: Mortality sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Università del Piemonte Orientale Amedeo Avogadro city: Novara zip: 28100 country: Italy name: Alberto Dal Molin, Prof role: CONTACT phone: +390321660607 email: alberto.dalmolin@med.uniupo.it name: INES BASSO role: CONTACT phone: +393927599727 email: ines.basso@uniupo.it lat: 45.44694 lon: 8.62118 hasResults: False
<\|newrecord\|> nctId: NCT06285552 id: 4792/0842 briefTitle: Evaluation of the Comprehensive Family Support Program (PAIF) overallStatus: RECRUITING date: 2024-02-20 date: 2026-07 date: 2026-07 date: 2024-02-29 date: 2024-04-12 name: University of Seville class: OTHER name: Gobierno de Cantabria name: Loyola University name: University of Jaen briefSummary: The goal of this study is to evaluate the effectiveness of positive parenting programs targeted to parents of toddlers, children and adolescents carried out in Cantabria (Spain).
We will collect information from the participants before the intervention, in the last session of the program and some months after, to verify if there have been some changes in the family dynamics of these parents, and if these changes continue after some time. Besides, we will compare these results with information from other families that are not taking part in the program. The main caregivers of the participating families and the practitioners in charge of the intervention will provide the information for the study.
We expect that families participating in the programs will improve their parenting competencies and their family dynamics, and that these change will stay after the program. conditions: Parenting studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participants will be assigned to the manualized program according to the inclusion criteria. The comparison group will be composed of families in areas where the intervention is not available but with similar sociodemographic characteristics. primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Positive parenting PAIF program measure: Perception of the parental role measure: Parenting practices (Authoritative parenting style: Warmth and Support, Reasoning/Induction, Democratic Participation) measure: Parenting practices (Overreactivity and Laxness) measure: Satisfaction with the intervention measure: Children adjustment measure: Social support measure: Satisfaction with Family Life sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Consejería de Inclusión Social, Juventud, Familias E Igualdad status: RECRUITING city: Santander state: Cantabria zip: 39004 country: Spain name: JOSÉ ANGEL RODRÍGUEZ role: CONTACT phone: 942 207 756 email: rodriguez_ja@cantabria.es lat: 43.46472 lon: -3.80444 hasResults: False
<\|newrecord\|> nctId: NCT06285539 id: 2022-502968-20 briefTitle: Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases acronym: DRIMID overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-12 date: 2026-12 date: 2024-02-29 date: 2024-02-29 name: UMC Utrecht class: OTHER name: Alfasigma S.p.A. name: ReumaNederland name: Autoimmune Research and Collaboration Hub briefSummary: Research into novel therapies for rare, immune-mediated inflammatory diseases (IMIDs) is limited due to small patient populations. Patients with Behçet's disease (BD), idiopathic inflammatory myopathy (IIM, also known as myositis) and IgG4-related disease (IgG4-RD) are treated with high-dosed glucocorticoids, methotrexate, azathioprine and mycophenolate mofetil, mostly for long periods of time with attendant risks of long-term toxicity, including infections. Therefore, there is an urgent need for new, more specific anti-inflammatory therapies such as targeted synthetic and biological disease-modifying antirheumatic drugs. Due to the role of type 1 interferon in both BD, IIM and IgG4-RD, JAK-STAT inhibition may be a promising treatment strategy in these conditions, because JAK1 is critical for the signal transduction of pro-inflammatory cytokine receptors. Previous research showed that JAK1 inhibition reduces activation of type 1 interferon-regulated proteins and key chemokines that control tissue inflammation. conditions: Behcet's Disease conditions: Idiopathic Inflammatory Myopathies conditions: IgG4-related Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A 26-week multicenter, open-label, uncontrolled, non-randomized, non-blinded proof-of-concept, two-stage phase 2 study primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Filgotinib measure: EQ-5D-5L measure: Disease activity in Behcet's patients measure: Disease activity in myositis patients measure: Disease activity in IgG4-RD patients measure: Corticosteroid toxicity measure: Corticosteroid dosage measure: VAS score of pain measure: Fatigue measure: Treatment-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC city: Amsterdam country: Netherlands name: Joost Raaphorst, Dr. role: CONTACT email: j.raaphorst@amsterdamumc.nl name: Joost Raaphorst, Dr. role: PRINCIPAL_INVESTIGATOR name: Sander W Tas, Prof. dr. role: SUB_INVESTIGATOR lat: 52.37403 lon: 4.88969 facility: Hagaziekenhuis city: Den Haag country: Netherlands name: Robbert J Goekoop, MD role: CONTACT email: r.goekoop@hagaziekenhuis.nl name: Robbert J Goekoop, MD role: PRINCIPAL_INVESTIGATOR lat: 52.07667 lon: 4.29861 facility: Zuyderland Medical Center city: Heerlen country: Netherlands name: Cesar Magro Checa, Dr role: CONTACT email: c.magrocheca@zuyderland.nl name: Cesar Magro Checa, Dr role: PRINCIPAL_INVESTIGATOR lat: 50.88365 lon: 5.98154 facility: Radboud university medical center city: Nijmegen country: Netherlands name: Rogier Thurlings, Dr role: CONTACT email: rogier.thurlings@radboudumc.nl name: Rogier Thurlings, Dr role: PRINCIPAL_INVESTIGATOR lat: 51.8425 lon: 5.85278 facility: Erasmus MC city: Rotterdam country: Netherlands name: Jan van Laar, Dr. role: CONTACT email: j.vanlaar@erasmusmc.nl name: Jan van Laar, Dr. role: PRINCIPAL_INVESTIGATOR lat: 51.9225 lon: 4.47917 facility: University Medical Center city: Utrecht country: Netherlands name: Anne Karien Marijnissen, Dr. role: CONTACT email: a.c.a.marijnissen@umcutrecht.nl name: Jaap M. van Laar, Prof. Dr. role: PRINCIPAL_INVESTIGATOR name: Bettina C. Geertsema-Hoeve, MD role: SUB_INVESTIGATOR lat: 52.09083 lon: 5.12222 hasResults: False
<\|newrecord\|> nctId: NCT06285526 id: 2023/0046/OB id: 2023-A00350-45 type: REGISTRY domain: French Minister briefTitle: Glycocalyx Monitoring in Major Abdominal Surgery acronym: GLYCOCHIP overallStatus: RECRUITING date: 2022-07-05 date: 2024-07-05 date: 2025-01-05 date: 2024-02-29 date: 2024-02-29 name: University Hospital, Rouen class: OTHER briefSummary: The study of the microcirculation and glycocalyx could be an essential element in the monitoring of our patients undergoing major abdominal surgery. It would enable us to better target the objectives of anaesthesia and resuscitation, which until now have been based essentially on macro-circulatory parameters. conditions: Major Abdominal Surgery studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy name: Cephalic DuodenoPancreatectomy measure: Glycocalyx thickness measure: Glycocalyx thickness and a biological marker of tissue hypoperfusion measure: Glycocalyx thickness and a biological marker of tissue hypoxia measure: Blood cell velocity and macrocirculatory function measure: Perfused capillary density and macrocirculatory function measure: Variation of glycocalyx thickness and the daily entry-exit balance (BES) Day 1 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rouen University Hospital status: RECRUITING city: Rouen zip: 76000 country: France name: DEMAILLY Zoé, MD role: CONTACT phone: 02 32 88 24 40 phoneExt: +33 email: Zoe.Demailly@chu-rouen.fr name: Thomas CLAVIER, MD role: CONTACT phone: 02 32 88 82 92 phoneExt: +33 email: Thomas.Clavier@chu-rouen.fr lat: 49.44313 lon: 1.09932 hasResults: False
<\|newrecord\|> nctId: NCT06285513 id: 2021/387/OB id: 2023-A00503-42 type: REGISTRY domain: Frecnh Ministry briefTitle: Cardiovascular Metabolic Remodeling in Shock acronym: METASHOCK overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-02 date: 2026-02 date: 2024-02-29 date: 2024-02-29 name: University Hospital, Rouen class: OTHER briefSummary: The aim of the study is to increase our knowledge of energy dysfunction in the cardiovascular dysfunction observed during shock states by analysing the omics molecules involved. conditions: Shock studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Cardiac ultrasound measure: Evaluation of the prognostic capacity of the initial metabolomic profile of patients in shock sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital of Rouen city: Rouen country: France name: Grégoire JOLLY, MD role: CONTACT lat: 49.44313 lon: 1.09932 hasResults: False
<\|newrecord\|> nctId: NCT06285500 id: UNIQUE id: 23-5095 type: OTHER domain: University Health Network briefTitle: Umbrella Study for Single Patient Treatments in Oncology acronym: UNIQUE overallStatus: RECRUITING date: 2024-02-01 date: 2027-02-01 date: 2029-02-01 date: 2024-02-29 date: 2024-02-29 name: University Health Network, Toronto class: OTHER briefSummary: The purpose of this study is to collect data on how advanced and rare cancers respond to biomarker-based treatments. conditions: Advanced Cancer conditions: Rare Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 400 type: ESTIMATED name: Patient-specific treatments measure: Overall response rate for the overall cohorts and the number of patients accessing precision targeted therapy measure: Overall survival rate measure: Progression-free survival rate measure: Number of participants with adverse events as assessed by CTCAE v5.0 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network, Princess Margaret Cancer Centre status: RECRUITING city: Toronto state: Ontario zip: M5G 2M9 country: Canada name: Amit Oza, Dr. role: CONTACT phone: 416 946 4450 email: amit.oza@uhn.ca lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06285487 id: 23-1600 briefTitle: Depression in Youth Onset Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-06 date: 2026-06 date: 2024-02-29 date: 2024-02-29 name: University of Colorado, Denver class: OTHER briefSummary: The main purpose of this study is to compare a group-based interpersonal psychotherapy (IPT) program and a Type 2 Diabetes education program to determine if there are differences in depression levels, diabetes distress, and glycemic control in adolescents with Type 2 Diabetes. conditions: Type 2 Diabetes conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Group Program measure: Acceptability of IPT-T2D measure: Depression Changes measure: Changes in Glycemic Control sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: Children's Hospital Colorado city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 hasResults: False
<\|newrecord\|> nctId: NCT06285474 id: 22-001323 briefTitle: Investigating LIFUP in Anhedonic Depression acronym: ILIAD overallStatus: ENROLLING_BY_INVITATION date: 2022-10-27 date: 2024-04-30 date: 2024-04-30 date: 2024-02-29 date: 2024-02-29 name: University of California, Los Angeles class: OTHER name: Wellcome Trust briefSummary: This study will observe changes in brain imaging, behavior, and symptom measures following intervention with low intensity focused ultrasound pulsation (LIFUP) targeting reward circuitry in individuals who are depressed and anhedonic. conditions: Depression conditions: Anhedonia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: Low Intensity Focused Ultrasound Pulsation (LIFUP) measure: Change in Patient health questionnaire-14 self report measure (PHQ-14) from baseline measure: Change in Positive valence systems scale-21 self report measure (PVSS-21) from baseline measure: Changes in MRI images from Pre-scan to week 5 measure: Change in Ecological momentary assessment (EMA) from W0/Baseline measure: Changes in digital behavioral phenotype sleep measurement measure: Changes in digital behavioral phenotype physical activity measurement measure: Changes in heart rate measure: Changes in heart rate variability measure: Changes in respiratory rate measure: changes in World Health Organization (WHO) -5 Wellbeing index score from W0/Baseline to end of study measure: changes in Pittsburgh Sleep Quality Index (PSQI) score from W0/Baseline to end of study measure: changes in Quick Inventory of Depressive Symptoms (QIDS-SR15) score from W0/Baseline to end of study measure: changes in Patient Health Questionnaire (PHQ-9) score from day 2 to week 2 measure: changes in Brief Irritability Test (BITe) score from W0/Baseline to end of study measure: changes in Generalized Anxiety Disorder (GAD-7) score from W0/Baseline to end of study measure: Changes in Snaith Hamilton Pleasure Scale (SHAPS) score from W0/Baseline to end of study measure: Changes in Suicidal Ideation measure from Pre-scan to end of study measure: changes in Apathy Motivation Index (AMI) score from W0/Baseline to end of study measure: changes in Eudaimonic Well-Being Questionnaire (EWBQ) score from W0/Baseline to end of study measure: Changes in Work and Social Adjustment Scale (WSAS) score from W0/Baseline to end of study measure: Changes in Ruminative Response Scale (RRS) - brooding subscale score from W0/Baseline to end of study measure: changes in Trauma History Questionnaire (THQ) score from W0/Baseline to end of study measure: changes in Routines Survey from W0/Baseline to end of study measure: changes in USDA Housing and Food Insecurity score from W0/Baseline to end of study measure: changes in Holmes-Rahe Life Stress Survey score from W0/Baseline to end of study measure: Changes in emotion recognition accuracy scores from Pre-scan to end of study measure: Changes in emotion recognition response times from Pre-scan to end of study measure: Changes in continuous concentration accuracy scores from Pre-scan to end of study measure: Changes in continuous concentration response times from Pre-scan to end of study measure: Changes in continuous concentration error scores from Pre-scan to end of study measure: Changes in Apple Gathering task behavior from Pre-scan to end of study sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California Los Angeles city: Los Angeles state: California zip: 90095-1563 country: United States lat: 34.05223 lon: -118.24368 hasResults: False
<\|newrecord\|> nctId: NCT06285461 id: T2566/2023 briefTitle: Food Intake, Endocrine Factors and Brown Fat acronym: FoodBAT overallStatus: RECRUITING date: 2024-02-20 date: 2025-06-30 date: 2026-06-30 date: 2024-02-29 date: 2024-04-10 name: Turku University Hospital class: OTHER_GOV name: University of Turku briefSummary: This study will investigate how the acute intake of foods with high and low hedonic reward differentially affects brown adipose tissue and the interplay between gut peptides, brown fat, and the brain (gut-BAT-brain axis). conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This will be a crossover study in which participants undergo two postprandial test days with meals with high- or low-hedonic reward and two weeks of washout between interventions. primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: Non-palatable meal name: Palatable meal measure: Brown adipose tissue metabolism measure: Changes in gut peptides measure: Differences in μ-opioid receptors in the human brain measure: Energy expenditure/Meal-induced thermogenesis measure: Visual Analogue scale (VAS) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Turku PET Centre status: RECRUITING city: Turku zip: 20520 country: Finland name: Kirsi A Virtanen role: CONTACT phone: +358407626564 email: kianvi@utu.fi lat: 60.45148 lon: 22.26869 hasResults: False
<\|newrecord\|> nctId: NCT06285448 id: A24-028 briefTitle: Feasibility of Lecanemab Registry and Clinical Outcome Measures overallStatus: ENROLLING_BY_INVITATION date: 2024-01-02 date: 2025-12-31 date: 2026-06-30 date: 2024-02-29 date: 2024-03-01 name: HealthPartners Institute class: OTHER briefSummary: Available FDA approved treatments for Alzheimer's disease (AD) temporary alleviate symptoms but have no bearing on overall disease progression. However, recent FDA approval of lecanemab (July 2023), a disease modifying therapy based on a phase 3 clinical trial demonstrated efficacy (cognitive) in persons with AD. Delaying the disease progression may impact not only the person living with dementia (PLWD), but also their Care Partners. It may provide the ability to achieve "life goals" as a family or may increase/reduce stress and burden on the family due to the complexity of the treatment regimen. Recent secondary analysis of this Phase 3 trial suggests quality of life showed less decline in PLWD and less increase in burden in Care Partners. The investigators propose to create a registry/database for persons living with dementia who receive lecanemab infusions at HealthPartners and their Care Partners. The investigators plan to test the feasibility of collecting outcomes data for specific patient and family focused outcomes, and outcomes that are typically not included in clinic. The outcome of this study will help in the overall goal of studying the impact of lecanemab in real-world settings in a larger cohort of PLWD and Care Partners. conditions: Alzheimer Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Lecanemab measure: Feasibility of enrollment measure: Feasibility of completing visits measure: Qualitative experience at 3 months measure: Qualitative experience at 12 months sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: HealthPartners Neuroscience Center city: Saint Paul state: Minnesota zip: 55130 country: United States lat: 44.94441 lon: -93.09327 hasResults: False
<\|newrecord\|> nctId: NCT06285435 id: coagulation activation in PV briefTitle: Coagulation Activation in Patients With Pemphigus overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-10 date: 2026-02 date: 2024-02-29 date: 2024-02-29 name: Assiut University class: OTHER briefSummary: Aim of work:
1. To evaluate the plasma markers of coagulation activation: prothrombin F1+2 and d-dimer levels in pemphigus patients with active disease and compare them with age and sex-matched controls.
2. To evaluate the correlation of these markers with disease severity score by using Pemphigus Disease Area Index (PDAI) and with disease activity by measurement of anti-desmoglein 1 and 3 antibody titers. conditions: Pemphigus studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 54 type: ESTIMATED name: prothrombin fragment 1+2 measure: Comparison of coagulation activation markers in pemphigus patients with controls measure: Correlation of markers with disease severity sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06285422 id: SC262-101 briefTitle: Study Evaluating SC262 in Subjects With r/r B-cell Malignancies (VIVID) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-03 date: 2029-03 date: 2024-02-29 date: 2024-04-04 name: Sana Biotechnology class: INDUSTRY briefSummary: SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers. conditions: Non Hodgkin's Lymphoma conditions: Large B-cell Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: SC262 measure: Evaluate safety and tolerability of SC262 measure: Evaluate preliminary anti-tumor activity of SC262 measure: Evaluate cellular kinetics and persistence of SC262 measure: Evaluate cellular kinetics and persistence of SC262 measure: Evaluate cellular kinetics and persistence of SC262 measure: Evaluate host immunogenicity to SC262 sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06285409 id: 24-02 briefTitle: Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium overallStatus: RECRUITING date: 2024-04-04 date: 2024-10 date: 2024-10 date: 2024-02-29 date: 2024-04-12 name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital class: OTHER briefSummary: This study will investigate the effects of drugs called "uterotonics" that help with the contraction of the uterus after a baby is born. This uterine contraction is very important to stop the bleeding after delivery. An uncontracted uterine state is called "uterine atony", which can lead to an excessive amount of post-delivery bleeding. Carbetocin is an uterotonic drug that works well to prevent post-delivery bleeding. In some cases, carbetocin is not enough to contract the uterus, and ongoing bleeding continues. When that happens, there are other uterotonic medications that can be used. In this study, we aim to find which uterotonic drug, amongst those available (oxytocin, carbetocin, ergometrine or carboprost), is more effective to lower the risk of post-delivery bleeding once carbetocin has already been administered.
This study will be done by using a very small sample of uterine tissue, taken from the incision site, following delivery by cesarean section. The sample is taken to the laboratory and will be exposed to carbetocin followed by other uterotonic drugs. The information obtained from this study will help modify the treatment for uterine atony and post-delivery bleeding to lower the risk further. conditions: Postpartum Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Carbetocin name: Oxytocin name: Carbetocin name: Oxytocin name: Ergonovine name: Carboprost measure: Motility index measure: Amplitude of contraction measure: Frequency of contraction measure: Integrated area under response curve (AUC) sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Mount Sinai Hospital status: RECRUITING city: Toronto state: Ontario zip: M5G1X5 country: Canada name: Mrinalini Balki, MD role: CONTACT phone: 416-586-4800 phoneExt: 5270 email: mrinalini.balki@uhn.ca name: Wafa Bellan, MD role: SUB_INVESTIGATOR name: Ronald George, MD role: SUB_INVESTIGATOR name: Joseph Park, BSc role: SUB_INVESTIGATOR name: Anuradha Baishnob, BSc role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06285396 id: 24-01 briefTitle: Effect of Ephedrine, Phenylepinephrine, and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section: An In-vitro Study overallStatus: RECRUITING date: 2024-03-18 date: 2024-07 date: 2024-07 date: 2024-02-29 date: 2024-04-12 name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital class: OTHER briefSummary: The goal of this study is to learn about how medication that is used to help treat low blood pressure during a Cesarean delivery (CD) can cause changes to the uterine muscle tissue and its ability to contract, in patients with Type II and gestational diabetes.
Spinal anesthesia administered during elective CD has been known to cause hypotension (low blood pressure) as a side effect during the procedure, and is prevented by administration of vasopressors (medication to raise blood pressure) by the anesthesiologist after the delivery of the baby. Vasopressors treat hypotension by interacting with receptors on blood vessels that increase blood pressure, which can also cause changes to uterine contractility. Inadequate uterine contraction after CD can expose mothers to postpartum hemorrhage (PPH), with diabetic patients displaying a 2.5-times higher risk of PPH.
It is important to understand how vasopressor(s) might affect the uterine contractility of women with Type II and gestational diabetes. Since medication to contract the uterus is also routinely administered at delivery, it is important to study the effect of these drugs in combination. The purpose of this study is to compare uterine contractility patterns and receptor distribution in women with type II and gestational diabetic and control term pregnant patients with administration of vasopressors. This will be done using small uterine tissue samples taken from the incision site following CD, which will then be used for experiments in the laboratory. conditions: Postpartum Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Ephedrine name: Phenylephrine name: Norepinephrine name: Oxytocin measure: Motility index measure: Amplitude of contraction measure: Frequency of contraction measure: Integrated area under response curve (AUC) sex: FEMALE minimumAge: 19 Years maximumAge: 40 Years stdAges: ADULT facility: Mount Sinai Hospital status: RECRUITING city: Toronto state: Ontario zip: M5G1X5 country: Canada name: Mrinalini Balki, MD role: CONTACT phone: 416-586-4800 phoneExt: 5270 email: mrinalini.balki@uhn.ca name: Caroline Carruthers role: SUB_INVESTIGATOR name: Joseph Park, BSc role: SUB_INVESTIGATOR name: Cynthia Maxwell, MD role: SUB_INVESTIGATOR name: Anuradha Baishnob, BSc role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06285383 id: Kar.neck briefTitle: The Effects of Music on Neck Pain overallStatus: RECRUITING date: 2024-02-15 date: 2024-03-15 date: 2024-04-15 date: 2024-02-29 date: 2024-02-29 name: KTO Karatay University class: OTHER briefSummary: The effects of passive music listening on pain, anxiety and quality of life in patients with chronic neck pain in addition to physical therapy will be examined. conditions: Pain, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Music listening name: classic physical therapy measure: Beck anxiety inventory measure: Visual Analogue Scale measure: Short form-36 sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Mustafa Savaş Torlak status: RECRUITING city: Karatay state: Eyalet/Yerleşke zip: 42000 country: Turkey name: Mustafa S Torlak role: CONTACT phone: +905373660138 email: mustafa.savas.torlak@karatay.edu.tr lat: 37.86726 lon: 32.52863 hasResults: False
<\|newrecord\|> nctId: NCT06285370 id: 0761-CN001 id: CTR20230672 type: OTHER domain: National Medical Products Administration briefTitle: A Study to Evaluate the Efficacy and Safety of KW-0761 in Chinese Subjects With Mycosis Fungoides or Sézary Syndrome Previously Treated With Systemic Therapy overallStatus: RECRUITING date: 2023-05-29 date: 2025-10-31 date: 2026-01-31 date: 2024-02-29 date: 2024-04-29 name: Kyowa Kirin China Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The purpose of the study is to evaluate the efficacy and safety of mogamulizumab (KW-0761) in chinese subjects with mycosis fungoides or sézary syndrome previously treated with systemic therapy conditions: Cutaneous T-Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an open-label, multicenter, single arm study. primaryPurpose: TREATMENT masking: NONE maskingDescription: No Masking count: 20 type: ESTIMATED name: Mogamulizumab measure: Overall Response Rate measure: Skin disease response rate; measure: Lymth nodes response rate measure: Visceral metastases response rate; measure: Blood disease response rate; measure: Progression Free Survival measure: Duration of response (DOR) measure: Time to response (TTR) measure: Response rate of lymph node evaluated by Lugano 2014. measure: Response rate of viscera evaluated by Lugano 2014 criteria. measure: To evaluate pharmacokinetics (plasma mogamulizumab concentration) of mogamulizumab. measure: To evaluate immunogenicity (anti-mogamulizumab antibody) of mogamulizumab. measure: To evaluate the effects of skin disease on health-related Quality of Life (HRQoL) -Skindex 29. measure: The incidence and frequency of treatment-related adverse events (TEAEs) and drug-related TEAEs as assessed by CTCAE v5.0. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital Chinese Academy of Medical Sciences status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100021 country: China name: Yuankai Shi role: CONTACT phone: 13701251865 email: syuankai@cicams.an.cn name: Yuankai Shi role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Peking University First Hospital, Department of Dermatology and Venereology status: RECRUITING city: Beijing state: Beijing zip: 100034 country: China name: Ping Tu role: CONTACT phone: 13021262219 email: tup0207@sina.com name: Ping Tu role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Sun Yat-sen University Cancer Center, Department of Medical Oncology status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Huiqiang Huang role: CONTACT phone: 13808885154 email: huang_sysu@163.com name: Huiqiang Huang role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: The 2nd Affiliated Hospital of Harbin Medical University status: NOT_YET_RECRUITING city: Harbin state: Heilongjiang zip: 150001 country: China name: Yuzhen Li role: CONTACT phone: 13936367628 email: liyuzhenchina@126.com name: Yuzhen Li role: PRINCIPAL_INVESTIGATOR lat: 45.75 lon: 126.65 facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei country: China name: Liling Zhang role: CONTACT phone: 15871725926 email: lily1228@sina.com name: Liling Zhang role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 facility: Hunan Cancer Hospital status: NOT_YET_RECRUITING city: Changsha state: Hunan zip: 410031 country: China name: Hui Zhou role: CONTACT phone: 13975879796 email: zhouhui9403@126.com name: Hui Zhou role: PRINCIPAL_INVESTIGATOR lat: 28.19874 lon: 112.97087 facility: The Affiliated Hospital of Inner Mongolia Medical University status: NOT_YET_RECRUITING city: Hohhot state: Inner Mongolia zip: 010000 country: China name: Da Gao role: CONTACT phone: 13947130473 email: gaoda72@163.com name: Da Gao role: PRINCIPAL_INVESTIGATOR lat: 40.81056 lon: 111.65222 facility: The First Hospital of China Medical University status: NOT_YET_RECRUITING city: Shenyang state: Liaoning zip: 110002 country: China name: Xinghua Gao role: CONTACT phone: 13940152467 email: gaobarry@hotmail.com name: Xinghua Gao role: PRINCIPAL_INVESTIGATOR lat: 41.79222 lon: 123.43278 facility: Zhongshan Hospital Fudan University status: NOT_YET_RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Peng Liu role: CONTACT phone: 1581725926 email: liu.peng@zshospital.sh.cn name: Peng Liu role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: West China Hospital, Sichuan University status: NOT_YET_RECRUITING city: Chengdu state: Sichuan zip: 610044 country: China name: Lin Wang role: CONTACT phone: 18980601701 email: LKZWL@126.com name: Lin Wang role: PRINCIPAL_INVESTIGATOR name: Liqun Zou role: PRINCIPAL_INVESTIGATOR lat: 30.66667 lon: 104.06667 facility: ZheJiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang zip: 310005 country: China name: Haiyan Yang role: CONTACT phone: 18960860662 email: yanghaiyantb@126.com name: Haiyan Yang role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 facility: First Affiliated Hospital of Zhengzhou University status: NOT_YET_RECRUITING city: Henan state: Zhengzhou zip: 450052 country: China name: Xinhua Wang role: CONTACT phone: 15036115299 email: xinwang512@163.com name: Xinhua Wang role: PRINCIPAL_INVESTIGATOR hasResults: False
<\|newrecord\|> nctId: NCT06285357 id: EPISTOP_22 briefTitle: The Effect of the Association EGCG, Folic Acid and Vitamin B12 in Preventing the Persistence of HPV Infection. overallStatus: RECRUITING date: 2024-02-19 date: 2025-02 date: 2025-12 date: 2024-02-29 date: 2024-03-18 name: Lo.Li.Pharma s.r.l class: INDUSTRY briefSummary: The purpose of the study is to test the effect of the administration of a dietary supplement consisting of epigallocatechin gallate (EGCG), vitamin B12 and folic acid in the treatment of infections with papilloma virus of the cervix. conditions: HPV Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: EGCG + folic acid + B12 measure: HPV DNA test negativity sex: FEMALE minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliero-Universitaria di Modena status: RECRUITING city: Modena zip: 41124 country: Italy name: Giovanni Grandi role: CONTACT lat: 44.64783 lon: 10.92539 hasResults: False
<\|newrecord\|> nctId: NCT06285344 id: kilis_3 briefTitle: Impact of Workload and Fatigue on Sleep in OR Nurses overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-06-01 date: 2024-02-29 date: 2024-02-29 name: Kilis 7 Aralik University class: OTHER name: Hasan Kalyoncu University briefSummary: This study aims to explore the impact of individual workload and fatigue levels on the sleep quality of operating room (OR) nurses, highlighting a critical aspect of healthcare professionals' well-being that directly affects patient safety and care quality. Operating room nurses face unique challenges due to the high-stress, fast-paced environment of surgical settings, which can lead to increased stress levels, emotional challenges, and a higher incidence of fatigue compared to other nursing specialties. Factors contributing to this fatigue include the demanding nature of surgical procedures, the need for constant vigilance, and the irregular hours associated with shift work, all of which can impair sleep quality.
The literature review suggests that while the relationship between workload, fatigue, and sleep quality has been extensively studied in general nursing populations, there is a lack of specific focus on operating room nurses. These professionals work under distinct conditions that may exacerbate the effects of workload and fatigue on sleep quality, yet comprehensive studies targeting this group are limited. Understanding the nuances of how workload and fatigue specifically impact the sleep quality of OR nurses is crucial for developing targeted interventions aimed at improving their health and job performance, thereby enhancing patient care and safety.
This cross-sectional and correlational study seeks to fill the gap in the literature by examining the specific effects of workload and fatigue on sleep perception among OR nurses. By identifying these relationships, the study aims to contribute valuable insights into strategies for mitigating fatigue and improving sleep among this critical group of healthcare workers, with the ultimate goal of ensuring both nurse well-being and patient safety. conditions: Shift Work conditions: Sleep Perception studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 250 type: ESTIMATED measure: Demographic Information Form measure: Individual Workload Perception Scale (IWPS) measure: Chalder Fatigue Scale (CFS) measure: Richard-Campbell Sleep Questionnaire (RCSQ) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Islam Elagöz city: Kilis zip: 79100 country: Turkey lat: 36.71611 lon: 37.115 hasResults: False
<\|newrecord\|> nctId: NCT06285331 id: 2023ZDSYLL483-P01 briefTitle: the Impact of Manual or Mechanical Ways to Perform PLR on the Accuracy of Evaluation of Fluid Responsiveness acronym: PLR overallStatus: RECRUITING date: 2023-11-06 date: 2025-12-31 date: 2025-12-31 date: 2024-02-29 date: 2024-03-04 name: Southeast University, China class: OTHER briefSummary: Our goal was to study the impact of different ways to perform passive leg raising (PLR) on the accuracy of evaluation of fluid responsiveness. conditions: Circulatory Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Automatic Bed name: Manual measure: Accuracy of fluid responsiveness evaluation measure: Mortality sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongda Hospital Southeast University status: RECRUITING city: Nanjing state: Jiangsu zip: 210009 country: China name: Jingyuan Xu, M.D. role: CONTACT lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06285318 id: 64007957MMY4004 briefTitle: A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials acronym: REALiTEC overallStatus: RECRUITING date: 2023-12-18 date: 2024-07-30 date: 2026-01-28 date: 2024-02-29 date: 2024-04-25 name: Janssen-Cilag Ltd. class: INDUSTRY briefSummary: The purpose of this study is to describe the use of teclistamab in the treatment of patients with RRMM outside of clinical trials. conditions: Relapsed/Refractory Multiple Myeloma (RRMM) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 180 type: ESTIMATED name: teclistamab measure: Describe Baseline Characteristics of Patients with Relapsed/Refractory Multiple Myeloma (RRMM) who Received Teclistamab Outside of Clinical Trials measure: Describe the Use of Teclistamab in the Treatment of Patients with RRMM Outside of Clinical Trials measure: Describe the Safety Management of Teclistamab in the Treatment of Patients with RRMM Outside of Clinical Trials measure: Describe the Clinical Outcomes of Teclistamab in the Treatment of Patients with RRMM Outside of Clinical Trials sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet status: RECRUITING city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 facility: Odense University Hospital status: RECRUITING city: Odense zip: 5000 country: Denmark lat: 55.39594 lon: 10.38831 facility: Sygehus Lillebælt, Vejle status: RECRUITING city: Vejle zip: 7100 country: Denmark lat: 55.70927 lon: 9.5357 facility: Hopital Albert Calmette - CHU Lille status: RECRUITING city: Lille cedex zip: 59037 country: France lat: 50.63297 lon: 3.05858 facility: Institut Paoli Calmettes status: RECRUITING city: Marseille zip: 13009 country: France lat: 43.29551 lon: 5.38958 facility: Hopital Saint Louis status: RECRUITING city: Paris zip: 75475 country: France lat: 48.85341 lon: 2.3488 facility: Institut Universitaire du Cancer Toulouse Oncopole status: RECRUITING city: Toulouse Cedex 9 zip: 31100 country: France lat: 43.60426 lon: 1.44367 facility: Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii status: RECRUITING city: Wurzburg zip: 97080 country: Germany lat: 49.79391 lon: 9.95121 facility: Sheba Medical Center status: RECRUITING city: Ramat Gan zip: 52621 country: Israel lat: 32.08227 lon: 34.81065 facility: Tel Aviv Sourasky Medical Center status: RECRUITING city: Tel Aviv Yafo zip: 6423906 country: Israel lat: 32.08088 lon: 34.78057 facility: Policlinico Sant'Orsola Malpighi status: RECRUITING city: Bologna zip: 40138 country: Italy lat: 44.49381 lon: 11.33875 facility: Policlinico di Milano status: RECRUITING city: Milano zip: 20121 country: Italy lat: 45.46427 lon: 9.18951 facility: Presidio Ospedaliero Santo Spirito in Sassia status: RECRUITING city: Roma zip: 65124 country: Italy lat: 41.89193 lon: 12.51133 facility: Hosp. Univ. de La Paz status: RECRUITING city: Madrid zip: 28046 country: Spain lat: 40.4165 lon: -3.70256 facility: Hosp. Costa Del Sol status: RECRUITING city: Malaga zip: 29603 country: Spain lat: 36.72016 lon: -4.42034 facility: Länssjukhuset Ryhov status: RECRUITING city: Jonkoping zip: 551 85 country: Sweden lat: 57.78145 lon: 14.15618 hasResults: False
<\|newrecord\|> nctId: NCT06285305 id: kilis_2 briefTitle: Surgical ICU Nurses' Attitudes on End-of-Life Care overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-06-01 date: 2024-02-29 date: 2024-02-29 name: Kilis 7 Aralik University class: OTHER name: Hasan Kalyoncu University briefSummary: This study aims to explore the attitudes and behaviors of nurses working in surgical intensive care units (ICUs) towards end-of-life care, alongside identifying the barriers they face in providing such care. Despite the universal need for end-of-life care, with an estimated 56.8 million people requiring it annually, only a fraction receive adequate services. The concept of a "good death" has evolved, now emphasizing patient and family wishes, and aligning with clinical, cultural, and ethical standards. In the U.S., a significant portion of deaths occur in hospitals, often involving surgical interventions in the final stages of life. Nurses in ICUs play a crucial role in delivering end-of-life care, making their attitudes and behaviors pivotal to the quality of care provided. Previous studies have indicated a positive correlation between nurses' attitudes towards end-of-life care and their ethical conduct in care delivery. However, research specifically focusing on surgical ICU nurses and the challenges they encounter in end-of-life care is limited. This study seeks to fill that gap, enhancing understanding of the factors that influence end-of-life care in surgical ICUs and potentially guiding improvements in care practices and policy. conditions: PATİENT CARE conditions: Intensive Care Unit studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 250 type: ESTIMATED measure: Descriptive Information Form measure: Attitudes and Behaviors Towards End-of-Life Care Scale for Intensive Care Nurses measure: Barriers to End-of-Life Care in Surgical Intensive Care Form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Islam city: Kilis zip: 79100 country: Turkey lat: 36.71611 lon: 37.115 hasResults: False
<\|newrecord\|> nctId: NCT06285292 id: RC24_0097 briefTitle: Prospective and Comparative Evaluation of a Medical Device Composed of a Perineal Probe Connected to a Mobile Application in the Management of Stress Urinary Incontinence. acronym: PRIME overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-06 date: 2026-06 date: 2024-02-29 date: 2024-02-29 name: Nantes University Hospital class: OTHER name: FIZIMED Company briefSummary: Stress urinary incontinence (SUI) affects around 40% of women and has a major impact on quality of life. The gold standard for the treatment of SUI is pelvicfloor rehabilitation, but this presents constraints in terms of availability of healthcare professionals, as well as organization and travel for patients. Innovative devices offer self-training exercises for the pelvicfloor, thus promoting motivation and adherence to treatment. The hypothesis of this study is to prove that the use of a pelvicfloor medical device combined with 2 rehabilitation sessions is not inferior to pelvic-perineal rehabilitation. conditions: Urinary Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 138 type: ESTIMATED name: EMY measure: Urinary symptoms using the ICIQ-UI SF questionnaire measure: Quality of life using the I-QoL questionnaire measure: Urinary symptoms using the ICIQ-UI SF questionnaire measure: Cost-utility ratio using the EQ-5D questionnaire measure: Qualitative component sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06285279 id: NJCT-2401 briefTitle: FKC288 in Participants With Autoimmune Kidney Diseases overallStatus: RECRUITING date: 2024-03-04 date: 2026-12-31 date: 2028-12-31 date: 2024-02-29 date: 2024-04-02 name: Nanjing University School of Medicine class: OTHER briefSummary: This study is a single-center, open-label, dose-escalation exploratory clinical trial, expected to enroll 6 to 12 participants. It will use a BOIN (Bayesian Optimal Interval) design for dose escalation, with four predetermined dose groups (0.3×10\^6 cells/kg, 1.0×10\^6 cells/kg, 3.0×10\^6 cells/kg, and an alternative dose of 0.1×10\^6 cells/kg). Each dose group plans to enroll 1-2 or 3-6 participants with relapsed or refractory autoimmune-mediated kidney diseases (such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, and IgG4-related diseases). conditions: Lupus Nephritis conditions: ANCA-associated Vasculitis conditions: Membranous Nephropathy - PLA2R Induced conditions: IgG4-Related Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: FKC288 measure: The proportion of subjects with dose-limiting toxicity measure: The proportion of subjects with adverse events measure: Proportion of subjects achieving renal response measure: Duration of response (DoR) of all subjects measure: Progression-free survival (PFS) of all subjects measure: Overall survival (OS) of all subjects sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jinling Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210016 country: China name: Xianghua Huang, MD role: CONTACT phone: 13770648824 email: hxhszb@163.com lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06285266 id: kilis_1 briefTitle: Nursing Students' Perceptions and Participation in Surgical Clinical Learning acronym: NSPSCP_CL overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-04-30 date: 2024-06-01 date: 2024-02-29 date: 2024-02-29 name: Kilis 7 Aralik University class: OTHER name: Hasan Kalyoncu University briefSummary: This cross-sectional study investigates the perceptions of nursing students regarding the clinical learning environment (CLE) in surgical services and their participation in clinical practices. Surgical services present a complex, dynamic, and intense learning environment crucial for the development of nursing students' professional competencies. The study explores the challenges nursing students face in these settings, including limited opportunities for participation in intraoperative processes and intensive care units, and the impact of these challenges on their learning outcomes and professional development.
Previous research has highlighted various factors that can either facilitate or hinder nursing students' ability to engage effectively in clinical practices, such as the learning atmosphere, support from nurse educators, peer support, and effective communication. However, there is a noted gap in understanding the specific difficulties encountered in surgical services, the adequacy of students' clinical skills and knowledge, and their ability to apply theoretical knowledge in practice.
By examining nursing students' experiences, this study aims to shed light on the suitability and quality of CLEs in surgical services, contributing valuable insights for optimizing clinical learning and enhancing nursing education programs. The hypotheses tested whether nursing students' perceptions of CLEs in surgical services and their participation in clinical practices are influenced by their descriptive characteristics.
Keywords: Nursing Student, Surgical Services, Clinical Practice, Clinical Learning Environment conditions: Clinical Practice studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED measure: Descriptive Characteristics Form measure: Clinical Learning Environment Scale (CLES): measure: Clinical Practice Participation Determination Form: sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06285253 id: MIRO-01-001 briefTitle: miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-01-31 date: 2025-02-28 date: 2024-02-29 date: 2024-03-29 name: Miromatrix Medical Inc. class: INDUSTRY briefSummary: The clinical trail will assess the safety of miroliverELAP for the treatment of acute liver failure without underlying chronic liver disease. miroliverELAP is an external liver assist combination product consisting of a single-use MIRO-001 bioengineered liver graft and an extracorporeal blood circuit. miroliverELAP Is intended to support the native (failed) liver for up to 48-hours of continuous treatment to allow time for liver recovery or to identify a transplantable liver. conditions: Acute Liver Failure conditions: Acute Liver Injury, Drug Induced studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single arm, open label, safety study primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: miroliverELAP treatment measure: Survival measure: Adverse Events measure: 21-day survival sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California San Francisco Medical Center city: San Francisco state: California zip: 94143 country: United States name: Bilal Hameed, MD role: CONTACT lat: 37.77493 lon: -122.41942 facility: Emory University School of Medicine city: Atlanta state: Georgia zip: 30322 country: United States lat: 33.749 lon: -84.38798 facility: Northwestern Memorial Hospital city: Chicago state: Illinois zip: 60611 country: United States name: Justin Boike, MD role: CONTACT lat: 41.85003 lon: -87.65005 facility: University of Michigan Medical School city: Ann Arbor state: Michigan zip: 48109 country: United States name: Lena Napolitano, MD role: CONTACT lat: 42.27756 lon: -83.74088 facility: University of Minnesota Medical School city: Minneapolis state: Minnesota zip: 55455 country: United States name: Thomas Leventhal, MD role: CONTACT lat: 44.97997 lon: -93.26384 facility: Mayo Clinic city: Rochester state: Minnesota zip: 55902 country: United States lat: 44.02163 lon: -92.4699 facility: Mount Sinai Recanati/Miller Transplantation Institute city: New York state: New York zip: 10029 country: United States lat: 40.71427 lon: -74.00597 facility: Cleveland Clinic Foundation city: Cleveland state: Ohio zip: 44195 country: United States lat: 41.4995 lon: -81.69541 facility: Intermountain Healthcare city: Salt Lake City state: Utah zip: 84103 country: United States name: Richard Gilroy, MD role: CONTACT lat: 40.76078 lon: -111.89105 facility: Virginia Commonwealth University Medical Center city: Richmond state: Virginia zip: 23970 country: United States lat: 37.55376 lon: -77.46026 hasResults: False
<\|newrecord\|> nctId: NCT06285240 id: 1167-007 briefTitle: Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia Taking Stable Donepezil Treatment (MK-1167-007) overallStatus: RECRUITING date: 2024-03-28 date: 2024-07-25 date: 2024-07-25 date: 2024-02-29 date: 2024-04-03 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: The main purpose of this study is to assess the safety and efficacy of MK-1167 administered to participants with Alzheimer's Disease (AD) receiving stable Donepezil treatment. conditions: Alzheimer's Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 16 type: ESTIMATED name: MK-1167 name: Donepezil name: Placebo measure: Number of participants experiencing an Adverse Event (AE) measure: Number of participants discontinuing study treatment due to an AE measure: Area Under the Plasma Concentration-Time Curve from Dosing to 24 Hours Postdose (AUC0-24) of MK-1167 measure: Maximum Plasma Concentration (Cmax) of MK-1167 measure: Plasma Concentration at 24 hours postdose (C24) measure: Time to Reach Maximum Plasma Concentration (Tmax) of MK-1167 measure: Apparent Terminal Half-Life (t½) of MK-1167 measure: Oral Clearance (CL/F) of MK-1167 from Plasma measure: Apparent Volume of Distribution (Vz/F) of MK-1167 sex: ALL minimumAge: 50 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Velocity Clinical Research, Hallandale Beach ( Site 0001) status: RECRUITING city: Hallandale Beach state: Florida zip: 33009 country: United States name: Study Coordinator role: CONTACT phone: 954-455-5757 lat: 25.9812 lon: -80.14838 facility: CenExel iResearch, LLC ( Site 0003) status: RECRUITING city: Decatur state: Georgia zip: 30030 country: United States name: Study Coordinator role: CONTACT phone: 404-537-1281 lat: 33.77483 lon: -84.29631 facility: CenExel iResearch, LLC ( Site 0004) status: RECRUITING city: Savannah state: Georgia zip: 31405 country: United States name: Study Coordinator role: CONTACT phone: 912-744-0800 lat: 32.08354 lon: -81.09983 hasResults: False
<\|newrecord\|> nctId: NCT06285227 id: CM313-100001 briefTitle: Study of CM313 in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-04-30 date: 2025-04-30 date: 2024-02-29 date: 2024-02-29 name: Keymed Biosciences Co.Ltd class: INDUSTRY briefSummary: This study is a single center, randomized, open/double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacokinetic characteristics, and immunogenicity of CM313 administered subcutaneously or intravenously at different doses in healthy male subjects. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 51 type: ESTIMATED name: CM313 injection measure: Adverse event sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06285214 id: OAG1050 briefTitle: Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome overallStatus: RECRUITING date: 2022-05-26 date: 2026-06 date: 2026-06 date: 2024-02-29 date: 2024-04-18 name: Imbrium Therapeutics class: INDUSTRY name: Purdue Pharma LP briefSummary: The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with interstitial cystitis/bladder pain syndrome, compared to placebo. conditions: Interstitial Cystitis/Bladder Pain Syndrome studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: V117957 name: Placebo measure: Change from baseline for bladder pain/discomfort scores over last 12 hours (morning and evening). measure: Change from baseline in mean number of micturitions per 12 hours (morning and evening) measure: Change from baseline in Patient Perception of Intensity of Urgency Scale (PPIUS) measure: Change from baseline in Bladder Pain / Interstitial Cystitis Symptom Score (BPIC-SS) measure: Change from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) measure: Change from baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) measure: Change from baseline in Subject Global Response Assessment (SGRA) measure: Change from baseline in Symptom Impact Sleep Questionnaire (SISQ) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Urology Centers of Alabama, PC status: RECRUITING city: Homewood state: Alabama zip: 35209 country: United States name: Central Contact role: CONTACT lat: 33.47177 lon: -86.80082 facility: Urological Associates of Southern Arizona status: RECRUITING city: Tucson state: Arizona zip: 85715 country: United States name: Central Contact role: CONTACT lat: 32.22174 lon: -110.92648 facility: Applied Research Center of Arkansas status: RECRUITING city: Little Rock state: Arkansas zip: 72212 country: United States name: Central Contact role: CONTACT lat: 34.74648 lon: -92.28959 facility: Investigational Site status: RECRUITING city: Escondido state: California zip: 92025 country: United States name: Central Contact role: CONTACT lat: 33.11921 lon: -117.08642 facility: Urology Group of Southern California status: RECRUITING city: Los Angeles state: California zip: 90017 country: United States name: Central Contact role: CONTACT lat: 34.05223 lon: -118.24368 facility: Hope Clinical Research, LLC status: RECRUITING city: Los Angeles state: California zip: 91303 country: United States name: Central Contact role: CONTACT lat: 34.05223 lon: -118.24368 facility: Tri Valley Urology Medical Group status: RECRUITING city: Murrieta state: California zip: 92562 country: United States name: Central Contact role: CONTACT lat: 33.55391 lon: -117.21392 facility: Accel Research Sites status: RECRUITING city: DeLand state: Florida zip: 32720 country: United States name: Central Contact role: CONTACT lat: 29.02832 lon: -81.30312 facility: Accel Research Site - Neurostudies status: RECRUITING city: Decatur state: Georgia zip: 30033 country: United States name: Central Contact role: CONTACT lat: 33.77483 lon: -84.29631 facility: Providea Health Partners LLC status: RECRUITING city: Evergreen Park state: Illinois zip: 60805 country: United States name: Central Contact role: CONTACT lat: 41.72059 lon: -87.70172 facility: Otrimed Clinical Research status: TERMINATED city: Edgewood state: Kentucky zip: 41017 country: United States lat: 39.01867 lon: -84.58189 facility: Southern Clinical Research Associates status: RECRUITING city: Metairie state: Louisiana zip: 70001 country: United States name: Central Contact role: CONTACT lat: 29.98409 lon: -90.15285 facility: Boston Clinical Trials status: RECRUITING city: Boston state: Massachusetts zip: 02131 country: United States name: Central Contact role: CONTACT lat: 42.35843 lon: -71.05977 facility: Bay State Clinical Trials, Inc. status: RECRUITING city: Watertown state: Massachusetts zip: 02472 country: United States name: Central Contact role: CONTACT lat: 42.37093 lon: -71.18283 facility: Revive Research Institute, Inc status: RECRUITING city: Dearborn Heights state: Michigan zip: 48127 country: United States name: Central Contact role: CONTACT lat: 42.33698 lon: -83.27326 facility: CentraCare - Urology Clinic status: TERMINATED city: Sartell state: Minnesota zip: 56377 country: United States lat: 45.62163 lon: -94.20694 facility: Adult & Pediatric Urology P.C. status: RECRUITING city: Omaha state: Nebraska zip: 68114 country: United States name: Central Contact role: CONTACT lat: 41.25626 lon: -95.94043 facility: Great Lakes Physician, PC status: WITHDRAWN city: Cheektowaga state: New York zip: 14225 country: United States lat: 42.90339 lon: -78.75475 facility: AccuMed Research Associates status: RECRUITING city: Garden City state: New York zip: 11530 country: United States name: Central Contact role: CONTACT lat: 40.72677 lon: -73.6343 facility: Manhattan Medical Research Practice status: TERMINATED city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: Unified Women's Clinical Research-Lyndhurst Clinical Research status: RECRUITING city: Winston-Salem state: North Carolina zip: 27103 country: United States name: Central Contact role: CONTACT lat: 36.09986 lon: -80.24422 facility: The Lindner Research Center at The Christ Hospital status: WITHDRAWN city: Cincinnati state: Ohio zip: 45219 country: United States lat: 39.12713 lon: -84.51435 facility: MidLantic Urology status: TERMINATED city: Bala-Cynwyd state: Pennsylvania zip: 19004 country: United States lat: 40.00761 lon: -75.23407 facility: Antria, Inc. status: WITHDRAWN city: Indiana state: Pennsylvania zip: 15701 country: United States lat: 40.62146 lon: -79.15253 facility: Epic Clinical Research status: RECRUITING city: Lewisville state: Texas zip: 75057 country: United States name: Central Contact role: CONTACT lat: 33.04623 lon: -96.99417 facility: Urology of Virginia, PLLC status: WITHDRAWN city: Virginia Beach state: Virginia zip: 23462 country: United States lat: 36.85293 lon: -75.97799 hasResults: False
<\|newrecord\|> nctId: NCT06285201 id: TJ202001BE104 briefTitle: Study of Felzartamab in Healthy Adult Subjects overallStatus: RECRUITING date: 2024-03-27 date: 2024-12-31 date: 2024-12-31 date: 2024-02-29 date: 2024-04-15 name: TJ Biopharma Co., Ltd. class: INDUSTRY briefSummary: A Phase 1 Clinical Study to Evaluate the Pharmacokinetic Comparability, Safety, Tolerability, and Immunogenicity of Felzartamab for Injection Pre- and Post-changes of Process in Healthy Male Adult Subjects in China (Randomized, Double-blind, Single-dose, Two-formulation, Two-sequence, Two-period Crossover Design) conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: T name: R measure: Primary PK Endpoint sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The First Hospital of Jilin University status: RECRUITING city: Jilin state: Changchun country: China name: Xiaojiao Li, Doctor role: CONTACT phone: +8613514314089 email: xingxingsuo123456@126.com lat: 43.85083 lon: 126.56028 hasResults: False
<\|newrecord\|> nctId: NCT06285188 id: APHP221174 id: 2023-A01398-37 type: REGISTRY domain: ID-RCB briefTitle: Immunomonitoring of Mold Invasive Infections acronym: IMMUNOFIL overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2026-03 date: 2024-02-29 date: 2024-02-29 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Mold invasive infections are associated with an important mortality despite optimization of the antifungal treatment. In a few case reports, immune checkpoints inhibitors, initially developed for neoplastic diseases, have shown a potential beneficial effect in such devastating infections by restoring an efficient immune response. The investigators propose a longitudinal monitoring of the adaptative immune response, notably immune checkpoint expression on T cells, during mold invasive infections to help identify the patients who could benefit from the adjunction of immunotherapy and the optimal timing of such strategy. conditions: Invasive Fungal Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: Immune checkpoint expression on T cells measure: Aspergillus/Mucorales FLUOROSPOT measure: T cell proliferation measure: Immune checkpoint expression on monocytes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Necker Enfants Malades city: Paris zip: 75015 country: France name: Alexandra SERRIS, MD role: CONTACT phone: +33 6 68 80 24 92 email: alexandra.serris@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06285175 id: APP-22-04497 briefTitle: REINVENT: A Brain and Muscle Computer Interface for Stroke acronym: REINVENT overallStatus: COMPLETED date: 2021-06-01 date: 2023-12-15 date: 2024-02-15 date: 2024-02-29 date: 2024-02-29 name: University of Southern California class: OTHER briefSummary: Stroke is a leading cause of adult disability in the United States. High doses of repeated task-specific practice have shown promising results in restoring upper limb function in chronic stroke (\>6 months after onset). However, it is currently challenging to provide such doses in standard clinical practice. At-home telerehabilitation services supervised by a clinician are a potential solution to provide higher-dose interventions. However, telerehabilitation systems developed for repeated task-specific practice typically require a minimum level of active movement. Therefore, severely impaired people necessitate alternative therapeutic approaches. Measurement and feedback of electrical muscle activity via electromyography (EMG) have been previously implemented in the presence of minimal or no volitional movement to improve motor performance in people with stroke. Specifically, muscle neurofeedback training to reduce unintended co-contractions of the impaired hand may be a targeted intervention to improve motor control in severely impaired populations. In this study, we examine the effects of a low-cost, portable, and modular EMG biofeedback system (Tele-REINVENT) for supervised and unsupervised upper limb telerehabilitation after stroke during a 6-week home-based training program that reinforces activity of the wrist extensor muscles while avoiding coactivation of flexor muscles via computer games. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 14 type: ACTUAL name: Tele-REINVENT measure: Fugl Meyer Assessment - Upper Extremity measure: Maximum EMG activity measure: Corticomuscular coherence sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Southern California city: Los Angeles state: California zip: 90033 country: United States lat: 34.05223 lon: -118.24368 hasResults: False
<\|newrecord\|> nctId: NCT06285162 id: 69HCL23_1372 id: 2024-A00294-43 type: OTHER domain: ID-RCB briefTitle: Analgesia Nociception Index to Explore Autonomic Nervous System in Patients With Continuous Renal Replacement Therapy acronym: UFANI overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-07 date: 2025-07 date: 2024-02-29 date: 2024-02-29 name: Hospices Civils de Lyon class: OTHER briefSummary: The Analgesia Nociception Index (ANI) reflects the balance between sympathetic and parasympathetic tone. It is based on a specific interpretation of the R-R interval variation. During fluid removal by net ultrafiltration in patients with fluid overload and continuous renal replacement therapy, some data suggest that haemodynamic variation could be induced by the autonomic nervous system. The study aims to investigate ANI variations in this context and their association with the haemodynamic variations observed. conditions: Critically Ill conditions: Renal Replacement Therapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Percentage of changes in ANI. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel city: Bron zip: 69500 country: France name: Martin RUSTE, MD role: CONTACT phone: +33472118956 phoneExt: +33 email: martin.ruste@chu-lyon.fr name: Martin RUSTE, MD role: PRINCIPAL_INVESTIGATOR name: Matthias JACQUET-LAGREZE, MD role: SUB_INVESTIGATOR lat: 45.73333 lon: 4.91667 hasResults: False

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