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A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination with Ipilimumab versus Nivolumab in combination with Ipilimumab placebo in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

The aim of the study is to compare the Overall Response Rate (ORR) and assess Duration of Response (DoR) of the treatment of nivolumab in combination with ipilumumab vs. nivolumab in combination with ipilimumab placebo, as determined by a blinded…

A Phase 4, Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Assess the Safety and Efficacy of Adalimumab Used in Conjunction with Surgery in Subjects with Moderate to Severe Hidradenitis Suppurativa

Primary objective:Assess the safety and efficacy of adalimumab prior to surgery in subjects with moderate to severe HS who are surgical candidates.Secondary objectives:Assess the impact of adalimumab on the planned HS surgical site before surgery,…

Phase Ib, multicenter, open label study of PDR001 in combination with platinum-doublet chemotherapy in PD-L1 unselected, metastatic NSCLC patients

Primary: Dose confirmation part: To establish the Maximum Tolerated Dose (MTD) and/or Recommended dose for expansion (RDE) of PDR001 with platinum-doublet chemotherapy in treatment naïve patients with PD-L1 unselected, advanced NSCLC of squamous or…

A Phase 2b Multicenter, Randomized, Placebo-Controlled, Double-Blind Dose-Ranging Study to Evaluate ABT-494 (Upadacitinib) in Adult Subjects with Moderate to Severe Atopic Dermatitis

To evaluate the safety and efficacy of multiple doses of ABT-494 (Upadacitinib) monotherapy versus placebo in the treatment of adults with moderate to severe atopic dermatitis.

PRODEO: PROfylactic Haloperidol in patients defined as high risk for DElirium with delirium risk mOdel

Research questionWill prophylactic administration of haloperidol to patients with a high risk of developing a delirium according to DEMO, reduce the incidence of a delirium? HypothesesProphylactic administration of haloperidol in post-operative…

Laparoscopic versus Open Gastrectomy - A multicenter prospectively randomized controlled trial

To evaluate the benefits, risks and costs of laparoscopic gastrectomy as an alternative to open gastrectomy (gold standard) as treatment for gastric cancer in a Western population.

CANGLIA: Endocannabinoid control of microglia activation as a new therapeutic target in the treatment of schizophrenia

The primary objective of this study is to compare microglia activation as measured with proton Magnetic Resonance Spectroscopy (1H-MRS) between recent-onset schizophrenia patients who are randomised to CBD and those randomised to placebo. Secondary…

OPtimising thERapy to prevent Avoidable hospital admissions in the Multimorbid elderly: a cluster randomised controlled trial

Overall ObjectiveThe objective of this RCT is to evaluate whether the Systematic Tool to Reduce Inappropriate Prescribing (STRIP) including STRIP assistant (STRIPA) implemented by an appropriately qualified team will lead to an improvement in…

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…

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the
Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered ALS-008176 Regimens in Adult Subjects Hospitalized with Respiratory Syncytial Virus

Primary ObjectiveFor Part 1:The primary objective is to characterize the pharmacokinetics (PK) and to confirm the population PK (popPK) model derived from healthy volunteers in hospitalized adults who are infected with RSV.For Part 2:The primary…

Virtual reality exposure before elective pediatric day-care surgery: effects on pre- and postoperative anxiety and pain

The objective is:(1) To test the efficacy of VRE versus CAU in 200 children undergoing surgery on the anxiety level of the child during induction of anesthesia (primary outcome), pre- and postoperative child anxiety, pre- and postoperative parental…

Phase 2 Study Comparing Pembrolizumab with Intermittent/Short-term Dual MAPK Pathway Inhibition Plus Pembrolizumab in patients harboring the BRAFV600 mutation (IMPemBra)

Primary objectives: To explore the safety, feasibility, and the immune-activating capacity of different schemes of continuous/intermittent dabrafenib+trametinib during treatment with pembrolizumab as compared to pembrolizumab monotherapySecondary…

Efficacy of a physical activity coaching system for patients with COPD

Primary objective: To study physical activity of COPD patients before, during, and after pulmonary rehabilitation. To evaluate whether and to what extent our designed physical activity coaching system can support the maintainance of physical…

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 1/2, Single-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Study of Subcutaneously Administered
ALN-GO1 in Healthy Adult Subjects, and Patients with Patients with Primary Hyperoxaluria Type 1

Primary* Evaluate the safety and tolerability of single- and multiple-ascending doses of ALN-GO1, respectively, in healthy adult subjects and in patients with PH1Secondary* Characterize the pharmacokinetics (PK) of ALN-GO1* Evaluate the…

A Phase III, randomized, multicenter, parallel-group,
non-inferiority study evaluating the efficacy, safety, and
tolerability of switching to dolutegravir plus lamivudine in
HIV-1 infected adults who are virologically suppressed

PrimaryTo demonstrate the non-inferior antiviral activity of switching to DTG +3TC once daily compared to continuation of TBR over 48 weeks in HIV-1 infected, ART therapy (ART)-experienced, virologically suppressed subjectsSecondary- To demonstrate…

A 6-part first-in-human study of LOU064 consisting of a 4 part randomized, double-blind, placebo-controlled SAD and MAD study to investigate the safety and tolerability in healthy volunteers, subjects with atopic diathesis and subjects with atopic dermatitis, an open-label food effect study and a double-blind formulation effect study in healthy volunteers

To explore the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of LOU064 over a treatment period of 4 weeks in a cohort of subjects with atopic dermatitis.

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…

A randomized, open label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy

The primary objective of the entire study is to compare rogaratinib (BAY1163877) with chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall survival (OS) of patients with FGFR positive urothelial carcinoma.

Phase I/II trial of S 81694 administered intravenously in;combination with paclitaxel to evaluate the safety,;pharmacokinetic and efficacy in metastatic breast cancer

The purpose of this study is to determine the safety profile, the maximum tolerated dose (MTD) and the associated dose-limiting toxicities (DLTs) of S 81694 in combination with paclitaxel in mBC patients, and to investigate the antitumour activity…