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* If taking the supplement for 16 days improves exercise performance, or the speed with which the body responds to the commencement of exercise. |
* If taking the supplement improves cognitive function. |
Participants will visit the lab on 5 separate occasions to: |
* complete some cognitive tests |
* complete exercise performance tests |
* provide blood samples |
All exercise tests will be on an exercise bike. |
After 28 (or 46 for pre-menopausal females) days to make sure the supplement has left the body fully, participants will consume the opposite supplement and repeat the tests. conditions: Exercise Performance conditions: Cognitive Function studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Trials will be randomised and counterbalanced to remove any trial-order effect. primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Partners Innovate UK and Mitocholine Ltd will also be masked. Masking will be performed by an individual outside of the research group. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Mitochondrial Substrate Supplement name: Placebo Supplement measure: Exercise Capacity measure: VO2 kinetic response to exercise measure: Cognitive Function (Stroop test) measure: Cognitive Function (decision reaction test) measure: Grip Strength measure: Capillary Blood Lactate measure: Questionnaire 1 measure: Questionnaire 2 measure: Venous Blood [Betaine] measure: Venous Blood [Choline] measure: Venous blood [S-Adenosyl methionine] measure: Venous blood [glucose]. measure: Venous blood [insulin]. measure: Venous blood [trimethylamine N-oxide]. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Richards Building St. Lukes Campus University of Exeter status: RECRUITING city: Exeter state: Devon zip: EX2 4TH country: United Kingdom name: Jimmy T Wangdi, PhD role: CONTACT phone: 01392 661000 email: [email protected] name: Matthew I Black, PhD role: CONTACT email: [email protected] lat: 50.7236 lon: -3.52751 hasResults: False |
<|newrecord|> nctId: NCT06374628 id: 0001 briefTitle: Pre-pectoral Tissue Expander and Acellular Dermal Matrix for a Two-stage Muscle Sparing Breast Reconstruction overallStatus: RECRUITING date: 2019-06-01 date: 2024-04-01 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Rossella Elia, MD PhD class: OTHER briefSummary: The aim of the research is to evaluate clinical outcomes of a two stage muscle sparing prepectoral breast reconstruction using tissue expander (TE) entirely covered by an ADM. The authors aim to report surgical indications, technical tips, clinical and histological outcomes with the final objective of delineate a decision-making algorithm for immediate prosthetic breast reconstruction. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 44 type: ESTIMATED name: breast reconstruction measure: Patient satisfaction measure: Pain Evaluation measure: Complication rate sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: AOU Policlinico status: RECRUITING city: Bari state: BA country: Italy name: Rossella Elia role: CONTACT phone: 3409616476 email: [email protected] lat: 41.11148 lon: 16.8554 hasResults: False |
<|newrecord|> nctId: NCT06374615 id: 2024-07 briefTitle: Insights Into Tick-Borne Diseases: a Study From an Endemic Area of Northern Italy acronym: TICKTOC overallStatus: RECRUITING date: 2024-03-25 date: 2029-03 date: 2029-03 date: 2024-04-18 date: 2024-04-18 name: IRCCS Sacro Cuore Don Calabria di Negrar class: OTHER briefSummary: This is a monocentric, experimental, non-pharmacological and non-device no profit study. |
The study is experimental because all the visits and blood withdrawals foreseen by the protocol do not fall within the normal clinical practice. conditions: Tick-Borne Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 384 type: ESTIMATED name: IgG and IgM search for specific Tick-Borne Patogens measure: Number of individuals diagnosed with Tick-Borne Diseases (TBD) over the total number of individuals who were bitten by a tick which carried an identified TBP. measure: Number of identified Tick-Borne Patogenees (TBPs) on the total number of analyzed ticks measure: Number of individuals who developed symptoms and were diagnosed for a TBP infection during the 12 weeks' follow-up period measure: Number of individuals who developed specific antibodies against a TBP after tick bite. measure: List of novel TBPs that were not previously found in the study areas. sex: ALL minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Sacro Cuore Don Calabria hospital status: RECRUITING city: Negrar state: Verona zip: 37024 country: Italy name: Andrea Tedesco role: CONTACT email: [email protected] name: Andrea Tedesco role: PRINCIPAL_INVESTIGATOR lat: 45.52918 lon: 10.93899 hasResults: False |
<|newrecord|> nctId: NCT06374602 id: 33 briefTitle: Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer overallStatus: RECRUITING date: 2024-03-25 date: 2026-03-25 date: 2026-06-25 date: 2024-04-18 date: 2024-04-18 name: Saint Petersburg State University, Russia class: OTHER briefSummary: This pilot phase 2 study evaluate the effectiveness and safety of pembrolizumab and lenvatinib in patients with anaplastic thyroid cancer. Patients with anaplastic thyroid cancer who are treatment-naive (BRAF-negative) and who were previously treated with chemptherapy or targeted therapy are scheduled to undergo pembrolizumab and lenvatinib and evaluate the outcomes according to the primary and secondary endpoints. conditions: Anaplastic Thyroid Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Pembrolizumab + Lenvatinib measure: Objective response rate measure: Progression-Free Survival measure: Safety and Tolerability assessment (Incidence of Treatment-Emergent Adverse Events) measure: Overall survival measure: The assessment of conversion to resectability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Saint Petersburg State University Hospital status: RECRUITING city: Saint Petersburg zip: 190020 country: Russian Federation name: Ernest Dzhelialov role: CONTACT phone: +7(911)134-50-44 email: [email protected] lat: 59.93863 lon: 30.31413 hasResults: False |
<|newrecord|> nctId: NCT06374589 id: 202303123 briefTitle: Closed-Loop O2 Use During High Flow Oxygen Treatment Of Critical Care Adult Patients (CLOUDHFOT) acronym: CLOUDHFOT overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-21 date: 2024-08-30 date: 2024-12-30 date: 2024-04-18 date: 2024-04-18 name: Başakşehir Çam & Sakura City Hospital class: OTHER_GOV name: Hamilton Medical AG briefSummary: High flow nasal oxygen therapy (HFNO) is an established modality in the supportive treatment of patients suffering from acute hypoxemic respiratory failure. The high humidified gas flow supports patient's work of breathing, reduces dead space ventilation, and improves functional residual capacity while using an unobtrusive patient's face interface \[Mauri et al, 2017; Möller et al, 2017\]. |
As hyperoxia is considered not desirable \[Barbateskovic et al, 2019\] during any oxygen therapy, the inspired O2 concentration is usually adapted to a pre-set SpO2 target-range of 92-96% in patients without hypercapnia risk, and of 88-92% if a risk of hypercapnia is present \[O'Driscoll et al, 2017; Beasley et al, 2015\]. In most institutions, the standard of care is to manually adapt the FiO2, although patients frequently have a SpO2 value outside the target range. |
A new closed loop oxygen controller designed for HFNO was recently developed (Hamilton Medical, Bonaduz, Switzerland). The clinician sets SpO2 targets, and the software option adjusts FiO2 to keep SpO2 within the target ranges. The software option offers some alarms on low and high SpO2 and high FiO2. Given the capability, on the one hand, to quickly increase FiO2 in patients developing sudden and profound hypoxia, and, on the other hand, of automatically preventing hyperoxia in patients improving their oxygenation, such a system could be particularly useful in patients treated with HFNO. |
A short-term (4 hours vs 4 hours) crossover study indicated that this technique improves the time spent within SpO2 pre-defined target for ICU patients receiving high-flow nasal oxygen therapy \[Roca et al, 2022\]. Due to its simplicity, HFNO is increasingly used outside the ICU during transport and in the Emergency Room (ER). This environment poses specific challenges, as patients may deteriorate very quickly and depending on patient's flow, healthcare providers can easily be overwhelmed. We thus propose to evaluate closed loop controlled HFNO in ER patients. |
The hypothesis of the study is that closed loop oxygen control increases the time spent within clinically targeted SpO2 ranges and decreases the time spent outside clinical target SpO2 ranges as compared to manual oxygen control in ER patients treated with HFNO. conditions: Acute Hypoxemic Respiratory Failure conditions: Acute Hypercapnic Respiratory Failure conditions: Respiratory Depression conditions: Respiratory Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: Closed-loop FiO2 controller name: Conventional measure: Percentage of time spent in optimal SpO2 range measure: Percentage of time with SpO2 signal available measure: Percentage of time with SpO2 below target range measure: Percentage of time with SpO2 above target range measure: Percentage of time with SpO2 outside optimal range measure: Percentage of time with with FiO2 below 40% measure: Percentage of time with with FiO2 above 60% measure: Percentage of time with with FiO2 = 100% measure: Mean SpO2/FiO2 measure: Number of events with SpO2 below of target range (duration >10 s) measure: Number of events with SpO2 below of target range (duration >60 s) measure: Number of events with SpO2 below the predefined low SpO2 emergency limit measure: Number of events with SpO2 above the predefined low SpO2 emergency limit measure: Total oxygen use sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr.Suat Seren Chest Diseasees Hospital city: Izmir zip: 35230 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False |
<|newrecord|> nctId: NCT06374576 id: GCIEL briefTitle: Improving eHealth Literacy of Older Adults in Hong Kong overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-12 date: 2024-04-18 date: 2024-04-18 name: The University of Hong Kong class: OTHER name: Sino Group name: NG TENG FONG Charitable Foundation briefSummary: This study is an randomized controlled trial (RCT) study to examine the feasibility and effectiveness of a community-based health promotion education intervention for improving the eHealth literacy of older adults conditions: eHealth Literacy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 184 type: ESTIMATED name: Lecture on eHealth literacy name: Digital intervention on eHealth literacy name: Lecture on general health name: Digital intervention on general health measure: eHealth literacy measure: Health Knowledge Learning Intention measure: Online Health Information Seeking measure: Online Health Information Scanning measure: Health-promotion behaviors measure: Health Decision Change sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: The University of Hong Kong city: Hong Kong country: China name: Sophia SC Chan, PhD role: CONTACT phone: 85239176610 email: [email protected] name: Sophia SC Chan, PhD role: PRINCIPAL_INVESTIGATOR lat: 22.39407 lon: 114.13737 hasResults: False |
<|newrecord|> nctId: NCT06374563 id: BUC-IACUC-221109-6 briefTitle: Tackling Pressure Ulcer Via Bee Venom Phonophoresis acronym: ulcer overallStatus: COMPLETED date: 2022-11-09 date: 2024-01-01 date: 2024-03-01 date: 2024-04-18 date: 2024-04-18 name: Badr University class: OTHER briefSummary: This study aimed to investigate the efficiency of topical Bee Venom gel versus phonophoresis of Bee Venom gel to accelerate healing of chronic pressure ulcer conditions: Bee Venom conditions: Pressure Ulcers conditions: Phonophoresis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ACTUAL name: group 1 received topical Bee venom gel name: Group 2: Phonophoresis of Bee Venom gel measure: wound surface area wound surface area measure: wound volume sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Badr University in Cairo city: Cairo zip: 11837 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06374550 id: 20231026 briefTitle: Jump Start on the Go: Improving Resiliency and the Social-Emotional Development of At-Risk Preschool Children overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-01 date: 2025-12-01 date: 2024-04-18 date: 2024-04-18 name: University of Miami class: OTHER briefSummary: The purpose of this study is to test the Jump Start on the Go (JS Go), an app-based program and see how helpful it is at improving resiliency and behavior support within childcare settings. conditions: Mental Health Wellness 1 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 250 type: ESTIMATED name: Jump Start on the Go name: Jump Start Plus Coronavirus Support measure: Change in classroom practices as measured by Health Environment Rating Scale measure: Change in child behaviors as measured by Devereux Early Childhood Assessments (DECA) measure: Change in child behaviors as measured by Strengths and Difficulties Questionnaire (SDQ) measure: Change in resiliency as measured by Brief Resiliency Coping Scale measure: Change in stress as measured by Childcare Worker Job Stress Index measure: Change in stress as measured by Everyday Stressors Index measure: Change in satisfaction as measured by Teacher Opinion and Satisfaction survey sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami city: Miami state: Florida zip: 33136 country: United States name: Ruby Natale, PhD, PsyD role: CONTACT phone: 305-243-4617 email: [email protected] name: Ruby Natale, PhD, PsyD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False |
<|newrecord|> nctId: NCT06374537 id: 2017-0784 briefTitle: Evaluate the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients. overallStatus: RECRUITING date: 2019-05-22 date: 2026-05-22 date: 2027-05 date: 2024-04-18 date: 2024-04-22 name: University of Illinois at Chicago class: OTHER briefSummary: This research is being done to better understand the impact of the use of a specific physical activity training program (GH Method) in dialysis/kidney disease patients. conditions: Frailty conditions: Pain, Chronic conditions: Dialysis; Complications conditions: Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Muscle Therapy measure: Rate at which subjects will see changes in their physical abilities. measure: Rate at which exercise will change body composition measure: Rate at which exercise will change handgrip strength. measure: Rate at which subjects enrolled in the exercise intervention will have an overall changed sense of well-being. measure: Rate at which subjects enrolled in the exercise intervention will have an overall changed in their quality of life. measure: Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in depression. measure: Rate at which subjects enrolled in the exercise intervention will have an overall change in pain intensity. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Illinois at Chicago status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Ilaria Santi role: CONTACT phone: 312-996-9594 email: [email protected] name: Natalie Isho role: CONTACT phone: 312-996-4708 email: [email protected] lat: 41.85003 lon: -87.65005 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-07-25 uploadDate: 2024-04-15T15:15 filename: Prot_SAP_000.pdf size: 1911663 hasResults: False |
<|newrecord|> nctId: NCT06374524 id: R24-03 briefTitle: Greater Occipital Nerve Block for Spontaneous Intracranial Hypotension overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2026-02-01 date: 2026-06-01 date: 2024-04-18 date: 2024-04-18 name: University Health Network, Toronto class: OTHER briefSummary: SIH is a debilitating neurological disorder caused by a cerebrospinal fluid leak, with an estimated incidence of 5 per 100,000 persons per year, of which mostly women between the ages of 35 years and 55 years (1). The typical presentation is moderate-to-severe orthostatic headache and several other possible neurological symptoms, that significantly impact patients' quality of life (2). |
Treatment of SIH usually starts with conservative measures, consisting of strict supine bed rest, hydration, caffeine, and simple analgesics (3). The vast majority of patients will require invasive treatments for their CSF leak, such as epidural blood patches, fibrin glue patches, endovascular coiling, and/or surgical repair (4). These specialized treatments are only offered in tertiary care centers and require specialized personnel and resources, which implicates a certain waiting time for the patients before permanent treatment is offered (5). In the meantime, due to the lack of an effective and accessible alternative, patients continue to suffer. |
The GONB has been reported as a simple, safe, and effective treatment to provide short-to-intermediate term relief of migraine (6), cervicogenic headache, cluster headache (7), occipital neuralgia, and more recently, post-dural puncture headaches (PDPH) (8). As the pathophysiology of intracranial hypotension caused by SIH or PDPH is very similar (9), it is stipulated that the effect of GONB will be similar for SIH patients. However, to date, no studies exploring the efficacy of GONB for SIH have been performed. |
We propose to do a prospective observational study to explore the outcome of GONB for SIH. GONB can serve as a bridge therapy to control the debilitating headache of SIH while patients are awaiting permanent SIH treatment. Moreover, GONB can be performed by physicians of different specialties including neurology, which makes it an accessible treatment for all patients. Lastly, by offering better symptom control, this intervention could potentially restore patients' ability to work and reduce healthcare costs. conditions: Spontaneous Intracranial Hypotension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 34 type: ESTIMATED name: greater occipital nerve block measure: Change in headache intensity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06374511 id: NFEC-2023-546 briefTitle: Prospective Cohort Study of Complications and Outcomes in Cirrhosis overallStatus: RECRUITING date: 2024-01-01 date: 2024-04-04 date: 2025-12-31 date: 2024-04-18 date: 2024-04-18 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: This is a multi-center, nested cohort study intended to investigate the prevalence, risk factors, and outcomes of complications in patients with acutely decompensated cirrhosis, especially focused on Cytomegalovirus (CMV) reactivation, bacterial infections, hepatic encephalopathy, and Hepatorenal syndrome. Patients diagnosed with acutely decompensated cirrhosis were enrolled. Upon enrollment, detailed baseline data were collected and samples were harvested. Complications were assessed during hospitalization. Post-discharge follow-up was conducted through telephonic interviews at Day 30 and Day 90. conditions: Decompensated Cirrhosis conditions: CMV Reactivation conditions: Overt Hepatic Encephalopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 660 type: ESTIMATED name: Test for CMV reactivation measure: Incidence of CMV reactivation measure: Incidence of hepatic encephalopathy measure: Response to anti-CMV therapy measure: Response to treatment for hepatic encephalopathy (HE) measure: Survival sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510515 country: China name: Jinjun Chen, PHD role: CONTACT phone: 86-18588531001 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06374498 id: 2023P003247 briefTitle: Study to Determine the Clinical Significance of Intravascular OCT-NIRAF overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-04-30 date: 2027-04-30 date: 2024-04-18 date: 2024-04-18 name: Massachusetts General Hospital class: OTHER briefSummary: Patients undergoing coronary angiography for stable or acute coronary disease presentations and eligible for percutaneous coronary intervention (PCI) will be imaged with OCT-NIRAF at baseline and with CCTA 12 months apart to demonstrate that: |
1. NIRAF coronary artery signal level (patient, artery, lesion basis) is correlated with the severity of coronary artery disease. |
2. NIRAF coronary artery signal level is a predictor of plaque progression on a per patient, per artery, or per lesion basis. conditions: Cardiovascular Diseases conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 40 type: ESTIMATED name: OCT-NIRAF measure: Plaque size estimation using OCT-NIRAF measure: Plaque progression estimate using OCT-NIRAF sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States name: Nitasha Bhat, MD role: CONTACT phone: 617-724-4515 email: [email protected] lat: 42.35843 lon: -71.05977 hasResults: False |
<|newrecord|> nctId: NCT06374485 id: AU409-LEES-2021-03 briefTitle: Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment overallStatus: RECRUITING date: 2024-04-12 date: 2026-02-28 date: 2026-08-28 date: 2024-04-18 date: 2024-04-18 name: Lee's Pharmaceutical Limited class: INDUSTRY briefSummary: This study is a Phase I, dose-escalation study of AU409 in advanced hepatocellular carcinoma patients who failed standard treatment. A '3+3' dose-escalation design will be utilized to gradually increase the dose of AU409, aiming to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor efficacy of multi-dose AU409 in patients with advanced HCC. conditions: Advanced Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: AU409 capsules measure: Dose Limiting Toxicity measure: Maximum Tolerated Dose measure: Recommended Phase 2 Dose measure: Objective Response Rate measure: Disease Control Rate measure: Duration of Response measure: Progression-free Survival measure: Overall Survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Clinical Oncology, Queen Mary Hospital status: RECRUITING city: Hong Kong country: China name: Chi Leung Chiang role: PRINCIPAL_INVESTIGATOR name: Albert Chan role: SUB_INVESTIGATOR name: Aya El HELALI role: SUB_INVESTIGATOR lat: 22.39407 lon: 114.13737 hasResults: False |
<|newrecord|> nctId: NCT06374472 id: IRB00001194 briefTitle: Surgical Treatment of Fractures of the Dorso-lombar Spine overallStatus: COMPLETED date: 2018-01-01 date: 2022-01-01 date: 2022-01-01 date: 2024-04-18 date: 2024-04-18 name: Ibn Jazzar Hospital class: OTHER briefSummary: Trauma to the thoracolumbar spine is responsible for potentially serious lesions, most often involving the functional prognosis in the short, medium and long term, and rare The frequency of these traumas is explained by falls from high places, especially during work accidents or suicide attempts, but also by the perpetual increase in accidents on public roads ly the vital prognosis conditions: Spine Fracture studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 80 type: ACTUAL name: Osteosynthesis measure: Age (in years) measure: Sex measure: Neurological status ( Frenkel classification) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IBN jazzar hospital city: Kairouan zip: 3190 country: Tunisia lat: 35.6781 lon: 10.09633 hasResults: False |
<|newrecord|> nctId: NCT06374459 id: 24-x109 id: BC200714 type: OTHER_GRANT domain: Department of Defense briefTitle: Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2031-11-30 date: 2031-11-30 date: 2024-04-18 date: 2024-04-18 name: Washington University School of Medicine class: OTHER name: United States Department of Defense name: Aclaris Therapeutics, Inc. briefSummary: This is a phase Ib/II study evaluating the safety and efficacy of zunsemetinib (ATI-450) with capecitabine in patients with hormone receptor-positive and HER2-negative (HR+/HER2-) metastatic breast cancer (MBC). conditions: Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The Phase I portion of the study is sequential and patients will not be randomized and the Phase II portion is parallel and patients will be randomized. primaryPurpose: TREATMENT masking: NONE count: 138 type: ESTIMATED name: Zumsemetinib name: Capecitabine name: Zoledronic acid name: Denosumab measure: Number of participants with adverse events (Phase Ib only) measure: Recommended phase II dose of zunsemetinib (Phase Ib only) measure: Percent change in serum CTX (Phase II only) measure: Progression-free survival (PFS) (Phase II only) measure: Treatment-induced changes in DEXA BMD (g/cm^2) at hip and spine (Phase Ib only) measure: Treatment-induced changes in sCTX by clinical assay (Phase II only) measure: Objective response rate (ORR) (Phase II only) measure: Clinical benefit rate (Phase II only) measure: Overall survival (OS) (Phase II only) measure: Treatment-induced changes in DEXA BMD (g/cm^2) at hip and spine (Phase II only) measure: Treatment-induced changes in quality of life as measured by EORTC QLQ-C30 (Phase II only) measure: Treatment-induced changes in pain as measured by Brief Pain Inventory (BPI) (Phase II only) measure: Number of participants with adverse events (Phase II only) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Kansas Cancer Center city: Westwood state: Kansas zip: 66205 country: United States name: Qamar Khan, M.D. role: CONTACT phone: 913-588-1227 name: Qamar Khan, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.04056 lon: -94.6169 facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States name: Matthew Goetz, M.D. role: CONTACT phone: 507-284-2511 email: [email protected] name: Matthew Goetz, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States name: Cynthia X Ma, M.D., Ph.D. role: CONTACT phone: 314-362-8903 email: [email protected] name: Cynthia X Ma, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR name: Sheila Stewart, Ph.D. role: SUB_INVESTIGATOR name: Roberto Civitelli, M.D. role: SUB_INVESTIGATOR name: Jingqin (Rosy) Luo, Ph.D. role: SUB_INVESTIGATOR name: Foluso Ademuyiwa, M.D. role: SUB_INVESTIGATOR name: Nusayba Bagegni, M.D. role: SUB_INVESTIGATOR name: Ron Bose, M.D., Ph.D. role: SUB_INVESTIGATOR name: Andrew Davis, M.D. role: SUB_INVESTIGATOR name: Ashley Frith, M.D., Ph.D. role: SUB_INVESTIGATOR name: Faisal Fa'ak, M.D. role: SUB_INVESTIGATOR name: Lindsay Peterson, M.D. role: SUB_INVESTIGATOR name: Rama Suresh, M.D. role: SUB_INVESTIGATOR lat: 38.62727 lon: -90.19789 hasResults: False |
<|newrecord|> nctId: NCT06374446 id: 22-172 briefTitle: Effect of Virtual Reality in Patients With Long Covid-19 overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-06-15 date: 2024-06-30 date: 2024-04-18 date: 2024-04-18 name: Istinye University class: OTHER briefSummary: SARS-CoV-2 was first detected in Wuhan, Hubei Province, China, in late 2019. It is a highly contagious virus that has been reported to occur in humans and is said to cause pneumonia. |
Covid-19 infection is transmitted through droplets during coughing and sneezing and through contact with the mouth, nose or eyes after contaminated hands. The most obvious symptoms of Covid-19 symptoms include cough, dyspnea and fever. Covid-19, which can also be seen asymptomatic, is in intensive care it may be severe enough to require hospitalization, cause multiple organ failure and even death it could be. Musculoskeletal symptoms such as fatigue, myalgia, and arthralgia are common with Covid-19 are the symptoms. The first case in Turkey was reported on March 11, 2020. |
Long-term Covid or Chronic Post Covid Syndrome are multi-system syndromes that last more than 12 weeks and physical, cognitive, psychological, social and occupational domains. The most commonly reported long covid symptoms are; fatigue, shortness of breath, cough, joint pain, chest pain. |
Virtual reality application provides its users with content created using computer technology. In a virtual environment with a high perception of reality, the aim is to enable mirror neuron activation, enabling the individual to interact with virtual objects and events with three-dimensional movements and to create the perception of doing all these in the real world. |
Virtual reality for training, treatment, rehabilitation, analysis and testing purposes in healthcare can be used. It is possible to use virtual reality for different purposes, for treatment and rehabilitation. With virtual reality applications in treatment and rehabilitation processes It was stated that patient motivation will increase and patient fear and anxiety will decrease. |
No study was found in the literature investigating the effect of virtual reality application on fatigue, functional capacity and respiratory function in long-term Covid-19 patients. The purpose of this study; To investigate the effect of virtual reality application on fatigue, functional level and respiratory function in long-term Covid-19 patients. conditions: COVID-19 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: Classical Treatment name: Virtual Reality Combined with Classical Treatment name: Virtual Reality name: Control Group measure: Fatigue measure: Kinesiophobia measure: Evaluation of Respiratory Function measure: Shuttle Walking Test measure: Endurance Shuttle Walking Test measure: Sit and Reach Test measure: Peripheral Muscle Strength measure: The Nottingham Health Profile measure: Dyspnea measure: Energy Consumption measure: Posture Analysis measure: Covid-19 Yorkshire Performance measure: FACIT Fatigue Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06374433 id: PREDICOM-01 briefTitle: Investigating the Plasticity of Human Predictive Coding Through Neuromodulation acronym: PREDICOM overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-12-31 date: 2024-04-18 date: 2024-04-18 name: Università Vita-Salute San Raffaele class: OTHER name: Alessia Santoni name: Sara Stottmeier name: Klara Hemmerich name: Giuseppe Di Dona name: Luigi Ferini-Strambi briefSummary: The hypothesis of the study is to investigate how different trm (tES) methods (transcranial Alternating Current Stimulation, tACS, and transcranial Random Noise Stimulation, tRNS) applied at different stimulation frequencies and networks can modulate the predictive mechanisms in human perception and cognition. This is an interventional, monocentric, cross-sectional randomized, single-blinded study on healthy adult volunteers, recruited through online advertisements, flyers and oral transmission. Volunteers will be recruited from the general population of young adults. conditions: Human Brain and Cognition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 210 type: ESTIMATED name: Occipital tACS at IAF-2Hz name: Occipital tACS at IAF+2Hz name: Frontal tACS at 4-7 Hz name: Occipital tRNS name: Frontal tRNS name: Sham/placebo tACS name: Sham/placebo tRNS measure: Behavioral measures sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06374420 id: MD.21.11.564 briefTitle: Small Airway Disease And Bronchial Hyperreactivity In Patients With Post Acute Covid-19 Syndrome overallStatus: COMPLETED date: 2021-09-01 date: 2023-09-01 date: 2024-04-01 date: 2024-04-18 date: 2024-04-19 name: Mansoura University class: OTHER briefSummary: The aim of this work is to estimate the frequency of small airway disease and/or the bronchial hyperreactivity in follow up of postacute covid survivors. conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ACTUAL measure: investigating pulmonary sequelae of covid-19. measure: investigating pulmonary sequelae of covid-19. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mansoura University city: Mansoura state: Dakhlia zip: 050 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False |
<|newrecord|> nctId: NCT06374407 id: GT-001 briefTitle: The MIND-GUT Digital Pilot Intervention Study acronym: MINDGUT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-05 date: 2026-12 date: 2024-04-18 date: 2024-04-18 name: University of Skövde class: OTHER name: State University of New York - Downstate Medical Center name: Albert Einstein College of Medicine name: Göteborg University name: Uppsala University name: Kristianstad University name: University of Pavia name: The Food Scientist AB (Sweden) briefSummary: This 12-week pilot study aims to evaluate the feasibility and effectiveness of a dietary intervention targeting diet, obesity, mental health, and the gut microbiome in promoting weight loss and enhancing mental health among obese men and women aged 30-50. Participants, excluding those with specific medical conditions, will be randomly assigned to either an intervention or control group using a meal planning smartphone app. Clinical assessments will include anthropometry, mental health questionnaires, dietary recalls, and stool sample collections. The study's endpoints include program retention, adherence, changes in body weight, mental health, and gut microbiome diversity. Statistical analyses will evaluate intervention effects and the potential mediating roles of the gut microbiome. This pilot study has implications for health policies, public healthcare, digital health companies, and the biotech and pharmacology industries. Future plans involve a large-scale intervention study in multiple countries with ongoing collaborations. conditions: Obesity conditions: Depressive Symptoms conditions: Anxiety conditions: Stress conditions: Eating Habit conditions: Dysbiosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: We plan to randomly assign participants to either the intervention or control group. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Participants will be blinded to their group assignment and will use a smartphone app for meal planning. However, those in the intervention group may have some awareness of their assignment due to specific food choices. Meanwhile, the control group will have access to a variety of foods and recipes, maintaining blinding between the groups regarding their assigned diets, addressing a common challenge in diet intervention studies. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 126 type: ESTIMATED name: Dietary intervention based on the MIND diet measure: Program retention measure: Adherence measure: Acceptability measure: Study effectiveness: change in eating attitudes at follow-up measure: Study effectiveness: change in stress levels at follow-up measure: Study effectiveness: change in depression symptoms at follow-up measure: Study effectiveness: change in anxiety symtoms at follow-up measure: Study effectiveness: change in body weight at follow-up measure: Study effectiveness: change in % total fat mass at follow-up measure: Study effectiveness: change in % visceral fat mass at follow-up measure: Study effectiveness: change in waist circumference at follow-up measure: Study effectiveness: change in hip circumference at follow-up measure: Study effectiveness: change in microbiome variety at follow-up sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: University of Skövde city: Skövde zip: 54128 country: Sweden name: Gianluca Tognon, PhD role: CONTACT lat: 58.39118 lon: 13.84506 hasResults: False |
<|newrecord|> nctId: NCT06374394 id: 217848 id: 2023-510196-59-00 type: OTHER domain: EU CTR Number briefTitle: A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2024-12-03 date: 2025-05-20 date: 2024-04-18 date: 2024-04-18 name: GlaxoSmithKline class: INDUSTRY briefSummary: This study will assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above. conditions: Respiratory Syncytial Virus Infections studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE maskingDescription: Click here to enter text. count: 850 type: ESTIMATED name: RSVPreF3 OA investigational vaccine name: COVID-19 mRNA vaccine measure: RSV-A neutralization titers measure: RSV-B neutralization titers measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against pseudovirus bearing S protein measure: RSV-A neutralization titers expressed as GMT measure: RSV-A neutralization titers expressed as Mean Geometric Increase (MGI) measure: RSV-A neutralization titers expressed as Seroresponse Rate (SRR) measure: Percentage of participants having RSV-A neutralizing titers >= assay cut-off value measure: RSV-B neutralization titers expressed as GMT measure: RSV-B neutralization titers expressed as MGI measure: RSV-B neutralization titers expressed as SRR measure: Percentage of participants having RSV-B neutralizing titers >= assay cut-off value measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the pseudovirus bearing S protein expressed as GMT measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the the pseudovirus bearing S protein expressed as MGI measure: Percentage of participants having SARS-CoV-2 Omicron XBB.1.5 neutralization titers >= assay cut-off value measure: Percentage of participants reporting each solicited administration site event measure: Percentage of participants reporting each solicited systemic event measure: Percentage of participants reporting unsolicited adverse events (AEs) measure: Percentage of participants reporting serious adverse events (SAEs) measure: Percentage of participants reporting potential immune-mediated diseases (pIMDs) sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site city: Coral Gables state: Florida zip: 33134 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Jeffrey B. Rosen role: PRINCIPAL_INVESTIGATOR lat: 25.72149 lon: -80.26838 facility: GSK Investigational Site city: Savannah state: Georgia zip: 31406 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Paul Bradley role: PRINCIPAL_INVESTIGATOR lat: 32.08354 lon: -81.09983 facility: GSK Investigational Site city: Evansville state: Indiana zip: 47714 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Hubert Sulit Reyes role: PRINCIPAL_INVESTIGATOR lat: 37.97476 lon: -87.55585 facility: GSK Investigational Site city: Omaha state: Nebraska zip: 68134 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Brandon James Essink role: PRINCIPAL_INVESTIGATOR lat: 41.25626 lon: -95.94043 facility: GSK Investigational Site city: Secaucus state: New Jersey zip: 07094 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Johnathan Blizzard role: PRINCIPAL_INVESTIGATOR lat: 40.78955 lon: -74.05653 facility: GSK Investigational Site city: Rochester state: New York zip: 14609 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Patrick Connors role: PRINCIPAL_INVESTIGATOR lat: 43.15478 lon: -77.61556 facility: GSK Investigational Site city: Winston-Salem state: North Carolina zip: 27103 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Jonathan Paul Wilson role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 facility: GSK Investigational Site city: North Charleston state: South Carolina zip: 29405 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Kelly Morales role: PRINCIPAL_INVESTIGATOR lat: 32.85462 lon: -79.97481 facility: GSK Investigational Site city: Newport News state: Virginia zip: 23606 country: United States name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: George H Freeman role: PRINCIPAL_INVESTIGATOR lat: 37.08339 lon: -76.46965 facility: GSK Investigational Site city: Antwerpen zip: 2000 country: Belgium name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Yven Van Herrewege role: PRINCIPAL_INVESTIGATOR lat: 51.21989 lon: 4.40346 facility: GSK Investigational Site city: Edegem zip: 2650 country: Belgium name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Nikita Hanning role: PRINCIPAL_INVESTIGATOR lat: 51.15662 lon: 4.44504 facility: GSK Investigational Site city: Gent zip: 9000 country: Belgium name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Isabel Leroux-Roels role: PRINCIPAL_INVESTIGATOR lat: 51.05 lon: 3.71667 facility: GSK Investigational Site city: Kluisbergen zip: 9690 country: Belgium name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Klaas Vercruysse role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site city: Mechelen zip: 2800 country: Belgium name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Claudia Cornelis role: PRINCIPAL_INVESTIGATOR lat: 51.02574 lon: 4.47762 facility: GSK Investigational Site city: Breda zip: 4818 CK country: Netherlands name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Simone van der Sar role: PRINCIPAL_INVESTIGATOR lat: 51.58656 lon: 4.77596 facility: GSK Investigational Site city: Enschede zip: 7512 KZ country: Netherlands name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Paolo Zocca role: PRINCIPAL_INVESTIGATOR lat: 52.21833 lon: 6.89583 facility: GSK Investigational Site city: Utrecht zip: 3584 BA country: Netherlands name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Marc Bonten role: PRINCIPAL_INVESTIGATOR lat: 52.09083 lon: 5.12222 facility: GSK Investigational Site city: Zutphen zip: 7207 AE country: Netherlands name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Martijn Goosens role: PRINCIPAL_INVESTIGATOR lat: 52.13833 lon: 6.20139 facility: GSK Investigational Site city: Boadilla del Monte state: Madrid zip: 28660 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Silvina Laura Natalini role: PRINCIPAL_INVESTIGATOR lat: 40.405 lon: -3.87835 facility: GSK Investigational Site city: Barcelona zip: 08023 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Fernando Cereto Castro role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: GSK Investigational Site city: Barcelona zip: 08907 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Cristina Masuet Aumatell role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: GSK Investigational Site city: Coruña zip: 15006 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Maria Jose Pereira Rodriguez role: PRINCIPAL_INVESTIGATOR lat: 43.37135 lon: -8.396 facility: GSK Investigational Site city: Madrid zip: 28040 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Helena Moza Moríñigo role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: GSK Investigational Site city: Madrid zip: 28041 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Pablo Rojo Conejo role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: GSK Investigational Site city: Majadahonda zip: 28222 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: [email protected] name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: [email protected] name: Jenry Borda Olivas role: PRINCIPAL_INVESTIGATOR lat: 40.47353 lon: -3.87182 hasResults: False |
<|newrecord|> nctId: NCT06374381 id: 854990 briefTitle: PEACE for ImPACT Study overallStatus: ENROLLING_BY_INVITATION date: 2023-12-01 date: 2027-11 date: 2027-11 date: 2024-04-18 date: 2024-04-18 name: University of Pennsylvania class: OTHER name: Institute of Education Sciences name: Michigan State University briefSummary: Investigators will test the impact of the PEACE implementation toolkit and determine the level of implementation support needed to improve early intervention providers use of caregiver coaching with families of young children with autism who receive early intervention services. The study will also assess caregiver and child outcomes for families receiving caregiver coaching and the cost effectiveness of the PEACE implementation toolkit. The investigators will enroll 200 early intervention providers, and 400 parent-child dyads. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcome assessors will be masked to randomization condition. whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: PEACE Online Resources name: PEACE Weekly Group Facilitation name: PEACE Weekly Individual Facilitation measure: Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool measure: Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO) measure: Autism Impact Measure (AIM) measure: Social Communication Checklist (SCC) measure: Confusion, Hubbub, and Order Scale (CHAOS) measure: Acceptability, Appropriateness, and Adoption measure measure: Qualitative Interview sex: ALL minimumAge: 12 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Mental Health city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-30 uploadDate: 2024-04-12T13:20 filename: Prot_SAP_000.pdf size: 508769 hasResults: False |
<|newrecord|> nctId: NCT06374368 id: JID-SURG briefTitle: Small Bowel Diversion overallStatus: ACTIVE_NOT_RECRUITING date: 2019-05-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-24 name: University of Ostrava class: OTHER name: Institute for Clinical and Experimental Medicine name: Vitkovice Hospital briefSummary: In an effort to replicate metabolic surgery's durable results in metabolic disease while minimizing its risks, two innovative methods has been created. Two surgical methods to create a bowel-to-bowel anastomosis, similar to the type used in current metabolic surgeries. It be to create a jejuno-ileal, side-to-side anastomosis and jejunocolic side-to-side anastomosis. The side-to-side jejuno-ileal anastomosis and side-to-side jejunocolic anastomosis provides two routes for ingested food. The new, shorter route has a malabsorptive effect similar to that seen in Roux en-Y gastric bypass (RYGB) and biliopancreatic diversion (BPD) - procedures which leads to weight loss. Additionally, delivery of non-absorbed macronutrients to the distal ileum, or transverse colon can enhance incretin effect and improve Type 2 Diabetes parameters. However, the native route is also preserved, which theoretically reduces the risk of malnutrition, diarrhea, and metabolic derangements seen in other metabolic surgeries.The side-to-side jejuno-ileal anastomosis was already tested in the Pilot Study of the GI Windows Self-Forming Magnetic (SFM) Anastomosis Device for Crea-tion of an Incisionless Small Bowel Bypass for Treatment of Obesity and Diabetes in year 2015 (15). The results of this study demonstrated the safety of this approach without seri-ous adverse events. This non-surgical approach resulted in Significant weight loss, favorable changes in insulin and incretin responses to a mixed meal and Significant improvement in A1C in T2DM (16).In summary, metabolic disease is a growing pandemic with suboptimal clinical solutions. The surgical side-to-side jejuno-ileal anastomosis and side-to-side jejuno-colic anastomosis without gastrectomy potentially represents a new class of therapy that may produce durable clinical results generally associated with surgery while minimizing its attendant risks. conditions: Obesity conditions: Type2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ACTUAL name: jejuno-ileal diversion name: jejuno-colic diversion measure: Total body weight loss measure: Glycated hemoglobin loss measure: Diabetes medication loss measure: Total cholesterol loss measure: Low density lipoprotein loss measure: High density lipoprotein loss measure: Leptin metabolism evaluation measure: Adiponectin metabolism evaluation measure: Change from baseline quality of life-Lite measure: Change from baseline quality of life - Sort Form Survey sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Ostrava, Faculty of Medicine city: Ostrava country: Czechia lat: 49.83465 lon: 18.28204 hasResults: False |
<|newrecord|> nctId: NCT06374355 id: Semibranch_Retro briefTitle: Semibranch Registry - Retrospective overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-04 date: 2030-10 date: 2024-04-18 date: 2024-04-22 name: University Hospital Muenster class: OTHER briefSummary: The goal of this registry is to evaluate the semibranch in branched endovascular arotic repair, which is a new tool in endovascular branched aortic repair. conditions: Aortic Aneurysm conditions: Endovascular Aortic Repair conditions: Stent-Graft Endoleak studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Semibranch CMD branched aortic stentgraft measure: Freedom from target vessel instability measure: Mortality measure: Technical success measure: Morbidity measure: Freedom of Endoleak type I and III measure: Long term mortality measure: Branch patency sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Muenster University Hospital city: Münster country: Germany lat: 51.96236 lon: 7.62571 hasResults: False |
<|newrecord|> nctId: NCT06374342 id: SO01-TK-SUBSTITUTES briefTitle: BONE SUBSTITUTES OUTCOMES overallStatus: RECRUITING date: 2021-09-16 date: 2026-09-16 date: 2032-09-30 date: 2024-04-18 date: 2024-04-18 name: Teknimed class: INDUSTRY briefSummary: A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Bone Substitute range of products: CERAFORM, TRIHA+, NANOGEL, and all their private labels. |
TEKNIMED bone substitutes are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting. |
The study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites. conditions: Bone Resorption studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 425 type: ESTIMATED name: Bone defect name: Spine fusion name: Cage filling measure: Successful bone repair measure: Alleviation of Pain measure: Bone reconstruction measure: Well-being measure: Patient satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pôle Rachis Hôpital Privé d'Eure et Loir status: RECRUITING city: Mainvilliers state: Eure Et Loir zip: 28300 country: France name: Jean MEYBLUM, MD role: CONTACT email: [email protected] name: Jean MEYBLUM, MD role: PRINCIPAL_INVESTIGATOR lat: 48.45003 lon: 1.45607 facility: Hôpital Joseph Ducuing status: RECRUITING city: Toulouse state: Haute Garonne zip: 31000 country: France name: Gérard GIORDANO, MD role: CONTACT email: [email protected] name: Gérard GIORDANO, MD role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 facility: Clinique Médipole Garonne status: RECRUITING city: Toulouse state: Haute Garonne zip: 31100 country: France name: Dominique VARDON, MD role: CONTACT email: [email protected] name: Dominique VARDON, MD role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 facility: CHRU Brabois status: RECRUITING city: Nancy state: Meurthe Et Moselle zip: 54000 country: France name: Didier MAINARD, MD role: CONTACT email: [email protected] name: Didier MAINARD, MD role: PRINCIPAL_INVESTIGATOR lat: 48.68439 lon: 6.18496 facility: Clinique du Pré status: RECRUITING city: Le Mans state: Sarthe zip: 72000 country: France name: Jean-Patrick RAKOVER, MD role: CONTACT phone: 02 43 77 54 21 email: [email protected] name: Jean-Patrick RAKOVER, MD role: PRINCIPAL_INVESTIGATOR lat: 48.0 lon: 0.2 facility: OCM Klinik GmbH status: RECRUITING city: München state: Bavière zip: D-81369 country: Germany name: Markus SCHROEDEL, MD role: CONTACT email: [email protected] name: Markus SCHROEDEL, MD role: PRINCIPAL_INVESTIGATOR lat: 48.13743 lon: 11.57549 hasResults: False |
<|newrecord|> nctId: NCT06374329 id: S68717 briefTitle: Effect of Interceptive Strategies on the Clinical Outcome of Impacted Maxillary Permanent Canines acronym: RCTcanines2 overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2026-08-01 date: 2027-08-01 date: 2024-04-18 date: 2024-04-24 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: Karolinska Institutet name: University of Copenhagen name: Palacky University name: The University of Hong Kong briefSummary: Canine impaction is a sign of abnormal dental development with potentially far-reaching consequences (such as significant root resorption and loss of lateral incisors. This compromises both aesthetics and function of the teeth, making the prediction of canine tooth impaction increasingly important. Interceptive orthodontic measures, such as extraction of deciduous canines or molars or maxillary expansion aim to create extra space in the dental arch, allowing the canines to position themselves better and normalizing their eruption pattern. |
This study corresponds to the second phase of an RCT, based on the results of the first phase, published in July 2023 (S59030) (Willems G, Butaye C, Raes M, Zong C, Begnoni G, Cadenas de Llano-Pérula M. Early prevention of maxillary canine impaction: a randomized clinical trial. Eur J Orthod. 31;45(4):359-369). The first phase compared the effect of 3 interceptive strategies (expansion, extraction and no intervention) on the position of impacted maxillary canines, finding that maxillary expansion provides the most improvement on impacted canine position. In second phase, 8-year-old patients without posterior crossbite and lack of space in the dental arch are randomized to treatment with 'slow maxillary expansion with removable plates' or 'no treatment'. These groups are additionally compared with patients with a crossbite and lack of space, which always receive expansion treatment. All selected patients will be followed up for at least 18 months. The primary endpoint is to investigate the effect of maxillary expansion with removable plates on the position of maxillary canines prone to impaction during early mixed dentition, assessed on panoramic X-rays. The secondary endpoint is the assessment of the need for additional orthodontic treatment. conditions: Tooth Impaction conditions: Canine Teeth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Interceptive Slow Maxillary Expansion with removable plates measure: Position of the impacted maxillary canine towards the dental midline (3^ML). measure: Need for subsequent interventions (extraction of deciduous or permanent teeth, other orthodontic interventions, surgical exposure) sex: ALL minimumAge: 7 Years maximumAge: 10 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06374316 id: 2302888 briefTitle: Air Purifiers in Classrooms for Infection Control - a Pilot Study overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-15 date: 2024-05-01 date: 2024-05-01 date: 2024-04-18 date: 2024-04-18 name: Norwegian Institute of Public Health class: OTHER_GOV name: SINTEF Health Research briefSummary: This study aims to investigate the acceptability and feasibility of deploying air purifiers equipped with HEPA (high-efficiency particulate air) filters in classrooms, to study air purifiers as an infection control measure. It will also evaluate the direct effect of air purifiers on air quality, comparing ceiling-mounted purifiers, portable purifiers and no purifier. conditions: Feasibility conditions: Acceptability studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: We will select schools for participation in arm 1 and 2, respectively, based on the feasibility of installing ceiling-mounted and placing portable air purifiers in each relevant classroom. In arm 3, all three classrooms will be equipped with both ceiling-mounted and portable air purifiers, as well as indoor air quality sensors. |
For this arm, we will randomize the three classrooms to each of three weekly programs for the air purifiers; |
Program 1) Week 1, 4, and 7: Ceiling-mounted ON, Week 2, 5, and 8: No purifier on, Week 3, 6, and 9: Portable ON. Program 2) Week 1, 4, and 7: Portable ON, Week 2, 5, and 8: Ceiling-mounted ON, Week 3, 6, and 9: No purifier on. Program 3) Week 1, 4, and 7: No purifier on Week 2, 5, and 8: Portable ON, Week 3, 6, and 9: Ceiling-mounted ON. |
Each classroom will be assigned a computer-generated random number and will based on the ascending order of the random numbers be allocated to the three predetermined sequences of programs. primaryPurpose: OTHER masking: NONE count: 6 type: ACTUAL name: Ceiling-Mounted Air Purifiers name: Portable Air Purifiers name: Portable or Ceiling Mounted Air Purifiers measure: Effectiveness of air purifiers versus no air purifier on improving air quality in classrooms. measure: Effectiveness of ceiling mounted versus portable air purifier on improving air quality in classrooms. measure: Acceptability of having Air Purifiers in Classrooms measure: Untoward events when installing air purifiers in classrooms measure: Untoward events when running air purifiers in classrooms measure: How student absence data can be collected from existing school registration systems. measure: Response rate of class teachers to the study surveys. measure: Response rate of students/their guardians to study surveys. measure: Proportion of absence due to respiratory disease. measure: Absence frequency among students sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Norwegian Institute of Public Health city: Oslo country: Norway lat: 59.91273 lon: 10.74609 hasResults: False |
<|newrecord|> nctId: NCT06374303 id: CHRBSS 00001940 briefTitle: Novel Intervention to Improve Food Insecurity Among Individuals With Opioid Use Disorder: A Randomized Clinical Trial overallStatus: COMPLETED date: 2022-04-19 date: 2023-11-20 date: 2023-11-20 date: 2024-04-18 date: 2024-04-18 name: University of Vermont class: OTHER briefSummary: The adverse consequences of illicit opioid use (e.g., overdose, premature death) are the focus of intensive research efforts. However, other serious health problems among individuals with opioid use disorder (OUD) have received far less attention. Food insecurity (FI) is 4-7 times greater among individuals with OUD than the general population. In addition to the increased healthcare utilization and costs, poor health outcomes, and adverse social consequences associated with FI in the general population, patients with co-occurring FI and OUD are at increased risk for licit and illicit drug use, sexual and drug risk behaviors, infectious disease, and a two-fold greater odds of premature death. |
In this randomized pilot study, we evaluated a novel, mail-based meal delivery intervention for improving household FI and other outcomes among individuals receiving methadone or buprenorphine maintenance for OUD. |
Fifty adults with FI and OUD were randomized to one of two 12-week experimental conditions: Nutritional Education (NE) participants received brief education, a list of FI-related resources in their community, and assistance with contacting those resources. NE + Meal Delivery (NE+MD) participants received the same educational platform plus weekly meal deliveries using a commercial service that delivers premade, refrigerated meals directly to the participant's home. |
The primary outcome of household FI was measured at monthly assessments using the USDA Household Food Security Survey. Secondary measures included depression symptoms (Beck Depression Inventory), quality of life (RAND-36 Quality of Life Survey), and drug use as measured by biochemical urinalysis. |
The NE+MD intervention was associated with significant improvements in household FI, with fewer NE+MD participants meeting criteria for FI vs. NE participants at all three assessment timepoints (p's\<.05). Retention rates were similar between the two groups (88% and 84% for NE+MD and NE conditions, respectively; p=.68). Intervention acceptability was also high, with NE+MD participants rating the enjoyment and convenience of the meals at 81 and 93, respectively (range: 0-100). |
Changes in FI status were also associated with improvements in other areas of functioning. NE+MD participants experienced reductions in depression symptomatology, with Beck Depression Inventory scores lower than intake at Weeks 4 and 8 (p's\<.05) and no changes among NE participants. NE+MD participants also experienced improvements on four of the eight subscales of the RAND-36 Quality of Life Health Survey (i.e., General Health, Bodily Pain, Mental Health, Role Emotional; p's\<.05), with no changes among NE participants. |
This study represents the first effort to develop and evaluate a novel intervention to reduce FI and related problems among individuals with OUD. These pilot data support the feasibility, acceptability and initial efficacy of the NE+MD intervention for improving household FI, as well as provide exciting new preliminary evidence suggesting that FI may be linked to participants' mental and physical health. conditions: Food Security studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, parallel-groups pilot study primaryPurpose: TREATMENT masking: NONE count: 50 type: ACTUAL name: NE + Meal Delivery (NE+MD) intervention measure: Household food insecurity Survey sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Vermont city: Burlington state: Vermont zip: 05401 country: United States lat: 44.47588 lon: -73.21207 hasResults: False |
<|newrecord|> nctId: NCT06374290 id: HSC-MS-24-0024 briefTitle: Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-02-15 date: 2025-04-15 date: 2024-04-18 date: 2024-04-18 name: The University of Texas Health Science Center, Houston class: OTHER briefSummary: The purpose of this study is to assess the feasibility and safety of injectable naltrexone (NTX;380 mg) in conjunction with oral bupropion (BUP; 450 mg daily)NTX-BUP administration among individuals with schizophrenia spectrum disorders that smoke cigarettes and to evaluate change on smoking-related measures and symptoms of schizophrenia. conditions: Smoking Cessation studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: Naltrexone (Vivitrol) name: Bupropion measure: Feasibility as assessed by the percentage of participants that enroll in the study measure: Percentage of participants that complete 3 weeks of treatment measure: Safety as assessed by the percentage of participants that show no serious adverse events measure: Change in number of cigarettes smoked per day (CPD) measure: Change in smoking urges as assessed by the Questionnaire on Smoking Urges (QSU) measure: Reduction in number of cigarettes consumed when price is at 0 as assessed by the Cigarette Purchasing Task (CPT) measure: Change in psychiatric symptoms as assessed by the score on the Brief Psychiatric Rating Scale (BPRS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Texas health Science Center at Houston city: Houston state: Texas zip: 77030 country: United States name: Jin H Yoon, PhD role: CONTACT phone: 713-486-2800 email: [email protected] name: Jessica Vincent role: CONTACT phone: (713) 486-2645 email: [email protected] lat: 29.76328 lon: -95.36327 hasResults: False |
<|newrecord|> nctId: NCT06374277 id: 23-09339-IAA briefTitle: Pharmacy-led Transitions of Care Intervention to Improve Medication Adherence acronym: MedAAAction overallStatus: RECRUITING date: 2024-04-06 date: 2027-09-30 date: 2028-01-31 date: 2024-04-18 date: 2024-04-25 name: University of Tennessee class: OTHER name: Sponsor GmbH briefSummary: Socioeconomically disadvantaged populations with multiple chronic conditions have high rates of nonadherence to essential chronic disease medications after hospital discharge. Medication nonadherence after hospital discharge is significantly associated with increased mortality and higher rates of readmissions and costs among these patients. Major patient-reported barriers to essential medication use after hospital discharge among low-income individuals are related to social determinants of health (SDOH) and include: 1) financial barriers , 2) transportation barriers, and 3) system-level barriers. Although, medication therapy management services are important during care transitions, these services have not proven effective in improving medication adherence after hospital discharge, highlighting a critical need for innovative interventions. The Medication Affordability, Accessibility, and Availability in Care Transitions (Med AAAction) Study will test the effectiveness of a pharmacy-led care transitions intervention versus usual care through a pragmatic randomized controlled trial of 388 Medicaid and uninsured hospital in-patients with MCC from three large healthcare systems in Tennessee. The intervention will involve: 1) medications with zero copay, 2) bedside delivery then home delivery of medications, and 3) care coordination provided by certified pharmacy technicians/health coaches to assist with medication access, medication reconciliation, and rapid and ongoing primary care follow-up. We will examine the impact of the intervention during 12 months on 1) medication adherence (primary outcome) and 2) rapid primary care follow-up, 30-day readmissions, hospitalizations and emergency department visits, and costs. We will conduct key informant interviews to understand patient experience with the acre received during and after care transitions. By examining effectiveness of the intervention on outcomes including medication adherence, health care utilization, costs, and patient experience, this study will provide valuable results to health systems, payers, and policymakers to assist in future implementation and sustainability of the intervention for socioeconomically disadvantaged populations. conditions: Diabetes conditions: Hypertension conditions: High Cholesterol/Hyperlipidemia conditions: Coronary Artery Disease conditions: Congestive Heart Failure conditions: Chronic Lung Disease conditions: Chronic Kidney Diseases conditions: Arrythmia conditions: Stroke conditions: Depression conditions: Anxiety conditions: Pulmonary Embolism conditions: Heart Attack studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Eligible patients who sign consent forms and complete baseline surveys will be randomized to the Med AAAction intervention group or the usual care in a 1:1 ratio, stratified by health system. The participants will be enrolled before hospital discharge. The Med AAAction intervention will include the following components: 1) medications with zero copay, 2) bedside delivery and subsequent home delivery of medications, and 3) care coordination provided by certified pharmacy technicians/health coaches to assist with medication access, medication reconciliation, and rapid and ongoing primary care follow-up after hospital discharge. The intervention will be provided for one-year. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 388 type: ESTIMATED name: Med AAAction intervention measure: Adherence to chronic disease medications measure: Health care utilization measure: Cost measure: Qualitative Evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Tennessee Medical Center status: NOT_YET_RECRUITING city: Knoxville state: Tennessee zip: 37920 country: United States name: Shauntá M Chamberlin role: CONTACT phone: 865-305-5061 email: [email protected] lat: 35.96064 lon: -83.92074 facility: University of Tennessee Health Science Center/Regional One Health status: RECRUITING city: Memphis state: Tennessee zip: 38103 country: United States name: Kay Ryan, PharmD role: CONTACT phone: 901-545-7840 email: [email protected] lat: 35.14953 lon: -90.04898 hasResults: False |
<|newrecord|> nctId: NCT06374264 id: NM100 briefTitle: Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder acronym: aNiMatO overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2024-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-24 name: MedRhythms, Inc. class: INDUSTRY name: Alexion Pharmaceuticals, Inc. briefSummary: The purpose of this proof of concept study is to assess the acceptability and safety of MR-C-014 in persons with Neuromyelitis optica spectrum disorder (NMOSD) who have a gait deficit. conditions: Neuromyelitis Optica Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: MR-C-014 measure: Participant acceptability of MR-C-014 measure: Number of device-related adverse events (AEs) measure: 6-Minute Walk Test (6MWT) measure: Number of walks per week measure: Spatiotemporal symmetry of gait as measured by the MR-C-014 sensors measure: Spatiotemporal variability of gait as measured by the MR-C-014 sensors measure: Stride length as measured by the MR-C-014 sensors measure: Falls Efficacy Scale-International (FES-I) measure: Number of falls as recorded in Falls Diary measure: Multiple Sclerosis Walking Scale (MSWS-12) measure: Visual Analogue Scale (VAS) measure: Generalized Anxiety Disorder-7 (GAD-7) measure: 9 Hole Peg Test (9-HPT) measure: Symbol Digit Modalities Test (SDMT) measure: Fatigue Scale for Motor and Cognitive Functions (FSMC) measure: Expanded Disability Status Scale (EDSS) Ambulation Score measure: Activities-Specific Balance Confidence Scale (ABC) measure: Patient Experience and Satisfaction Survey sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States name: Eric Klawiter, MD role: CONTACT email: [email protected] lat: 42.35843 lon: -71.05977 hasResults: False |
<|newrecord|> nctId: NCT06374251 id: 0S-23-2 id: NCI-2023-08890 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 0S-23-2 type: OTHER domain: USC / Norris Comprehensive Cancer Center id: P30CA014089 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA014089 briefTitle: Narrative Medicine for Improving Well-Being in Patients With Gastrointestinal Cancers overallStatus: RECRUITING date: 2023-09-27 date: 2024-09-27 date: 2025-03-27 date: 2024-04-18 date: 2024-04-18 name: University of Southern California class: OTHER name: National Cancer Institute (NCI) briefSummary: This clinical trial assesses whether narrative medicine methods may improve the sense of well-being among gastrointestinal (GI) (digestive system) cancer patients. Narrative medicine is a clinical approach where providers can use a patient's own narrative (perspective) of their illness to promote healing and resilience. By applying narrative medicine's main tool, close reading, to clinical practice, clinicians learn to listen and attend to patients more deeply. This allows for freer communication and the creation of a healthcare encounter that centers on the psychological and emotional well being of the patient in addition to their medical conditions. Narrative medicine can include close reading, creative or reflective writing, and discussion. These methods may help patients with GI cancer to reflect on their life stories, both inside and outside of their illness experience, and help them gather skills to optimize their well-being. conditions: Malignant Digestive System Neoplasm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 10 type: ESTIMATED name: Discussion name: Interview name: Survey Administration measure: Number of participants who complete the narrative medicine sessions measure: Change in well-being scores sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: USC / Norris Comprehensive Cancer Center status: RECRUITING city: Los Angeles state: California zip: 90033 country: United States name: Eve L. Makoff role: CONTACT phone: 323-865-3000 email: [email protected] name: Eve L. Makoff role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False |
<|newrecord|> nctId: NCT06374238 id: UG3HL165839 type: NIH link: https://reporter.nih.gov/quickSearch/UG3HL165839 id: UG3HL165839 type: NIH link: https://reporter.nih.gov/quickSearch/UG3HL165839 briefTitle: Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain acronym: PRESENCE overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2027-12 date: 2028-05 date: 2024-04-18 date: 2024-04-18 name: University of Pittsburgh class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The study, known as the Peer suppoRt for adolescents and Emerging adults with Sickle cell pain: promoting ENgagement in Cognitive behavioral thErapy (PRESENCE), aims to determine the effectiveness of digital CBT in reducing pain, opioid use, and healthcare utilization among AYAs with SCD. It also seeks to understand the role of personalized peer support in enhancing engagement and outcomes of digital CBT interventions. |
By leveraging existing infrastructure for delivering virtual peer support interventions, tailored digital CBT programs for individuals with SCD, and partnerships with CBOs, the study aims to provide valuable insights into the feasibility and effectiveness of digital CBT as a pain management strategy for this vulnerable population. conditions: Pain conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Three-arm, phase III randomized controlled effectiveness trial. Participants will be randomized 3:3:2 into (1) CBT + peer, (2) self-guided CBT, or (3) UC, stratified by site primaryPurpose: TREATMENT masking: NONE count: 470 type: ESTIMATED name: CBT+ Health coach name: CBT w/o Health Coach ( self-guided) name: Usual Care measure: Determine the effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs usual care (UC) to improve pain intensity for AYAs with SCD and chronic pain measure: Determine the effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs usual care (UC) to improve pain interference for AYAs with SCD and chronic pain measure: Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain intensity for AYAs with SCD and chronic pain measure: Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain interference for AYAs with SCD and chronic pain measure: Determine the sustained effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs UC to improve pain intensity for AYAs with SCD and chronic pain measure: Determine the sustained effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs UC to improve pain interference for AYAs with SCD and chronic pain measure: Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain intensity of AYAs with SCD and chronic pain measure: Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain interferences of AYAs with SCD and chronic pain sex: ALL minimumAge: 16 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06374225 id: 23-0866 briefTitle: Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention acronym: SAVE-O2 AI overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12-31 date: 2026-05-01 date: 2024-04-18 date: 2024-04-18 name: University of Colorado, Denver class: OTHER name: United States Department of Defense name: O2matic ApS name: IDTS Medical, Inc. briefSummary: This study is a multicenter randomized controlled trial to determine the effectiveness of a closed loop/autonomous oxygen titration system (O2matic PRO100) to maintain normoxemia (goal range SpO2 90-96%, target 93%) during the first 72 hours of acute injury or illness, compared to standard provider-driven methods (manual titration with SpO2 target of 90-96%). conditions: Critical Illness conditions: Wounds and Injury conditions: Disease Attributes conditions: Pathologic Processes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Automated Titration (O2matic) measure: Proportion of time spent within the targeted normoxemia range measure: Amount of supplemental oxygen administered measure: Proportion of time spent in hypoxemia (SpO2<88%) measure: Proportion of time spent in hyperoxemia (SpO2 >96%) measure: Time to Room Air sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: Oregon Health and Sciences University city: Portland state: Oregon zip: 97239 country: United States lat: 45.52345 lon: -122.67621 facility: Vanderbilt University Medical Center city: Nashville state: Tennessee zip: 37232 country: United States lat: 36.16589 lon: -86.78444 hasResults: False |
<|newrecord|> nctId: NCT06374212 id: 24-0191 briefTitle: Anifrolumab for Hidradenitis Suppurativa overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-12 date: 2024-04-18 date: 2024-04-18 name: University of North Carolina, Chapel Hill class: OTHER name: AstraZeneca briefSummary: This clinical trial aims to study if a drug called anifrolumab works to treat Hidradenitis Suppurativa (HS) as well as its effect in quality of life before and after treatment. Anifrolumab is a monoclonal antibody that inhibits several processes that have been shown to be involved in the development of HS. |
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