Braunschschweig, Germany
A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.
The population under study comprises a real-world patient population with difficult to treat depression: patients diagnosed with unipolar or bipolar disorder with chronic or recurrent depression who fail to achieve an adequate response to standard psychiatric management. The diagnosis of depression and comorbid disorders will be determined based on the Mini International Neuropsychiatric Interview (MINI). A minimum of five hundred (500) patients will be implanted with a VNS Therapy System and up to eighty (80) sites may participate in this study. Enrollment will take 8 years, based on competitive enrollment. For each subject a baseline visit will occur between 1 and 6 weeks before implant. Once implanted with the device, subjects will be followed-up for a minimum of 36 months and a maximum of 60 months. The study may stop when the last subject has reached the 36 months follow-up.
Phase
N/ASpan
573 weeksSponsor
LivaNovaWilhelmshaven
Recruiting
Therapy Optimisation for the Treatment of Hairy Cell Leukemia
Evaluation of remission status will take place 4 months after treatment. In addition, it will be tested whether patients with non-optimal response will have a benefit from a second cycle of cladribine. Non-optimal response is: patients with detectable residual disease; achievement of partial remission or detectable residual infiltration in the bone marrow.
Phase
2/3Span
1235 weeksSponsor
University of GiessenWilhelmshaven
Recruiting
A Non-interventional, Prospective Study With Benralizumab
This is a prospective observational study to investigate the asthma control and health realted quality of life (HRQL) of benralizumab treated patients in routine clinical practice, their asthma medication intake, and their changes in asthma medication during the study, up to 52 weeks. The asthma control will be analyzed by using the Asthma Control Test (ACT) and the Asthma Impairment and Risk Questionnaire (AIRQ®) at different timepoints during the study period either collected by the investigator or self-reported by the patient. In addition, health realted quality of life will be assessed at baseline and routine follow-up visits using the mini Asthma Quality of Life Questionnaire (miniAQLQ) which is collected by the investigator. To investigate the medication intake and assess the changes in asthma medication, the patients will record their weekly medication intake in a paper-based or an electronic medication diary throughout the study.
Phase
N/ASpan
127 weeksSponsor
AstraZenecaWilhelmshaven
Recruiting
Wilhelmshaven
Recruiting
PROCARE - PROstate Cancer Real World Evidence Registry
This prospective real-world data and long-term follow-up registry study aims at documenting routine treatment and course of disease of patients with metastatic prostate cancer and patients with biochemical recurrence after local treatment. This may include the following patient cohorts: Cohort 1: biochemical recurrence after local curative intended treatment (e.g. radical prostatectomy, radiotherapy of the prostate or combination thereof) Cohort 2: non-metastatic castration-resistant prostate cancer Cohort 3: metastatic hormone-sensitive prostate cancer Cohort 4: metastatic castration-resistant prostate cancer These cohorts will be recruited independently at various time frames. No specific study treatment is defined. All treatments are prescribed and performed according to each center's medical practice. Any treatment choice or change in regimen is performed at the discretion of each treating physician. During the routine visits, routine data on the course of the disease and therapy are documented for all cohorts at certain time points (after inclusion, then every 3 or 6 months and when changing therapy), standardized quality of life questionnaires (FACT-P and EQ-5D-5L) and biomaterial is collected.
Phase
N/ASpan
466 weeksSponsor
UroTrials Company (GmbH)Wilhelmshaven, Lower Saxony
Recruiting