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Purpose: This prospective randomized case control study aims to look at the longevity of sealants with bonding agent cured prior to sealant placement vs those with uncured bond. The study will be performed by USC graduate pediatric personnel.
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Methods: A split mouth prospective randomized control study will be performed on pediatric dental patients at Long Beach Memorial's Children's Dental Health Clinic and USC Pediatric Dental Clinic, placing sealants with cured bond on half of a mouth and sealants with uncured bond on the contralateral half. Intraoral photos will be obtained at the initial visit and recalls to evaluate the overall retention/longevity of the sealant placement. The goal of this study is determine which sealant has higher longevity and to provide recommendations for future pediatric dentists regarding sealant procedures. conditions: Dental Sealant conditions: Sealant Retention studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: After baseline examination, a randomized generator, will be used in order to issue which side will bonding agent cured prior to sealant placement. Randomization will be a simple randomization, and will be determined by the provider flipping a coin. Randomization will be performed to ensure graders of sealants will be blinded to which side of bond is cured prior to sealant placement.
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Heads indicates the RIGHT side of mouth WILL be cured prior to sealant placement. The left side of the mouth will have bond and sealant cured together after.
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Tails indicates the LEFT side of the mouth WILL be cured prior to sealant placement. The right side of the mouth will not have bond cured prior to sealant placement. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 217 type: ESTIMATED name: Ultradent Ultra Seal XT Plus measure: Sealant Longevity measure: Caries measure: Molar hypomineralization sex: ALL minimumAge: 5 Years maximumAge: 14 Years stdAges: CHILD facility: Herman Ostrow School of Dentistry of USC status: RECRUITING city: Los Angeles state: California zip: 90089 country: United States name: Catherine Pham, DDS, MPH role: CONTACT phone: 213-740-0412 email: [email protected] lat: 34.05223 lon: -118.24368 hasResults: False
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<|newrecord|> nctId: NCT06342245 id: 2023.568 briefTitle: Low-temperature Radiofrequency Coblation Micro-tenotomy for the Treatment of Achilles Tendinopathy acronym: AT RCT overallStatus: NOT_YET_RECRUITING date: 2024-06-11 date: 2027-06-10 date: 2027-06-11 date: 2024-04-02 date: 2024-04-02 name: Chinese University of Hong Kong class: OTHER briefSummary: This is a prospective randomized, double-blinded, placebo-controlled superiority trial with two parallel groups and a 1:1 allocation ratio to investigate the effectiveness of radiofrequency coblation micro-tenotomy for patients with Achilles tendinopathy. All participants will be randomized into two groups: the intervention group (n=24; radiofrequency coblation micro-tenotomy + endoscopic Achilles debridement) and the control group (n=24; endoscopic Achilles debridement only). Adults (age \>18) with clinically diagnosed midportion Achilles tendinopathy will be recruited and scheduled for ultrasound screening. All participants will undergo a 12-week eccentric exercise program taught by a registered physiotherapist / athletic trainer. Undergo Endoscopic Achilles debridement and Radiofrequency coblation micro-tenotomy intervention. Criteria for discontinuing or modifying allocated interventions, Strategies to improve adherence to interventions, Relevant concomitant care permitted or prohibited during the trial and Provisions for post-trial care. Outocme measure will use VISA-A, pain scores, ultrasound measurement of thickness and vascularity, calf muscle strength, and ankle range of motion. conditions: Achilles Tendinopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a multicentre prospective randomized, double-blinded, placebo-controlled superiority trial with two parallel groups and a 1:1 allocation ratio to investigate the effectiveness of radiofrequency coblation micro-tenotomy for patients with Achilles tendinopathy. All participants will be randomized into two groups: the intervention group (n=24; radiofrequency coblation micro-tenotomy + endoscopic Achilles debridement) and the control group (n=24; endoscopic Achilles debridement only).
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Investigators will obtain written consent from all participants before the commencement of this study. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 48 type: ESTIMATED name: Radiofrequency coblation micro-tenotomy measure: Victorian Institute of Sports Assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06342232 id: BEH1986 id: 423629 type: OTHER_GRANT domain: Saskatchewan Health Research Foundation briefTitle: The Efficacy of Neurofeedback Mindfulness in Migraine Management overallStatus: COMPLETED date: 2021-09-09 date: 2022-12-24 date: 2023-03-01 date: 2024-04-02 date: 2024-04-02 name: University of Saskatchewan class: OTHER name: Saskatchewan Health Research Foundation briefSummary: This longitudinal randomized controlled trial explored how long-term practice of neurofeedback mindfulness would be helpful for migraine management when compare dot a similar controlled intervention. All the participants went through assigned 10 minutes practices on a daily basis for 8 weeks. Behavioural reports and migraine characteristics were compared before and after the intervention. conditions: Migraine Headaches studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 101 type: ACTUAL name: Neurofeedback mindfulness name: Simple attention controlled task measure: Migraine Disability measure: Migraine Severity measure: Headache Management Self-efficacy measure: Anxiety measure: Depression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Saskatchewan city: Saskatoon state: Saskatchewan zip: S7N5A2 country: Canada lat: 52.13238 lon: -106.66892 hasResults: False
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<|newrecord|> nctId: NCT06342219 id: 423629 briefTitle: Chronic Migraines and Neurofdeeback Mindfulness overallStatus: NOT_YET_RECRUITING date: 2024-12 date: 2025-12 date: 2026-06 date: 2024-04-02 date: 2024-04-02 name: University of Saskatchewan class: OTHER name: Saskatchewan Health Research Foundation briefSummary: As the second phase of our study on migraine headaches and neurofeedback mindfulness, we will explore how chronic migraineurs will benefit from a long term practice (8 weeks) of neurofeedback mindfulness compared to a similar attention group and a waitlisted group. This randomized controlled trial will also explore if migrianuers could decrease their dependence on medicine intake after completion of the study. conditions: Chronic Migraine, Headache studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 135 type: ESTIMATED name: Neurofeedback Mindfulness name: Attention Task measure: Migraine Disability measure: Migraine Severity measure: Headache management self-efficacy measure: Dependence on medicine measure: Anxiety measure: Depression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Saskatchewan city: Saskatoon state: Saskatchewan zip: S7N5A2 country: Canada lat: 52.13238 lon: -106.66892 hasResults: False
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<|newrecord|> nctId: NCT06342206 id: CMUH111-REC2-144 briefTitle: The Assessment of Acute /Chronic Phase in Patients With Ischemic Cerebral Stroke Using TCM Diagnostic Tools overallStatus: RECRUITING date: 2022-09-08 date: 2022-09-21 date: 2024-09-07 date: 2024-04-02 date: 2024-04-02 name: China Medical University Hospital class: OTHER briefSummary: Cerebral infarction is the second cause of death and the third cause of disability. More than 13.7 million patients worldwide are diagnosed with stroke every year, and the number of deaths is 5.5 million, of which ischemic stroke is the major type, accounting for 87%. Sequelae of stroke are problems that require long-term medical care. If we can intervene and assist with Traditional Chinese Medicine (TCM) at early stage, it will be a great boon for patients. In clinical practice, TCM collects data as the basis for diagnosis through the four diagnostic methods-look, listen, question, and feel the pulse. Among these, tongue diagnosis and pulse diagnosis belong to the categories of look and feel the pulse. At present, the objective examination instruments of TCM developed are mainly tongue diagnostic instruments and pulse diagnostic instruments. Therefore, we hope to utilize tongue and pulse diagnoses as the main reference to analyze the changes in ischemic stroke stages. The data of this study are collected from China Medical University Hospital and YuanRung Hospital-for further statistical analysis. Ischemic stroke patients (ICD-10: I63) who were hospitalized within 1 week from the date of diagnosis were eligible to join this research project. Tongue and pulse examinations were collected once per week within 1 month. A total of 4 tongue-pulse examinations were collected in each case, which were categorized into acute stage (24 hours to 1 week), subacute stage (1 to 3 weeks) and chronic stage (more than 3 weeks). \[30\] This research is to study the changes of tongue and pulse diagnoses in acute, subacute and chronic stages among ischemic patients who receive TCM diagnosis and treatment. Through utilizing objective evaluation of Chinese and Western medical examination instruments, we hope to establish clear diagnostic standards for TCM syndrome types, so as to evaluate the efficacy of clinical diagnosis and treatment. The goal is to improve the quality of TCM care and to provide Chinese and Western integrated treatment for stroke patients in the future. This research can also serve as a reference for related TCM research and development. conditions: Stroke, Ischemic studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 24 type: ESTIMATED measure: Differences between tongue diagnosis and pulse diagnosis in acute and chronic stroke patients sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: YuanRung Hospital status: RECRUITING city: Changhua zip: 510 country: Taiwan name: LI-CHI TSAI role: CONTACT phone: 0919688481 name: YEN-HUA YANG role: CONTACT phone: 0912587467 lat: 24.07327 lon: 120.56276 hasResults: False
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<|newrecord|> nctId: NCT06342193 id: virtual reality briefTitle: Effect of Virtual Reality Glasses on Anxiety During Cystoscopy: A Randomised Controlled Trial overallStatus: RECRUITING date: 2024-03-14 date: 2024-06-15 date: 2024-06-15 date: 2024-04-02 date: 2024-04-02 name: Uşak University class: OTHER briefSummary: The aim of this study was to investigate the effect of using virtual reality glasses as a distraction method on anxiety in men undergoing cystoscopy under local anaesthesia. conditions: Cystoscopy conditions: Virtual Reality conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: virtual reality group measure: anxiety sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Usak Training and Research Hospital status: RECRUITING city: Uşak state: Center zip: 64100 country: Turkey name: Yucel Can Danisman role: CONTACT phone: +905532864569 email: [email protected] name: Fatma Susam, PhD role: SUB_INVESTIGATOR name: Yucel Can Danisman role: PRINCIPAL_INVESTIGATOR name: Ozan Ozavci role: SUB_INVESTIGATOR name: Shahnaza Mahmudova role: SUB_INVESTIGATOR name: Erkan Arslan, MD role: SUB_INVESTIGATOR name: Adem Tuncekin, MD role: SUB_INVESTIGATOR name: Bilgen Arikan, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.67351 lon: 29.4058 hasResults: False
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<|newrecord|> nctId: NCT06342180 id: Usakupcos1 briefTitle: Metabolic Differences Between Subtypes of Polycystic Ovary Syndrome overallStatus: COMPLETED date: 2022-01-01 date: 2022-09-01 date: 2023-07-20 date: 2024-04-02 date: 2024-04-02 name: Uşak University class: OTHER briefSummary: We aimed to investigate serum uric acid levels in patients with different phenotype of policystic ovary syndrome and to compare healthy controls. conditions: Uric Acid Concentration, Serum, Quantitative Trait Locus 7 conditions: Polycystic Ovary Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 300 type: ACTUAL name: Serum uric acid level measure: Uric acid levels in PCOS subtypes sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Usak Egitim Ve Araştırma Hastanesi city: Uşak zip: 64100 country: Turkey lat: 38.67351 lon: 29.4058 hasResults: False
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<|newrecord|> nctId: NCT06342167 id: NCC4409 briefTitle: Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-14 date: 2026-07-01 date: 2026-12-01 date: 2024-04-02 date: 2024-04-03 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: At present, concurrent chemoradiotherapy (cCRT) with platin-based dual-drug regimen is the standard treatment for inoperable, locally advanced esophageal cancer in patients with a good performance status. However, cCRT has substantial toxic effects, and a large number of patients with older age, malnutrition and other morbidities, cannot tolerate cCRT. Several phase II trials showed combining PD-1 inhibitor with definitive cCRT provided encouraging activity and acceptable toxicity in patients with locally advanced esophageal squamous cell carcinoma (LA-ESCC).
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Therefore, this single-arm, multicenter, phase II trial aims to assess the efficacy and safety of immunotherapy plus radiotherapy with immunonutrition support in patients with LA-ESCC and positive PD-L1 expression who are intolerant to cCRT. conditions: Locally Advanced Esophageal Squamous Cell Carcinoma conditions: Sintilimab conditions: Radiotherapy conditions: Concurrent Chemoradiotherapy conditions: Immunonutrition studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 57 type: ESTIMATED name: Radiotherapy name: Programmed Cell Death Protein 1 Inhibitor name: Immunonutrition support measure: 1-year Progression-free survival rate (PFS) measure: Objective response rate measure: Progression-free survival measure: Overall survival rate measure: Overall survival measure: Incidence of adverse events sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College city: Beijing state: Beijing zip: 100021 country: China lat: 39.9075 lon: 116.39723 facility: Department of Radiation Oncology，Clinical Oncology School of Fujian Medical University，Fujian Cancer Hospital city: Fujian state: Fujian country: China facility: Department of Oncology, Affiliated Hospital, Hebei University of Engineering city: Handan state: Hebei country: China lat: 36.60056 lon: 114.46778 facility: Department 1st of Radiation Oncology, Anyang Tumor Hospital city: Anyang state: Henan country: China lat: 36.096 lon: 114.38278 facility: Department of Radiation Oncology the first affiliated hospital of Xinxiang Medical University city: Xinxiang state: Henan country: China lat: 35.19033 lon: 113.80151 facility: Department of Radiation Oncology, General Hospital of Ningxia Medical University city: Yinchuan state: Ningxia country: China lat: 38.46806 lon: 106.27306 facility: Department of Radiation Oncology，Fei County People's Hospital city: Feixian state: Shandong country: China facility: Department of Radiation Oncology, Affiliated hospital of Jining Medical University city: Jining state: Shandong country: China lat: 35.405 lon: 116.58139 facility: Taizhou hospital of Wenzhou Medical University city: Taizhou state: Zhejiang zip: 317000 country: China lat: 32.49069 lon: 119.90812 hasResults: False
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<|newrecord|> nctId: NCT06342154 id: MCBU-SBF-YC-03 briefTitle: Does Endorphin Massage Reduce the Anxiety of Pregnant Women? overallStatus: RECRUITING date: 2023-10-09 date: 2024-10-09 date: 2024-12-10 date: 2024-04-02 date: 2024-04-02 name: Celal Bayar University class: OTHER briefSummary: Before cesarean section surgery, researchers will demonstrate endorphin massage to the husbands of pregnant women, and they will be asked to apply the massage before the surgery. The stress levels and pain levels of women will be compared before and after the massage. conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized study with experimental and control group primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 68 type: ESTIMATED name: Endorphin Massage measure: visual analog scale (VAS) measure: State and Trait Anxiety Scales measure: cortisol level sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi status: RECRUITING city: Manisa zip: 45060 country: Turkey lat: 38.61202 lon: 27.42647 hasResults: False
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<|newrecord|> nctId: NCT06342141 id: 24-1423 briefTitle: Empagliflozin for No-reflow Phenomenon in PCI for STEMI acronym: EMPA-PCI overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-01-15 date: 2025-03-15 date: 2024-04-02 date: 2024-04-02 name: Instituto Nacional de Cardiologia Ignacio Chavez class: OTHER briefSummary: Myocardial infarction remains, in our current era, a leading cause of morbidity and mortality both domestically and globally. A significant contributor to this issue is reperfusion injury, which enlarges the infarction, deteriorates ventricular function, leads to poorer outcomes, and currently has no specific treatment. Originally developed as an antidiabetic, empagliflozin has shown significant benefits in other organs and systems. Recent years have seen the demonstration of its cellular and vascular effects in animal models, potentially contributing to the reduction of reperfusion damage. However, no human studies have yet confirmed these effects.
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Consequently, this double-blind, randomized, parallel-arm clinical trial was designed to evaluate the effect of empagliflozin treatment, administered from the pre-intervention period through to 3 days post-intervention, on the incidence of the no-reflow phenomenon in patients with ST-segment elevation myocardial infarction (STEMI) undergoing coronary angioplasty compared to a placebo.
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Before entering the hemodynamics room, participants in the intervention group will receive a loading dose of 25 mg of empagliflozin or a placebo. In-hospital treatment will continue with 10 mg empagliflozin daily for 3 days for the intervention group, while the control group will receive a placebo. Patients will be monitored weekly during the first month and bi-weekly during the second and third months.
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The primary outcome will be the incidence of the no-reflow phenomenon, measured through the Thrombolysis in Myocardial infarction (TIMI) flow scale in the coronary angiography performed to treat the infarction. Secondary outcomes will include the reduction of ST segment on the electrocardiogram, troponin levels, differences in the longitudinal strain by echocardiogram, and infarct size by magnetic resonance imaging. conditions: STEMI conditions: No-Reflow Phenomenon studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 162 type: ESTIMATED name: Empagliflozin 25 milgrams (Mg) name: Empagliflozin 10 Mg name: Placebo 25 Mg name: Placebo 10 Mg measure: Non-Reflow Phenomenon measure: Infract size measure: Longitudinal Strain measure: High-sensitivity Troponin Clearance measure: Creatine Kinase-myocardial band Clearance measure: Adverse Cardiovascular Events sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06342128 id: MVI_Kidney_001 briefTitle: Molecular Landscape of Microvascular Inflammation in Kidney Allografts overallStatus: RECRUITING date: 2022-01-01 date: 2024-06 date: 2024-12 date: 2024-04-02 date: 2024-04-03 name: Paris Translational Research Center for Organ Transplantation class: OTHER briefSummary: Microvascular inflammation in kidney allografts has been widely reappraised in the recent update of Banff classification. There is a critical need to better understand the pathophysiological mechanisms associated with the various phenotypes of microvascular inflammation that are observed in kidney transplants, particularly in order to develop targeted therapeutic approaches. conditions: Kidney Rejection Transplant studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: No intervention measure: RNA-based molecular signatures assessed using bulk and spatial transcriptomics measure: Probability of graft survival based on outcome data measure: Probability of patient survival on outcome data sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris status: RECRUITING city: Paris zip: 75010 country: France name: Carmen Lefaucheur, MD PhD role: CONTACT email: [email protected] lat: 48.85341 lon: 2.3488 facility: Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris status: RECRUITING city: Paris zip: 75015 country: France name: Alexandre Loupy, MD PhD role: CONTACT phone: +33612491082 email: [email protected] lat: 48.85341 lon: 2.3488 facility: Bichat Hospital, Assistance Publique - Hôpitaux de Paris status: RECRUITING city: Paris zip: 75018 country: France name: Aurélie Sannier, MD PhD role: CONTACT email: [email protected] lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06342115 id: CLEMENT TRIAL briefTitle: Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens acronym: CLEMENT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-04 date: 2025-04 date: 2024-04-02 date: 2024-04-02 name: Beneficência Portuguesa de São Paulo class: OTHER name: Merck Sharp & Dohme LLC briefSummary: The study proposes a planned, double-blind, non-inferiority clinical trial involving patients with febrile neutropenia and risk of extended-spectrum beta-lactamase (ESBL) infection. The goal is:
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- Analyze the efficacy and tolerability of Ceftolozane/tazobactam (CEF/TAZ) compared to the current standard of care (meropenem) in patients with febrile neutropenia and risk of ESBL infection.
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Patients will be randomly assigned to receive CEF/TAZ or meropenem, with assessment of clinical response, toxicity and microbiological evolution. Stool samples will be collected before, during and after treatment for intestinal microbiota analysis and intestinal microbiome analysis to evaluate possible effects on GVHD. Analysis of the results will include the taxonomic classification of the organisms present. Data will be analyzed to assess non-inferiority in clinical response, incidence of GVHD, antimicrobial resistance and other outcomes. conditions: Febrile Neutropenia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 176 type: ESTIMATED name: Ceftolozane-Tazobactam name: Meropenem measure: Percentage of Participants With Clinical Response of Clinical Cure at the End-of-Therapy (EOT) Visit in the Intent-to-Treat (ITT) Population measure: Percentage of Participants With Clinical Response of Clinical Cure at the End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population measure: Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Intent-to-Treat (ITT) Population measure: Incidence of microbiologically documented infections and identification of causative organisms in culture measure: In-hospital mortality measure: Occurrence of graft versus host disease (GVHD) measure: Frequency of multidrug resistant-pathogen infections or colonization measure: Faecal microbiota analysis measure: Percentage of Participants Who Report 1 or More Adverse Event (AE) measure: Percentage of Participants With Any Serious Adverse Event (SAE) measure: Percentage of Participants Discontinuing Study Drug Due to an Adverse Event (AE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: A Beneficência Portuguesa de São Paulo city: São Paulo country: Brazil name: João Prats, MD role: CONTACT phone: +55 11 3505 5031 lat: -23.5475 lon: -46.63611 hasResults: False
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<|newrecord|> nctId: NCT06342102 id: ID 4286 briefTitle: PENG and LFCN Block Versus FIC Block for Multimodal Analgesia After Total Hip Replacement Surgery: a Retrospective Analysis Focused on Movement (Retro-PvF) acronym: Retro-PvF overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2024-03-26 date: 2024-04-30 date: 2024-04-02 date: 2024-04-04 name: Ospedale Edoardo Bassini class: OTHER briefSummary: Total hip arthroplasty is a major surgical procedure performed on a growing number of patients. Optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation, thus expediting hospital discharge. Amongst the many peripheral nerve blocks, FIB (fascia iliaca block) has been recommended as the block of choice by many international guidelines since it offers the best pain control with a relatively low risk of motor block. PENG (pericapsular nerve group) and its association with LFCN (lateral femoral cutaneous nerve) has been proposed as an effective alternative that offers comparable, If not better, pain control with a considerably lower risk for motor block compared to FIB. Given the novelty of this block, there are few published papers on the subject, mostly case series or case reports thus justifying the need for retrospective study. conditions: Regional Anesthesia Block conditions: Regional Anesthesia conditions: Total Hip Replacement Surgery conditions: Total Hip Arthroplasty \(THA\) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 80 type: ESTIMATED name: PENG + LFCN block name: FIC block measure: Movement of the lower limb affected by surgery measure: pain control measure: pain control measure: pain control measure: Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses measure: Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses measure: Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses measure: time to first opioid request measure: time to first postoperative ambulation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06342089 id: NCT06342089 briefTitle: Association Between Molar Incisor Hypomineralization And Type I Diabetes Milletus. overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2024-11 date: 2025-05 date: 2024-04-02 date: 2024-04-05 name: Cairo University class: OTHER briefSummary: * Determine the association between molar incisor hypomineralization and type I diabetes millutes, its severity and treatment need via clinical examination of children with type I diabetes millutes .
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* Teeth will be cleaned gently using gauze and wet with saliva during examination. A disposable diagnostic set (mirror, probe) will be used for each patient where mirrors will be used for proper visualization especially for maxillary teeth.
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* Blunt explorers will be used to aid in tactile sensation if needed, as during the differentiation between rough and smooth enamel edges and/or during the inspection of the caries extent if it exists. No diagnostic radiographs will be taken.
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* The severity and treatment needs of each case with MIH will be recorded in patient's chart.
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* The results of the study will be regularly monitored by the supervisors who will have full access to these results. conditions: Molar Incisor Hypomineralization studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: RETROSPECTIVE count: 238 type: ESTIMATED name: Type I diabetes milletus measure: Association between molar incisor Hypomineralization and type I diabetes milletus measure: Severity of molar incisor Hypomineralization among among a group of children with type I diabetes milletus. measure: Treatment need sex: ALL minimumAge: 8 Years maximumAge: 14 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06342076 id: 2023-596 briefTitle: Comparison of the Efficacy of Peripheral Nerve Blocks in Major Open Gynaecological Cancer Surgery overallStatus: COMPLETED date: 2024-01-01 date: 2024-03-01 date: 2024-03-01 date: 2024-04-02 date: 2024-04-02 name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital class: OTHER_GOV briefSummary: The aim of this prospective randomized study was to compare the effectiveness of subcostal transversus abdominis plane block or rectus sheath block applied in addition to posterior transversus abdominis plane block for postoperative analgesia in major gynecological cancer surgeries.
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The main question(s) it aims to answer are:
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\[Is subcostal transversus abdominis plane block more effective in postoperative analgesia? \] \[Is there a difference in pain scores at 24 hours after surgery? \] Since pain scores within the first 24 hours after surgery will be evaluated, participants will be asked to give a value between 0 and 10 at certain time periods. conditions: Postoperative Pain conditions: Postoperative Complications conditions: Analgesia conditions: Regional Anesthesia Morbidity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective randomize study primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Prospective randomize study count: 50 type: ACTUAL name: Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block name: Patients undergoing rectus sheat block and posterior transversus abdominis plane block measure: visuel analog scale measure: amount of opioid used sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Başakşehir Çam and Sakura City Hospital city: Istanbul state: Basaksehir country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06342063 id: 20-0070-E briefTitle: The Effects of Preoperative Blood Flow Restriction Training in Patients Undergoing ACL Reconstruction acronym: BFRACL overallStatus: COMPLETED date: 2021-04-01 date: 2023-10-31 date: 2024-01-31 date: 2024-04-02 date: 2024-04-02 name: Women's College Hospital class: OTHER briefSummary: This prospective feasibility study is designed to assess pre-operative BFR in patients awaiting ACL reconstruction. This study will serve the following: (1) to determine if BFR improves strength testing prior to surgery and (2) to determine if BFR reduces QF muscle group atrophy prior to surgery. Additionally, preliminary results on pre-operative clinical and quality of life scores will be collected. If this study shows encouraging results, it will serve as a template for a more comprehensive randomized control trial. conditions: ACL Injury conditions: Sports Physical Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients were recruited and randomized to one of the two treatment arms. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcome measurement was blinded to participant intervention. whoMasked: OUTCOMES_ASSESSOR count: 32 type: ACTUAL name: Blood Flow Restriction Therapy name: Blood Flow Restriction Therapy Sham measure: Biodex Strength Testing measure: Short Form Health Survey 12 (SF-12) measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Mount Sinai Hospital city: Toronto state: Ontario zip: M5G 1X5 country: Canada lat: 43.70011 lon: -79.4163 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2022-10-28 uploadDate: 2024-03-07T20:51 filename: Prot_000.pdf size: 303762 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-10-28 uploadDate: 2024-03-23T13:30 filename: ICF_001.pdf size: 892575 hasResults: False
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<|newrecord|> nctId: NCT06342050 id: STU-2023-0548 id: R01MD011686 type: NIH link: https://reporter.nih.gov/quickSearch/R01MD011686 briefTitle: Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-WLS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-08 date: 2024-04-02 date: 2024-04-02 name: University of Texas Southwestern Medical Center class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The goal of this cross-sectional observational study is to examine potential relationships between the blood and gut microbiota of patients with obesity before and after weight loss surgery (WLS) and evaluate potential ethnic differences in the blood and gut microbiotas before and after the WLS.
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The main aims / objectives of this sub-study are:
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* Aim 1. Compare the relationship between the blood and the gut microbiomes among a sample of (1) pre-WLS and (2) 6-month post-WLS participants.
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Hypothesis: Blood bacterial composition will resemble that of the gut microbiome among pre-WLS participants. Because the effect of WLS on the blood microbiome is not known, our post-WLS results will be mostly exploratory.
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* Aim 2. Determine racial differences in the blood microbiome of the pre- and post-WLS groups.
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Hypothesis2: Ethnic differences will be detected in both the pre- and post-WLS groups. conditions: Obesity conditions: Metabolic Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED measure: Gut Microbial Composition measure: Blood Microbial Composition measure: Body Weight (kg) measure: Body Height (meters) measure: Fat Mass (Kg) measure: Fat-free Mass (Kg) measure: Body water (%) measure: Skeletal Muscle Mass (kg) measure: Fasting Glucose (mg/dL) measure: Fasting Insulin (mIU/L) measure: Lipopolysaccharides (%) measure: Lipopolysaccharides binding protein (mIU/L) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-19 uploadDate: 2024-03-27T14:38 filename: Prot_SAP_000.pdf size: 316789 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-19 uploadDate: 2024-03-27T14:39 filename: ICF_001.pdf size: 297665 hasResults: False
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<|newrecord|> nctId: NCT06342037 id: N22TON briefTitle: NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial acronym: TONIC-3 overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-04-01 date: 2030-04-01 date: 2024-04-02 date: 2024-04-18 name: The Netherlands Cancer Institute class: OTHER name: Hoffmann-La Roche briefSummary: This is a single center, non-blinded, multi-cohort, non-comparative phase II trial to study the safety and efficacy of tiragolumab with atezolizumab and/or ipilimumab in advanced triple-negative breast cancer. conditions: Metastatic Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Tiragolumab name: Atezolizumab name: Ipilimumab measure: PFS-12 measure: Incidence of adverse events measure: Objective response rate measure: Clinical benefit rate measure: Progression-free survival measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06342024 id: 23-871 briefTitle: Pistachio Consumption on Inflammatory Markers and Lean Body Mass overallStatus: RECRUITING date: 2024-02-20 date: 2025-05-30 date: 2025-08-31 date: 2024-04-02 date: 2024-04-02 name: Virginia Polytechnic Institute and State University class: OTHER briefSummary: Pistachio nuts (Pistacia vera L.) are a nutrient- and energy-dense food, and are a significant source of 15 different micronutrients. In addition to an excellent micronutrient profile, pistachios are a good source of monounsaturated and polyunsaturated fats (linoleic acid, oleic acid, and plant sterols). Pistachios have the lowest amount of total fat, and the highest protein, fiber, and phytosterol content compared to other nuts. They possess a high antioxidant content. Specifically, pistachios have high amounts of lutein, zeaxanthin, and phenolic compounds (e.g., anthocyanins, flavonoids, and proanthocyanidins). These aforementioned compounds are known for their anti-inflammatory effects. Pistachios also have been shown to reduce the risk of cardiovascular disease, metabolic syndrome, and all-cause mortality.
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The purpose of this study will be to determine the effects of consuming 1.5 ounces of pistachios per day compared to consuming no pistachios per day on inflammatory markers (creatine kinase, C-reactive protein, cortisol, Interleukin-8, tumor necrosis factor-alpha, copper-zinc superoxide dismutase, and glutathione peroxidase concentrations) and lean body mass in women and men, 40 to 60 years of age, who have been recreationally active for at least six months (exercising three to five days per week). It is hypothesized that pistachio consumption will significantly lower inflammatory response and significantly increase lean body mass.
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This will be a randomized study where participants will first complete a two-week baseline run-in period during which they will consume their typical diet. Following this, participants will be randomized to one of two groups for six months: consuming 1.5 ounces of pistachios per day or a control group (consuming no pistachios). Those consuming pistachios will be in addition to their usual diet.
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The overall goal of this study is to evaluate the effects of pistachio consumption on inflammatory markers and lean body mass in women and men, 40 to 60 years of age, who exercise three to five days per week. This study could provide a simple, healthy way for recreationally active individuals to decrease inflammation and improve body composition. conditions: Inflammatory Response studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Eligible participants will be randomized to one of two groups (pistachio vs. control) using permuted block randomization with stratification to balance assignment by sex. Randomization allocation tables will be created by a biostatistician not involved in the clinical trial using SAS software, version 9.4 (SAS Institute, Cary, NC, USA). The tables will be stored within the REDCap system at Virginia Tech, in such a way that only the biostatistician will be able to view them. Study outcomes will be analyzed blind to allocation status. primaryPurpose: OTHER masking: NONE maskingDescription: Not apply count: 144 type: ESTIMATED name: Pistachio group measure: C-reactive protein concentrations in the blood measure: Creatine kinase concentrations in the blood measure: Cortisol concentrations in the blood measure: Interleukin-8 concentrations in the blood measure: Tumor necrosis factor-alpha concentrations in the blood measure: Copper-zinc superoxide dismutase concentrations in the blood measure: Glutathione peroxidase concentrations in the blood measure: Lean body mass measure: Body weight measure: Height measure: Body Mass Index measure: Magnesium concentrations in the blood measure: Iron concentrations in the blood measure: Zinc concentrations in the blood sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Virginia Polytechnic Institute and State University status: RECRUITING city: Blacksburg state: Virginia zip: 24061 country: United States name: Stella L Volpe, PhD role: CONTACT phone: 540-231-3805 email: [email protected] name: Alexandra Hanlon, PhD role: CONTACT phone: 540-231-5657 email: [email protected] lat: 37.22957 lon: -80.41394 hasResults: False
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<|newrecord|> nctId: NCT06342011 id: KY-2024-039 briefTitle: Effect of Anti-inflammatory Diet in Patients With Inflammatory Bowel Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-12-31 date: 2024-04-02 date: 2024-04-02 name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: For the first time, this study developed an anti-inflammatory diet （AID） recipe suitable for Inflammatory bowel disease（IBD） patients and developed an AID application program to verify the intervention effect of AID on IBD patients, which not only promoted the application of AID in IBD patients and promoted the promotion of AID model, but also provided new ideas for the prevention and treatment strategies for IBD patients. conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 88 type: ESTIMATED name: Anti-inflammatory diet group measure: C-reactive protein measure: Erythrocyte sedimentation rate (ESR) measure: Leukocyte measure: Self-Rating Anxiety Scale，SAS measure: Self-Rating depression scale，SDS measure: Simplified Chinese version of Inflammatory Bowel Disease Quality of Life Scale (IBDQ) measure: Inflammatory Bowel Disease Self-Efficacy Scale (IBD-SES) measure: Body Mass Index sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Fourth Affiliated Hospital of Zhejiang University School of Medicine city: Yiwu state: Zhejiang zip: 322000 country: China name: Xia Qian, BA role: CONTACT phone: 15968110117 email: [email protected] lat: 29.31506 lon: 120.07676 hasResults: False
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<|newrecord|> nctId: NCT06341998 id: HERO2020 briefTitle: Clinical Study of Chemotherapy in the Treatment of Recurrent/Refractory Yolk Sac Tumor in Children acronym: SCRRYST overallStatus: COMPLETED date: 2020-06-01 date: 2024-01-01 date: 2024-02-01 date: 2024-04-02 date: 2024-04-02 name: Shandong First Medical University class: OTHER briefSummary: Remarkable progress has been made in treating germ-cell tumor (GCT) through the use of platinum-based regimens. However, part of yolk sac tumor (YST) with cisplatin resistance or recurrence is nevertheless prone to relapse after second-line treatment. This leaves a gap in effective treatment, which needs to be filled by novel therapeutic approaches. This paper is the first one to report the treatment combining sirolimus with nab-paclitaxel, ifosfamide, and carboplatin (S-TIC) for children with repeated relapsed or refractory yolk sac tumor (rrrYST). conditions: Germ Cell Tumor conditions: Yolk Sac Tumor studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ACTUAL name: sirolimus combined with chemotherapy in the treatment of recurrent/refractory yolk sac tumor in children measure: Objective Response Rate Allocation 'Non-Randomized' implies that this is a multi-arm study, but only one arm has been specified. Objective Response Rate measure: Progression-free Survival sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Shandong Cancer Hospital and Institute city: Jinan state: Shandong zip: 250117 country: China lat: 36.66833 lon: 116.99722 hasResults: False
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<|newrecord|> nctId: NCT06341985 id: IEO 1593 briefTitle: DOsimetry and Radiation Induced NAusea in Head and Neck Cancers acronym: DORIAN overallStatus: RECRUITING date: 2021-11-15 date: 2024-11-15 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: European Institute of Oncology class: OTHER briefSummary: This is a prospective cohort study for the analysis of correlation between dosimetric parameters and RANV (Radiation Associated Nausea and Vomiting) in patients with head and neck cancer undergoing exclusive radiotherapy (RT).
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The primary purpose of this study is to search for a potential correlation between dosimetry and physician- and patient-rated symptoms in patients treated with exclusive radiotherapy for head and neck cancer. conditions: Head and Neck Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 180 type: ESTIMATED name: Exclusive radiotherapy measure: Evaluation of nausea (acute toxicity) using CTCAE V5.0 measure: Evaluation of nausea (acute toxicity) using M.D. Anderson Symptom Inventory (MDASI-SCORE) questionnaire measure: Identification of the organs at risk most strongly correlated with the onset of nausea measure: Identification of dosimetric cutoffs for the onset of nausea measure: Comparison of dosimetric analysis between 3D conformal, IMRT and proton therapy techniques measure: Development of machine-learning predictive models for the onset of nausea sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona status: RECRUITING city: Ancona country: Italy name: Giovanna Mantello role: CONTACT email: [email protected] lat: 43.5942 lon: 13.50337 facility: Ospedale "Mons. Dimiccoli" status: RECRUITING city: Barletta country: Italy name: Alessia Di Rito role: CONTACT email: [email protected] lat: 41.31429 lon: 16.28165 facility: Azienda Ospedaliera S.Pio status: RECRUITING city: Benevento country: Italy name: Angela Argenone role: CONTACT email: [email protected] lat: 41.1307 lon: 14.77816 facility: Ospedale MultiMedica status: RECRUITING city: Castellanza country: Italy name: Gianpiero Catalano role: CONTACT email: [email protected] lat: 45.61079 lon: 8.89616 facility: IRCCS Ospedale Policlinico San Martino status: RECRUITING city: Genova country: Italy name: Liliana Belgioia role: CONTACT email: [email protected] lat: 44.40478 lon: 8.94438 facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Stefania Volpe role: CONTACT lat: 45.46427 lon: 9.18951 facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milan country: Italy name: Italo Dell'Oca role: CONTACT email: [email protected] lat: 45.46427 lon: 9.18951 facility: Azienda Ospedaliero-Universitaria di Modena status: RECRUITING city: Modena country: Italy name: Elisa D'Angelo role: CONTACT email: [email protected] lat: 44.64783 lon: 10.92539 facility: Azienda Ospedaliero Universitaria Ospedale Maggiore della Carità di Novara status: RECRUITING city: Novara country: Italy name: Carla Pisani role: CONTACT email: [email protected] lat: 45.44694 lon: 8.62118 facility: Fondazione IRCCS Policlinico San Matteo status: RECRUITING city: Pavia country: Italy name: Sara Colombo role: CONTACT email: [email protected] lat: 45.19205 lon: 9.15917 facility: Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata status: RECRUITING city: Roma country: Italy name: Giuseppina Apicella role: CONTACT email: [email protected] lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliero Universitaria Policlinico Umberto I status: RECRUITING city: Roma country: Italy name: Francesca De Felice role: CONTACT email: [email protected] lat: 41.89193 lon: 12.51133 facility: Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina status: RECRUITING city: Roma country: Italy name: Orietta Caspiani role: CONTACT email: [email protected] lat: 41.89193 lon: 12.51133 facility: I.R.C.C.S. MultiMedica - Sesto San Giovanni status: RECRUITING city: Sesto San Giovanni country: Italy name: Gianpiero Catalano role: CONTACT email: [email protected] lat: 45.53329 lon: 9.22585 hasResults: False
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<|newrecord|> nctId: NCT06341972 id: IRB00247005 id: K23HL155735 type: NIH link: https://reporter.nih.gov/quickSearch/K23HL155735 briefTitle: Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention acronym: SMARA overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2027-02-01 date: 2027-09-01 date: 2024-04-02 date: 2024-04-02 name: Johns Hopkins University class: OTHER name: Francis Family Foundation name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: A growing number of patients are surviving a stay in the intensive care unit (ICU) but may experience long-lasting psychological problems, but research evaluating such treatment for ICU patients is scant.
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The goal of this pilot randomized controlled trial is to evaluate the feasibility, acceptability, and potential benefit of an evidence-based psychological intervention for anxiety and associated outcomes for ICU patients.
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The main question\[s\] it aims to answer are:
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* Is this intervention feasible and acceptable in ARF patients?
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* Is this intervention in the ICU and hospital associated with reduced anxiety symptoms?
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Participants will participate in a cognitive behavioral therapy informed self-management intervention aimed to reduce anxiety symptoms. Researchers will compare the intervention group to patients who receive usual care to see if the intervention reduces symptoms at the the conclusion of the intervention and at 3 months follow-up. conditions: Respiratory Failure conditions: Anxiety conditions: Critical Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: pilot randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Cognitive behavioral therapy based self-management for anxiety measure: Treatment Satisfaction Questionnaire measure: average accrual rate of 2 patients/month across all patients measure: treatment feasibility as assessed by sessions completed measure: treatment feasibility as assessed by drop out rate measure: Visual Analog Scale - Anxiety measure: State Anxiety Inventory measure: Hopkins Rehab Engagement Scale measure: Self Efficacy for Managing Chronic Disease Rating Scale measure: Hospital Anxiety and Depression Scale measure: Quality of Life as assessed by the European Quality of Life Scale (EQ-5D) measure: Post Traumatic Stress Disorder as assessed by the Impact of Events Scale - 6 measure: Healthcare Utilization as assessed by Healthcare Utilization interview measure: Montreal Cognitive Assessment - Blind sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06341959 id: GerodentPLUS1 briefTitle: Can a Low-threshold Check-up Motivate Older People to Schedule a Dental Visit? overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-30 date: 2024-12-30 date: 2024-04-02 date: 2024-04-26 name: University Ghent class: OTHER briefSummary: There is little research on the effect of oral screening campaigns for improving oral health in older people. Therefore, the aim of this study is to investigate the effect of a low-threshold contact with an oral health professional, including an oral health examination, on dental attendance of older people (65 years of age or older). conditions: Oral Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention group will be provided with tools to facilitate dental contact and will be informed about the importance of regular dental visits. Participants are given the opportunity to receive an oral examination. Afterwards, each participant will receive brochures with oral hygiene instructions to take home. Participants will receive information about any identified oral pathology. A referral letter for the dentist and a report for the general practitioner will also be prepared to increase social influence. If the participant doesn't have a dentist, the participant will receive a list of contact information for dentists in the area.
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In the control group, no oral examination will be performed. However, participants will be given a list of nearby dentists and flyers with oral hygiene instructions. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 194 type: ESTIMATED name: Oral screening measure: Contacted a dentist sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2024-03-25 uploadDate: 2024-03-25T05:59 filename: Prot_SAP_ICF_000.pdf size: 743439 hasResults: False
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<|newrecord|> nctId: NCT06341946 id: Soh-Med-24-02-05MD briefTitle: Role of Endoscopic Third Ventriculostomy in Management of Malfunctioning Ventriculoperitoneal Shunt overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2025-10-01 date: 2025-11 date: 2024-04-02 date: 2024-04-02 name: Sohag University class: OTHER briefSummary: The aim of this study is to analyze our experience in management of malfunctioning ventriculoperitoneal shunt by using endoscopic third ventriculostomy (ETV). conditions: Hydrocephalus conditions: Shunt Malfunction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All patients with malfunctioning VP shunt will be included in this study primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Endoscopic third ventriculostomy measure: Glasgow Coma Scale (GCS) measure: visual analogue scale( VAS ) measure: visual acuity measure: radiological CT brain and or MRI brain sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06341933 id: 2024-BÇEK/41 briefTitle: Risk Factors for AKI in Patients Undergoing VATS for Pulmonary Resection overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-15 date: 2025-04-15 date: 2024-04-02 date: 2024-04-02 name: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital class: OTHER briefSummary: This study aims to investigate the potential factors contributing to the development of Acute Kidney Injury (AKI) in patients undergoing pulmonary resection with Video Assisted Thoracoscopic Surgery (VATS) for lung malignancy. The study will focus on demographic data, laboratory parameters, perioperative fluid management, and haemodynamics.
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The research will be conducted at SBÜ Ankara Atatürk Sanatorium Training and Research Hospital. The study will involve patients who have given informed consent and will undergo VATS with standard anaesthesia monitoring. Anaesthesia management will follow our routine protocol in our clinic.
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Patients will be divided into two groups based on whether they have a more than 25% decrease in estimated glomerular filtration rate (t-GFH) and/or a 1.5-fold increase in serum creatinine and/or a 6-hour urine volume of less than 0.5 ml/kg/h. The patients will be divided into two groups based on this definition, and the risk factors between these groups will be analysed.
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The preoperative routine blood values, demographic data (age, gender, height, weight, and BMI), ASA physical status, smoking and alcohol habits, comorbidities, and regular medication use will be recorded. Intraoperative urine output and haemodynamic parameters will also be monitored. Routine blood gas analysis, blood urea nitrogen (BUN), glomerular filtration rate (GFR), albumin, haemoglobin, sodium, potassium, chlorine, and magnesium will be measured and recorded, along with urine output and t-GFH. Patients will be evaluated in the hospital on the day the surgeon calls for a postoperative check-up and on the 30th postoperative day to see if there are any complications. conditions: Acute Kidney Injury conditions: Surgery conditions: Lung Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Duration of Surgery name: Volume of Fluid in Surgery name: Blood Loss measure: Glomerular Filtration Rate measure: Serum Creatinine measure: Amount of Urine sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Atatürk Sanatorium Training and Research Hospital city: Ankara state: Keçiören zip: 06290 country: Turkey name: Ali ALAGÖZ, professor role: CONTACT phone: 5079193765 phoneExt: +9 email: [email protected] name: Fatma ÖZTÜRK YALÇIN, specialist role: SUB_INVESTIGATOR name: Onur KÜÇÜK, specialist role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06341920 id: RS198 - 332551 briefTitle: BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery acronym: BoneFit overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-07-01 date: 2027-12-01 date: 2024-04-02 date: 2024-04-02 name: University of Hull class: OTHER name: Hull University Teaching Hospitals NHS Trust briefSummary: To conduct a pilot feasibility study to determine the effect of a student-led prehabilitation service in people awaiting total hip or knee replacement surgery. conditions: Orthopedic Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention v control primaryPurpose: TREATMENT masking: NONE maskingDescription: Masking is not possible - referrals/care providers know whether they/referral is involved in the intervention or not. count: 50 type: ESTIMATED name: Experimental: BoneFit intervention name: Placebo Comparator: Control measure: Recruitment measure: Adherence and attendance measure: Acceptability measure: Physical fitness measure: Length of stay measure: Readmission rates measure: Overall quality of life measure: Knee or hip specific pain, function and quality of life sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-13 uploadDate: 2024-03-12T06:12 filename: Prot_000.pdf size: 218343 hasResults: False
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<|newrecord|> nctId: NCT06341907 id: SAHoWMU-CR2024-07-107 briefTitle: Application of MRD Combined With Personalized Vaccine in the Treatment of Postoperative Recurrence Prevention of EOC overallStatus: RECRUITING date: 2024-01-01 date: 2026-12-31 date: 2026-12-31 date: 2024-04-02 date: 2024-04-02 name: Second Affiliated Hospital of Wenzhou Medical University class: OTHER briefSummary: The goal of this clinical trial is as follows:(1) Establish a clinical technical system for ctDNA dynamic monitoring of MRD in postoperative EOC patients, providing a new technical means for postoperative recurrence prevention and monitoring of EOC patients.(2) Establish a clinical technical system for adjuvant treatment of postoperative recurrence prevention for EOC patients with conventional protocols combined with personalized vaccines, so as to provide a new treatment method for postoperative recurrence prevention for EOC patients, with a view to obtaining a better survival prognosis.(3) To establish and improve the prediction process of Neoantigen for ovarian cancer and the in vitro evaluation system of the effectiveness of neoantigen vaccine, achieve independent innovation of tumor neoantigen vaccine treatment technology, and cultivate a group of technical forces to master the development of modern tumor vaccine drugs.(4) The new technology system has been promoted and applied in 5 hospitals in the province. conditions: Epithelial Ovarian Cancer studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Neoantigen polypeptide vaccine measure: ORR measure: PFS measure: OS measure: CA 125 measure: Safety Index sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Second Affiliated Hospital of Wenzhou Medical University status: RECRUITING city: Wenzhou state: Zhejiang zip: 325000 country: China name: Xinxin Zhang role: CONTACT phone: +86 150 6781 0815 email: [email protected] lat: 27.99942 lon: 120.66682 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-13 uploadDate: 2024-03-13T05:17 filename: Prot_SAP_000.pdf size: 541225 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-16 uploadDate: 2024-03-13T05:18 filename: ICF_001.pdf size: 254239 hasResults: False
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<|newrecord|> nctId: NCT06341894 id: OBU-II-BC-126 briefTitle: Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer overallStatus: RECRUITING date: 2023-11-17 date: 2027-06 date: 2029-06 date: 2024-04-02 date: 2024-04-02 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer. conditions: Early Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1163 type: ESTIMATED name: Dalpiciclib name: Endocrine therapy measure: invasive Disease-free Survival (iDFS) measure: Disease-free Survival (DFS) measure: AEs and SAEs sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu country: China name: Xiaoan Liu, Professor role: CONTACT phone: 025-68308162 email: [email protected] lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06341881 id: KMU/DIR/CTU/2024/006 id: KMU-CTU-2024-2001 type: OTHER domain: Khyber Medical University Clinical Trial Unit briefTitle: Understanding the Need and Feasibility of Transitional Care Training Program Among Family Caregivers of Geriatric Stroke Survivors in Pakistan overallStatus: RECRUITING date: 2024-02-27 date: 2024-05 date: 2025-01 date: 2024-04-02 date: 2024-04-02 name: Khyber Medical University Peshawar class: OTHER briefSummary: The main intention of the study is to understand the need and feasibility of transitional care training program among family caregivers of geriatric stroke survivors in Pakistan conditions: Stroke conditions: Stroke, Ischemic conditions: Stroke Hemorrhagic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The most commonly two armed parallel study design would be used to conduct the current study. The study participants in an intervention group would be compared with that of a control group. Equal number of Participants would be allocated with random assignment in the two groups. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The study participants would not be informed of what group they are in. Independent outcome assessors would be utilized for the assessment. Further outcomes assessors and data analysts' would be kept unaware of intervention or group allocations to carry out their assessment after inclusion of participants into the study. whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Transitional Care Training Program measure: Physical care measured via Training Evaluation Assessment Checklist (TEAC) Questionnaire measure: Psychological care measured via Training Evaluation Assessment Checklist (TEAC) Questionnaire measure: Social Care measured via Training Evaluation Assessment Checklist (TEAC) measure: Training Need Assessment measure: Training Program Development sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Khyber Medical University status: RECRUITING city: Peshawar state: Khyber Pakhtunkhwa zip: 25000 country: Pakistan name: Sardar Ali, PHD Scholar role: CONTACT phone: +92 349-5182270 email: [email protected] lat: 34.008 lon: 71.57849 facility: MTI-HMC (Medical Teaching Institution-Hayatabad Medical Complex), -Peshawar status: RECRUITING city: Peshawar state: Khyber Pakhtunkhwa zip: 25000 country: Pakistan name: Awal Khan, MSN role: CONTACT phone: +92 343 9757103 email: [email protected] name: Sardar Ali, PHD Scholar role: PRINCIPAL_INVESTIGATOR lat: 34.008 lon: 71.57849 facility: MTI-KTH (Medical Teaching Institution-Khyber Teaching Hospital), Peshawar-Pakistan status: RECRUITING city: Peshawar state: Khyber Pakhtunkhwa zip: 25000 country: Pakistan name: Asmat Pasha, MSN role: CONTACT phone: +92 3319205016 email: [email protected] lat: 34.008 lon: 71.57849 hasResults: False
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<|newrecord|> nctId: NCT06341868 id: KACH.2023.0067 id: 23KACH008 type: OTHER domain: Keller Army Community Hospital briefTitle: Dynamic Muscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction in Military Academy Cadets overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-09-01 date: 2024-04-02 date: 2024-04-02 name: Keller Army Community Hospital class: FED name: Medical Technology Enterprise Consortium briefSummary: The goal of this clinical trial is to examine the effects of 12 weeks of post-operative use of a novel wearable electrical stimulation knee sleeve device (KneeStim) on post-operative biomechanical function (gait). Participants will be United States Military Academy cadets aged 17-27 years. The main questions it aims to answer are:
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* Examine the effects of KneeStim wear on cadets' post-operative gait
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* Examine changes in site-specific skeletal muscle mass
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* Examine the changes in patient-reported outcomes
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* Assess time to return to full duty
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* Compare Bioelectrical Impedance Analysis (BIA) measurements to Magnetic Resonance Imaging (MRI) measurements (total thigh volume)
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