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Filter by:This study consists of two parts: Phase I is a dose escalation study to determine the Recommended Phase II Dose (RP2D) of MGD013 monotherapy and that of MGD013 when in combination with Brivanib Alaninate (ZL-2301) in subjects with advanced liver cancer (including hepatocellular carcinoma and intrahepatic cholangiocarcinoma). Phase II is a dose expansion study and consists of two parts: Part 1 is to assess the safety and efficacy of MGD013 monotherapy and MGD013 in combination with ZL-2301 in subjects with advanced hepatocellular carcinoma (HCC); in Part 2, a therapeutic method (MGD013 monotherapy or MGD013 in combination with ZL-2301, determined by the sponsor according to the obtained data) will be selected for dose expansion study in HCC subjects who have previously failed immune checkpoint inhibitor treatment, to further evaluate the safety and efficacy of the study treatments in the specific group of subjects.
The main purpose of the study is to evaluate safety and efficacy of Alkotinib capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinib.While exploring the relationship between biomarkers and drug efficacy and safety.
This is a single center, open-label, Phase 2a study to assess the photonumeric scale, morphological, and histopathological changes associated with Collagenase Clostridium Histolyticum (CCH) in adult women with moderate or severe Edematous Fibrosclerotic Panniculopathy (EFP).
Advance care planning (ACP) is critical to the provision of quality end-of-life (EoL) care and has been associated with greater likelihood of patients' EoL wishes being followed. Despite the importance of engaging in ACP, less than half of cancer patients engage in ACP and those with low health literacy are at greatest risk of not completing advance directives. Major limitations of prior work include not effectively improving knowledge of ACP and patients viewing ACP as irrelevant. The proposed studies aim to address these prior limitations by developing and pilot testing empirically grounded, novel, easy-to-understand, and engaging communication tools that apply the medium of animated videos to communicate ACP. Specifically, the proposed studies will develop and pilot-test four animated videos (description of ACP; importance of engaging in ACP now; importance of communicating ACP to loved ones, health care proxies, and providers; and how to communicate wishes and complete advance directives).
Interprofessional education in childhood cancer is a multifaceted field. It involves multiple healthcare professionals with general and specialised knowledge and skills. Complex treatment, care and rehabilitation require continuous professional development and maintenance of healthcare professionals' competencies in their own professional field. Limited knowledge exists on comparing interprofessional and monoprofessional education and only few randomised studies have evaluated the effectiveness and efficiency of interprofessional education. One clinical area among others where healthcare professionals collaborate is in gastrointestinal toxicities and side effects. These are frequent and potentially severe clinical problems in childhood cancer that involve multiple healthcare professionals. Objectives: To study the effect of interprofessional versus monoprofessional case-based learning on healthcare professionals' attitudes on interprofessional learning and collaboration. Trial design: single centre investigator-initiated cluster randomized trial Methods: Participants: Employees with patient-related work at the childhood cancer departments and affiliated with childhood cancer at Rigshospitalet are eligible for inclusion. The setting is the childhood cancer department. Outcome: The primary outcome is to improve healthcare professionals' interprofessional attitude. Measurements: The primary outcome is attitudes measured by the Assessment of Interprofessional Team Collaboration Scale (AITCS). Secondary outcome is Readiness for Interprofessional Learning Scale (RIPLS) Questionnaire, and Safety Attitudes Questionnaire (SAQ). Knowledge will be measured by written test as multiple choice questionnaire (MCQ). Timepoints: The self-reported questionnaires will be distributed to the participants approximately one month before and one month after the educational intervention. On the day of the educational intervention, participants will answer the multiple choice questionnaire. Analysis: Linear mixed regression will be used to compare differences in mean scores postintervention, adjusted for differences between the two groups. Results: We hypothesise that interprofessional case-based learning positively affects the healthcare professionals' interprofessional attitudes.
This 12-month study will evaluate the efficacy of aripiprazole lauroxil compared to oral aripiprazole in preventing the re-emergence of psychotic symptoms in patients with a recent onset of schizophrenia.
This project will assess the feasibility of a cluster-randomized trial with crossover of our intervention, targeted gown and glove use, among high-risk residents of community nursing homes to prevent Staphylococcus aureus and carbapenem gram negative bacteria acquisition and infection.
This study is being done in patients who have been receiving corticosteroids or other immunosuppressive therapies for the treatment of cGVHD for at least 6 months. The purpose of this study is to find out if itacitinib in combination with corticosteroids or other immunosuppressive therapies is safe and effective in people with cGVHD.
We want to assess the level of anxiety of patients who arrive in the operating room before performing regional anesthesia.
This is a First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patients with Advanced Tumors, composed of a Phase I dose escalation and dose expansion stage and a Phase II dose extension stage.