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A randomised, double-blind (sponsor unblinded), placebocontrolled, parallel-group, multicentre study to evaluate the efficacy and safety of GSK2269557 administered in addition to standard of care in adult subjects diagnosed with an acute exacerbation of Chronic Obstructive Pulmonary Disease (PII116678)

Primary: To evaluate the effect of once daily repeat inhaled doses of GSK2269557 on lung parameters derived from HRCT scans in subjects with acute exacerbation of COPD,compared to placebo. Secondary: Other lung parameters derived from high…

Efficacy of Verapamil/ Verapamil-Kenacort injection versus Kenacort injection in Scar Treatment

Scar volume and POSAS score will be measured in the Verapamil group, these will be compared to the scar volume and POSAS score in the Kenacort+Verapamil group and the Kenacort group. In addition, complications/ adverse effects will be reported.

A multi-centre, double-blind, parallel-group, randomised controlled study to investigate efficacy, safety and tolerability of orally administered BI 409306 during a 12-week treatment period compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.

The primary objective of this study is to assess efficacy and safety of BI 409306 at doses of 10 mg, 25 mg and 50 mg once daily, 25 mg twice daily compared to placebo over a 12-week treatment period in patients with the following criteria: mild…

A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF)

To determine the effect size of PRM-151 relative to placebo in change from Baseline to Week 28 in mean FVC% predicted, pooling subjects on a stable dose of pirfenidone or nintedanib and subjects not on other treatment for IPF.

A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn*s Disease

Primary Objectives* To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe active CD* To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active CD.Secondary Objectives* To explore the PK…

The Park-in-Shape study: a randomized controlled trial evaluating the effects of exercise on motor and non-motor symptoms in Parkinson*s disease.

Objectives: To evaluate whether aerobic exercise leads to clinically relevant improvements in 1) motor and 2) non-motor symptoms as well as quality of life and physical fitness.

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients with Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract

The primary objective of this study is as follows:* To evaluate the effect of presatovir on RSV viral load in autologous or allogeneic HCT recipients with an acute RSV lower respiratory tract infection (LRTI)The secondary objectives of this study…

A phase II randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with exemestane and everolimus versus placebo in combination with exemestane and everolimus when administered to metastatic HER2 negative hormone receptor positive breast cancer subjects with bone metastases.

The objective of this study is to assess efficacy and safety of radium 223 dichloride in combination with exemestane and everolimus in subjects with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor positive breast cancer…

A randomized controlled multicenter trial of a five day course of oral colistin and neomycin followed by restoration of the gut microbiota using fecal transplantation to eradicate intestinal carriage of extended spectrum beta-lactamase or carbapenemase-producing Enterobacteriaceae in high-risk patients

The purpose of this study is to evaluate the efficacy of two antibiotics ( neomycin sulfate and colistin sulfate), followed by fecal bacteria therapy , to multidrug - resistant bacteria (E - ESBL and EPC) to be eradicated from the intestine.

A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Proof of Concept, and Dose-Finding Adaptive Phase 2a/2b Study to Investigate the Safety, Tolerability and Efficacy and Effect on Quality of Life of Human Recombinant Alkaline Phosphatase in the Treatment of Patients With Sepsis-Associated Acute Kidney Injury.

The primary objectives of the study are as follows:• To investigate the effect of recAP on renal function and related clinical parameters in patients with SA-AKI.• To determine the therapeutic dose(s) of recAP to support the pivotal Phase 3 program.…

A PHASE 2 RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF MHAA4549A,
A MONOCLONAL ANTIBODY, IN COMBINATION WITH OSELTAMIVIR VERSUS OSELTAMIVIR FOR
TREATMENT OF SEVERE INFLUENZA A INFECTION

2. OBJECTIVES2.1 SAFETY OBJECTIVESThe safety objectives for this study are as follows:* To evaluate the safety of MHAA4549A in combination with oseltamivir compared with placebo and oseltamivir in patients with severe influenza A, focusing on the…

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients with Respiratory Syncytial Virus (RSV) Infection of the Upper Respiratory Tract

The co-primary objectives of this study are as follows:* To evaluate the effect of presatovir (GS-5806) on RSV viral load and development of lower respiratory tract complication (LRTC) in RSV positive autologous or allogeneic HCT recipients with…

A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Safety and Tolerability of JNJ-54861911 in Subjects in the Early (Predementia) Alzheimer*s Disease Spectrum

This safety study in subjects in the early (predementia) AD spectrum is performed to investigate primarily the safety and tolerability of JNJ-54861911 during 6 months of treatment.

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

The purpose of this study is to investigate the effectiveness and safety of riociguat (BAY 63-2521) in patients with diffuse cutaneous systemic sclerosis.

A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease

Primary Study Objective: The primary objective of this study is to assess the efficacy of laquinimod 0.5 mg and 1.0 mg qd in patients with HD after 12 months of treatment using the UHDRS-TMS.Secondary Study Objectives:• To assess the effect of…

A phase II randomized, double-blind, placebo-controlled trial of radium-223 dichloride versus placebo when administered to metastatic HER2 negative hormone receptor positive breast cancer subjects with bone metastases treated with hormonal treatment background therapy

The objective of this study is to assess the efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative), hormone receptor positive breast cancer with bone metastases treated with…

A Phase 2A Multicenter, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Safety and Tolerability Trial of PQ912 in Subjects with early Alzheimer's Disease

To assess the safety and tolerability of multiple doses of PQ912 compared with placebo in subjects with early stage of Alzheimers Disease.

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled
Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hospitalized Adults with Respiratory Syncytial Virus (RSV) Infection

The primary objective of this study is to evaluate the effects ofpresatovir (GS-5806) on RSV viral load in RSV-positive adults hospitalizedwith acute respiratory infectious symptoms.The secondary objectives of this study are to evaluate:- The effect…

A randomized, multicenter, open-label, Phase 2 study with a safety run-in part to evaluate safety,
pharmacodynamics and efficacy of azacitidine compared to no anticancer treatment in children
and young adults with acute myeloid leukemia in molecular relapse after first complete
remission

Primary Objectives:Safety Run-in PartTo establish a safe and tolerable dose of azacitidine to be used in the randomized part of thestudy.Randomized PartTo evaluate the effect of azacitidine treatment in AML subjects at molecular relapse after…

A MULTI-CENTRE RANDOMISED CLINICAL TRIAL OF BIOMARKER-DRIVEN MAINTENANCE TREATMENT FOR FIRST-LINE METASTATIC COLORECTAL CANCER (MODUL)

EFFICACY OBJECTIVESWithin each cohort, the study has the following co-primary efficacy objectives:· Assessing early efficacy during the Maintenance Treatment Phase based on a 20%reduction in tumour size after 2 months of treatment· Evaluating PFSThe…