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The added value of couple-based interventions compared to individual treatment for patients with personality disorder and their partners

Studies examining the effect of couple therapy or couple-based interventions in treatment for personality disorder are very scarce and more research is required. Therefore, the present study examines the effect of couple-based interventions in…

Continuous monitoring of ventilation with the Hexoskin smart shirt to detect dynamic hyperinflation in COPD patients

The main objective of this study is to assess the ability of a wearable measurement system, the Hexoskin smart shirt, to detect and quantify dynamic hyperinflation. Secondary objectives are to determine the optimal measurement procedure and to…

Function and body composition of patients with mitochondrial disease

1. Determine body composition of MD patients;2. Determine physical function of MD patients;3. Determine the association of body composition and physical function of MD patients.

ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain

To evaluate the safety and efficacy of ReActiv8 for the treatment of adults with Chronic Low Back Pain and no prior spine surgery when used in conjunction with medical management.

Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination with Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination with Ipilimumab 3 mg/kg in Subjects with Previously Untreated, Unresectable or Metastatic Melanoma

Primary Objective:The primary objective is to compare the incidence of drug-related Grade 3 - 5 AEs of N3I1 to N1I3 in subjects with previously untreated, unresectable or metastatic melanoma.Secondary Objective:• To evaluate the ORR, as determined…

Evaluation of a novel alternative protein source to stimulate post-exercise muscle protein synthesis

From p11 of C1 protocol document:1) To define the characteristics of mealworm protein ingestion on protein/digestion absorption kinetics and both whole-body and myofibrillar muscle protein synthesis after a single bout of resistance exercise in…

A randomized and open-label dose-finding, phase 2, efficacy, safety and pharmacokinetic study of once-per-cycle prophylactic injections of ANF-RHO TM versus pegfilgrastim (NeulastaR) in non-metastatic breast cancer patients at high risk of chemotherapy-induced neutropenia (CIN)

Primary Objective:- To assess the efficacy of escalating doses of ANF-RHO versus Neulasta in the duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] * 2.0 x 109/L) in the first chemotherapy cycle (21-day cycle FE100C).Secondary…

A Phase III, Randomized, Open Label Trial of Nivolumab in combination with Ipilimumab versus Pemetrexed with Cisplatin or Carboplatin as First Line Therapy in unresectable Pleural Mesothelioma

Primary Objectives:• To compare progression free survival (PFS) as determined by blinded independent central review (BICR) and overall survival (OS) of nivolumab combined with ipilimumab to pemetrexed plus cisplatin or carboplatin regimen as first…

Phase-based treatment versus direct trauma-focused treatment in patients with Complex PTSD.

The purpose of the present study is to determine superiority in efficacy of a phase-based treatment (i.e., EMDR therapy preceded by Skills Training in Affective and Interpersonal Regulation, STAIR) versus trauma-focused treatment alone (i.e., EMDR…

A Phase 3 Randomized, Multicenter, Multinational, Double-blinded Study Comparing the Efficacy and Safety of Repeated Biweekly Infusions of NeoGAA (GZ402666) and Alglucosidase Alfa in Treatment naïve Patients with Late-onset Pompe Disease

The overall objective of this study is to evaluate the efficacy and safety of neoGAA in treatment-naïve patients with LOPD as compared to alglucosidase alfa, when this is administered biweekly for a period of 49 weeks. Also, there is an open-label…

The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study

Primary objectiveTo compare the effect on pulmonary vascular resistance (PVR) of an initial triple oral regimen (macitentan, tadalafil, selexipag) versus an initial dual oral regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-…

Secondary Manifestations of Arterial Disease - Influence of Cardiovascular Prognosis and Treatment Effect Predictions on Patient and Physician Decision-Making: a Three-armed, Blinded, Randomized Controlled Trial

The primary objective is to compare differences between the communication strategies (personalized vs. standard, and personalized using iARR vs. personalized vs. CVD-free prognosis) on decisional certainty in patients with CVD at 1 month post-…

Growing up with X and Y chromosome trisomy: the TRIXY study

The aims of this study are to1) To identify information processing deficits that can help explain predict communication impairments, language deficits, social problems and increased risk for psychopathology.2) To assess if lack of regulation of…

A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects with Dementia with Lewy Bodies (DLB)

To assess the long-term safety and tolerability of 35 mg and 70 mg RVT-101 in subjects with DLB

Neutrophil Inhibition during RSV bronchiolitis and other respiratory tract infections

To determine ex vivo neutrophil functions following exposure to therapeutic antibodies targeting inhibitory receptors expressed by neutrophils from RSV bronchiolitis patients. A secondary aim is to study soluble inhibitory receptors (such as LAIR-1…

Randomised controlled trial of the effects of cognitive behavioral therapy for insomnia on sleep, impulsivity and aggression in forensic psychiatric patients

Evaluating the effects of cognitive behavioral therapy for chronic insomnia (CBT-I) on sleep, general psychopathology, impulsivity and aggression in forensic psychiatric patients.

Localizing the eloquent cortex in children with epilepsy: Development and validation of a child-friendly fMRI protocol

Develop and implement a new functional MRI protocol for function mapping in young children.

A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure

Despite continuous improvements in the medical management of pediatric patients with CHD, the risk of thrombotic events remains an important complication for pediatric patients following the Fontan procedure.The National Heart, Lung and Blood…

A prospective, randomized, international, multicenter, double-arm, controlled, open label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal.

The primary objective is to assess the proportion of patients in each treatment arm with a satisfactory clinical response as defined by a composite primary endpoint at Week 24.The secondary objective is to demonstrate safety and clinical effect at…

A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA) /Irinotecan (FOLFIRI)/Cetuximab with a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients with BRAF V600E mutant Metastatic Colorectal Cancer

Safety Lead-inIn patients with BRAF V600E mutant (BRAFV600E) metastatic colorectal cancer (mCRC):Primary: • Assess the safety/tolerability of the combination of encorafenib + binimetinib + cetuximabSecondary:• Assess the activity of encorafenib +…