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Found 12 Actively Recruiting clinical trials
RECRUITING
The prerequisite for participation in this observational study is the independent decision of the treating physician and patient to start an approved injectable or oral DMT for RMS as routine medical treatment. This decision must have been made prior to enrollment in this study. Cohort 1: The prospective observational period per patient in the core part will be up to approx. two years from the time of consent (2 years +2 months visit window). If a patient re-consents to the extension part, then the prospective extension observational period will be additional approx. two years, resulting in a total observational period (prospectively for the core and extension part \& retrospectively for the potential gap between core and extension part) of approx. 4 years (+ 2 month visit window). Cohort 2: The prospective observational period per patient will be up to approx. two years from the time of consent (2 years + 2 months visit window). The observational period will not be dictated by the protocol. The follow-up documentation will take place at a frequency defined as per investigator's discretion. The diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy and to routine clinical care, can be performed as telemedicine visits and will take place as per investigator's discretion.
RECRUITING
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.
RECRUITING
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 aromatase inhibitor (AI) ± luteinizing hormone-releasing hormone (LHRH) with curative intent according to the current effective local 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 current effective local summary of product characteristics. To understand reasons for treatment decision, and to analyze the clinical adoption of ribociclib + AI ± LHRH after EU approval over time, baseline data will be collected from cohorts of ribociclib + AI ± 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 Austrian 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 + AI ± 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.
RECRUITING
The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.
RECRUITING
The main purpose of the study is to evaluate participant satisfaction after administration of ocrelizumab subcutaneous (SC) after 12 months using the therapy administration satisfaction questionnaire subcutaneous (TASQ-SC).
RECRUITING
The objectives of the study are to confirm safety and performance of the Zimmer® Nexel™ Total Elbow when used in primary or revision total elbow replacement by analysis of standard scoring systems, radiographs, and adverse event records. The safety of the device will be monitored using the frequency and incidence of reporting adverse events. The performance of the device will be evaluated by assessing the pain and functional performance, survival of the device, patient health status, and radiographic success of the implant.
RECRUITING
This prospective non-interventional study is intended to generate new data and insights into first-line (1L) treatment of newly diagnosed advanced high-grade epithelial Ovarian cancer (OC) in Germany relevant for patients, physicians and payers. It will capture the influence of 1L Poly ADP ribose polymerase inhibitor (PARPi) maintenance treatment (MTX) on medical routine in Germany, especially on: * outcome of the 3-steps 1L treatment phase (including surgery, Chemotherapy (CTX) and MTX) including the potential of patients with primary advanced OC to be cured, * patient's follow-up (FU) during and after MTX therapy, * patient-reported outcomes (PROs), experiences and needs, * physician's experience, * BRCA/HRD and genomic scar testing behavior at diagnosis/during 1L therapy, * patient selection for different 1L systemic treatment approaches, * use and safety of drugs, * treatment sequence in case of recurrence
RECRUITING
Significant tricuspid regurgitation is a common finding in elderly patients, with an incidence of 5.6% after the age of 70 years, according to the Framingham Heart Study. TR is an independent predictor for adverse prognosis and has limited treatment options. Tricuspid valve (TV) intervention is indicated when symptomatic TR-related right heart failure (RHF) is present. However, the surgical risk is usually deemed to be too high due to the presence of advanced age, pulmonary hypertension, right ventricular (RV) impairment, major organ failure and other co-morbidities. Moreover, isolated tricuspid valve surgery has an in-hospital mortality of approx. 8,7%, according to recent data. High TR prevalence, coupled with low incidence of isolated TV surgery, has created a considerable population in need of alternative, percutaneous therapies to improve outcomes. Recently, a variety of interventional procedures and devices have been developed which simulate different surgical approaches like suture or ring annuloplasty, coaptation enhancement, neochordae repair, or even valve replacement. Among them, coaptation devices attempt to correct leaflet malcoaptation by using the edge-to-edge clip technique, similar to treatment of functional mitral regurgitation. To date, most TTVR interventions have been performed off-label with the MitraClip device. Last year, the first TR dedicated device (TriClipTM, Abbott Medical) has been approved (CE mark), after showing good feasibility, safety and effectiveness, and meanwhile sustained and marked clinical benefit with low mortality after 12 months. Although most TTVR studies have enrolled high-risk cohorts, criteria for patient selection and timing of intervention have yet to be defined. Based on scientific surgical data, it seems reasonable to expect poorer outcomes in patients with several comorbidities, advanced cardiac remodeling and RHF-related major organ dysfunction e.g., renal and hepatic function impairment. Whether or not this assumption can be extrapolated to TTVR needs to be investigated. In this registry, the investigators aim to evaluate if percutaneous therapy with the TriClip system is safe and effective in patients at high and prohibitive risk and wether or not procedural success is the main determinant of short-, mid- and long-term outcomes.
RECRUITING
This registry aims * to confirm an excellent outcome in pre-/perimenopausal patients treated by endocrine therapy (+ ovarian suppression) in patients with low genomic risk by MammaPrint® without chemotherapy use in a real-world setting. * to evaluate management of ovarian function in patients treated by adjuvant chemotherapy according to investigator decision. * to evaluate adherence to endocrine therapy (+/- ovarian function suppression). * to evaluate the prognostic impact of clinicopathological markers (e.g., estrogen receptor (ER), progesterone receptor (PR), HER2 receptor, Ki-67 at baseline and after preoperative endocrine therapy (if any performed) by local pathology assessment compared to genomic signature result. * to assess the course of quality of life (QLQ BR23 and QLQ-C30) until 5 years of treatment with OFS (Baseline, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years) In general, WSG aim to assess the quality of surveillance care in younger breast cancer patients. WSG want to gain knowledge about endocrine induction treatment for indication of chemotherapy followed by endocrine treatment or endocrine treatment alone. Also, WSG aim at changes in duration of endocrine treatment (especially in high-risk patients up to 10 years) and introduction of intensified endocrine therapy (OFS) in combination with GnRH-analogues since publication of the SOFT and TEXT trials.
RECRUITING
This prospective, multicenter, non-interventional study (NIS) seeks to evaluate treatment with nemolizumab of moderate-to-severe AD in adolescents and adults over an approximately 12-month period using physician assessments in routine clinical practice and PRO measures. Treatment with nemolizumab will be determined solely by the participant's physician prior to study enrollment. No additional visits, procedures, or laboratory tests are required outside of routine clinical practice. The visit structure is not defined by the study protocol but is determined by routine medical practice. The visit schedule is intended to facilitate a systematic data assessment according to clinical routine. A sub-study will be completed in Germany and the UK at selected sites in which participants will complete the Peak Pruritus (PP) Numerical Rating Scale (NRS), Average Pruritus (AP) NRS, Sleep Disturbance (SD) NRS, and Pain NRS on a daily basis from Day -1 to Day 14. Data collection will occur remotely, and no clinic visits will be required.
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