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Dynamics of Androgen Receptor genomics and transcriptomics after neoadjuvant androgen ablation (DARANA)

1. To assess the effects of 3 months neoadjuvant androgen ablation with enzalutamide on the surgicial margin status of men with non-metastasized prostate cancer.2. To properly evaluate the effects of androgen ablation on gene expression, analyses of…

RITUXIMAB IN LIFE THREATENING THERAPY RESISTANT PROGRESSIVE INTERSTITIAL PNEUMONITIS

The main objective of this study is to assess the effects of rituximab (RTX) as a rescue therapy for therapy resistant progressive IMID- IP patients. Specifically there is an objective assessment of (1) pulmonary function tests (PFTs) and (2)…

Sandostatin therapy in sarcoidosis

Primary Objective: To evaluate efficacy of SST looking at the change in uptake on SRS in a subset of chronically active patients in which intensification of corticosteroid therapy is not indicated. . Secondary Objective(s): To study the composite…

Allogeneic Stem Cell Transplantation of NiCord, Umbilical Cord Blood-derived Ex Vivo Expanded Stem and Progenitor Cells, in Adolescents and Adult Patients with Hematological Malignancies

The overall study objective is to evaluate the safety and efficacy of NiCord®: single ex-vivo expanded cord blood unit transplantation in patients with hematological malignancies following myeloablative therapy.

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, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn*s Disease who have Completed the MT-1303-E13 Study

Primary Objective:* To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active CDSecondary Objectives:* To evaluate the long-term effects of MT-1303 on clinical outcomes in subjects with moderate to…

Non invasive imaging of [18F]HX4 with Positron-Emission-Tomography (PET) in Cervix Cancer.

The aim of this study is to (i) determine non-invasive visualisation of tumour hypoxia with [18F] HX4 PET imaging in cervix carcinomas; (ii) correlate [18F] HX4 PET images with blood and tissue markers for hypoxia; (iii) investigate the quality and…

Addition of stereotactic radiotherapy to the standard FOLFIRINOX treatment in locally advanced pancreatic cancer patients to determine efficacy and feasability (LAPC-1)

This is a prospective phase II non-randomized single-center study in patients with LAPC. Patients are first treated with up to 8 cycles of FOLFIRINOX, followed by stereotactic radiotherapy for a total dose of 40 Gy in 5 fractions. Due to the known…

Dosefinding trial studying effect of 4 weeks Intervention on safety and efficacy in males with Metabolic syndrome treated with oral Eubacterium hallii

To investigate different dosages of 4 weeks oral Eubacterium hallii treatment on safety and efficacy parameters.

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…

Thyroid hormone analog therapy of patients with severe psychomotor retardation caused by mutations in the MCT8 thyroid hormone transporter: The Triac Trial.

1. Normalization of the abnormal serum TH parameters and thereby improving the clinical condition of the AHDS patients2. Observation of changes in cognitive and motor function.

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 Ib/II study on the addition of Nab-paclitaxel (Abraxane) to capecitabine and oxaliplatin in the first-line treatment of metastastasized oesophagogastric carcinoma

Primary objectivePhase 1: To assess the safety and tolerability of Nab-paclitaxel added to oxaliplatin and capecitabine at their currently optimal doses.Phase 2: To determine the anti-tumor activity of Nab-paclitaxel when co-administered with…

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.…