Demonstration of superiority of iberdomide plus isatuximab compared to iberdomide with respect to bone marrow minimal residual disease (MRD) negativity rates (sensitivity 2x10^-6 via next-generation flow cytometry [NGF]) after two years of maintenance therapy.

PFS, defined as time from randomization to disease progression or death from any cause, whichever occurs first.

Prior inclusion and treatment within the GMMG-HD8 / DSMM XIX trial Received at least one cycle high dose melphalan therapy (HDM) and autologous stem cell transplantation (ASCT) At least Partial Response (PR) according to IMWG criteria at inclusion in the trial Age of at least 18 years at trial inclusion WHO performance status of 0, 1, or 2 Negative pregnancy test at inclusion (women of childbearing potential) For all men and women of childbearing potential: patients must be willing and capable to use adequate contraception during the complete therapy Ability of patient to understand character and individual consequences of the clinical trial Written informed consent (must be available before enrolment in the trial)

Main exclusion criteria: Subjects with gastrointestinal disease that may significantly alter the absorption of iberdomide Patient has known hypersensitivity (or contraindication) to any of the components of study therapy that are not amenable to premedication with steroids or H1 blockers and that would prohibit further treatment with these agents (e.g. known intolerance or hypersensitivity to infused proteins products, sucrose, histidine, and polysorbate 80 as well as intolerance to arginine and Poloxamer 188) Patients with a history of serious allergic reaction to another immunomodulatory agent (thalidomide, lenalidomide, or pomalidomide)", as angioedema and severe dermatologic reactions, including Grade 4 rash and exfoliative or bullous rash Patients currently being treated with strong inhibitors or inducers of CYP3A4/5 Systemic AL amyloidosis (except for localized AL amyloidosis limited to the skin or the bone marrow), plasma cell leukemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal-protein and skin abnormalities or Waldenström macroglobulinemia. Previous systemic anti-myeloma treatment other than administered within the GMMG-HD8 / DSMM XIX trial (including up to two cycles cycle high dose melphalan therapy (HDM) and autologous stem cell transplantation (ASCT). Local, consolidative radiotherapy for myeloma disease is permitted unless performed in case of progressive disease according to IMWG criteria Severe cardiac dysfunction (NYHA classification III-IV) Significant hepatic dysfunction (ASAT and/or ALAT ≥ 3 times normal level and/or serum bilirubin ≥ 1.5 times normal level if not due to hereditary abnormalities as Gilbert's disease), unless related to MM or HDM/ASCT. Patients with active or uncontrolled hepatitis B or C or detectable liver disease due to hepatitis B or C. In case of history of hepatitis B or C, it must be clarified whether it has been overcome and negative circulating HBV-DNA or HCV-RNA must be provided. Positive hepatitis B status may only be acceptable in absence of circulating HBV-DNA or signs of chronic or acute infection and if an adequate prophylaxis is being implemented during the course of the study. Prophylaxis for patients with history of hepatitis B or C should be set on a patient individual basis.

Prävalenz psychosozialer Faktoren bei Patienten mit / ohne wahrscheinlichen Wachbruxismus

Sekundäre Ziele: • Korrelation zwischen psychosozialen Faktoren und dem Wachbruxismus • Vergleich Patienten mit / ohne wahrscheinlichen Wachbruxismus • geschlechtsspezifische Unterschiede in der Prävalenz des Wachbruxismus und der psychosozialen Faktoren

festsitzende Versorgung und Bezahnung einschließlich des 2. Molaren.

fehlendes Einverständnis des Patienten, sekundärer oder Schlafbruxismus, Verdachtsdiagnose Arthropathie, chronische Schmerzen (GCPS >2), demenziell erkrankte Patienten oder Patienten mit anderen kognitiven Beeinträchtigungen, die nicht in der Lage sind der Studie zuzustimmen, Patienten, die der Teilnahme an der Studie aus anderen Gründen nicht zustimmen

Ausmaß der Erkrankung im Kolon zu bestimmen

FAP mit intaktem Kolon

voroperiertes Kolon bei bek. FAP

Verbesserung der Raten einer kompletten Remission (CR) bei HR ALL-Rezidiv-Patienten

Verbesserung der Raten des ereignisfreien Überlebens (EFS) und des Gesamtüberlebens (OS) Verbesserung der MRD-Reduktion nach Induktion mit versus ohne Bortezomib Evaluation der Toxizität der Induktion mit versus ohne Bortezomib Evaluation der Wirksamkeit der Konsolidierungselemente bezüglich Reduktion der MRD-Last bis zur allo-HSZT

Morphologisch bestätigte Diagnose eines ersten Rezidivs einer B-Vorläufer- oder T-Zell-ALL Kinder unter 18 Jahren zum Zeitpunkt des Einschlusses in die Studie Erfüllung aller HR-Kriterien Einschluss des Patienten in einem teilnehmenden Prüfzentrum Vorliegende schriftliche Einverständniserklärung Beginn der Behandlung während laufender Studie Keine Teilnahme an anderen klinischen Studien, die mit diesem Studienprotokoll interferieren (außer ALL-Ersterkrankungsstudien) innerhalb von 30 Tagen vor Einschluss in die Studie

BCR-ABL/ t(9;22) positive ALL Schwangerschaft oder positiver Schwangerschaftstest (Urinprobe positiv für β-HCG > 10 U/l) Sexuell aktive Jugendliche, die nicht in die Benutzung hocheffektiver Kontrazeption (Pearl Index<1) bis 12 Monate nach Ende der antileukämischen Therapie einwilligen Stillen Rezidiv nach allogener HSZT Neuropathie > II° Ablehnung des gesamten Protokolls oder bedeutsamer Teile durch den Patienten selbst, seine Eltern/Erziehungsberechtigten oder seinen rechtlichen Vormund Keine Einwilligung für Speicherung und Weitergabe von pseudonymisierten medizinischen Daten aus Studiengründen Schwere Begleiterkrankungen, die nach Einschätzung des Prüfarztes keine protokollgemäße Behandlung zulassen (z.B. Fehlbildungssyndrome, kardiale Malformationen, Stoffwechselstörungen) Patienten, die unwillig oder unfähig sind, die Studienprozeduren zu erfüllen Unterbringung in einer Anstalt auf gerichtliche oder behördliche Anordnung

Prospectively register all newly diagnosed patients (children, adolescents, and young adults) with rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma and tumours within a non-interventional study (NIS) with the following aims: Primary objectives:  Collect data on patients obtained within routinely workup and standard treatment given in the participating centres outside clinical trials. Off-label use will not be included into this registry/NIS.  Collect information about incidence of different types of soft tissue tumours as a rare disease  Assess the quality of treatment by the means of data collection and data check provided by the registry and the CWS reference centres.  Prospectively collect information on epidemiologic, diagnostic, molecular, clinical and treatment data of patients with STS and other soft tissue tumours to determine whether a relationship exists between outcomes and specific characteristics  Collect survival data including long-term follow-up, quality of life  Observation of the use of approved or licensed drugs INSIDE the approved indications, population, and/or posology (NO off-label use): - RMS treated with standard regimens (only if not included into the FaR-RMS study). No off-label use1 - NTRK positive NRSTS treated with NTRK inhibitors - ALK positive NRSTS (inflammatory myofibroblastic tumours) treated with ALK inhibitors - NRSTS treated with standard systemic treatment. No off-label use1  If additional drugs are approved for RMS/NRSTS in the near future, they will also be documented in SoTiSaR 2.0-NIS  Create a database for the reassessment of the present therapy stratification system and find new risk factors by the linkage of biological information to long-term outcome

 Provide a basis for innovative clinical phase-I/-II/-III trials being prepared in cooperation with other national and international groups. Their feasibility is depending on the existence of a registry for standardised treated patients with all types and risk groups of soft tissue sarcoma (STS).  Provide a basis for innovative clinical phase-II and -III trials and for allocation of patients into phase I-II trials on targeted therapies  Provide a clinical data basis for an independent sarcoma tumour and tissue repository  Identify sarcoma specific surrogate endpoints  Facilitate the conduct of other clinical and laboratory-based sarcoma research  Serve as an information resource for sarcoma researchers, clinicians and patients  Conduct long-term follow-up to assess late morbidities and quality of life (in cooperation with the late effects groups) and to identify late effects of disease and treatment  Implement high-quality information systems by optimising the linkage between data from the registry, data from the clinical trials conducted by the CWS Study Group and data from biological studies e.g. INFORM.

The primary objective of this trial is to assess potential effects of the administration of Bepanthen® Solution as mouth rinse (dexpanthenol solution) in the intensity of radiation-induced mucositis compared to placebo mouth rinse at Visit 8 (End of IMP treatment)

The secondary objectives of this trial are to assess potential effects of the administration of Bepanthen® Solution as mouth rinse (dexpanthenol solution), on the intensity of radiation-induced mucositis over time during radiotherapy and the Follow up phase (assessed at Visit 2 to Visit 10), on the occurrence of radiation-induced mucositis at all assessment points, on radiation-induced impairment of taste and smell tasting at all assessment points compared to placebo mouth rinse. Further secondary objectives are the evaluations whether the administration of Bepanthen® Solution as mouth rinse (dexpanthenol solution) improve or preserve quality of life (assessed by the trial personnel or from the subject's perspective) compared to placebo mouth rinse at all assessment points. Iluence subjects' contentment with and compliance to radiotherapy and IMP treatment compared to placebo mouth rinse at Visit 8 (End of treatment). Additionally, safety and tolerance of the IMP are evaluated as secondary endpoints during the clinic.

1. Subjects male or female, aged ≥ 18 years 2. The subject has given written consent to participate in the clinical trial. 3. Subjects with a confirmed diagnosis of head and neck cancer and indication for a curative radiother apy. This includes the ICD-10 (International Statistical Classification Of Diseases And Related Health Problems, 10th revision)-Codes: C00 to C14, C32, and C76. Indication-specific inclusion criteria: 4. Subjects with a life expectancy of at least 6 months

1. Subject without legal capacity who is unable to understand the nature, scope, significance and conse quences of this clinical trial, even if the subject has a legally acceptable representative 2. Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the trial results, or may interfere with the subject's participation in this clinical trial 3. Simultaneous participation in another clinical trial, or participation in a clinical trial taking an investiga tional product, up to 30 days prior to participation in that clinical trial. 4. Reported history (within the last 12 months before screening) or persistent abuse of medication, abuse of drugs or alcohol misuse as assessed by the investigator considering participant's safety and adher ence to treatment 5. Known allergy/ incompatibility against Bepanthen® solution or dexpanthenol Indication specific exclusion criteria: 6. Subjects with a pre-irradiation in the neck area 7. Subjects under systemic corticosteroid therapy

• To evaluate the safety and tolerability of T-DXd with rilvegostomig To evaluate the efficacy of T-DXd with rilvegostomig vs SoC in terms of OS in the FAS (HER2 IHC 3++) population

• To evaluate the efficacy of T-DXd with rilvegostomig vs SoC in terms of OS in the ITTFAS population (HER2 IHC 3+/2+) • To evaluate the efficacy of T-DXd monotherapy vs SoC in terms of OS in the FAS (HER2 IHC 3++) population • To evaluate the efficacy of T-DXd monotherapy vs SoC in terms of OS in the ITTFAS population • To further evaluate efficacy of T‑DXd with rilvegostomig vs SoC in terms of PFS in FAS (HER2 IHC 3++) and ITTFAS populations • To further evaluate efficacy of T‑DXd monotherapy vs SoC in terms of PFS in FAS (HER2 IHC 3++) and ITTFAS populations To further evaluate the efficacy of T-DXd with rilvegostomig vs SoC in terms of ORR in the FAS (HER2 IHC 3++) and ITTFAS populations • To further evaluate the efficacy of T-DXd monotherapy vs SoC in terms of ORR in the FAS (HER2 IHC 3++) and ITTFAS populations • To further evaluate efficacy of T‑DXd with rilvegostomig vs SoC in terms of DoR in patients with HER2‑expressing BTC in the FAS (IHC 3++) and ITTFAS populations • To further evaluate efficacy of T‑DXd monotherapy vs SoC in terms of DoR in patients with HER2‑expressing BTC in the FAS (HER2 IHC 3++) and ITTFAS populations • To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of OS, PFS, DoR and ORR in FAS (HER2 IHC 3++) and ITTFAS populations • To assess the safety and tolerability of T‑DXd with rilvegostomig vs SoC • To assess the safety and tolerability of T‑DXd monotherapy vs SoC • To assess the safety and tolerability of T‑DXd with rilvegostomig vs T-DXd monotherapy • To describe patient-reported tolerability of T‑DXd with rilvegostomig in comparison to SoC based on a summary of symptomatic AEs and overall side-effect bother • To describe patient-reported tolerability of T‑DXd monotherapy in comparison to SoC based on a summary of symptomatic AEs and overall side-effect bother • To describe patient-reported tolerability of T‑DXd with rilvegostomig in comparison to T-DXd monotherapy based on a summary of symptomatic AEs and overall side-effect bother • To assess TTD in physical functioning in patients treated with T-DXd with rilvegostomig vs SoC • To assess TTD in physical functioning in patients treated with T-DXd monotherapy vs SoC • To assess TTD in physical functioning in patients treated with T-DXd with rilvegostomig vs T-DXd monotherapy • To assess the PK of T-DXd, total anti-HER2 antibody, DXd and rilvegostomig in serum • To investigate the immunogenicity of T-DXd and of rilvegostomig

Sign and date the written informed consent form prior to any mandatory study specific procedures, sampling, and analyses. 2 Male and female patients must be at least 18 years of age. Other age restrictions may apply as per local regulations. 3 Male and female patients must be ≥ 30 kg. 4 Unresectable, previously untreated, locally advanced or metastatic BTC. Prior treatment in the perioperative and/or adjuvant setting is permissible provided there is > 6 months (180 days) between the end of adjuvant treatment and the diagnosis of locally advanced or metastatic disease. 5 Has histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC: (a) In the safety run-in portion of the study, locally-confirmed HER2 IHC test results (IHC 3+ or IHC 2+) are used for eligibility determination. (b) In the randomized portion of the study, established by prospective central testing of tumor tissue or a histologically confirmed HER2-expressing (IHC 3+) BTC from an existing local result. 6 Patients must provide an FFPE tumor sample that is no older than 3 years for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 status, and other correlatives. The mandatory FFPE tumor sample should be from the most recent biopsy but can be either from the primary tumor or metastatic biopsy. Archival samples taken from a surgical or diagnostic biopsy confirming HER2 status can be accepted. Specimens with limited tumor content and cytology samples are inadequate for defining tumor HER2 or PD-L1 status. Additional details on sample requirements are defined in the Diagnostic Testing Manual and Central Laboratory Manual. Note: This is a requirement for all patients including IHC 3+ patients enrolled via local results. 7 Has at least one target lesion assessed by the Investigator based on RECIST v1.1 Note: This is a requirement for the randomized portion of trial only. 8 Left ventricular ejection fraction ≥ 50% within 28 days before study intervention. 9 WHO/ECOG performance status of 0 or 1. 10 Adequate organ and bone marrow function within 14 days before randomization (Parameters for Adequate Organ and Bone Marrow Function listed in Table 10). Note: Transfusion (red blood cell or platelet) or G-CSF administration is not allowed within 14 days prior to the day on which bone marrow function is assessed, or at any time after this day and prior to C1D1 11 Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner. For women of childbearing potential, a negative result for serum pregnancy test (test must have a sensitivity of at least 25 mIU/mL) must be available at the screening visit and urine beta-human chorionic gonadotropin pregnancy test prior to each administration of investigational product. Women of childbearing potential are defined as those who are not surgically sterile (ie, underwent bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause (Section 5.3). 12 Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, as presented in Table 12, from the time of screening and must agree to continue using such precautions for 7 months after the last dose of IMP. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IMP (Section 5.3). 13 Female patients must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study treatment administration. Preservation of ova may be considered prior to enrollment in this study. 14 Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening for 6 months after the last dose of IMP. It is strongly recommended for the female partners of a male patient to also use at least one highly effective method of contraception, as described in Table 12 (Section 5.3). 15 Patients with HBV infection (as characterized by positive HBsAg and/or anti-HBc with detectable HBV DNA [≥10 IU/mL or above the limit of detection per local laboratory]) must receive antiviral therapy prior to randomization per institutional practice to ensure adequate viral suppression. Patients must remain on antiviral therapy for the study duration and for 6 months after the last dose of study treatment. Patients who test positive for anti-HBc with undetectable HBV DNA (< 10 IU/mL or under the limit of detection per local laboratory) do not require antiviral therapy unless HBV DNA exceeds 10 IU/mL or reaches detectable limits per local laboratory during the course of treatment. Patients with active co-infection of HBV and HCV as evidenced by positive anti-HCV antibody and actively co-infected with HBV and hepatitis D virus are not eligible. 16 Adequate treatment washout period before randomization, defined in Table 11.

Patients are eligible to be included only if none of the exclusion criteria apply: 1 Prior exposure to other HER2 targeting therapies, ADCs, immune checkpoint inhibitors (eg, anti-PD-1/PD-L1 or CTLA-4) and therapeutic anticancer vaccines. 2 Has histologically confirmed ampullary carcinoma. 3 Has a history of substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the Investigator, interfere with the patient's participation in the clinical study or evaluation of the clinical study results. 4 Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Patients with clinically inactive brain metastases may be included in the study. Patients with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study randomization. 5 Patients with a medical history of myocardial infarction within 6 months before randomization/enrollment, symptomatic congestive heart failure (New York Heart Association Class II to IV), unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke. Patients with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before enrollment to rule out myocardial infarction. 6 Serious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease); active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment. 7 Has an active autoimmune, connective tissue or inflammatory disorders (eg, rheumatoid arthritis, Sjogren's, sarcoidosis etc) that has required systemic treatment in the past 2 years (eg, with the use of disease modifying agents, corticosteroids, or immunosuppressive drugs), or where there is documented, or a suspicion of pulmonary involvement at the time of screening. Replacement therapy (eg, thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. Full details of the disorder should be recorded in the eCRF for patients who are included in the study 8 Corrected QT interval (QTcF) prolongation to > 470 msec (females) or > 450 msec (males) based on average of the screening triplicate 12-lead ECG. 9 Criteria related to lung disorders: − History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. − Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion etc). − Prior pneumonectomy (complete). 10 Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. 11 Active primary immunodeficiency, known uncontrolled active HIV infection or HCV. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Subjects should be tested for HIV prior to randomization/enrollment if required by local regulations or institutional review board/ethics committee. 12 Acute hepatitis A. 13 Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan or rilvegostomig. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IMP. 14 Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Note: Patients may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to > Grade 2 for at least 3 months prior to [randomization/enrollment/Cycle 1 Day 1] and managed with Standard-of-Care treatment) that the Investigator deems related to previous anticancer therapy, such as: − Chemotherapy-induced neuropathy − Fatigue − Residual toxicities from prior immune-oncology treatment: Grade 1 or Grade 2 endocrinopathies which may include: o Hypothyroidism/hyperthyroidism o Type 1 diabetes o Hyperglycemia o Adrenal insufficiency o Adrenalitis o Skin hypopigmentation (vitiligo) 15 Known allergy or hypersensitivity to study treatment or any of the study drug and/or any of the excipients. 16 History of severe hypersensitivity reactions to other monoclonal antibodies. 17 Pregnant or breastfeeding female patients, or patients who are planning to become pregnant. 18 History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence, adequately resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin, lentigo maligna that has undergone potentially curative therapy or adequately treated in situ disease without evidence of disease. 19 A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or CART (Drainage and CART are not allowed within 2 weeks prior to randomization).screening assessment). 20 Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs. The following are exceptions to this criterion: − Intranasal, inhaled, topical steroids or local steroid injections (eg, intra-articular injection). − Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent. − Steroids as premedication for hypersensitivity reactions or as an anti-emetic (eg, CT scan premedication). 21 Any concurrent anticancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is allowed. 22 History of allogenic organ transplant

To investigate the survival time (the time from randomization until date of death, tracheostomy or permanent continuous (>22 hours per day) ventilator dependence) compared between control group and experimental group.

Secondary objectives To assess the change of total score of ALS Functional Rating Scale - Revised (ALSFRS-R) and Rasch Overall ALS Disability Scale (ROADS) from baseline, the effect on individual Quality of Life, respiratory function, body mass index and Neurofilament Light Chain (NfL) serum levels. To assess the difference between observed and predicted ALSFRS-R decrease per month using an NfL-based prediction model. To assess the difference between the observed and predicted survival in the NFASSESS score groups. To assess changes of eating habits. To assess safety and tolerability of the study intervention.

Possible, probable (clinically or laboratory supported) or definite ALS according to the revised version of the El Escorial criteria1 - Disease duration (onset of first paresis or bulbar symptoms) < 36 months - Loss of ALS functional rating scale revised (ALSFRS-R) of ≥ 0.33 points/month based on the formula: (48 - ALSFRS-R at Screening Visit) / (Months between Onset and Screening Visit) - Age ≥18 years. - Either continuously treated with a stable dose of riluzole, OR not treated with riluzole for the last 4 weeks prior to inclusion - Either continuously treated with a stable dose of edaravone, OR not treated with edaravone for the last 4 weeks prior to inclusion - Either continuously treated with a stable dose of sodiumphenylbutyrate/ taurursodiol, OR not treated with sodiumphenylbutyrate/ taurursodiol for the last 4 weeks prior to inclusion - Capable of thoroughly understanding all information given - full written informed consent according to good clinical practice (GCP)

Previous participation in another interventional study involving an active treatment within the preceding 4 weeks - Tracheostomy or continuous permanent ventilator dependence (>22 hours per day) - Pregnancy or breastfeeding - Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS - Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment. - Evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms. - Liable to be not cooperative or comply with study requirements as assessed by the investigator, or unable to be reached in the case of emergency

Subjektive Erfassung paroxysmaler Episoden

Objektiv messbare Parameter paroxysmaler Episoden (Video, EEG, EKG, Elektrodermale Aktivität) Fragebögen und Klinische Interviews (Verknüpfung mit separater Untersuchung) Molekularbiologische Parameter (Verknüpfung mit separater Untersuchung)

Geschlecht: Alle Mindestalter: 18 Jahre Höchstalter: 65 Jahre Weitere Einschlusskriterien: Patienten mit dissoziativen und funktionellen Störungen: Volljährige Patienten bis einschließlich 65 Jahren mit Diagnosen aus dem Bereich der affektiven Störungen (ICD-10 F30-F39), der neurotischen, Belastungs- und somatoformen Störungen (ICD-10 F40-F48), der Persönlichkeits- und Verhaltensstörungen (ICD-10 F60-F69) und/oder der Verhaltens- und emotionalen Störungen mit Beginn in der Kindheit und Jugend (ICD-10 F90-F98). Patienten mit neurologischen Erkrankungen: Volljährige Patienten bis einschließlich 65 Jahren mit Diagnosen aus den Bereichen entzündlicher Krankheiten des Zentralnervensystems (ICD-10 G00-G09), extrapyramidaler Krankheiten und Bewegungsstörungen (ICD-10 G20-G26), episodischer und paroxysmaler Krankheiten des Zentralnervensystems (ICD-10 G40-G47) und/oder mit Symptomen, die das Nervensystem und das Muskel-Skelett-System betreffen (ICD-10 R25-R29). Patienten mit synkopalen Anfällen: Volljährige Patienten bis einschließlich 65 Jahren mit den Diagnosen Synkope und Kollaps (ICD-10 R55) und/oder sonstige und nicht näher bezeichnete Krämpfe (ICD-10 R56.8). Durchführung einer medizinisch indizierten Video-EEG- Untersuchung. Verfügbarkeit eines Smartphones.

Jünger als 18 oder älter als 65 Jahre, fehlende Einwilligungsfähigkeit, akute Suizidalität, stattgehabte Hirnoperation (Ausnahmen: Implantation von Tiefenelektroden, epilepsiechirurgische Eingriffe). Bestimmte infektiöse und parasitäre Krankheiten (ICD-10 A00-B99), bösartige Tumorerkrankungen (ICD-10 C00-C97), organische psychische Störungen (ICD-10 F00-F09), schwerwiegende Psychische und Verhaltensstörungen durch psychotrope Substanzen (aus ICD-10 F10-F19), Schizophrenie, schizotypie und wahnhafte Störungen (ICD-10 F20-F29), Intelligenzstörungen (ICD-10 F70-F79), schwere Entwicklungsstörungen (aus ICD-10 F80-F89), Systematrophien, die vorwiegend das Zentralnervensystem betreffen (ICD-10 G10-G14), Sonstige degenerative Erkrankungen des Nervensystems (ICD-10 G30-G32), zerebrovaskuläre Krankheiten (ICD-10 I60-I69), Schwangerschaft, Geburt und Wochenbett (ICD-10 ICD-10 O00-O99).