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Rinsing of contaminated postoperative oncological wounds with tap water or an antiseptic agent * a randomized controlled clinical trial

Determine whether there is a difference in the reduction of bacterial contamination between tap water and antiseptic agent (AdvaCyn) of contaminated postoperative oncological wounds.By using the Visual Analogue Score (VAS score), to measure 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…

Efficacy of a predefined vitamin D dosing regimen in vitamin D-insufficient multiple myeloma patients.

The primary objective of this study is to determine the efficacy of a predefined vitamin D dosing regimen on the prevalence of vitamin D insufficiency in MM patients. Secondary objectives are to detect the influence of several variables (age, gender…

Pregnancy related Acute hyperTension Intervention Action: a randomized trial comparing labetalol and nicardipine in women with acute hypertension in pregnancy (Platina-trial)

OBJECTIVE: To compare, in women with acute severe hypertensive disorders, clinical effectiveness of labetalol and nifedipine.

ATLAS-PPX trial: an open-label, multinational, switching study to describe the efficacy and safety of fitusiran prophylaxis in patients with hemophilia A and B with inhibitory antibodies to factor VIII or IX previously receiving bypassing agent prophylaxis.

1.3. Study Design Rationale The ATLAS-PPX trial (ALN-AT3SC-009) is a multicenter, multinational, open-label Phase 3 switching study designed to demonstrate the efficacy and safety of fitusiran in patients with hemophilia A or B, with inhibitory…

Effect and safety of semaglutide 2.4 mg once-weekly in subjects with overweight or obesity who have reached target dose during run-in period

Primary objective: To compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to reduced-calorie diet and increased physical activity in subjects with overweight or obesity who have reached target dose of…

A Randomized, Active-Controlled, Blinded, Phase III Clinical Trial of BMS-986213 (Fixed Dose Combination of Relatlimab [anti-LAG-3] and Nivolumab) in Combination with Chemotherapy versus Placebo in Combination with Chemotherapy as First-Line Treatment in Participants with Unresectable, Locally Advanced or Metastatic LAG-3 Postive Gastric or Gastroesophageal Junction Adenocarcinoma

Primary ObjectivesThe main purpose of this study is to compare how long subjects with oesophageal cancer live overall (called overall survival, OS) or live without disease progression (called progression free survival, PFS) after receiving BMS-…

A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, Without Inhibitory Antibodies to Factor VIII or IX

The ATLAS-A/B trial (ALN-AT3SC-004) is a multicenter, multinational, randomized, openlabel Phase 3 study designed to demonstrate the efficacy and safety of fitusiran in patients with hemophilia A or B without inhibitory antibodies to FVIII or FIX…

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis

To test the hypothesis that mirikizumab is superior to placebo in inducing clinical remission at Week 12 in patients with moderately to severely active ulcerative colitis (UC)

An open-label randomised cross-over study to evaluate the albuminuria lowering effect of dapagliflozin, exenatide and their combination in patients with type 2 diabetes

The main objective of the study is to determine the albuminuria lowering effect of the GLP1-RA exenetide, SGLT-2 inhibitor dapagliflozin and their combination in patients with type 2 diabetes and micro- or macroalbuminuria.Secondary objectives are…

A 24-week randomized, controlled, multicenter, open-label study to evaluate the effect of reminder notifications and motivational/adaptive messaging on treatment adherence of COPD
subjects receiving Ultibro® Breezhaler® treatment using the Concept2 inhaler for dose administration and tracking

This study will evaluate the effect of dose tracking in conjunction with reminder notificationsand motivational/adaptive messages over 24 weeks on treatment adherence behavior insubjects with COPD. The dose tracking is done by the Concept2 inhaler…

Safety and Efficacy of turoctocog alfa pegol (N8-GP) in Prophylaxis and Treatment of Bleeds in Previously N8-GP Treated Patients with Severe Haemophilia A

Primary objective:To investigate the safety of turoctocog alfa pegol during continuous use for prevention and treatment of bleeding episodes of previously turoctocog alfa pegol treated severe haemophilia A patients.Secondary objectives:To…

PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS

Primary Objective:The primary objective of this study is to provide confirmatory data on the beneficial effect of 2.0 g/kg of Octagam 10% given every 4 weeks compared with placebo in subjects with active DM based on the percentage of responders at…

TArget-Site Concentrations of prophylactic cefazolin in foot and Ankle surgery

To analyze the difference in fT>MIC at the target site and infection rate for a single dose of 1 and 2g of cefazolin.

BioXmark liquid fiducial markers for image guided radiotherapy in bladder cancer, a safety and performance trial

This study will evaluate usability, safety and performance of a cystoscopic guided injection of a marker (BioXmark) at the tumor site in patients with bladder cancer on planning CT and CBCT during the irradiation period.

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection who Are at Risk of Developing Complications

The primary objective is to evaluate superiority of pimodivir (Pi) in combination with standard-of-care (SOC) treatment (tmt) compared toplacebo in combination with SOC treatment, with respect to the time to resolution of influenza-related symptoms.

A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients with Hemophilia A or B, with Inhibitory Antibodies to Factor VIII or IX

1.3. Study Design Rationale The ATLAS-INH trial (ALN-AT3SC-003) is a multicenter, multinational, randomized, openlabel Phase 3 study designed to demonstrate the efficacy and safety of fitusiran in patients with haemophilia A or B with inhibitory…

TAME Cardiac Arrest Trial. Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest: A Phase III Multi-Centre Randomised Controlled Trial

The primary objective of this study is to determine whether targeted therapeutic mild hypercapnia (TTMH) improves neurological outcome at 6 months compared to standard care (targeted normocapnia) (TN).

PROphylactic Mesh to prevent Incisional hernias at the former Stoma Site: the PROMISS-trial

To evaluate the incidence of incisional hernias after stoma reversal after preventive mesh placement compared to no mesh placement. Secondly the incidence of parastomal hernias will be recorded and complications caused by preventive mesh placement…

A multicenter, randomized, open label, efficacy assessor-blinded study of risankizumab compared to secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systematic therapy.

The objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.