Sã¼meg, Hungary

Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

Evaluation and Further Development of an Artificial Intelligence-based Algorithm for Clinical Decision Support

A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo

Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study

The objective of this multicenter study is to collect preoperative, intraoperative, intermediate (approx. 2 years), mid-term (approx. 5 years), and long-term (approx. 10 years) postoperative data, on related clinical complications and clinical outcomes on the Sponsors market-approved hand and wrist Pyrocarbon implants, to demonstrate safety and performance of these implants in a real-world setting.

SA Versus SOI Surfaces for Single Implant-supported Crown

This study aimed to evaluate if there are some benefits using novel implant surface. This surface should improve the secondary implant stability, reducing the overall time needed for the osseointegration. main benefits in clinical practice should be reduced treatment time.

MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO)

Femara (letrozole) is an extensively investigated, marketed aromatase inhibitor (AI) widely used as treatment in the maintenance phase of estrogen-receptor (ER) positive breast cancer, as it inhibit the synthesis of estrogens. Estrogen is a well known driver of cancer growth in ER-positive tumors and a high percentage of the epithelial ovarian cancers express ER as well. Of which low grade ovarian cancers demonstrates the highest level of expression, supporting our strategy of a sub-group analysis (LOGOS). Therefore, letrozole in this study be investigated prospectively and evaluated as maintenance therapy after standard surgical and chemotherapy treatment in comparison to placebo (which is the current standard maintenance treatment) in subjects with primary, ER-positive low or high grade serous or endometrioid epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) of FIGO Stage II-IV, whose cancer has not progressed by the end of the platinum-based chemotherapy. The objectives are to evaluate the letrozole maintenance treatment compared to placebo in terms of - progression-free survival (PFS; primary endpoint) - overall survival (OS) - quality-adjusted progression free survival (QAPFS) - time to first subsequent treatment (TFST) - quality-adjusted time without symptoms of toxicity (Q-TWiST) - health related quality of life (QoL) assessed by EQ-5D-5L, FACT-ES and FACT-O questionnaires Methods: 540 for this study eligible subjects are 1:1 allocated in this randomized, controlled, double-blinded, multi-centre study to either the test (letrozole) or control (placebo) group. The maximum maintenance treatment duration is 5 years or until symptoms of toxicity or progression of underlying disease. Health and health-related quality of life will continuously be assessed at study entry and during routine recalls which are scheduled every 12 weeks for the first 2 years, followed by every 24 weeks for the next 3 years. Procedures performed to assess the participants' health are the same as are performed during the regular routine ovarian cancer follow-up visits: blood tests, physical as well as gynaecological examinations and may include imaging. In addition, the participants are asked to complete during the study quality of life (QoL) specific questionnaires and wear an activity tracker for one week just before the scheduled visits. These assessments will be used for the evaluation of letrozole's efficacy and burden in comparison to the standard maintenance treatment. Survival follow-up data after the mainentance treatment duration of 5 years (study end) are obtained for up to another 7 years.

Efficacy of Metamizole Versus Ibuprofen and a Short Educational Intervention Versus Standard Care in Acute Low Back Pain

Purpose Low back pain (LBP) is among the top three most common diseases worldwide resulting in a life with pain-related disability. In patients with persistent LBP over 3 months, the risk for chronic pain increases dramatically and effective interventions should aim to prevent pain persistence without overtreatment. Therefore, during an acute LBP episode, the most common recommendations are to use pain medication to alleviate pain and to keep patients physically active. Non-opioid and opioid pain medication is increasingly used to control pain. Despite the frequency of LBP, only few high-quality studies assessed the efficacy of pain medication. Since the 1990s, the use of opioid pain medication for non-cancer pain has soared and resulted in an epidemic of opioid dependence and abuse in the U.S. This, despite the fact that randomized clinical trials found little or no additional efficacy of opioids compared to non-opioid medication in LBP. Moreover, opioids are associated with potentially severe side-effects, including confusion, sedation, respiratory depression and dependence. Therefore, non-opioid pain medications that are safe and effective are urgently needed to control pain. Non-steroidal anti-inflammatory drugs (NSAIDs) are considered to be effective for LBP and recommended by guidelines. However, adverse events including kidney injury and gastrointestinal bleeding, limit the use of NSAIDs in many patients. Metamizole is an effective non-opioid analgesic and antipyretic with a favorable gastrointestinal and renal safety profile and therefore, a valuable treatment option in many LBP patients with contraindications for NSAIDs. Metamizole has been increasingly used in many countries such as Germany, France, Spain, and Switzerland. Despite its increased use, the role of metamizole for the treatment of LBP is unclear and has so far not been systematically studied. This surprising lack of efficacy data may be due to an ongoing controversy over the risk of metamizole-associated agranulocytosis, a serious hematological adverse event. Even though the overall risk of agranulocytosis is increased compared to other drugs, it only occurs in a small proportion of susceptible patients and the overall safety profile of metamizole is still favorable compared to other analgesics such as NSAIDs or opioids, which carry their own specific risks. Many patients have reservations against regular intake of pain medication and limit physical activity to keep pain manageable without medication, which is against the guidelines' recommendation. However, education to encourage activity may help to improve pain control and function as well. In a busy primary care practice extended educational sessions that have been shown to be effective are not feasible. A short educational intervention that provides evidence-based information on the nature of LBP and promotes physical activity may also improve outcome. Objectives This study aims to assess (A) whether metamizole is non-inferior to ibuprofen in a new episode of acute or subacute LBP and (B) whether a short educational intervention including evidence-based patient information is superior to usual care alone. Methods The EMISI trial is a randomized, double-blind, controlled trial (RCT) using a factorial design recruiting patients consulting general practitioners (GP) practices and the outpatient Division of the Department of General Internal Medicine at the University Hospital Bern, Switzerland. Patients are randomized into one of four groups (1:1:1:1): metamizole + educational intervention vs. metamizole + standard care vs. ibuprofen + educational intervention vs. ibuprofen + standard care. Patients assigned to the educational information will receive an information leaflet and a phone call by a member of the research team to discuss evidence based information on LBP. All patients will receive usual care provided by their GPs that includes additional pain medications and non-pharmacological measures at the GPs discretion. The primary outcome (A) Comparison of ibuprofen vs. metamizole: change from baseline pain on the numeric rating scale (NRS) to day 14 (non-inferiority). B) Comparison of the short intervention vs. usual care: change from baseline Core Outcome Measures Index (COMI) sum-score to 42 days follow-up (superiority). Statistical analysis Analysis will include an intention-to-treat (ITT) and a per-protocol (PP) analysis for the comparison of the primary between metamizole and ibuprofen outcome (NRS change from baseline to follow-up at 14 days). Both analyses need to meet non-inferiority in order to claim success. The comparison of the primary outcome between the intervention and the usual care group (COMI change from baseline to day 42) will be performed according to intention-to-treat principle. Based on the sample size calculation for both interventions, 120 patients will be included into the study.