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Filter by:This study aims to establish and present the prevalence figures and demographics of the co-morbidity of ADHD and DCD. It further aims to design an exercise intervention, to be utilised in the management of the symptoms of both conditions. Furthermore, it aims at establishing the efficacy of this exercise intervention, when compared with the current and most commonly used intervention, that is: neurostimulant drugs.
This is a multicenter, single-arm, phase II study to evaluate the efficacy and safety of CS1001 monotherapy for Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma (ENKTL)
This is a Prospective, Multicenter, Randomized Controlled study to evaluate Stereotactic Body Radiation Therapy (SBRT) as a potential treatment for stage IV non-small cell lung cancer (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) and has been receiving treatment with a targeted agent such as gefitinib, erlotinib and icotinib.
Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects with vancomycin. A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted. The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin.
Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects treated with vancomycin. A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted. The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin. Ridinilazole plasma concentration will be assessed in a subset of patients.
Subjects with physician-diagnosed aspirin-exacerbated respiratory disease (AERD) who remain unacceptably symptomatic with a SNOT 22 score > 18 despite routine medical therapy will be enrolled in this single center, single-blinded study assessing the efficacy of dupilumab in AERD.
One factor that limits the effectiveness of adjuvant hormone therapy for breast cancer is medication nonadherence. Adherence to long-term medication regimens requires valuation of temporally distant outcomes. Thus, interventions that improve valuation of the future, a phenomenon known as delay discounting, may improve medication adherence in breast cancer treatment and improve survival. This study will investigate the acute efficacy of a prospective thinking intervention (episodic future thinking) for reducing delay discounting and improving valuation of future health in breast cancer patients. Patients will engage in either episodic future thinking or a control condition during completion of delay discounting tasks in which they choose between immediate and delayed outcomes.
The main objective of this project is to conduct a study of RFP-C for children with disruptive behaviors. Regulation Focused Psychotherapy for Children (RFP-C) is a twice a week, play therapy intervention.
Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix™ device and meet existing MDD/MEDDEV requirements
This is an open-label, non-randomized, prospective, descriptive study of the Nellcor™ Bedside Respiratory Patient Monitoring System using the Nellcor™ Respiration Rate parameter and Nellcor™ Adult Respiratory Sensor The study is intended to gain further information in the clinical space on the function of the Nellcor™ Respiration Rate parameter. The primary objective is to describe spot check (e.g. manual observation) of respiration rate versus cumulative automated counting (trend) of respiratory rate as measured using the Nellcor™ Bedside Respiratory Patient Monitoring System with the Nellcor™ Respiration Rate parameter.