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Other authors have suggested that using a RME (Rapid Maxillary expansion) or headgrear (EOT) to create sufficient space within the dental arch for the permanent canine tooth will encourage the tooth to erupt (Baccetti et al., 2011). This approach might be less traumatic to a child who may have had no experience of dental treatment, other than routine check-ups. If either or both approaches are shown to be effective then their widespread use would be advantageous to both the child and the healthcare provider, because the need for an operation, under general anaesthetic, to uncover the tooth and extensive brace treatment to straighten the tooth will be avoided. conditions: Ectopic Tooth Eruption conditions: Palatal Expansion Technique conditions: Randomized Clinical Trial studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 318 type: ESTIMATED name: Extraction of the primary canine teeth name: Expansion measure: Succeful eruption of the palatally displaced canines into the dental arch measure: Cost effectiveness of the interventions measure: Prevalence and severity of damage to surrounding teeth either due to the unerupted tooth or orthodontic intervention. sex: ALL minimumAge: 10 Years maximumAge: 12 Years stdAges: CHILD facility: Gothenbrug University status: RECRUITING city: Gothenburg country: Sweden name: Farhan Bazargani, DDS, PhD role: CONTACT name: Björn Ludwig, DDS, PhD role: PRINCIPAL_INVESTIGATOR name: Martyn Coborune, DDS, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.70716 lon: 11.96679 hasResults: False
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<|newrecord|> nctId: NCT06267976 id: REB23-1003 briefTitle: Validation of the ProSomnus® RPMO2 Device overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-05-31 date: 2024-06-30 date: 2024-02-20 date: 2024-04-02 name: ProSomnus Sleep Technologies class: INDUSTRY briefSummary: The purpose of the study is to:
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1. Evaluate the SpO2 accuracy of the oximeter component of the ProSomnus RPMO2 Device during non-motion conditions over the range of 70-100% SaO2 by comparison to SaO2 values determined by arterial blood sample specimen analyzed by a CO-oximeter.
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2. Evaluate the pulse rate performance simultaneously collected over the SpO2 range. conditions: Healthy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: ProSomnus RPMO2 measure: SpO2 accuracy measure: Pulse rate accuracy sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of Calgary city: Calgary state: Alberta zip: T2N4N1 country: Canada name: Brad Hansen role: CONTACT phone: 403-210-8925 email: [email protected] lat: 51.05011 lon: -114.08529 hasResults: False
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<|newrecord|> nctId: NCT06267963 id: C4391010 id: 2023-507074-40-00 type: REGISTRY domain: CTIS (EU) briefTitle: A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-31 date: 2024-04-18 date: 2024-04-18 date: 2024-02-20 date: 2024-04-16 name: Pfizer class: INDUSTRY briefSummary: The purpose of this study is to learn about how much PF-07220060 will be taken up and processed by healthy male participants.
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The study is seeking for participants who:
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* are males aged 18 to 65 years and are healthy.
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* have Body mass index (BMI) between 17.5 and 30.5 kilograms/meter2
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* have a total body weight of at least 50 kilograms.
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The study consists of two groups. In group 1, participants will take one amount of PF-07220060 by mouth. In group 2, participants will take one amount by mouth and one amount as an injection through a vein at the study clinic.
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In group 1, participants will stay at the clinic site for up to 15 days. In group 2, the duration of participants' stay depends on the results of group 1.
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During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07220060 in participants' blood, urine, and feces samples. This will help to know how much the study medicine is getting taken up by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 9 weeks from the screening until the follow-up. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 12 type: ACTUAL name: Oral [14C]PF-07220060 name: Oral PF-07220060 name: IV [14C] PF-07220060 measure: Cumulative recovery (%) of radioactivity in urine and feces (adjusted for vomitus, if any), expressed as a percent of total oral radioactive dose administered. measure: Amount of metabolites of [14C]PF-07220060 in plasma, urine, and feces. measure: Dose normalized AUCinf of intravenous radiolabeled PF-07220060 in plasma (if data permit) measure: The absolute oral bioavailability (F) of PF-07220060 measure: The fraction of PF-07220060 dose absorbed (Fa) measure: Number of participants with treatment emergent clinically significant laboratory abnormalities measure: Number of participants with treatment emergent clinically significant abnormal ECG measurements measure: Number of participants with treatment emergent clinically significant abnormal vital measurements measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) measure: Number of participants with treatment emergent clinically significant abnormal physical examination sex: MALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PRA Health Sciences city: Groningen zip: 9728 NZ country: Netherlands lat: 53.21917 lon: 6.56667 hasResults: False
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<|newrecord|> nctId: NCT06267950 id: PILUO-INFANT briefTitle: Effect of Oral Feeding in Infants With Pierre Robin Syndrome overallStatus: RECRUITING date: 2024-02-29 date: 2024-10 date: 2024-10 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding) and the PNG group (with Nasogastric Tube Feeding), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared. conditions: Pierre Robin Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: systematic therapy name: intermittent oro-esophageal tube feeding name: gastric tube feeding measure: Number of patients diagnosed as the pulmonary infection "Positive" measure: Nutritional status-total protein measure: Nutritional status-hemoglobin measure: Nutritional status-albumin measure: Body weight measure: The Functional Oral Intake Scale for Infants sex: ALL minimumAge: 1 Month maximumAge: 12 Months stdAges: CHILD facility: Hsinchu Rehabilitation Hospital status: RECRUITING city: Xinzhu country: Taiwan name: Haim Liu, Master role: CONTACT lat: 22.46205 lon: 120.47335 hasResults: False
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<|newrecord|> nctId: NCT06267937 id: 101 briefTitle: Hip Fractures in Chile: Implications for Public Health Policy and Healthcare Delivery overallStatus: COMPLETED date: 2023-03-10 date: 2023-03-10 date: 2024-01-30 date: 2024-02-20 date: 2024-02-20 name: University of Chile class: OTHER name: Instituto Sistemas Complejos de Ingeniería, Universidad de Chile, Santiago, Chile briefSummary: Hip fractures in individuals aged 60 and above pose significant challenges in terms of morbidity, mortality, and healthcare costs. While countries like the United Kingdom and Australia have optimized their healthcare systems for timely management of hip fractures, the situation in Chile presents distinct challenges due to its mixed healthcare system. This study aims to assess survival rates following hip fractures in Chile and identify associated risk factors using national databases from 2012 to 2018. A comprehensive analysis of 35,520 patients revealed that factors such as age, type of health insurance, access to surgery, and treatment in public hospitals significantly influence mortality rates after hip fractures. The study found that patients with hip fractures experience lower 5-year survival rates compared to the general population, particularly when affiliated with public insurance and treated in public institutions. Modifiable factors like delayed surgery and prolonged hospital stays contribute to increased mortality rates. The findings underscore the urgent need for optimized public health policies and healthcare delivery systems to enhance outcomes for hip fracture patients in Chile.Hip fractures in individuals aged 60 and above pose significant challenges in terms of morbidity, mortality, and healthcare costs. While countries like the United Kingdom and Australia have optimized their healthcare systems for timely management of hip fractures, the situation in Chile presents distinct challenges due to its mixed healthcare system. This study aims to assess survival rates following hip fractures in Chile and identify associated risk factors using national databases from 2012 to 2018. conditions: Hip Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 46380 type: ACTUAL name: Access to surgery name: type of intitution measure: survival after hip fracture sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: hospital Clinico Universidad de Chile city: Santiago state: Region Metropolitana zip: 8380456 country: Chile lat: -33.45694 lon: -70.64827 hasResults: False
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<|newrecord|> nctId: NCT06267924 id: Olith10703 briefTitle: SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines overallStatus: ENROLLING_BY_INVITATION date: 2024-02-28 date: 2024-08-31 date: 2024-09-30 date: 2024-02-20 date: 2024-03-19 name: Otolith Labs class: INDUSTRY name: MCRA briefSummary: The goal of this virtual clinical trial is to compare the effectiveness of two study devices in providing temporary relief to adults aged 18-75 who suffer from symptoms of chronic Vestibular Migraines (VM), also known as Migraine Associated Vertigo.
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Participants will be:
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* Enrolled up to 50 days; enrollment, 14 days in Baseline Phase (no device), 7 days in Transition Phase, 28 days in Treatment Phase (study device)
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* Randomized and stratified into groups based on the referring clinic to be assigned one study device
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* Asked to use the study device as instructed by the study coordinator
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* Asked to submit daily diaries reporting their symptoms and use of device, and to participate in tele-health visits with study coordinators
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* Asked to provide their vertigo diagnosis from their physician
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* Compensated for their participation
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Researchers will compare the randomized groups to determine which group responds better to which device. conditions: Vestibular Migraine conditions: Migraine Associated Vertigo studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The proposed clinical trial for the study device will be a randomized, sham-controlled, double-blind study with two-parallel arms (active/sham device). primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Otoband Experimental name: Otoband Sham measure: DHI Change in Scores measure: Number of related adverse events measure: Change in number of vestibular migraine episodes weekly measure: Global Impression of Change (severity of episodes) measure: DHI change from transition to end of study measure: Device responder rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Otolith Labs city: Washington state: District of Columbia zip: 20001 country: United States lat: 38.89511 lon: -77.03637 hasResults: False
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<|newrecord|> nctId: NCT06267911 id: 202223-10 id: 160/U/2022 type: OTHER_GRANT domain: Fundació La Marató de TV3 briefTitle: Rehabilitation Gaming System for Intensive Care Units acronym: RGS-ICU overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-04 date: 2026-04 date: 2024-02-20 date: 2024-04-23 name: University of the Balearic Islands class: OTHER name: Corporacion Parc Tauli name: Hospital Son Llatzer name: Fundació La Marató de TV3 briefSummary: Admission to an Intensive Care Unit (ICU) is a potentially traumatic experience for a mentally vulnerable person. Beyond the stress and anxiety associated with the ICU environment and medical procedures, survivors of critical illness are at risk of developing cognitive and psychological sequelae related to Post-Intensive Care Syndrome (PICS). These disorders are associated with high economic, medical and personal costs.
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This trial aims to evaluate the efficacy of an innovative neuropsychological e-health intervention for early cognitive stimulation and psychological support of people in critical care, i.e. the Rehabilitation Gaming System for Intensive Care Units (RGS-ICU) intervention, in improving comfort during ICU admission and cognition and mental health three and 12 months after ICU discharge. The RGS-ICU intervention, applied as an adjunct to standard ICU care, is based on non-immersive virtual reality techniques and has been specifically designed and developed to suit the needs of people in critical care and the characteristics of the ICU environment. To ensure the safety of the intervention, participants' physiological parameters will be automatically recorded by advanced continuous monitoring systems as part of standard ICU care.
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The investigadors hypothesize that the cognitive stimulation and psychological support protocols of the RGS-ICU intervention, applied as an adjunct to standard ICU care, in addition to being safe for people in critical care units, will improve comfort during ICU admission and cognitive and mental health outcomes after ICU discharge, compared to receiving standard ICU care alone.
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The findings derived from this trial may contribute to establish a novel and superior paradigm of human-centered ICU care to improve the comfort of people admitted to the ICU. This achievement could also have a relevant impact on medical and economic costs during ICU admission, and on functionality and health-related quality of life after ICU discharge associated with the reduction of cognitive and psychological sequelae linked to PICS.
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The RGS-ICU intervention has been designed at Corporacion Parc Taulí with the collaboration of the University of the Balearic Islands and has been developed by Eodyne Systems S.L., a company dedicated to the development of science-based technological solutions for intervention, monitoring, diagnosis, and prognosis in stroke and other brain disorders. conditions: Critical Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Cognitive stimulation and psychological support (RGS-ICU) measure: Attention performance measure: Working memory performance measure: Learning/memory performance measure: Executive function performance measure: Processing speed performance measure: Incidence of Treatment-Emergent Adverse Events [Safety] measure: Dyspnea intensity measure: Pain intensity measure: Worry intensity measure: Sadness intensity measure: Comfort experienced measure: Anxiety symptoms measure: Symptoms of depression measure: Symptoms of post-traumatic stress disorder measure: Subjective cognition measure: Functionality measure: Health-related quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of the Balearic Islands city: Palma De Mallorca state: Balearic Islands zip: 07122 country: Spain name: Guillem Navarra-Ventura, PhD role: CONTACT phone: +34971259888 email: [email protected] lat: 39.56939 lon: 2.65024 facility: Hospital Universitari Son Llàtzer city: Palma De Mallorca state: Balearic Islands zip: 07198 country: Spain name: Gemma Rialp, MD, PhD role: CONTACT phone: +34871202000 email: [email protected] lat: 39.56939 lon: 2.65024 facility: Corporacion Parc Tauli city: Sabadell state: Catalonia zip: 08208 country: Spain name: Sol Fernández-Gonzalo, PhD role: CONTACT phone: +34937236673 email: [email protected] lat: 41.54329 lon: 2.10942 hasResults: False
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<|newrecord|> nctId: NCT06267898 id: EBMT- 842205547 briefTitle: Non Interventional Study on Iron Toxicity After First Allo-transplant in MDS/CMML overallStatus: COMPLETED date: 2009-11-01 date: 2015-01-29 date: 2015-05-21 date: 2024-02-20 date: 2024-02-20 name: European Society for Blood and Marrow Transplantation class: NETWORK name: Novartis briefSummary: Stem cell transplantation and blood product transfusions are standard of care for Myelodysplastic Syndromes (MDS). Several studies have shown changes in serum ferritin and non-transferrin-bound iron (NTBI) in patients undergoing stem cell transplantation. A large proportion of MDS patients are at risk for organ damage from tissue siderosis, due to the development of iron overload.
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Toxic effects of iron may play an important role in the complications associated with HSCT. Iron chelation therapy may reduce the acute and chronic treatment-related toxicity by removing excess of iron, iron radicals and reactive oxygen species (ROS).
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There is little information about the efficacy and safety of iron chelation in MDS patients. This audit wants to evaluate the effect of iron toxicity on treatment-related mortality in untreated, adult MDS or CMML patients during and after treatment with myeloablative conditioning (MAC) and reduced intensity conditioning (RIC) allo-HSCT, by prospectively collecting data from 200 MDS or CMML patients from 2009 onwards. conditions: MDS conditions: CMML studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 222 type: ACTUAL measure: non-relapse mortality (treatment related mortality). measure: treatment-related toxic effects measure: relapse rate measure: event-free survival measure: overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Antwerp University Hospital (UZA) city: Antwerp zip: 2650 country: Belgium lat: 51.21989 lon: 4.40346 facility: University Hospital Gasthuisberg city: Leuven zip: 3000 country: Belgium lat: 50.87959 lon: 4.70093 facility: University of Liege city: Liege zip: 4000 country: Belgium lat: 50.63373 lon: 5.56749 facility: Charles University Hospital city: Pilsen zip: 304 60 country: Czechia lat: 49.74747 lon: 13.37759 facility: University Hospital city: Essen zip: 45122 country: Germany lat: 51.45657 lon: 7.01228 facility: University Hospital Leipzig city: Leipzig zip: 04103 country: Germany lat: 51.33962 lon: 12.37129 hasResults: False
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<|newrecord|> nctId: NCT06267885 id: Children NOF fracture fixation briefTitle: Fixation of Fracture Neck of Femur in Children overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-02 date: 2026-03 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: Find the best way for fixation of fracture neck of femur in children either by cannulated screws or wagner's technique conditions: Fracture Neck of Femur studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: Cannulated screws vs wagner's technique measure: The better method for fixation of fracture neck of femur sex: ALL minimumAge: 1 Year maximumAge: 14 Years stdAges: CHILD facility: Assiut university city: Assiut country: Egypt name: Mina Maged role: CONTACT lat: 27.18096 lon: 31.18368 hasResults: False
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<|newrecord|> nctId: NCT06267872 id: HVTN 309 briefTitle: A Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2025-12-12 date: 2026-07-11 date: 2024-02-20 date: 2024-02-20 name: National Institute of Allergy and Infectious Diseases (NIAID) class: NIH name: National Institutes of Health (NIH) name: Department of Health and Human Services name: Duke University name: Access to Advanced Health Institute (AAHI) briefSummary: This is a multicenter, open-label, phase 1 clinical trial to test two human immunodeficiency virus (HIV) vaccines with two adjuvants. An adjuvant is an ingredient used with some vaccines that may help people make an immune response. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).
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About 42 people will take part in the HVTN 309 clinical trial. This clinical trial will take place at multiple sites in the US and South Africa and the clinical trial is divided into 3 parts: Part A, Part B and Part C. About 3 people will participate in Part A of this study. After results from Part A are reviewed, it will be determined whether or not Part B and Part C of the clinical trial will proceed. conditions: HIV studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: NONE count: 42 type: ESTIMATED name: CD4BS CH505M5 Pr-NP1 name: CH505TF chTrimer name: 3M-052-AF (labeled as AP 60-702) name: Aluminum Hydroxide Suspension (Alum) name: ACU-026-001-1 (labeled as empty LNP) measure: Frequency of local reactogenicity signs and symptoms after receipt of any study vaccine measure: Frequency of systemic reactogenicity signs and symptoms after receipt of any study vaccine measure: Number of serious adverse events (SAEs) leading to early participant withdrawal or permanent discontinuation measure: Number of medically attended adverse events (MAAEs) leading to early participant withdrawal or permanent discontinuation measure: Number of adverse events of special interest (AESIs) leading to early participant withdrawal or permanent discontinuation measure: Number of adverse events (AEs) leading to early participant withdrawal or permanent discontinuation measure: Part C only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry measure: Part C only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay measure: Part C only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay measure: Parts B and C: Response rate of serum IgG binding Abs to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA) measure: Parts B and C: Magnitude of serum IgG binding Abs to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA) measure: Part B only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay measure: Part B only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay measure: Parts B and C: Response rate of differential serum Ab neutralization of precursor detection virus and corresponding epitope KO virus, as measured by TZM-bl assay measure: Parts B and C: Magnitude of differential serum Ab neutralization of precursor detection virus and corresponding epitope KO virus, as measured by TZM-bl assay measure: Parts B and C: Response rate of serum Ab neutralization of heterologous HIV-1 strains, as measured by TZM-bl assay measure: Parts B and C: Magnitude of serum Ab neutralization of heterologous HIV-1 strains, as measured by TZM-bl assay measure: Parts B and C: Response rate of CD4+ and CD8+ T-cell responses, as measured by flow cytometry measure: Parts B and C: Magnitude of CD4+ and CD8+ T-cell responses, as measured by flow cytometry measure: Part B only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Alabama CRS (Site ID: 31788) city: Birmingham state: Alabama zip: 35222 country: United States name: Heather Logan, A.N.P. role: CONTACT phone: 205-873-8686 email: [email protected] lat: 33.52066 lon: -86.80249 facility: The Ponce de Leon Center CRS (Site ID: 5802) city: Atlanta state: Georgia zip: 30308 country: United States name: Ericka Patrick, M.S.N role: CONTACT phone: 404-616-6313 email: [email protected] lat: 33.749 lon: -84.38798 facility: Vanderbilt Vaccine (VV) CRS (Site ID: 30352) city: Nashville state: Tennessee zip: 37232 country: United States name: Shonda E. Sumner, B.S.N. role: CONTACT phone: 615-343-6906 email: [email protected] lat: 36.16589 lon: -86.78444 facility: Setshaba Research Centre CRS (Site ID: 31829) city: Soshanguve state: Gauteng zip: 0152 country: South Africa name: Magdeline K. Molapo role: CONTACT phone: 27-12-7992422 email: [email protected] facility: Isipingo CRS (Site ID: 31635) city: Isipingo state: Kwa Zulu Natal zip: 4110 country: South Africa name: Girisha Kistnasami, B.Sc., D.P.M. role: CONTACT phone: 27-31-2423600 email: [email protected] lat: -29.98639 lon: 30.91853 facility: Klerksdorp CRS (Site ID: 30325) city: Klerksdorp state: North West Province zip: 2571 country: South Africa name: Olebogeng Jonkane role: CONTACT phone: None Listed email: [email protected] lat: -26.85213 lon: 26.66672 hasResults: False
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<|newrecord|> nctId: NCT06267859 id: No. 2 of 2023/11/7 briefTitle: Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children overallStatus: RECRUITING date: 2023-11-08 date: 2033-12-30 date: 2034-01-30 date: 2024-02-20 date: 2024-02-28 name: Tashkent Pediatric Medical Institute class: OTHER briefSummary: The goal of the clinical study is to clarify the course of common congenital, infectious, and non-infectious diseases in children living in Uzbekistan, and to develop methods for their treatment and rehabilitation.
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The main questions it aims to answer:
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* Analysis of common congenital diseases among children;
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* Analysis of commonly diagnosed bronchopulmonary and cardiovascular diseases among children;
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* Based on the results of the primary research, common diseases among children will be identified;
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* Analysis of existing treatment methods and their effectiveness;
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* Development of modern methods of treatment and rehabilitation of children. conditions: Respiratory Diseases conditions: Congenital Heart Defects studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: identification of children from the group of "frequently ill children" primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: working with children from the "frequently ill children" group whoMasked: PARTICIPANT count: 110 type: ESTIMATED name: The use of a combination of microelements and vitamins against the background of physiotherapy measure: Working with archival documentation. measure: Formation of a group of patients to study immunity and the antioxidant system in venous blood. measure: Clinical scientific research. measure: Clinical trial evaluation. sex: ALL minimumAge: 3 Days maximumAge: 15 Years stdAges: CHILD facility: Turdieva Shokhida Tolkunovna status: RECRUITING city: Tashkent state: Yunus-obad District zip: 100140 country: Uzbekistan name: Shokhida T Turdieva, M.D., D.Sc. role: CONTACT phone: +998935872570 email: [email protected] name: Kholida B Abdurashidova role: CONTACT phone: +998935092934 email: [email protected] name: Gulmira R Nasirova, Ph.D. role: SUB_INVESTIGATOR lat: 41.26465 lon: 69.21627 hasResults: False
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<|newrecord|> nctId: NCT06267846 id: NBI-1070770-MDD2029 briefTitle: A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder overallStatus: RECRUITING date: 2024-03-20 date: 2025-09 date: 2025-12 date: 2024-02-20 date: 2024-04-12 name: Neurocrine Biosciences class: INDUSTRY briefSummary: To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive disorder (MDD). conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 72 type: ESTIMATED name: NBI-1070770 name: Placebo measure: Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5 measure: Change in Total MADRS Score from Baseline at Postbaseline Timepoints sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neurocrine Clinical Site status: RECRUITING city: Little Rock state: Arkansas zip: 72211 country: United States lat: 34.74648 lon: -92.28959 facility: Neurocrine Clinical Site status: RECRUITING city: Rogers state: Arkansas zip: 72758 country: United States lat: 36.33202 lon: -94.11854 facility: Neurocrine Clinical Site status: RECRUITING city: Lemon Grove state: California zip: 91945 country: United States lat: 32.74255 lon: -117.03142 facility: Neurocrine Clinical Site status: RECRUITING city: Long Beach state: California zip: 90806 country: United States lat: 33.76696 lon: -118.18923 facility: Neurocrine Clinical Site status: RECRUITING city: Hollywood state: Florida zip: 33024 country: United States lat: 26.0112 lon: -80.14949 facility: Neurocrine Clinical Site status: RECRUITING city: Decatur state: Georgia zip: 30030 country: United States lat: 33.77483 lon: -84.29631 facility: Neurocrine Clinical Site status: RECRUITING city: Savannah state: Georgia zip: 31405 country: United States lat: 32.08354 lon: -81.09983 facility: Neurocrine Clinical Site status: RECRUITING city: Gaithersburg state: Maryland zip: 20877 country: United States lat: 39.14344 lon: -77.20137 facility: Neurocrine Clinical Site status: RECRUITING city: North Canton state: Ohio zip: 44730 country: United States lat: 40.87589 lon: -81.40234 facility: Neurocrine Clinical Site status: RECRUITING city: Houston state: Texas zip: 77008 country: United States lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06267833 id: MSKUSBFFTR01 briefTitle: The Effect of Trunk and Upper Extremity Exercises Added to the Otago Exercise Program acronym: Otago Exercise overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-01-01 date: 2026-06-01 date: 2024-02-20 date: 2024-02-20 name: Muğla Sıtkı Koçman University class: OTHER briefSummary: This study is designed to investigate the effect of adding trunk and upper extremity exercises in traditional and mobile game formats to the Otago exercise program on balance performance, fall risk, and fear in older adults. A randomized controlled, cross-sectional, single-blind (evaluator) study will be conducted with 36 older adults aged 65 and older enrolled at Muğla Sıtkı Koçman University (MSKÜ) Elderly Studies Application and Research Center. Participants will be divided into three randomized groups: control group (12 individuals receiving the Otago exercise program), study group 1 (12 individuals receiving additional trunk and upper extremity exercises with traditional methods added to the Otago exercise program), and study group 2 (12 individuals receiving additional trunk and upper extremity exercises with mobile game method added to the Otago exercise program). Participant demographics informations will be recorded in Form 1. Participants' cognitive functions , levels of independence in activities of daily living, fall risk , and fear of falling will be evaluated. Balance performance will be assessed using the Mini Balance Evaluation Systems Test (Mini-BESTest), portable computerized kinetic balance measurement (SportKAT 650-TS), "5 Times Sit-to-Stand" and "Four-Stage Balance Test" from the Otago Exercise Program. Participants' body sway will be assessed simultaneously with the second part of the Mini-BESTest using a mobile application. All assessments will be conducted by a researcher blinded to the exercises, both before and after the exercises, in a one-on-one face-to-face setting. In the exercise protocol, a personalized, home-based, 30-minute Otago exercise program consisting of strength, balance, and walking exercises performed three times a week will be implemented for 8 weeks with home visits and telerehabilitation sessions (via Videoconferencing) under the supervision of the responsible researcher. In addition to the Otago exercise program, trunk and upper extremity exercises (totaling 45 minutes) will be implemented in study group 1 using traditional methods and in study group 2 using the mobile game method. Telerehabilitation sessions will be conducted via an Android-based tablet if the study is supported by Tübitak 1002 A Rapid Support Module. Individual smartphones of participants will be used if the study is not supported. All questionnaires, scales, and tests used in the initial assessments will be repeated at the end of the 8-week exercise protocol for all participants. conditions: Geriatrics conditions: Balance conditions: Exercise conditions: Fall Prevention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: exercise measure: Mini BESTest measure: Functional Reach Test measure: International Falls Efficacy Scale sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06267820 id: 2010 briefTitle: Postoperative Pain Control by Adding Ketorolac to Bupivacaine in Transversus Abdominis Plane Block in Children overallStatus: COMPLETED date: 2023-06-01 date: 2023-12-01 date: 2023-12-10 date: 2024-02-20 date: 2024-02-20 name: Sohag University class: OTHER briefSummary: Control of of pain in children is fundamental. TAP block is associated with less side effects compared with other neuraxial techniques especially when done under ultrasound guidance.
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Ketorolac has analgesic effect comparable to morphine. Children were arranged randomly into two equal groups, forty-five children in each.
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Group (K) (n= 45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).
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Group (T) (n =45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) conditions: Postoperative Pain, Acute studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: Bupivacain name: Ketorolac measure: 1st analgesic requirement measure: Number of patients who requested analgesia measure: heart rate measure: Total rescue analgesia measure: Satisfaction of the parents regarding their children analgesia measure: Number of children in each group who required analgesia in the first 24 h postoperatively measure: blood pressure sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Fouad Ibrahim Soliman city: Sohag zip: 52514 country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False
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<|newrecord|> nctId: NCT06267807 id: 114369 id: NL84520.091.23 type: OTHER domain: Protocol ID METC briefTitle: Lymphatic Phenotype in Noonan Syndrome Spectrum Disorders acronym: LENS overallStatus: RECRUITING date: 2024-03-27 date: 2025-03-13 date: 2025-06-01 date: 2024-02-20 date: 2024-02-20 name: Radboud University Medical Center class: OTHER briefSummary: To get a better insight into the central conducting lymphatic system in adult volunteers with Noonan Syndrome (NS) without clinical symptoms or signs of lymphatic disease compared to NS and CardioFacioCutaan syndrome patients with severe lymphatic disease conditions: Lymphatic System Disorders Congenital conditions: Lymphatic Diseases conditions: Noonan Syndrome conditions: Lymphatic Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 15 type: ESTIMATED name: Dynamic contrast-enhanced lymphangiography measure: Central lymphatic system anatomy and flow descriptive parameters. measure: Diameter Thoracic duct measure: Lymph flow velocity measure: Demographics age measure: Demographics gender measure: Demographics measure: Demographics weight measure: Demographics clinical history measure: Demographics genetic background sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radboudumc status: RECRUITING city: Nijmegen state: Gelderland zip: 6500 HB country: Netherlands name: Lotte ER Kleimeier, Msc role: CONTACT phone: 024036106873 email: [email protected] lat: 51.8425 lon: 5.85278 hasResults: False
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<|newrecord|> nctId: NCT06267794 id: ODISEA Study briefTitle: Prolonged Release Pirfenidone Versus Placebo in Compensated Cirrhosis. acronym: ODISEA overallStatus: COMPLETED date: 2015-06-26 date: 2021-12-30 date: 2023-03-24 date: 2024-02-20 date: 2024-02-20 name: Jorge L Poo class: OTHER briefSummary: This will be a multicenter, double-blind clinical trial to evaluate the safety and efficacy of two doses of prolonged release pirfenidone, compared against placebo plus conventional therapy in patients with compensated liver cirrhosis. The study will be conducted in compliance with International Standard good clinical practices (GCPs) and the Declaration of Helsinki. The protocol is approved by a local Institutional Review Board and registered in clinical trials.gov. conditions: Liver Fibrosis conditions: Cirrhosis, Liver conditions: Chronic Liver Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blind, placebo-controlled multicenter study primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Placebo will be identical to medication.
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Methods to assign treatment:
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Before assigning numbers to subjects, the researcher must confirm that the inclusion criteria have been met, that none of the exclusion criteria apply, that written and signed informed consent has been obtained, that the evaluations of the scrutiny (of admission) and that the required laboratory results are available and meet the admission criteria. To do this, the centers will be assisted with a check list format that contains all the selection criteria.
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The person responsible for the medication at the research site will contact the Randomization center, where the treatment will be assigned to the patient. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 180 type: ACTUAL name: Pirfenidone 1200 mg name: Pirfenidone 1800 mg name: Placebo measure: Change in liver fibrosis measure: Clinical side effects measure: Improvement in Child Pugh score measure: Improvement in MELD score measure: Improvement in bilirrubin and albumin measure: Improvement in prothrombin time measure: Improvement in liver enzymes measure: Improvement in EuroQol Visual analog scales measure: Improvement in EuroQol five dimensions Scale measure: Improvement in modified fatigue impact scale (MFIS) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06267781 id: TRANSPLANT-PRO briefTitle: RRMS: Disease PROgression and Myeloid Profiling After Bone Marrow TRANSPLANTation and Second Line Therapies acronym: TRANSPLANTPRO overallStatus: RECRUITING date: 2022-09-02 date: 2027-09-02 date: 2027-09-02 date: 2024-02-20 date: 2024-02-20 name: IRCCS San Raffaele class: OTHER briefSummary: To study whether highly effective therapies can halt disease progression in people with multiple sclerosis by modulating the peripheral myeloid landscape. conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Number of fading/disappearing paramagnetic rim lesions (PRLs) measure: Surrogate biomarkers of disease progression (MSFC) measure: Surrogate biomarkers of disease progression (sNfL) measure: Surrogate biomarkers of disease progression (RNFL) measure: Surrogate biomarkers of disease progression (cortical lesions) measure: Surrogate biomarkers of disease progression (atrophy) measure: Changes in myeloid landscape sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Raffaele status: RECRUITING city: Milan zip: 20132 country: Italy name: Massimo Filippi, MD role: CONTACT phone: 00390226433054 email: [email protected] name: Anna A. Bellini, MD role: CONTACT phone: 00390226432154 email: [email protected] lat: 45.46427 lon: 9.18951 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-05-03 uploadDate: 2024-02-15T03:19 filename: Prot_SAP_000.pdf size: 10630791 hasResults: False
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<|newrecord|> nctId: NCT06267768 id: REC Reference No.:HE-OT2023/13 id: Proj.Ref.No.: 2023/3007-R7052 type: OTHER_GRANT domain: Research Donation Fund, Hong Kong Metropolitan University briefTitle: The Effects of Inspiratory Pressures on Diaphragmatic Contraction in People After Stroke overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-11-30 date: 2025-11-30 date: 2024-02-20 date: 2024-03-27 name: Hong Kong Metropolitan University class: OTHER name: Shenzhen Second People's Hospital briefSummary: This is a cross-sectional study to determine the optimal inspiratory muscle training (IMT) intensity for stroke survivors. Participants will breathe through a pressure threshold inspiratory loading device with varying loads in random order. Each IMT intensity protocol consists of 10 breaths. During the test, accessory inspiratory muscle activity will be measured with surface electromyography (sEMG) and diaphragm thickness will be used to assessed with ultrasonography. Repeated-measures ANOVA will be used for statistical analysis to determine the most effective training intensity for future study. conditions: Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 130 type: ESTIMATED name: Various intensities of inspiratory muscle training measure: Diaphragmatic thickening fraction measure: Muscle activation of the sternocleidomastoid muscle measure: Perceived Exertion Borg scale sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-29 uploadDate: 2024-01-08T21:03 filename: Prot_SAP_000.pdf size: 563906 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-29 uploadDate: 2024-02-15T09:59 filename: ICF_001.pdf size: 197199 hasResults: False
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<|newrecord|> nctId: NCT06267755 id: P.T.REC/012/004884 briefTitle: Efficacy of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain acronym: MTP overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-08-30 date: 2024-08-30 date: 2024-02-20 date: 2024-02-20 name: Cairo University class: OTHER briefSummary: this study will be conducted to investigate the effect of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: extracorporeal shockwave and traditional therapy primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: opaque sealed envelope whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Extracorporeal Shockwave therapy name: Traditional physical therapy measure: muscle thickness measure: hypoechoic area intensity measure: neck disability measure: pressure pain threshold measure: cervical range of motion measure: pain intensity sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06267742 id: CHN097 briefTitle: Clinical Trial to Evaluate MDW for Early Detection of Sepsis overallStatus: RECRUITING date: 2022-06-23 date: 2024-03-31 date: 2024-09-30 date: 2024-02-20 date: 2024-02-28 name: Beckman Coulter, Inc. class: INDUSTRY name: Peking Union Medical College Hospital name: West China Hospital name: Second Affiliated Hospital, School of Medicine, Zhejiang University briefSummary: This study is intended to clinically verify Monocyte Distribution Width (MDW) parameter of DxH 900 Hematology Analyzer for use in early detection and risk assessment of sepsis, severe sepsis, and septic shock in critically ill patients in Emergency Department (ED). This study is also aimed to provide study supporting data for the product to be marketed in China. conditions: Sepsis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2200 type: ESTIMATED name: Complete Blood Count (CBC) with Differential measure: sensitivity, specificity sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing country: China name: Huadong Zhu, MD role: CONTACT lat: 39.9075 lon: 116.39723 facility: West China Hospital, Sichuan University status: RECRUITING city: Chengdu country: China name: Yaxiong Zhou, MD role: CONTACT lat: 30.66667 lon: 104.06667 facility: The Second Affiliated Hospital of Zhejiang University School of Medicine status: RECRUITING city: Hangzhou country: China name: Mao Zhang, MD role: CONTACT lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06267729 id: D9660C00001 briefTitle: Study of AZD0754 in Participants With Metastatic Prostate Cancer acronym: APOLLO overallStatus: RECRUITING date: 2024-03-12 date: 2027-05-24 date: 2027-05-24 date: 2024-02-20 date: 2024-04-29 name: AstraZeneca class: INDUSTRY briefSummary: The purpose of this study is to evaluate the safety, tolerability, and antitumour activity of AZD0754 CAR T-cell therapy in participants with metastatic prostate cancer. conditions: Metastatic Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE maskingDescription: Open-Label count: 60 type: ESTIMATED name: AZD0754 measure: Incidence of participants with Dose-limiting Toxicity (DLTs)/DLT-like events, Adverse Events (AEs), including Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs). measure: Presence of replication-competent lentivirus (RCL) in peripheral blood samples measure: Prostate-specific antigen (PSA) response rate - PSA50 measure: PSA response rate - PSA90 measure: Duration of PSA Response (DoPSA50, DoPSA90) measure: Durable PSA Response Rate (DRRPSA50, DRRPSA90) measure: Time to PSA Response (TTPSA50, TTPSA90) measure: Time to PSA Progression (TTPSAP50, TTPSAP90) measure: Best Overall Response (BOR) measure: Objective Response Rate (ORR) measure: Time to Response (TTR) measure: Duration of Response (DoR) measure: Durable Response Rate (DRR) measure: Disease Control Rate (DCR) measure: Percentage change in tumor size measure: Radiographic Progression-free Survival (rPFS) measure: Overall Survival (OS) measure: Time from AZD0754 Infusion to the first Symptomatic Skeletal-related Events (SSRE) measure: Pharmacokinetics - maximum observed serum concentration (Cmax) of AZD0754 measure: Pharmacokinetics - time taken to reach maximum serum concentration (Tmax) of AZD0754 measure: Pharmacokinetics - Last measurable serum concentration (Clast) of AZD0754 measure: Pharmacokinetics - time of last measurable serum concentration (Tlast) of AZD0754 measure: Pharmacokinetics - Exposure of AZD0754 measure: Biomarker - STEAP2 expression in Tumor sex: MALE minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: RECRUITING city: Duarte state: California zip: 91010 country: United States lat: 34.13945 lon: -117.97729 facility: Research Site status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33612 country: United States lat: 27.94752 lon: -82.45843 facility: Research Site status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30322 country: United States lat: 33.749 lon: -84.38798 facility: Research Site status: RECRUITING city: Hackensack state: New Jersey zip: 07601 country: United States lat: 40.88593 lon: -74.04347 facility: Research Site status: NOT_YET_RECRUITING city: New York state: New York zip: 10065 country: United States lat: 40.71427 lon: -74.00597 facility: Research Site status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 facility: Research Site status: RECRUITING city: Houston state: Texas zip: 77030 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: RECRUITING city: East Melbourne zip: 3002 country: Australia lat: -37.81667 lon: 144.9879 hasResults: False
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<|newrecord|> nctId: NCT06267716 id: 274-2023 briefTitle: Pericapsular Nerve Block and Iliopsoas Fascial Plane Block in Hip Surgery overallStatus: RECRUITING date: 2024-02-23 date: 2024-07-30 date: 2024-08-30 date: 2024-02-20 date: 2024-02-28 name: Haseki Training and Research Hospital class: OTHER briefSummary: This prospective randomized interventional study aims to compare the effects of two peripheral nerve blocks, the periencapsular nerve block (PENG) and iliopsoas block (IPB), on analgesia and motor function after hip surgery.
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The main questions it aims to answer are the effectivity of postoperative pain management the preservation of motor movement.
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Participants will receive standardized general anesthesia and postoperative PENG or IPB in either Group.
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Researchers will compare the total amount of rescue analgesia and numeric rating scale with accompanying evaluating motor function at the same time intervals within 24 hour. conditions: Hip Fractures conditions: Peripheral Nerve Block studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective randomized standardized triple-blind primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The participants under general anaesthesia and the orthopaedic surgeon responsible for the study will be blinded to the study groups and the specific block procedures. This surgeon will serve as the sole evaluator of postoperative outcomes. Intraoperative results will be recorded by the anaesthesia technician, who is present in the operating room and unaware of the block procedures. Moreover, the data analysis will be conducted before the data are unblinded. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: PENG block name: IPB measure: postoperative motor block measure: pain scores measure: total analgesia, intraoperative measure: total rescue analgesia sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haseki Training and Research Hospital status: RECRUITING city: Istanbul state: Sultangazi zip: 34000 country: Turkey name: Berna Caliskan role: CONTACT phone: +905067108770 email: [email protected] lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06267703 id: 2023-01939_VR briefTitle: Multi-omics Analyses on Etiology and Early Detection of Stomach Cancer Precursor Lesions overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2026-12-31 date: 2026-12-31 date: 2024-02-20 date: 2024-02-21 name: Karolinska Institutet class: OTHER briefSummary: The overall aim is to utilize multi-omics approach to identify novel etiopathogenesis and early detection biomarkers for stomach cancer precursor lesions. To achieve this aim, first the investigators will use stored serum samples to perform metabolomics profiling among 12,599 twin subjects, among whom 1034 were deemed to have chronic atrophic gastritis based on measured pepsinogen I and II levels. Logistic regression will be used to search for metabolites related to the risk of chronic atrophic gastritis. Second, the investigators will further measure serum proteome by using two quantitatively precise proteomics assays, among the above-mentioned twin subjects. Identified protein biomarkers will be combined with metabolomics biomarkers to create a prediction model for chronic atrophic gastritis. The results will hopefully improve our understanding of the etiological factors and provide promising early detection biomarkers for stomach cancer precursor lesions. conditions: Chronic Atrophic Gastritis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 12599 type: ACTUAL name: Metabolomic profiling measure: Chronic atrophic gastritis sex: ALL minimumAge: 46 Years maximumAge: 97 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska Institutet city: Solna state: Stockholm zip: 17165 country: Sweden lat: 59.36004 lon: 18.00086 hasResults: False
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<|newrecord|> nctId: NCT06267690 id: SYSUFAH2021025 briefTitle: A CT-based Radiomics Model to Predict Survival-graded Fibrosis in PDAC overallStatus: COMPLETED date: 2021-01-13 date: 2023-08-31 date: 2023-08-31 date: 2024-02-20 date: 2024-02-20 name: First Affiliated Hospital, Sun Yat-Sen University class: OTHER briefSummary: Tumor fibrosis plays an important role in chemotherapy resistance in pancreatic ductal adenocarcinoma (PDAC), however there remains a contradiction in the prognostic value of fibrosis. We aimed to investigate the relationship between tumor fibrosis and survival in patients with PDAC, classify patients into high- and low-fibrosis groups, and develop and validate a CT-based radiomics model to non-invasively predict fibrosis before treatment. conditions: Pancreatic Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 295 type: ACTUAL name: surgery measure: fibrosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shi Siya city: Guangzhou state: Guangdong zip: 510000 country: China lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06267677 id: 2007/3928 briefTitle: Efficacy of Liquid Versus Powder Protein Supplementation to Optimize Protein Intake After Bariatric Surgery overallStatus: COMPLETED date: 2008-01-02 date: 2008-04-18 date: 2009-03-06 date: 2024-02-20 date: 2024-02-20 name: Hospital Clinic of Barcelona class: OTHER briefSummary: The goal of this randomized control trial is to compare the effect of a liquid formula rich in nutrients and low in calories (supplement) with the progressive diet with conventional foods that we usually recommend in patients after surgery. The main question it aims to answer is if the addition of a high-protein, volume-controlled nutritional supplement as a fundamental part of the diet during the first two months after surgery will preserve the patient's nutritional status and prevent the appearance of nutritional deficits and associated complications.
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Participants will be evaluated at the beginning, at 1 month and at the end of the study (2m) and the following determinations will be made:
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* Analytical determination
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* Nitrogen balance by determining urea N2 in 24-hour urine
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* Anthropometric determinations
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* Body composition determined by impedanciometry
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* Resting energy expenditure and nutrient oxidation measured by indirect calorimetry.
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* Energy, protein and hydration intake.
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* Gastrointestinal tolerance through self-registration of symptoms. Researchers will compare the effect of a complete hypocaloric liquid formula group with the usual progressive diet group to see if they achieve the protein intake goal established for patients after obesity surgery, preservation of nutritional status and lean mass during the rapid phase of weight loss and the gastrointestinal tolerance during the first two months after surgery. conditions: Body Composition conditions: Obesity conditions: Protein Supplementation conditions: Bariatric Surgery Candidate conditions: Weight Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ACTUAL name: High protein liquid formula measure: protein intake measure: evaluate nutritional deficiencies measure: Tolerance sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06267664 id: PI-GR-23-3263 briefTitle: Real-world Effectiveness and Tolerability of Triptans-Ditans-Gepants (TRIDIGEP) acronym: TRIDIGEP overallStatus: RECRUITING date: 2023-12-04 date: 2024-09-30 date: 2024-12-01 date: 2024-02-20 date: 2024-02-21 name: Hospital Clínico Universitario de Valladolid class: OTHER briefSummary: Migraine is the third most prevalent disease and the leading reason of years lived with disability in the most productive years of the life. Migraine associated disability can be alleviated by acute and preventive treatment. The migraine landscape has changed recently, with the approval of novel acute treatments, including oral Calcitonin gene-related peptide antagonists, the gepants (Rimegepant, Ubrogepant, Zavegepant) and 5-HT-1F antagonists, the Ditans (Lasmiditan). These have joined Triptans as acute "migraine-specific" drugs.
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The TRIDIGEP study will be an open-label, multiple attack, prospective cohort study.
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This study aims to describe 1) the effectiveness of the acute treatments of migraine attacks in routine clinical practice, 2) the tolerability of the drugs, and 3) to explore potential response and tolerability predictors.
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The endpoints recommended by the International Headache Society will be employed, including: 1) Pain freedom; 2) Absence of the most bothersome symptom; 3) Sustained pain freedom; 4) Total freedom from migraine; 5) Headache relief; 6) Duration of attacks; 7) Time lost due to an attack; 8) Need of rescue medication. The study endpoints will be assessed at 2, 8 and 24 hours after the acute drug use. Data will be collected by the patients themselves, with a validated data collection instrument within a RedCap questionnaire, using QR codes. conditions: Migraine conditions: Migraine Disorders conditions: Migraine With Aura conditions: Headache Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1500 type: ESTIMATED name: Patients with migraine treated with triptans, Lasmiditan or Gepants measure: Pain freedom at 2 hours measure: Absence of the most bothersome symptom measure: Pain freedom at 8 hours measure: Pain freedom at 24 hours measure: Sustained pain freedom measure: Total freedom from migraine at 2 hours measure: Total freedom from migraine at 8 hours measure: Total freedom from migraine at 24 hours measure: Headache relief at 2 hours measure: Headache relief at 8 hours measure: Headache relief at 24 hours measure: Time to meaningful relief measure: Time to pain freedom measure: Time to migraine freedom measure: Need of rescue medication at 2 hours measure: Need of rescue medication at 8 hours measure: Need of rescue medication at 24 hours measure: Tolerability of the drugs measure: Response predictors at 2 hours measure: Response predictors at 24 hours measure: Tolerability predictors measure: Time lost due to an attack sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínico Universitario de Valladolid status: RECRUITING city: Valladolid zip: 47010 country: Spain name: David Garcia Azorin, MD, PhD role: CONTACT phone: +34665872228 email: [email protected] name: Yesica González Osorio role: CONTACT phone: 634330426 email: [email protected] lat: 41.65518 lon: -4.72372 hasResults: False
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<|newrecord|> nctId: NCT06267651 id: Steroid in ulcerative colitis briefTitle: Value Of ACE Index (Albumin, CRP And Endoscopy) In Predicting Intra Venous Steroid Response In Acute Severe Ulcerative Colitis In Assiut University Hospitals overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2026-06 date: 2027-01 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: 1. Determine if the ACE index can predict resoponse to I V steroid in Acute severe ulcerative colitis
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2. identify on admission a high-risk population who may beneft from earlier second line medical treatment or surgical intervention. ( steroid non responder groups ) conditions: Early Detection of Complication of Ulcerative Colitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 95 type: ESTIMATED measure: Early prevention of complication of ulcerative colitis sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06267638 id: Chomthong hospital, Thailand briefTitle: Comparison of Postoperative Pain Score Between Perioperative Intravenous Ketamine and Placebo in Patients Undergoing Unilateral Total Knee Arthroplasty Under General Anesthesia overallStatus: RECRUITING date: 2024-01-22 date: 2025-12-31 date: 2025-12-31 date: 2024-02-20 date: 2024-03-12 name: Ministry of Health, Thailand class: OTHER_GOV briefSummary: The goal of this clinical trial is to compare postoperative pain score between perioperative intravenous ketamine and placebo in patients undergoing unilateral total knee arthroplasty under general anesthesia. The main question\[s\] it aims to answer are:
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* Can perioperative intravenous ketamine reduce postoperative pain score during rest and movement at 0, 2, 4, 8, 12, 18, 24 hours better than no administration of Ketamine in patients undergoing Unilateral total knee arthroplasty under general anesthesia?
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* Can perioperative intravenous ketamine reduce morphine consumption in postoperative 24 hours, length of hospital stay, first time to receive opioid and side effect or complication from ketamine and opioid better than no administration of Ketamine in patients undergoing Unilateral total knee arthroplasty under general anesthesia? Participants will receive intravenous ketamine intraoperative TKA and comparison group will receive placebo that is normal saline. Researchers will compare perioperative intravenous ketamine and placebo to see postoperative pain score, morphine consumption in postoperative 24 hours, length of hospital stay, first time to receive opioid and side effect or complication from ketamine and opioid. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Ketamine group name: Placebo group measure: Postoperative pain score at rest and movement measure: First time to receive intravenous analgesic drug measure: Morphine consumption measure: Length of hospital stay measure: side effect and complication from ketamine and opioid sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chomthong hospital status: RECRUITING city: Chiangmai zip: 50160 country: Thailand name: Numphung Sukantarat, master role: CONTACT phone: 66855426519 email: [email protected] lat: 18.79038 lon: 98.98468 hasResults: False
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<|newrecord|> nctId: NCT06267625 id: Elderly Individuals briefTitle: Physical Impairments in Elderly Individuals overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-03-15 date: 2026-12-15 date: 2024-02-20 date: 2024-02-20 name: Izmir Democracy University class: OTHER briefSummary: There are no studies in the literature reporting the dyspnea, posture, strength, physical activity, functional mobility and balance in elderly individuals. The aims of this observational study are; 1) to evaluate dyspnea, posture, strength, physical activity, functional mobility and balance in elderly individuals, 2) to reveal the relationships between these parameters of research group. conditions: Aging Disorder studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: Physical Evaluations of individuals measure: Dyspnea score measure: Posture score measure: Cough strength measure: Handgrip strength measure: Functional mobility score measure: Physical activity score measure: Functional Mobility score measure: Balance score measure: Cognitive function score sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Izmir Democracy University city: İzmir zip: 35140 country: Turkey name: GÜLŞAH BARĞI, Assoc.Dr. role: CONTACT phone: +90 531 793 8766 email: [email protected] name: ESRA SUDE AKIN, BSc role: CONTACT phone: +90 543 581 4690 email: [email protected] lat: 38.41273 lon: 27.13838 hasResults: False
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<|newrecord|> nctId: NCT06267612 id: KY20231109-11 briefTitle: Corheart 6 LVAS Long-term Follow-up Study overallStatus: NOT_YET_RECRUITING date: 2024-02-10 date: 2030-06-30 date: 2030-06-30 date: 2024-02-20 date: 2024-02-20 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: The purpose of this clinical study is to explore the long-term efficacy and safety of the Corheart 6 Left Ventricular Assist System (LVAS) as a treatment for patients with advanced heart failure.
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The study will be a single-arm, prospective, single-center, non-blinded, and non-randomized study with a follow-up duration of five years. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Corheart 6 Left Ventricular Assist System measure: Device implantaion success rate at 24 months post-implantation measure: Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) measure: Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) questionnaire measure: Functional status as measured by the Six Minute Walk Test (6MWT) measure: Functional status as measured by the New York Heart Association (NYHA) Classification measure: Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score measure: Stroke severity as assessed by the modified Rankin Scale (mRS) score measure: Adverse events measure: Device-related re-operations measure: Device-related re-hospitalizations measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing First Hospital city: Nanjing state: Jiangsu country: China name: Zhibing Qiu role: CONTACT email: [email protected] lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06267599 id: ACAR-Style Bladder Suture briefTitle: Bladder Suture in Uterus-Sparing Surgery and Hysterectomy for Placenta Percreta overallStatus: COMPLETED date: 2023-09-01 date: 2023-12-01 date: 2024-01-01 date: 2024-02-20 date: 2024-02-20 name: Necmettin Erbakan University class: OTHER briefSummary: This study aimed to evaluate the short-term and long-term complications of placenta percreta with bladder invasion. This evaluation focuses on cases where bladder dissection and ACAR-style bladder sutures were applied in cases of placenta percreta with bladder invasion that underwent uterine-sparing surgery or hysterectomy. conditions: Placenta Percreta conditions: Bladder Injury conditions: Sutures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 81 type: ACTUAL name: ACAR-Style Bladder Suture measure: Comparison of intraoperative bleeding and complication rates of the two groups measure: Comparison of postoperative bleeding between two groups measure: Comparison of complication rate between two groups sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Cemre Alan city: Konya country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
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<|newrecord|> nctId: NCT06267586 id: PN23.007 briefTitle: Effects of PeptiSleep in Healthy Males and Females With Mild to Moderate Sleep Impairment overallStatus: RECRUITING date: 2024-04-08 date: 2024-12-30 date: 2025-02-20 date: 2024-02-20 date: 2024-04-24 name: Nuritas Ltd class: INDUSTRY name: RDC Clinical Pty Ltd briefSummary: Examining the effects of PeptiSleep, a plant-based sleep aid, in healthy males and females with mild to moderate sleep impairment conditions: Sleep studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, single-blind, placebo-controlled, parallel dose response study conducted over 70 days primaryPurpose: OTHER masking: SINGLE maskingDescription: Participants will be unaware of arm allocation however as each arm contains a different number of capsules to be consumed, the investigator will be aware of the arm allocation whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: PeptiSleep name: Placebo MCC micro-crystalline cellulose measure: Safety and Tolerability of a dose range of PeptiSleep via adverse event reporting measure: Safety via electrolytes and liver function tests measure: Sleep Quality via Leeds Sleep Evaluation Questionnaire measure: Insomnia severity via the Insomnia Severity Index Questionnaire measure: Sleep onset time via self-reported recording in a Sleep Diary measure: Sleep pattern via self-reported recording in a Sleep Diary measure: Daytime Sleepiness via the Epworth Sleepiness Scale measure: Stress via the Perceived Stress Scale measure: Stress via self reported Profile of Mood States Questionnaire measure: Anxiety via self-reported Beck Anxiety Inventory questionnaire measure: Stress via Salivary cortisol test measure: Alertness via Reaction Time Test measure: Circadian cycles via melatonin and serotonin via blood test measure: Markers associated with inflammation via blood test measure: Sleep onset latency via wearable sleep tracker measure: Total sleep time spent in sleep phases via wearable sleep tracker measure: Blood pressure via blood pressure machine measure: Heart rate via blood pressure machine measure: Body Temperature via wearable sleep tracker measure: BMI via height and weight measurements measure: Bedtime via wearable sleep tracker measure: Total time awake via wearable sleep tracker measure: Sleep quantity via wearable sleep tracker measure: Sleep efficiency via wearable sleep tracker measure: Sleep score via wearable sleep tracker measure: Nocturnal heart rate via wearable sleep tracker measure: Heart Rate variability via wearable sleep tracker measure: Blood Oxygen sensing via sleep tracker measure: Respiratory rate via sleep tracker measure: Daily Readiness Score via sleep tracker sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RDC Clinical status: RECRUITING city: Brisbane state: Fortitude Valley Queensland zip: 4006 country: Australia name: Amanda Rao role: CONTACT name: Amanda Rao role: PRINCIPAL_INVESTIGATOR lat: -27.46794 lon: 153.02809 hasResults: False
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<|newrecord|> nctId: NCT06267573 id: Kerolos protocol briefTitle: Thoracoabdominal Aortic Aneurysms overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-09-15 date: 2026-09-10 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: Evaluation of the effectiveness of the different modalities for treatment of thoracoabdominal aortic aneurysms. FEVAR and BEVAR devices are widely used now due to its feasability and wide range of use . We aim to evaluate the effectiveness of these new devices in the management of TAAA conditions: Thoracoabdominal Aortic Aneurysm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Fenestrated and branched endovascular devices for TAAA measure: Successful cannulation of the target vessels with complete in-line flow to target organs. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06267560 id: CTQJ230A12303 briefTitle: Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD overallStatus: NOT_YET_RECRUITING date: 2024-05-27 date: 2027-06-21 date: 2027-06-21 date: 2024-02-20 date: 2024-02-20 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated levels of Lp(a) who are treated for cardiovascular (CV) risk factors according to local practice/guidelines for the reduction of cardiovascular risk. conditions: Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Eligible participants will be randomized after the screening period or Guideline recommended SOC implementation period (if needed) in a 2:1 ratio to subcutaneous injections of pelacarsen (TQJ230) 80 mg QM or placebo QM either to be self-administered or administered by caregiver or site personnel approximately every 30 days for up to 12 months. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: TQJ230 name: Placebo measure: Change in log-transformed Lp(a) concentration from baseline at week 52 measure: Incidence proportion of study discontinuations due to TEAEs measure: Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06267547 id: 2023P003522 briefTitle: Healthy Activities Improve Lives (HAIL) acronym: HAIL overallStatus: RECRUITING date: 2024-04-23 date: 2026-12-01 date: 2027-02-01 date: 2024-02-20 date: 2024-04-29 name: Massachusetts General Hospital class: OTHER name: National Institute on Aging (NIA) briefSummary: The investigators have developed an online platform to support the 8-week, F\&S! exercise program called the Healthy Activity Improves Lives (HAIL) online platform. The aim of this study is to perform a cluster randomization of four racially diverse churches or senior centers to either the standard F\&S! program, or the combined HAIL Online Platform + F\&S! program to examine the efficacy of the HAIL online platform + F\&S! program for older adults in black communities. conditions: Physical Activity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: HAIL Online Platform name: Fit and Strong! Program measure: Feasibility and Retention measure: Acceptability measure: Acceptability (Feedback Form) measure: Acceptability (Exit Interviews) measure: Changes in Physical Activity (Steps) measure: Changes in Physical Activity (MVPA) measure: Changes in Aerobic Capacity measure: Changes in Physical Strength measure: Motivation to Change measure: Utilization of Healthcare Resources measure: Fall History measure: Chronic Conditions measure: Changes in Overall Wellbeing measure: Changes in Depression measure: Changes in Anxiety measure: Changes in Physical Functioning measure: Changes in Social Isolation measure: Changes in Confidence in Exercises measure: Satisfaction with program measure: Satisfaction with program measure: Use of online program measure: Use of online program sex: ALL minimumAge: 60 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Roslindale Baptist Church status: RECRUITING city: Boston state: Massachusetts zip: 02131 country: United States name: Lydia Townsend role: CONTACT lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06267534 id: YCH briefTitle: Mindfulness-based Mobile Applications Program overallStatus: COMPLETED date: 2022-09-09 date: 2022-09-22 date: 2022-09-22 date: 2024-02-20 date: 2024-02-20 name: Yu-Chien Huang class: OTHER briefSummary: The goal of this type of study: quasi-experimental clinical trial . The purpose of this study is to explore the effects of applying mindfulness-based mobile applications program to maintaining mental health of emergency nurses during providing care to COVID-19 patients. The main question\[s\] it aims to answer are:
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1. To explore the effect of mindfulness-based mobile device-assisted program on care stress of emergency nurses caring for COVID-19 patients.
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2. To explore the impact of mindfulness-based mobile device-assisted programs on the psychological distress of emergency nurses caring for COVID-19 patients.
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3. To explore the impact of a mindfulness-based mobile device-assisted program on compassion fatigue in emergency nurses caring for COVID-19 patients.
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Participants will Mindfulness-based mobile device is provided to experimental group as assistance for 2 weeks. In the contrary, no intervention measure was assigned in the control group. Scale exam was performed before and after the program in both groups at the same time. conditions: COVID-19 conditions: Cell Phone Use conditions: Nurse conditions: Mental Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 102 type: ACTUAL name: mindfulness-based mobile applications program measure: The impact of mindfulness-based mobile device assistance program on the care stress of emergency nursing staff caring for COVID-19 patients measure: Effects of mindfulness-based mobile device assistance program on psychological distress among emergency nursing staff caring for COVID-19 patients measure: Effects of a mindfulness-based mobile device-assisted program on compassion fatigue among emergency nursing staff caring for COVID-19 patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yu-Chien Huang city: Taipei state: Zhongzheng District zip: 100 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06267521 id: 2023-1473 id: Protocol Version 2/8/2024 type: OTHER domain: UW Madison id: L&S/PSYCHOLOGY/PSYCHOLOGY type: OTHER domain: UW Madison id: A487400 type: OTHER domain: UW Madison id: AWD00000302 type: OTHER_GRANT domain: US Department of Defense DARPA briefTitle: The STRENGTHEN Study overallStatus: RECRUITING date: 2024-03-06 date: 2025-02 date: 2025-02 date: 2024-02-20 date: 2024-03-27 name: University of Wisconsin, Madison class: OTHER name: United States Department of Defense briefSummary: This study uses two different types of interventions including electrical brain stimulation delivered during sleep, and brief, daily meditation training. The investigators are trying to figure out whether these techniques, either alone or in combination with each other, can positively impact the brain networks that support our ability to think flexibly and to regulate our emotions. 48 participants will be enrolled and can expect to be on study for up to 9 months. conditions: Cognitive Flexibility conditions: Emotional Regulation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Participants will not know whether they are in a group receiving active stimulation (groups 2, 3, and 4) or sham stimulation (group 1). However, participants will know whether they are performing meditation (groups 1, 3, and 4) or listening to only the didactic meditation material (group 2), and participants will be aware of how many nights they are undergoing stimulation (1 night per week for group 3, 2 nights per week for groups 1, 2, and 4). Thus, participants will be only partially blind to condition. Investigators will not be blind to condition. whoMasked: PARTICIPANT count: 48 type: ESTIMATED name: Healthy Minds Program name: Sham Meditation Didactic Material name: Sham Stimulation in Lab name: Stimulation in Lab name: MRI Scanner measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score measure: Change in General Anxiety Disorder (GAD-7) Score measure: Change in Single-item Suicide Question measure: Change in Healthy Minds Index (HM Index) measure: Change in the Perceived Stress Scale (PSS) Score measure: Change in Emotional Styles Questionnaire (ESQ) Score measure: Change in Cognitive Flexibility Inventory (CFI) Score: Alternatives Subscale measure: Change in Cognitive Flexibility Inventory (CFI) Score: Control Subscale measure: Change in Difficulties in Emotion Regulation Scale-18 (DERS-18) Score measure: Change in PROMIS Sleep Disturbance Score measure: Change in PTSD Checklist for DSM-5 (PCL-5) measure: Change in World Health Organization-5 (WHO-5) measure: Change in Restorative Sleep Questionnaire (RSQ) Score measure: Change in Sleep Depth Question (SDQ) Score measure: Change in Pittsburgh Sleep Quality Index (PSQI) Score measure: Change in Suicide Risk Survey measure: Change in Brief Suicide Cognitions Scale (B-SCS) Score measure: Change in Passive and Active Suicidal Ideation Scale (PASIS) Score measure: Change in NIH Toolbox Loneliness Score measure: Change in Five Facet Mindfulness Questionnaire (FFMQ) Score measure: Change in Drexel Defusion Scale (DDS) Score measure: Change in PROMIS Meaning and Purpose Score measure: Change in Digital Working Alliance Inventory (D-WAI) Score measure: Change in Perseverative Thinking Questionnaire (PTQ) Score measure: Change in Experiences Questionnaire's Decentering subscale (EQ-D) Score measure: Change in Experience Sampling / Ecological Momentary Assessment measure: Change in Death Implicit Association Test Score measure: Change in Reversal Learning Task Score measure: Change in Multi-Source Interference Task Score measure: Change in Emotional Stroop Score: Reaction Time measure: Change in Emotional Stroop Score: Percent Correct measure: Change in Meteor Mission Score: Mean Reaction Time measure: Change in Meteor Mission Score: Coefficient of Variation measure: Change in Meteor Mission Score: Percent Correct measure: Change in Emotional Persistence Task Score measure: Change in Change Your Mind Task Score: Mean Change measure: Change in Change Your Mind Task Score: Accuracy measure: Change in Change Your Mind Task Score: Response Time measure: Change in Spectral Power Density During Stimulation-Free Sleep measure: Resting-state fMRI Connectivity Z-Scores sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Center for Healthy Minds status: RECRUITING city: Madison state: Wisconsin zip: 53703 country: United States lat: 43.07305 lon: -89.40123 hasResults: False
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<|newrecord|> nctId: NCT06267508 id: LMU-IMPH-LIFE2Scale briefTitle: Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment acronym: LIFE2Scale overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2025-12 date: 2024-02-20 date: 2024-02-20 name: Michael Hoelscher class: OTHER name: National Institute for Medical Research (NIMR) - Mbeya Medical Research Centre (MMRC) name: Instituto Nacional de Saúde (INS), Ministério da Saúde name: University of Liverpool briefSummary: This study aims to improve HIV healthcare services for mothers living with HIV and their newborns in Tanzania and Mozambique. The main questions it aims to answer are: 1) does enhancing screening with maternal HIV viral load monitoring at delivery identify more mother-child pairs at high-risk for HIV vertical transmission? and 2) are high-risk infants linked to appropriate prevention and care? The study will expand access to HIV testing services to more rural settings using a hub-and-spoke referral system. conditions: Vertical Human Immunodeficiency Virus Transmission conditions: HIV Infection Pediatric conditions: Infant Death conditions: Infant Morbidity conditions: Infant, Newborn, Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 6000 type: ESTIMATED name: Maternal HIV viral load testing at delivery for VHT risk assessment measure: Proportion of HIV-exposed infants correctly identified as low- or high-risk and receiving birth EID testing and ePNP or ART as appropriate within 7 days of life measure: Turnaround times for EID testing at birth, 4-6 weeks, and 14 weeks (time from sample collection to receipt of results by the health facility and communication of results to the mother/caregiver) and maternal PoC VL testing at delivery and 14 weeks measure: Proportion and rate of VHT at birth, week 4-8, and week 14 measure: Risk-factors associated with VHT measure: Adherence to PNP and ePNP measure: Proportion and rate of clinical endpoints (mortality, morbidity) among HIV-positive infants at week 14, month 6, and month 12 measure: Age at ART initiation among HIV-positive infants measure: Risk factors for poor ART adherence among high-risk mothers and infants measure: Proportion of HIV-positive infants virally suppressed at week 14, month 6, and month 12 measure: Risk factors for poor viral suppression among HIV-positive infants measure: Proportion of HIV-positive infants on ART that experience grade III or greater laboratory ART toxicity measure: Retention to HIV EID and infant health care services measure: Proportion of pregnant women presenting with criteria considered high-risk for VHT at delivery measure: Proportion of mothers virally suppressed at week 14 post-partum measure: Proportion and rate of post-partum mothers newly fulfilling high-risk criteria based on socio-behavioural criteria (i.e., adherence issues) measure: Characteristics of transmitted viral strains (lineages, subtypes, resistance mutations) among HIV-positive infants and in comparison to their mothers viral sequences measure: Proportion of HIV-positive infants who develop acquired drug resistance mutations during the study measure: Characteristics of infant and maternal HIV strains to be neutralized against a panel of known broadly neutralizing antibody candidates (e.g., VRC07, 10-1074) and maternal autologous antibodies at time of transmission measure: Average public healthcare and healthcare-related expenditures measure: Average health worker time needed to care for mothers and infants per clinic visit, including for enhanced counselling sessions measure: Cost per HIV-exposed infant fulfilling the primary outcome measure: Empirical cost-effectiveness (incremental cost-effectiveness ratio) relating intervention costs to life-years saved among HIV-positive infants measure: Average global and dimensional patient satisfaction measure: Hub-and-spoke model and provider satisfaction (health care personnel, focal point persons, counsellor) measure: Socio-behavioural and personal aspects related to high-risk criteria for mother-child pairs (adherence, retention, disclosure, emotional well-being and health care satisfaction) measure: Descriptions of tasks, functions, acceptability, challenge and workloads related to PVHT and neonatal HIV focal persons measure: Descriptions of tasks, functions, acceptability, challenge and workloads related to counsellors (enhanced high-risk counselling) measure: Description on eHealth functionality, satisfaction, acceptance of linkage procedures sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro de Investigacao Operacional de Beira (CIOB), Instituto Nacional de Saúde (INS), Ministério da Saúde, city: Beira country: Mozambique name: Joaquim Lequechane role: CONTACT name: Ilesh Jani, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: -19.84361 lon: 34.83889 facility: National Institute for Medical Research (NIMR) city: Mbeya country: Tanzania name: Issa Sabi, MD, PhD role: CONTACT name: Issa Sabi, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: -8.9 lon: 33.45 hasResults: False
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<|newrecord|> nctId: NCT06267495 id: EOCXLFE briefTitle: Epithelium-on Cross-linking Versus Observation of Fellow Eyes of Patients With Unilateral Clinically Evident Keratoconus overallStatus: COMPLETED date: 2017-01-01 date: 2024-01-31 date: 2024-01-31 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease. The management of young patients, diagnosed with clinically evident KC in one eye and with no clinical signs of KC in the other eye, represents a real challenge for many ophthalmologists.
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The aim of the current study is to investigate the effectiveness and safety of epithelium-on accelerated CXL to stabilize the eye with no clinical signs of KC, in young patients with unilateral clinically evident KC, compared with standard care and follow-up only. conditions: Keratoconus studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: Epithelium-on corneal cross-linking (epi-on CXL) measure: Steep keratometry value measure: Maximum keratometry value measure: Corrected distance visual acuity sex: ALL minimumAge: 12 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT facility: Tiba Eye Center city: Assiut zip: 71516 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False
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<|newrecord|> nctId: NCT06267482 id: 122311 briefTitle: Using ROSA for Challenging The TKA Standard of Care overallStatus: RECRUITING date: 2024-04-16 date: 2025-04 date: 2025-06 date: 2024-02-20 date: 2024-04-18 name: Lawson Health Research Institute class: OTHER name: Zimmer Biomet briefSummary: This is a prospective, randomized controlled trial using the cruciate retaining, MC Persona to comparing the conventional TKA to ROSA assisted TKA. Patients will be randomized to one of three study trial arms.
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1. Standard of care medial parapetallar approach (Control)
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