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<\|newrecord\|> nctId: NCT06351137 id: INIV2023 briefTitle: Timecost of Intranasal Versus Intravenous Analgesia in Traumatic Pain overallStatus: RECRUITING date: 2024-03-13 date: 2024-06-01 date: 2024-06-01 date: 2024-04-08 date: 2024-04-08 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER briefSummary: Prehospital treatment of acute traumatic pain is common in military practice. Analgesics are usually administered intravenously (IV). Research from the civil prehospital environment shows that obtaining IV access can be difficult and time consuming, delaying onset of treatment. The challenges for obtaining IV access in the military prehospital setting are even bigger, for example in combat environments. However, this has not been assessed.
Current guidelines also offer alternative routes of administration for analgesics, for example intranasal (IN) administration. IN administration is a fast, easy and effective route of administration. This study determines whether IN administration of analgesia is faster and leads to increased healthcare provider satisfaction compared to IV administration in patients with acute traumatic pain in a simulated military prehospital environment. conditions: Acute Pain Due to Trauma conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Intravenous administration name: Intranasal administration measure: Time required for administration of analgesic (minutes) measure: Total time spent on scene (minutes) measure: Time required for obtaining IV access measure: Time required preparing IN administration measure: Satisfaction of the navy nurse regarding the used route of administration. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC status: RECRUITING city: Amsterdam state: Noord-Holland zip: 1105AZ country: Netherlands name: Midas N de Grunt, MD role: CONTACT phone: +31205669111 email: m.n.degrunt@amsterdamumc.nl name: Markus W Hollmann, PhD role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 hasResults: False
<\|newrecord\|> nctId: NCT06351124 id: 00005294 briefTitle: Beta-Hydroxybutyrate Feasibility Treating IBS acronym: BHB overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-12-31 date: 2024-04-08 date: 2024-04-08 name: University of Texas at Austin class: OTHER briefSummary: This clinical trial aims to understand the feasibility of patients taking ketone body supplement beta-hydroxybutyrate (BHB) for 4 weeks with a confirmed diagnosis of Crohn's disease and starting new therapy for active disease.
The main questions it aims to answer are:
* BHB supplementation will be feasible and acceptable to patients.
* BHB supplementation will be associated with a reduction in systemic inflammation.
* BHB supplementation will be associated with a reduction in pro-inflammatory bacterial colonies.
Participants will:
* Take 3 capsules x 3 times per day for 4 weeks.
* Document food consumption using a 24-hour food recall questionnaire.
* Provide blood and fecal samples twice, at the beginning of the study and the 4-week mark.
Researchers will compare the group taking the ketone body supplement and the group not taking the supplement to see if the supplement provides relief of symptoms suffered from Crohn's disease. conditions: Crohn's Disease conditions: Irritable Bowel Syndrome studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This will be a prospective, open-label, randomized, two-arm pilot trial of adults primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Eligible consenting patients will be randomized to either standard of care therapy (control) vs standard of care therapy plus BHB supplementation (intervention). BHB will be supplemented as a capsule taken orally three times daily for four weeks for those randomized to the intervention arm. count: 12 type: ESTIMATED name: Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Inflammatory Bowel Disease measure: Ability to enroll patients who meet the inclusion criteria within the target time frame measure: Adherence to proposed study timelines and anticipated study costs measure: Patient adherence to the intervention measure: Microbial Diversity measure: BHB Blood Levels measure: Gastrointestinal Symptoms measure: Quality of Life measure: Clinical Response measure: Systemic Inflammation measure: Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Texas at Austin city: Austin state: Texas zip: 78712 country: United States name: Michelle Stickler, Associate Vice President, DEd role: CONTACT phone: 512-475-6323 email: m.stickler@austin.utexas.edu name: Thomas Street, Executive Director role: CONTACT phone: 512 495 5142 email: thomas.street@austin.utexas.edu lat: 30.26715 lon: -97.74306 hasResults: False
<\|newrecord\|> nctId: NCT06351111 id: IRB-24-240 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-08 date: 2024-04-08 name: [Redacted] hasResults: False
<\|newrecord\|> nctId: NCT06351098 id: 2024579 briefTitle: Longitudinal Investigation of Sleep, Memory, and Brain Development Across the Nap Transition acronym: HSR overallStatus: RECRUITING date: 2023-11-05 date: 2028-06 date: 2028-06 date: 2024-04-08 date: 2024-04-08 name: University of Maryland, College Park class: OTHER name: University of Massachusetts, Amherst briefSummary: To examine the relations between sleep (nap transitions, sleep physiology), memory, and brain development longitudinally, the researchers will assess n=180 children (in order to acquire n=152 usable data sets) who are 36-54 months of age and habitual nappers at enrollment. In each wave, the researchers will assess memory, memory change over a nap and equivalent waking interval, sleep physiology of the nap, and brain structure and function (using Magnetic Resonance Imagining or MRI). Additionally, overnight sleep physiology will be assessed in all participants. Waves will take place approximately every 6 months. For all children, three waves will be collected. With these data, the researchers will address the following aims:
* Examine neural markers that predict the sleep transition (Aim 1);
* Examine changes in sleep-dependent memory processing (mnemonic discrimination) over both nap and overnight sleep intervals, across the sleep transition (Aim 2);
* Examine changes in sleep microstructure in both nap and overnight sleep across the sleep transition (Aim 3)
* Examine interrelations among brain, memory and sleep microstructure across the sleep transition (Aim 4) conditions: Memory studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 180 type: ESTIMATED name: nap measure: Memory sex: ALL minimumAge: 36 Months maximumAge: 60 Months stdAges: CHILD facility: University of Maryland status: RECRUITING city: College Park state: Maryland zip: 20742 country: United States name: Tracy Riggins, Ph.D. role: CONTACT phone: 301-405-5905 email: riggins@umd.edu name: Postdoctoral Fellow role: CONTACT phone: 301-405-5922 email: napstudy@umd.edu lat: 38.98067 lon: -76.93692 facility: University of Massachusetts status: RECRUITING city: Amherst state: Massachusetts zip: 01003 country: United States name: Rebecca MC Spencer, PhD role: CONTACT phone: 413-577-6128 email: rspencer@umass.edu name: Postdoctoral Fellow role: CONTACT phone: 413-545-4831 email: preschoolnapstudy@gmail.com lat: 42.36723 lon: -72.51852 hasResults: False
<\|newrecord\|> nctId: NCT06351085 id: 1937769-1 briefTitle: Enhancing Lung Cancer Screening Through Human-Centered Intervention acronym: ELFE overallStatus: RECRUITING date: 2022-11-10 date: 2025-04-14 date: 2025-04-14 date: 2024-04-08 date: 2024-04-08 name: University of California, Davis class: OTHER briefSummary: The purpose of this study is to further understand the factors involved in increasing lung cancer screening. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients of the intervention clinics will be assigned one of two interventions: 1) Pre Visit Planner (PVP) or 2) PVP + patient education delivered via the MyUCDHealth patient web portal. primaryPurpose: SCREENING masking: SINGLE maskingDescription: Biostatistician created a randomized table to allocate patient in either intervention 1 or 2. whoMasked: PARTICIPANT count: 2869 type: ESTIMATED name: Pre-Visit Planner name: Pre-Visit Planner + MyChart measure: Lung Cancer Screening measure: Completion of Interviews with Staff and Patients sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, Davis status: RECRUITING city: Sacramento state: California zip: 95817 country: United States name: Moon Chen, M.P.H, Ph.D role: CONTACT phone: 916-548-3928 email: mschenjr@ucdavis.edu name: Moon Chen, M.P.H, Ph.D role: PRINCIPAL_INVESTIGATOR lat: 38.58157 lon: -121.4944 hasResults: False
<\|newrecord\|> nctId: NCT06351072 id: NOXANI briefTitle: Correlation Between qNOX and Analgesia Nociception Index (ANI) Values During General Anesthesia acronym: ANI overallStatus: RECRUITING date: 2024-04-02 date: 2024-09-01 date: 2024-10-01 date: 2024-04-08 date: 2024-04-26 name: University of Padova class: OTHER briefSummary: qNOX and ANI are two indexes evaluting the analgesia conduction during general anesthesia.
No trials have compared them, so with this trial authors want to explore the correlations between them. conditions: Analgesia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Correlation between qNOX and ANI values measure: Correlation between qNOX from CONOX and Analgesia nocicpetion index (ANI) values and postoperative pain measure: Correlation between qNOX from CONOX and analgesia nocicpetion index (ANI) values and postoperative delirium sex: FEMALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Treviso Regional Hospital status: RECRUITING city: Treviso state: TV zip: 31100 country: Italy name: Federico Linassi role: CONTACT email: federico.linassi@gmail.com lat: 45.66673 lon: 12.2416 hasResults: False
<\|newrecord\|> nctId: NCT06351059 id: UE-0083 briefTitle: Acoustic Emission Biomarkers for the Detection and Monitoring of Early Knee Osteoarthritis overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2024-07-31 date: 2024-12-31 date: 2024-04-08 date: 2024-04-19 name: Schulthess Klinik class: OTHER name: Ecole Polytechnique Fédérale de Lausanne briefSummary: The aim of this exploratory study is to further investigate the potential of acoustic emission biomarkers, assessed by the inmodi knee brace, to diagnose osteoarthritis (OA) at earlier stages. Therefore, 20 healthy participants and 100 patients with increased risk of knee OA will be recruited from the Schulthess Klinik in Zurich and examined twice with 9 ± 3 months' time interval. Anthropometric data, EOS radiographs and MR images of both knees, PROMs and acoustic emission data will be collected and evaluated. Artificial Intelligence algorithm will then be used to identify and validate the most promising acoustic emission biomarkers with a prognosis value in the prediction of knee osteoarthritis progress. conditions: Osteoarthritis, Knee conditions: Diagnosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 120 type: ACTUAL name: InModi acoustic emission analysis measure: acoustic emissions measure: kinematic data measure: MRI / MOAKS measure: EOS / leg alignment measure: PROMS sex: ALL minimumAge: 35 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Schulthess Klinik city: Zürich state: ZH zip: 8008 country: Switzerland lat: 47.36667 lon: 8.54999 hasResults: False
<\|newrecord\|> nctId: NCT06351046 id: NCT05178082_WP3 briefTitle: Preventive Interventions for Chronic Pain Worsening overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2026-07-30 date: 2027-01-30 date: 2024-04-08 date: 2024-04-08 name: Rigshospitalet, Denmark class: OTHER name: The Novo Nordic Foundation briefSummary: This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has three arms (1:1:1): Mindfulness Based Stress Reduction (MBSR) group, Virtual Reality based Pain Self-management (VRPS) program group, and a control group (usual care). Included will be 78 patients at least 18 years old; fluent in the Danish language; complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10); access to internet; and willing and available to participate in the study. Excluded will be specialized or multidisciplinary pain treatment at baseline; history of epilepsy, seizure disorder, nausea or dizziness, hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment; injury to eyes, face or neck. conditions: Chronic Non-Cancer Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has three arms (1:1:1): MBSR group, VRPS group, and a control group (usual care). Participants will be randomly assigned to one of the groups. Assessments will occur at baseline and 2, 6, 9, and 12 months after intervention. primaryPurpose: PREVENTION masking: NONE maskingDescription: The statistical analysis of the data will be blinded count: 78 type: ESTIMATED name: Online Mindfullness Based Stress Reduction Program name: Virtual Reality-based Pain Self-management program measure: Pain intensity measure: Pain intensity and interference in daily activities measure: Pain catastrophizing measure: Pain acceptance measure: Health status measure: Health related quality of life measure: Anxiety measure: Depression measure: Use of medication measure: Use of healthcare system measure: Number of absent days at work measure: Satisfaction with the intervention sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06351033 id: ADP_012023 briefTitle: Ozonized Oil as Dietary Supplement in Macular Degeneration overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-31 date: 2024-12 date: 2024-12 date: 2024-04-08 date: 2024-04-08 name: Alba Di Pardo class: OTHER briefSummary: Macular degeneration, also called age-related macular degeneration (AMD), is a leading cause of visual impairment and severe vision loss.
AMD is a disease with a multifactorial etiology. The main factors which, associated with the genetic ones, increase the risk of WMD onset are represented by smoking, obesity, hypertension, cardio-vascular diseases, a diet rich in dietary fat and alcohol intake. From an organic point of view, AMD is a disease that affects the macular region of the retina, causing progressive loss of central vision.
Retinal cells are characterized by high oxygen consumption. Reactive oxygen species (ROS), such as superoxide anion, hydrogen peroxide and hydroxyl radical are the standard product of cellular metabolism within the mitochondria. Under physiological conditions, ROS are neutralized by a system of antioxidants. In case of cellular metabolism disturbances or insufficiency of the antioxidant system, an excess of ROS can be produced which contributes to oxidative stress, widely described as exerting deleterious effects on cells. The high oxygen requirement and low levels of antioxidant enzymes make the retina extremely sensitive to oxidative stress and more susceptible to cell death. Prevention of neuronal death in the retina becomes a crucial aspect for the management of WMD.
The treatment of choice for AMD today is the use of anti-VEGF (Vascular Endothelial Growth Factor) drugs, they are effective for neo-vascular AMD, acting on the inhibition of the angiogenic protein VEGF, which is produced in the retina and induced by hypoxia and other conditions. It is practice, however, to support the integration of nutritional supplements such as zinc, resveratrol, carotenoids such as lutein and zeaxanthin, vitamin E and Omega-3 fatty acids.
The aim of this study is to evaluate the efficacy of ozonated oil with high ozonides (HOO) administered orally as gastro-resistant capsules (O3Zone, GS Pharma, Malta), as an integrative and complementary treatment in patients affected by macular degeneration in the possible slowing of disease progression. conditions: Maculopathy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: High ozonide (HOO) ozonated oil measure: evaluation of any slowing down of the maculopathy measure: evaluation of any slowing down of the maculopathy measure: evaluation of any slowing down of the maculopathy measure: evaluation of any slowing down of the maculopathy and closure of the study sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Neuromed city: Pozzilli country: Italy lat: 41.51142 lon: 14.06252 hasResults: False
<\|newrecord\|> nctId: NCT06351020 id: LM302-03-101 briefTitle: LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma. overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-08-10 date: 2026-12-15 date: 2024-04-08 date: 2024-04-08 name: LaNova Medicines Zhejiang Co., Ltd. class: INDUSTRY briefSummary: This study will assess the efficacy and safety of LM-302 Versus Treatment of Physician's Choice (TPC) in Subjects With locally advanced or metastatic, Claudin (CLDN) 18.2-positive, Gastric or Gastroesophageal Junction Adenocarcinoma who have progressed on or after 2 lines of systemic therapy conditions: Locally Advanced or Metastatic GC and GCJ Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: experimental arm:LM-302 control arm:Apatinib or Irinotecan primaryPurpose: TREATMENT masking: NONE count: 375 type: ESTIMATED name: LM-302 name: Apatinib name: Irinotecan measure: Overall Survival (OS) measure: Progression Free Survival (PFS) measure: Objective response rate (ORR) measure: Duration of response (DoR) measure: Disease control rate (DCR) measure: AE and SAE measure: Evaluate the immunogenicity of LM-302 measure: Evaluation of pharmacokinetic characteristics of LM-302 measure: Evaluation of pharmacokinetic characteristics of LM-302 measure: Evaluation of pharmacokinetic characteristics of LM-302 measure: Evaluation of pharmacokinetic characteristics of total antibody measure: Evaluation of pharmacokinetic characteristics of total antibody measure: Evaluation of pharmacokinetic characteristics of total antibody measure: Evaluation of pharmacokinetic characteristics of MMAE measure: Evaluation of pharmacokinetic characteristics of MMAE measure: Evaluation of pharmacokinetic characteristics of MMAE sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06351007 id: NMM-4650-23-24-1 briefTitle: Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK) acronym: EPAK overallStatus: RECRUITING date: 2023-09-19 date: 2024-07 date: 2024-07 date: 2024-04-08 date: 2024-04-08 name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran class: OTHER briefSummary: A fundamental strategy to improve adherence to nutritional treatment in patients with chronic kidney disease is the implementation of educational programs. The aim of this study is to evaluate the effect of a multidisciplinary educational program on dietary adherence, nutritional knowledge, nutritional status, metabolic control and quality of life in patients with chronic kidney disease, predialysis, peritoneal dialysis and hemodialysis.
A randomized clinical trial will be carried out, in which patients who meet the inclusion criteria will be randomly assigned to three possible groups: predialysis educational intervention, dialysis educational intervention and control group. At the initial visit, the nutritional status will be evaluated by means of anthropometric parameters, screening and dynamometry, the biochemical parameters of interest will be extracted from the clinical record, nutritional knowledge and quality of life will be evaluated, and the diet will be explained. In the second visit, adherence to the diet will be evaluated and the food registry will be carried out. In the intervention groups, the educational program will begin with a duration of five months. Patients will come twice a month to the hospital to participate in the educational sessions and attend group psychology sessions. After completion of the educational program, the same measurements as at the beginning of the study will be carried out in the three groups. conditions: Chronic Kidney Disease conditions: Predialysis conditions: Peritoneal Dialysis conditions: Hemodialysis conditions: Educational Activities conditions: Adherence conditions: Nutritional Status studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 63 type: ESTIMATED name: Nutritional education and psychological intervention name: Standard care measure: Patients´ dietary attitude measure: Dietary adherence measure: Nutritional knowledge measure: Muscle status measure: Muscle functionality measure: Nutritional status of predialysis patients measure: Nutritional status of dialysis patients measure: Patients´ quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán status: RECRUITING city: Mexico City zip: 14080 country: Mexico name: Ximena Atilano Carsi, PhD role: CONTACT phone: 00 52 55 56 17 65 42 email: ximena.atilanoc@incmnsz.mx lat: 19.42847 lon: -99.12766 hasResults: False
<\|newrecord\|> nctId: NCT06350994 id: APHP230625 id: IDRCB 2023-A01957-38 type: OTHER domain: ANSM briefTitle: Early Assessment of Cardiac Function After Treatment With CAR-T Cells acronym: Cardio CAR-T overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-10 date: 2027-01 date: 2024-04-08 date: 2024-04-08 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: CAR-T cells (Chimeric Antigen Receptor) are a new immunotherapy, based on the genetic modification of autologous T lymphocytes. CAR-T cell therapy is not devoid of complications.
Among the most frequent complications are the risk of infection, cytokine release syndrome (CRS) and neurotoxicity. Nevertheless, some authors have reported serious acute cardiac events in a limited number of patients, often contemporaneous with CRS or sepsis, questioning the imputability of CAR-T cells in this heart disease.
This study aims to estimate the incidence of a possible early cardiotoxicity associated with CAR-T cells.
The main endpoint will be the change in cardiac function (LVEF: left ventricular ejection fraction) assessed by ultrasound between the pre CAR-T assessment and the early post CAR-T ultrasound (D3-D5). conditions: Car T- Cell conditions: Hematologic Malignancy conditions: Acute Lymphoblastic Leukemia conditions: Lymphoma, B-Cell conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: Estimation of the incidence of possible early CAR-T cells infusion-induced cardiotoxicity measure: Characterization of the putative CAR-T cells infusion-induced cardiotoxicity: incidence, phenotype, clinical, rhythmic and biological manifestations measure: Determination of its possible association with a cytokine release syndrome and the levels of inflammatory biomarkers from the analysis of the serum library of these patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Critical care medicine department city: Paris zip: 75012 country: France name: Jérémie JOFFRE, MD, PhD role: CONTACT phone: +33 1 49 28 21 45 email: Jeremie.joffre@aphp.fr name: Hafid AIT-OUFELLA, Professor role: CONTACT phone: +33 1 49 28 21 45 email: hafid.ait-oufella@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06350981 id: FORE813 briefTitle: Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-01 date: 2025-03-01 date: 2024-04-08 date: 2024-04-08 name: Foundation for Orthopaedic Research and Education class: OTHER name: Pacira Pharmaceuticals, Inc briefSummary: The goal of this clinical trail is to to compare the efficacy of thoracolumbar interfascial plane block with Exparel vs with standard of care 0.25% Bupivacaine HCl in patients undergoing 1-3 level elective transforaminal lumbar interbody fusion. The investigators hypothesize that thoracolumbar interfascial plane block with Exparel will outperform standard of care (supplemented with interfascial plane block of 0.25% Bupivacaine HCl) with regards to pain reduction, narcotic use, length of hospital stay, time to mobilization with physical therapy, narcotic usage in the hospital, and post operative pain scores. conditions: Back Pain conditions: Surgery-Complications conditions: Narcotic Use conditions: Physical Stress conditions: Post Operative Pain studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Study subjects will be randomized to either Group 1 or Group 2 in a 1:1 ratio based on the randomization scheme in sealed envelopes maintained by the study coordinator. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 76 type: ESTIMATED name: Exparel name: Bupivacain measure: Compare efficacy of thoracolumbar interfacial plane block with Exparel vs. standard of care (0.25% Bupivacaine HCL) is surgical subjects undergoing 1-3 level elective transforaminal lumbar interbody fusion. measure: Total Postsurgical opioid consumption measure: Time to discharge measure: Time to ambulation measure: Maximum ambulated distance measure: Numeric Rating Pain Scale (Physical Therapy) measure: Numeric Rating Pain Scale measure: Oswestry Disability Index (ODI) measure: Pain Catastrophizing Scale (PCS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Foundation for Orthopaedic Research and Education city: Tampa state: Florida zip: 33607 country: United States name: Deborah H Warren role: CONTACT phone: 813-910-3688 email: dwarren@foreonline.org lat: 27.94752 lon: -82.45843 hasResults: False
<\|newrecord\|> nctId: NCT06350968 id: MEC-2023-0151 id: 10200012110003 type: OTHER_GRANT domain: ZonMw briefTitle: Implementation of Online Advance Care Planning Tool for (Hemato-)Oncological Patients Within the Cancer Network Concord acronym: INDEED overallStatus: RECRUITING date: 2023-10-01 date: 2026-06-30 date: 2026-12-31 date: 2024-04-08 date: 2024-04-08 name: Erasmus Medical Center class: OTHER name: Maasstad Hospital name: Spijkenisse Medical Center name: Franciscus &Vlietland name: IJsselland name: Ikazia Hospital, Rotterdam name: Van Weel-Bethesda hospital name: Albert Schweitzer Hospital name: Beatrix hospital briefSummary: The aim of this mixed-methods study is to describe both the implementation process and outcomes of the online module Advance Care Plan for (hemato-)oncology patients within the oncology-network CONCORD.
The main question is: How is implementation and assurance of the advance care plan in daily care for (hemato-)oncological patients within CONCORD achieved, so that early integration of advance care planning in oncological care takes place and patient preferences are discussed?
Healthcare providers and patients are asked to use the module and share their experiences with it. conditions: Oncology conditions: Advance Care Planning conditions: Implementation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Implementation outcome measure: Intervention outcome measure: Implementation outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Joica Benschop status: RECRUITING city: Rotterdam zip: 3023TB country: Netherlands name: Joica Benschop, MSc role: CONTACT phone: +31622586583 email: j.benschop@erasmusmc.nl name: Wendy Oldenmenger, PhD role: CONTACT phone: +31651072608 email: w.h.oldenmenger@erasmusmc.nl lat: 51.9225 lon: 4.47917 hasResults: False
<\|newrecord\|> nctId: NCT06350955 id: 2022-01389 briefTitle: IV Iron-induced Hypophosphatemia After RYGB acronym: IVORY overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-06 date: 2026-06 date: 2024-04-08 date: 2024-04-08 name: Lucie Favre class: OTHER briefSummary: The primary objective of the study is to compare the incidence of hypophosphatemia in RYGB patients treated with intravenous (IV) single dose of iron isomaltoside (Monofer®) or ferric carboxymaltose (Ferinject®). conditions: Hypophosphatemia conditions: Roux-en-Y Gastric Bypass studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 94 type: ESTIMATED name: Iron isomaltoside name: Iron Carboxymaltose measure: incidence of hypophosphatemia in RYGB patients treated with intravenous iron sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06350942 id: 1451_01/BVNTW-VNCSKTE briefTitle: One Trocar-assisted Retroperitoneoscopic Ureteroureterostomy for Ureteral Duplication overallStatus: COMPLETED date: 2016-09 date: 2020-12 date: 2024-02 date: 2024-04-08 date: 2024-04-08 name: National Children's Hospital, Vietnam class: OTHER name: Vinmec Research Institute of Stem Cell and Gene Technology briefSummary: Ureteral duplication, a common anomaly affecting about 0.8% of the population, presents challenges in pediatric urology due to its diverse clinical presentations and anatomical complexity. Traditional treatments like upper pole moiety (UPM) heminephrectomy can lead to loss of renal function in the remaining lower pole moiety (LPM). Ureteroureterostomy (UU) is a safer alternative, increasingly preferred regardless of renal function or reflux presence. Minimally invasive techniques like laparoscopic and robotic procedures show promise, but robotic-assisted UU is costly, while laparoscopic UU has technical challenges. A novel approach is proposed: single-trocar retroperitoneoscopic-assisted UU, combining laparoscopic visualization advantages with simplified extracorporeal suturing, offering a promising solution for managing complete ureteral duplication. The present study was designed to describe the operative technique and outcome of OTAU in 40 cases of complete ureteral duplication in children. conditions: Ureteral Duplication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: one trocar-assisted retroperitoneoscopic ureteroureterostomy (OTAU) measure: Mean operating time measure: Intraoperative complications measure: Conversion to open measure: Early postoperative complications measure: Median length of hospital stays measure: Mean UPM renal pelvis' APD measure: Mean SFU of UPM renal pelvis measure: Mean UPM ureter's diameter measure: Mean UPM DRF measure: Mean DRF of operated side sex: ALL minimumAge: 1 Month maximumAge: 10 Years stdAges: CHILD facility: The National Hospital of Pediatrics city: Hanoi country: Vietnam lat: 21.0245 lon: 105.84117 facility: Vinmec Research Institute of Stem Cell and Gene Technology city: Hanoi country: Vietnam lat: 21.0245 lon: 105.84117 hasResults: False
<\|newrecord\|> nctId: NCT06350929 id: RC31/24/0017 briefTitle: Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients acronym: NORAFLOW overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2025-05 date: 2024-04-08 date: 2024-04-08 name: University Hospital, Toulouse class: OTHER briefSummary: Arterial hypotension is a frequent complication of general anesthesia and a significant contributor to postoperative complications. It is a critical marker for the development of acute renal failure and postoperative myocardial infarction. Chronic heart failure (CHF) patients are increasingly encountered in the operating room, and their perioperative morbidity and mortality are substantial, with specific management lacking precise recommendations.
The main objective is to assess the impact of a diluted norepinephrine bolus on cardiac output in chronic heart failure patients experiencing arterial hypotension after anesthesia induction. conditions: Hypotension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Cardiac output monitoring by the Starling™ SV Sebac® measure: Evaluation of the impact of a bolus of diluted norepinephrine on cardiac output in chronic heart failure patients presenting with arterial hypotension after anesthetic induction. measure: Evaluation of the role of preload dependence before anesthetic induction in the variation of cardiac output after a norepinephrine bolus. measure: Evaluation of the impact of the norepinephrine bolus on blood pressure correction. measure: Evaluation of the impact of the norepinephrine bolus on heart rate. measure: Evaluation of the safety of use of norepinephrine in chronic heart failure patients during hospitalization. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Toulouse Rangueil city: Toulouse zip: 31400 country: France name: François LABASTE, Dr role: CONTACT phone: 0561322822 phoneExt: +33 email: labaste.f@chu-toulouse.fr lat: 43.60426 lon: 1.44367 hasResults: False
<\|newrecord\|> nctId: NCT06350916 id: IRB00082594 id: LCI-GI-CRC-SEAMLESS-2020 type: OTHER domain: Atrium Health briefTitle: Application to Improve Patient Engagement and Decrease Postoperative Opioid Consumption in Patients for Colorectal Surgery overallStatus: COMPLETED date: 2021-01-28 date: 2021-07-30 date: 2021-10-01 date: 2024-04-08 date: 2024-04-08 name: Wake Forest University Health Sciences class: OTHER name: Atrium Health Levine Cancer Institute briefSummary: The purpose of this study is to evaluate whether patient-centered educational material delivered before and immediately after surgery can help improve outcomes for patients undergoing colorectal surgery. conditions: Colorectal Surgery studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 75 type: ACTUAL name: SeamlessMD® Mobile Application measure: Perioperative ERAS metric completion rate measure: Postoperative hospital length of stay measure: Postoperative complications measure: 30-day readmission measure: Postoperative Opioid Consumption sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Levine Cancer Institute city: Charlotte state: North Carolina zip: 28204 country: United States lat: 35.22709 lon: -80.84313 hasResults: False
<\|newrecord\|> nctId: NCT06350903 id: ICM 2024-3356 briefTitle: Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial F-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Imaging acronym: SWEET-HEART overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-06 date: 2024-04-08 date: 2024-04-09 name: Matthieu Pelletier-Galarneau, MD MSc class: OTHER briefSummary: The overall objective of this study is to assess if the empagliflozin has the potential to substitute the high fat low carb (HFLC) diet for the preparation of cardiovascular FDG-PET studies. conditions: Myocardial Suppression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: DIAGNOSTIC masking: NONE count: 36 type: ESTIMATED name: Fast + High-fat low-carbohydrate diet name: Fast + Empagliflozin measure: Levels of serum Beta-hydroxybutyrate (BHB) mmol/L measure: Proportions of serum Beta-hydroxybutyrate (BHB) >0.5 mmol/L measure: Proportions of glycemia levels (mmol/L) <3.5 mmol/L measure: Acceptability and tolerance of each protocol, as reported by patients by a dedicated survey. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06350890 id: HTD1801.PCT105 briefTitle: Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes overallStatus: RECRUITING date: 2023-11-05 date: 2025-03 date: 2025-09 date: 2024-04-08 date: 2024-04-18 name: HighTide Biopharma Pty Ltd class: INDUSTRY briefSummary: The goal of this clinical study is to evaluate the efficacy and safety of Berberine Ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes, inadequately controlled with diet and exercise alone. conditions: T2DM (Type 2 Diabetes Mellitus) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 405 type: ESTIMATED name: HTD1801 name: Placebo measure: Primary Endpoint: Mean Change in HbA1c measure: Double Blind (DB) Phase: Mean Change in Fasting Plasma Glucose measure: DB Phase: Mean Change in 2-Hour Postprandial Glucose measure: DB Phase: Proportion of patients achieving HbA1c <7.0% measure: DB Phase: Proportion of patients achieving HbA1c <6.5% measure: DB Phase: Mean Change in Insulin Sensitivity (HOMA-IR) measure: DB Phase: Mean Change in Low-Density Lipoprotein Cholesterol (LDL-C) measure: Open Label Extension (OLE) Phase: Mean Change in HbA1c measure: OLE Phase: Mean change in 2-Hour Postprandial Glucose measure: OLE Phase: Proportion of patients achieving HbA1c <7.0% measure: OLE Phase: Proportion of patients achieving HbA1c <6.5% measure: OLE Phase: Mean Change in Insulin Sensitivity (HOMA-IR) measure: OLE Phase: Mean Change in LDL-C sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuancheng People's Hospital status: RECRUITING city: Xuancheng state: Anhui country: China lat: 25.40949 lon: 116.3841 facility: Beijing Pinggu Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Fuwai Hospital, CAMS & PUMC status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking University People's Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Chongqing University Three Gorges Hospital status: RECRUITING city: Chongqing state: Chongqing country: China lat: 29.56278 lon: 106.55278 facility: Nanfang Hospital, Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Huizhou Municipal Central Hospital status: RECRUITING city: Huizhou state: Guangdong country: China lat: 23.11147 lon: 114.41523 facility: Shenzhen People's Hospital status: RECRUITING city: Shenzhen state: Guangdong country: China lat: 22.54554 lon: 114.0683 facility: Liuzhou People's Hospital status: RECRUITING city: Liuzhou state: Guangxi country: China facility: Cangzhou Central Hospital status: RECRUITING city: Cangzhou state: Hebei country: China lat: 38.31667 lon: 116.86667 facility: Handan First Hospital status: RECRUITING city: Handan state: Hebei country: China lat: 36.60056 lon: 114.46778 facility: Hengshui People's Hospital (Harrison International Peace Hospital) status: RECRUITING city: Hengshui state: Hebei country: China lat: 37.73222 lon: 115.70111 facility: Hebei Petro China Center Hospital status: RECRUITING city: Langfang state: Hebei country: China lat: 39.50972 lon: 116.69472 facility: The First Hospital of Hebei Medical University status: RECRUITING city: Shijiazhuang state: Hebei country: China lat: 38.04139 lon: 114.47861 facility: The Fourth Affiliated Hospital of Harbin Medical University status: RECRUITING city: Harbin state: Heilongjiang country: China lat: 45.75 lon: 126.65 facility: The First Hospital of Qiqihar status: RECRUITING city: Qiqihar state: Heilongjiang country: China lat: 47.34088 lon: 123.96045 facility: The Third Affiliated Hospital of Qiqihar Medical College status: RECRUITING city: Qiqihar state: Heilongjiang country: China lat: 47.34088 lon: 123.96045 facility: The First Affiliated Hospital of Henan University of Science and Technology (Jinghua) status: RECRUITING city: Luoyang state: Henan country: China lat: 34.68361 lon: 112.45361 facility: The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan) status: RECRUITING city: Luoyang state: Henan country: China lat: 34.68361 lon: 112.45361 facility: The First Affiliated Hospital of Nanyang Medical College status: RECRUITING city: Nanyang state: Henan country: China lat: 32.99472 lon: 112.53278 facility: Zhumadian Central Hospital status: RECRUITING city: Zhumadian state: Henan country: China lat: 32.97944 lon: 114.02944 facility: Huangshi Central Hospital status: RECRUITING city: Huangshi state: Hubei country: China lat: 30.24706 lon: 115.04814 facility: Jingzhou Central Hospital status: RECRUITING city: Jingzhou state: Hubei country: China lat: 30.35028 lon: 112.19028 facility: The Central Hospital of Wuhan status: RECRUITING city: Wuhan state: Hubei country: China lat: 30.58333 lon: 114.26667 facility: The First People's Hospital of Changde City status: RECRUITING city: Changde state: Hunan country: China lat: 29.04638 lon: 111.6783 facility: Hunan Provincial People's Hospital status: RECRUITING city: Changsha state: Hunan country: China lat: 28.19874 lon: 112.97087 facility: Yueyang People's Hospital status: RECRUITING city: Yueyang state: Hunan country: China lat: 29.37455 lon: 113.09481 facility: Baotou City Central Hospital status: RECRUITING city: Baotou state: Inner Mongolia country: China lat: 40.65222 lon: 109.82222 facility: Inner Mongolia Autonomous Region People's Hospital status: RECRUITING city: Hohhot state: Inner Mongolia country: China lat: 40.81056 lon: 111.65222 facility: The First People's Hospital of Changzhou status: RECRUITING city: Changzhou state: Jiangsu country: China lat: 31.77359 lon: 119.95401 facility: Huai'an First People's Hospital status: RECRUITING city: Huai'an state: Jiangsu country: China lat: 33.50389 lon: 119.14417 facility: The Second People's Hospital of Lianyungang status: RECRUITING city: Lianyungang state: Jiangsu country: China lat: 34.59845 lon: 119.21556 facility: Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: Nanjing First Hospital status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: Nanjing Jiangning Hospital status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: Sir Run Run Hospital Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: The Second Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital of Xuzhou Medical University status: RECRUITING city: Xuzhou state: Jiangsu country: China lat: 34.18045 lon: 117.15707 facility: Affiliated Hospital of Jiangsu University status: RECRUITING city: Zhenjiang state: Jiangsu country: China lat: 32.21086 lon: 119.45508 facility: Pingxiang People's Hospital status: RECRUITING city: Pingxiang state: Jiangxi country: China lat: 27.61672 lon: 113.85353 facility: The Second Norman Bethune Hospital of Jilin University status: RECRUITING city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 facility: Tonghua Central Hospital status: RECRUITING city: Tonghua state: Jilin country: China lat: 41.71972 lon: 125.92639 facility: Panjin Liaohe Oilfield Gem Flower Hospital status: RECRUITING city: Panjin state: Liaoning country: China lat: 41.121 lon: 122.0739 facility: The Sixth People's Hospital of Shenyang status: RECRUITING city: Shenyang state: Liaoning country: China lat: 41.79222 lon: 123.43278 facility: Qinghai Provincial People's Hospital status: RECRUITING city: Xining state: Qinghai country: China lat: 36.62554 lon: 101.75739 facility: The Second Affiliated Hospital of Shaanxi University of Chinese Medicine status: RECRUITING city: Xianyang state: Shaanxi country: China lat: 34.33778 lon: 108.70261 facility: Jinan Central Hospital status: RECRUITING city: Jinan state: Shandong country: China lat: 36.66833 lon: 116.99722 facility: Liaocheng People's Hospital status: RECRUITING city: Liaocheng state: Shandong country: China lat: 36.45596 lon: 115.97766 facility: Shanghai East Hospital of Tongji University status: RECRUITING city: Shanghai state: Shanghai country: China lat: 31.22222 lon: 121.45806 facility: The Third People's Hospital of Datong status: RECRUITING city: Datong state: Shanxi country: China lat: 40.09361 lon: 113.29139 facility: Yuncheng Central Hospital status: RECRUITING city: Yuncheng state: Shanxi country: China lat: 35.02306 lon: 110.99278 facility: People's Hospital of Tianjin status: RECRUITING city: Tianjin state: Tianjin country: China lat: 39.14222 lon: 117.17667 facility: The First People's Hospital of Kashgar status: RECRUITING city: Kashgar state: Xinjiang country: China lat: 39.47066 lon: 75.98951 facility: The Second Affiliated Hospital of Kunming Medical University status: RECRUITING city: Kunming state: Yunnan country: China lat: 25.03889 lon: 102.71833 facility: Huzhou Central Hospital status: RECRUITING city: Huzhou state: Zhejiang country: China lat: 30.8703 lon: 120.0933 hasResults: False
<\|newrecord\|> nctId: NCT06350877 id: PA RCT briefTitle: 1:1 and Group-based Exercise Intervention for Post-secondary Student Mental Health and Well-being overallStatus: RECRUITING date: 2024-01-08 date: 2025-01 date: 2025-01 date: 2024-04-08 date: 2024-04-08 name: University of Toronto class: OTHER briefSummary: Post-secondary students report alarming rates of feeling overwhelmed, hopeless, anxious, and depressed. To better support student mental health, there is a well-documented need to improve the range and quality of mental health services available to students. Focussing on formalized treatment approaches and strategies supporting well-being in the campus community more generally are needed. Physical activity is an alternative therapeutic approach that could be implemented as an evidence-based lifestyle intervention for supporting mental health and well-being on post-secondary campuses.
Despite the growing evidence supporting physical activity for student mental health, there are significant knowledge gaps in the literature. First, there is a paucity of research exploring the effects of different delivery styles (i.e., one-on-one (1:1) vs. group) on primary (i.e., mental health symptomology including anxiety symptoms, depression symptoms, psychological distress) and secondary (i.e., social support, social connectedness) outcomes. Secondly, the maintenance effects of a physical activity program on mental health or sustained physical activity behaviour change are largely unknown. Lastly, limited research has explored contextual implementation factors (e.g., intervention reach, adherence, and program satisfaction) that may influence the sustainability and scale-up of physical activity programs for student mental health. Examining contextual implementation factors is critical for optimizing physical activity intervention delivery and for facilitating wider dissemination of research findings into practice. The goal of this 3-arm parallel randomized controlled trial is to test the effectiveness of 1:1 physical activity intervention and group-based physical activity intervention compared to a wait-list control group in supporting post-secondary student mental health. The main questions include:
* Are there group differences between 1:1, group-based delivery, and waitlist control in the immediate (post-intervention) and follow-up (1-month) maintenance effects on the primary and secondary outcomes?
* Grounded in recommendations for process evaluation of complex interventions, what are contextual implementation factors that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination?
Trial participants will be randomly assigned to one of the following groups:
1. 1:1 physical activity training;
2. Group-based physical activity training consisting of small 5-8 person groups; or
3. Waitlist control. Students will participate in the physical activity intervention after the intervention and follow-up period (10 weeks); however, their participation will not be monitored or evaluated.
The physical activity training will involve a 6-week physical activity intervention consisting of weekly 1-hour sessions. Each session involves: (1) 30-minutes of behaviour change coaching (e.g., goal setting, action-planning, brainstorming strategies to overcome barriers to engaging in physical activity); and (2) 30-minutes of supervised and structured physical activity training. To address the aims of the study, participants will complete self-report questionnaires at baseline, post-intervention (following completion of the 6-week physical activity intervention), and 1-month following completion of the physical activity intervention. Questionnaires will assess demographic characteristics, primary outcomes (i.e., mental health symptomology including anxiety symptoms, depression symptoms, psychological distress), secondary outcomes (i.e., social support, social connectedness, physical activity behaviour) and contextual implementation factors (e.g., intervention reach, adherence, and program satisfaction) that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination. It is hypothesized that there will be no group differences between 1:1 delivery and group-based delivery on the primary outcomes. It is also hypothesized that group-based delivery, in comparison to 1:1 delivery will achieve greater improvements and more favourable maintenance effects in the secondary outcomes. Lastly, it is hypothesized that in comparison to the control group, 1:1 delivery and group-based delivery will be more effective in achieving change in the primary and secondary outcomes. conditions: Physical Activity conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A 3-arm parallel Randomized Controlled Trial (RCT) assessing the immediate (post-intervention) and short-term (1-month) impact of the experimental arms (1:1 physical activity delivery and group-based physical activity delivery) compared to a 10-week control arm (wait-list control) will be conducted. A parallel arm design will be implemented, whereby participants will be randomized to a study arm and each study arm will be allocated a different intervention. The protocol adheres to CONSORT guidelines and SPIRIT recommendations for reporting of clinical trial protocols. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Following completion of the baseline assessment (T1), students will be randomly assigned to an experimental arm or the control arm by a program coordinator for the study. To prevent care provider bias, the physical activity coaches will remain blind to the purpose of group allocation and hypotheses of the study. Research Randomizer (www.randomizer.org) will be used to allocate participants into three equal groups using a blocked design (with an allocation ratio of 1:1:1). whoMasked: CARE_PROVIDER count: 93 type: ESTIMATED name: Physical Activity Intervention measure: Depression measure: Anxiety measure: Psychological distress measure: Social Support measure: Social Connectedness measure: Physical Activity Behaviour measure: Intervention Reach measure: Therapeutic Alliance measure: Intervention Satisfaction measure: Coach Perceptions sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Toronto, Mental Health and Physical Activity Research Centre status: RECRUITING city: Toronto state: Ontario zip: M5S 2W6 country: Canada name: Melissa L deJonge, Msc role: CONTACT phone: 9059739414 email: melissa.dejonge@utoronto.ca name: Catherine M Sabiston, PhD role: CONTACT phone: 416-978-5837 email: catherine.sabiston@utoronto.ca name: Melissa L deJonge, Msc role: SUB_INVESTIGATOR name: Delaney E Thibodeau, Msc role: SUB_INVESTIGATOR name: Sandra Yeun, PhD role: SUB_INVESTIGATOR name: Luc Simard role: SUB_INVESTIGATOR name: Catherine M Sabiston, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06350864 id: FMASU R11/2024 briefTitle: HFNC Versus Conventional Oxygen Therapy in Prolonged Upper Gastrointestinal Endoscopy in the ICU overallStatus: RECRUITING date: 2024-01-20 date: 2024-06 date: 2024-07 date: 2024-04-05 date: 2024-04-05 name: Ain Shams University class: OTHER briefSummary: Conventional supplemental oxygen therapy (COT) during upper gastrointestinal (UGI) endoscopy via nasal catheter is considered the standard practice in maintenance of oxygenation and prevention of hypoxia. However, it is still unclear if this oxygen delivery method is optimal in a prolonged (more than 15 minutes) procedure in patients admitted to the ICU. Because of shortage of data in this concern, this prospective, randomized, controlled clinical trial study will aim to evaluate and compare the efficacy of high-flow nasal cannula (HFNC) oxygen therapy versus COT in patients who will undergo prolonged either diagnostic or therapeutic UGI endoscopy in the intensive care unit (ICU) . conditions: Upper Gastrointestinal Bleeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective, randomized, comparative, controlled clinical trial study primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The patients and anesthesiologists in charge of the case will be unmasked as High-flow nasal cannula HFNC) shape,setting and preparation are completely different from the Conventional nasal oxygen therapy (COT), so masking both of them is impossible. whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: High-flow nasal cannula (HFNC) name: Conventional nasal oxygen therapy (COT) name: Upper gastrointestinal endoscopy (UGE) including gastroscopy name: Upper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA) measure: Any occurrence of at least moderate hypoxemia of any duration measured by pulse oximetry during the procedure. measure: The median lowest SpO2 -Any episode of hypoxia -Clinically significant hypoxia -Sedation and procedure related adverse effects -Endoscopy procedure time -Anesthetic time -Propofol total used doses measure: Any episode of hypoxia occurring less than 1 minute, from 1 to 5 minutes, or more than 5 minutes measure: Clinically significant hypoxia measure: Sedation related adverse effects (SRAEs) measure: Procedure-related adverse events (PRAEs) measure: Endoscopy procedure time measure: Anesthetic time sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Ain Shams University-Faculty of Medicine status: RECRUITING city: Cairo country: Egypt name: Ahmed M Mohamed, MD role: CONTACT phone: 002 01121318459 email: drahmed.mostafa.mohamed@med.asu.edu.eg name: Wessam Z Selima, MD role: CONTACT phone: 002 01001958858 email: w.z.selima@med.asu.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06350851 id: BA161WP1 briefTitle: Development of a New Rapid Diagnostic Test to Support Onchocerciasis Elimination acronym: Obi1 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-04 date: 2024-04-05 date: 2024-04-05 name: Bioaster class: OTHER briefSummary: Onchocerciasis, also known as river blindness, is one of the disease targeted for elimination by the World Health Organization (WHO) in the group of Neglected Tropical Diseases. Existing diagnostic tools for onchocerciasis have limitations that make mapping, epidemiological assessments and verification of elimination of onchocerciasis difficult. It is in this context that WHO, in its 2021-2030 roadmap for onchocerciasis, has identified the development of new diagnostic tests, or the improvement of existing diagnostic tests, as a critical condition for achieving the goal of eliminating onchocerciasis transmission.
To this end, a series of cross-sectional studies will be carried out in Cameroun over a one year period to collect and characterize biological samples for the development and evaluation of a new rapid diagnostic test for onchocerciasis. The study will target individuals aged 18 and over, mono-infected with one of the filarial species Onchocerca volvulus, Loa loa or Mansonella perstans; and non-infected.
At the end of this study, data on the endemicity of onchocerciasis, loiasis and mansonellosis in the selected communities will be updated. More importantly, a new rapid diagnostic test will be developed, which can then be used to monitor the activities of onchocerciasis control programs. conditions: Onchocerciasis conditions: Loiasis conditions: Mansonelliasis conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 400 type: ESTIMATED name: Biological samples collection (blood drawing + feces) measure: Evaluation of the performance of the prototype diagnostic test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Higher Institute for Scientific and Medical Research city: Yaounde zip: 5797 country: Cameroon name: Joseph KAMGNO role: CONTACT phone: +237 6 75 06 91 58 email: contact@ismcm.org name: Joseph KAMGNO role: PRINCIPAL_INVESTIGATOR lat: 3.86667 lon: 11.51667 hasResults: False
<\|newrecord\|> nctId: NCT06350838 id: KN-BCG-I briefTitle: Clinical Study to Investigate the Safety and Tolerance of Therapeutic BCG in Postoperative Adjuvant Therapy in Subjects With Moderate to High-risk Non-muscular Invasive Bladder Cancer (NMIBC) overallStatus: COMPLETED date: 2022-11-11 date: 2023-02-13 date: 2023-02-13 date: 2024-04-05 date: 2024-04-05 name: Chengdu CoenBiotech Co., Ltd class: INDUSTRY name: Hunan Cancer Hospital briefSummary: Phase I clinical study to investigate the safety and tolerance of therapeutic BCG in postoperative adjuvant therapy in subjects with moderate to high-risk non-muscular invasive bladder cancer (NMIBC) conditions: Non-muscular Invasive Bladder Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ACTUAL name: BCG for Therapeutic Use measure: Incidence of Treatment-Emergent Adverse Events(TEAE) and serious Treatment-Emergent Adverse Events; measure: Effects on clinical laboratory tests index of blood biochemistry, such as the concentration of alanine aminotransferase (ALT). measure: Effects on clinical laboratory tests index of blood routine, such as white blood cell count, red blood cell count, platelet count. measure: Effects on clinical laboratory tests index of coagulation function, such as activated partial thromboplastin time (APTT). measure: Effects on clinical laboratory tests index of urine routine, such as white urine albumin count, urine red blood cell count. measure: Effects on vital signs,such as temperature. measure: Effects on P wave, QRS complex, QT interval and so on by 12-lead electrocardiogram. measure: Effects on the periodic activity of echocardiography，such as the heart wall recorded as the relationship curve between the corresponding activity and time of each structure. measure: Effects on physical examination, refers to the detection and measurement of the development level of human form, structure and function. measure: Exposure condition of the test drug in the blood, refer to plasma concentration of the test drug(BCG). measure: Shedding condition of the test drug in urine. measure: To investigate the immune response characteristics of therapeutic BCG in patients with moderate and high- risk non-invasive bladder cancer after surgery. sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 415000 country: China lat: 28.19874 lon: 112.97087 hasResults: False
<\|newrecord\|> nctId: NCT06350825 id: 2023-SR-543 briefTitle: Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients overallStatus: RECRUITING date: 2016-01-01 date: 2027-12-31 date: 2028-12-31 date: 2024-04-05 date: 2024-04-05 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP) conditions: Metastatic Prostate Cancer conditions: Therapy, Directly Observed studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized control primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Cytoreductive prostatectomy or brachytherapy name: ADT+second-generation antiandrogens ± chemotherapy measure: rPFS measure: Safety of CRP in mHSPC patients sex: MALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210029 country: China name: Shangqian Wang, M.D. role: CONTACT phone: 13770561625 email: wsq5501@126.com name: Lixin Hua, M.D. role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2024-03-20 uploadDate: 2024-03-20T11:18 filename: Prot_ICF_000.pdf size: 125657 hasResults: False
<\|newrecord\|> nctId: NCT06350812 id: PB119110 briefTitle: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2025-04-29 date: 2025-04-29 date: 2024-04-05 date: 2024-04-05 name: PegBio Co., Ltd. class: OTHER briefSummary: The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, PK characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: PB-119 name: Placebo measure: Incidence of Treatment-Emergent Adverse Events measure: Pharmacokinetic profile measure: Pharmacokinetic profile measure: Pharmacokinetic profile measure: Pharmacokinetic profile measure: Effectiveness index measure: Effectiveness index sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06350799 id: 01741 briefTitle: Chronic Obstructive Pulmonary Disease and Community Health Worker Home-visits overallStatus: COMPLETED date: 2019-03-14 date: 2021-05-27 date: 2023-04-28 date: 2024-04-05 date: 2024-04-05 name: VA Puget Sound Health Care System class: FED name: Public Health - Seattle and King County name: University of Washington briefSummary: We examined a Community Health Worker (CHW) program for Chronic Obstructive Pulmonary Disease (COPD) in Veteran Participants. The goal of this study was to assess participants' perceived acceptability, appropriateness, and feasibility of the intervention, explore participants' COPD health outcomes, and gather insights from participants and CHWs to inform potential improvements.
Veteran participants enrolled in the 12-week intervention and received a series of 9 CHW home, phone, or video visits. These visits provided education and chronic disease self-management practices to improve COPD health.
Researchers examined the participant and CHW perception of the intervention through qualitative interviews and surveys. conditions: COPD studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 9 type: ACTUAL measure: Acceptability, Appropriateness, Feasibility sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA Puget Sound Health Care System city: Seattle state: Washington zip: 98108 country: United States lat: 47.60621 lon: -122.33207 hasResults: False
<\|newrecord\|> nctId: NCT06350786 id: ROM Study id: PZ00P1_201972 type: OTHER_GRANT domain: Swiss National Science Foundation briefTitle: Conditioned Open-label Placebos to Facilitate Opioid Reduction in Patients With Chronic Non-cancer Pain acronym: ROM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2025-07 date: 2024-04-05 date: 2024-04-05 name: Cosima Locher class: OTHER name: Brown University name: University of Basel briefSummary: This study aims to evaluate whether the reduction of the daily morphine equivalent dose (MED) in patients with chronic non-cancer pain (CNCP) can be decreased with an open-label placebo (OLP) intervention in comparison to an electronic monitoring (EM) control group. The participants will receive the intervention (OPL or EM) over the duration of six weeks. Diverse psychological and health measures will be assessed with questionnaires over the course of the intervention. Furthermore, evaluation outcomes, qualitative outcomes and safety outcomes will be assessed. It is hypothesized that the OLP-intervention group in comparison to the EM-control group will have a significantly lower consumption of MED over the course of the study. Furthermore, this study aims to evaluate whether the OLP intervention can reduce opioid withdrawal symptoms in comparison to the control group. conditions: Chronic Non-cancer Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 86 type: ESTIMATED name: P-Dragees blue Lichtenstein, Placebo dragees name: Control group (EM) measure: Daily opioid consumption (MED): measure: Subjective opioid withdrawal symptoms measure: Pain severity measure: Pain disability measure: Anxiety measure: Depression measure: Pain Opioid Analgesics Beliefs Scale - Cancer measure: Treatment Expectancy measure: Placebo pill count measure: Opioid adherence measure: Rationale credibility measure: Placebo understanding measure: Patient Provider Connection measure: Medication history measure: Primary treating physicians' acceptability of the OLP approach: measure: Primary treating physicians' treatment expectancies measure: Qualitative Outcomes measure: Safety Outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06350773 id: FMBSUREC/06122022/ Zaher briefTitle: Phosphodiesterase Type 5 Inhibitors in Patients With Group 2 Pulmonary Hypertension overallStatus: RECRUITING date: 2023-01-10 date: 2024-07 date: 2024-11 date: 2024-04-05 date: 2024-04-08 name: Beni-Suef University class: OTHER briefSummary: The goal of this clinical trial is to test the efficacy of tadalafil in patients with group II pulmonary hypertension with elevated pulmonary vascular resistance (PVR). The main question it aims to answer is:
• Can tadalafil improve patients with group II pulmonary hypertension with elevated PVR? Participants will undergo right heart catheterization (RHC) to make sure they are fulfilling the inclusion criteria, then will be asked to take tadalafil 20 mg for two weeks then 40 mg if tolerated for 12 weeks, then participants will be followed up. Investigators will compare the drug group with another age- and sex- matched control placebo group. conditions: Group 2 Pulmonary Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: tadalafil 20 mg then 40 mg if tolerated measure: Functional capacity of the patients measure: heart failure symptoms measure: right ventricular function measure: right ventricular function measure: right ventricular function measure: right ventricular function measure: right ventricular function sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beni Suef University status: RECRUITING city: Cairo state: Beni Suef zip: 62511 country: Egypt name: Hesham Boshra Mahmoud, Doctorate role: CONTACT phone: 201001402250 email: heshamboshra@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06350760 id: UJA_PROCARE-I+ briefTitle: Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems W/Add-On Modules acronym: PROCARE-I+ overallStatus: RECRUITING date: 2023-03-15 date: 2024-07-31 date: 2024-12-31 date: 2024-04-05 date: 2024-04-05 name: University of Jaén class: OTHER name: Universidad Miguel Hernandez de Elche name: University Rovira i Virgili name: University of Miami briefSummary: PROCARE is a preventive intervention that has shown its effectiveness in selective prevention to reduce young people's risk of developing emotional problems. In this study, an uncontrolled pre-post study is carried out where this personalized transdiagnostic preventive intervention in online mode is applied in the indicated population, with the following objectives: 1) provide data about whether there are improvements in the emotional state of adolescents after implementing PROCARE-I+; and 2) evaluate if there is any risk factor that predicts anxiety-depressive symptoms and/or emotional difficulties. The sample was made up of 30 adolescents who showed symptoms of anxiety and/or depression and a high risk of developing an emotional disorder and who benefited from the preventive, transdiagnostic, online and personalized intervention called PROCARE-I+. After the analysis of the data collected at the pre-intervention and post-intervention time, the data revealed that the intervention had an impact on improving the emotional state of the adolescents in terms of anxious-depressive symptomatology, quality of life and emotional regulation. On the other hand, the data revealed the absence of predictive relationships between the presence of a risk factor and suffering from symptoms of anxiety and depression; In contrast, predictive relationships were found between the presence of the family risk factor and suffering from some emotional difficulty. conditions: Anxiety Disorders and Symptoms conditions: Depressive Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To-arm interventions are carried out, measuring at the pre-intervention moment and at the post-intervention moment. primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Active control condition name: PROCARE-I+ 8-session measure: Self-reported anxiety and mood symptomatology measure: Factors associated with adolescents' mental health measure: Resilience measure measure: Health-related quality of life measure: Absence of emotional disorders measure: Economic evaluations measure: Psychological flexibility measure: Emotional regulation measure: Bullying measure: Expressed Emotion measure: Ecoanxiety measure: Exam anxiety measure: Videogames addiction measure: Smartphone addiction sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Universidad Miguel Hernández status: RECRUITING city: Elche state: Alicante zip: 03202 country: Spain name: José Antonio Piqueras, Ph. D. role: CONTACT phone: 966658343 email: jpiqueras@umh.es name: José Antonio Piqueras, Ph. D. role: SUB_INVESTIGATOR lat: 38.26218 lon: -0.70107 facility: University of Jaén status: RECRUITING city: Jaén state: Jaen zip: 23071 country: Spain name: Luis Joaquín García-López, Ph. D. role: CONTACT phone: 953213412 email: ljgarcia@ujaen.es name: Luis Joaquín García-López, Ph. D. role: PRINCIPAL_INVESTIGATOR name: José Antonio Muela-Martínez, Ph. D. role: PRINCIPAL_INVESTIGATOR name: Lourdes Espinosa-Fernández, Ph. D. role: PRINCIPAL_INVESTIGATOR name: Laura Zafra-Palomino, Ph. D. stud role: PRINCIPAL_INVESTIGATOR name: David Jiménez-Vázquez, Ph. D. stud role: PRINCIPAL_INVESTIGATOR lat: 37.76922 lon: -3.79028 facility: Universitat Rovira i Virgili status: RECRUITING city: Tarragona zip: 43003 country: Spain name: Josefa Canals, M.D. role: CONTACT phone: 977257895 email: josefa.canals@urv.cat name: Josefa Canals, M.D. role: SUB_INVESTIGATOR lat: 41.11667 lon: 1.25 hasResults: False
<\|newrecord\|> nctId: NCT06350747 id: CelalBayarU-SBF-OT-02 briefTitle: The Effect of Laughter Yoga on Nurses' Perceived Stress, Sleep Quality, and Burnout Levels overallStatus: RECRUITING date: 2024-04-01 date: 2024-07-01 date: 2024-07-30 date: 2024-04-05 date: 2024-04-18 name: Celal Bayar University class: OTHER briefSummary: The aim of the study was to investigate the effects of laughter yoga on nurses' perceived stress, sleep quality, and burnout levels. conditions: Healthy Participants studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: pretest-posttest with control group primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 64 type: ESTIMATED name: Laughter Yoga measure: Perceived Stress Scale measure: Jenkins Sleep Scale measure: Maslach Burnout Scale sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi status: RECRUITING city: Manisa zip: 45060 country: Turkey name: Özge Topsakal, PhD role: CONTACT phone: 05549165599 email: ozgebydr_19@hotmail.com lat: 38.61202 lon: 27.42647 hasResults: False
<\|newrecord\|> nctId: NCT06350734 id: 18-004675 id: NCI-2024-00973 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 18-004675 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study overallStatus: RECRUITING date: 2018-10-12 date: 2029-01-31 date: 2029-01-31 date: 2024-04-05 date: 2024-04-05 name: Mayo Clinic class: OTHER briefSummary: This study evaluates the effect of bladder cancer treatment on quality of life. conditions: Stage 0a Bladder Cancer AJCC v8 conditions: Stage 0is Bladder Cancer AJCC v8 conditions: Stage I Bladder Cancer AJCC v8 conditions: Stage II Bladder Cancer AJCC v8 conditions: Stage IIIA Bladder Cancer AJCC v8 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 704 type: ESTIMATED name: Non-Interventional Study measure: Change in quality of life outcomes - PROMIS-29 measure: Change in quality of life outcomes - Bladder Cancer Index measure: Patient level characteristics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Arizona status: RECRUITING city: Scottsdale state: Arizona zip: 85259 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Mark D. Tyson, M.D., M.P.H. role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: Mayo Clinic in Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Paul R. Young, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 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: Matthew T. Gettman, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
<\|newrecord\|> nctId: NCT06350721 id: DizzyVR briefTitle: Feasibility, Usability and Safety of the Vestibular Rehabilitation Using the Immersive Virtual Reality Software DizzyVR acronym: DizzyVR overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-10-01 date: 2024-04-05 date: 2024-04-05 name: Universidad Loyola Andalucia class: OTHER name: University of Seville name: Universitat Politècnica de València name: Universidad de Zaragoza briefSummary: The goal of this pilot study is to assess the safety and feasibility of the immersive virtual reality system called DizzyVR in participants diagnosed with a vestibular disorder. The main questions it aims to answer are:
* To assess the feasibility, usability and safety of the system DizzyVR for the vestibular rehabilitation in participants with vestibular disorders.
* To detect and record possible adverse events due to the use of DizzyVR.
* To examine the degree of adherence of the participants to the intervention.
* To know the average success rate of the different games in each session.
* To evaluate the average difficulty levels overcome throughout the intervention.
* To know the usability and satisfaction with the system reported by participants and therapists.
Participants will receive the vestibular rehabilitation based on the novel immersive virtual systema, DizzyVR. conditions: Vestibular Disorder conditions: Physical Disability studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: DizzyVR measure: Retention rate of participants measure: User Satisfaction Evaluation Questionnaire (USEQ) measure: Register of risk and number of adverse events experimented by the stakeholders measure: Adherence rate measure: Dropout rates sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06350708 id: 2024-18304-33663 id: 336664 type: OTHER domain: Integrated Research Application System (IRAS) briefTitle: Virtual Reality (VR) Paediatric Tracheostomy Training overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-10 date: 2024-07-10 date: 2024-04-05 date: 2024-04-05 name: University of Manchester class: OTHER briefSummary: This study aims to evaluate the use of an unsupervised virtual reality training tool. This tool is used to teach nurses, doctors and other healthcare workers and their students how to manage tracheostomy emergencies in children. conditions: Educational Study studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 69 type: ESTIMATED name: Virtual reality (VR) tracheostomy educational tool measure: Performance in simulation (time to key specific intervention, time to completion of scenario, and number of correct interventions completed) measure: Knowledge using a bespoke knowledge multiple choice questionnaire adapted from a validated question bank. measure: Participant satisfaction measured using a bespoke data collection tool. measure: Virtual Reality Sickness measure: Usability using the validated system usability scale sex: ALL minimumAge: 18 Years maximumAge: 68 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Manchester city: Manchester state: Greater Manchester zip: M13 9PL country: United Kingdom name: Jonathan R Abbas, MBChB role: CONTACT email: jonathan.abbas@postgrad.manchester.ac.uk lat: 53.48095 lon: -2.23743 hasResults: False
<\|newrecord\|> nctId: NCT06350695 id: HP-00103478 id: 1R21AG080424-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R21AG080424-01 briefTitle: The ROle of Compression StocKings in Heart Failure Patients acronym: ROCK-HF overallStatus: RECRUITING date: 2024-01-17 date: 2025-06-01 date: 2026-01-01 date: 2024-04-05 date: 2024-04-05 name: University of Maryland, Baltimore class: OTHER name: National Institute on Aging (NIA) briefSummary: Congestive heart failure (CHF) occurs when the heart is weak and not able to effectively pump blood to the body. One of the common manifestations of CHF is fluid overload and swelling of the legs. Diuretics or "water pills" are usually the treatment for fluid overload and leg swelling; however, in some patients' diuretics are no longer effective or the effectiveness is limited due to poor kidney function. The presence of chronic swelling of the legs could potentially damage the veins; additionally, it could lead to chronic skin changes in the legs and in the worst cases to a leg ulcer. Compression stockings are used in patients with venous diseases to reduce the swelling of the legs and improve mobility and quality of life. Although, there is a theoretical risk that compression stockings might push the fluid of the legs back to the heart and lungs worsening the CHF. The purpose of this study is to determine whether the use of knee-high tight socks (tight stockings with strong compression) vs. knee-high soft socks (soft stockings with minimum compression) are effective in preventing swelling and skin changes and safe in patients with CHF. During the first visit (in-person) a routine medical test will be performed including blood tests, review of the medication doses, current weight, an ultrasound images of the veins, (venous reflux ultrasound), questions about health status and a brief physical exam. The participants will be randomly assigned to receive tight compression vs. soft compression socks. Participants will be asked to wear the socks at least 8 hours a day for 5 days a week. There will be a total of 3 virtual visit (by video or telephone); the first one after one week, then after one month and two months. During the virtual visit participants will be asked about symptoms, current medications and doses, and current weight. The participants are expected to return to the clinic after 3 months for a second in-person visit. During this visit the investigators will ask questions about participant's health, they will perform a brief physical exam of their legs, and check participants weight and medicines; also, a venous ultrasound of the legs, questions about health status will be performed. The duration of the study is 3 months. conditions: Heart Failure，Congestive conditions: Leg Edema conditions: Venous Insufficiency conditions: Venous Ulcers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective randomized-control 1:1 single blind study primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: low grade compression stockings (10-15 mmHg) name: high grade compression stockings (20-30 mmHg) measure: Incidence of adverse events. measure: Change in symptoms of heart failure. measure: Change in kidney function. measure: Change in venous reflux. measure: Change in C Class from the CEAP classification for venous insufficiency. measure: Mobility of the patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Maryland status: RECRUITING city: Baltimore state: Maryland zip: 21201 country: United States name: Rydica Newton, Research Coordinator role: CONTACT phone: 410-706-3941 email: RNewton@som.umaryland.edu name: Kim Nordstrom role: CONTACT email: knordstrom@som.umaryland.edu name: Rafael S Cires-Drouet, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 hasResults: False
<\|newrecord\|> nctId: NCT06350682 id: HP-00107323 briefTitle: Resilient HIV Implementation Science With SGM Youths Using Evidence acronym: RISE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-09 date: 2028-06 date: 2024-04-05 date: 2024-04-05 name: University of Maryland, Baltimore class: OTHER name: University of Florida briefSummary: The Resilient HIV Implementation Science with SGM Youths using Evidence (RISE) Clinical Research Center will use a Type 2 hybrid-effectiveness-implementation study to evaluate the effectiveness and implementation of HMP, a youth-tailored digital health platform. It is hypothesized that SGM youths in the HMP intervention group will demonstrate improved PrEP initiation and viral load suppression over 12 months compared to the delayed HMP group. conditions: Hiv studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 1500 type: ESTIMATED name: HealthMPowerment (HMP) measure: PrEP initiation for HIV seronegative seropositive measure: Viral load suppression for HIV measure: RE-AIM measure: HIV testing cascade measure: PrEP continuum measure: HIV care and treatment continuum measure: Implementation effectiveness sex: MALE minimumAge: 15 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06350669 id: 9576-22-SMC briefTitle: App-supported Vestibular Rehabilitation (RCT) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-03 date: 2024-04-05 date: 2024-04-22 name: University of Haifa class: OTHER name: Sheba Medical Center name: Ben-Gurion University of the Negev briefSummary: A randomized controlled trial to assess the efficacy of an app-assisted vestibular rehabilitation in increasing adherence to VR and treatment outcomes conditions: Vestibular Disorder conditions: Vestibular Diseases conditions: Vestibular Abnormality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The patients will be randomly assigned to either the intervention group (app-assisted vestibular rehabilitation) or the control group ("standard" vestibular rehabilitation/no app) primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Vestibular rehabilitation phone application measure: Adherence measures measure: Timed up and go (TUG) measure: Demographics and medical history intake measure: Vestibular functions- physical examination measure: Oculomotor functions- physical examination measure: Visual Analogue Scale (VAS) measure: Dizziness Handicap Inventory (DHI) measure: Activities-specific Balance Confidence Scale (ABC) measure: Dynamic Gait Index (DGI) measure: 10-Meters Walk Test (10MWT) measure: 2-Minute Walk Test (2MWT) measure: Dynamic Visual Acuity (DVA) measure: Video Head Impulse Test (vHIT) measure: Suppression Head Impulse Test (SHIMP) measure: Exercise difficulty levels and symptoms severity measure: Cognitive reserve index questionnaire (CRIQ) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sheba Medical Center city: Ramat Gan country: Israel name: Yoav Gimmon, PT, Ph.D role: CONTACT email: yoavgimmon@gmail.com name: Amit Wolfovitz, M.D role: PRINCIPAL_INVESTIGATOR name: Shelly Levy-Tzedek, PhD role: PRINCIPAL_INVESTIGATOR name: Liran Kalderon, M.Sc.PT role: PRINCIPAL_INVESTIGATOR lat: 32.08227 lon: 34.81065 hasResults: False
<\|newrecord\|> nctId: NCT06350656 id: IRBN282022/CHUSTE briefTitle: Study of Cerebral Compliance in Neurosurgical Intensive Care Units (EC2) acronym: EC2 overallStatus: RECRUITING date: 2023-03-31 date: 2024-04 date: 2024-04 date: 2024-04-05 date: 2024-04-05 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: Despite the massive use of intracranial pressure in neuro-resuscitation, there is still no cerebral compliance evaluation index used in current practice to guide therapy.
In treatment guidelines for intracranial hypertension, patients are placed in a prone position at about 30 degrees. Several times a day, during nursing care, patients are flattened, which corresponds to a cerebral compliance test by adding a volume of cerebrospinal fluid to the cranial box. conditions: Cerebrospinal; Disorder studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Clinical data collection name: Therapeutic data collection name: IntraCranial Pression (ICP) values collection measure: Intracranial pressure (mmHg) measure: Correlation between ICP (Intra Cranial Pressure) doses and cerebral compliance sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CENTRE HOSPITALIER Charponnay status: RECRUITING city: Chaponnay zip: 69970 country: France name: PIERRE-HENRI MURGAT, MD role: PRINCIPAL_INVESTIGATOR lat: 45.63097 lon: 4.94299 facility: CENTRE HOSPITALIER UNIVERSITAIRE Grenoble status: RECRUITING city: Grenoble zip: 38000 country: France name: JEAN FRANCOIS PAYEN, MD role: PRINCIPAL_INVESTIGATOR lat: 45.16667 lon: 5.71667 facility: HOPITAL NORD La Tronche status: RECRUITING city: La Tronche zip: 38170 country: France name: KEVIN LAGARDE, MD role: PRINCIPAL_INVESTIGATOR lat: 45.20429 lon: 5.73645 facility: APHP status: RECRUITING city: Paris zip: 75010 country: France name: SAMUEL GAUGUIN, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hopital Lariboisiere - Ahph status: RECRUITING city: Paris zip: 75010 country: France name: JEROME CARTAILLIER, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: CENTRE HOSPITALIER UNIVERSITAIRE Rennes status: RECRUITING city: Rennes zip: 35000 country: France name: YOANN LAUNEY, MD PHD role: PRINCIPAL_INVESTIGATOR lat: 48.11198 lon: -1.67429 facility: CENTRE HOSPITALIER UNIVERSITAIRE Saint-Etienne status: RECRUITING city: Saint-Étienne zip: 42055 country: France name: CLEMENT MAGAND, MD role: PRINCIPAL_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False
<\|newrecord\|> nctId: NCT06350643 id: 287064 id: P50MD017319-03S1 type: NIH link: https://reporter.nih.gov/quickSearch/P50MD017319-03S1 briefTitle: The Black Health Block Quit and Screen Project overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-12 date: 2024-12 date: 2024-04-05 date: 2024-04-05 name: University of Arkansas class: OTHER name: Virginia Commonwealth University name: Coalition for a Tobacco Free Arkansas name: National Institute on Minority Health and Health Disparities (NIMHD) name: National Medical Association briefSummary: The Black Health Block Quit and Screen Project seeks to engage Black health care providers in helping Black smokers quit tobacco use, including menthol cigarettes and flavored cigars, and screen for lung cancer early as strategies to reduce multiple chronic disease disparities.
The goal of this clinical trial is to test the feasibility and impact of the Black Health Block Culturally Tailored Training alone versus the Health Disparities and Lung Cancer Screening Training + the Black Health Block Culturally Tailored training modules on changes in knowledge, attitudes, and behavioral intentions related to provider advice to quit smoking and referrals for low dose computed tomography among health care providers randomly assigned to each condition. Participants will complete the training modules and complete pre- and post-tests to assess these outcomes. conditions: Knowledge conditions: Attitudes conditions: Behavioral Intention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 300 type: ESTIMATED name: Black Health Block Culturally Tailored training name: Health Disparities and Lung Cancer Screening training measure: Familiarity with treatment guidelines for tobacco and nicotine treatment measure: Weaver et al. 2012 Provider Attitudes and Perceptions about smoking cessation measure: Weaver et al. 2012 Provider Perceptions about provider barriers to providing smoking cessation interventions to patients measure: Provider Perceptions about patient barriers to smoking cessation measure: Behavioral intentions to screen and advise patients about smoking cessation measure: Familiarity with lung cancer screening guidelines measure: Knowledge about low dose computed tomography for lung cancer screening measure: Perceptions about shared decision-making for low dose computed tomography for lung cancer screening measure: Perceptions about provider barriers to referring patients to low dose computed tomography for lung cancer screening measure: Provider Perceptions about patient barriers to get screened for lung cancer measure: Behavioral intentions to advise patients to get screened for lung cancer via low dose computed tomography measure: Diversity of enrolled healthcare providers measure: Retention: Percent of providers complete the training after enrolling measure: Adherence to completing training modules: Percent of modules completed measure: Preferences regarding training measure: Satisfaction with training sex: ALL minimumAge: 21 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Virginia Commonwealth Univesity city: Richmond state: Virginia zip: 23284 country: United States name: Mignonne Guy, PhD role: CONTACT phone: 804-828-1731 email: mguy@vcu.edu name: Mignonne Guy, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.55376 lon: -77.46026 hasResults: False
<\|newrecord\|> nctId: NCT06350630 id: 20PH284 id: 2024-512653-25-00 type: CTIS briefTitle: Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA) Nephropathy Course QUIgAN Study acronym: QUIgAN overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-12-31 date: 2030-12-31 date: 2024-04-05 date: 2024-04-05 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER name: Ministry of Health, France briefSummary: immunoglobulin A (IgA) nephropathy (Berger disease) is the most frequent primary glomerulonephritis worldwide. This disease accounts for about 5% of the causes of end stage renal disease in France, representing a major public health issue. Its pathophysiology seems to be triggered by mucosal immunity abnormalities leading to the systemic misaddressing of mucosal IgA, generation of circulating immunoglobulin A1 (IgA1) immune complexes finally deposited in renal glomeruli leading to renal tissue inflammation and scarring processes. Among this pathogeny, innate immunity is involved at several steps, including mucosal immunity.
In this regard, hydroxychloroquine has been shown to generate a global anti-inflammatory effect, particularly through its action on Toll like receptors and dendritic cells. This drug is well tolerated, widely used for other auto-immune diseases (e.g. Systemic Lupus Erythematosus) and very low priced.
One randomized controlled study conducted in China has recently shown a significant drop in proteinuria of IgA nephropathy patients treated with hydroxychloroquine (-48.4%) compared to the placebo group (+10.0%), after a quite short-term follow-up (6 months) and a moderate statistical power (30 patients in each group).
Considering (i) the potential mechanism of therapeutic effect on this disease, (ii) the well documented safety profile of the drug for rheumatologic indications and posologies, and its low cost (iii) its efficacy in reducing proteinuria in IgA nephropathy patients in a preliminary Chinese randomized control study, the investigators aim in this study at establishing the beneficial impact of hydroxychloroquine on IgA nephropathy in a double blind randomized controlled trial on a Caucasian French population with harder outcomes and a longer follow-up compared to the Chinese preliminary study. conditions: IgA Nephropathy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: double blind trial randomized primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 334 type: ESTIMATED name: Hydroxychloroquine Oral Tablet name: Placebo oral tablet measure: Absolute difference in estimate Glomerular Filtration Rate (GFR) between hydroxychloroquine group and control group evolution measure: nephrological follow-up: proteinuria measure: nephrological follow-up: albuminuria measure: nephrological follow-up: GFR measure: nephrological follow-up: hematuria measure: nephrological follow-up: systolic and diastolic blood pressure measure: nephrological follow-up: proteinuria measure: nephrological follow-up: albuminuria measure: nephrological follow-up: GFR measure: nephrological follow-up: hematuria measure: nephrological follow-up: systolic and diastolic blood pressure measure: nephrological follow-up: proteinuria measure: nephrological follow-up: albuminuria measure: nephrological follow-up: hematuria measure: nephrological follow-up: systolic and diastolic blood pressure measure: end stage renal disease (GFR< 15mL/min/1.73m²) measure: death measure: adverse events (pruritus, gastro-intestinal disorders) and serious adverse events (QT enlargement, cardiomyopathy, ophthalmologic disorders, neuromyopathy, cytopenia) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Gabriel Montpied city: Clermont-Ferrand zip: 63000 country: France lat: 45.77966 lon: 3.08628 facility: Hospices Civils de Lyon city: Lyon zip: 69437 country: France lat: 45.74848 lon: 4.84669 facility: AP-HM Hôpital de la Conception city: Marseille zip: 13385 country: France name: Thomas ROBERT, MD role: CONTACT phone: 0662426166 phoneExt: +33 email: thomas.robert@ap-hm.fr lat: 43.29551 lon: 5.38958 facility: APHP Hôpital Bichat city: Paris zip: 75018 country: France name: Eric DAUGAS, PU-PH role: CONTACT phone: 0140257101 phoneExt: +33 email: eric.daugas@aphp.fr lat: 48.85341 lon: 2.3488 facility: APHP Hôpital de Tenon city: Paris zip: 75020 country: France name: Khalil EL KAROUI, PU-PH role: CONTACT phone: 0156016317 phoneExt: +33 email: khalil.el-karoui@aphp.fr lat: 48.85341 lon: 2.3488 facility: CHU Lyon Sud city: Pierre-Bénite zip: 69495 country: France name: Sarah MEZAACHE, MD role: CONTACT phone: 0478863712 phoneExt: +33 email: sarah.mezaache@chu-lyon.fr lat: 45.7009 lon: 4.82511 facility: CHU de Saint-Etienne city: Saint-Étienne zip: 42055 country: France name: Nicolas MAILLARD, MD role: CONTACT phone: 0477828127 phoneExt: +33 email: nicolas.maillard@chu-st-etienne.fr name: Carine LABRUYERE role: CONTACT phone: 0477120469 phoneExt: +33 email: carine.labruyere@chu-st-etienne.fr lat: 45.43389 lon: 4.39 hasResults: False
<\|newrecord\|> nctId: NCT06350617 id: 2023-12-028 briefTitle: Personalized rTMS Protocol Based on Functional Reserve to Enhance Ambulatory Function in PD Patients overallStatus: RECRUITING date: 2024-02-20 date: 2025-09-30 date: 2025-09-30 date: 2024-04-05 date: 2024-04-05 name: Samsung Medical Center class: OTHER name: National Research Foundation of Korea name: Ministry of Food and Drug Safety, Korea name: Seoul National University Hospital name: Bucheon St. Mary's Hospital name: Saint Vincent's Hospital, Korea name: Severance Hospital name: Kumoh National Institute of Technology name: NEUROPHET briefSummary: The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each patient with Parkinson's disease, compared to conventional high-frequency rTMS therapy on bilateral primary motor cortex (M1). Investigators hypothesized that the functional reserve of each patient with Parkinson's disease will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to patient with Parkinson's disease regardless of their severity, predicted mechanism of motor function recovery, or functional reserves. conditions: Parkinson's Disease and Parkinsonism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective, single-blind with blind observer, parallel-group design, multi-center, randomized controlled clinical trial primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The participants, assessors, and investigators will be blinded, not be aware of the group allocation. Statistical analysis will also be conducted by data analysts without awareness of the group allocation. Only clinicians applying rTMS intervention will not be blinded, as they will apply rTMS over different stimulation sites based on the protocols. Blinding will be continued until the end of the study, including data analysis. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: High-Frequency, ipsilateral M1 name: High-Frequency, bilateral M1 name: High-Frequency, Lt. DLPFC name: High-Frequency, bilateral M1 measure: Differences of Timed Up and Go Test (TUG) measure: Differences of Timed Up and Go Test (TUG) measure: Differences of Timed Up and Go Test (TUG) measure: Differences of Timed Up and Go Test-Cognitive (TUG-Cog) measure: Differences of Timed Up and Go Test-Cognitive (TUG-Cog) measure: Differences of Timed Up and Go Test-Cognitive (TUG-Cog) measure: Differences of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III measure: Differences of MDS-UPDRS, Part III measure: Differences of New Freezing of Gait Questionnaire (FoG-Q) measure: Differences of New Freezing of Gait Questionnaire (FoG-Q) measure: Differences of Digit span Test measure: Differences of Digit span Test measure: Differences of Trail making Test measure: Differences of Trail making Test measure: Differences of Gait lab parameter (Gait speed) measure: Differences of Gait lab parameter (Gait speed) measure: Differences of Gait lab parameter (Stride length) measure: Differences of Gait lab parameter (Stride length) measure: Differences of Gait lab parameter (Step count) measure: Differences of Gait lab parameter (Step count) measure: Differences of Gait lab parameter (Cadence) measure: Differences of Gait lab parameter (Cadence) measure: Differences of Gait lab parameter (Swing ratio) measure: Differences of Gait lab parameter (Swing ratio) measure: Differences of Gait lab parameter (Stride time) measure: Differences of Gait lab parameter (Stride time) measure: Differences of Gait lab parameter (Pressure distribution) measure: Differences of Gait lab parameter (Pressure distribution) sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul zip: 06351 country: Korea, Republic of name: Won Hyuk Chang, PhD role: CONTACT phone: +82-2-3410-6068 email: wh.chang@samsung.com lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06350604 id: PRO-2023-355 briefTitle: Project WHADE: A Partner-Based Physical Activity Program for Women overallStatus: RECRUITING date: 2024-01-02 date: 2024-06 date: 2024-07 date: 2024-04-05 date: 2024-04-05 name: Rowan University class: OTHER briefSummary: This study is designed to test the feasibility and acceptability of a new method for supporting physical activity among women ages 40-65 who have risk factors for cardiovascular disease. Each participant receives a trained physical activity coach and a physical activity partner; the partner is another woman in the program. Partners communicate with each other between weekly coaching sessions to provide support for physical activity behavior change. conditions: Hypertension conditions: Type 2 Diabetes conditions: Metabolic Syndrome conditions: Smoking conditions: High Cholesterol conditions: PreDiabetes conditions: Prehypertension studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All participants receive the same intervention primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Project WHADE: A Partner-Based Physical Activity Program for Women measure: Frequency of partner communication measure: Satisfaction with partner communication measure: Physical activity behavior - steps measure: Physical activity behavior - active minutes sex: FEMALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rowan University status: RECRUITING city: Glassboro state: New Jersey zip: 08028 country: United States name: Sofia Gular, B.A. role: CONTACT phone: 856-256-4872 email: projectwhade@rowan.edu name: Danielle Arigo, Ph.D. role: CONTACT phone: 8562564500 phoneExt: 53775 email: arigo@rowan.edu lat: 39.70289 lon: -75.11184 hasResults: False
<\|newrecord\|> nctId: NCT06350591 id: 6038674 briefTitle: Evaluating Changes in Skeletal Muscle Proteins Following Resistance Exercise and Single-Leg Disuse overallStatus: RECRUITING date: 2024-04-01 date: 2024-08 date: 2024-08 date: 2024-04-05 date: 2024-04-05 name: Queen's University class: OTHER briefSummary: Skeletal muscle plays a critical role in supporting human health. Beyond its role in providing the force to move, skeletal muscle accounts for a large proportion of metabolic rate, glucose disposal, and amino acid storage. Skeletal muscle is dynamically regulated by environmental stimuli, such as loading (i.e., resistance training\]) and unloading (i.e., disuse atrophy) as well as the intake of essential amino acids (EAAs). However, the precise mechanisms that regulate skeletal muscle mass in response to various conditions (e.g., EAA supplementation, resistance training, and unloading) are not completely understood. Therefore, concerted efforts to better understand the mechanisms regulating skeletal muscle size are needed that aid in the development of therapeutic interventions to combat age, disease, and disuse related muscular atrophy. conditions: Healthy conditions: Skeletal Muscle Atrophy conditions: Skeletal Muscle Hypertrophy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: parallel, within-subject design primaryPurpose: BASIC_SCIENCE masking: NONE count: 14 type: ESTIMATED name: Immobilization name: Resistance training measure: Changes in average rates of muscle synthesis measure: Dynamic proteomic profiling measure: Protein expression (phosphorylation and content) of novel and known targets implicated in protein translation and mitochondrial-related protein expression measure: Muscle torque measure: Quadriceps skeletal muscle volume sex: FEMALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: School of Kinesiology and Health Studies status: RECRUITING city: Kingston state: Ontario zip: K7L 3N6 country: Canada name: Chris McGlory, PhD role: CONTACT phone: 6135336000 phoneExt: 75410 email: chris.mcglory@queensu.ca name: Kristine Boileau, BSc role: CONTACT email: 22kb15@queensu.ca name: Chris McGlory, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.22976 lon: -76.48101 hasResults: False
<\|newrecord\|> nctId: NCT06350578 id: BUHOOTH-D-23-00073 briefTitle: A Randomized Clinical Trial Comparing Hall vs. Conventional Technique in Primary Molars. overallStatus: RECRUITING date: 2023-12-06 date: 2025-03 date: 2025-06 date: 2024-04-05 date: 2024-04-05 name: Primary Health Care Corporation, Qatar class: OTHER_GOV briefSummary: This study aims to assess the comparative effectiveness of the Hall technique (HT) and the conventional technique (CT) for placing Stainless Steel Crowns (SSCs) in primary molars with approximal caries. conditions: Dental Caries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A binary outcome non-inferiority randomized trial. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Single-blind whoMasked: CARE_PROVIDER count: 80 type: ESTIMATED name: Hall Crown Technique name: Conventional SSC Technique measure: Restoration survival at 12 months measure: Occlusal vertical dimension (OVD) resolution measure: Tooth survival measure: Procedural time measure: Participant's cooperation measure: Participant's pain perception measure: Treatment perceptions and opinions of the parents sex: ALL minimumAge: 3 Years maximumAge: 9 Years stdAges: CHILD facility: Primary Healthcare Corporation status: RECRUITING city: Doha country: Qatar name: Research Section role: CONTACT phone: +97444069917 email: researchsection@phcc.gov.qa lat: 25.28545 lon: 51.53096 hasResults: False
<\|newrecord\|> nctId: NCT06350565 id: DEX20240104 briefTitle: A Clinical Pharmacological Study of Dose Halving of Dexamethasone in Pregnant Women With Preterm Labour With Preterm Birth at Greater Than or Equal to 34 Gestational Weeks (34GW+) overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-04-30 date: 2025-12-31 date: 2024-04-05 date: 2024-04-16 name: Peking University Third Hospital class: OTHER briefSummary: This study plans to conduct a DEX dose halving study and a normal dose study in 34+0-35+6 GW women with preterm preterm labour. In addition, this study plans to conduct a DEX dose halving study and a normal dose study in 34-38+6 GW preterm pregnant women with GDM or diabetic co-pregnancy to explore the feasibility of dose halving in pregnant women with diabetes mellitus. conditions: Respiratory Distress Syndrome of Newborn studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Dexamethasone measure: Respiratory distress syndrome measure: PK parameters (analysed in conjunction with population pharmacokinetic (PPK) modelling): area under the blood concentration curve, Cmax, Tmax, Kel, t1/2, CL, VZ measure: Pharmacodynamics measure: Measurability indicators measure: Blood biochemistry findings in newborns measure: DEX potential safety marker test sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06350552 id: PA224ES-1-03 briefTitle: Prevalence of Postural Abnormalities in Dialysis Patients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-04 date: 2024-04 date: 2024-04-05 date: 2024-04-23 name: Pardis Specialized Wellness Institute class: OTHER briefSummary: The goal of this observational study is to investigate and compare the prevalence of forward head , hyper kyphosis and balance in hemodialysis and peritoneal dialysis patients. The main questions it mains to answer are:
What is the prevalence of forward head posture in hemodialysis and peritoneal dialysis patients? What is the prevalence of hyper kyphosis in hemodialysis and peritoneal dialysis patients? Is there any relation between postural abnormalities and physical function in hemodialysis and peritoneal dialysis patients?
Participants will answer 2 questionnaires and will do some functional tests. conditions: End Stage Renal Disease conditions: Hemodialysis Complication conditions: Peritoneal Dialysis Complication studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 390 type: ESTIMATED measure: Prevalence of thoracic hyper kyphosis measure: Prevalence of forward head measure: Balance level measure: Cardiopulmonary function's level measure: Fall risk level sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Khorshid Dialysis Center city: Isfahan country: Iran, Islamic Republic of lat: 32.65246 lon: 51.67462 hasResults: False
<\|newrecord\|> nctId: NCT06350539 id: 10-007 briefTitle: Personalized Models for Cancer Research overallStatus: RECRUITING date: 2024-02-15 date: 2034-02-15 date: 2034-02-15 date: 2024-04-05 date: 2024-04-05 name: New York Stem Cell Foundation Research Institute class: OTHER name: Stevens Institute of Technology briefSummary: The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate cancer research ranging from disease mechanisms to personalized medicine approaches that will help to realize the promise of precision medicine for oncology. conditions: Solid Tumor, Adult studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 500 type: ESTIMATED name: Biological Sample Collection measure: Implement organoid culture technologies. measure: Validate genotypic and phenotypic relevance of tumor-derived organoids for biobanking. measure: Establish functional testing using organoid cultures alone or in combination with additional cell types. measure: Perform drug testing and screens to identify new targets and/or new therapeutic strategies to effectively treat cancer. measure: Develop a Laboratory Developed Test (LDT) for CLEP/FDA approval that will inform clinicians of each patient's tumor responses to FDA approved drugs. measure: Develop stem cells from individual patient samples to study tumor evolution. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: New York Stem Cell Foundation Research Institute status: RECRUITING city: New York state: New York zip: 10019 country: United States name: Becca Wood role: CONTACT phone: 212-927-1801 email: clinicalresearch@nyscf.org name: Lisa Voltolina role: CONTACT phone: 6462133911 email: lvoltolina@nyscf.org name: Laura Andres-Martin, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

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