Clinical trials

The aim of this observational study is to test the IntelliLung decision support system based on artificial intelligence. This system is intended to help to set the ventilator. The study includes patients with and without ARDS (acute respiratory distress syndrome) who are receiving invasive mechanical ventilation, as well as patients with additional extracorporeal lung support. The study will be conducted in several centers. The main question of the study: How well do the mechanical ventilation settings of healthcare staff match the recommendations of the IntelliLung system?

The aim is rapid collection of real-life data on the epidemiology, treatment and disease course in patients with VEXAS syndrome during routine clinical practice and collect biomaterials to evaluate genotype-phenotype associations, determine optimal treatment schedule, identify diagnostic features and biomarkers

This phase II clinical trial evaluates the efficacy, safety and tolerability of Obrixtamig in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.

A registry for the study of the epidemiology, clinical course, and progression of myelodysplastic neoplasms (MDS), myelodysplastic/myeloproliferative neoplasms (MDS/MPN overlap syndromes), and their precursor syndromes (CHIP, CCUS)

Invasive mechanical ventilation is one of the most important and life-saving therapies in the intensive care unit (ICU). In most severe cases, extracorporeal lung support is initiated when mechanical ventilation is insufficient. However, mechanical ventilation is recognised as potentially harmful, because inappropriate mechanical ventilation settings in ICU patients are associated with organ damage, contributing to disease burden. Studies revealed that mechanical ventilation is often not provided adequately despite clear evidence and guidelines. Variables at the ventilator and extracorporeal lung support device can be set automatically using optimization functions and clinical recommendations, but the handling of experts may still deviate from those settings depending upon the clinical characteristics of individual patients. Artificial intelligence can be used to learn from those deviations as well as the patient's condition in an attempt to improve the combination of settings and accomplish lung support with reduced risk of damage.

This is a registry study in adult patients with newly diagnosed or refractory/relapsed acute myeloid leukemia. Investigator's sites: 60 sites in Germany. Primary objectives: * Identification of epidemiological data on AML: age, prognostic factors and subgroup distributions. Incidence and age distribution are compared with the data of population-related tumor registry. * Evaluation of the most important patient-relevant clinical endpoints (outcomes): relapse-free survival (RFS) / time to relapse (TTR), calculation of cumulative incidence of relapse (CIR) and overall survival (OS) * Documentation of treatment strategy

The aim of the planned study is the development of surgical assistance functions on the basis of clinical routine data and the evaluation of the technical feasibility of an intraoperative demonstration and visualization of such assistance functions in visceral surgery. Furthermore, this trial aims to provide preliminary data on the clinical outcome of such assistance systems.

Recent evidence suggests that postoperative hyperamylasemia (POH) is a predictor of morbidity after pancreatectomy. This is based on the assumption that pancreatitis after pancreatectomy (PPAP) is a major trigger for the development of complications and is indicated by hyperamylasemia. Standardized prospective analysis and correlation with other laboratory parameters, hasn't been performed to date. Therefore the overall study aims are: * To prospectively evaluate the incidence and assess the clinical value of biochemical changes for the postoperative course. * To confirm and improve the definition and classification of postpancreatectomy acute pancreatitis (PPAP) of the International Study Group of Pancreatic Surgery (ISGPS) and to provide knowledge for effective early management of complications.

The aim of the study is to evaluate the technical feasibility and applicability of a surgical assistance system based on image recognition algorithms in a first-in-human pilot study. In addition, this study will provide preliminary data on the oncological outcome of the assistance system.

The primary objective of this clinical trial is to evaluate whether primary total pancreatectomy with simultaneous islet autotransplantation compared with pancreatic head resection (alone) can reduce perioperative morbidity and time to initiation of adjuvant therapy in patients with a high-risk constellation for pancreatic fistulas.

The study PROSa+ aims to assess patient-reported outcomes (PROs), patient-reported experiences (PREs), and the socioeconomic situation of long-term sarcoma survivors (≥ 5 years post-diagnosis, with or without active disease) in Germany. The mixed-methods research design includes a multicenter observational study with a cross-sectional questionnaire survey involving 1,600 participants (paper, online), qualitative interviews with up to 60 participants, and longitudinal analyses combining data from existing sarcoma registries and the previous PROSa study conducted between 2017 and 2020.

In patients with squamous cell carcinoma of the oral cavity, the oropharynx and larynx with local advanced tumors (pathologic stage T3 = pT3) and or lymph node involvement (pN+) postoperative radio - or radiochemotherapy is the standard of care. Postoperative radiochemotherapy is indicated in patients with multiple lymph node metastasis, lymph node metastasis with extracapsular spread and / or residual tumor (R1-Status) after resection. Oropharyngeal cancer caused by HPV (human papillomavirus 16) is a distinct subgroup with a known sensitivity to radiotherapy (RTx) or radiochemotherapy (RCTx). Additionally a superior outcome after R(C)Tx over HPV negative patients was shown for patients treated with primary or adjuvant RCTx. To date it is unknown if the total dose of the radiotherapy can be safely reduced with the aim to decrease the therapy associated late effects. Patients with a HPV associated carcinoma that take part in the study will be treated with a reduced radiotherapy dose, chemotherapy will be prescribed based on clinical factors (number of affected lymph node, presence of extracapsular spread or residual tumor). Radiation dose will be reduced in two steps.

The aim of this study is to compare the effectiveness and tolerability of two conditioning chemotherapies prior to allogeneic stem cell transplantation. The following will also be investigated: * Survival * Remission and Relapse rate * Engraftment or graft failure * Graft versus Host Disease (GvHD)

This phase I/II clinical trial evaluates the safety and efficacy of the combined administration of midostaurin and gemtuzumab ozogamicin in the frame of first-line standard chemotherapy in newly diagnosed acute myeloid leukemia (AML) patients displaying a cytogenetic aberration or fusion transcript in the core-binding factor (CBF) genes or FMS-like tyrosine Kinase 3 (FLT3) mutation.

The goal of this observational study is to better understand how the immune system and certain tumor markers are linked to treatment response in patients with advanced non-small cell lung cancer (NSCLC) who receive immunochemotherapy. The investigators aim to answer the following questions: * Can the investigators successfully analyze immune markers and gene activity from small tumor samples (biopsies)? * Are these markers connected to how well patients respond to immunochemotherapy and how their disease progresses? What will participants do? * Provide tumor tissue samples (biopsies) at key points: before treatment, about 6 weeks after starting immunochemotherapy, and if the cancer grows or treatment changes. * Allow their tumor samples to be analyzed in the lab using advanced techniques to measure immune and genetic markers. * Share clinical information (such as treatment response and disease progression) so investigators can study how it relates to these markers. This study does not test a new drug or treatment.

The purpose of this phase I study is to determine whether MDC-CAR-BCMA001 (BCMA directed CAR T-cells) is safe and tolerable in the treatment of relapsed and refractory B-cell malignancies

In view of the manifold options for mono- and combination therapy that have now emerged for patients with pulmonary (arterial) hypertension (PH/PAH), controlled clinical trials can only provide part of the information needed for optimal management. In order to gather adequate data on PAH/PH treatment in routine clinical care, the ongoing COMPERA registry prospectively documents consecutive patients with newly initiated treatment of PAH/PAH since May 2007. The internet-based registry fulfills high quality standards through several measures (planned minimum centre contribution of at least 10 patients per year, automated plausibility checks of data at entry, queries, monitoring with source data verification in \>50% of participating centers). It can be applied, among further purposes, for quality assurance: individual centers can confidentially compare their results with the combined outcome of other centers and the recommendations from guidelines. It is expected that the register contributes to optimization of specific drug therapy for PAH and PH. Since July 2013, also children of any age can be documented (COMPERA-KIDS).

The goal is the replication of the primary outcome (EASI 75 at week 16) of the Heads Up trial (Blauvelt, A, Teixeira, H, Simpson, E et al (2021) doi:10.1001/jamadermatol.2021.3023) and the evaluation of the patient reported outcomes (POEM, DLQI and RECAP) in a head-to-head comparison of upadacitinib versus dupilumab treatment in moderate-to-severe atopic dermatitis (AD).

This study is an evaluation of the flexible and integrative psychiatric care model (according to § 64b of the German Social Code Book V (SGB V)) (FIT) at the Pfalzklinikum. The central concern of this evaluation is to answer the question whether the FIT model offer advantages over standard care. The orientation of model care is a more cross-sectoral provision of services through more flexible treatment intensities.

The goal of this clinical trial is to test the performance of neuronal networks trained on ultrasonic raw Data (=radiofrequency data) for the assessment of liver diseases in patients undergoing a clinical ultrasound examination. The general feasibility is currently evaluated in a retrospective cohort. The main questions the study aims to answer are: * Can a neuronal network trained on RF Data perform equally good as elastography in the assessment of diffuse liver diseases? * Can a neuronal network trained on RF Data perform better than a neuronal network trained on b-mode images in the assessment of diffuse liver diseases? * Can a neuronal network trained on RF Data distinguish focal pathologies in the liver from healthy tissue? To answer these questions participants with a clinically indicated fibroscan will undergo: * a clinical elastography in Case ob suspected diffuse liver disease * a reliable ground truth (if normal ultrasound is not sufficient e.g. contrast enhanced ultrasound, biopsy, MRI or CT) in case of focal liver diseases, depending on the standard routine of the participating center * a clinical ultrasound examination during which b-mode images and the corresponding RF-Data sets are captured

maintenance of AML or MDS patients with known IDH1 mutation after allogeneic stem cell transplantation within past 100 days

Explore the best tolerable and efficacious dose of Gilteritinib when combined with standard treatment with Venetoclax and Azacitidine in AML patients with FLT3 mutations which are ineligible for intensive chemotherapy

Patients with gastric or colon cancer with peritoneal carcinomatosis will receive a biopsy of the tumor during their primary curative surgery. The operation is performed according to standard and includes resection of the primary tumor and any metastases and followed by HIPEC (Intraperitoneal hyperthermic chemoperfusion) according to the respective hospital standard. Organoid cultures from the biopsies are established in the research laboratory. Various chemotherapeutic agents are tested on these tumor organoids in the laboratory and the tumor organoids are analyzed in detail with regard to genetic alterations in order to find alterations that can be addressed, if necessary, by means of targeted drugs against peritoneal carcinomatosis.

Late side effects in radio(chemo)therapy \[R(CH)T\] pose a critical limitation to patients' overall survival and quality of life. Even though toxicities of the heart are highly relevant for patients with cancer in the thoracic region, risk stratification models for these toxicities are lacking. In this study, liquid, functional and imaging biomarkers are being investigated for their use in prediction of cardiac toxicity following R(CH)T for patients with thoracic malignancies.

Brain tumors are the second most frequent malignant diseases in children and adolescents. In the study the short and medium term consequences of proton therapy on cognitive processes in particular on executive functions in pediatric patients shall be highlighted/analysed/evalutated. In a second step, these results are to be compared with 1. a group of children and adolescents who had only /exclusively had operative therapy and 2. with a healthy control group. Thus, the extent to which these treatment options differ in terms of their short and medium-term effect is assessed. Methods of neurocognitive/neurophysiology brain research approaches are applied that may potentially visualize even small / subtle changes in mental activities/neurocognitive function. Therefore the effects of treatment can be evaluated and the neuropsychological outcome of children and adolescents with brain tumors can be improved.