There are about 25560 clinical studies being (or have been) conducted in Germany. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).
Prospective randomized evaluation of adaptive radiotherapy in the definitive radiotherapy of locally advanced gynecologic carcinoma (e.g. cervical carcinoma, endometrial carcinoma, vaginal carcinoma), in the postoperative situation or first series of external beam radiotherapy and in patients in whom radical surgery or HDR brachytherapy as dose boost is not an option.
This is a retrospective, observational, single-arm, multi-centre, post-market clinical investigation designed to verify clinical performance and safety of Episealer Talus post-operation for treatment of focal osteochondral defects on the talus bone in the ankle. This retrospective investigation aims to collect data from patients with focal osteochondral defects treated with Episealer Talus, to provide insight on the potential benefit of Episealer Talus in the treatment of focal osteochondral defects. The aim for the clinical investigation is to collect data from approximately 25 adult subjects who were treated for focal osteochondral defect with Episealer Talus implant in 6 clinics (Sweden and Germany) since January 2020, when the devices were CE-marked. The data collected for each subject will include demographics and data generated in relation to the surgery itself and the post-surgery phases including e.g. focal defect grade and position, collected through medical record review. Each subject will also be asked to complete a set of QoL questionnaires (SEFAS, FAOS and VAS).
One goal of the investigators of the Department of Anesthesiology and Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin is a continuous improvement in the quality of care to the patients. One focus is the freezing preoperatively during surgery, and on the follow-up study to assess the perceived waiting times in the anesthesiology outpatient clinic. The project aims to quality assurance and quality improvement of the CharitéCentrum for Anesthesiology and Intensive Care Medicine 007, Charité - Universitätsmedizin Berlin .
This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device collection will hereafter be referred to as the Volt™ PFA system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.
Open-label, single-arm, prospective multicenter phase II clinical trial to determine the efficacy of immunotherapy with durvalumab concomitant with radiochemotherapy, followed by durvalumab maintenance therapy in combination with stereotactic radiotherapy in extensive stage SCLC
For almost 60 years, millions of women globally have relied on oral contraceptive (OC) pills for pregnancy prevention and addressing menstrual irregularities. However, 4-10% of users experience mood-related side effects such as depression and anxiety, often leading to discontinuation of OC use. Previous studies also indicate that OC usage may lead to chronic alterations in brain structure and the regulation of the hypothalamic-pituitary-adrenal axis, a system involved in regulating stress responses. In the proposed study the investigators aim to investigate in more detail how women who start taking oral contraception (OC) and women who stop taking OC differ in their stress reactivity and their mood from long-term OC users. Furthermore, assessing hormones will help to shed light on the connection between OC, stress reaction, sex hormones and the brain. To achieve this, individual biomarkers will be evaluated, including changes in brain anatomy, functional responses and connectivity during acute psychosocial stress and early changes in mood and well-being through ambulatory assessment.
Oxytocin is a hypothalamic neuropeptide that is best known for its peripheral physiological effects in the female organism i.e., uterine contractions during birth. The neuropeptide furthermore affects reward processing and metabolic functions such as eating behavior and body weight. Oxytocin receptors are present in brain regions associated with the processing of rewards, e.g., ventral tegmental area (VTA), nucleus accumbens (NAcc) and nucleus stria terminalis. Previous studies indicate that oxytocin interacts with sex hormones such as estradiol in a sex-specific manner. Despite known sex differences in oxytocin function, most studies i.e., on the metabolic effects of oxytocin in humans have so far focused on young, healthy men. Intranasal oxytocin administration has emerged as a method to experimentally investigate central nervous effects of oxytocin in the absence of relevant side effects. In the proposed study the investigators aim to systematically investigate the acute effect of intranasal oxytocin on reward processing in relation to circulating and synthetic sex hormones in healthy, naturally cycling women and in women taking hormonal oral contraceptive pills. The investigators will administer 24 international units (IU) of intranasal oxytocin vs. placebo and investigate neural correlates in a 3T MRI scanner including functional imaging during a reward processing task, changes in brain anatomy and connectivity. Additionally, metabolic functions, eating behavior and changes in mood and wellbeing will be assessed and blood will be drawn to assess parameters of hormonal and metabolic status.
In patients with lung carcinoma who receive radiotherapy preoperatively or alternatively curative, high-dose radiotherapy instead of surgery, there are also deformations of the thorax from fraction to fraction. Currently, ART for lung carcinomas is carried out as part of patient care in the radiotherapy clinic. Patients are irradiated during repeated breath-holding manoeuvres in deep inspiration. The breath-holding manoeuvre is practised several times before the daily irradiation. An optical surface detection device is available for this purpose, which is used to compare the body surface in the patient's thorax area on the treatment table with the target surface to be achieved during radiotherapy planning, which took place days before the current fraction. If the target surface is reproducibly achieved, a conebeam CT is taken to determine the current tumour extent and the deformations occurring in comparison to the dose distribution to be applied. For this purpose, the normal tissues heart, lung and tracheal tree are automatically contoured by the Ethos therapy system in the cone-beam CT. A specialist physician and a physicist are present at the Ethos device during this process. These organ contours are used to determine the extent of the current target volume and the adaptive radiotherapy plan is adjusted to the new target volume. If the current tumour extent is not sufficiently covered by the initial radiotherapy plan planned for the series with its planned tolerances, or if the surrounding normal tissue is exposed to too much radiation, then the online adaptive radiotherapy plan for the current treatment is selected by the specialist. Otherwise, the initial radiotherapy plan is used by the planning CT as for IGRT. The aim of this study is to treat patients in ART readiness on the Ethos therapy device over 10 radiotherapy fractions. The dose distribution is always compared with the adaptive and the initial series plan on the anatomy of the day by the specialist and medical physics expert. The ART plan is applied when dosimetric advantages are present. The aim of this study is to prospectively analyse in how many patients safety margins around the clinical target volume can be reduced with ART compared to IGRT. The percentage of patients who benefit from ART will be determined prospectively. The criterion for a relevant benefit from ART is the effective uniform dose (EUD) in the target volume with the accumulated dose distribution across the first 7 fractions. If the EUD is below 95% of the target dose with IGRT and above 95% of the target dose with ART, then an advantage is determined with ART. Patients with a benefit from ART receive ART for the further fractions of the series, while the others continue to be treated with IGRT.
A Study to evaluate the pharmacokinetics, safety, and tolerability in paediatric population for treating juvenile idiopathic arthritis (JIA).