Rijmenam, Belgium
The Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block in Patients Undergoing Primary Total Hip Arthoplasty:
Phase
N/ASpan
56 weeksSponsor
Diakonie-Klinikum StuttgartStuttgart, Baden-Württemberg
Recruiting
A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis
Prospective, primary data will be collected from patients with sNfL outcomes in the context of switching to ofatumumab or continuing their current therapy. Data collection will cover a maximum period of 24 months. The observational period will not be dictated by the protocol. Baseline and follow-up visits will take place at a frequency defined as per Investigator´s discretion following clinical routine. The diagnostic or monitoring procedures are only those ordinarily applied to therapeutic strategy and routine clinical care. During the observation phase of the study, data will be collected according to standard of care as recommended by KKNMS (Competence Network Multiple Sclerosis in Germany). Eligible participants for the study are patients who have received treatment with category 1 DMTs and those who have included sNfL into their treatment decision-making process. These patients have the option to either continue their current DMT or switch to ofatumumab. According to local treatment guidelines, DMT category 1 include dimethylfumarate/diroximelfumarate, glatirameroids, Interferon beta and teriflunomide. The decision to switch to ofatumumab or to continue the current DMT category 1 therapy must be made by the treating physician independently of the decision to enroll the patient in the study.
Phase
N/ASpan
152 weeksSponsor
Novartis PharmaceuticalsStuttgart
Recruiting
Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML
Phase
3Span
328 weeksSponsor
Stichting Hemato-Oncologie voor Volwassenen NederlandStuttgart
Recruiting
Comparative Analysis of Postprandial Effects in Healthy and Obese Individuals
Phase
N/ASpan
51 weeksSponsor
University of HohenheimStuttgart, Baden-Württemberg
Recruiting
Healthy Volunteers
Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia
Phase
2Span
202 weeksSponsor
Goethe UniversityStuttgart
Recruiting
The Effect of Mediterranean Diet and Mindfulness Eating on Depression Severity in People With Obesity and Major Depressive Disorder
Depression and obesity are highly prevalent diseases that are strongly correlated. There is a growing gap in care and treatment options for those affected. The effectiveness of a Mediterranean Diet on mental health has already been shown in various studies. Additionally to physiological effects of nutrient intake, also the psychological factor of changing the way of eating seem to play a role. The present study investigates the effect of a Mediterranean Diet and Mindful Eating on depression severity in people with obesity and clinically diagnosed major depressive disorder. The factorial design allows to investigate potential synergistic effects of the interventions. Participants will be randomized to one of the four intervention groups (mediterranean diet, mindful eating, their combination and a befriending control group). The intervention consists of a 12-week period, where five individual nutrition consueling meetings will take place, followed by a 12-week follow up. The primary outcome is depression severity. Secondary outcomes and analyzes include quality of life, self-efficacy, mediterranean diet and mindfulness eating scores, anthropometric measurements, as well as mediator and moderator analysis, a microbiome analysis, a qualitative evaluation and an economic analysis.
Phase
N/ASpan
43 weeksSponsor
University Hospital TuebingenStuttgart
Recruiting
Healthy Volunteers
SCAD : a Registry of Spontaneous Coronary Artery Dissection
Observational, multicentre, international retrospective and prospective cohort study. Since this is an observational study, a formal sample size is not necessary. At least 500 prospectively recruited patients and 500 historical cases will be enrolled. Patient data will be collected at the following time-points: - First SCAD event visit (retrospectively on chart review) - First follow-up: at time of enrolment - Yearly follow-up: up to 1, 2, 3, 4 and 5 years post enrolment or until study completion Approximately 30 countries and 120 sites will participate in this registry.
Phase
N/ASpan
353 weeksSponsor
European Society of CardiologyStuttgart
Recruiting
TRIcvalve BiCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)
This is a prospective multicenter clinical investigation designed to evaluate the safety and effectiveness of the TricValve® Transcatheter Bicaval Valve System for improving outcomes in symptomatic subjects with severe TR deemed by the local Heart Team to be at high risk for tricuspid valve surgery. Patients who meet all of the study inclusion criteria, will be treated with the TricValve System. After the intervention, patients will be followed up closely for 12 months. Long term safety and efficacy data will be collected annually up to 5 years.
Phase
N/ASpan
271 weeksSponsor
P+F Products + Features USA Inc.Stuttgart
Recruiting
A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease.
During the screening period study eligibility will be assessed and the participants' individual LDL-C target according to guideline (Mach et al., 2020) will be determined. Among other criteria, at screening, a participant must be on a stable maximally tolerated dose of a HI statin with either atorvastatin ≥40 mg once a day (QD) or rosuvastatin ≥20 mg QD (+/- Ezetimibe [10mg]) for ≥ 4 weeks with which, however, a target LDL-C of < 70 mg/dL is not reached. During the open-label treatment period, all participants, who fulfill the inclusion/exclusion criteria, will be randomized at V1 (Day 1) in a 1:1 open-label fashion to either Inclisiran sodium 300 mg s.c. (administered at Day 1 and Day 90) or to BPA tablets 180 mg p.o. (given once daily). Participants will be required to maintain their background lipid-lowering treatment (maximally tolerated statin dose +/- Ezetimibe) unchanged for the duration of the study. The end of treatment (EOT) is reached at day 150. A Safety-Follow-up call will be conducted 30 days after EOT visit (Day 180). The overall study duration is approximately 190 days but can vary depending on individual screening and the visit windows allowed for the treatment period and EOS visit.
Phase
4Span
67 weeksSponsor
Novartis PharmaceuticalsStuttgart
Recruiting
Pasireotide as Maintenance Treatment in Synovial Sarcoma and Desmoplastic Small Round Cell Tumor
Desmoplastic small round cell tumor (DSRCT) is an extremely rare, aggressive sarcoma. It originates from the serosal surface of the abdominal cavity and the hallmark characteristic of DSRCT is the EWSR1-WT1 gene fusion. Synovial sarcoma (SySa) is also a rare fusion-gene driven (SS18-SSX1, SS18-SSX2, or rarely, SS18-SSX4) soft-tissue sarcoma. Selected somatostatin receptor (SSTR) family members, i.e., SSTR2, SSTR3 and SSTR5, were highly expressed in patients with available transcriptome data, providing the basis for treatment with a somatostatin analog such as pasireotide with high affinity for SSTR1, 2, 3, and 5. The primary aim of the study is to assess the clinical efficacy of pasireotide maintenance therapy for prolonging progression-free (PFS) and overall survival (OS) in patients with SSTR2/3/5-expressing advanced SySa and DSRCT. Furthermore measurable residual disease (MRD) before, during, and after pasireotide maintenance therapy are assessed. Pasireotide is applied in adults with 60 mg and in adolescents 60 mg (body surface area [BSA] >1.6 m²) or 40 mg (BSA 1.1-1.6 m²) via intragluteal via intragluteal depot injection every 28±3 days. The sample size is planned for the entire study population with subsequent sensitivity analysis in two subgroups, i.e., adolescents and adults. The primary efficacy analysis is be based on a two-sided, one-sample log-rank test using a significance level of 5%. The sample size was calculated assuming exponential data, planning for a power of 90% to detect a hazard ratio of 0.5. With a sample size of n=28, the expected number of events during the study is 22. Safety is assessed continuously according to CTCAE v5.0. The recruitment period is planned for 2 years starting in 2024 followed by a minimal follow-up of the last patient of 6 months leading to estimated trial completion in 2027.
Phase
2Span
202 weeksSponsor
University Hospital HeidelbergStuttgart, Baden-Württemberg
Recruiting