16 results
To assess whether treatment with DBS can reduce or resolve TDD and if DBS can induce beneficial or side effects in particular psychiatric and or cognitive symptoms.
1. Clinically relevant reduction of symptom severity by use of Citrus/Cydonia comp. subcutaneous injections2. To examine the safety of treatment3. To examine treatment effects on immunological parameters4. To develop and validate an immunological…
Several observational studies have shown that Citrus/Cydonia comp. might be an effective treatment option for patients suffering from seasonal allergic rhinitis. In these studies Citrus/Cydonia comp. was either administered subcutaneously or given…
The primary objective is to investigate the cognitive effect of low-frequency stimulation of the nucleus basalis of Meynert (NBM) in advanced Parkinson*s disease (PD) patients, who were previously treated with deep brain stimulation (DBS) of the…
MAIN OBJECTIVEDose escalation phase :- To determine the MTD and/or RDE of alpelisib (BYL719) in combination with everolimus, and the MTD and/or RDE of alpelisib in combination with everolimus and exemestaneDose expansion part:- To describe safety…
Establishing efficacy and safety of the electrodes and implantable pulse generators (IPGs), which are used for deep brain stimulation (DBS) in patients with obsessive-compulsive disorder (OCD).
In this study, we will test whether STN-DBS related apathy can be reversed by switching stimulation to a more dorsal contact on the electrode.
Primary: The primary objective is to determine whether treatment with alpelisib in combination with fulvestrant prolongs progression free survival (PFS) compared to treatment with placebo in combination with fulvestrant based on local radiological…
Establishing efficacy of MFB DBS for TRD by comparing active DBS with sham DBS. Secondary aims are establishing an adverse events profile, establishing effects on quality of life, cost-effectiveness, (neuro)psychological and neuroimaging measures.
Primary objective:* To demonstrate the efficacy of alpelisib as measured by the proportion of participants randomized to alpelisib with a response at Week 24 in at least one of the following groups:* Group 1 (>= 18 yr-old)* Group 2 (6 - 17 yr…
The study has been designed to demonstrate whether alpelisib in combination with trastuzumab (and fulvestrant in case of HR+) shows a higher clinical benefit compared with trastuzumab in combination with chemotherapy.Some of the secondary objectives…
In the current phase 2 study we will investigate the efficacy of the combination of fulvestrant and alpelisib directly after progression on 1st or 2nd line therapy with fulvestrant with or without a CDK 4/6 inhibitor in patients with HR+HER2-…
To assess the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment per RECIST v1.1 in cohort A and cohort B 13-03-2019: new cohort added (3 cohorts now)
The purpose of the study is to determine whether treatment with alpelisib in combination with olaparib can delay the time to cancer progression compared to standard-of-care chemotherapy in participants with your type of ovarian cancer known as…
The goal is to assess the effect of MGB-DBS on tinnitus severity. Secondary objectives are:- To assess side effects of MGB-DBS on hearing and neuropsychological functioning.- To explore neurophysiological hallmarks.
Primary ObjectivesSafety run-in Part 1:To confirm the recommended dose of alpelisib in combination with trastuzumab and pertuzumab for Part 2.Double-blind, randomized, placebo-controlled Part 2:To determine whether treatment with alpelisib in…