[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"healthy-volunteer-male-subjects\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:healthy-volunteer-male-subjects":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100626106","ecological-test-standardization-for-concussion-assessment-in-football-players-100626106",false,"NCT07431320","Ecological Test Standardization for Concussion Assessment in Football Players","COMOFOOT","Inclusion Criteria:\n\nProfessional football players:\n\n* Male professional football players from French clubs\n* Aged 18 years and older\n* Provided written informed consent to participate\n* Adequate understanding of written and spoken French\n\nYouth football players from training centers:\n\n* Registered in a training center affiliated with a French football club\n* Aged 16 years and older\n* Provided written assent to participate, with parental or legal guardian consent for minors\n* Adequate understanding of written and spoken French\n\nExclusion Criteria:\n\nAll players:\n\n* History of concussion in the past 6 months (for inclusion, a statement from the club physician confirming no concussion in the past 6 months will be requested)\n* Physically unfit (if applicable, a medical certificate from the club physician will be required, e.g., incapacitating musculoskeletal injury)",true,"MALE","16 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","Concussion is a major concern in the sports world. It represents an immediate and transient alteration of neurological functions due to a direct or indirect trauma, with or without loss of consciousness. Concussions affect between 1.6 and 3.8 million people per year in the United States across all sports. The prevalence varies depending on the sport. In France, the incidence of sport-related concussions is estimated at 200,000 cases. According to the French Academy of Medicine (March 2025), concussions account for between 5% and 9% of all sports-related injuries. Among these cases, 30% involve individuals aged 5 to 19. Football (soccer) is one of the most affected sports, with its 2 million registered players. In French professional football (Ligue 1 and 2), during the 2023-2024 season, one concussion was recorded every 55 matches on average (declared concussion). During the 2018-2019 and 2019-2020 seasons, the rate of matches with concussion was approximately 2.5%. In professional rugby, it is estimated that one concussion occurs every three matches in France.\n\nThere are no precise statistics on the number or frequency of concussions in amateur football in France, due to a lack of reporting and insufficient diagnosis. Currently, practical recommendations exist for managing football players from the moment of impact on the field, implemented within the French Football Federation. The current concussion protocol includes a standardized tool for evaluating concussion intended for healthcare professionals, the SCAT6. However, this protocol is not always sufficient, and return-to-play sometimes occurs too early. Indeed, current assessments are too brief and do not evaluate all cognitive functions. They do not allow a clear understanding of the real on-field consequences. It is estimated that 50% of athletes return to play too early after a concussion, with risks of neurological complications or prolonged symptoms.\n\nHowever, defining rest time and return-to-play criteria is not straightforward. In practice, return to play relies, among other things, on neuropsychological tests, whose interpretation is difficult in the absence of baseline data. The concussion protocol does not allow for an accurate determination of whether performance has normalized without this neuropsychological baseline.\n\nRecent European and international recommendations advise conducting pre-season assessments to provide comparative values. Several studies have been published on the type of pre-season assessments to perform, most using paper-and-pencil or computerized neurocognitive tests.\n\nThe current concussion protocol relies mainly on paper-and-pencil tests. However, the literature shows dissociations between cognitive performance measured in ecological environments and performance measured through paper-and-pencil tests. Ecological tasks have the advantage of closely approximating the daily actions of a player and assessing cognitive functioning more precisely.\n\nThus, these ecological tasks, combined with a baseline assessment, would improve the evaluation of athletes following a concussion. These tasks would facilitate return-to-play decisions through more objective observations and normed data. Finally, ecological tasks would enhance player monitoring and allow a more accurate understanding of their health status.\n\nFor this reason, it seems necessary to develop a standardized ecological test performed in real-game situations. This would improve decision-making regarding return to play without medically endangering the player and would allow better understanding of the cognitive effects of concussion. These tasks will first be reviewed and tested by experts (players, football staff members, national concussion reference physician, and neuropsychologists) for feedback and refinement.",[27,28,29,30,31],"Concussion, Brain","Sports-related Concussion","Football Players","Traumatic Brain Injury, Mild","Healthy Volunteer Male Subjects",[33,34,35,36],"ecological test","reliability","standardization","cognitive assessments","NOT_YET_RECRUITING","2026-02-18",{"date":40,"type":41},"2026-02-24","ACTUAL",{"date":43,"type":21},"2026-04",{"date":45,"type":21},"2028-04",{"name":47,"class":48},"Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":16,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":49},"100605007","phase-1-a-comparative-bioavailability-study-of-tamsulosin-04-mg-prolonged-release-tablets-versus-the-reference-drug-omnic-ocas-tamsulosin-hydrochloride-04-mg-prolonged-release-film-coated-tablets-in-healthy-adult-male-subjects-under-fasting-conditions-100605007","NCT07156916","A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Film-coated Tablets, in Healthy Adult Male Subjects, Under Fasting Conditions","A Prospective, Randomised, Open Label, Single Dose, Two-treatment, Two-period, Two-sequence, Crossover Bioequivalence Study of Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Tablets (Synthon Hispania SL, Spain) Versus the Reference Drug Omnic Ocas®, Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Film-coated Tablets (Astellas Pharma Europe B.V., the Netherlands), in Healthy Adult Male Subjects, Under Fasting Conditions","Inclusion Criteria:\n\n1. Capable of understanding the informed consent form (ICF) and giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n2. Healthy male subjects aged 18 to 45 years inclusive, at the time of signing the ICF, able to tolerate venipuncture.\n3. Verified diagnosis of being \"healthy\" according to results of standard clinical, laboratory and instrumental methods of examination.\n4. Body weight ≥50 kg and ≤ 120 kg, Body Mass Index between ≥18.5 and ≤30.0 kg\u002Fm2.\n5. Non-smokers (for at least 3 months).\n6. Subjects should be willing to remain abstinent (refrain from heterosexual intercourse) or use double barrier contraception during participation in the study and for 30 days thereafter. Double-barrier contraceptive method: condom used together with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository.\n\nExclusion Criteria:\n\n1. History or presence of allergies.\n2. Known hypersensitivity or intolerance to tamsulosin and\u002For other alpha 1 adreno-receptor antagonists and\u002For any other excipient of the study drugs.\n3. History of drug-induced angioedema.\n4. History, presence or necessity of glaucoma or cataract surgery.\n5. History or presence of acute or chronic diseases of cardiovascular (including arterial hypotension), bronchopulmonary, nervous, endocrine, reproductive systems (including ejaculation disorders), and also diseases of the gastrointestinal tract, liver (including hepatic insufficiency), urinary tract and kidneys (including renal insufficiency), blood, mental diseases; history of convulsive attacks.\n6. Acute infectious diseases (e.g. influenza, acute respiratory viral infections incl. COVID-19) less than 4 weeks before the first IMP administration.\n7. The presence of any other condition which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subject's ability to participate in the study.\n8. Surgery on the gastrointestinal tract (except appendectomy).\n9. Deviations from the normal parameters in clinical blood count analysis, biochemical blood analysis, urinalysis.\n10. History or presence of orthostatic hypotension or syncope.\n11. Systolic blood pressure measured in a sitting position, less than 100 mmHg or above 130 mmHg and\u002For diastolic blood pressure below 60 mmHg or above 89 mmHg.\n12. Heart rate less than 60 or more than 80 beats per minute.\n13. Deviation on the ECG intervals and heart rate or ECG morphology.\n14. Positive test results for HIV or hepatitis B or C or syphilis at screening.\n15. Positive test result for cotinine in the urine at screening or before randomisation.\n16. Positive screen for drugs or alcohol at screening or before randomisation.\n17. Known or suspected drug or alcohol abuse as judged by the Investigator.\n18. Alcohol consumption more than 10 units of alcohol a week (1 unit equivalent to 200 ml of dry wine or 50 ml of strong alcoholic drinks or 500 ml of beer) during the six months prior to the first administration of the IMP.\n19. Intake of xanthine containing substances (e.g., coffee, tea, chocolate, energy drinks, cola) as well as citrus fruits (grapefruit, grapefruit juice etc.) and cranberry (including juices, fruit drinks, etc.) within the last 72 hours before the IMP administration.\n20. Administration of medicines that have a significant effect on circulatory dynamics, liver function, etc. (barbiturates, omeprazol, cimetidin, NSAIDs, ACE inhibitors, angiotensin II receptor antagonists, diuretics, etc.) less than 2 months or 5 half-lives (whatever is longer) before screening.\n21. The use of depot-forms of any drugs for 3 months or 5 half-lives (whatever is longer) before screening.\n22. Use of any prescribed or non-prescribed medication, herbal remedies, vitamins and minerals during the two weeks prior to the first administration of the IMP or longer (at least 5 elimination half-lives) if the medication has a long half-life.\n23. Mental, physical and other reasons that do not allow the subjects according to investigator's opinion to assess their behavior adequately, to follow correctly the requirements of the clinical study protocol and to assess the expected risks and possible discomfort.\n24. Dehydration (e.g. due to diarrhea, vomiting, or other causes) within the last 48 hours before the IMP administration.\n25. Subjects who have been on a special diet (for whatever reason, e.g. vegetarians or hypocaloric diet \\[less than 1000 cal\u002Fday\\]) during the 28 days prior to the first IMP administration and intention to maintain the diet during the study.\n26. Intention to perform excessive physical activities during the trial.\n27. Plasma donation within one month from screening or blood donation\u002Fblood loss \\>500 ml within 3 months before screening.\n28. Unwillingness or inability to follow the procedures and restrictions outlined in the protocol and the ICF.\n29. Participation in another clinical study within 3 months before the first IMP administration.\n30. Difficulty swallowing tablets or fasting or consuming standard meals.\n31. Any reason in the opinion of the Investigator, would prevent the subject from participating in the study.\n32. Scheduled to have vaccination during the study.","18 Years","45 Years",{"count":60,"type":21},46,[62],"PHASE1","The aim of this study is to evaluate the bioequivalence and safety of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), compared to Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets (Astellas Pharma Europe B.V., the Netherlands), after single dose administration in healthy adult male subjects under fasting conditions.",[31],[66,67],"Bioequivalence","Tamsulosin","RECRUITING","2025-10-02",{"date":71,"type":41},"2025-10-03",{"date":73,"type":41},"2025-09-08",{"date":75,"type":21},"2026-05-01",{"name":77,"class":78},"Berlin-Chemie AG Menarini Group","INDUSTRY"]