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NCT ID: NCT04873583 Recruiting - Paediatric Stroke Clinical Trials

High Dose Steroids in Children With Stroke

PASTA
Start date: November 16, 2021
Phase: Phase 3
Study type: Interventional

This clinical trial deals with focal cerebral arteriopathy and childhood stroke, a rare but devastating condition. Focal cerebral arteriopathy (FCA) is an inflammatory vessel wall disease provoked by infection and there is increasing evidence that inflammatory processes play a crucial role in childhood stroke, influencing the outcome of the disease. Analysis of existing data suggests that outcomes are improved and that there is less stroke recurrence in children treated with steroids to reduce the acute inflammatory processes. This clinical trial will be conducted in over 20 hospitals in several countries in order to investigate this. Participants will be randomly separated into two groups. The first group will be treated with standard of care (including aspirin) combined with high dose steroids. The second group will be treated with standard of care (including aspirin) but without steroid treatment. The objective is to investigate if children treated with a combination of high dose steroid and aspirin will have a better and quicker recovery of FCA, better clinical functional outcome, and less recurrence compared to children treated with aspirin alone. This project has been identified by international pediatric stroke experts as the most important topic for a clinical trial in the field and is as well one of the most important research priorities identified by parents. The study results will also provide insight into the evolution of inflammatory vessel disease.

NCT ID: NCT04873362 Recruiting - Breast Cancer Clinical Trials

A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

Astefania
Start date: May 4, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes. As of June 4, 2024, this study is no longer accepting any newly screened participants.

NCT ID: NCT04869306 Recruiting - Tooth, Impacted Clinical Trials

Effect of Hyaluronic Acid on Tissue Healing After Removal of Impacted Mandibular Third Molars (LM3)

Start date: November 29, 2021
Phase: N/A
Study type: Interventional

Hyaluronic acid (HY) is used in dentistry to improve wound healing after oral and periodontal surgical interventions. After the application of HY, a positive effect on the wound healing of extraction sockets and periodontal defects has been described. The removal of a mandibular wisdom tooth (LM3) often leads to remaining residual defects with increased probing depths distal to the second molar. To date, the influence of HY on periodontal healing of the distal aspect of the second molar after removal of the LM3 has not yet been investigated. Accordingly, the aim of this double-blind, controlled and randomized clinical study is the influence of the application of HY Gel or HY Gel in combination with an absorbable collagen sponge on the periodontal healing of the second molar after surgical removal of the LM3 compared to the standard procedure (blood clot). A total of 102 patients with an impacted LM3 and a pre-existing bone defect of at least 5 mm distal to the second molar will be included. In the HY test group (n = 34), HY gel is applied to the LM3 extraction socket, and in the HY + C test group (n = 34) HY gel and an absorbable collagen sponge, while the control group (n = 34) does not receive any additional treatment. Patients are followed up for 12 months and the presence of an increased probing depth (≥ 5mm) on the distal side of the second molar is defined as the main parameter. A more stable blood clot and thus improved wound healing including periodontal healing is expected through the use of HY.

NCT ID: NCT04867837 Recruiting - Clinical trials for Acute Major Bleeding

Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor

Start date: September 1, 2021
Phase: Phase 3
Study type: Interventional

This is a multicentre, prospective, randomised, double-blinded, group-sequential, parallel-group, adaptive design, phase 3 study to demonstrate the haemostatic efficacy and safety of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on DOAC therapy with factor Xa inhibitor. Patients will be randomised 1:1 to either of two study groups: low-dose vs. high-dose OCTAPLEX.

NCT ID: NCT04865302 Recruiting - Preterm Birth Clinical Trials

Cerebral Oxygenation in Preterm Neonates With Respiratory Support During Skin-to-skin Care on the First Day After Birth

Kangaroo
Start date: October 1, 2021
Phase:
Study type: Observational

This is a prospective observational pilot study investigating if skin-to-skin care (SSC) has an influence on cerebral oxygenation and perfusion measured with near-infrared spectroscopy (NIRS) compared to incubator care in ventilated preterm neonates on the first day after birth.

NCT ID: NCT04863664 Recruiting - Tachyarrhythmia Clinical Trials

Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)

Start date: June 21, 2021
Phase: N/A
Study type: Interventional

The LEADR study is designed to assess the safety and efficacy of the Next Generation ICD lead. The LEADR LBBAP study is being conducted under the existing US FDA Investigational Device Exemption (IDE) for the Next Generation ICD Lead and is designed to confirm the safety and defibrillation efficacy of the Next Generation ICD Lead when placed in the LBBAP location in ICD and LOT-CRT patient population.

NCT ID: NCT04859985 Recruiting - Clinical trials for Coronary Artery Disease

The SELUTION DeNovo Study

Start date: May 15, 2021
Phase: N/A
Study type: Interventional

A Prospective Randomized, Multi-center, International, Single-blind, Clinical trial compared the Selution DEB strategy versus DES strategy.

NCT ID: NCT04857905 Recruiting - Brain Metastases Clinical Trials

Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Background. Brain metastases (BM) are the most common intracranial tumor and occur in 20-40% of all oncological patients. The most common primary cancer in brain metastases is lung cancer, followed by melanoma, breast cancer, renal cancer and colorectal cancer. The incidence of brain metastases has been increasing but the occurrence of brain metastases is still associated with high morbidity and poor prognosis. The main treatment methods are stereotactic radiosurgery (SRS), microsurgical resection and whole brain irradiation (WBRT). In contrast to microsurgical resection, Gamma Knife radiosurgery (GKRS) is a non-invasive neurosurgical method, which allows treatment in multimorbid patients with contraindications for surgery in general anesthesia. Furthermore, stereotactic radiosurgery is the only local treatment method for multiple disseminated and thereby non-resectable brain metastases. In general, microsurgical resection is considered the treatment of choice for BM exceeding >3 cm in diameter. However, since the establishment of the dose-staged technique, larger metastases can also be treated radiosurgically in selected patients. This novel method allows the application of high cumulative dose for the treatment of complex brain metastases. Aim. The aim of the study is to evaluate the clinical outcome in brain metastases patients with tumor volume between 8 and 20 ccm3. The clinical outcome will be compared between surgically and radiosurgically treated BM patients. Patients and methods. The investigators plan to conduct an explorative prospective study including about 50 radiosurgically and 50 surgically treated patients with brain metastases. If a patient fulfill study-relevant inclusion criteria at the time of BM diagnosis, the principle study investigator will offer both treatment options to the patient. Depending on patient's choice, he/she will be categorized either to surgical or to radiosurgical treatment group. For the outcome evaluation of the different treatment options, a comprehensive database will be established. The study participations will not interfere with any clincally indicated therapeutic decisions and the study participants will not be exposed to any additional risks since both treatments represent suitable therapy options.

NCT ID: NCT04853589 Recruiting - Alveolar Osteitis Clinical Trials

Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

Alveolar osteitis (AO; syn. dry socket) is one of the most frequent complications following tooth removal and it is defined as presence of severe postoperative pain in and around the extraction site, which increases in severity at any time between one and three days after extraction, accompanied by a partially or completely disintegrated blood cloth within the alveolar socket, with or without halitosis, and at the same time excluding any other cause for the pain (Blum 2002). To enhance standard treatment of AO, which consists of curettage of the dry socket, rinsing with saline solution, and inducing bleeding from the exposed alveolar bone walls, numerous products have been tested. One of them is hyaluronic acid (HY). The aim of the present study is to investigate the potential effect of HY gel application in the treatment of AO. Specifically, the application of HY only (HY test group; n = 20) or the combination of HY and an absorbable collagen sponge (HY+C test group; n = 20) will be compared to standard treatment (blood clot; control group, n=20). Clinical and patient related outcome parameters will be recorded for up to 14 days after treatment. A more stable blood clot and thus improved wound healing with faster pain reduction is expected through the use of HY.

NCT ID: NCT04851925 Recruiting - Clinical trials for Vestibular Schwannoma

MR Fingerprinting for Vestibular Schwannomas

Start date: February 24, 2021
Phase:
Study type: Observational

MR Fingerprinting (MRF) will be performed in patients who will be treated with Gamma Knife radio surgery for a vestibular schwannoma before the intervention. Fifty patients will be included with a vestibular schwannoma of minimum 1cm in size. During follow-up, response of the tumor to radiosurgery will be evaluated for each patient with MRI. The aim of the study is to find patterns of vestibular schwannomas in MRF data which correlate with the type of response to radio surgery, i.e. tumor control after radiosurgery, further tumor growth despite radiosurgery, cystic transformation after radiosurgery.