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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... |
Primary study parameters/outcome of the study: |
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. |
Secondary study parameters/outcome of the study (if applicable): |
Secondary study parameters are composed whether the measured values comply with the desired assay specificity and accuracy. |
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. |
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; |
* Precision in the normal range (60-140%): min. 30% |
* Precision in the low range (3-10%): min. 50% |
* Limit of Detection range min. 100 % FVIII activity |
* 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; |
* Precision in the normal range (60-140%) of control samples: min. 30% |
* Precision in patient with hemophilia A: min. 50% |
* Limit of Detection, high range \> 400 nM thrombin activity |
* Limit of Detection measured with Plasma, low range \< 50 nM thrombin |
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 (... |
* von Willebrand Factor antigen levels |
* von Willebrand Factor ristocetin activity levels |
* Prothrombin Fragment 1+2 levels |
* ADAMTS13 activity |
* FVIII antigen levels |
* 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 EnzySyste... |
<|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: Presag... |
<|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 ... |
<|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, Kazakhs... |
Main Questions: |
1. Development, validation, and implementation of the mobile application "Colorectal Leakage App," based on the Dutch Leakage Score. |
2. Evaluate the diagnostic effectiveness of the application in detecting anastomotic leakage after colorectal surgeries. |
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. |
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 stu... |
<|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,... |
<|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:... |
<|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 ... |
<|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:... |
<|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... |
* To evaluate the perception and satisfaction of patients on MMS service |
* 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 |
* To identify and categorize the types of drug-related problems identified during MMS |
* To evaluate the cost-effectiveness of implementing MMS in community pharmacies |
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 b... |
<|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 inflam... |
<|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: M... |
<|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 ... |
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, ... |
<|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 (B... |
<|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:... |
<|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 briefSummar... |
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. Th... |
<|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:... |
<|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 se... |
<|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:... |
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). |
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. |
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 ... |
<|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 b... |
<|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 investigate... |
<|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 b... |
<|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 Cen... |
<|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... |
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... |
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 developme... |
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: OUT... |
<|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 observa... |
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 Physiothera... |
<|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., ... |
<|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 ... |
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 (includin... |
The secondary objectives are: |
* To evaluate whether administration of STP7 (mavoglurant) alters the pharmacokinetics of cocaine and/or its major metabolite, benzoylecgonine. |
* To determine the pharmacokinetic of STP7 (mavoglurant) administered at a dose of 200 mg twice a day. |
* 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: TREATM... |
<|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 proje... |
<|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 cla... |
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