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  • Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study

    Phase

    N/A

    Span

    169 weeks

    Sponsor

    iOMEDICO AG

    Bad Mergentheim

    Recruiting

  • MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes (MyREMEDY)

    Rationale: Type 1 diabetes is a disease that asks constant attention, self-care activities and responsibility from the diagnosed person for the duration of their entire life. Because of this constant burden, many people with type 1 diabetes experience mental health problems such as fatigue, excessive worrying about their blood glucose (especially about dangerously low blood glucose), or eating problems. However, most people with type 1 diabetes who experience such symptoms do not receive professional help. This can have multiple reasons. Oftentimes, the problems are not severe enough to be classified as a disorder. Some people also prefer to work on the problems on their own, at their own pace. For people who experience mental health problems around their diabetes and to support them individually with as little barriers as possible, MyDiaMate was developed. Objective: To investigate the effectiveness of MyDiaMate in reducing mental health problems in adults with type 1 diabetes who experience distress related to their disease across four countries (NL, DE, UK, ES). Study design and procedure: Multi-national randomised-controlled trial (intervention : wait-list control group, randomised 2:1 per country). After screening has confirmed study participation, participants will: 1. Complete the baseline assessment and be randomisation afterwards 2. Use MyDiaMate for 3 months in case of intervention group membership, or get care as usual in case of waitlist control group membership 3. At 3 months, all participants fill in the first follow-up assessment. Additionally, intervention group members will be asked about their satisfaction with and opinion on MyDiaMate (questionnaire and interviews). 4. All participants then receive access to MyDiaMate for the remaining 3 months of the study. 5. At 6 months, all participants complete the second follow-up assessment. Afterwards, the study ends for all participants and access to MyDiaMate is revoked. Study population: Adults with type 1 diabetes who have been diagnosed more than 6 months ago and who experience distress in relation to their type 1 diabetes. Intervention: The intervention group receives access to the online self-help programme MyDiaMate for 6 months. MyDiaMate is focused on mental health in type 1 diabetes. It includes psychoeducation and teaches coping strategies that are based on cognitive-behavioural therapy concepts. Moreover, videos in which people with type 1 diabetes talk about their experiences in coping with the disease are embedded in MyDiaMate. MyDiaMate users can also choose to make use of diaries and a module that helps with setting realistic goals. MyDiaMate can be accessed via a private mobile phone, tablet, or laptop/computer whenever wished. Because MyDiaMate is self-help, there is no schedule in when/how much participants should access MyDiaMate. Participants can make use of MyDiaMate as much as they want to, in a way that suits them best personally. Members in the waitlist control group receive access to MyDiaMate after 3 months, for 3 months, if so wished. They too can make use of MyDiaMate in a way that fits their personal time and needs best. Main study parameters/endpoints: The main study outcome is change in diabetes distress in the intervention group between the baseline and the 3 months assessment. Secondary study outcomes are changes in emotional well-being, psychological self-efficacy in relation to diabetes, social engagement, and fatigue between the baseline and the 3 months assessment in participants from the intervention group. Moreover, in line with the secondary objective, the investigators will make use of MyDiaMate log data such as time spent in MyDiaMate and frequency of use in participants of the intervention group across the first 3 months and investigate in relation to the main and secondary outcomes as well as descriptive data such as age or gender, for which subgroup of MyDiaMate users the application programme is most effective. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no risks related to use of MyDiaMate. The burden of study participation is low, as participants are not instructed to use MyDiaMate in a certain way/intensity and filling in the non-invasive study questionnaires takes around 2 hr in total and is spread across 6 months. Both the intervention and control group have access to MyDiaMate during study participation (for 6 months in case of intervention group membership, for 3 months after 3 months in case of wait-list control group membership). Study participants benefit from study participation because they receive access to MyDiaMate, which may possibly help them with improving the diabetes-related mental health and teaches a variety of type 1 diabetes specific coping strategies, all of which is based on well-researched concepts of psychoeducation and cognitive behavioural therapy.

    Phase

    N/A

    Span

    70 weeks

    Sponsor

    Maartje de Wit

    Bad Mergentheim, Baden-Württemberg

    Recruiting

  • Precision Mental Health in Diabetes - Subtypes of Mental Health, Trajectories, and Patterns With Glycaemic Control

    Comorbid mental disorders as well as mental symptoms are common in people with type 1 diabetes (T1D) and type 2 diabetes (T2D). Depression, anxiety, and eating problems are particularly prevalent, and diabetes-related distress may contribute to or interact with mental disorders. Furthermore, while the management of diabetes aims to achieve near-normal glucose levels to prevent health decline and complications, glycemic outcomes may be impaired in people with significant mental comorbidity. The objective of the PRO-MENTAL study is to use precision monitoring to identify evidence-based subgroups of people with diabetes with regard to mental disorders/problems and glycemic outcomes, to determine typical patterns and derive patient trajectories for informing a precision medicine approach offering personalized interventions for people with T1D and T2D. Precision monitoring uses continuous glucose monitoring (CGM) and ecological momentary assessment (EMA) methods as well as patient-reported outcomes (PRO) according to self-report scales and interviews. Another aim is to answer epidemiological questions regarding depressive, anxiety and eating disorders in people with T1D and T2D (including assessment of bipolar disorders for differential diagnosis). In addition to clinical disorders, subclinical (=elevated) mental symptoms (e.g., depressive symptoms) and diabetes-related distress will be investigated as adverse factors in diabetes. The findings of the study will serve as the basis for developing a precision medicine approach with personalized interventions for specific subgroups of people with T1D and T2D and mental comorbidity. The primary research question refers to prospective associations of psychological disturbances/problems, especially depressive symptoms, anxiety symptoms, diabetes distress, and eating disorder symptoms, with self-management/health behaviors and glycemic outcomes. Using diagnostic interviews assessing affective, anxiety, and eating disorders and the collection of behavioral, somatic and psychological variables using questionnaires and surveys, subgroups and trajectories will be identified. In longitudinal analyses, the prognostic and moderating contribution of these parameters to the prediction of glycemic and mental health outcomes will be investigated. Secondary objectives of the study are to identify predictors and/or moderators that may explain the incidence and persistence as well as associations between the above mental health variables and diabetes outcomes. For this purpose, measures of health-related quality of life, well-being, sleep quality, hypoglycemic anxiety, fear of sequelae, problems of diabetes treatment, diabetes acceptance, stressful life events, alcohol misuse, social support, COVID-19-related burden, and psychological resilience are also collected.

    Phase

    N/A

    Span

    87 weeks

    Sponsor

    Forschungsinstitut der Diabetes Akademie Mergentheim

    Bad Mergentheim, Baden-Württemberg

    Recruiting

  • A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight

    Phase

    3

    Span

    110 weeks

    Sponsor

    Eli Lilly and Company

    Bad Mergentheim, Baden-Württemberg

    Recruiting

  • Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

    Phase

    3

    Span

    110 weeks

    Sponsor

    Amgen

    Bad Mergentheim

    Recruiting

  • A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence

    This non-interventional study aims to provide information on real-world effectiveness, safety and tolerability, management of adverse events, QoL and patient compliance of patients with HR+/HER2- early breast cancer at high risk of recurrence treated with ribociclib in combination with an non-steroidal aromatase inhibitor (NSAI) ± luteinizing hormone-releasing hormone (LHRH) with curative intent according to the German summary of product characteristics. In order to put the results of patients treated with ribociclib into perspective, socio-economic data, data on QoL and patient compliance will also be collected from patients treated with abemaciclib + endocrine therapy (ET) ± LHRH as described in the respective local summary of product characteristics. To understand reasons for treatment decision, and to analyze the clinical adoption of ribociclib + NSAI ± LHRH after EU approval over time, baseline data will be collected from cohorts of ribociclib + NSAI ± LHRH, abemaciclib + ET ± LHRH, and additionally from patients treated with ET monotherapy ± LHRH and analyzed cross-sectionally. The study is planned to be rolled out into a broad set of German and optionally Austrian and Swiss breast centers and gynecological practices to describe clinical routine in a representative subset of the local healthcare eco-system. It will gather insights into the potential benefits and risks associated with ribociclib + NSAI ± LHRH in the adjuvant treatment of HR+/HER2- eBC patients at high risk of recurrence. This knowledge will inform about clinical decision-making and contribute to improved patient outcomes in routine practice.

    Phase

    N/A

    Span

    276 weeks

    Sponsor

    Novartis Pharmaceuticals

    Bad Mergentheim

    Recruiting

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