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Each visit in this study is expected to last between 2 - 3 hours. This study is not a treatment study, but it could help improve treatment in the future. Participants in this study are paid for their time. conditions: Anxiety Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 40 type: ESTIMATED name: Active transcranial focused ultrasound (tFUS) name: Sham transcranial focused ultrasound (tFUS) measure: Change in Fear-Potentiated Startle Reflex measure: Change in speed to initiate avoidance behavior measure: Change in Electroencephalography (EEG)-Assessed Contingent Negative Variation During Escape/ Avoidance Preparation measure: Change in Electroencephalography (EEG)-Assessed N200 During Implicit Approach/ Avoid Bias Assessment measure: Change in Electroencephalography (EEG)-Assessed Theta-Band Power During Behavioral Tasks measure: Change in High-Frequency Heart Rate Variability/ Respiratory Sinus Arrhythmia measure: Change in Task-Based Heart Rate (Beats per Minute) Changes measure: Change in Task-Based Galvanic Skin Conductance measure: Change in State Anxiety During Session measure: Task-Related Regional Brain Activation sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of South Carolina city: Charleston state: South Carolina zip: 29425 country: United States lat: 32.77657 lon: -79.93092 hasResults: False
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<|newrecord|> nctId: NCT06273891 id: INOVA-2023-58 briefTitle: Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes acronym: PRACET overallStatus: RECRUITING date: 2024-03-08 date: 2025-08-01 date: 2025-10-01 date: 2024-02-23 date: 2024-03-15 name: Inova Fairfax Hospital class: OTHER briefSummary: The goal of this study is to help identify the best antibiotic treatment for pregnant people when their water breaks prematurely (a condition abbreviated as PPROM). Current practice is to attempt to maintain the pregnancy until at least 34 weeks gestational age, when the risks of prematurity to the baby are lessened. Research shows that antibiotics help the pregnancy last longer, but there have been limited studies about which combination works best. Currently, both azithromycin and erythromycin are accepted antibiotic treatments, in addition to ampicillin and amoxicillin. Participants diagnosed with PPROM will be randomized to receive ampicillin and amoxicillin plus either azithromycin or erythromycin, in addition to the care they would normally receive. Studying these two drugs will help decide the best care for future patients with PPROM. conditions: Premature Rupture of Membrane studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 140 type: ESTIMATED name: Erythromycin name: Azithromycin measure: Latency period sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Inova Fairfax Medical Campus status: RECRUITING city: Falls Church state: Virginia zip: 22042 country: United States name: Ellen M Murrin, DO role: CONTACT phone: 703-776-6040 email: [email protected] name: Antonio Saad, MD, MBA role: PRINCIPAL_INVESTIGATOR name: Ellen M Murrin, DO role: PRINCIPAL_INVESTIGATOR lat: 38.88233 lon: -77.17109 hasResults: False
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<|newrecord|> nctId: NCT06273878 id: RS1439/20 briefTitle: From Fetal-maternal Interface Immune Tolerance to Endometrial Cancer Immune Escape: Potential Targets for Immunotherapy overallStatus: RECRUITING date: 2023-01-15 date: 2025-01-15 date: 2025-01-15 date: 2024-02-23 date: 2024-02-23 name: Regina Elena Cancer Institute class: OTHER name: Università degli Studi dell'Insubria briefSummary: Non-interventional retro-prospective study on Endometrial tissue samples taken from surgically treated patients. conditions: Endometrial Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 80 type: ESTIMATED measure: Validate the differential expression of LOX-1 and NALP3 receptors. measure: Characterize phenotypic alterations. measure: Evaluate the predictive and/or prognostic value. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Institute - IFO - status: RECRUITING city: Rome state: RM zip: 00144 country: Italy name: Benito Chiofalo, Doctor role: CONTACT phone: ND email: [email protected] name: Valentina Bruno, Doctor role: CONTACT phone: ND email: [email protected] lat: 41.89193 lon: 12.51133 facility: "Regina Elena" National Cancer Institute status: RECRUITING city: Rome zip: 00144 country: Italy name: Benito Chiofalo, Doctor role: CONTACT phone: ND email: [email protected] name: Valentina Bruno, Doctor role: CONTACT phone: ND email: [email protected] lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06273865 id: HEMSTOL77 briefTitle: Version Testing of EnzySystem Version A for Hemophilia A overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-10-15 date: 2024-12-15 date: 2024-02-23 date: 2024-02-23 name: Radboud University Medical Center class: OTHER name: Enzyre B.V. briefSummary: Background of the study:
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To measure blood clotting, blood is taken from a vein. This blood is processed in the laboratory and then tested. A new device has been developed that requires only a very small volume of blood (5-10 drops of blood) to perform the laboratory tests. The long-term goal is that this device can be used by a doctor or at home to quickly measure blood clotting. In this research we want to compare this new system with the standard methods - measurement in the laboratory - and evaluate whether the correct value is determined.
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Objective of the study:
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The primary objective of this study is to demonstrate that the EnzySystem HemA version A can record thrombin generation TG and quantify FVIII activity levels within a time frame of 60 min in fresh whole blood samples of healthy volunteers and patients with hemophilia A in the Enzyre laboratory (for healthy volunteers) and the Radboudumc (for patients with hemophilia A).
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Study design:
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This is a cross-sectional observational study. All participants are asked to fill a questionnaire prior to blood collection. The blood of healthy volunteers will be collected in an office of Enzyre BV, the blood of patients will be collected in the Radboudumc. Blood collection, by venepuncture, will be conducted by a Radboudumc research nurse or physician of the research team in both locations. In total, four blood tubes with citrate as anticoagulant will be drawn (a total of around 11 mL).
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Study population:
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The study population consists of 20 healthy volunteers: evenly distributed between male and female; ages spread over the range from 20 to 70 years old; recruited by Enzyre via advertisement. 20 Patients: 5 severe hemophilia A; 5 moderate hemophilia A; 10 mild hemophilia A; recruited from the Hemophilia Treatment Center (HTC) Nijmegen-Eindhoven-Maastricht (NEM) (location Radboudumc).
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Primary study parameters/outcome of the study:
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Demonstrate that the EnzySystem HemA version A can record TG and quantitative FVIII activity levels within a time frame of 60 min in fresh blood samples of healthy volunteers and patients with hemophilia A.
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Secondary study parameters/outcome of the study (if applicable):
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Secondary study parameters are composed whether the measured values comply with the desired assay specificity and accuracy.
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Outcomes are analysed for equivalence compared to one-stage FVIII assay, FVIII chromogenic assay, thrombin generation via the Nijmegen Hemostasis Assay, and possibly via the Technoclone assay.
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Is it possible to measure FVIII activity with the EnzySystem HemA version A in fresh blood samples of healthy volunteers and patients with hemophilia A, compared to the gold standard with;
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* Precision in the normal range (60-140%): min. 30%
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* Precision in the low range (3-10%): min. 50%
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* Limit of Detection range min. 100 % FVIII activity
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* Limit of Detection low range min. 3 % FVIII activity Is it possible to measure TG with the EnzySystem HemA version A in fresh blood samples of healthy volunteers and patients with hemophilia A, compared to the gold standard with;
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* Precision in the normal range (60-140%) of control samples: min. 30%
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* Precision in patient with hemophilia A: min. 50%
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* Limit of Detection, high range \> 400 nM thrombin activity
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* Limit of Detection measured with Plasma, low range \< 50 nM thrombin
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Other study parameters All samples will also be tested for other hemostasis specific parameters as these parameters may affect a proper measurement of both FVIII activity and Thrombin Generation. The following parameters will be measured in plasma obtained from the whole blood vacutainers. Moreover, left over samples (plasma) will eventually be used to develop other coagulation related parameters.
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* von Willebrand Factor antigen levels
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* von Willebrand Factor ristocetin activity levels
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* Prothrombin Fragment 1+2 levels
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* ADAMTS13 activity
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* FVIII antigen levels
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* blood group conditions: Hemophilia A studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Several assays measure: Time between venipuncture and EnzySystem assay results measure: Validity of EnzySystem FVIII activity results measure: Validity of EnzySystem thrombin generation results sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radboud university medical center city: Nijmegen zip: 6525 GA country: Netherlands lat: 51.8425 lon: 5.85278 hasResults: False
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<|newrecord|> nctId: NCT06273852 id: PBL-0405-01 briefTitle: A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-02-23 date: 2024-02-29 name: Pure Biologics S.A. class: INDUSTRY name: Presage Biosciences briefSummary: This is a multi-center, single arm, open-label, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in microdose quantities via the CIVO device. conditions: Head and Neck Squamous Cell Carcinoma conditions: Soft Tissue Sarcoma Adult conditions: Triple Negative Breast Cancer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an exploratory clinical trial to evaluate intratumoral mechanistic effects of novel and approved agents on intact human tumors. This substudy is not blinded. primaryPurpose: BASIC_SCIENCE masking: NONE count: 15 type: ESTIMATED name: PBA-0405 measure: Quantification of Cell Death and Immune Cell Biomarkers by immuno-histochemistry (IHC) and In-Situ Hybridization (ISH) measure: Number of Patients with Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06273839 id: B3461114 briefTitle: A Study to Learn How Different Forms of Study Medicine Tafamidis Are Taken Up Into The Blood in Healthy Adults overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-27 date: 2024-05-27 date: 2024-05-27 date: 2024-02-23 date: 2024-04-02 name: Pfizer class: INDUSTRY briefSummary: The purpose of this clinical trial is to compare the amount of tafamidis in the blood of healthy adult participants after taking three different forms of tafamidis by mouth. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 12 type: ACTUAL name: Tafamidis 61 mg free acid tablet (Test 1) name: Tafamidis 70 mg free acid tablet (Test 1) name: Tafamidis 61 mg free acid capsule (Reference) measure: Area under the concentration-time curve (AUCinf) measure: Maximum observed plasma concentration (Cmax) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pfizer Clinical Research Unit - Brussels city: Brussels state: Bruxelles-capitale, Région DE zip: B-1070 country: Belgium lat: 50.85045 lon: 4.34878 hasResults: False
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<|newrecord|> nctId: NCT06273826 id: 01 briefTitle: "Colorectal Leakage App" for Early Detection of Anastomotic Leakage After Colorectal Surgeries overallStatus: RECRUITING date: 2024-01-19 date: 2025-01 date: 2025-05 date: 2024-02-23 date: 2024-02-23 name: National Research Oncology and Transplantology Center, Kazakhstan class: OTHER briefSummary: The aim of this prospective observational study is to evaluate the effectiveness of the mobile application "Colorectal Leakage App" in the early diagnosis of anastomotic leakage after colorectal surgeries at the National Research Oncology Center in Astana, Kazakhstan.
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Main Questions:
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1. Development, validation, and implementation of the mobile application "Colorectal Leakage App," based on the Dutch Leakage Score.
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2. Evaluate the diagnostic effectiveness of the application in detecting anastomotic leakage after colorectal surgeries.
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3. Determine the frequency of anastomotic leakage after colorectal surgeries performed in the colorectal surgery sector of the National Research Oncology Center in the Astana city.
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Participants in the study, individuals aged 18 and above undergoing colorectal surgeries, will be monitored by the mobile application "Colorectal Leakage App" in the postoperative period for early identification of anastomotic leakage. conditions: Anastomotic Leak Large Intestine conditions: Anastomotic Leak Rectum studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: "Colorectal Leakage App" measure: Diagnostic effectiveness of "Colorectal Leakage App". measure: Frequency of anastomotic leakage after colorectal surgeries. measure: Mortality within 30 days measure: Delay in the diagnosis of anastomotic leakage measure: Duration of hospital stay. measure: Number of days in the ICU. measure: Number of days between surgery and detection of AL. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Research Oncology Center status: RECRUITING city: Astana zip: 010000 country: Kazakhstan name: Saule Khamzina, MD role: CONTACT phone: +77757172961 email: [email protected] lat: 51.1801 lon: 71.44598 hasResults: False
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<|newrecord|> nctId: NCT06273813 id: NOV-1776-CL-101 briefTitle: Treatment of Topical Ketorolac Gel in Acute Gouty Flare overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-12 date: 2024-12 date: 2024-02-23 date: 2024-02-23 name: Novilla Pharmaceuticals class: INDUSTRY briefSummary: This study will be a phase 1, open-label, bioavailability, safety and PK study of topically applied transcutaneous ketorolac tromethamine gel 12.5% (/w) (NOV-1776) versus intravenous administration of approved ketorolac tromethamine injection, USP (15mg/mL) comparator in healthy volunteers, including an evaluation of safety, tolerability, and efficacy in gout participants with flare-up. conditions: Acute Gouty Arthritis conditions: Acute Pain conditions: Gout Flare studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: All cohost 1 subjects receive single ketorolac tromethamine injection, followed by escalating doses of ketorolac tromethamine gel Cohort 2 and 3 subjects receive doses of ketorolac tromethamine gel for 5 days primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Ketorolac Tromethamine 15 MG/ML name: Ketorolac Tromethamine measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of topical ketorolac tromethamine sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Paratus Clinical, city: Blacktown zip: 2148 country: Australia name: Rahul Rahul role: CONTACT phone: +61 1300 742 326 email: [email protected] name: Rahul Rahul role: PRINCIPAL_INVESTIGATOR lat: -33.76667 lon: 150.91667 facility: Linear Clinical Research Ltd city: Nedlands zip: 6009 country: Australia name: Jasmine Williams role: CONTACT phone: +61 8 6382 5100 lat: -31.98184 lon: 115.8073 hasResults: False
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<|newrecord|> nctId: NCT06273800 id: M23CMC briefTitle: Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients acronym: Chemosense overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2035-07-15 date: 2036-07-15 date: 2024-02-23 date: 2024-03-29 name: The Netherlands Cancer Institute class: OTHER briefSummary: This study is a prospective, multicenter study in which a serum sample will be collected at the day of starting neo adjuvant treatment in breast cancer patients conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: collection of serum sample blood at first day of neo adjuvant treatment primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Blood sample measure: pCR rate measure: Radiological reduction on tumor size measure: Pathological reduction on tumor size measure: Residual cancer burden (RCB) measure: Distant recurrence free interval (DRFI) measure: Recurrence-free interval (RFI) measure: Overall survival (OS) sex: FEMALE minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Antoni van Leeuwenhoek city: Amsterdam state: Noord-Holland zip: 1066CX country: Netherlands name: Laura Bornes, PhD role: CONTACT name: Veerle Geurts, PhD role: CONTACT name: Marleen Kok, MD role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 hasResults: False
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<|newrecord|> nctId: NCT06273787 id: Mitu briefTitle: Effect of Diaphragmatic Release in Sleep Quality During Pregnancy overallStatus: RECRUITING date: 2023-11-01 date: 2024-02-29 date: 2024-03-17 date: 2024-02-23 date: 2024-02-23 name: MTI University class: OTHER briefSummary: Sleep disordered breathing (SDB) is very common during pregnancy, and is most likely explained by hormonal, physiological and physical changes. Maternal obesity, one of the major risk factors for SDB, together with physiological changes in pregnancy may predispose women to develop SDB. SDB has been associated with poor maternal and fetal outcomes. Thus, early identification, diagnosis and treatment of SDB are important in pregnancy. conditions: SLEEP APNEA PREGNANCY studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment group a : Diaphragmatic Release in addition to positioning instruction group b: positioning instruction primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: diaphragmatic release measure: pittshurgh sleep quality index measure: diaphragmatic excursion assessment sex: FEMALE minimumAge: 30 Years maximumAge: 40 Years stdAges: ADULT facility: MTI status: RECRUITING city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06273774 id: 8189-020 id: MK-8189-020 type: OTHER domain: Merck briefTitle: A Study of MK-8189 in Participants With Bipolar I Disorder (MK-8189-020) overallStatus: RECRUITING date: 2024-04-08 date: 2024-09-10 date: 2024-09-10 date: 2024-02-23 date: 2024-04-23 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: The goal of this study is to evaluate the safety and tolerability of MK-8189 in participants with stable bipolar I disorder. There will be no hypothesis testing in this study. conditions: Bipolar I Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: MK-8189 name: Placebo measure: Number of Participants Who Experience One or More Adverse Events (AEs) measure: Number of Participants Who Discontinue Study Treatment Due to an AE sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hassman Research Institute Marlton Site ( Site 0006) status: RECRUITING city: Marlton state: New Jersey zip: 08053 country: United States name: Study Coordinator role: CONTACT phone: 267-981-8911 lat: 39.89122 lon: -74.92183 hasResults: False
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<|newrecord|> nctId: NCT06273761 id: UW 23-550 briefTitle: Evaluation of Medication Management Service overallStatus: RECRUITING date: 2024-02-06 date: 2026-08-01 date: 2027-05-01 date: 2024-02-23 date: 2024-02-23 name: The University of Hong Kong class: OTHER name: Hong Kong Jockey Club Charities Trust name: Hong Kong Sheng Kung Hui Welfare Council name: Hong Kong Young Women's Christian Association name: Haven of Hope Hospital name: Pok Oi Hospital name: St. James Settlement name: Aberdeen Kai-fong Welfare Association name: Health In Action name: Lok Sin Tong Benevolent Society, Kowloon briefSummary: Medication management services (MMS) is a pharmacist-led service of optimizing the medication use and health outcomes, by promoting medication safety and enhancing the ability in self-management of health and diseases of patients and their caregivers. Yet, only limited evidence on the implementation of MMS service in Hong Kong is available. The goal of this clinical trial is to evaluate the cost effectiveness and effects of implementing MMS in community pharmacies owned by 8 non-government organizations (NGOs) in Hong Kong on humanistic and clinical outcomes in patients with hypertension and/or type II diabetes mellitus. The clinical trial aims to look into the following aspects:
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* To evaluate the perception and satisfaction of patients on MMS service
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* To investigate whether MMS could improve patients' adherence to their medication regimen, health-related quality of life, health outcomes and health service utilization, as well as their ability to understand and cope with their illness and drug-related problems
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* To identify and categorize the types of drug-related problems identified during MMS
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* To evaluate the cost-effectiveness of implementing MMS in community pharmacies
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MMS services will be rolled out in a total of 8 NGO community pharmacies progressively (2 pharmacies per phase) in 4 successive phases. Participants will complete the questionnaires at the following time points throughout the trial, namely 1) during recruitment, 2) baseline (1 month before MMS), 3) 3 months after MMS begins, 4) 12 months after MMS begins, and 5) 24 months after MMS begins. Researchers will compare the results of questionnaires conducted at different time points to identify the potential changes in the effects of MMS. Furthermore, researchers will link up the electronic health records of the participants and identify the potential changes in the health outcomes and health service utilizations after receiving MMS. conditions: Medication Adherence conditions: Medication Safety conditions: Diabetes Mellitus, Type 2 conditions: Hypertension conditions: Polypharmacy conditions: High Risk Medications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 640 type: ESTIMATED name: Medication Management Service (MMS) measure: Medication adherence measure: Additional health service utilization measure: Patient perception and satisfaction measure: Patient perceived sensitivity to medicines measure: Social impact measure: Health-related quality of life measure: Drug-related problems measure: Change in costs measure: Change in effectiveness measure: Incremental cost effectiveness ratio (ICER) measure: Beliefs in medicines sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aberdeen Kai-Fong Welfare Association A-Lively Community Pharmacy status: RECRUITING city: Hong Kong country: Hong Kong name: Kam Kit Mak role: CONTACT phone: 3550 5460 email: [email protected] lat: 22.27832 lon: 114.17469 facility: Health In Action Community Pharmacy status: RECRUITING city: Hong Kong country: Hong Kong name: Ka Shing Mak role: CONTACT phone: 3612 9515 email: [email protected] lat: 22.27832 lon: 114.17469 facility: Hong Kong Sheng Kung Hui Welfare Council Community Pharmacy status: RECRUITING city: Hong Kong country: Hong Kong name: Sze Yin Lee role: CONTACT phone: 2116 0382 email: [email protected] lat: 22.27832 lon: 114.17469 facility: PHARM+ Haven of Hope Community Pharmacy status: RECRUITING city: Hong Kong country: Hong Kong name: Mei Lun Bruce Tsui role: CONTACT phone: 2156 2280 email: [email protected] lat: 22.27832 lon: 114.17469 facility: PHARM+ Pok Oi Hospital Community Pharmacy status: RECRUITING city: Hong Kong country: Hong Kong name: Kwok leung Li role: CONTACT phone: 59506880 email: [email protected] name: Anson Tsz Kin Leung role: CONTACT email: [email protected] lat: 22.27832 lon: 114.17469 facility: PHARM+ St. James' Settlement Community Pharmacy status: RECRUITING city: Hong Kong country: Hong Kong name: Kit Sze Chan role: CONTACT phone: 2835 4320 email: [email protected] lat: 22.27832 lon: 114.17469 facility: PHARM+ The Lok Sin Tong Community Pharmacy status: RECRUITING city: Hong Kong country: Hong Kong name: William Ho Ching Yuen role: CONTACT phone: 21872780 email: [email protected] lat: 22.27832 lon: 114.17469 facility: PHARM+ YWCA Community Pharmacy status: RECRUITING city: Hong Kong country: Hong Kong name: Sui Hong Ho role: CONTACT phone: 2511 6020 email: [email protected] lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06273748 id: RChildUV briefTitle: RChildUV:Study on Non-infectious Chronic Uveitis in Pediatric Age overallStatus: RECRUITING date: 2022-02-10 date: 2032-02-01 date: 2032-05-02 date: 2024-02-23 date: 2024-03-08 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Uveitis is an inflammatory disease of the uvea, one of the highly vascularized fundamental structures of the eye. It is a rare condition in children, with an incidence in the pediatric population ranging from 2% to 14% of all uveitis cases. The diagnosis and management of patients with uveitis rely on a multidisciplinary approach involving an ophthalmologist, a rheumatologist, and an infectious disease specialist to establish the correct diagnosis and assess the involvement of other organs. In Italy, there is no national or regional registry for non-infectious chronic uveitis as per the Prime Ministerial Decree (DPCM) of March 3, 2017 (Identification of surveillance systems and registries for mortality, tumors, and other diseases). However, many clinical centers adopt data recording systems to evaluate the quality of care and to study diseases and outcomes. The Universitary Hospital Meyer Institute Research Hospital (IRCCS) is a national referral center for managing these pediatric cases of non-infectious chronic uveitis, estimated to constitute 95% of all pediatric uveitis cases conditions: Uveitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 290 type: ESTIMATED measure: Describe a population of paediatric patients with chronic non-infectious uveitis measure: Describe a population of paediatric patients with chronic non-infectious uveitis measure: Identify any differences between the different forms of uveitis in terms of characteristics and outcomes measure: Identify risk factors for a more severe course measure: Frequency achievement of response for each drug according to the definition of response measure: Time to archieve the response after drug initiation measure: Achievement of inactive disease on therapy according to the definition of MIWGUC measure: Time to achieve inactive disease on therapy according to the definition of MIWGUC measure: Presence and percentages of flares on therapy after achievement of remission on therapy measure: Time to the first flare on therapy measure: Time to flare after drug withdrawal sex: ALL minimumAge: 1 Year maximumAge: 16 Years stdAges: CHILD facility: Cincinnati Children's Hospital Medical Center status: RECRUITING city: Cincinnati state: Ohio zip: 45207 country: United States name: Sheila Angels-Han role: CONTACT lat: 39.12713 lon: -84.51435 facility: - ATTIKON General Hospital status: RECRUITING city: Athens zip: 12462 country: Greece name: Lampros Fotis role: CONTACT lat: 37.97945 lon: 23.71622 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence state: Firenze country: Italy name: Gabriele Simonini role: CONTACT email: [email protected] lat: 43.77925 lon: 11.24626 facility: Ospedale Spedali Civili di Brescia status: NOT_YET_RECRUITING city: Brescia country: Italy name: Marco Cattalini role: CONTACT lat: 45.53558 lon: 10.21472 facility: IRCCS materno infantile Burlo Garofolo status: RECRUITING city: Trieste country: Italy name: Serena Pastore role: CONTACT lat: 45.64953 lon: 13.77679 hasResults: False
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<|newrecord|> nctId: NCT06273735 id: 2019-PS-33b id: PV7350 type: OTHER domain: Martini-Klinik briefTitle: Prospective Trial: Myocardial Injury After Noncardiac Surgery (MINS) Following Radical Prostatectomy overallStatus: RECRUITING date: 2023-08-14 date: 2024-03 date: 2026-10 date: 2024-02-22 date: 2024-02-22 name: Martini-Klinik am UKE GmbH class: OTHER name: Universitätsklinikum Hamburg-Eppendorf briefSummary: The aim of this study is to prospectively analyse the rate of MINS in the standardised radical prostatectomy patient clientele at the Martini-Clinic and to identify risk factors. Pre- and postoperative troponin levels are determined (1st and 2nd postoperative day). The patient's height, weight, age and cardiovascular risk factors (including determination of the Revised Cardiac Risk Index) are recorded in the medical history as well as previous medical and interventional cardiological therapy. Furthermore, the prostate carcinoma-associated tumour and surgical parameters are determined. Clinically significant cardiovascular events during the inpatient stay are also described. Finally, a description of the rate of events, a check for correlation with the Revised Cardiac Risk Index and an identification of risk factors are carried out. conditions: Myocardial Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Pre- and postoperative determination of troponin as part of the study and 24-month FU survey measure: rate of MINS in standardised open and robot-assisted radical prostatectomy sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Martini-Klinik am UKE GmbH status: RECRUITING city: Hamburg zip: 20246 country: Germany name: Markus Graefen, Professor role: CONTACT phone: +4904741051300 email: [email protected] name: Anke Renter role: CONTACT phone: +49407410533115 email: [email protected] lat: 53.57532 lon: 10.01534 hasResults: False
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<|newrecord|> nctId: NCT06273722 id: 2024-0059 briefTitle: D-OCT for Detection and Subtyping of BCC: a Diagnostic Cohort Study overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-01 date: 2024-12-31 date: 2024-02-22 date: 2024-02-22 name: Maastricht University Medical Center class: OTHER briefSummary: The current gold standard for diagnosing basal cell carcinoma (BCC) is the histopathological examination of biopsy specimen. However, non-invasive imaging modalities such as optical coherence tomography (OCT) may replace biopsy if BCC presence and its subtype can be established with high confidence. Subtype differentiation is crucial; while superficial BCCs (sBCC) can be treated topically, nodular (nBCC) and infiltrative BCCs (iBCC) require excision. Dynamic OCT (D-OCT) is a functionality integrated within the OCT device, enabling the visualization of vascular structures through speckle variance.
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Descriptive studies have unveiled vascular shapes and patterns associated with BCC and its respective subtypes. These findings suggest that D-OCT could contribute to the accuracy of BCC detection and subtyping. Yet comparative clinical studies between OCT and D-OCT are lacking. In the proposed diagnostic cohort study, we aim to assess whether D-OCT assessment is superior to OCT in terms of accuracy for BCC detection and subtyping. conditions: Basal Cell Carcinoma conditions: Optical Coherence Tomography studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 424 type: ESTIMATED name: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner measure: Diagnostic accuracy for BCC detection on D-OCT assessment measure: Diagnostic accuracy for BCC subtyping on D-OCT assessment measure: Diagnostic value of vascular structures and patterns sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06273709 id: 2023-3698 briefTitle: Remote Assessment of OCT Scans for BCC Detection overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-07-01 date: 2024-12-31 date: 2024-02-22 date: 2024-02-22 name: Maastricht University Medical Center class: OTHER briefSummary: Basal cell carcinoma (BCC) is the most common form of cancer and entails approximately 80% of all cutaneous malignancies. This locally destructive neoplasm is commonly diagnosed by punch biopsy which is considered painful, causes procedural scarring and carries a small risk of infection and re-bleeding associated with invasive procedures. Moreover, awaiting the results of the subsequent histopathological examination causes treatment delay and can be stressful for the patient. The drawbacks of biopsy could be overcome by optical coherence tomography (OCT), a non-invasive diagnostic modality that may replace biopsy in up to 66% of patients. However, OCT assessors are scarce which hinders the implementation of OCT. This problem may be addressed by teledermatology in which remote OCT assessment by an assessor facilitates simultaneous assessment for multiple clinics. Remote OCT assessment withholds the OCT assessor from visually inspecting the lesion. But the effect of visual inspection on the diagnostic accuracy remains unknown and the question arises whether visual inspection is necessary for accurate OCT assessment. In this diagnostic case-control study we will determine whether distant OCT assessment without visual information on the lesion is non-inferior to distant OCT assessment with clinical and dermoscopic photographs (CDP-OCT). conditions: Basal Cell Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner measure: Diagnostic accuracy of high-confidence BCC diagnosis with and without clinical/dermoscopic photographs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06273696 id: 2019-519 id: NU2GGH001927 type: OTHER_GRANT domain: Centers for Disease Control and Prevention briefTitle: Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania overallStatus: COMPLETED date: 2019-05-01 date: 2019-06-11 date: 2019-07-30 date: 2024-02-22 date: 2024-02-22 name: IntraHealth International class: OTHER name: Ministry of Health, Tanzania name: President Office Regional Administration and Local Government, Tanzania name: Centers for Disease Control and Prevention name: Jhpiego name: World Health Organization briefSummary: The goal of this observational study was to evaluate the safety and acceptability of the ShangRing device for male circumcision among men in Shinyanga, Tanzania. The main question aims to answer both provider acceptability (practicality of device use and placement and removal times) and client acceptability (comfort during placement and removal, experience while wearing the ring, and penile appearance after healing). Participants voluntarily underwent male circumcision using the ShangRing device and before being discharged, were interviewed about their experience. Participants were also interviewed at device removal day (day 7), during a follow-up phone call (day 10), a sample were selected to participate in in-depth interviews (day28), and finally all men were asked to return for a follow-up visit (day 49). conditions: Penile Infection conditions: Penile Haematoma conditions: Penile Bleeding conditions: Deformity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 575 type: ACTUAL name: ShangRing measure: Number of Adverse Events measure: Number of Clients with Adverse Events measure: Descriptions of Adverse Events measure: Provider Training measure: Client Follow-up Visit Rate measure: Client Preference for ShangRing Over Surgical Circumcision measure: Client Recommendation Rate measure: Cosmetic Result Acceptability measure: Client Experience While Performing Routine Activities measure: Client Discomfort measure: Provider Ease of Application measure: Provider Preference measure: Provider Recommendation measure: Description of Procedures measure: Healing rate sex: MALE minimumAge: 13 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Kahama District Hospital city: Shinyanga country: Tanzania lat: -3.66393 lon: 33.42118 facility: Ushetu Health Centre city: Shinyanga country: Tanzania lat: -3.66393 lon: 33.42118 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2018-10-22 uploadDate: 2024-02-14T09:36 filename: Prot_000.pdf size: 2701616 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2018-07-01 uploadDate: 2023-01-18T15:12 filename: ICF_001.pdf size: 173615 hasResults: False
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<|newrecord|> nctId: NCT06273683 id: INOVA-2023-145 briefTitle: Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery overallStatus: RECRUITING date: 2024-03-11 date: 2024-12 date: 2024-12 date: 2024-02-22 date: 2024-03-20 name: Inova Health Care Services class: OTHER briefSummary: One in three women of reproductive age utilize tubal sterilization for contraception, and sterilization is often requested at time of cesarean delivery. Complete salpingectomy for the purpose of permanent sterilization at the time of cesarean birth is increasingly being performed worldwide.
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A preferred complete salpingectomy technique for the purpose of sterilization at the time of cesarean delivery has not emerged in current practice. The objective is to compare short-term clinical outcomes and cost of salpingectomy using a hand-held bipolar energy instrument with those of traditional suture ligation. This retrospective cohort study will be conducted from 2017-2023 at a single tertiary care hospital. The investigators hypothesize that bipolar energy instrument use will not significantly improve clinical outcomes. conditions: Permanent Sterilization conditions: Pregnancy Related studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 900 type: ESTIMATED name: Hand-held bipolar energy instrument name: Traditional suture ligation measure: Change in Hemoglobin levels on postoperative day one measure: Completion rate of sterilization measure: Total procedure estimated blood loss measure: Adjacent organ damage measure: Need for blood transfusion measure: Total operative time measure: ICU admission measure: Length of hospital stay measure: Hospital readmission postoperatively measure: Reoperation rates measure: Pain score measure: Surgical site infection measure: Cost sex: FEMALE minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inova Fairfax Medical campus status: RECRUITING city: Falls Church state: Virginia zip: 22042 country: United States name: Jean W Thermolice, MD role: CONTACT phone: 703-531-3000 email: [email protected] name: Bianca Nguyen, MD role: CONTACT email: [email protected] name: Sofia Girald-Berlingeri, MD role: SUB_INVESTIGATOR name: Bianca Nguyen, MD role: SUB_INVESTIGATOR name: Catherine Kim, MD role: SUB_INVESTIGATOR name: Miranda Newell, MS role: SUB_INVESTIGATOR name: Renee Brenner, BS role: SUB_INVESTIGATOR lat: 38.88233 lon: -77.17109 hasResults: False
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<|newrecord|> nctId: NCT06273670 id: 04-2023-200279 briefTitle: Postpartum Initiation of Long-acting Reversible Contraceptives: Knowledge Attitude and Practice Study (KAP) acronym: KAP overallStatus: RECRUITING date: 2023-06-15 date: 2024-12 date: 2025-10 date: 2024-02-22 date: 2024-02-22 name: Assiut University class: OTHER briefSummary: Comparing Knowledge, attitude and Practice of clients and service providers about the regular (6 weeks) versus earlier initiation of LARC, through a structured questionnaire prepared in English and translated to local language i.e. Arabic. conditions: Contraception studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 600 type: ESTIMATED name: screening and data collection measure: Clients' knowledge measure: Clients' attitude measure: Clients' practice measure: Providers' knowledge measure: Providers' attitude measure: Providers' practice sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Assiut University status: RECRUITING city: Assiut zip: 71515 country: Egypt name: mahmoud abdelaleem, Doctorate role: CONTACT phone: +201018880201 email: [email protected] lat: 27.18096 lon: 31.18368 hasResults: False
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<|newrecord|> nctId: NCT06273657 id: Apokus-002 briefTitle: Effects of Medisinstart for Type 2 Diabetes overallStatus: RECRUITING date: 2024-02-07 date: 2026-02 date: 2026-02 date: 2024-02-22 date: 2024-02-22 name: Apokus AS class: OTHER name: Norwegian Pharmacy Association briefSummary: Medisinstart is a counseling service in pharmacies where patients who start taking a new medicine receive two follow-up appointments with a pharmacist. The aim of the service is to promote correct medication use and increase patient adherence. The effect of Medisinstart has previously been studied among patients starting a new cardiovascular drug. The aim of the project is to map the effects of Medisinstart among patients starting a new medication for type 2 diabetes. Knowledge about the effects of Medisinstart is important in order to maximize the benefits of the service for patients and society. The project is being conducted as a randomized controlled trial among adult patients starting a new medication for type 2 diabetes. The intervention group receives Medisinstart, while the control group only receives prescription dispensing as normal. Data collection includes HbA1c analysis in blood samples and responses to questionnaires. HbA1c is an established measure of glycemic control. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 500 type: ESTIMATED name: Medisinstart measure: HbA1c measure: HbA1c measure: Self-reported adherence measure: Self-reported adherence measure: Frequency of medication-related problems measure: Patients' beliefs about their medicines measure: Diabetes Self-Management measure: Diabetes Treatment Satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Apotek 1 Andslimoen status: RECRUITING city: Bardufoss zip: 9325 country: Norway lat: 69.06448 lon: 18.51521 facility: Apotek 1 Brandbu status: RECRUITING city: Brandbu zip: 2760 country: Norway lat: 60.42214 lon: 10.50428 facility: Apotek 1 Brummundal status: RECRUITING city: Brumunddal zip: 2380 country: Norway lat: 60.88095 lon: 10.93948 facility: Sykehusapoteket i Drammen status: RECRUITING city: Drammen zip: 3004 country: Norway lat: 59.74389 lon: 10.20449 facility: Vitusapotek Gjøvik status: RECRUITING city: Gjøvik zip: 2806 country: Norway lat: 60.79574 lon: 10.69155 facility: Vitusapotek Jessheim status: RECRUITING city: Jessheim zip: 2050 country: Norway lat: 60.14151 lon: 11.17515 facility: Boots apotek Kløfta status: RECRUITING city: Kløfta zip: 2040 country: Norway lat: 60.07407 lon: 11.13805 facility: Vitusapotek Leksvik status: RECRUITING city: Leksvik zip: 7120 country: Norway lat: 63.67274 lon: 10.6232 facility: Apotek 1 Lena status: RECRUITING city: Lena zip: 2850 country: Norway lat: 60.67391 lon: 10.81317 facility: Boots apotek Loddefjord status: RECRUITING city: Loddefjord zip: 5171 country: Norway lat: 60.36879 lon: 5.22607 facility: Sykehusapoteket i Oslo, Aker status: RECRUITING city: Oslo zip: 0586 country: Norway lat: 59.91273 lon: 10.74609 facility: Vitusapotek Røa status: RECRUITING city: Oslo zip: 0751 country: Norway lat: 59.91273 lon: 10.74609 facility: Ryfylke apotek status: RECRUITING city: Rennesøy zip: 4150 country: Norway facility: Vitusapotek Jekta status: RECRUITING city: Tromsø zip: 9015 country: Norway lat: 69.6489 lon: 18.95508 facility: Sykehusapoteket i Trondheim status: RECRUITING city: Trondheim zip: 7030 country: Norway lat: 63.43049 lon: 10.39506 facility: Vitusapotek Ulefoss status: RECRUITING city: Ulefoss zip: 3830 country: Norway lat: 59.28245 lon: 9.26548 facility: Apotek 1 Veakrossen status: RECRUITING city: Veavåg zip: 4276 country: Norway facility: Vitusapotek Åfjord status: RECRUITING city: Åfjord zip: 7170 country: Norway lat: 63.96113 lon: 10.22408 facility: Boots apotek Linnea status: RECRUITING city: Øystese zip: 5610 country: Norway lat: 60.38825 lon: 6.19251 hasResults: False
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<|newrecord|> nctId: NCT06273644 id: HNF1719-24 briefTitle: Clinical Research on Acute Intermittent Porphyria and the Use of Carbohydrate-Rich Diet as a Treatment overallStatus: RECRUITING date: 2024-01-27 date: 2027-10-31 date: 2037-12-31 date: 2024-02-22 date: 2024-02-22 name: Nordlandssykehuset HF class: OTHER name: University of Oslo name: Nord University name: UiT The Arctic University of Norway name: Norwegian University of Science and Technology name: The University of Texas Medical Branch, Galveston briefSummary: The main aim of this clinical trial is to learn about the effect of carbohydrate-rich diet as a treatment for AIP (acute intermittent porphyria).
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Aim: Investigate the diet's impact on tissue and serum glucose, plasma insulin, cytokine levels, amino acids, and gut microbiota in AIP, and their correlation with PBG (Porphobilinogen).
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Aim: Assess the diet's effect on AIP symptoms and health status in AIP. Aim: Measure the effect of a high-carbohydrate diet on mitochondrial activity in AIP Aim: Map and detect potential mutations in mitochondrial genomic DNA in AIP Aim: Discover new markers in AIP through RNA sequencing and machine learning.
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Participants will follow two diet plans, a 4-week intervention with 60-65 E% carbohydrates and a 4 week intervention with 40-45 E% carbohydrates. conditions: Porphyria, Acute Intermittent studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study is a crossover study involving 50 individuals with AIP. The study design was chosen to determine whether the treatment has an effect compared to baseline analyses and whether the sequence of treatment has an effect, as well as whether one of the interventions is more effective than the other. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Blinding is attempted by labeling the provided diet plans as A and B. The physician recording outcome variables and the researcher performing statistical analysis are blinded to the given diet. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Carbohydrates measure: Change in Urine Porphobilinogen/creatinine measure: Urine Porphobilinogen/creatinine concentration, percentage change of repeated measurements measure: Number of Hospitalizations,sick leaves, and doctor visits due to AIP measure: Health status measure: Plasma Glucose level measure: Interstitial fluid glucose level measure: Number of hypoglycemic events measure: Amino acid profile measure: Plasma insulin, glucose, c-peptide measure: HOMA score measure: HbA1c measure: Cytokines in plasma measure: Intestinal microbiota composition measure: Physical activity measure: Blood pressure measure: Body composition, metabolic age measure: Mitochondrial oxygen consumption rate measure: ALAS1mRNA measure: Urine-ALA/creatinine & urine-porphyrins measure: Mitochondrial function-related genes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nordland Hospital Trust status: RECRUITING city: Bodø state: Nordland zip: 8092 country: Norway name: Elin Storjord, MD PhD role: CONTACT phone: +4797072484 email: [email protected] name: Hilde Thunhaug, IC nurse role: CONTACT phone: +47 95057864 email: [email protected] name: Elin Storjord, MD PhD role: PRINCIPAL_INVESTIGATOR name: Amy Dickey, MD role: SUB_INVESTIGATOR name: Bjørn Steen Skålhegg, PhD, Prof. role: SUB_INVESTIGATOR name: Bård O. Karlsen, PhD role: SUB_INVESTIGATOR name: Elin Røst, Master role: SUB_INVESTIGATOR name: Erik Knutsen, PhD role: SUB_INVESTIGATOR name: Hilde Thunhaug, Bachelor role: SUB_INVESTIGATOR name: Jonas Aakre Wik, PhD role: SUB_INVESTIGATOR name: Andersen Karl, MD, Prof. role: SUB_INVESTIGATOR name: Pettersen Kristin, Bachelor role: SUB_INVESTIGATOR name: Marlene B. Karlsen, Master role: SUB_INVESTIGATOR name: Nina Lorentsen, Master role: SUB_INVESTIGATOR name: Ole-Lars Brekke, MD,PhD,Prof role: SUB_INVESTIGATOR name: Randolf Hardersen, MD, PhD role: SUB_INVESTIGATOR name: Rita Laastad, Bachelor role: SUB_INVESTIGATOR name: Steinar Daae Johansen, PhD, Dean role: SUB_INVESTIGATOR name: Tor Erik Jørgensen, PhD role: SUB_INVESTIGATOR name: Vegar Rangul, PhD role: SUB_INVESTIGATOR name: Åse Emblem, PhD role: SUB_INVESTIGATOR name: Fredrik Ellefsrud, MD role: SUB_INVESTIGATOR name: Tor Claudi, MD role: SUB_INVESTIGATOR lat: 67.28 lon: 14.40501 hasResults: False
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<|newrecord|> nctId: NCT06273631 id: 2022-SR-481 briefTitle: Effect of Changes in Carbohydrate Intake on Glucose Control in Patients With Type 1 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-12-31 date: 2024-02-22 date: 2024-02-22 name: Yang Tao class: OTHER briefSummary: The blood glucose fluctuates greatly in T1DM patients, especially in the middle and late stages of the disease, and carbohydrate (CHO) is the main determinant of postprandial glucose response (PGR). Based on the previous investigation to understand how nutritional habits affect blood glucose control, we will conduct dietary intervention studies in T1DM patients to explore whether the adjustment of dietary pattern is beneficial to blood glucose control, and further explore the relevant mechanism through the detection of related metabolic indicators. conditions: Type 1 Diabetes conditions: Diet Intervention conditions: Glucose Control studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: multiple-diverse carbohydrate diet name: middle carbohydrate diet measure: Change of time in range (TIR) measure: Change of coefficient of variation of blood glucose（CV） measure: Change of mean amplitude of glycemic excursions（MAGE） measure: Change in large amplitude of glycemic excursions (LAGE) from baseline measure: Change in GA（glycosylated albumin）from baseline measure: Change in HbA1c from baseline measure: Change in 1,5-anhydroglucitol (1,5-AG) from baseline measure: Change in time above range(TAR) from baseline measure: Change in time below range(TBR) from baseline measure: Change in total insulin dose from baseline measure: Change in blood lipids from baseline measure: Change in body weight from baseline measure: Change in Incidence of hypoglycemic events from baseline measure: Change in gut microbiota from baseline measure: Change in metabolomics from baseline measure: Change in autoimmunity from baseline sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06273618 id: iLO-ML-23396 briefTitle: iLookOut Micro-learning to Improve Knowledge Retention overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-02 date: 2027-02 date: 2024-02-22 date: 2024-03-25 name: Milton S. Hershey Medical Center class: OTHER briefSummary: This project investigates whether a multi-faceted strategy involving iLookOut's evidence-based Core Training plus an innovative follow-up Micro-Learning can promote knowledge retention and change behavior among early childhood professionals (ECPs) with regard to child abuse and its reporting. Additionally, this study will evaluate if non-ECPs experience similar improvements and retention of knowledge and changes in behavior as do ECPs. conditions: Knowledge conditions: Attitudes conditions: Practice studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Early Childhood Professionals (ECPs) will be randomized to 1 of 4 groups, which will differ in terms of when they receive access to Micro-Learning. Non-ECPs will constitute a separate group, which will receive access to Micro-Learning immediately upon completing the Core Training. primaryPurpose: OTHER masking: NONE count: 12000 type: ESTIMATED name: Micro-Learning measure: Change in knowledge about child maltreatment and its reporting as assessed by validated iLookOut knowledge test measure: Change in behavior regarding child maltreatment and its reporting as measured by self-report questionnaire measure: Comparison of early childhood professionals vs. non-early childhood professionals sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Penn State College of Medicine city: Hershey state: Pennsylvania zip: 17033 country: United States lat: 40.28592 lon: -76.65025 hasResults: False
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<|newrecord|> nctId: NCT06273605 id: 102828 briefTitle: The Egg Up Trial - Testing a New Treatment Pathway for Infants With Newly Diagnosed Egg Allergy overallStatus: RECRUITING date: 2024-04-09 date: 2025-08-30 date: 2025-08-30 date: 2024-02-22 date: 2024-04-17 name: Murdoch Childrens Research Institute class: OTHER briefSummary: The goal of this study is to test the safety and feasibility of a change in management approach for infants with newly diagnosed egg allergy. Infants with newly diagnosed egg allergy will have egg introduced via a gradual and graded home based approach known as an "egg ladder" supervised by a dietitian. The main questions this study aims to answer are how safe and feasible are home-based dietitian-led "egg ladders" as a treatment pathway to achieve tolerance of egg for newly diagnosed infants with egg allergy. conditions: Food Allergy conditions: Food Allergy in Infants studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Egg Ladder measure: Number and severity of adverse events related to baked egg ingestion (step 1) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history. measure: Number and severity of adverse events related to ingestion of well cooked egg as an ingredient (step 2) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history. measure: Number and severity of adverse events related ingestion of well cooked whole egg (step 3) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history. measure: Number and severity of adverse events related to ingestion of lightly cooked whole egg (step 4) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history. measure: Number and severity of adverse events related to raw egg ingestion (step 5) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history. measure: Feasibility of the home-based, egg ladder protocol to achieve egg allergy resolution 12 months from egg allergy diagnosis measure: Change from baseline (diagnosis) in parent reported Quality of Life scores using the Food Allergy Quality of Life Questionnaire (FAQLQ-PF) to study completion (12 months from diagnosis) measure: Change from baseline (diagnosis) in parental anxiety scores measured using the Impairment Measure for Parental Food Allergy - Associated Anxiety and Coping Tool (IMPAACT) to study completion (12 months from diagnosis) measure: Heath care costs sex: ALL minimumAge: 4 Months maximumAge: 12 Months stdAges: CHILD facility: Murdoch Children's Research Institute (MCRI) status: RECRUITING city: Melbourne state: Victoria zip: 3052 country: Australia name: Vicki McWilliam, PhD role: CONTACT phone: 0418588953 email: [email protected] name: Kirsten Perrett, MD, PhD role: CONTACT email: [email protected] lat: -37.814 lon: 144.96332 hasResults: False
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<|newrecord|> nctId: NCT06273592 id: 2023-15558 briefTitle: The Impact of a Plant-based Meat Meal Versus an Animal Meat Meal on Erectile Function in Healthy Men. acronym: Erection 2 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-02-22 date: 2024-02-22 name: Montefiore Medical Center class: OTHER name: Beyond Meat briefSummary: The goal of this study is to determine whether erectile function is differentially impacted by a single plant-based meat meal versus a single animal meat meal in healthy men with normal erectile function. conditions: Erectile Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized crossover design primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Outcomes assessor will be blinded to randomization group and order of testing. whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Animal-based meal name: Plant-based meat meal measure: Percent of time with ≥70% erection during overnight sleep after 1 meal measure: Erection events per hour during overnight sleep after 1 meal measure: Tumescence events per hour during overnight sleep after 1 meal. measure: Heart rate measure: Blood pressure sex: MALE minimumAge: 18 Years maximumAge: 32 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06273579 id: 2010-270, NEU-09-042-Trial 5 briefTitle: Efficiency of Verbal Intelligent Tutor Instruction in Neurosurgical Simulation overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-10 date: 2024-12 date: 2024-02-22 date: 2024-03-05 name: McGill University class: OTHER briefSummary: At the Neurosurgical Simulation and Artificial Intelligence Learning Centre, we seek to provide surgical trainees with innovative technologies that allow them to improve their surgical technical skills in risk-free environments, potentially improving patient operative outcomes. The Intelligent Continuous Expertise Monitoring System (ICEMS), a deep learning application that assesses and trains neurosurgical technical skill and provides continuous intraoperative feedback, is one such technology that may improve surgical education.
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In this randomized controlled trial, medical students from four Quebec universities will be blinded and randomized to one of three groups (one control and two experimental). Group 1 (control) will be provided with verbal AI tutor feedback based on the ICEMS error detection. Group 2 will be tutored by a human instructor who will receive ICEMS error data and deliver verbal instruction identical to that which the AI tutor delivers. Group 3 will be tutored by a human instructor who will be provided with ICEMS data but may deliver feedback as they feel is appropriate to correct the error.
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The aim of this study is to determine how the method of delivery of verbal surgical error instruction influences trainee response to instruction and overall surgical performance. Evaluating trainee responses to AI instructor verbal feedback as compared to feedback from human instructors will allow for further development, testing, and optimization of the ICEMS and other AI tutoring systems. conditions: Surgical Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE maskingDescription: Double (Participant, Expert Instructor)
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Both study participants and expert instructors are unaware of the intervention (varying the method of delivery of verbal error instruction). Moreover, when rating performance in the realistic scenario using the OSATS, experts are unaware of which group any given trainee is part of. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: Experimental Group - Verbal expert instructor feedback in AI's words name: Experimental Group - Verbal expert instructor feedback in expert's own words measure: Response to instruction measure: Average Intelligent Continuous Expertise Monitoring System (ICEMS) expertise score measure: Objective Structured Assessment of Technical Skills (OSATS) global rating measure: Difference in the strength of emotions elicited measure: Difference in cognitive load sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neurosurgical Simulation and Artificial Intelligence Learning Centre city: Montréal state: Quebec zip: H2X 4B3 country: Canada name: Rolando F Del Maestro, MD, PhD role: CONTACT phone: (519) 708-0346 email: [email protected] name: Bianca Giglio, BSc role: CONTACT phone: (514) 802-1608 email: [email protected] lat: 45.50884 lon: -73.58781 hasResults: False
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<|newrecord|> nctId: NCT06273566 id: 20230202 briefTitle: French Validation of the AdT-Physio Scale acronym: Trans-AdT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-07-31 date: 2024-02-22 date: 2024-03-19 name: Pole Sante Grace de Dieu class: OTHER briefSummary: The goal of this observational study is to translate and validate the Adt-Physio scale in French, and to validate on a large number of patients the French translation of the Adt-Physio scale as a tool for evaluating adherence and perception of the intervention of a physiotherapist in patients with cystic fibrosis.
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participants will have to answer the French trans-AdT scale, the Brief Cope and GSES questionnaire. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 121 type: ESTIMATED name: Questionnaire measure: AdT-Physio scale (Adherence to Treatment of Physiotherapy scale) sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PSLA GDD city: Caen zip: 14000 country: France lat: 49.18585 lon: -0.35912 hasResults: False
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<|newrecord|> nctId: NCT06273553 id: RG002-A1201 briefTitle: A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3 overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-10 date: 2027-12 date: 2024-02-22 date: 2024-02-22 name: RinuaGene Biotechnology Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to to evaluate the safety, tolerability, immunogenicity, and efficacy of RG002 Injection in subjects with HPV16/18 associated Cervical Intraepithelial Neoplasia Grade 2 or 3(CIN2/3). conditions: Human Papillomavirus Associated Intraepithelial Neoplasia conditions: Cervical Intraepithelial Neoplasia Grade 2/3 conditions: Human Papillomavirus Type 16 Infection conditions: Human Papillomavirus Type 18 Infection studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: RG002 injection measure: Part A: Safety and Tolerability of RG002 Injection, measured by the incidence of adverse events measure: Part A: Maximum tolerated dose (MTD) and/or RP2D of RG002 Injection measure: Part B: Primary efficacy of RG002 Injection, measured by the proportion of subjects with histopathological regression measure: Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with histopathological regression measure: Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with clearance of HPV16/18 measure: Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with histopathological regression and clearance of HPV16/18 measure: Part A and B: Immunogenicity of RG002 Injection,measured by the level of cellular immune response measure: Part A and B: Immunogenicity of RG002 Injection,measured by the proportion of T lymphocytes measure: Part A and B: Immunogenicity of RG002 Injection,measured by the expression of cytokines in serum measure: Part A and B: Immunogenicity of RG002 Injection,measured by the serum levels of anti-HPV16 and anti-HPV18 IgG antibodies. measure: Part A and B: Exposure level of RG002 Injection, measured by mRNA measure: Part A and B: Exposure level of RG002 Injection, measured by cationic lipids measure: Part A and B: Anti-drug antibody (ADA) to polyethylene glycol (PEG) of RG002 injection, measured by the serum titer of anti-PEG IgG and anti-PEG IgM measure: Part B: Secondary efficacy, measured by proportion of subjects with histopathological regression measure: Part B: Secondary efficacy, measured by proportion of subjects with clearance of HPV16/18 measure: Part B: Secondary efficacy, measured by proportion of subjects with histopathological regression and clearance of HPV16/18 measure: Part B: Safety and tolerability of RG002 Injection, measured by the incidence of adverse events measure: Part B: Optionally assess the biomarker of RG002 Injection, measured by the level of potential biomarkers and the level of infiltrating T cells and myeloid cells in the lesions. sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06273540 id: STA-P7-C001 briefTitle: Phase1, STP7 Cocaine Drug-Drug Interaction Study overallStatus: RECRUITING date: 2024-04-15 date: 2024-09-30 date: 2024-09-30 date: 2024-02-22 date: 2024-04-19 name: Stalicla SA class: INDUSTRY name: National Institute on Drug Abuse (NIDA) briefSummary: This is a double-blind, placebo-controlled, parallel group study to compare the effects of STP7 (mavoglurant) vs placebo control on i.v. cocaine's physiological and subjective effects in non-treatment seeking, cocaine-experienced males or females participants between 18 and 59 years of age.
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The primary objective of this study is to determine if there are clinically meaningful interactions between oral STP7 (mavoglurant) treatment concurrent with 20 and 40 mg i.v. cocaine infusions by measuring adverse events and cardiovascular responses including heart rate, blood pressure, and electrocardiogram (including corrected QT interval).
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The secondary objectives are:
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* To evaluate whether administration of STP7 (mavoglurant) alters the pharmacokinetics of cocaine and/or its major metabolite, benzoylecgonine.
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* To determine the pharmacokinetic of STP7 (mavoglurant) administered at a dose of 200 mg twice a day.
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* To evaluate whether STP7 (mavoglurant) treatment alters the subjective effects of cocaine measured by Visual Analog Scales (VAS) and Brief Substance Craving Scale (BSCS). conditions: Cocaine Use Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: STP7 (mavoglurant) or Placebo measure: Incidence of Treatment-Emergent Adverse Events. measure: Heart Rate response following the STP7 treatment with the cocaine infusion. measure: Heart Rate response following the STP7 treatment with the cocaine infusion. measure: Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion . measure: Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion. measure: Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion. measure: Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion. measure: ECG changes (HR) following the STP7 treatment with the cocaine infusion. measure: ECG changes (RR) following the STP7 treatment with the cocaine infusion. measure: ECG changes (PR) following the STP7 treatment with the cocaine infusion. measure: ECG changes (QRS) following the STP7 treatment with the cocaine infusion. measure: ECG changes (QT) following the STP7 treatment with the cocaine infusion. measure: ECG changes (HR) following the STP7 treatment with the cocaine infusion. measure: ECG changes (RR) following the STP7 treatment with the cocaine infusion. measure: ECG changes (PR) following the STP7 treatment with the cocaine infusion. measure: ECG changes (QRS) following the STP7 treatment with the cocaine infusion. measure: ECG changes (QT) following the STP7 treatment with the cocaine infusion. measure: Pharmacokinetics: Maximum Plasma Concentration [Cmax] of cocaine. measure: Pharmacokinetics: Maximum Plasma Concentration [Cmax] of benzoylecgonine. measure: Pharmacokinetics: Maximum Plasma Concentration [Cmax] of STP7. measure: Pharmacokinetics: Maximum Plasma Concentration [Cmax] of STP7. measure: Pharmacokinetics: time to maximum plasma concentration [Tmax] of cocaine. measure: Pharmacokinetics: time to maximum plasma concentration [Tmax] of benzoylecgonine. measure: Pharmacokinetics: time to maximum plasma concentration [Tmax] of STP7. measure: Pharmacokinetics: time to maximum plasma concentration [Tmax] of STP7. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time t of cocaine. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time t of benzoylecgonine. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time of STP7. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time of STP7. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of cocaine. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of benzoylecgonine. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of STP7. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of STP7. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of cocaine. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of benzoylecgonine. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of STP7. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of STP7. measure: Pharmacokinetics: trough plasma concentration (Ctrough) of cocaine. measure: Pharmacokinetics: trough plasma concentration (Ctrough) of benzoylecgonine. measure: Pharmacokinetics: trough plasma concentration (Ctrough) of STP7. measure: Pharmacokinetics: trough plasma concentration (Ctrough) of STP7. measure: Pharmacokinetics: terminal rate constant of cocaine. measure: Pharmacokinetics: terminal rate constant of benzoylecgonine. measure: Pharmacokinetics: terminal rate constant of STP7. measure: Pharmacokinetics: terminal rate constant of STP7. measure: Pharmacokinetics: half-life of cocaine. measure: Pharmacokinetics: half-life of benzoylecgonine. measure: Pharmacokinetics: half-life of STP7. measure: Pharmacokinetics: half-life of STP7. measure: Pharmacokinetics: clearance of cocaine. measure: Pharmacokinetics: clearance of benzoylecgonine. measure: Pharmacokinetics: clearance of STP7. measure: Pharmacokinetics: clearance of STP7. measure: Pharmacokinetics: Clearance from plasma after oral administration of cocaine. measure: Pharmacokinetics: Clearance of benzoylecgonine from plasma after oral administration (CL/F) of cocaine. measure: Pharmacokinetics: Clearance from plasma after oral administration (CL/F) of STP7. measure: Pharmacokinetics: Clearance from plasma after oral administration (CL/F) of STP7. measure: Visual evaluation of the STP7 on the subjective effects of cocaine at screening measure: Visual evaluation of the STP7 on the subjective effects of cocaine at baseline and during treatment measure: Craving evaluation of the STP7 on the subjective effects of cocaine. sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Altasciences Clinical Kansas status: RECRUITING city: Overland Park state: Kansas zip: 66212 country: United States name: Debra Kelsh, MD role: CONTACT lat: 38.98223 lon: -94.67079 hasResults: False
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<|newrecord|> nctId: NCT06273527 id: 808681 briefTitle: Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33) overallStatus: NOT_YET_RECRUITING date: 2024-11 date: 2027-06 date: 2027-06 date: 2024-02-22 date: 2024-02-22 name: University of California, San Diego class: OTHER briefSummary: The proposed project aims to test the cognitive and neural effects of a cognitive training in a sample of individuals seeking treatment for anxiety, depression, or traumatic stress symptoms. Participants will be randomly assigned to one of two groups. Group 1 will receive a computer-based program that is designed as a cognitive training intervention and Group 2 will receive a similar computer-based exercise that researchers think will be less effective in training thinking skills (also known as a control or sham condition). Participants will be compared on cognitive performance and brain response during cognitive tasks from baseline to post-treatment. conditions: Anxiety Disorders conditions: Depression conditions: Post Traumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 128 type: ESTIMATED name: COGENT name: Sham Program measure: Change in cognitive performance measure: Reading Span Blood Oxygen Level Dependent (BOLD) Response measure: Neuropsychological Performance measure: Repetitive Negative Thinking (RNT) measure: Disability measure: Suicide Cognitions measure: Mood and Emotions measure: Self-reported attention measure: Anxiety Symptoms measure: Symptoms of Depression measure: PTSD Symptoms sex: ALL minimumAge: 21 Years maximumAge: 55 Years stdAges: ADULT facility: UC San Diego city: San Diego state: California zip: 92037 country: United States name: Edith Jimenez role: CONTACT phone: 858-822-1470 email: [email protected] name: Nathalie Dugas role: CONTACT phone: 858-534-2148 email: [email protected] lat: 32.71533 lon: -117.15726 hasResults: False
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<|newrecord|> nctId: NCT06273514 id: TECAR and DN intervention briefTitle: Comparison the Effects of TECAR With Dry Needling in the Treatment of Myofascial Trigger Points overallStatus: COMPLETED date: 2020-12-01 date: 2022-12-31 date: 2022-12-31 date: 2024-02-22 date: 2024-02-22 name: Medical University of Silesia class: OTHER briefSummary: The aim of the study is to assess the effectiveness of dry needling (DN) and capacitive and resistive transfer of energy (TECAR) therapy in the treatment of myofascial trigger points (MTrPs) as well comparison of their efficacy.
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Research hypothesis:
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Capacitive and resistive energy transfer therapy is comparable to dry needling therapy for the treatment of myofascial trigger points.
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It is estimated that the presence of trigger points is the main cause of pain in 30-85% of patients visiting primary health care facilities and pain management clinics. The presence of trigger points may significantly affect the patient's functional status and daily functioning. Recently, diagnostic criteria and methods of treating trigger points have evolved significantly. However, the usefulness of different imaging methods in the diagnosis of trigger points has not yet been established. Despite numerous studies, the long-term effectiveness of the dry needling method is still unknown. Furthermore, there is no available research on the short- and long-term effectiveness of capacitive and resistive energy transfer therapy in the treatment of trigger points.
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Therefore, the objectives of the work were:
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Determination and comparison of the short- and long-term effects of capacitive and resistive energy transfer therapy and the dry needling technique of myofascial trigger points located in the upper trapezius muscle (UT) on the strength, neck range of motion and pain intensity within this muscle.
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The study is planned to include a group of 26 men aged 25 to 45 who suffer from pain caused by the presence of myofascial trigger points in the upper trapezius muscle. The subjects will be divided into two groups of equal number of people. The first group will undergo therapy using the dry needling technique, while the second group will undergo capacitive and resistive energy transfer therapy.
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In order to determine the immediate effects of capacitive and resistive energy transfer therapy and dry needling techniques, measurements of muscle strength, the intensity of pain in the upper trapezius muscle and neck range of motion will be performed before and after each therapeutic session (2 session in 2 weeks are planed). In turn, to determine the long-term effects of capacitive and resistive energy transfer therapy and dry needling, the next above-mentioned measurements will be performed four weeks after the end of first therapy. conditions: Myofascial Pain Syndrome of Neck conditions: Myofascial Trigger Point Syndrome conditions: Myofascial Trigger Point Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 22 type: ACTUAL name: TECAR name: Dry needling measure: Pain - Pressure pain threshold (PPT) measure: Pain - numerical rating scale (NRS) measure: Muscle strength measure: Cervical spine range of motion (ROM) sex: MALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: Medical fit city: Ruda Śląska state: Śląsk zip: 41-717 country: Poland lat: 50.2584 lon: 18.85632 hasResults: False
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<|newrecord|> nctId: NCT06273501 id: D-NR 2022-02876-01 briefTitle: MRI and Magnetometer-guided Sentinel Lymph Node Detection in Vulvar Cancer acronym: POSVUC overallStatus: ENROLLING_BY_INVITATION date: 2022-03-24 date: 2024-12-01 date: 2024-12-31 date: 2024-02-22 date: 2024-02-22 name: Sahlgrenska University Hospital, Sweden class: OTHER briefSummary: The aim of the feasibility study is to evaluate whether SPIO-MRI and a magnetometer could be a potential substitute to the routine dual technique in pre-and intraoperative SLN localization. Secondary, to explore if SPIO-MRI could predict lymph node status in comparison to histopathological analysis. conditions: Vulvar Cancer conditions: Lymph Node Metastasis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 20 type: ESTIMATED name: Magtrace measure: Sentinel lymph node identification sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Obstetrics and gynecology city: Gothenburg zip: 41345 country: Sweden lat: 57.70716 lon: 11.96679 hasResults: False
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<|newrecord|> nctId: NCT06273488 id: EXZL20240002 briefTitle: The Role of Auricular Point Diagnosis and Treatment in ERAS During TKA overallStatus: RECRUITING date: 2024-03-23 date: 2024-11-01 date: 2024-12-01 date: 2024-02-22 date: 2024-04-08 name: Peking Union Medical College class: OTHER briefSummary: To further improve the surgical outcomes of patients undergoing total knee arthroplasty (TKA). This study aims to use ear acupoint therapy to address the following clinical issues: 1 The degree of postoperative inflammation and edema in the patient; 2. Patient pain; 3. Patient functional recovery. 4. Surgical scar repair for patients; 5. Patient perioperative anxiety and postoperative satisfaction. Exploring the safety and effectiveness of ear acupoint therapy in the postoperative application of TKA, leveraging the advantages of suitable traditional Chinese medicine techniques in simplicity, convenience, effectiveness, and cost-effectiveness, and further improving the ERAS Chinese and Western medicine collaborative plan for TKA. conditions: Auriculotherapy conditions: Arthroplasty, Replacement, Knee conditions: Enhanced Recovery After Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 86 type: ESTIMATED name: Auriculotherapy measure: Range of motion(ROM) measure: Visual Analogue Pain Scale (VAS) measure: Self-Assessment Survey for Anxiety（SAS） measure: Acupoint electrical measurement value(AE) measure: Vancouver Scar Assessment Scale（VSS） measure: Dosage of painkillers measure: Hospital stay measure: HSS knee joint scoring measure: Thigh circumference(knee joint circumference) measure: Kine siphobia (TSK) score measure: C-reactive protein (CRP) measure: Erythrocyte Sedimentation Rate(ESR) measure: Postoperative satisfaction measure: Expenses during hospitalization measure: Demand rate and satisfaction rate of auricular point diagnosis and treatment measure: Adverse events related to auricular acupuncture diagnosis and treatment measure: Affected limb drainage volume measure: Preoperative Anxiety Scale (PAS-7) score measure: Total number of pain pump uses (presses) sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: qindong Mi role: CONTACT phone: 8615871784551 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06273475 id: OUH RoboRehab briefTitle: Robot-Assisted Training Versus Standard Training in Ischemic Stroke overallStatus: RECRUITING date: 2024-05-01 date: 2025-03-01 date: 2027-02-01 date: 2024-02-22 date: 2024-04-18 name: Odense University Hospital class: OTHER name: University of Southern Denmark name: Rigshospitalet, Denmark name: Herlev and Gentofte Hospital name: Stanford University name: Sygehus Lillebaelt name: Danish Association of the Physically Disabled briefSummary: The aim of this randomised controlled trial (RCT) nested in a prospective cohort, is to investigate the superior effect of late-phase robot-assisted versus standard training on motor function, physical function, fatigue, and quality of life in a moderately-to-severely impaired chronic stroke population following subacute rehabilitation.
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The main hypothesis of the study is:
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Robot-assisted training has a superior effect on motor function (Fugl-Meyer Lower Extremity Assessment; primary outcome), physical function, fatigue, and quality of life in moderately-to-severely impaired chronic stroke-affected individuals in comparison to standard training. conditions: Stroke conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicentre randomised (1:1) parallel-group intervention study with assessor-blinding. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Data will be analysed by the PhD student blinded towards group allocation. The test leader responsible for RCT outcome assessment will be blinded towards group allocation. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Robot-assisted Training name: Standard Training measure: Fugl-Meyer Lower Extremity Assessment of Motor Function measure: Modified Rankin Scale Score (between-group change) measure: Functional Ambulation Category (between-group change) measure: Berg Balance Scale (between-group change) measure: Barthel-100 Index (between-group change) measure: Global Rating of Change (between-group change) measure: International Physical Activity Questionnaire - Short Form (between-group change) measure: Fatigue Severity Scale 7 (between-group change) measure: EQ-5D-5L Quality of Life (between-group change) measure: Hand-grip strength (between-group change) measure: Gait speed (between-group change) measure: Contractile Muscle Power (between-group change) measure: Modified Sit-to-Stand Test (between-group change) measure: Blood Biomarkers (between-group change) measure: Modified Ashworth Scale (between-group change). measure: Oxford Cognitive Screen (between-group change) measure: Montreal Cognitive Assessment (between-group change) measure: Major Depression Inventory (between-group change) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet and Herlev Gentofte Hospital status: NOT_YET_RECRUITING city: Copenhagen country: Denmark name: Jon Skovgaard Jensen, Ph.d.-student role: CONTACT email: [email protected] name: Christina Rostrup Kruuse, Professor, MD, PhD, DMSc role: PRINCIPAL_INVESTIGATOR lat: 55.67594 lon: 12.56553 facility: Odense University Hospital status: RECRUITING city: Odense country: Denmark name: Jon Skovgaard Jensen, Ph.d.-student role: CONTACT email: [email protected] name: Anders Holsgaard-Larsen, Professor role: PRINCIPAL_INVESTIGATOR lat: 55.39594 lon: 10.38831 hasResults: False
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<|newrecord|> nctId: NCT06273462 id: NMCSD.2024.0006 briefTitle: Palmitoylethanolamide for Chronic Inflammatory Pain Conditions overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-05-30 date: 2024-02-22 date: 2024-02-22 name: Navy Medical Center San Diego class: FED briefSummary: The goal of this clinical trial is to evaluate if a supplement called palmitoylethanolamide (PEA) is effective in reducing the pain in patients with chronic inflammatory pain conditions. The main question the trial aims to answer is if PEA works better at treating a patients pain and improving their function better than a placebo.
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Participants will be divided into two equal groups and asked to take either PEA or a placebo for 8 weeks. conditions: Chronic Pain studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective Randomize Double Blind Placebo Controlled study comparing the supplement palmitoylethanolamide (PEA) to a visually identical placebo primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double Blinded, patients will receive visually identical capsules from research pharmacist with study label indicating PEA vs Placebo whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Palmitoylethanolamide 600mg twice a day name: placebo measure: Pain Level measure: Pain interference and function measure: Pain Catastrophizing Scale (PCS) measure: Patient Reported Outcome Measurement Information System (PROMIS) (Pain interference, Social satisfaction; Physical function) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Naval Medical Center San Diego city: San Diego state: California zip: 92118 country: United States name: Naval Medical Center Institutional Review Board role: CONTACT phone: 619-532-9927 email: [email protected] name: Brian McLean COL, USA MC, MD role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 hasResults: False
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<|newrecord|> nctId: NCT06273449 id: 385/2023 briefTitle: A Smart Digital Workflow Towards High Precision and Through-Put Production for Removable Partial Dentures overallStatus: RECRUITING date: 2022-12-29 date: 2024-08-30 date: 2024-08-30 date: 2024-02-22 date: 2024-02-22 name: National Dental Centre, Singapore class: OTHER name: National Medical Research Council (NMRC), Singapore briefSummary: Tooth loss is a major chronic problem in dentistry and edentulous elderly endures poorer quality of life worldwide. Removable partial dentures (RPDs) are the most widely accepted and cost-effective treatment for patients to restore oral functions. RPDs contain three components including the metal framework, denture base and acrylic teeth. Conventionally, RPD fabrication involves tedious clinical and dental laboratory procedures and is time consuming, labour-intensive, and often imprecise, therefore incapable of meeting the growing demands of RPD by an ageing population. The challenges to achieve a high quality and high-throughput RPD service lie in three aspects: 1) accuracy in capturing oral profile; 2) immediate oral information analysis and device design, and 3) automation in production. conditions: Partial-edentulism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: 1. Conventional: The Standard of Care (SOC) workflow, which will act as a baseline compared to the other 2 groups.
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2. Partial digital workflow: Adopts the same teeth profile capture method, where a physical impression of teeth profile is taken from the subject. However, instead of using physical wax pattern on the stone model for design, the stone model is scanned and, on the scan, the design is performed digitally. For fabrication of RPD, instead of using lost wax casting, the digital design is used for additive manufacturing.
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3. SmartRPD digital workflow Adopts a different teeth profile capture method by using the intraoral scanner to digitally scan and save the subject's teeth profile. From the intraoral scan, a digital model of the subject's teeth profile is created but on the digital model instead, the design of RPD is digitally performed. The digital design is used for additive manufacturing. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 141 type: ESTIMATED name: Group 3 - 3D Printed Removable Partial Denture name: Group 2 - 3D Printed Removable Partial Denture measure: Evaluation of Precision in Fabricated Metal Frameworks Across Three Workflows measure: Comparison of Patient Satisfaction with RPD Prostheses Fabricated Using Three Workflows measure: Comparison of Fabrication Cost and Time Across Three Workflows sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Dental Centre Singapore status: RECRUITING city: Singapore zip: 168938 country: Singapore name: Hazel Goh Si Ying role: CONTACT phone: 63248754 email: [email protected] name: Zi Ying Phang role: PRINCIPAL_INVESTIGATOR name: Khim Hean Teoh role: SUB_INVESTIGATOR name: Janice Tan Zhi Hui role: SUB_INVESTIGATOR lat: 1.28967 lon: 103.85007 hasResults: False
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