{"ctNumber":"2023-510488-36-01","ctStatus":"Authorised","startDateEU":"2025-06-01","decisionDate":"2024-11-20T12:30:05.029","publishDate":"2026-09-23T03:33:41.064121096","ctPublicStatusCode":3,"authorizedApplication":{"authorizedPartI":{"id":145143,"rowSubjectCount":0,"products":[{"id":606560,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11462467","productPharmForm":"CAPSULE","euMpNumber":"PRD11418427","prodAuthStatus":1,"prodName":"Psilocybin capsules 15 mg","pharmForm":"CAPSULE","sponsorProductCode":"Psilocybin capsules 15 mg","activeSubstanceName":"PSILOCYBINE","euSubstNumber":"SUB10158MIG","nameOrg":"AVEXTRA PHARMA GMBH","productSubstances":[{"productPk":"11462467","substancePk":"382388","nameOrg":"AVEXTRA PHARMA GMBH","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"PSILOCYBINE","substanceEvCode":"SUB10158MIG"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"25","doseUomTotal":"mg milligram(s)","maxTotalDoseAmount":"40","maxTreatmentPeriod":2,"timeUnitCode":"1","evCode":"PRD11418427","sponsorProductCodeEdit":"Psilocybin capsules 15 mg","miaNumber":"F001/004/2023","devices":[],"characteristics":["1","2"],"routes":["ORAL"],"allSubstancesChemicals":true,"productName":"Psilocybin capsules 15 mg","jsonActiveSubstanceNames":"psilocybine","pharmaceuticalFormDisplay":"CAPSULE"},{"id":606562,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11462465","productPharmForm":"CAPSULE","euMpNumber":"PRD11418426","prodAuthStatus":1,"prodName":"Psilocybin capsules 1 mg","pharmForm":"CAPSULE","sponsorProductCode":"Psilocybin capsules 1 mg","activeSubstanceName":"PSILOCYBINE","euSubstNumber":"SUB10158MIG","nameOrg":"AVEXTRA PHARMA GMBH","productSubstances":[{"productPk":"11462465","substancePk":"382388","nameOrg":"AVEXTRA PHARMA GMBH","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"PSILOCYBINE","substanceEvCode":"SUB10158MIG"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"25","doseUomTotal":"mg milligram(s)","maxTotalDoseAmount":"40","maxTreatmentPeriod":2,"timeUnitCode":"1","evCode":"PRD11418426","sponsorProductCodeEdit":"Psilocybin capsules 1 mg","miaNumber":"F001/004/2023","devices":[],"characteristics":["1","2"],"routes":["ORAL"],"allSubstancesChemicals":true,"productName":"Psilocybin capsules 1 mg","jsonActiveSubstanceNames":"psilocybine","pharmaceuticalFormDisplay":"CAPSULE"},{"id":606561,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11462466","productPharmForm":"CAPSULE","euMpNumber":"PRD11418428","prodAuthStatus":1,"prodName":"Psilocybin capsules 25 mg","pharmForm":"CAPSULE","sponsorProductCode":"Psilocybin capsules 25 mg","activeSubstanceName":"PSILOCYBINE","euSubstNumber":"SUB10158MIG","nameOrg":"AVEXTRA PHARMA GMBH","productSubstances":[{"productPk":"11462466","substancePk":"382388","nameOrg":"AVEXTRA PHARMA GMBH","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"PSILOCYBINE","substanceEvCode":"SUB10158MIG"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"mg milligram(s)","maxDailyDoseAmount":"25","doseUomTotal":"mg milligram(s)","maxTotalDoseAmount":"40","maxTreatmentPeriod":2,"timeUnitCode":"1","evCode":"PRD11418428","sponsorProductCodeEdit":"Psilocybin capsules 25 mg","miaNumber":"F001/004/2023","devices":[],"characteristics":["1","2"],"routes":["ORAL"],"allSubstancesChemicals":true,"productName":"Psilocybin capsules 25 mg","jsonActiveSubstanceNames":"psilocybine","pharmaceuticalFormDisplay":"CAPSULE"}],"trialDetails":{"clinicalTrialIdentifiers":{"fullTitle":"PsyPal; Psilocybin Therapy for Psychological Distress in Palliative Patients","fullTitleTranslations":[{"id":12352733,"uuid":"47001460-5172-4f50-961c-615e9d4dfc72","attributeTranslation":"PsyPal; Psilocybine Therapie voor psychologische stress bij palliatieve patiënten","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352732,"uuid":"47001460-5172-4f50-961c-615e9d4dfc72","attributeTranslation":"PsyPal; Terapia com psilocibina para o sofrimento psicológico em doentes paliativos","language":20,"languageDescription":"Portuguese"},{"id":12352734,"uuid":"47001460-5172-4f50-961c-615e9d4dfc72","attributeTranslation":"PsyPal; Psilocybin-terapi mod psykologisk lidelse hos palliative patienter","language":3,"languageDescription":"'Danish"},{"id":12352735,"uuid":"47001460-5172-4f50-961c-615e9d4dfc72","attributeTranslation":"PsyPal; Psilocybinová terapie psychických potíží u paliativních pacientů","language":2,"languageDescription":"Czech"}],"publicTitle":"PsyPal; Psilocybin Therapy for Psychological Distress in Palliative Patients","publicTitleTranslations":[{"id":12352818,"uuid":"5cec77a2-a5c9-48c9-ae4e-2d197e1604e3","attributeTranslation":"PsyPal; Psilocybin-terapi mod psykologisk lidelse hos palliative patienter","language":3,"languageDescription":"'Danish"},{"id":12352819,"uuid":"5cec77a2-a5c9-48c9-ae4e-2d197e1604e3","attributeTranslation":"PsyPal; Terapia com psilocibina para o sofrimento psicológico em doentes paliativos","language":20,"languageDescription":"Portuguese"},{"id":12352816,"uuid":"5cec77a2-a5c9-48c9-ae4e-2d197e1604e3","attributeTranslation":"PsyPal; Psilocybinová terapie psychických potíží u paliativních pacientů","language":2,"languageDescription":"Czech"},{"id":12352817,"uuid":"5cec77a2-a5c9-48c9-ae4e-2d197e1604e3","attributeTranslation":"PsyPal; Psilocybine Therapie voor psychologische stress bij palliatieve patiënten","language":37,"languageDescription":"Dutch (Netherlands)"}],"shortTitle":"18870","secondaryIdentifyingNumbers":{"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"4","trialCategory":"2","justificationForTrialCategory":"PsyPal concerns a phase II trial and explores the safety and efficacy of psilocybin therapy in patients with a terminal illness (COPD, MS, ALS, or APD) for the first time.","trialCategoryId":134413},"medicalCondition":{"partIMedicalConditions":[{"id":152303,"medicalCondition":"Chronic obstructive pulmonary disease (COPD), amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and atypical Parkinson disorder (APD), particularly multiple system atrophy (MSA), progressive supranuclear palsy (PSP), and corticobasal syndrome (CBS).","medicalConditionTranslations":[{"id":12352630,"uuid":"621ba146-bd8e-4c23-bdbc-502d36f3bff4","attributeTranslation":"Chronická obstrukční plicní nemoc (CHOPN), amyotrofická laterální skleróza (ALS), roztroušená skleróza (MS) a atypická Parkinsonova porucha (APD), zejména mnohočetná systémová atrofie (MSA), progresivní supranukleární obrna (PSP) a kortikobazální syndrom (CBS) .","language":2,"languageDescription":"Czech"},{"id":12352629,"uuid":"621ba146-bd8e-4c23-bdbc-502d36f3bff4","attributeTranslation":"Kronisk obstruktiv lungesygdom (KOL), amyotrofisk lateral sklerose (ALS), multipel sklerose (MS) og atypisk Parkinsons sygdom (APD), især multipel systematrofi (MSA), progressiv supranukleær parese (PSP) og kortikobasalt syndrom (CBS) .","language":3,"languageDescription":"'Danish"},{"id":12352628,"uuid":"621ba146-bd8e-4c23-bdbc-502d36f3bff4","attributeTranslation":"Chronische obstructieve longziekte (COPD), amyotrofische laterale sclerose (ALS), multiple sclerose (MS) en atypische Parkinson-stoornis (APD), met name meervoudige systeematrofie (MSA), progressieve supranucleaire verlamming (PSP) en corticobasaal syndroom (CBS) .","language":18,"languageDescription":"Dutch"},{"id":12352631,"uuid":"621ba146-bd8e-4c23-bdbc-502d36f3bff4","attributeTranslation":"Doença pulmonar obstrutiva crônica (DPOC), esclerose lateral amiotrófica (ELA), esclerose múltipla (EM) e distúrbio de Parkinson atípico (DPA), particularmente atrofia de múltiplos sistemas (MSA), paralisia supranuclear progressiva (PSP) e síndrome corticobasal (CBS) .","language":20,"languageDescription":"Portuguese"}],"isConditionRareDisease":false}]},"trialObjective":{"trialScopes":[{"code":"4","trialScopeId":442033},{"code":"5","trialScopeId":442034}],"mainObjective":"To examine medium/high-dose psilocybin therapy safety and efficacy in reducing symptoms of depression in patients with COPD, ALS, MS, or APD, compared to the low-dose control group. This will be determined by using the clinician-administered Montgomery Åsberg Depression Rating Scale (MADRS) score and comparing changes between scores at Baseline and Primary endpoint (6 weeks post Dose 2).","mainObjectiveTranslations":[{"id":12352815,"uuid":"69ae5cbb-d5fc-46a3-8a13-0a74fa4c9a8c","attributeTranslation":"Examinar a segurança e eficácia da terapêutica com doses médias/altas de psilocibina na redução dos sintomas de depressão em doentes com DPOC, ELA, EM ou DPA, em comparação com o grupo de controlo de dose baixa. Isto será determinado utilizando a pontuação da Escala de Avaliação da Depressão de Montgomery Åsberg (MADRS) administrada pelo médico e comparando as alterações entre as pontuações na linha de base e no endpoint primário (6 semanas após a Dose 2).","language":20,"languageDescription":"Portuguese"},{"id":12352814,"uuid":"69ae5cbb-d5fc-46a3-8a13-0a74fa4c9a8c","attributeTranslation":"Om de veiligheid en werkzaamheid van medium/hoge dosering psilocybinetherapie te onderzoeken bij het verminderen van depressiesymptomen bij patiënten met COPD, ALS, MS of APD, vergeleken met de lage dosering controlegroep. Dit zal worden bepaald door gebruik te maken van de door de clinicus toegediende Montgomery Åsberg Depression Rating Scale (MADRS) score en door veranderingen tussen scores bij baseline en primair eindpunt (6 weken na dosis 2) te vergelijken.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352813,"uuid":"69ae5cbb-d5fc-46a3-8a13-0a74fa4c9a8c","attributeTranslation":"Zkoumat bezpečnost a účinnost terapie středními/vysokými dávkami psilocybinu při snižování symptomů deprese u pacientů s CHOPN, ALS, RS nebo APD ve srovnání s kontrolní skupinou s nízkou dávkou. To bude určeno pomocí klinického hodnocení Montgomery Åsberg Depression Rating Scale (MADRS) a porovnáním změn mezi skóre ve výchozím stavu a primárním koncovým bodem (6 týdnů po dávce 2).","language":2,"languageDescription":"Czech"},{"id":12352812,"uuid":"69ae5cbb-d5fc-46a3-8a13-0a74fa4c9a8c","attributeTranslation":"At undersøge medium/højdosis psilocybinbehandlings sikkerhed og effektivitet til at reducere symptomer på depression hos patienter med KOL, ALS, MS eller APD sammenlignet med lavdosiskontrolgruppen. Dette vil blive bestemt ved at bruge den kliniker-administrerede Montgomery Åsberg Depression Rating Scale (MADRS) score og sammenligne ændringer mellem score ved baseline og primært endepunkt (6 uger efter dosis 2).","language":3,"languageDescription":"'Danish"}],"secondaryObjectives":[{"id":521121,"number":1,"secondaryObjective":"To determine the response rate to psilocybin therapy, defined as a ≥50% reduction in MADRS score between baseline and primary endpoint","secondaryObjectiveTranslations":[{"id":12352821,"uuid":"1bad3671-4ee5-49f2-84f3-a9251c8d3380","attributeTranslation":"For at bestemme responsraten på psilocybinbehandling, defineret som en ≥50 % reduktion i MADRS-score mellem baseline og primært endepunkt","language":3,"languageDescription":"'Danish"},{"id":12352822,"uuid":"1bad3671-4ee5-49f2-84f3-a9251c8d3380","attributeTranslation":"Om de respons op psilocybinetherapie te bepalen, gedefinieerd als een reductie van ≥50% in de MADRS-score tussen de baseline en het primaire eindpunt","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352823,"uuid":"1bad3671-4ee5-49f2-84f3-a9251c8d3380","attributeTranslation":"Para determinar a taxa de resposta à terapêutica com psilocibina, definida como uma redução ≥50% na pontuação MADRS entre o valor inicial e o desfecho primário","language":20,"languageDescription":"Portuguese"},{"id":12352820,"uuid":"1bad3671-4ee5-49f2-84f3-a9251c8d3380","attributeTranslation":"Ke stanovení míry odpovědi na léčbu psilocybinem, definované jako ≥50% snížení skóre MADRS mezi výchozím a primárním koncovým bodem","language":2,"languageDescription":"Czech"}]},{"id":521122,"number":2,"secondaryObjective":"To evaluate the effect of psilocybin therapy on end-of-life anxiety, as measured by the change in DADDS score between baseline and primary endpoint.","secondaryObjectiveTranslations":[{"id":12352824,"uuid":"322000cf-196b-4bcf-b862-7757c686cb87","attributeTranslation":"At evaluere effekten af ​​psilocybinbehandling på angst ved livets afslutning, målt ved ændringen i DADDS-score mellem baseline og primært endepunkt.","language":3,"languageDescription":"'Danish"},{"id":12352825,"uuid":"322000cf-196b-4bcf-b862-7757c686cb87","attributeTranslation":"Avaliar o efeito da terapêutica com psilocibina na ansiedade do fim de vida, medida pela alteração da pontuação DADDS entre o valor inicial e o desfecho primário.","language":20,"languageDescription":"Portuguese"},{"id":12352826,"uuid":"322000cf-196b-4bcf-b862-7757c686cb87","attributeTranslation":"Om het effect van psilocybinetherapie op angst aan het einde van het leven te evalueren, gemeten aan de hand van de verandering in de DADDS-score tussen de uitgangswaarde en het primaire eindpunt.","language":18,"languageDescription":"Dutch"},{"id":12352827,"uuid":"322000cf-196b-4bcf-b862-7757c686cb87","attributeTranslation":"Vyhodnotit účinek terapie psilocybinem na úzkost na konci života, měřený změnou skóre DADDS mezi výchozím a primárním cílovým parametrem.","language":2,"languageDescription":"Czech"}]},{"id":521123,"number":3,"secondaryObjective":"To evaluate the effect of psilocybin therapy on symptoms of anxiety and depression, as measured by the change in HADS score between baseline and primary endpoint.","secondaryObjectiveTranslations":[{"id":12352829,"uuid":"e799f425-69b5-43ac-a852-c06168084f6e","attributeTranslation":"Om het effect van psilocybinetherapie op symptomen van angst en depressie te evalueren, gemeten aan de hand van de verandering in HADS-score tussen de uitgangswaarde en het primaire eindpunt.","language":18,"languageDescription":"Dutch"},{"id":12352828,"uuid":"e799f425-69b5-43ac-a852-c06168084f6e","attributeTranslation":"Avaliar o efeito da terapêutica com psilocibina nos sintomas de ansiedade e depressão, medido pela alteração da pontuação HADS entre o valor inicial e o desfecho primário.","language":20,"languageDescription":"Portuguese"},{"id":12352831,"uuid":"e799f425-69b5-43ac-a852-c06168084f6e","attributeTranslation":"At evaluere effekten af ​​psilocybinbehandling på symptomer på angst og depression, målt ved ændringen i HADS-score mellem baseline og primært endepunkt.","language":3,"languageDescription":"'Danish"},{"id":12352830,"uuid":"e799f425-69b5-43ac-a852-c06168084f6e","attributeTranslation":"Vyhodnotit účinek terapie psilocybinem na symptomy úzkosti a deprese, měřeno změnou skóre HADS mezi výchozím a primárním koncovým bodem.","language":2,"languageDescription":"Czech"}]},{"id":521124,"number":4,"secondaryObjective":"To assess the impact of psilocybin therapy on demoralization, as measured by the change in Demoralisation Scale-II (DS-II) between baseline and primary endpoint.","secondaryObjectiveTranslations":[{"id":12352835,"uuid":"c2fc07fa-e142-41a1-8a02-ae6dc9597db2","attributeTranslation":"Posoudit dopad terapie psilocybinem na demoralizaci, měřeno změnou Demoralisation Scale-II (DS-II) mezi výchozím a primárním koncovým bodem.","language":2,"languageDescription":"Czech"},{"id":12352834,"uuid":"c2fc07fa-e142-41a1-8a02-ae6dc9597db2","attributeTranslation":"At vurdere virkningen af ​​psilocybinbehandling på demoralisering, målt ved ændringen i Demoralisation Scale-II (DS-II) mellem baseline og primært endepunkt.","language":3,"languageDescription":"'Danish"},{"id":12352832,"uuid":"c2fc07fa-e142-41a1-8a02-ae6dc9597db2","attributeTranslation":"Para avaliar o impacto da terapêutica com psilocibina na desmoralização, medido pela alteração da Escala de Desmoralização-II (DS-II) entre o valor inicial e o endpoint primário.","language":20,"languageDescription":"Portuguese"},{"id":12352833,"uuid":"c2fc07fa-e142-41a1-8a02-ae6dc9597db2","attributeTranslation":"Om de impact van psilocybinetherapie op demoralisatie te beoordelen, gemeten aan de hand van de verandering in Demoralisation Scale-II (DS-II) tussen de baseline en het primaire eindpunt.","language":18,"languageDescription":"Dutch"}]},{"id":521125,"number":5,"secondaryObjective":"To evaluate the effect of psilocybin therapy on health-related quality of life, as measured by the change in EQ-5D-5L between baseline and primary endpoint.","secondaryObjectiveTranslations":[{"id":12352837,"uuid":"5f56fc00-a0c2-4d53-ae73-4cd3035bd568","attributeTranslation":"Para avaliar o efeito da terapêutica com psilocibina na qualidade de vida relacionada com a saúde, medida pela alteração do EQ-5D-5L entre o valor inicial e o endpoint primário.","language":20,"languageDescription":"Portuguese"},{"id":12352838,"uuid":"5f56fc00-a0c2-4d53-ae73-4cd3035bd568","attributeTranslation":"Vyhodnotit účinek terapie psilocybinem na kvalitu života související se zdravím, měřenou změnou EQ-5D-5L mezi výchozím a primárním koncovým bodem.","language":2,"languageDescription":"Czech"},{"id":12352836,"uuid":"5f56fc00-a0c2-4d53-ae73-4cd3035bd568","attributeTranslation":"Om het effect van psilocybinetherapie op de gezondheidsgerelateerde kwaliteit van leven te evalueren, gemeten aan de hand van de verandering in EQ-5D-5L tussen de uitgangswaarde en het primaire eindpunt.","language":18,"languageDescription":"Dutch"},{"id":12352839,"uuid":"5f56fc00-a0c2-4d53-ae73-4cd3035bd568","attributeTranslation":"At evaluere effekten af ​​psilocybinbehandling på sundhedsrelateret livskvalitet, målt ved ændringen i EQ-5D-5L mellem baseline og primært endepunkt.","language":3,"languageDescription":"'Danish"}]},{"id":521126,"number":6,"secondaryObjective":"To assess the impact of psilocybin therapy on caregiver burden, as measured by the change in Zarit Burden Interview (ZBI-7) between baseline and primary endpoint.","secondaryObjectiveTranslations":[{"id":12352843,"uuid":"0d4bf4a7-70c3-4111-8147-e810897bd03c","attributeTranslation":"Om de impact van psilocybinetherapie op de belasting van mantelzorgers te beoordelen, gemeten aan de hand van de verandering in het Zarit Burden Interview (ZBI-7) tussen de baseline en het primaire eindpunt.","language":18,"languageDescription":"Dutch"},{"id":12352840,"uuid":"0d4bf4a7-70c3-4111-8147-e810897bd03c","attributeTranslation":"Avaliar o impacto da terapêutica com psilocibina na sobrecarga do cuidador, medido pela alteração da Zarit Burden Interview (ZBI-7) entre o valor inicial e o endpoint primário.","language":20,"languageDescription":"Portuguese"},{"id":12352841,"uuid":"0d4bf4a7-70c3-4111-8147-e810897bd03c","attributeTranslation":"At vurdere virkningen af ​​psilocybinbehandling på omsorgsbyrden, målt ved ændringen i Zarit Burden Interview (ZBI-7) mellem baseline og primært endepunkt.","language":3,"languageDescription":"'Danish"},{"id":12352842,"uuid":"0d4bf4a7-70c3-4111-8147-e810897bd03c","attributeTranslation":"Posoudit dopad terapie psilocybinem na zátěž pečovatele, měřeno změnou v Zarit Burden Interview (ZBI-7) mezi výchozím a primárním cílovým parametrem.","language":2,"languageDescription":"Czech"}]},{"id":521127,"number":7,"secondaryObjective":"To assess the impact of psilocybin therapy on clinical functioning, as measured by the change in disease-specific measures between baseline and primary endpoint: a.\tCOPD \tCOPD Assessment Test (CAT) \tSt George's respiratory questionnaire (SGRQ-C) \tLung function (FEV1, RV, TLC, and IRC) o\tALS \tAmyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R) \tAmyotrophic lateral sclerosis assessment questionnaire (ALSAQ-5)  o\tMS \tExpanded Disability Status Scale (EDSS) \tMcDonald criteria o\tAPD \tParkinson's Disease Questionnaire (PDQ-8) \tUnified Parkinson's Disease Rating Scale (MDS-UPDRS) \tRey Auditory Verbal Learning Test (RAVLT) \tLetters and Numbers Sequence \tTrail Making Test (TMT) \tVerbal Fluency \tDigit Span \tDigit Symbol Substitution Test \tIrregular Word Reading Test (TeLPI)","secondaryObjectiveTranslations":[{"id":12352846,"uuid":"04dc1fd7-37d8-48f7-9c4d-044cbfe7b1e2","attributeTranslation":"Om de impact van psilocybinetherapie op het klinisch functioneren te beoordelen, gemeten aan de hand van de verandering in ziektespecifieke metingen tussen de baseline en het primaire eindpunt:\na. COPD\n COPD Assessment Test (CAT)\n St George's respiratory questionnaire (SGRQ-C)\n Longfunctie (FEV1, RV, TLC en IRC)\no ALS\n Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R)\n Amyotrophic lateral sclerosis assessment questionnaire (ALSAQ-5)\no MS\n Expanded Disability Status Scale (EDSS)\n McDonald-criteria\no APD\n Parkinson's Disease Questionnaire (PDQ-8)\n Unified Parkinson's Disease Rating Scale (MDS-UPDRS)\n Rey Auditory Verbal Learning Test (RAVLT)\n Letters en cijfers sequentie\n Trail Making Test (TMT)\n Verbale vloeiendheid\n Cijferreeks\n Cijfersymboolsubstitutietest\n Test voor het lezen van onregelmatige woorden (TeLPI)","language":18,"languageDescription":"Dutch"},{"id":12352844,"uuid":"04dc1fd7-37d8-48f7-9c4d-044cbfe7b1e2","attributeTranslation":"For at vurdere virkningen af ​​psilocybinbehandling på klinisk funktion, målt ved ændringen i sygdomsspecifikke mål mellem baseline og primært endepunkt:\nen. KOL\n COPD Assessment Test (CAT)\n St George's respiratoriske spørgeskema (SGRQ-C)\n Lungefunktion (FEV1, RV, TLC og IRC)\no ALS\n Amyotrofisk lateral sklerose Funktionel vurdering Skala-revideret (ALSFRS-R)\n Amyotrofisk lateral sklerose vurderingsspørgeskema (ALSAQ-5)\no MS\n Udvidet handicapstatusskala (EDSS)\n McDonald-kriterier\no APD\n Parkinsons sygdom spørgeskema (PDQ-8)\n Unified Parkinsons Disease Rating Scale (MDS-UPDRS)\n Rey Auditory Verbal Learning Test (RAVLT)\n Bogstaver og talrækkefølge\n Trail Making Test (TMT)\n Verbal flydende\n Cifferspænd\n Digit Symbol Substitution Test\n Uregelmæssig ordlæsningstest (TeLPI)","language":3,"languageDescription":"'Danish"},{"id":12352847,"uuid":"04dc1fd7-37d8-48f7-9c4d-044cbfe7b1e2","attributeTranslation":"Para avaliar o impacto da terapêutica com psilocibina no funcionamento clínico, medido pela alteração das medidas específicas da doença entre o valor inicial e o desfecho primário:\num. DPOC\n Teste de Avaliação da DPOC (CAT)\n Questionário respiratório de St George (SGRQ-C)\n Função pulmonar (FEV1, RV, TLC e IRC)\no ELA\n Escala de Avaliação Funcional da Esclerose Lateral Amiotrófica revista (ALSFRS-R)\n Questionário de avaliação da esclerose lateral amiotrófica (ALSAQ-5)\no EM\n Escala Expandida de Estado de Incapacidade (EDSS)\n Critérios McDonald\no DPA\n Questionário de Doença de Parkinson (PDQ-8)\n Escala Unificada de Avaliação da Doença de Parkinson (MDS-UPDRS)\n Teste de Aprendizagem Auditiva Verbal Rey (RAVLT)\n Sequência de Letras e Números\n Teste de Percurso (TMT)\n Fluência Verbal\n Extensão de dígitos\n Teste de substituição de símbolos de dígitos\n Teste de leitura de palavras irregulares (TeLPI)","language":20,"languageDescription":"Portuguese"},{"id":12352845,"uuid":"04dc1fd7-37d8-48f7-9c4d-044cbfe7b1e2","attributeTranslation":"K posouzení dopadu terapie psilocybinem na klinické fungování, měřeno změnou v měření specifických pro onemocnění mezi výchozím a primárním koncovým bodem:\nA. COPD\n COPD Assessment Test (CAT)\n Respirační dotazník svatého Jiří (SGRQ-C)\n Funkce plic (FEV1, RV, TLC a IRC)\no ALS\n Revidovaná stupnice funkčního hodnocení amyotrofické laterální sklerózy (ALSFRS-R)\n Dotazník hodnocení amyotrofické laterální sklerózy (ALSAQ-5)\no MS\n Rozšířená stupnice stavu postižení (EDSS)\n Kritéria McDonald\no APD\n Dotazník Parkinsonovy nemoci (PDQ-8)\n Jednotná stupnice hodnocení Parkinsonovy choroby (MDS-UPDRS)\n Reyův sluchový test verbálního učení (RAVLT)\n Posloupnost písmen a číslic\n Trail Making Test (TMT)\n Verbální plynulost\n Rozpětí číslic\n Test záměny číslicových symbolů\n Test nepravidelného čtení slov (TeLPI)","language":2,"languageDescription":"Czech"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":990624,"number":1,"principalInclusionCriteria":"COPD: diagnosis by specialist","principalInclusionCriteriaTranslations":[{"id":12352736,"uuid":"c7a27ad0-edcf-4220-980b-6f483f3794ad","attributeTranslation":"COPD: diagnóstico por especialista","language":20,"languageDescription":"Portuguese"},{"id":12352738,"uuid":"c7a27ad0-edcf-4220-980b-6f483f3794ad","attributeTranslation":"COPD: diagnóza u specialisty","language":2,"languageDescription":"Czech"},{"id":12352737,"uuid":"c7a27ad0-edcf-4220-980b-6f483f3794ad","attributeTranslation":"COPD: diagnose af specialist","language":3,"languageDescription":"'Danish"},{"id":12352739,"uuid":"c7a27ad0-edcf-4220-980b-6f483f3794ad","attributeTranslation":"COPD: diagnose door specialist","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":990625,"number":10,"principalInclusionCriteria":"APD: Diseases in the spectrum of Progressive supranuclear palsy (PSP), fulfilling possible and probable criteria, according to the MDS diagnostic criteria","principalInclusionCriteriaTranslations":[{"id":12352741,"uuid":"07bb9695-535b-4fa6-8ab9-326015acbee8","attributeTranslation":"APD: Sygdomme i spektret af progressiv supranukleær parese (PSP), der opfylder mulige og sandsynlige kriterier i henhold til MDS' diagnosekriterier.","language":3,"languageDescription":"'Danish"},{"id":12352742,"uuid":"07bb9695-535b-4fa6-8ab9-326015acbee8","attributeTranslation":"APD: Nemoci ve spektru progresivní supranukleární paralýzy (PSP), které splňují možná a pravděpodobná kritéria podle diagnostických kritérií MDS.","language":2,"languageDescription":"Czech"},{"id":12352740,"uuid":"07bb9695-535b-4fa6-8ab9-326015acbee8","attributeTranslation":"APD: Doenças no espetro da paralisia supranuclear progressiva (PSP), que satisfazem os critérios possíveis e prováveis, de acordo com os critérios de diagnóstico da MDS.","language":20,"languageDescription":"Portuguese"},{"id":12352743,"uuid":"07bb9695-535b-4fa6-8ab9-326015acbee8","attributeTranslation":"APD: Ziekten in het spectrum van progressieve supranucleaire parese (PSP), die voldoen aan mogelijke en waarschijnlijke criteria, volgens de diagnostische criteria van MDS.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":990626,"number":11,"principalInclusionCriteria":"APD: Clinically Established and Clinically Probable Multiple System Atrophy (MSA) according to the MDS diagnostic criteria","principalInclusionCriteriaTranslations":[{"id":12352744,"uuid":"3d3d0229-0916-4304-a6b9-a98f532f2787","attributeTranslation":"APD: Atrofia de Sistemas Múltiplos (MSA) clinicamente estabelecida e clinicamente provável de acordo com os critérios de diagnóstico MDS","language":20,"languageDescription":"Portuguese"},{"id":12352747,"uuid":"3d3d0229-0916-4304-a6b9-a98f532f2787","attributeTranslation":"APD: Klinicky prokázaná a klinicky pravděpodobná mnohočetná systémová atrofie (MSA) podle diagnostických kritérií MDS.","language":2,"languageDescription":"Czech"},{"id":12352746,"uuid":"3d3d0229-0916-4304-a6b9-a98f532f2787","attributeTranslation":"APD: Klinisk etableret og klinisk sandsynlig multipel systematrofi (MSA) i henhold til de diagnostiske kriterier for MDS.","language":3,"languageDescription":"'Danish"},{"id":12352745,"uuid":"3d3d0229-0916-4304-a6b9-a98f532f2787","attributeTranslation":"APD: Klinisch vastgestelde en klinisch waarschijnlijke multipele systeematrofie (MSA) volgens de diagnostische criteria van MDS.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":990627,"number":12,"principalInclusionCriteria":"Patient meets ICD-10 criteria for major depressive disorder documented through the completion of the mood section of the Mini International Neuropsychiatric Interview by a screening psychologist or physician","principalInclusionCriteriaTranslations":[{"id":12352749,"uuid":"5a56f3e2-262a-484a-8c04-d1d4b9915bbd","attributeTranslation":"Pacient splňuje kritéria MKN-10 pro velkou depresivní poruchu doložená vyplněním části Mini International Neuropsychiatric Interview o náladě screeningovým psychologem nebo lékařem.","language":2,"languageDescription":"Czech"},{"id":12352750,"uuid":"5a56f3e2-262a-484a-8c04-d1d4b9915bbd","attributeTranslation":"O doente preenche os critérios da CID-10 para perturbação depressiva major, documentada através do preenchimento da secção de humor da Mini International Neuropsychiatric Interview por um psicólogo ou médico responsável pelo rastreio","language":20,"languageDescription":"Portuguese"},{"id":12352748,"uuid":"5a56f3e2-262a-484a-8c04-d1d4b9915bbd","attributeTranslation":"Patienten opfylder ICD-10-kriterierne for svær depressiv lidelse dokumenteret gennem udfyldelse af stemningsafsnittet i Mini International Neuropsychiatric Interview af en screeningspsykolog eller -læge.","language":3,"languageDescription":"'Danish"},{"id":12352751,"uuid":"5a56f3e2-262a-484a-8c04-d1d4b9915bbd","attributeTranslation":"De patiënt voldoet aan de ICD-10 criteria voor een depressieve stoornis gedocumenteerd door het invullen van het stemmingsgedeelte van het Mini International Neuropsychiatric Interview door een screeningspsycholoog of arts.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":990628,"number":13,"principalInclusionCriteria":"Patient has a MADRS score of > 19","principalInclusionCriteriaTranslations":[{"id":12352752,"uuid":"e9e862d1-c53f-4c23-ac73-88ca067663c9","attributeTranslation":"Pacient má skóre MADRS > 19.","language":2,"languageDescription":"Czech"},{"id":12352753,"uuid":"e9e862d1-c53f-4c23-ac73-88ca067663c9","attributeTranslation":"O doente tem uma pontuação MADRS > 19","language":20,"languageDescription":"Portuguese"},{"id":12352754,"uuid":"e9e862d1-c53f-4c23-ac73-88ca067663c9","attributeTranslation":"Patienten har en MADRS-score på > 19","language":3,"languageDescription":"'Danish"},{"id":12352755,"uuid":"e9e862d1-c53f-4c23-ac73-88ca067663c9","attributeTranslation":"Patiënt heeft een MADRS score van > 19","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":990629,"number":14,"principalInclusionCriteria":"Patient should have a life expectancy of at least 6 months (assessed by study physician)","principalInclusionCriteriaTranslations":[{"id":12352759,"uuid":"f6c5aebd-9184-4481-b824-7b7c093297e9","attributeTranslation":"Patienten skal have en forventet levetid på mindst 6 måneder (vurderet af forsøgslægen)","language":3,"languageDescription":"'Danish"},{"id":12352757,"uuid":"f6c5aebd-9184-4481-b824-7b7c093297e9","attributeTranslation":"Pacient by měl mít očekávanou délku života alespoň 6 měsíců (podle posouzení studijního lékaře).","language":2,"languageDescription":"Czech"},{"id":12352758,"uuid":"f6c5aebd-9184-4481-b824-7b7c093297e9","attributeTranslation":"De patiënt moet een levensverwachting hebben van ten minste 6 maanden (beoordeeld door de onderzoeksarts)","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352756,"uuid":"f6c5aebd-9184-4481-b824-7b7c093297e9","attributeTranslation":"O doente deve ter uma esperança de vida de pelo menos 6 meses (avaliada pelo médico do estudo)","language":20,"languageDescription":"Portuguese"}]},{"id":990630,"number":15,"principalInclusionCriteria":"Patient is at least 18 years of age","principalInclusionCriteriaTranslations":[{"id":12352762,"uuid":"d9447b40-c484-4c89-a6b0-d9b7fe367a58","attributeTranslation":"Pacient je starší 18 let","language":2,"languageDescription":"Czech"},{"id":12352761,"uuid":"d9447b40-c484-4c89-a6b0-d9b7fe367a58","attributeTranslation":"Patienten er mindst 18 år gammel","language":3,"languageDescription":"'Danish"},{"id":12352763,"uuid":"d9447b40-c484-4c89-a6b0-d9b7fe367a58","attributeTranslation":"O doente tem pelo menos 18 anos de idade","language":20,"languageDescription":"Portuguese"},{"id":12352760,"uuid":"d9447b40-c484-4c89-a6b0-d9b7fe367a58","attributeTranslation":"De patiënt is minstens 18 jaar oud","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":990631,"number":16,"principalInclusionCriteria":"Patient has an identified caregiver/support person","principalInclusionCriteriaTranslations":[{"id":12352766,"uuid":"01da630b-0e4c-4333-8610-ec2f3ea12e3f","attributeTranslation":"O doente tem um prestador de cuidados/pessoa de apoio identificado","language":20,"languageDescription":"Portuguese"},{"id":12352764,"uuid":"01da630b-0e4c-4333-8610-ec2f3ea12e3f","attributeTranslation":"Pacient má určeného pečovatele/podpůrnou osobu","language":2,"languageDescription":"Czech"},{"id":12352767,"uuid":"01da630b-0e4c-4333-8610-ec2f3ea12e3f","attributeTranslation":"Patienten har en identificeret omsorgsperson/støtteperson","language":3,"languageDescription":"'Danish"},{"id":12352765,"uuid":"01da630b-0e4c-4333-8610-ec2f3ea12e3f","attributeTranslation":"Patiënt heeft een geïdentificeerde verzorger/ondersteuner","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":990632,"number":17,"principalInclusionCriteria":"Patient is able to read and understand the informed consent and all scales used in a local language. For those with ALS, MS, or APD, competency is ensured via neurologist assessment, cognitive screening, caregiver support during screening and interactive approaches where the screening clinician ask the patient to explain their understanding of consent elements, re-explaining potentially misunderstood information","principalInclusionCriteriaTranslations":[{"id":12352770,"uuid":"374616e6-19b4-42de-8911-5920898657b6","attributeTranslation":"O doente é capaz de ler e compreender o consentimento informado e todas as escalas utilizadas na língua local. Para aqueles com ELA, EM ou DPA, a competência é garantida através da avaliação do neurologista, rastreio cognitivo, apoio do cuidador durante o rastreio e abordagens interativas em que o médico de rastreio pede ao doente que explique a sua compreensão dos elementos de consentimento, reexplicando informações potencialmente mal compreendidas","language":20,"languageDescription":"Portuguese"},{"id":12352771,"uuid":"374616e6-19b4-42de-8911-5920898657b6","attributeTranslation":"Patiënt is in staat om de informed consent en alle schalen die in een lokale taal worden gebruikt te lezen en te begrijpen. Voor mensen met ALS, MS of APD wordt competentie gewaarborgd via neurologische beoordeling, cognitieve screening, ondersteuning van de verzorger tijdens screening en interactieve benaderingen waarbij de screeningsarts de patiënt vraagt ​​om zijn begrip van de toestemmingselementen uit te leggen, en mogelijk verkeerd begrepen informatie opnieuw uitlegt","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352769,"uuid":"374616e6-19b4-42de-8911-5920898657b6","attributeTranslation":"Pacient je schopen číst a rozumět informovanému souhlasu a všem používaným škálám v místním jazyce. U pacientů s ALS, RS nebo APD je kompetence zajištěna posouzením neurologa, kognitivním screeningem, podporou pečovatele během screeningu a interaktivními přístupy, kdy vyšetřující lékař požádá pacienta, aby vysvětlil, jak rozumí prvkům souhlasu, a znovu vysvětlí potenciálně nepochopené informace.","language":2,"languageDescription":"Czech"},{"id":12352768,"uuid":"374616e6-19b4-42de-8911-5920898657b6","attributeTranslation":"Patienten er i stand til at læse og forstå det informerede samtykke og alle skalaer, der bruges på et lokalt sprog. For personer med ALS, MS eller APD sikres kompetence via neurologvurdering, kognitiv screening, omsorgspersonstøtte under screening og interaktive tilgange, hvor screeningsklinikeren beder patienten om at forklare deres forståelse af samtykkeelementer og genforklare potentielt misforstået information","language":3,"languageDescription":"'Danish"}]},{"id":990633,"number":18,"principalInclusionCriteria":"Patient is able to and willing to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and completing all study evaluations","principalInclusionCriteriaTranslations":[{"id":12352772,"uuid":"8caaa51d-c1d4-4876-b65b-69def3e0c0dc","attributeTranslation":"Patienten er i stand til og villig til at overholde forsøgskravene, herunder at deltage i alle forsøgsbesøg, forberedende og opfølgende sessioner og gennemføre alle forsøgsevalueringer.","language":3,"languageDescription":"'Danish"},{"id":12352773,"uuid":"8caaa51d-c1d4-4876-b65b-69def3e0c0dc","attributeTranslation":"De patiënt is in staat en bereid om aan de vereisten van het onderzoek te voldoen, waaronder het bijwonen van alle studiebezoeken, voorbereidende en follow-up sessies en het voltooien van alle studie-evaluaties.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352774,"uuid":"8caaa51d-c1d4-4876-b65b-69def3e0c0dc","attributeTranslation":"O doente é capaz e está disposto a cumprir os requisitos do estudo, incluindo a participação em todas as visitas de estudo, sessões preparatórias e de acompanhamento, e a realização de todas as avaliações do estudo","language":20,"languageDescription":"Portuguese"},{"id":12352775,"uuid":"8caaa51d-c1d4-4876-b65b-69def3e0c0dc","attributeTranslation":"Pacient je schopen a ochoten dodržovat požadavky studie, včetně účasti na všech návštěvách studie, přípravných a následných sezeních a vyplnění všech hodnocení studie.","language":2,"languageDescription":"Czech"}]},{"id":990634,"number":19,"principalInclusionCriteria":"Patient is able to ingest capsules","principalInclusionCriteriaTranslations":[{"id":12352778,"uuid":"476a64fc-f849-4e95-bc7f-d1ae4bbede86","attributeTranslation":"Pacient je schopen požít tobolky","language":2,"languageDescription":"Czech"},{"id":12352779,"uuid":"476a64fc-f849-4e95-bc7f-d1ae4bbede86","attributeTranslation":"O doente é capaz de ingerir as cápsulas","language":20,"languageDescription":"Portuguese"},{"id":12352777,"uuid":"476a64fc-f849-4e95-bc7f-d1ae4bbede86","attributeTranslation":"Patienten er i stand til at indtage kapsler","language":3,"languageDescription":"'Danish"},{"id":12352776,"uuid":"476a64fc-f849-4e95-bc7f-d1ae4bbede86","attributeTranslation":"De patiënt is in staat om capsules in te nemen","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":990635,"number":2,"principalInclusionCriteria":"COPD: Postbronchodilator FEV1/FVC < 0,7 and FEV1 <80% pred","principalInclusionCriteriaTranslations":[{"id":12352783,"uuid":"80e751f9-a28d-4fcd-8e40-008f2cc80c30","attributeTranslation":"COPD: Postbronkodilaterende FEV1/FVC < 0,7 og FEV1 < 80 % præd.","language":3,"languageDescription":"'Danish"},{"id":12352780,"uuid":"80e751f9-a28d-4fcd-8e40-008f2cc80c30","attributeTranslation":"COPD: FEV1/FVC pós-broncodilatador < 0,7 e FEV1 <80% pred","language":20,"languageDescription":"Portuguese"},{"id":12352781,"uuid":"80e751f9-a28d-4fcd-8e40-008f2cc80c30","attributeTranslation":"COPD: Post Bronchodilator FEV1/FVC-ratio <0,7 en FEV1 <80%","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352782,"uuid":"80e751f9-a28d-4fcd-8e40-008f2cc80c30","attributeTranslation":"COPD: Postbronchodilatační FEV1/FVC < 0,7 a FEV1 < 80 % pred.","language":2,"languageDescription":"Czech"}]},{"id":990636,"number":3,"principalInclusionCriteria":"COPD: ≥ 40 years old","principalInclusionCriteriaTranslations":[{"id":12352784,"uuid":"46c67fa9-0ea5-41bc-bf1b-b9c44182c87d","attributeTranslation":"COPD: ≥ 40 jaar","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352787,"uuid":"46c67fa9-0ea5-41bc-bf1b-b9c44182c87d","attributeTranslation":"≥ 40 anos de idade","language":20,"languageDescription":"Portuguese"},{"id":12352785,"uuid":"46c67fa9-0ea5-41bc-bf1b-b9c44182c87d","attributeTranslation":"COPD: ≥ 40 let","language":2,"languageDescription":"Czech"},{"id":12352786,"uuid":"46c67fa9-0ea5-41bc-bf1b-b9c44182c87d","attributeTranslation":"≥ 40 år gammel","language":3,"languageDescription":"'Danish"}]},{"id":990637,"number":4,"principalInclusionCriteria":"COPD: ≥ 10 years smoking","principalInclusionCriteriaTranslations":[{"id":12352789,"uuid":"6d542a22-1e02-454b-a3a2-cc9d3c00419b","attributeTranslation":"COPD: ≥ 10 let kouření","language":2,"languageDescription":"Czech"},{"id":12352790,"uuid":"6d542a22-1e02-454b-a3a2-cc9d3c00419b","attributeTranslation":"COPD: ≥ 10 års rygning","language":3,"languageDescription":"'Danish"},{"id":12352788,"uuid":"6d542a22-1e02-454b-a3a2-cc9d3c00419b","attributeTranslation":"COPD: ≥ 10 anos a fumar","language":20,"languageDescription":"Portuguese"},{"id":12352791,"uuid":"6d542a22-1e02-454b-a3a2-cc9d3c00419b","attributeTranslation":"COPD: ≥ 10 jaar roken","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":990638,"number":5,"principalInclusionCriteria":"ALS: ALS according to Goldcoast criteria","principalInclusionCriteriaTranslations":[{"id":12352794,"uuid":"d2124c19-92fa-4feb-a665-b559caef6133","attributeTranslation":"ALS: ALS podle kritérií Goldcoast","language":2,"languageDescription":"Czech"},{"id":12352795,"uuid":"d2124c19-92fa-4feb-a665-b559caef6133","attributeTranslation":"ALS: ALS de acordo com os critérios Goldcoast","language":20,"languageDescription":"Portuguese"},{"id":12352792,"uuid":"d2124c19-92fa-4feb-a665-b559caef6133","attributeTranslation":"ALS: ALS i henhold til Goldcoast-kriterier","language":3,"languageDescription":"'Danish"},{"id":12352793,"uuid":"d2124c19-92fa-4feb-a665-b559caef6133","attributeTranslation":"ALS: ALS volgens Goldcoast-criteria","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":990639,"number":6,"principalInclusionCriteria":"ALS: ALS-FRS-R subscores of minimum 1 in item 2, 3 and 8, subscore of minimum 2 in item 1, 4 and 10 and a subscore of minimum 3 in item 11 and 12","principalInclusionCriteriaTranslations":[{"id":12352798,"uuid":"b4c693eb-d42c-4b14-9939-425996c512ef","attributeTranslation":"ALS: Pontuação mínima de 1 nos itens 2, 3 e 8 da ALS-FRS-R, pontuação mínima de 2 nos itens 1, 4 e 10 e pontuação mínima de 3 nos itens 11 e 12","language":20,"languageDescription":"Portuguese"},{"id":12352797,"uuid":"b4c693eb-d42c-4b14-9939-425996c512ef","attributeTranslation":"ALS: ALS-FRS-R subscores van minimaal 1 in item 2, 3 en 8, subscore van minimaal 2 in item 1, 4 en 10 en een subscore van minimaal 3 in item 11 en 12.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352799,"uuid":"b4c693eb-d42c-4b14-9939-425996c512ef","attributeTranslation":"ALS: ALS-FRS-R delscore på minimum 1 i punkt 2, 3 og 8, delscore på minimum 2 i punkt 1, 4 og 10 og delscore på minimum 3 i punkt 11 og 12.","language":3,"languageDescription":"'Danish"},{"id":12352796,"uuid":"b4c693eb-d42c-4b14-9939-425996c512ef","attributeTranslation":"ALS: ALS-FRS-R: dílčí skóre minimálně 1 v položkách 2, 3 a 8, dílčí skóre minimálně 2 v položkách 1, 4 a 10 a dílčí skóre minimálně 3 v položkách 11 a 12.","language":2,"languageDescription":"Czech"}]},{"id":990640,"number":7,"principalInclusionCriteria":"MS: Fulfilled diagnostic revised McDonald criteria for MS from 2017","principalInclusionCriteriaTranslations":[{"id":12352801,"uuid":"bff2115c-9093-43d5-bbb1-72069def26a2","attributeTranslation":"MS: Opfyldte de reviderede diagnostiske McDonald-kriterier for MS fra 2017","language":3,"languageDescription":"'Danish"},{"id":12352800,"uuid":"bff2115c-9093-43d5-bbb1-72069def26a2","attributeTranslation":"MS: Splňuje diagnostická revidovaná McDonaldova kritéria pro RS z roku 2017","language":2,"languageDescription":"Czech"},{"id":12352803,"uuid":"bff2115c-9093-43d5-bbb1-72069def26a2","attributeTranslation":"MS: voldeed aan de herziene diagnostische McDonald-criteria voor MS van 2017","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352802,"uuid":"bff2115c-9093-43d5-bbb1-72069def26a2","attributeTranslation":"MS: Preenchimento dos critérios de diagnóstico revistos da McDonald para a EM a partir de 2017","language":20,"languageDescription":"Portuguese"}]},{"id":990641,"number":8,"principalInclusionCriteria":"MS: EDSS ≥ 1,0","principalInclusionCriteriaTranslations":[{"id":12352805,"uuid":"4e388e81-1f09-4eea-b3b5-7269ba8aae62","attributeTranslation":"MS: EDSS ≥ 1,0","language":3,"languageDescription":"'Danish"},{"id":12352806,"uuid":"4e388e81-1f09-4eea-b3b5-7269ba8aae62","attributeTranslation":"MS: EDSS ≥ 1,0","language":20,"languageDescription":"Portuguese"},{"id":12352804,"uuid":"4e388e81-1f09-4eea-b3b5-7269ba8aae62","attributeTranslation":"MS: EDSS ≥ 1,0","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352807,"uuid":"4e388e81-1f09-4eea-b3b5-7269ba8aae62","attributeTranslation":"MS: EDSS ≥ 1,0","language":2,"languageDescription":"Czech"}]},{"id":990642,"number":9,"principalInclusionCriteria":"APD: Advanced to Late-Stage Parkinson’s Disease – patients with a diagnosis of Parkinson’s Disease per the MDS clinical diagnosis criteria with evidence of motor and non-motor fluctuations","principalInclusionCriteriaTranslations":[{"id":12352809,"uuid":"28b257c4-3cb3-43d4-ad52-295a0392051d","attributeTranslation":"APD: Doença de Parkinson em fase avançada a tardia - doentes com um diagnóstico de doença de Parkinson de acordo com os critérios de diagnóstico clínico da MDS com evidência de flutuações motoras e não motoras","language":20,"languageDescription":"Portuguese"},{"id":12352808,"uuid":"28b257c4-3cb3-43d4-ad52-295a0392051d","attributeTranslation":"APD: Advanced to Late-Stage Parkinson's Disease - patienter med en diagnose af Parkinsons sygdom i henhold til MDS' kliniske diagnosekriterier med tegn på motoriske og ikke-motoriske fluktuationer.","language":3,"languageDescription":"'Danish"},{"id":12352810,"uuid":"28b257c4-3cb3-43d4-ad52-295a0392051d","attributeTranslation":"APD: Parkinsonova nemoc v pokročilém až pozdním stadiu - pacienti s diagnózou Parkinsonovy nemoci podle kritérií klinické diagnózy MDS s prokázanými motorickými a nemotorickými fluktuacemi.","language":2,"languageDescription":"Czech"},{"id":12352811,"uuid":"28b257c4-3cb3-43d4-ad52-295a0392051d","attributeTranslation":"APD: Ziekte van Parkinson in gevorderd tot laat stadium - patiënten met een diagnose van de ziekte van Parkinson volgens de klinische diagnosecriteria van MDS met bewijs van motorische en niet-motorische fluctuaties.","language":37,"languageDescription":"Dutch (Netherlands)"}]}],"principalExclusionCriteria":[{"id":1690827,"number":1,"principalExclusionCriteria":"Patient has used a psychedelic substance in the past 6 months (e.g., psilocybin, LSD, 5-MeO-DMT, DMT, ayahuasca or mescaline)","principalExclusionCriteriaTranslations":[{"id":12352643,"uuid":"f06f59c0-4919-4465-b168-e9aa0b6ed3a7","attributeTranslation":"Patienten har brugt et psykedelisk stof inden for de seneste 6 måneder (f.eks. psilocybin, LSD, 5-MeO-DMT, DMT, ayahuasca eller meskalin).","language":3,"languageDescription":"'Danish"},{"id":12352641,"uuid":"f06f59c0-4919-4465-b168-e9aa0b6ed3a7","attributeTranslation":"O doente utilizou uma substância psicadélica nos últimos 6 meses (por exemplo, psilocibina, LSD, 5-MeO-DMT, DMT, ayahuasca ou mescalina)","language":20,"languageDescription":"Portuguese"},{"id":12352640,"uuid":"f06f59c0-4919-4465-b168-e9aa0b6ed3a7","attributeTranslation":"Patiënt heeft de afgelopen 6 maanden een psychedelische stof gebruikt (bijv. psilocybine, LSD, 5-MeO-DMT, DMT, ayahuasca of mescaline)","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352642,"uuid":"f06f59c0-4919-4465-b168-e9aa0b6ed3a7","attributeTranslation":"Pacient užil v posledních 6 měsících psychedelickou látku (např. psilocybin, LSD, 5-MeO-DMT, DMT, ayahuasca nebo meskalin).","language":2,"languageDescription":"Czech"}]},{"id":1690828,"number":10,"principalExclusionCriteria":"Patient is unwilling or unable to pause formal psychotherapy (days 0-42)","principalExclusionCriteriaTranslations":[{"id":12352646,"uuid":"585edc2e-0b4d-456f-be31-3b1b1df59423","attributeTranslation":"Patienten er uvillig eller ude af stand til at holde pause med formel psykoterapi (dag 0-42)","language":3,"languageDescription":"'Danish"},{"id":12352644,"uuid":"585edc2e-0b4d-456f-be31-3b1b1df59423","attributeTranslation":"Patiënt wil of kan formele psychotherapie niet pauzeren (dagen 0-42)","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352645,"uuid":"585edc2e-0b4d-456f-be31-3b1b1df59423","attributeTranslation":"Pacient není ochoten nebo schopen přerušit formální psychoterapii (dny 0-42).","language":2,"languageDescription":"Czech"},{"id":12352647,"uuid":"585edc2e-0b4d-456f-be31-3b1b1df59423","attributeTranslation":"O doente não quer ou não pode fazer uma pausa na psicoterapia formal (dias 0-42)","language":20,"languageDescription":"Portuguese"}]},{"id":1690829,"number":11,"principalExclusionCriteria":"Patient has neurological conditions (e.g., intracranial tumour, epilepsy, brain injuries, or other neurological disorders) expected by the PIs to conflict with the treatment / study protocol","principalExclusionCriteriaTranslations":[{"id":12352648,"uuid":"ca44ea94-a6b2-46cb-bad3-517e209306cc","attributeTranslation":"Patienten har neurologiske tilstande (f.eks. intrakranielle tumorer, epilepsi, hjerneskader eller andre neurologiske lidelser), som PI'erne forventer vil være i konflikt med behandlingen/forsøgsprotokollen.","language":3,"languageDescription":"'Danish"},{"id":12352650,"uuid":"ca44ea94-a6b2-46cb-bad3-517e209306cc","attributeTranslation":"Pacient má neurologické onemocnění (např. intrakraniální nádor, epilepsii, poranění mozku nebo jiné neurologické poruchy), u kterého hlavní vyšetřovatelé předpokládají, že bude v rozporu s léčbou / protokolem studie.","language":2,"languageDescription":"Czech"},{"id":12352651,"uuid":"ca44ea94-a6b2-46cb-bad3-517e209306cc","attributeTranslation":"De patiënt heeft neurologische aandoeningen (bijv. intracraniële tumor, epilepsie, hersenletsel of andere neurologische aandoeningen) waarvan de hoofdonderzoekers verwachten dat deze conflicteren met de behandeling/het studieprotocol.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352649,"uuid":"ca44ea94-a6b2-46cb-bad3-517e209306cc","attributeTranslation":"O doente tem condições neurológicas (por exemplo, tumor intracraniano, epilepsia, lesões cerebrais ou outras perturbações neurológicas) que, segundo os IPs, podem entrar em conflito com o protocolo de tratamento/estudo","language":20,"languageDescription":"Portuguese"}]},{"id":1690830,"number":12,"principalExclusionCriteria":"Cardiovascular conditions: recent stroke (< 1 year from signing of ICF), recent myocardial infarction (< 1 year from signing of ICF), uncontrolled hypertension (blood pressure > 140/90 mmHg), clinically significant arrhythmia within 1 year of signing the ICF, or QTc prolongation exceeding 450ms (males) / 470ms (females).","principalExclusionCriteriaTranslations":[{"id":12352654,"uuid":"07680931-76b0-4612-a5b4-c90ee140dd06","attributeTranslation":"Kardiovaskulære tilstande: nyligt slagtilfælde (< 1 år fra signering af ICF), nyligt myokardieinfarkt (< 1 år fra signering af ICF), ukontrolleret hypertension (blodtryk > 140/90 mmHg), klinisk signifikant arytmi inden for 1 år efter signering af ICF eller QTc-forlængelse, der overstiger 450ms (mænd) / 470ms (hun).","language":3,"languageDescription":"'Danish"},{"id":12352652,"uuid":"07680931-76b0-4612-a5b4-c90ee140dd06","attributeTranslation":"ardiovasculaire aandoeningen: recente beroerte (< 1 jaar na ondertekening van de ICF), recent myocardinfarct (< 1 jaar na ondertekening van de ICF), ongecontroleerde hypertensie (bloeddruk > 140/90 mmHg), klinisch significante aritmie binnen 1 jaar na ondertekening van de ICF, of QTc-verlenging van meer dan 450 ms (mannen) / 470 ms (vrouwen).","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352655,"uuid":"07680931-76b0-4612-a5b4-c90ee140dd06","attributeTranslation":"Kardiovaskulární stavy: nedávná cévní mozková příhoda (< 1 rok od podpisu ICF), nedávný infarkt myokardu (< 1 rok od podpisu ICF), nekontrolovaná hypertenze (krevní tlak > 140/90 mmHg), klinicky významná arytmie do 1 roku od podpisu ICF nebo prodloužení QTc přesahující 450 ms (muži) / 470 ms (ženy)","language":2,"languageDescription":"Czech"},{"id":12352653,"uuid":"07680931-76b0-4612-a5b4-c90ee140dd06","attributeTranslation":"Condições cardiovasculares: acidente vascular cerebral recente (< 1 ano a partir da assinatura do TCLE), enfarte do miocárdio recente (< 1 ano a partir da assinatura do TCLE), hipertensão não controlada (pressão arterial > 140/90 mmHg), arritmia clinicamente significativa no espaço de 1 ano após a assinatura do TCLE , ou prolongamento do QTc superior a 450ms (homens) / 470ms (mulheres).","language":20,"languageDescription":"Portuguese"}]},{"id":1690831,"number":13,"principalExclusionCriteria":"Patient has moderate to severe hepatic impairment (Child-Pugh score ≥ 7)","principalExclusionCriteriaTranslations":[{"id":12352657,"uuid":"82a1839d-cc84-4ce0-8443-c445014e33a7","attributeTranslation":"O doente tem insuficiência hepática moderada a grave (pontuação de Child-Pugh ≥ 7)","language":20,"languageDescription":"Portuguese"},{"id":12352656,"uuid":"82a1839d-cc84-4ce0-8443-c445014e33a7","attributeTranslation":"Pacient má středně těžkou až těžkou poruchu funkce jater (Childovo-Pughovo skóre ≥ 7).","language":2,"languageDescription":"Czech"},{"id":12352659,"uuid":"82a1839d-cc84-4ce0-8443-c445014e33a7","attributeTranslation":"Patiënt heeft matige tot ernstige leverfunctiestoornis (Child-Pugh score ≥ 7)","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352658,"uuid":"82a1839d-cc84-4ce0-8443-c445014e33a7","attributeTranslation":"Patienten har moderat til svær nedsat leverfunktion (Child-Pugh score ≥ 7)","language":3,"languageDescription":"'Danish"}]},{"id":1690832,"number":14,"principalExclusionCriteria":"Patient has insulin-dependent diabetes or who are taking oral hypoglycaemic agents and have a current risk of hypoglycaemia that would require medical intervention","principalExclusionCriteriaTranslations":[{"id":12352661,"uuid":"76e5ff99-3a6e-4188-9bbb-f2619757ae76","attributeTranslation":"Patienten har insulinkrævende diabetes eller tager orale hypoglykæmiske midler og har en aktuel risiko for hypoglykæmi, der kræver medicinsk indgriben.","language":3,"languageDescription":"'Danish"},{"id":12352663,"uuid":"76e5ff99-3a6e-4188-9bbb-f2619757ae76","attributeTranslation":"Doentes com diabetes insulino-dependente ou que estejam a tomar hipoglicemiantes orais e tenham um risco atual de hipoglicemia que exija intervenção médica","language":20,"languageDescription":"Portuguese"},{"id":12352660,"uuid":"76e5ff99-3a6e-4188-9bbb-f2619757ae76","attributeTranslation":"De patiënt heeft insulineafhankelijke diabetes of gebruikt orale hypoglykemie medicatie en heeft een huidig risico op hypoglykemie dat medische interventie vereist.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352662,"uuid":"76e5ff99-3a6e-4188-9bbb-f2619757ae76","attributeTranslation":"Pacient má diabetes závislý na inzulínu nebo užívá perorální hypoglykemika a má aktuální riziko hypoglykémie, které by vyžadovalo lékařský zásah.","language":2,"languageDescription":"Czech"}]},{"id":1690833,"number":15,"principalExclusionCriteria":"Patient has any physical or psychological symptoms, medications, blood test results or clinically significant findings at Screening or Baseline (based on the clinical judgement of clinical/medical study personnel) that would make a patient unsuitable for the study","principalExclusionCriteriaTranslations":[{"id":12352664,"uuid":"29e225ac-3e65-444d-9bd1-648ccb1099c1","attributeTranslation":"De patiënt heeft lichamelijke of psychologische symptomen, medicatie, uitslagen van bloedtesten of klinisch significante bevindingen bij Screening of Baseline (gebaseerd op het klinisch oordeel van klinisch/medisch onderzoekspersoneel) die een patiënt ongeschikt maken voor het onderzoek.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352667,"uuid":"29e225ac-3e65-444d-9bd1-648ccb1099c1","attributeTranslation":"Pacient má jakékoli fyzické nebo psychické příznaky, léky, výsledky krevních testů nebo klinicky významné nálezy při screeningu nebo výchozím vyšetření (na základě klinického posouzení klinického/medicínského personálu studie), které by pacienta činily nevhodným pro studii.","language":2,"languageDescription":"Czech"},{"id":12352666,"uuid":"29e225ac-3e65-444d-9bd1-648ccb1099c1","attributeTranslation":"O doente apresenta quaisquer sintomas físicos ou psicológicos, medicamentos, resultados de análises sanguíneas ou resultados clinicamente significativos no rastreio ou na linha de base (com base na apreciação clínica do pessoal clínico/médico do estudo) que tornariam o doente inadequado para o estudo","language":20,"languageDescription":"Portuguese"},{"id":12352665,"uuid":"29e225ac-3e65-444d-9bd1-648ccb1099c1","attributeTranslation":"Patienten har fysiske eller psykiske symptomer, medicin, blodprøveresultater eller klinisk signifikante fund ved screening eller baseline (baseret på klinisk/medicinsk forsøgspersonales kliniske vurdering), der ville gøre patienten uegnet til forsøget.","language":3,"languageDescription":"'Danish"}]},{"id":1690834,"number":16,"principalExclusionCriteria":"Patient has an allergy or intolerance to any of the materials contained in either drug product","principalExclusionCriteriaTranslations":[{"id":12352669,"uuid":"3ccac5f1-ffb2-4216-8cf7-cfd34df757a4","attributeTranslation":"De patiënt heeft een allergie of intolerantie voor een van de stoffen in een van beide geneesmiddelen","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352668,"uuid":"3ccac5f1-ffb2-4216-8cf7-cfd34df757a4","attributeTranslation":"O doente tem alergia ou intolerância a qualquer um dos materiais contidos em qualquer um dos medicamentos","language":20,"languageDescription":"Portuguese"},{"id":12352671,"uuid":"3ccac5f1-ffb2-4216-8cf7-cfd34df757a4","attributeTranslation":"Pacient má alergii nebo nesnášenlivost na některou z látek obsažených v obou léčivých přípravcích.","language":2,"languageDescription":"Czech"},{"id":12352670,"uuid":"3ccac5f1-ffb2-4216-8cf7-cfd34df757a4","attributeTranslation":"Patienten har en allergi eller intolerance over for nogen af de materialer, der er indeholdt i begge lægemidler","language":3,"languageDescription":"'Danish"}]},{"id":1690835,"number":17,"principalExclusionCriteria":"Cognitive and Neuropsychological assessment: Patients will be excluded if they score below mean minus 1.5 Standard Deviation according to normative age and scholarity adjusted data on the Montreal Cognitive Assessment (MoCA) assessment","principalExclusionCriteriaTranslations":[{"id":12352672,"uuid":"85f60069-e779-4f39-a98f-71a904adeaa2","attributeTranslation":"Avaliação cognitiva e neuropsicológica: Os doentes serão excluídos se obtiverem uma pontuação inferior à média menos 1,5 Desvio Padrão de acordo com os dados normativos ajustados à idade e à escolaridade na avaliação Montreal Cognitive Assessment (MoCA)","language":20,"languageDescription":"Portuguese"},{"id":12352674,"uuid":"85f60069-e779-4f39-a98f-71a904adeaa2","attributeTranslation":"Kognitivní a neuropsychologické hodnocení: Pacienti budou vyloučeni, pokud jejich skóre v hodnocení Montreal Cognitive Assessment (MoCA) bude nižší než průměrná hodnota minus 1,5 směrodatné odchylky podle normativních údajů upravených podle věku a vzdělanosti.","language":2,"languageDescription":"Czech"},{"id":12352675,"uuid":"85f60069-e779-4f39-a98f-71a904adeaa2","attributeTranslation":"Kognitiv og neuropsykologisk vurdering: Patienter vil blive ekskluderet, hvis de scorer under gennemsnittet minus 1,5 standardafvigelse i henhold til normative alders- og skoletidsjusterede data på Montreal Cognitive Assessment (MoCA)-vurderingen.","language":3,"languageDescription":"'Danish"},{"id":12352673,"uuid":"85f60069-e779-4f39-a98f-71a904adeaa2","attributeTranslation":"Cognitieve en neuropsychologische beoordeling: Patiënten worden uitgesloten als ze lager scoren dan het gemiddelde minus 1,5 standaarddeviatie volgens voor leeftijd en scholariteit gecorrigeerde normatieve gegevens op de Montreal Cognitive Assessment (MoCA) beoordeling.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1690836,"number":18,"principalExclusionCriteria":"Recent (2 weeks) change or planned change in antidepressant medication during the intervention","principalExclusionCriteriaTranslations":[{"id":12352677,"uuid":"0eb6b853-2524-4707-8d6b-698d06250ebb","attributeTranslation":"Nylig (2 uger) ændring eller planlagt ændring i antidepressiv medicin under interventionen","language":3,"languageDescription":"'Danish"},{"id":12352678,"uuid":"0eb6b853-2524-4707-8d6b-698d06250ebb","attributeTranslation":"Alteração recente (2 semanas) ou planeada da medicação antidepressiva durante a intervenção","language":20,"languageDescription":"Portuguese"},{"id":12352679,"uuid":"0eb6b853-2524-4707-8d6b-698d06250ebb","attributeTranslation":"Nedávná (2 týdny) změna nebo plánovaná změna antidepresivní medikace během intervence","language":2,"languageDescription":"Czech"},{"id":12352676,"uuid":"0eb6b853-2524-4707-8d6b-698d06250ebb","attributeTranslation":"Recente (2 weken) verandering of geplande verandering in antidepressieve medicatie tijdens de interventie","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1690837,"number":19,"principalExclusionCriteria":"Women who are pregnant, intend to become pregnant during the study, who are currently nursing or are unwilling to use Highly Effective Contraceptive Methods (section 8.2.1).","principalExclusionCriteriaTranslations":[{"id":12352683,"uuid":"8f05b857-c5ef-44a7-b458-c2f34ad60a3a","attributeTranslation":"Ženy, které jsou těhotné, plánují otěhotnět během studie, které v současné době kojí nebo nechtějí používat vysoce účinné antikoncepční metody (oddíl 8.2.1).","language":2,"languageDescription":"Czech"},{"id":12352680,"uuid":"8f05b857-c5ef-44a7-b458-c2f34ad60a3a","attributeTranslation":"Mulheres que estão grávidas, que pretendem engravidar durante o estudo, que estão a amamentar ou que não desejam utilizar Métodos Contracetivos Altamente Eficazes (secção 8.2.1).","language":20,"languageDescription":"Portuguese"},{"id":12352681,"uuid":"8f05b857-c5ef-44a7-b458-c2f34ad60a3a","attributeTranslation":"Vrouwen die zwanger zijn, van plan zijn om tijdens het onderzoek zwanger te worden, die momenteel borstvoeding geven of die niet bereid zijn om Zeer Effectieve Anticonceptiemethoden te gebruiken (paragraaf 8.2.1).","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352682,"uuid":"8f05b857-c5ef-44a7-b458-c2f34ad60a3a","attributeTranslation":"Kvinder, der er gravide, har til hensigt at blive gravide under undersøgelsen, som i øjeblikket ammer eller er uvillige til at bruge højeffektive præventionsmetoder (afsnit 8.2.1).","language":3,"languageDescription":"'Danish"}]},{"id":1690838,"number":2,"principalExclusionCriteria":"Patient is in active treatments for other psychiatric disorders, judged by the screening clinician to be a more significant clinical problem than depression / distress","principalExclusionCriteriaTranslations":[{"id":12352686,"uuid":"ab213467-c010-4d37-a715-a84461c4997c","attributeTranslation":"O doente está a ser tratado ativamente para outras perturbações psiquiátricas, que o médico responsável pelo rastreio considera constituírem um problema clínico mais significativo do que a depressão/angústia","language":20,"languageDescription":"Portuguese"},{"id":12352687,"uuid":"ab213467-c010-4d37-a715-a84461c4997c","attributeTranslation":"Patienten er i aktiv behandling for andre psykiatriske lidelser, som af screeningsklinikeren vurderes til at være et større klinisk problem end depression/lidelse.","language":3,"languageDescription":"'Danish"},{"id":12352684,"uuid":"ab213467-c010-4d37-a715-a84461c4997c","attributeTranslation":"Pacient se aktivně léčí s jinou psychiatrickou poruchou, kterou klinik provádějící screening považuje za závažnější klinický problém než depresi / úzkost.","language":2,"languageDescription":"Czech"},{"id":12352685,"uuid":"ab213467-c010-4d37-a715-a84461c4997c","attributeTranslation":"De patiënt is in actieve behandeling voor andere psychiatrische stoornissen, die volgens de screeningsarts een belangrijker klinisch probleem vormen dan depressie / distress","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1690839,"number":20,"principalExclusionCriteria":"COPD: Unresolved exacerbation or pulmonary infection within last 4 weeks","principalExclusionCriteriaTranslations":[{"id":12352688,"uuid":"b2720489-26a5-4a2c-aad9-bca442606142","attributeTranslation":"COPD: Uafsluttet eksacerbation eller lungeinfektion inden for de sidste 4 uger","language":3,"languageDescription":"'Danish"},{"id":12352691,"uuid":"b2720489-26a5-4a2c-aad9-bca442606142","attributeTranslation":"COPD: exacerbação não resolvida ou infeção pulmonar nas últimas 4 semanas","language":20,"languageDescription":"Portuguese"},{"id":12352690,"uuid":"b2720489-26a5-4a2c-aad9-bca442606142","attributeTranslation":"COPD: Nevyřešená exacerbace nebo plicní infekce během posledních 4 týdnů.","language":2,"languageDescription":"Czech"},{"id":12352689,"uuid":"b2720489-26a5-4a2c-aad9-bca442606142","attributeTranslation":"COPD: Onopgeloste exacerbatie of longinfectie in de afgelopen 4 weken","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1690840,"number":21,"principalExclusionCriteria":"ALS: Significant cognitive deficits (MoCA)","principalExclusionCriteriaTranslations":[{"id":12352694,"uuid":"b6db5f3f-7fac-4aff-b728-4d69491c4047","attributeTranslation":"ALS: Défices cognitivos significativos (MoCA)","language":20,"languageDescription":"Portuguese"},{"id":12352693,"uuid":"b6db5f3f-7fac-4aff-b728-4d69491c4047","attributeTranslation":"ALS: Signifikant kognitivt underskud (MoCA)","language":3,"languageDescription":"'Danish"},{"id":12352695,"uuid":"b6db5f3f-7fac-4aff-b728-4d69491c4047","attributeTranslation":"ALS: Významný kognitivní deficit (MoCA)","language":2,"languageDescription":"Czech"},{"id":12352692,"uuid":"b6db5f3f-7fac-4aff-b728-4d69491c4047","attributeTranslation":"ALS: Significante cognitieve beperkingen (MoCA)","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1690841,"number":22,"principalExclusionCriteria":"MS: Significant cognitive deficits (MoCA), epilepsy or radiologically isolated syndrome","principalExclusionCriteriaTranslations":[{"id":12352697,"uuid":"4c6bb938-33c0-4d2e-8b81-7338096c435e","attributeTranslation":"MS: Signifikant kognitivt underskud (MoCA), epilepsi eller radiologisk isoleret syndrom","language":3,"languageDescription":"'Danish"},{"id":12352699,"uuid":"4c6bb938-33c0-4d2e-8b81-7338096c435e","attributeTranslation":"MS: Défices cognitivos significativos (MoCA), epilepsia ou síndrome radiologicamente isolado","language":20,"languageDescription":"Portuguese"},{"id":12352696,"uuid":"4c6bb938-33c0-4d2e-8b81-7338096c435e","attributeTranslation":"MS: Významný kognitivní deficit (MoCA), epilepsie nebo radiologicky izolovaný syndrom.","language":2,"languageDescription":"Czech"},{"id":12352698,"uuid":"4c6bb938-33c0-4d2e-8b81-7338096c435e","attributeTranslation":"MS: Significante cognitieve beperkingen (MoCA), epilepsie of radiologisch geïsoleerd syndroom.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1690842,"number":23,"principalExclusionCriteria":"APD: Dementia (MoCa), or Schwab and England ADL scale with scores > 80% in the best functional state","principalExclusionCriteriaTranslations":[{"id":12352701,"uuid":"eb313de3-cc69-4a2f-8286-422bf4309f7c","attributeTranslation":"APD: Demens (MoCa) eller Schwab og England ADL-skala med score > 80 % i den bedste funktionelle tilstand","language":3,"languageDescription":"'Danish"},{"id":12352700,"uuid":"eb313de3-cc69-4a2f-8286-422bf4309f7c","attributeTranslation":"APD: Dementie (MoCa), of Schwab en England ADL-schaal met scores > 80% in de beste functionele toestand","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352702,"uuid":"eb313de3-cc69-4a2f-8286-422bf4309f7c","attributeTranslation":"APD: demence (MoCa) nebo Schwabova a Englandova škála ADL se skóre > 80 % v nejlepším funkčním stavu.","language":2,"languageDescription":"Czech"},{"id":12352703,"uuid":"eb313de3-cc69-4a2f-8286-422bf4309f7c","attributeTranslation":"APD: Demência (MoCa), ou escala ADL de Schwab e Inglaterra com pontuações > 80% no melhor estado funcional","language":20,"languageDescription":"Portuguese"}]},{"id":1690843,"number":3,"principalExclusionCriteria":"Patient meets ICD-10 criteria for schizophrenia spectrum or other psychotic disorders, including major depressive disorder with psychotic features (except substance/medication-induced or due to another medical condition) or bipolar I/II disorder","principalExclusionCriteriaTranslations":[{"id":12352706,"uuid":"9e3693ab-8a30-4f11-a0e5-cc4fbd7df53e","attributeTranslation":"O doente preenche os critérios da CID-10 para o espetro da esquizofrenia ou outras perturbações psicóticas, incluindo perturbação depressiva major com características psicóticas (exceto induzida por substâncias/medicamentos ou devida a outra condição médica) ou perturbação bipolar I/II","language":20,"languageDescription":"Portuguese"},{"id":12352704,"uuid":"9e3693ab-8a30-4f11-a0e5-cc4fbd7df53e","attributeTranslation":"Patienten opfylder ICD-10-kriterierne for skizofrenispektret eller andre psykotiske lidelser, herunder svær depressiv lidelse med psykotiske træk (undtagen stof-/medicininduceret eller på grund af en anden medicinsk tilstand) eller bipolar I/II-lidelse.","language":3,"languageDescription":"'Danish"},{"id":12352707,"uuid":"9e3693ab-8a30-4f11-a0e5-cc4fbd7df53e","attributeTranslation":"De patiënt voldoet aan de ICD-10-criteria voor het schizofreniespectrum of andere psychotische stoornissen, waaronder depressieve stoornis met psychotische kenmerken (behalve door middelen/medicatie veroorzaakt of als gevolg van een andere medische aandoening) of bipolaire stoornis I/II.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352705,"uuid":"9e3693ab-8a30-4f11-a0e5-cc4fbd7df53e","attributeTranslation":"Pacient splňuje kritéria MKN-10 pro spektrum schizofrenie nebo jiné psychotické poruchy, včetně velké depresivní poruchy s psychotickými rysy (s výjimkou poruchy vyvolané návykovými látkami/léky nebo v důsledku jiného zdravotního stavu) nebo bipolární poruchy I/II.","language":2,"languageDescription":"Czech"}]},{"id":1690844,"number":4,"principalExclusionCriteria":"Patients with any lifetime diagnosis of schizophrenia spectrum or other psychotic disorders","principalExclusionCriteriaTranslations":[{"id":12352709,"uuid":"e3b7d3ea-de8a-4466-8639-b28250d10151","attributeTranslation":"Patiënten met een levenslange diagnose van schizofrenie of andere psychotische stoornissen","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352710,"uuid":"e3b7d3ea-de8a-4466-8639-b28250d10151","attributeTranslation":"Pacienti s jakoukoli celoživotní diagnózou schizofrenního spektra nebo jiných psychotických poruch.","language":2,"languageDescription":"Czech"},{"id":12352711,"uuid":"e3b7d3ea-de8a-4466-8639-b28250d10151","attributeTranslation":"Patienter med en livstidsdiagnose af skizofrenispektret eller andre psykotiske lidelser","language":3,"languageDescription":"'Danish"},{"id":12352708,"uuid":"e3b7d3ea-de8a-4466-8639-b28250d10151","attributeTranslation":"Doentes com qualquer diagnóstico ao longo da vida do espetro da esquizofrenia ou de outras perturbações psicóticas","language":20,"languageDescription":"Portuguese"}]},{"id":1690845,"number":5,"principalExclusionCriteria":"Patient has a first-degree relative with schizophrenia spectrum, bipolar I disorder or other psychotic disorders (expect substance/medication-induced or due to another medical condition).","principalExclusionCriteriaTranslations":[{"id":12352713,"uuid":"f6331c3d-4ff3-4c83-a970-0de4ae660624","attributeTranslation":"Patienten har en førstegradsslægtning med skizofrenispektrum, bipolar I lidelse eller andre psykotiske lidelser (forvent stof/medicin-induceret eller på grund af en anden medicinsk tilstand).","language":3,"languageDescription":"'Danish"},{"id":12352712,"uuid":"f6331c3d-4ff3-4c83-a970-0de4ae660624","attributeTranslation":"Pacient má příbuzného 1. stupně se schizofrenním spektrem, bipolární poruchou I nebo jinými psychotickými poruchami (očekává se, že jsou vyvolány látkou/léky nebo v důsledku jiného zdravotního stavu)","language":2,"languageDescription":"Czech"},{"id":12352714,"uuid":"f6331c3d-4ff3-4c83-a970-0de4ae660624","attributeTranslation":"Patiënt heeft een familielid in de eerste graad met een schizofreniespectrumstoornis, bipolaire stoornis type I of andere psychotische stoornissen (uitgezonderd door middelen/medicijnen of als gevolg van een andere medische aandoening).","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352715,"uuid":"f6331c3d-4ff3-4c83-a970-0de4ae660624","attributeTranslation":"O doente tem um familiar de primeiro grau com espectro de esquizofrenia, perturbação bipolar I ou outras perturbações psicóticas (espera-se induzido por substância/medicamento ou devido a outra condição médica).","language":20,"languageDescription":"Portuguese"}]},{"id":1690846,"number":6,"principalExclusionCriteria":"Patients with a pre-existing psychiatric condition judged to be incompatible with safe exposure to psilocybin therapy","principalExclusionCriteriaTranslations":[{"id":12352718,"uuid":"45669e6e-24a9-4d82-b1fb-a8ab1c1f86f4","attributeTranslation":"Pacienti s již existujícím psychiatrickým onemocněním, které je považováno za neslučitelné s bezpečnou expozicí psilocybinu.","language":2,"languageDescription":"Czech"},{"id":12352719,"uuid":"45669e6e-24a9-4d82-b1fb-a8ab1c1f86f4","attributeTranslation":"Doentes com uma doença psiquiátrica pré-existente considerada incompatível com uma exposição segura à psilocibina","language":20,"languageDescription":"Portuguese"},{"id":12352717,"uuid":"45669e6e-24a9-4d82-b1fb-a8ab1c1f86f4","attributeTranslation":"Patiënten met een reeds bestaande psychiatrische aandoening die onverenigbaar wordt geacht met een veilige blootstelling aan psilocybine therapie","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352716,"uuid":"45669e6e-24a9-4d82-b1fb-a8ab1c1f86f4","attributeTranslation":"Patienter med en allerede eksisterende psykiatrisk tilstand, der vurderes at være uforenelig med sikker eksponering for psilocybinbehandling","language":3,"languageDescription":"'Danish"}]},{"id":1690847,"number":7,"principalExclusionCriteria":"Significant suicide risk as defined by (1) suicidal ideation with intent to act (defined as ≥ 5 on MADRS item 10), (2) suicidal attempts within the past year, or (3) clinical assessment of significant suicidal risk during patient interview","principalExclusionCriteriaTranslations":[{"id":12352720,"uuid":"44935b9c-8074-4ab2-bf1c-495d19a65c6d","attributeTranslation":"Betydelig selvmordsrisiko som defineret ved (1) selvmordstanker med intention om at handle (defineret som ≥ 5 på MADRS punkt 10), (2) selvmordsforsøg inden for det seneste år, eller (3) klinisk vurdering af betydelig selvmordsrisiko under patientinterviewet.","language":3,"languageDescription":"'Danish"},{"id":12352721,"uuid":"44935b9c-8074-4ab2-bf1c-495d19a65c6d","attributeTranslation":"Significant suïciderisico zoals gedefinieerd door (1) suïcidale ideatie met intentie tot handelen (gedefinieerd als ≥ 5 op MADRS item 10), (2) suïcidale pogingen in het afgelopen jaar, of (3) klinische beoordeling van significant suïcidaal risico tijdens het interview met de patiënt.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352723,"uuid":"44935b9c-8074-4ab2-bf1c-495d19a65c6d","attributeTranslation":"Významné sebevražedné riziko definované (1) sebevražednými myšlenkami s úmyslem jednat (definováno jako ≥ 5 v položce 10 MADRS), (2) sebevražednými pokusy v posledním roce nebo (3) klinickým hodnocením významného sebevražedného rizika během rozhovoru s pacientem.","language":2,"languageDescription":"Czech"},{"id":12352722,"uuid":"44935b9c-8074-4ab2-bf1c-495d19a65c6d","attributeTranslation":"Risco significativo de suicídio definido por (1) ideação suicida com intenção de agir (definida como ≥ 5 no item 10 da MADRS), (2) tentativas de suicídio no último ano, ou (3) avaliação clínica de risco significativo de suicídio durante a entrevista do paciente","language":20,"languageDescription":"Portuguese"}]},{"id":1690848,"number":8,"principalExclusionCriteria":"Patient meets ICD-10 criteria for active/current alcohol or drug use disorder","principalExclusionCriteriaTranslations":[{"id":12352725,"uuid":"c56c500b-6ba9-4f45-801c-60a99191dabf","attributeTranslation":"Pacient splňuje kritéria ICD-10 pro aktivní/současnou poruchu způsobenou užíváním alkoholu nebo drog.","language":2,"languageDescription":"Czech"},{"id":12352726,"uuid":"c56c500b-6ba9-4f45-801c-60a99191dabf","attributeTranslation":"Patiënt voldoet aan ICD-10 criteria voor actieve/huidige stoornis in alcohol- of drugsgebruik","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352727,"uuid":"c56c500b-6ba9-4f45-801c-60a99191dabf","attributeTranslation":"Patienten opfylder ICD-10-kriterierne for aktivt/aktuelt alkohol- eller stofmisbrug","language":3,"languageDescription":"'Danish"},{"id":12352724,"uuid":"c56c500b-6ba9-4f45-801c-60a99191dabf","attributeTranslation":"O doente preenche os critérios da CID-10 para perturbação ativa/atual do consumo de álcool ou de drogas","language":20,"languageDescription":"Portuguese"}]},{"id":1690849,"number":9,"principalExclusionCriteria":"Patient has ongoing treatment with antipsychotic drugs. Any prohibited agents must have been stopped at least 5x the elimination half-life of the specific drug at the time of baseline (see Appendix 1a of the Clinical Trial Protocol for Prohibited medications)","principalExclusionCriteriaTranslations":[{"id":12352729,"uuid":"194d5d9d-abb0-4d62-9cf1-55587940f909","attributeTranslation":"O doente está a fazer tratamento com medicamentos antipsicóticos. Quaisquer agentes proibidos devem ter sido interrompidos pelo menos 5x a meia-vida de eliminação do medicamento específico no momento da linha de base (ver Apêndice 1a do Protocolo de Ensaio Clínico para medicamentos proibidos)","language":20,"languageDescription":"Portuguese"},{"id":12352730,"uuid":"194d5d9d-abb0-4d62-9cf1-55587940f909","attributeTranslation":"Patienten har igangværende behandling med antipsykotiske lægemidler. Alle forbudte midler skal være stoppet mindst 5 gange eliminationshalveringstiden for det specifikke lægemiddel på tidspunktet for baseline (se bilag 1a i den kliniske forsøgsprotokol for forbudte lægemidler).","language":3,"languageDescription":"'Danish"},{"id":12352728,"uuid":"194d5d9d-abb0-4d62-9cf1-55587940f909","attributeTranslation":"De patiënt wordt continu behandeld met antipsychotische geneesmiddelen. Alle verboden middelen moeten zijn gestopt met ten minste 5x de eliminatiehalfwaardetijd van het specifieke geneesmiddel ten tijde van de uitgangswaarde (zie bijlage 1a van het protocol voor klinische proeven voor verboden geneesmiddelen).","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352731,"uuid":"194d5d9d-abb0-4d62-9cf1-55587940f909","attributeTranslation":"Pacient je trvale léčen antipsychotiky. Veškeré zakázané léky musí být v době stanovení výchozího stavu vysazeny alespoň na dobu 5násobku eliminačního poločasu konkrétního léku (viz příloha 1a protokolu klinického hodnocení týkající se zakázaných léků).","language":2,"languageDescription":"Czech"}]}]},"endPoint":{"primaryEndPoints":[{"id":1157955,"number":1,"endPoint":"The primary endpoint is the change in depressive symptoms from baseline to 6 weeks after the second dose of psilocybin (high dose session) compared low-dose control..","isPrimary":true,"endPointTranslations":[{"id":12352632,"uuid":"589159ff-49b7-4a4d-84c7-8a9c078a2403","attributeTranslation":"Primárním koncovým ukazatelem je změna depresivních symptomů od výchozí hodnoty do 6 týdnů po druhé dávce psilocybinu (sezení s vysokou dávkou) ve srovnání s kontrolní dávkou.","language":2,"languageDescription":"Czech"},{"id":12352633,"uuid":"589159ff-49b7-4a4d-84c7-8a9c078a2403","attributeTranslation":"Het primaire eindpunt is de verandering in depressieve symptomen vanaf baseline tot 6 weken na de tweede dosis psilocybine (sessie met hoge dosis) in vergelijking met de controlegroep met lage dosis.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352634,"uuid":"589159ff-49b7-4a4d-84c7-8a9c078a2403","attributeTranslation":"Det primære endepunkt er ændringen i depressive symptomer fra baseline til 6 uger efter den anden dosis psilocybin (højdosis session) sammenlignet med lavdosis kontrol.","language":3,"languageDescription":"'Danish"},{"id":12352635,"uuid":"589159ff-49b7-4a4d-84c7-8a9c078a2403","attributeTranslation":"O objetivo primário é a alteração dos sintomas depressivos desde a linha de base até 6 semanas após a segunda dose de psilocibina (sessão de dose elevada) em comparação com a dose baixa de controlo.","language":20,"languageDescription":"Portuguese"}]}],"secondaryEndPoints":[{"id":1157956,"number":1,"endPoint":"To assess change in clinical functioning, end-of-life anxiety, psychological/existential distress, health-related quality of life, and how it impacts caregiver ’s health- and economic burden.","isPrimary":false,"endPointTranslations":[{"id":12352638,"uuid":"a263b634-44ca-4d49-8489-8cf322e78b0e","attributeTranslation":"Beoordelen van veranderingen in klinisch functioneren, angst aan het einde van het leven, psychologische/existentiële stress, gezondheidsgerelateerde kwaliteit van leven en hoe dit van invloed is op het gebruik van gezondheidszorg.","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":12352636,"uuid":"a263b634-44ca-4d49-8489-8cf322e78b0e","attributeTranslation":"Avaliar as alterações no funcionamento clínico, a ansiedade no fim da vida, o stress psicológico/existencial, a qualidade de vida relacionada com a saúde e o modo como isso afecta a utilização dos cuidados de saúde","language":20,"languageDescription":"Portuguese"},{"id":12352637,"uuid":"a263b634-44ca-4d49-8489-8cf322e78b0e","attributeTranslation":"At vurdere ændringer i klinisk funktion, angst ved livets afslutning, psykologisk/eksistentiel stress, sundhedsrelateret livskvalitet og hvordan dette påvirker brugen af sundhedsydelser.","language":3,"languageDescription":"'Danish"},{"id":12352639,"uuid":"a263b634-44ca-4d49-8489-8cf322e78b0e","attributeTranslation":"Posoudit změny v klinickém fungování, úzkosti na konci života, psychologickém/existenciálním stresu, kvalitě života související se zdravím a jejich vliv na využívání zdravotní péče.","language":2,"languageDescription":"Czech"}]}]},"trialDuration":{"estimatedEndDate":"2027-01-01","estimatedRecruitmentStartDate":"2025-01-01"},"sourceOfMonetarySupport":[{"id":107054,"organisationName":"EU Horizon Grant"}],"populationOfTrialSubjects":{"ageRanges":[{"id":399185,"ageRangeCategoryCode":"3","ageRangeCategory":"3"},{"id":399184,"ageRangeCategoryCode":"4","ageRangeCategory":"4"}],"ageRangeSecondaryIds":[{"id":399186,"ageRangeCategoryCode":"4","ctAgeRangeCode":"7","ageRangeCategory":"4","ctAgeRange":"7"}],"clinicalTrialGroups":[{"code":"2","name":"Patients"}],"isFemaleSubjects":true,"isMaleSubjects":true,"isVulnerablePopulationSelected":false},"individualParticipantData":{"planToShareIPD":"2"}},"protocolInformation":{"studyDesign":{"periodDetails":[]}},"scientificAdviceAndPip":{"scientificAdvices":[],"paediatricInvestigationPlan":[]},"associatedClinicalTrials":[{"id":38550,"ctNumber":"2023-510488-36-00","sponsorName":"Universitair Medisch Centrum Groningen","fullTitle":"PsyPal; Psilocybin Therapy for Psychological Distress in Palliative Patients","sponsorAgreementOption":"NON_APPLICABLE","sponsorAgreementOptionName":"NON_APPLICABLE","parentClinicalTrialId":11203,"hasDocument":false,"associatedCtDocs":[]}],"references":[],"pubmedCode":[],"pubmedUrl":[]},"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-04-28","conclusionDate":"2026-04-28","therapeuticAreas":[{"code":"32","name":"Psychiatry and Psychology [F] - Psychological Phenomena [F02]"},{"code":"5","name":"Diseases [C] - Musculoskeletal Diseases [C05]"},{"code":"31","name":"Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]"},{"code":"25","name":"Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]"},{"code":"8","name":"Diseases [C] - Respiratory Tract Diseases [C08]"},{"code":"33","name":"Psychiatry and Psychology [F] - Mental Disorders [F03]"},{"code":"23","name":"Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]"},{"code":"10","name":"Diseases [C] - Nervous System Diseases [C10]"},{"code":"50","name":"Phenomena and Processes [G] - Biological Phenomena [G16]"}],"medicalConditions":[{"id":152303,"medicalCondition":"Chronic obstructive pulmonary disease (COPD), amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and atypical Parkinson disorder (APD), particularly multiple system atrophy (MSA), progressive supranuclear palsy (PSP), and corticobasal syndrome (CBS).","isConditionRareDisease":false}],"sponsors":[{"id":165551,"primary":true,"publicContacts":[{"id":488917,"type":"Public","functionalName":"Prof. Dr. Robert Schoevers","functionalEmailAddress":"r.a.schoevers@umcg","telephone":"+31503616161","organisation":{"id":317623,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Universitair Medisch Centrum Groningen","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100022118","organisationLocationStatus":"Active"}}],"scientificContacts":[{"id":488918,"type":"Scientific","functionalName":"Prof. Dr. Robert Schoevers","functionalEmailAddress":"r.a.schoevers@umcg","telephone":"+31503616161","organisation":{"id":317623,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Universitair Medisch Centrum Groningen","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100022118","organisationLocationStatus":"Active"}}],"thirdParties":[{"id":760711,"organisationAddress":{"id":531017,"organisation":{"id":563592,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Universitair Medisch Centrum Groningen","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100022118","organisationLocationStatus":"Active"},"address":{"addressId":570969,"oneLine":"Hanzeplein 1","addressLine1":"Hanzeplein 1","addressLine2":"","addressLine3":"","addressLine4":"","city":"Groningen","postcode":"9713 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