title: A Phase 1b Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-833923 (XL139) in Combination With Carboplatin and Etoposide Followed by BMS-833923 Alone in Subjects With Extensive-Stage Small Cell Lung Cancer

summary: The purpose of this study is to determine the maximum tolerated dose (MTD) of BMS-833923 administered in combination with carboplatin and etoposide followed by BMS-833923 alone in subjects with extensive-stage Small Cell Lung Cancer (SCLC).

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
France
Ireland
Australia
Canada

location_facility:
Karmanos Cancer Institute
Local Institution


type: EudraCT Number

title: Phase 1b Multiple Ascending Dose Study of BMS-833923 (XL139) Administered in Combination With Cisplatin and Capecitabine as First-Line Therapy in Patients With Inoperable, Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas

summary: The purpose of this study is to determine the maximum tolerated dose (MTD) of BMS-833923 administered in combination with Cisplatin and Capecitabine as first-line therapy in subjects with inoperable metastatic gastric, gastroesophageal or esophageal adenocarcinomas.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

location_country:
United States
Canada
France
Netherlands

location_facility: The University Of Texas Md Anderson Cancer Center

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Endoscopic Retrograde CholangioPancreatography Endomicroscopy Registry Outcomes Database

summary: This registry will collect data from patients routinely undergoing an ERCP and Cellvizio endomicroscopy procedure (and optionally an additional cholangiopancreatoscopy procedure) due to suspected pancreatic or bile duct cancer. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Mauna Kea Technologies

location_country:
Germany
United States
France

location_facility: New York Presbyterian Hospital/Columbia University Medical Center

intervention_type: Device


title: A Phase 2, Open-Label, Multiple Dose Level, 12-Week Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AT1001 in Female Patients With Fabry Disease

summary: Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease.

study_start_date_type: Actual

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Benjamin ER, Della Valle MC, Wu X, Katz E, Pruthi F, Bond S, Bronfin B, Williams H, Yu J, Bichet DG, Germain DP, Giugliani R, Hughes D, Schiffmann R, Wilcox WR, Desnick RJ, Kirk J, Barth J, Barlow C, Valenzano KJ, Castelli J, Lockhart DJ. The validation of pharmacogenetics for the identification of Fabry patients to be treated with migalastat. Genet Med. 2017 Apr;19(4):430-438. doi: 10.1038/gim.2016.122. Epub 2016 Sep 22.

family: Benjamin

full_name: Elfrida R. Benjamin

given: Elfrida R.

sequence: first

family: Della Valle

full_name: Maria Cecilia Della Valle

given: Maria Cecilia

sequence: additional

family: Wu

full_name: Xiaoyang Wu

given: Xiaoyang

family: Katz

full_name: Evan Katz

given: Evan

family: Pruthi

full_name: Farhana Pruthi

given: Farhana

family: Bond

full_name: Sarah Bond

given: Sarah

family: Bronfin

full_name: Benjamin Bronfin

given: Benjamin

family: Williams

full_name: Hadis Williams

given: Hadis

family: Yu

full_name: Julie Yu

given: Julie

family: Bichet

full_name: Daniel G. Bichet

given: Daniel G.

family: Germain

full_name: Dominique P. Germain

given: Dominique P.

family: Giugliani

full_name: Roberto Giugliani

given: Roberto

family: Hughes

full_name: Derralynn Hughes

given: Derralynn

family: Schiffmann

full_name: Raphael Schiffmann

given: Raphael

family: Wilcox

full_name: William R. Wilcox

given: William R.

family: Desnick

full_name: Robert J. Desnick

given: Robert J.

family: Kirk

full_name: John Kirk

given: John

family: Barth

full_name: Jay Barth

given: Jay

family: Barlow

full_name: Carrolee Barlow

given: Carrolee

family: Valenzano

full_name: Kenneth J. Valenzano

given: Kenneth J.

family: Castelli

full_name: Jeff Castelli

given: Jeff

family: Lockhart

full_name: David J. Lockhart

given: David J.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University College London - UCL Discovery

ReferenceCitation: Giugliani R, Waldek S, Germain DP, Nicholls K, Bichet DG, Simosky JK, Bragat AC, Castelli JP, Benjamin ER, Boudes PF. A Phase 2 study of migalastat hydrochloride in females with Fabry disease: selection of population, safety and pharmacodynamic effects. Mol Genet Metab. 2013 May;109(1):86-92. doi: 10.1016/j.ymgme.2013.01.009. Epub 2013 Jan 26.

title: A Phase 2 study of migalastat hydrochloride in females with Fabry disease: Selection of population, safety and pharmacodynamic effects

location_country:
Brazil
United States
France
Australia
Canada
United Kingdom


title: Gem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma

summary:
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and gemcitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells.

PURPOSE: This randomized phase II trial is studying giving combination chemotherapy together with gemcitabine to see how well it works compared to giving combination chemotherapy alone in treating patients with previously untreated aggressive stage II, stage III, or stage IV non-Hodgkin's lymphoma.

ReferenceType: result

ReferenceCitation: Aurer I, Eghbali H, Raemaekers J, Khaled HM, Fortpied C, Baila L, van der Maazen RW; EORTC Lymphoma Group. Gem-(R)CHOP versus (R)CHOP: a randomized phase II study of gemcitabine combined with (R)CHOP in untreated aggressive non-Hodgkin's lymphoma--EORTC lymphoma group protocol 20021 (EudraCT number 2004-004635-54). Eur J Haematol. 2011 Feb;86(2):111-6. doi: 10.1111/j.1600-0609.2010.01540.x. Epub 2010 Dec 22.

family: Aurer

full_name: Igor Aurer

given: Igor

family: Eghbali

full_name: Houchingue Eghbali

given: Houchingue

family: Raemaekers

full_name: John Raemaekers

family: Khaled

full_name: Hussein M. Khaled

given: Hussein M.

family: Fortpied

full_name: Catherine Fortpied

given: Catherine

family: Baila

full_name: Liliana Baila

given: Liliana

family: van der Maazen

full_name: Richard W.M. van der Maazen

given: Richard W.M.

journal_name: European Journal of Haematology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Gem-(R)CHOP versus (R)CHOP: a randomized phase II study of gemcitabine combined with (R)CHOP in untreated aggressive non-Hodgkin’s lymphoma - EORTC lymphoma group protocol 20021 (EudraCT number 2004-004635-54)

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Netherlands Croatia France Belgium Egypt

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen


title: Clinical Performance Evaluation of T-TAS 01 PL Chip

summary: This study will measure primary hemostatic ability using the T-TAS 01 System with PL chip, with a comparison to clinical truth.

ipd_sharing: No

lead_sponsor: Hikari Dx, Inc.

location_country:
United States
France

location_facility: Centre Hospitalier Universitaire de Bordeaux

intervention_type: Diagnostic Test


title: Effects of the Inspire Implantable Nerve Stimulation System on Obstructive Sleep Apnea

acronym: STAR

summary: The purpose of this clinical trial is to demonstrate long-term safety and efficacy of the Inspire system. The Inspire Upper Airway Stimulation (UAS) therapy is intended to treat moderate-to-severe obstructive sleep apnea by improving airway patency through stimulation of the hypoglossal nerve. Study objectives include demonstrating that the Inspire system improves key indices of sleep apnea in a pre-specified percentage of patients.

ReferenceCitation: Johnson MD, Dweiri YM, Cornelius J, Strohl KP, Steffen A, Suurna M, Soose RJ, Coleman M, Rondoni J, Durand DM, Ni Q. Model-based analysis of implanted hypoglossal nerve stimulation for the treatment of obstructive sleep apnea. Sleep. 2021 Apr 27;44(44 Suppl 1):S11-S19. doi: 10.1093/sleep/zsaa269.

name: Department of Biomedical Engineering, University of Minnesota, Minneapolis, MN

family: Johnson

full_name: Matthew D Johnson

given: Matthew D

name: Department of Biomedical Engineering, Jordan University of Science and Technology, Irbid, Jordan

family: Dweiri

full_name: Yazan M Dweiri

given: Yazan M

name: Minneapolis Clinic of Neurology and North Memorial Help Sleep Medicine, Maple Grove, MN

family: Cornelius

full_name: Jason Cornelius

given: Jason

name: Division of Pulmonary, Critical Care, and Sleep Medicine, Louis Stokes Veterans Affairs Medical Center and Case Medical Center, Case Western Reserve University, Cleveland, OH

family: Strohl

full_name: Kingman P Strohl

given: Kingman P

name: Department of Otorhinolaryngology, University of Lübeck, Lübeck, Germany

family: Steffen

full_name: Armin Steffen

given: Armin

name: Department of Otolaryngology-Head and Neck Surgery, Weill Cornell Medicine, New York, NY

family: Suurna

full_name: Maria Suurna

given: Maria

name: Department of Otolaryngology, University of Pittsburgh, Pittsburgh, PA

family: Soose

full_name: Ryan J Soose

given: Ryan J

name: Inspire Medical Systems, Inc., Minneapolis, MN

family: Coleman

full_name: Michael Coleman

given: Michael

family: Rondoni

full_name: John Rondoni

name: Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH

family: Durand

full_name: Dominique M Durand

given: Dominique M

family: Ni

full_name: Quan Ni

given: Quan

journal_name: Sleep

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Yu JL, Younes M. Relation between arousability and outcome of upper airway stimulation in the Stimulation for Apnea Reduction (STAR) Trial. J Clin Sleep Med. 2021 Apr 1;17(4):797-801. doi: 10.5664/jcsm.9050.

name: Department of Otorhinolaryngology-Head and Neck Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania

name: Department of Medicine, Division of Sleep Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania

family: Yu

full_name: Jason L. Yu

given: Jason L.

name: Sleep Disorders Centre, Winnipeg, Manitoba, Canada

family: Younes

full_name: Magdy Younes

given: Magdy

journal_name: Journal of Clinical Sleep Medicine

publisher: American Academy of Sleep Medicine (AASM)

ReferenceCitation: Op de Beeck S, Wellman A, Dieltjens M, Strohl KP, Willemen M, Van de Heyning PH, Verbraecken JA, Vanderveken OM, Sands SA; STAR Trial Investigators. Endotypic Mechanisms of Successful Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2021 Mar 15;203(6):746-755. doi: 10.1164/rccm.202006-2176OC.

name: Translational Neurosciences, Faculty of Medicine and Health Sciences, and

name: Department of Ear, Nose, and Throat, Head and Neck Surgery

name: Multidisciplinary Sleep Disorders Centre, and

family: Op de Beeck

full_name: Sara Op de Beeck

given: Sara

name: Division of Sleep and Circadian Disorders, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts; and

family: Wellman

full_name: Andrew Wellman

given: Andrew

family: Dieltjens

full_name: Marijke Dieltjens

given: Marijke

name: Department of Medicine, Case Western Reserve University, Cleveland, Ohio

full_name: Kingman P. Strohl

given: Kingman P.

family: Willemen

full_name: Marc Willemen

given: Marc

name: Laboratory of Experimental Medicine and Pediatrics, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium

name: Department of Pulmonology, Antwerp University Hospital, Edegem, Belgium

journal_name: American Journal of Respiratory and Critical Care Medicine

ReferenceCitation: Strollo PJ Jr, Soose RJ, Maurer JT, de Vries N, Cornelius J, Froymovich O, Hanson RD, Padhya TA, Steward DL, Gillespie MB, Woodson BT, Van de Heyning PH, Goetting MG, Vanderveken OM, Feldman N, Knaack L, Strohl KP; STAR Trial Group. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med. 2014 Jan 9;370(2):139-49. doi: 10.1056/NEJMoa1308659.

title: Upper-Airway Stimulation for Obstructive Sleep Apnea

location_country:
United States
Netherlands
France
Belgium
Germany

location_facility: Clinical Research Group of St. Petersburg, Inc.

location_facility: Deparment of Pulmonology Head and Neck Surgery, Universitair Ziekenhuis Antwerpen

location_facility: University of Pittsburgh Medical Center; Montefiore

location_facility: Wayne State University / Detroit Medical Center

location_facility: University Hospitals / Case Western Reserve


type: Other Identifier

title: An Open Label, Two Stage, Phase II Study to Evaluate the Efficacy and Tolerability of ZD6474 in Patients With Locally Advanced or Metastatic Hereditary Medullary Thyroid Carcinoma.

summary: The purpose of this open label, two stage, phase II study is to evaluate the efficacy and tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary thyroid carcinoma.

ReferenceType: background

ReferenceCitation: Wells SA Jr, Gosnell JE, Gagel RF, Moley J, Pfister D, Sosa JA, Skinner M, Krebs A, Vasselli J, Schlumberger M. Vandetanib for the treatment of patients with locally advanced or metastatic hereditary medullary thyroid cancer. J Clin Oncol. 2010 Feb 10;28(5):767-72. doi: 10.1200/JCO.2009.23.6604. Epub 2010 Jan 11.

lead_sponsor: Genzyme, a Sanofi Company


type: Other Grant/Funding Number

title: Canadian Study on the Endovascular Treatment of Unruptured Intracranial Aneurysms Versus Surgical Treatment. A Randomized Comparison of Clinical and Angiographic Results of Intracranial Aneurysms

acronym: CURES

summary:
Purpose:

Phase 1: (Pilot Phase)

To compare the treatment efficacy of surgical clipping and endovascular coiling for unruptured intracranial aneurysms.

To obtain better estimates of morbidity and mortality related to a surgical or endovascular treatment strategy at one year within the context of an RCT.

To show that an RCT comparing the morbidity and mortality of a surgical management strategy to an endovascular management strategy is feasible.

Phase 2:

To compare the results of surgical and endovascular management strategies, in terms of:

Overall mortality and morbidity at 1 and 5 years.
The clinical efficacy and safety of a surgical or endovascular management strategy at 1 and 5 years

Hypotheses: Phase 1 Hypotheses:

Surgical clipping of intradural, saccular, unruptured intracranial aneurysms is superior to endovascular management in terms of a lesser number of patients experiencing treatment failure.
An RCT comparing the clinical outcomes of a surgical versus endovascular management strategy is feasible.

Phase 1 Primary End-points:

• Treatment failure, hereby defined as having occurred when either: the intended initial modality (surgical or endovascular) fails to occlude the aneurysm, a "major" (saccular) angiographic aneurysm recurrence is found, or an intracranial hemorrhagic event occurs during the 1-year follow-up period.

Phase 1 Secondary End-points:

Overall morbidity and mortality at one year.
Occurrence of morbidity (mRS >2) or mortality following treatment.
Occurrence of failure of aneurysm occlusion using the initial intended treatment modality.
Occurrence of a "major" (saccular) angiographic aneurysm recurrence.
Occurrence of an intracranial hemorrhage following treatment.
Peri-treatment hospitalization lasting more than 5 days
Discharge following treatment to a location other than home

Treatment:

Trial feasibility, or the capacity for patient recruitment, would require enrollment of at least 8 patients per actively recruiting center per year.

Phase 2 Hypotheses:

It may be too early to explicitly define the primary hypothesis of Phase 2, however, the intent of Phase 2 can be expressed as:

One management strategy is superior to the other in terms of clinical outcome at five years.
One management strategy is superior to the other in terms of clinical efficacy at five years.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Naggara O, Darsaut T, Trystram D, Tselikas L, Raymond J. Unruptured intracranial aneurysms: why we must not perpetuate the impasse for another 25 years. Lancet Neurol. 2014 Jun;13(6):537-8. doi: 10.1016/S1474-4422(14)70091-2.

family: Naggara

full_name: Olivier Naggara

given: Olivier

family: Darsaut

full_name: Tim Darsaut

given: Tim

family: Trystram

full_name: Denis Trystram

given: Denis

family: Tselikas

full_name: Lambros Tselikas

given: Lambros

family: Raymond

full_name: Jean Raymond

given: Jean

journal_name: The Lancet Neurology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

location_country: Canada Belgium France

location_facility: Centre hospitalier universitaire de Liège

location_facility: Centre hospitalier de l'Université de Montréal - CHUM

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


title: A Phase 3, Multicenter, 2-Arm Randomized, Open-Label Study of Trastuzumab Deruxtecan in Subjects With HER2-Positive Metastatic and/or Unresectable Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma Subjects Who Have Progressed on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)

summary: This study will evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with ramucirumab and paclitaxel (Ram + PTX) in participants with HER2-positive gastric or gastro-esophageal junction (GEJ) adenocarcinoma who have progressed on or after a trastuzumab-containing regimen and have not received any additional systemic therapy.

ipd_sharing: Yes

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Singapore
Korea, Republic of
France
Japan

location_facility: Chonnam National University Hwasun Hospital

location_facility: Kobe City Medical Center General Hospital

location_facility: Chonbuk National University Hospital - Jeonbuk Regional Cancer Center

location_facility: National Hospital Organization Shikoku Cancer Center


title: A Phase Ib/II, Open Label, Multi-center Study Evaluating the Safety and Efficacy of BKM120 in Combination With Trastuzumab in Patients With Relapsing HER2 Overexpressing Breast Cancer Who Have Previously Failed Trastuzumab

summary:
This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab.

The study will further assess the safety and preliminary efficacy of BKM120 in combination with trastuzumab and capecitabine in patients with relapsing HER2 overexpressing breast cancer and brain metastases (BM) who have previously failed trastuzumab.

status: Terminated

design_allocation: Non-Randomized

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
France
Belgium
Spain
United States
United Kingdom

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: Karmanos Cancer Institute Dept.of KarmanosCancerInst (6)

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Washington University School Of Medicine-Siteman Cancer Ctr WA Siteman

location_facility: Sarah Cannon Research Institute Sarah Cannon Cancer Center SC

location_facility: University of Alabama at Birmingham/ Kirklin Clinic Univ AL - PI

status_simplified: Unknown


ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

lead_sponsor: Amgen

location_country:
Italy
Switzerland
France
Greece
Spain
United Kingdom

acronym: BEAN

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: ASL Lanciano Vasto Chieti - Presidio Ospedaliero Santa Annunziata

source: euctr

title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet's Disease (BEAN)

summary: The aim of this study is to estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric participants from 2 to < 18 years of age with oral ulcers associated with Behçet's disease (BD) through week 12.


title: Perioperative Chemotherapy Versus Surgery for Resectable Colorectal Liver Metastases: a Multicenter Propensity Score Matched Analysis on Long-term Outcomes

summary:
There is a degree of uncertainty regarding the role of perioperative chemotherapy (CTx) in the treatment of resectable colorectal liver metastases (CRLM). In the clinical practice, the combination of surgery and CTx is increasingly accepted as treatment for CRLM, especially in the context of patients with synchronous disease or metachronous disease with a high risk of recurrence. However, controversy exists whether all patients with resectable CRLM benefit from perioperative CTx.

There is paucity of good quality studies on this topic. A pooled analysis of two phase III randomized clinical trial, closed prematurely because of slow accrual, showed a marginal statistical significance in favor of adjuvant CTx. Nevertheless, long term results of the EPOC trial founded benefit in disease free survival (DFS) with no difference in overall survival (OS) when perioperative CTx with FOLFOX4 was compared with surgery alone for resectable CRLM. Furthermore, a retrospective series from Ayez et al showed that patients with a high CRS benefit from neo-adjuvant CTx while in patients with a low risk profile did not. On the other side, another retrospective series from the MSKCC showed the timing of additional CTx for resectable CRLM was not associated with improved outcomes. The ongoing CHARISMA trial is currently comparing the outcomes of neo-adjuvant CTx followed by surgery versus surgery alone in high-risk patients with resectable CRLM.

This uncertainty regarding CRLM management may partly be due to the fact that these studies are not well powered to detect minor differences in long term outcomes and they often involved a very heterogenous group of patients with both synchronous and metachronous CRLM, not stratified by clinical risk score (CRS) as described by Fong et al.

time_perspective: Retrospective

lead_sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

location_country:
United Kingdom
France
Spain

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Liverpool University Hospitals NHS Foundation Trust

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Centre Hospitalier Universitaire de Reims

intervention_type: Other


title: Experience From the Long-term Italian Subcutaneous Implantable Cardioverter Defibrillator Registry (ELISIR)

acronym: ELISIR

summary: The purpose of this registry is to collect data on implant parameters, early, mid and long-term clinical effectiveness of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) therapies in order to better understand how to improve the clinical care of patients and effectiveness of S-ICD therapies.

time_perspective: Other

ReferenceCitation: Ricciardi D, Ziacchi M, Gasperetti A, Schiavone M, Picarelli F, Diemberger I, Bontempi L, Di Belardino N, Bisignani G, De Bonis S, Mitacchione G, Calabrese V, Lavalle C, Piro A, Pignalberi C, Santini L, Grigioni F, Tondo C, Biffi M, Forleo GB. Clinical impact of defibrillation testing in a real-world S-ICD population: Data from the ELISIR registry. J Cardiovasc Electrophysiol. 2021 Feb;32(2):468-476. doi: 10.1111/jce.14833. Epub 2020 Dec 18.

name: Department of Cardiology Policlinico Universitario Campus Bio‐Medico Roma Italy

family: Ricciardi

full_name: Danilo Ricciardi

given: Danilo

name: Unit of Cardiology, Department of Experimental, Diagnostic and Specialty Medicine‐DIMES University of Bologna Bologna Italy

family: Ziacchi

full_name: Matteo Ziacchi

given: Matteo

name: Department of Cardiology Luigi Sacco Hospital Milan Italy

family: Gasperetti

full_name: Alessio Gasperetti

given: Alessio

family: Schiavone

full_name: Marco Schiavone

given: Marco

name: Department of Cardiology Ospedali Riuniti Anzio‐Nettuno Anzio Italy

family: Picarelli

full_name: Francesco Picarelli

given: Francesco

family: Diemberger

full_name: Igor Diemberger

given: Igor

name: Department of Cardiology Spedali Civili Brescia Brescia Italy

family: Bontempi

full_name: Luca Bontempi

given: Luca

family: Di Belardino

full_name: Natale Di Belardino

given: Natale

name: Department of Cardiology Ospedale “Ferrari”, Castrovillari Cosenza Italy

family: Bisignani

full_name: Giovanni Bisignani

given: Giovanni

family: De Bonis

full_name: Silvia De Bonis

given: Silvia

family: Mitacchione

full_name: Gianfranco Mitacchione

given: Gianfranco

family: Calabrese

full_name: Vito Calabrese

given: Vito

name: Department of Cardiovascular/Respiratory Diseases, Nephrology, Anesthesiology, and Geriatric Sciences Policlinico Umberto I Sapienza University of Rome Rome Italy

family: Lavalle

full_name: Carlo Lavalle

given: Carlo

family: Piro

full_name: Agostino Piro

given: Agostino

name: Division of Cardiology Ospedale San Filippo Neri Rome Italy

family: Pignalberi

full_name: Carlo Pignalberi

name: Division of Cardiology Ospedale G.B. Grassi Ostia Italy

family: Santini

full_name: Luca Santini

family: Grigioni

full_name: Francesco Grigioni

name: Heart Rhythm Center Centro Cardiologico Monzino, IRCCS Milan Italy

name: Department of Clinical Sciences and Community Health University of Milan Milan Italy

family: Tondo

full_name: Claudio Tondo

given: Claudio

family: Biffi

full_name: Mauro Biffi

given: Mauro

family: Forleo

full_name: Giovanni Battista Forleo

given: Giovanni Battista

journal_name: Journal of Cardiovascular Electrophysiology

title: Clinical impact of defibrillation testing in a real‐world S‐ICD population: Data from the ELISIR registry

ipd_sharing: Undecided

lead_sponsor: Luigi Sacco University Hospital

location_country: Italy Germany France Switzerland

location_facility: Ospedale Luigi Sacco - Polo Universitario

location_facility: Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"

location_facility: Policlinico Universitario Campus Bio-Medico


title: International Validation of Two Non-motor Scales in Parkinson's Disease: the Neuropsychiatric Fluctuations Scale (NFS) and the Shame in Parkinson's Disease (SPARK) Scale

summary: The goal of this project is to develop the international validation of two new rating scales, the Neuropsychiatric Fluctuations Scale (NFS) and the Shame in PARKinson's disease (SPARK) Scale, in order to improve the understanding of the extent and severity of non-motor symptoms in Parkinson's disease (PD).

lead_sponsor: University Hospital Inselspital, Berne

location_country:
Switzerland
France
Greece
Romania
Spain
Germany
United Kingdom

location_facility: Centre hospitalier régional universitaire de Besançon

location_facility: Insel Gruppe AG University Hospital Bern


title: The Impact of Deep Versus Standard Muscle Relaxation on Intra-operative Safety During Laparoscopic Surgery: a Multicenter Strategy Study

acronym: EURORELAX

summary: Muscle relaxants are routinely applied during anesthesia to facilitate endotracheal intubation and to improve surgical working conditions. Several investigations have shown that a deep neuromuscular block (NMB) improves the surgical working conditions over a moderate NMB and effectively precludes sudden deterioration of the surgical field. However, whether the improvement of surgical working conditions translates into less intra- and postoperative complications remains uncertain. Small prospective or retrospective studies shown an decrease of the incidence of intraoperative adverse events and postoperative complications after a deep NMB. There is a need to confirm these outcome data prospectively, in a large number of patients and clinics and during a variety of surgical procedures.

ReferenceCitation: Boon M, Martini C, Yang HK, Sen SS, Bevers R, Warlé M, Aarts L, Niesters M, Dahan A. Impact of high- versus low-dose neuromuscular blocking agent administration on unplanned 30-day readmission rates in retroperitoneal laparoscopic surgery. PLoS One. 2018 May 23;13(5):e0197036. doi: 10.1371/journal.pone.0197036. eCollection 2018.

ReferenceCitation: Torensma B, Martini CH, Boon M, Olofsen E, In 't Veld B, Liem RS, Knook MT, Swank DJ, Dahan A. Deep Neuromuscular Block Improves Surgical Conditions during Bariatric Surgery and Reduces Postoperative Pain: A Randomized Double Blind Controlled Trial. PLoS One. 2016 Dec 9;11(12):e0167907. doi: 10.1371/journal.pone.0167907. eCollection 2016.

ReferenceCitation: Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.

ReferenceCitation: Rosenthal R, Hoffmann H, Clavien PA, Bucher HC, Dell-Kuster S. Definition and Classification of Intraoperative Complications (CLASSIC): Delphi Study and Pilot Evaluation. World J Surg. 2015 Jul;39(7):1663-71. doi: 10.1007/s00268-015-3003-y.

ReferenceCitation: Madsen MV, Scheppan S, Mørk E, Kissmeyer P, Rosenberg J, Gätke MR. Influence of deep neuromuscular block on the surgeonś assessment of surgical conditions during laparotomy: a randomized controlled double blinded trial with rocuronium and sugammadex. Br J Anaesth. 2017 Sep 1;119(3):435-442. doi: 10.1093/bja/aex241.

ReferenceCitation: Özdemir-van Brunschot DMD, Braat AE, van der Jagt MFP, Scheffer GJ, Martini CH, Langenhuijsen JF, Dam RE, Huurman VA, Lam D, d'Ancona FC, Dahan A, Warlé MC. Deep neuromuscular blockade improves surgical conditions during low-pressure pneumoperitoneum laparoscopic donor nephrectomy. Surg Endosc. 2018 Jan;32(1):245-251. doi: 10.1007/s00464-017-5670-2. Epub 2017 Jun 22.

ReferenceCitation: Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13.

ReferenceCitation: Honing M, Reijnders-Boerboom G, Dell-Kuster S, van Velzen M, Martini C, Valenza F, Proto P, Cambronero OD, Broens S, Panhuizen I, Roozekrans M, Fuchs-Buder T, Boon M, Dahan A, Warlé M. The impact of deep versus standard neuromuscular block on intraoperative safety during laparoscopic surgery: an international multicenter randomized controlled double-blind strategy trial - EURO-RELAX TRIAL. Trials. 2021 Oct 26;22(1):744. doi: 10.1186/s13063-021-05638-2.

family: Honing

full_name: Maarten Honing

given: Maarten

family: Reijnders-Boerboom

full_name: Gabby Reijnders-Boerboom

given: Gabby

family: Dell-Kuster

full_name: Salome Dell-Kuster

given: Salome

family: van Velzen

full_name: Monique van Velzen

given: Monique

family: Martini

full_name: Chris Martini

given: Chris

family: Valenza

full_name: Franco Valenza

given: Franco

family: Proto

full_name: Paolo Proto

given: Paolo

family: Cambronero

full_name: Oscar Díaz Cambronero

given: Oscar Díaz

family: Broens

full_name: Suzanne Broens

given: Suzanne

family: Panhuizen

full_name: Ivo Panhuizen

given: Ivo

family: Roozekrans

full_name: Margot Roozekrans

given: Margot

family: Fuchs-Buder

full_name: Thomas Fuchs-Buder

given: Thomas

family: Boon

full_name: Martijn Boon

given: Martijn

family: Dahan

full_name: Albert Dahan

given: Albert

family: Warlé

full_name: Michiel Warlé

given: Michiel

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: The impact of deep versus standard neuromuscular block on intraoperative safety during laparoscopic surgery: an international multicenter randomized controlled double-blind strategy trial — EURO-RELAX TRIAL

ipd_sharing_description: Protocol and SAP will be published before start study. CSR will be reported after article publication in a peer reviewed journal.

lead_sponsor: Leiden University Medical Center

location_facility: Hospital Universitari I Politecnic La Fe


title: A Double-Masked, Randomized, Sham-Controlled, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Photobiomodulation (PBM) in Subjects With Dry Age-Related Macular Degeneration (AMD) (LIGHTSITE II)

summary: This LIGHTSITE II study is a double-masked, sham-controlled, parallel design, prospective multi-site study for the use of PBM as a treatment for visual impairment in subjects with dry AMD.

lead_sponsor: LumiThera, Inc.

location_country:
Italy
France
Spain
Germany
United Kingdom

location_facility: Universitätsklinikum Freiburg- Klinik für Augenheilkunde

location_facility: Klinik fur Ophthalmologie, Universitatsklinikum Schleswig-Holstein

location_facility: Institut ophtalmologique de l'Ouest- Clinique jules VERNE


title: A Prospective, Multi-center, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of ALLEVYN Gentle Border

summary: The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact layer to support performance claims.

lead_sponsor: Smith & Nephew Orthopaedics AG

location_country:
Germany
United Kingdom
France

location_facility: Klinikum Oldenburg, University Clinic for Dermatology and Allergy

location_facility: University Hospital Erlangen, Department of Dermatology

location_facility: Niels-Stensen-Kliniken Christliches Klinikum Melle GmbH

location_facility: Northumbria Healthcare NHS Foundation Trust


title: Efficacy of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis to Prevent ACLF Development: a Multicenter, Double-blind, Placebo Controlled Randomized Clinical Trial

summary: The aim of this study is to assess the efficacy of oral administration of simvastatin plus rifaximin in patients with decompensated cirrhosis to halt the progression of the disease as assessed by prevention of the development of ACLF

ReferenceCitation: Marrache MK, Rockey DC. Statins for treatment of chronic liver disease. Curr Opin Gastroenterol. 2021 May 1;37(3):200-207. doi: 10.1097/MOG.0000000000000716. Review.

family: Marrache

full_name: Mohamad Kareem Marrache

given: Mohamad Kareem

family: Rockey

full_name: Don C. Rockey

given: Don C.

journal_name: Current Opinion in Gastroenterology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Judit Pich

location_country:
Italy
Netherlands
France
Spain
Germany
United Kingdom

location_facility:
Academic Medical Centre
San Giovanni Battista Hospital
Universitatsklinikum Frankurt
Beajuon Hospital
Hospital Universitari Vall d'Hebrón
Royal Free Hospital
Hospital Clínic de Barcelona
Bologna University Hospital
Padova University Hospital


title: Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis In the Treatment of Abdominal Aortic Aneurysms

acronym: EXCeL

summary:
EVAR continues to evolve as a treatment option for AAA. New devices which are specifically designed to perform adequately across the spectrum of potential anatomic presentations for infrarenal EVAR are needed. The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the EXCeL Registry.

This study will assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis (CEXC Device) in patients who meet the IFU anatomic criteria (≥15mm proximal neck length and ≤90˚ proximal neck angulation; and ≥10mm proximal neck length and ≤60˚ proximal neck angulation) and in patients with challenging anatomic presentation that may present outside the IFU anatomic criteria. Successful outcomes from this study will provide evidence to support the CEXC Device as an option for expanding EVAR to a broader patient population with more challenging anatomic presentations.

ipd_sharing_description:
Data collected on each subject will be recorded on an online electronic CRF. A paper version of the CRFs may be printed at the sites to use as a working copy. Instructions for proper completion of the electronic CRF and how to use it online will be provided to the clinical site. The investigator or an authorized member of the investigational team must sign all completed CRFs, by using a unique signature code. This code will be provided to the user at the start of the study.

All records and other information about subjects participating in this registry will be treated as confidential. The sponsor, Department of Vascular Surgery, Catharina Hospital, Eindhoven, will collect data and monitors study records.Study data may be made available to third parties, e.g., in the case of an audit performed by regulatory authorities, provided the data are treated confidentially and that the subject's privacy is guaranteed.

lead_sponsor: Marc van Sambeek

location_facility:
Sant'Orsola Hospital
Complexo Hospitalario de Orense
APHP Hopital Européen
Klinikum Darmstadt
North Bristol NHS Trust
Catharina Hospital
San Martino Hospital
Rijnstate Hospital
San Carlos Hospital
Niels Stensen Kliniken
Blefast health and Social Care Trust


title: Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Implanted in Peripheral Vessels

acronym: EXPAND

summary: The primary objective of the VBX 17-04 registry is to collect post-market safety and performance data of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) in peripheral vessels in patients who require interventional treatment

lead_sponsor: W.L.Gore & Associates

location_country: Italy Netherlands France Spain Germany

location_facility: Azienda Ospedaliero-Universitaria di Padova

location_facility: University Hospital of Santiago de Compostela

location_facility: Azienda Ospedaliera Policlinico Sant'Orsola Malpighi

location_facility: Hospital Universitario Central de Asturias (HUCA)


title: A Phase 2, Double-blind, Active-controlled, Dose-titrating Efficacy and Safety Study of Firibastat Compared to Ramipril Administered Orally, Twice Daily, Over 12 Weeks to Prevent Left Ventricular Dysfunction After Acute MI

acronym: QUORUM

summary:
This is a multicenter, randomized, double-blind, active-controlled, dose-titrating phase 2 study to evaluate the safety and efficacy of firibastat administered orally BID (2 daily doses) versus ramipril administered orally BID over 12 weeks after acute anterior MI.

Subjects will be followed for 12 weeks (over 4 study visits). A total of 294 male and female subjects with a diagnosis of first acute anterior MI will be randomized. The subjects will need to have a primary percutaneous coronary intervention (PCI) of the index MI related artery within 24 hours after MI.

lead_sponsor: Quantum Genomics SA

location_country:
France
Poland
Slovakia
Hungary
Spain
Germany
United Kingdom

location_facility: NUSCH Bratislava Dpt. of Acute Cardiology

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II

location_facility: Groupe Hospitalier Pitie-Salpêtrière - Institut de Cardiologie


summary: AIMS-2-CT-01 is a randomized, double-blind, placebo controlled, study to explore the efficacy, safety and tolerability of Arbaclofen administered to children and adolescents (ages 5-17) for the treatment of social adaptive function in participants with ASD. The effects of Arbaclofen on social function in children and adolescents with ASD will be evaluated in a randomized, placebo controlled, parallel-group study of 16 weeks duration. Subjects who meet protocol criteria will be randomly allocated to receive either Arbaclofen or placebo in a 1:1 ratio in the Treatment Period. There will be 7 recruiting sites and randomization will be stratified by site. A sample of 130 patients will be recruited. Blinding will be maintained by utilizing identical tablets containing either Arbaclofen or placebo.

ReferenceCitation: Parellada M, San José Cáceres A, Palmer M, Delorme R, Jones EJH, Parr JR, Anagnostou E, Murphy DGM, Loth E, Wang PP, Charman T, Strydom A, Arango C. A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Arbaclofen Administered for the Treatment of Social Function in Children and Adolescents With Autism Spectrum Disorders: Study Protocol for AIMS-2-TRIALS-CT1. Front Psychiatry. 2021 Aug 24;12:701729. doi: 10.3389/fpsyt.2021.701729. eCollection 2021.

family: Parellada

full_name: Mara Parellada

given: Mara

family: San José Cáceres

full_name: Antonia San José Cáceres

given: Antonia

family: Palmer

full_name: Melanie Palmer

given: Melanie

family: Delorme

full_name: Richard Delorme

given: Richard

family: Jones

full_name: Emily J. H. Jones

given: Emily J. H.

family: Parr

full_name: Jeremy R. Parr

given: Jeremy R.

family: Anagnostou

full_name: Evdokia Anagnostou

given: Evdokia

family: Murphy

full_name: Declan G. M. Murphy

given: Declan G. M.

family: Loth

full_name: Eva Loth

given: Eva

family: Wang

full_name: Paul P. Wang

given: Paul P.

family: Charman

full_name: Tony Charman

given: Tony

family: Strydom

full_name: Andre Strydom

given: Andre

family: Arango

full_name: Celso Arango

given: Celso

currency_apc_doaj: USD

journal_name: Frontiers in Psychiatry

evidence: oa repository (via OAI-PMH doi match)

repository_institution: Newcastle Univesity - Newcastle University ePrints

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

lead_sponsor: Celso Arango, MD, PhD

location_facility: University of Salamanca & Complejo asistencial de Zamora

location_facility: Servicio de Psiquiatría del Niño y del Adolescente, Hospital General Universitario Gregorio Marañón, SERMAS


title: A Pragmatic, Randomized, Non-inferiority Trial Comparing the Effectiveness of Botulinum Toxin-based Treatment With Conventional Strabismus Surgery in Acquired Esotropia.

acronym: BISS

summary:
The purpose of the study is to evaluate if strabismus can be successfully treated requiring less surgical interventions with a Botox-based treatment regimen compared to a purely surgery based treatment regimen.

Experimental arm: Botulinum toxin injection in the horizontal extraocular muscles.

Control (active comparator) arm: Strabismus surgery on the horizontal extraocular muscles. No investigational product is used.

In Switzerland the standard procedure for treating large angle esotropia is surgery, which is performed on the horizontal eye muscles that may be either recessed or shortened leading to reduced or increased muscle function respectively.

As an alternative to strabismus surgery, botulinum toxin (Botox) can be applied in extraocular muscles. Botox prevents the release of acetylcholine in the synaptic cleft and thereby blocks the neuromuscular transmission thus inducing a palsy.

Current evidence on the use of Botox in strabismus is incoherent, is poorly supported by basic research findings and leaves dedicated clinicians in the dark. The objective is to shed light into this field of clinical research, which may help to guide future pediatric ophthalmologists in their management of strabismic patients. In a best case scenario, the results from this trial will prevent strabismus operation for many children with acquired large angle esotropia.

ReferenceCitation: Scott AB. Botulinum toxin injection into extraocular muscles as an alternative to strabismus surgery. Ophthalmology. 1980 Oct;87(10):1044-9.

ReferenceCitation: Tejedor J, Rodríguez JM. Early retreatment of infantile esotropia: comparison of reoperation and botulinum toxin. Br J Ophthalmol. 1999 Jul;83(7):783-7.

ReferenceCitation: Tejedor J, Rodríguez JM. Retreatment of children after surgery for acquired esotropia: reoperation versus botulinum injection. Br J Ophthalmol. 1998 Feb;82(2):110-4.

ReferenceCitation: Lee J, Harris S, Cohen J, Cooper K, MacEwen C, Jones S. Results of a prospective randomized trial of botulinum toxin therapy in acute unilateral sixth nerve palsy. J Pediatr Ophthalmol Strabismus. 1994 Sep-Oct;31(5):283-6.

ReferenceCitation: Carruthers JD, Kennedy RA, Bagaric D. Botulinum vs adjustable suture surgery in the treatment of horizontal misalignment in adult patients lacking fusion. Arch Ophthalmol. 1990 Oct;108(10):1432-5.

ReferenceCitation: de Alba Campomanes AG, Binenbaum G, Campomanes Eguiarte G. Comparison of botulinum toxin with surgery as primary treatment for infantile esotropia. J AAPOS. 2010 Apr;14(2):111-6. doi: 10.1016/j.jaapos.2009.12.162.

ReferenceCitation: McNeer KW, Tucker MG, Spencer RF. Botulinum toxin management of essential infantile esotropia in children. Arch Ophthalmol. 1997 Nov;115(11):1411-8.

ReferenceCitation: Lueder GT, Galli M, Tychsen L, Yildirim C, Pegado V. Long-term results of botulinum toxin-augmented medial rectus recessions for large-angle infantile esotropia. Am J Ophthalmol. 2012 Mar;153(3):560-3. doi: 10.1016/j.ajo.2011.08.019. Epub 2011 Oct 13.

ReferenceCitation: Gursoy H, Basmak H, Sahin A, Yildirim N, Aydin Y, Colak E. Long-term follow-up of bilateral botulinum toxin injections versus bilateral recessions of the medial rectus muscles for treatment of infantile esotropia. J AAPOS. 2012 Jun;16(3):269-73. doi: 10.1016/j.jaapos.2012.01.010.

ReferenceCitation: Baggesen K, Arnljot HM. Treatment of congenital esotropia with botulinum toxin type A. Acta Ophthalmol. 2011 Aug;89(5):484-8. doi: 10.1111/j.1755-3768.2009.01737.x. Epub 2009 Oct 30.

ReferenceCitation: Campos EC, Schiavi C, Bellusci C. Critical age of botulinum toxin treatment in essential infantile esotropia. J Pediatr Ophthalmol Strabismus. 2000 Nov-Dec;37(6):328-32; quiz 354-5.

ReferenceCitation: Biglan AW, Burnstine RA, Rogers GL, Saunders RA. Management of strabismus with botulinum A toxin. Ophthalmology. 1989 Jul;96(7):935-43.

ReferenceCitation: Kushner BJ, Morton GV. A randomized comparison of surgical procedures for infantile esotropia. Am J Ophthalmol. 1984 Jul 15;98(1):50-61.

ReferenceCitation: Helveston EM, Ellis FD, Schott J, Mitchelson J, Weber JC, Taube S, Miller K. Surgical treatment of congenital esotropia. Am J Ophthalmol. 1983 Aug;96(2):218-28.

ReferenceCitation: Scheiman M, Ciner E, Gallaway M. Surgical success rates in infantile esotropia. J Am Optom Assoc. 1989 Jan;60(1):22-31. Review.

ReferenceCitation: Hatt SR, Leske DA, Liebermann L, Holmes JM. Comparing outcome criteria performance in adult strabismus surgery. Ophthalmology. 2012 Sep;119(9):1930-6. doi: 10.1016/j.ophtha.2012.02.035. Epub 2012 Apr 26.

ReferenceCitation: Wan MJ, Mantagos IS, Shah AS, Kazlas M, Hunter DG. Comparison of Botulinum Toxin With Surgery for the Treatment of Acute-Onset Comitant Esotropia in Children. Am J Ophthalmol. 2017 Apr;176:33-39. doi: 10.1016/j.ajo.2016.12.024. Epub 2017 Jan 3.

ReferenceCitation: Dysli M, Keller F, Abegg M. Acute onset incomitant image disparity modifies saccadic and vergence eye movements. J Vis. 2015 Mar 18;15(3). pii: 12. doi: 10.1167/15.3.12.

ReferenceCitation: Dysli M, Abegg M. Gaze-dependent phoria and vergence adaptation. J Vis. 2016;16(3):2. doi: 10.1167/16.3.2.

ReferenceCitation: Mahan M, Engel JM. The resurgence of botulinum toxin injection for strabismus in children. Curr Opin Ophthalmol. 2017 Sep;28(5):460-464. doi: 10.1097/ICU.0000000000000408. Review.

ReferenceCitation: Pediatric Eye Disease Investigator Group, Christiansen SP, Chandler DL, Lee KA, Superstein R, de Alba Campomanes A, Bothun ED, Morin J, Wallace DK, Kraker RT. Tonic pupil after botulinum toxin-A injection for treatment of esotropia in children. J AAPOS. 2016 Feb;20(1):78-81. doi: 10.1016/j.jaapos.2015.09.011.

ReferenceCitation: Pehere N, Jalali S, Mathai A, Naik M, Ramesh K. Inadvertent intraocular injection of botulinum toxin A. J Pediatr Ophthalmol Strabismus. 2011 Jan 25;48 Online:e1-3. doi: 10.3928/01913913-20110118-06.

ReferenceCitation: Liu M, Lee HC, Hertle RW, Ho AC. Retinal detachment from inadvertent intraocular injection of botulinum toxin A. Am J Ophthalmol. 2004 Jan;137(1):201-2.

ReferenceCitation: Bradbury JA, Taylor RH. Severe complications of strabismus surgery. J AAPOS. 2013 Feb;17(1):59-63. doi: 10.1016/j.jaapos.2012.10.016. Epub 2013 Jan 23.

ReferenceCitation: Arès C, Superstein R. Retrobulbar hemorrhage following strabismus surgery. J AAPOS. 2006 Dec;10(6):594-5. Epub 2006 Oct 2.

ReferenceCitation: Rowe FJ, Noonan CP. Botulinum toxin for the treatment of strabismus. Cochrane Database Syst Rev. 2017 Mar 2;3:CD006499. doi: 10.1002/14651858.CD006499.pub4. Review.

ReferenceCitation: Lyons CJ, Tiffin PA, Oystreck D. Acute acquired comitant esotropia: a prospective study. Eye (Lond). 1999 Oct;13 ( Pt 5):617-20.

ReferenceCitation: BURIAN HM, MILLER JE. Comitant convergent strabismus with acute onset. Am J Ophthalmol. 1958 Apr;45(4 Pt 2):55-64.

ipd_sharing_description: The de-identified study dataset will be made publicly available for secondary analyses by publishing the data on a data sharing platform such as Dryad or BORIS, the public online data repository from the University of Bern.

location_country: France Switzerland

location_facility: Institut Ophtalmologique Sourdille Atlantique


status: Withdrawn

study_start_date_type: Anticipated

lead_sponsor: Gilead Sciences

location_country: Italy Spain France Poland

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Centre Hospitalier Régional Universitaire de Lille

title: Phase 1b Trial Evaluating Idelalisib in Children and Adolescents With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Mediastinal B-cell Lymphoma in Combination With RICE

summary: The primary objectives of this study are to evaluate safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of idelalisib; and to establish recommended phase 2 doses (RP2D) of idelalisib in combination with rituximab, ifosfamide, carboplatin, etoposide (RICE) in children and adolescents with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or mediastinal B-cell lymphoma (MBCL)


title: A Post Market Surveillance Multi-center Prospective Study to Evaluate the Safety and Efficacy of the VasQ External Support for Arteriovenous Fistula

acronym: VALUE

summary: This is a prospective single arm study enrolling patients who are scheduled for creation of a new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with upper arm AV fistula and 30 with forearm AV fistula. All patients will be implanted with the VasQ device, a subcutaneous arteriovenous conduit support for vascular access. The follow up period in this study will be for a duration of 12 months, with follow up visits scheduled at 1, 3, 6, 9, and 12 months.

ReferenceCitation: Chemla E, Velazquez CC, D'Abate F, Ramachandran V, Maytham G. Arteriovenous fistula construction with the VasQ™ external support device: a pilot study. J Vasc Access. 2016 May 7;17(3):243-8. doi: 10.5301/jva.5000527. Epub 2016 Apr 14.

lead_sponsor: Laminate Medical Technologies

location_country:
Germany
United Kingdom
France
Spain

location_facility: Harzklinikum Dorothea Christiane Erxleben

location_facility: Klinikum Ernst von Bergmann gemeinnützige GmbH


ReferenceCitation: McKone EF, Borowitz D, Drevinek P, Griese M, Konstan MW, Wainwright C, Ratjen F, Sermet-Gaudelus I, Plant B, Munck A, Jiang Y, Gilmartin G, Davies JC; VX08-770-105 (PERSIST) Study Group. Long-term safety and efficacy of ivacaftor in patients with cystic fibrosis who have the Gly551Asp-CFTR mutation: a phase 3, open-label extension study (PERSIST). Lancet Respir Med. 2014 Nov;2(11):902-910. doi: 10.1016/S2213-2600(14)70218-8. Epub 2014 Oct 9.

family: McKone

full_name: Edward F McKone

given: Edward F

family: Borowitz

full_name: Drucy Borowitz

given: Drucy

family: Drevinek

full_name: Pavel Drevinek

given: Pavel

family: Griese

full_name: Matthias Griese

given: Matthias

family: Konstan

full_name: Michael W Konstan

given: Michael W

family: Wainwright

full_name: Claire Wainwright

given: Claire

family: Ratjen

full_name: Felix Ratjen

given: Felix

family: Sermet-Gaudelus

full_name: Isabelle Sermet-Gaudelus

given: Isabelle

family: Plant

full_name: Barry Plant

given: Barry

family: Munck

full_name: Anne Munck

given: Anne

family: Jiang

full_name: Ying Jiang

given: Ying

family: Gilmartin

full_name: Geoffrey Gilmartin

given: Geoffrey

family: Davies

full_name: Jane C Davies

given: Jane C

journal_name: The Lancet Respiratory Medicine

title: Long-term safety and efficacy of ivacaftor in patients with cystic fibrosis who have the Gly551Asp- CFTR mutation: a phase 3, open-label extension study (PERSIST)

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
United States
United Kingdom
Germany
France
Ireland
Australia
Canada
Czech Republic

acronym: PERSIST

title: An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX-770 in Subjects With Cystic Fibrosis

summary: The primary objective of the study was to evaluate the safety of long-term VX-770 treatment in participants with cystic fibrosis (CF). The secondary objective of the study was to evaluate the efficacy of long-term VX-770 treatment in subjects with CF.


title: A Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder

acronym: ACES 263

summary: This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in subjects with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a treatment history for the current MDD episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant other than Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive symptom severity as assessed by the subject's self-report on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the investigator as part of the subject's medical and psychiatric history. An adequate trial is defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for combination treatments) at an approved dose as specified in the ATRQ.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
South Africa
Sweden
India
Croatia
France
Malaysia
Poland
Hungary
Spain
United States
Canada

location_facility:
Study Site 2
Study Site 1


ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Inc

primary_purpose: Basic Science

location_country:
Italy
Austria
United States
Sweden
United Kingdom
Germany
France
Bulgaria
Poland
Israel
Slovakia
Norway
Hungary
Belgium
Romania
Russian Federation
Spain
Turkey
Canada
Czech Republic

acronym: SHRINK

title: A Study to Evaluate the Overall Effect of Solifenacin 5mg and 10mg on Bladder Wall Thickness and Urinary Nerve Growth Factor in Female Subjects With Overactive Bladder and a Diagnosis of Detrusor Overactivity - A Double-blind, Randomised, Placebo-controlled, Parallel Group, Multi-centre Study.

summary: The purpose is to see if solifenacin has any effect on bladder wall thickness and urine inflammatory marker measurements after 12 weeks of treatment.


type: Registry Identifier

title: A One Year Open Label, Non-comparative Extension to a Randomized, Multicenter, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration (LIC) of Repeated Doses of 5-30mg/kg/Day ICL670 Relative to Deferoxamine (DFO) in Sickle Cell Disease (SCD) Patients With Transfusional Hemosideresis (THS) [Amendment 3: Extension Prolonged to 4-years]

summary: The safety, tolerability, effects on liver iron concentration and pharmacokinetics of ICL670 is studied in sickle cell disease patients with transfusional hemosiderosis.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
France
United States
United Kingdom
Canada

location_facility: University of Colorado Health Science Center

location_facility: University of South Alabama College of Medicine

location_facility: Grady Hospital, Georgia Comprehensive Sickle Cell Center

location_facility: Children's Hospital & Research Center at Oakland

location_facility: Children's Hospital of the King's Daughters


title: TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System

acronym: TRI-REPAIR

summary: The current management of tricuspid regurgitation (TR) is either conservative (by medication) or by surgery, usually in concomitant with other valves repair or replacement. TR can worsen or appear late after successful mitral valve surgery which portends a poor prognosis. However, standard surgical approaches requiring cardiopulmonary bypass and especially second surgery have an excessive risks. Thus many patients are denied surgery because of unfavorable risk-benefit balance. Therefore there is a need for novel devices enabling interventional cardiologists and cardiothoracic surgeons to perform tricuspid annuloplasty by transcatheter methods. Cardioband replicates established surgical techniques (e.g., annuloplasty) using transfemoral approach, without sutures and with adjusted on the beating heart. Similar to the approved indication for mitral annuloplasty. The Cardioband System is expected to allow for treatment of patients that would otherwise not undergo Tricuspid valve repair due to the invasiveness of current techniques.

ReferenceCitation: Nickenig G, Weber M, Schüler R, Hausleiter J, Nabauer M, von Bardeleben RS, Sotiriou E, Schäfer U, Deuschl F, Alessandrini H, Kreidel F, Juliard JM, Brochet E, Latib A, Montorfano M, Agricola E, Baldus S, Friedrichs KP, Deo SH, Gilmore SY, Feldman T, Hahn RT, Maisano F. Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study. EuroIntervention. 2021 Feb 5;16(15):e1264-e1271. doi: 10.4244/EIJ-D-20-01107.

family: Nickenig

full_name: Georg Nickenig

given: Georg

family: Weber

full_name: Marcel Weber

given: Marcel

family: Schüler

full_name: Robert Schüler

given: Robert

family: Hausleiter

full_name: Jörg Hausleiter

given: Jörg

family: Nabauer

full_name: Michael Nabauer

given: Michael

family: von Bardeleben

full_name: Ralph Stephan von Bardeleben

given: Ralph Stephan

family: Sotiriou

full_name: Efthymios Sotiriou

given: Efthymios

family: Schäfer

full_name: Ulrich Schäfer

given: Ulrich

family: Deuschl

full_name: Florian Deuschl

given: Florian

family: Alessandrini

full_name: Hannes Alessandrini

given: Hannes

family: Kreidel

full_name: Felix Kreidel

family: Juliard

full_name: Jean-Michel Juliard

given: Jean-Michel

family: Brochet

full_name: Eric Brochet

given: Eric

family: Latib

full_name: Azeem Latib

given: Azeem

family: Montorfano

full_name: Matteo Montorfano

given: Matteo

family: Agricola

full_name: Eustachio Agricola

given: Eustachio

family: Baldus

full_name: Stephan Baldus

given: Stephan

family: Friedrichs

full_name: Kai P. Friedrichs

given: Kai P.

family: Deo

full_name: Shekhar H. Deo

given: Shekhar H.

family: Gilmore

full_name: Suzanne Y. Gilmore

given: Suzanne Y.

family: Feldman

full_name: Ted Feldman

given: Ted

family: Hahn

full_name: Rebecca T. Hahn

given: Rebecca T.

family: Maisano

full_name: Francesco Maisano

given: Francesco

ReferenceCitation: Nickenig G, Weber M, Schueler R, Hausleiter J, Näbauer M, von Bardeleben RS, Sotiriou E, Schäfer U, Deuschl F, Kuck KH, Kreidel F, Juliard JM, Brochet E, Latib A, Agricola E, Baldus S, Friedrichs K, Vandrangi P, Verta P, Hahn RT, Maisano F. 6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation. J Am Coll Cardiol. 2019 Apr 23;73(15):1905-1915. doi: 10.1016/j.jacc.2019.01.062.

journal_name: Journal of the American College of Cardiology

location_facility: Universitätsklinik Hamburg Eppendorf, Herzzentrum

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: LMU Klinikum der Universität München, Medizinische Klinik I

location_facility: Bonn University - Universitätsklinikum Bonn


title: Exploratory Phase II Study in Patients After Treatment of High Grade Brain Tumors to Assess the Technical Performance of Tc-99m Tetrofosmin for Differentiation of Recurrence Versus Radiation Necrosis

summary: This study aims to assess the technical performance of Tc-99m tetrofosmin SPECT as compared to F-18 FDG PET for the differentiation of radiation necrosis from glioma relapse and to obtain estimates of diagnostic accuracy for Tc-99m tetrofosmin SPECT and F-18 FDG PET in an intra-individual comparison.

primary_purpose: Diagnostic

lead_sponsor: Proactina S.A.

location_country: Hungary France

location_facility: Országos Klinikai Idegtudományi Intézet (OKITI)

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum

location_facility: Service de Neurologie Mazarin Hôpital Pitié-Salpêtrière


title: An Open-label, Non-randomised, Phase I Study to Assess the Effect of Single and Multiple Oral Doses of Osimertinib (TAGRISSO™) on the Pharmacokinetics of a P-glycoprotein Probe Drug (Fexofenadine) in Patients With Advanced EGFRm NSCLC That Have Progressed on a Prior EGFR-TKI Regimen

summary:
This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase inhibitor (TKI) agent.

Part A will assess the effect of osimertinib on the pharmacokinetic (PK) parameters of fexofenadine, following single and multiple oral dosing of osimertinib in a fasted state.

Continuous Access will allow patients further access to osimertinib after the PK phase (Part A). All patients from Part A who completed treatment may continue to receive osimertinib 80 mg once daily until: they are no longer deriving clinical benefit; or any other reason

status: Active, not recruiting

ReferenceCitation: Calvo E, Lee JS, Kim SW, Moreno V, deCastro Carpeno J, Weilert D, Laus G, Mann H, Vishwanathan K. Modulation of Fexofenadine Pharmacokinetics by Osimertinib in Patients With Advanced EGFR-Mutated Non-Small Cell Lung Cancer. J Clin Pharmacol. 2019 Aug;59(8):1099-1109. doi: 10.1002/jcph.1403. Epub 2019 Mar 15.

name: START Madrid ‐ CIOCCCentro Integral Oncológico Clara CampalHospital Madrid Norte Sanchinarro Madrid Spain

family: Calvo

full_name: Emiliano Calvo

given: Emiliano

name: Department of Internal MedicineSeoul National University Bundang Hospital Seongnam South Korea

family: Lee

full_name: Jong‐Seok Lee

given: Jong‐Seok

name: Department of OncologyAsan Medical Center Seoul South Korea

family: Kim

full_name: Sang‐We Kim

given: Sang‐We

name: START MADRID ‐ FJDHospital Fundación Jiménez Díaz Madrid Spain

family: Moreno

full_name: Victor Moreno

given: Victor

name: Hospital Universitario La Paz Madrid Spain

family: Carpeno

full_name: Javier Carpeno

given: Javier

family: Weilert

full_name: Doris Weilert

given: Doris

name: QCPEarly Clinical DevelopmentIMED Biotech UnitAstraZeneca Waltham MA USA

family: Laus

full_name: Gianluca Laus

given: Gianluca

family: Mann

full_name: Helen Mann

given: Helen

family: Vishwanathan

full_name: Karthick Vishwanathan

given: Karthick

journal_name: The Journal of Clinical Pharmacology

title: Modulation of Fexofenadine Pharmacokinetics by Osimertinib in Patients With Advanced EGFR‐Mutated Non–Small Cell Lung Cancer

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: AstraZeneca

location_country:
Korea, Republic of
France
Spain


title: A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)

summary: To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Austria
United States
Germany
France
Australia
Canada


title: Multicenter Phase 2 Trial of ARQ 197 for Subjects With Relapsed or Refractory Germ Cell Tumors

summary: This is a multicenter, single-arm study for safety and efficacy.

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
United States
United Kingdom
France


title: A Phase II, Open-label, 1:1 Randomized, Controlled Trial Exploring the Efficacy of EMD 1201081 in Combination With Cetuximab in Second-Line Cetuximab-Naïve Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)

summary:
The purpose of this study is to determine if EMD 1201081 in combination with cetuximab is more efficient than cetuximab alone to control the cancer.

EMD 1201081 is an immune modulatory oligonucleotide (IMO) containing phosphorothioate oligodeoxynucleotide and acts as an agonist of Toll-like receptor 9 (TLR9).

EMD 1201081 has been studied in six clinical trials in over 170 subjects either as a monotherapy or in combination with chemotherapeutic agents or targeted therapies. Two studies have been conducted in healthy volunteers. In the other five studies, subjects with advanced solid tumors, renal cell carcinoma, non-small cell lung cancer and colorectal cancer have been treated with EMD 1201081. Two studies are still ongoing. Future clinical development of EMD 1201081 will focus on colorectal cancer (CRC) and squamous cell cancer of the head and neck (SCCHN).

In this Phase 2 study, subjects with recurrent or metastatic squamous cell cancer of the head and neck (R/M SCCHN), will be treated with cetuximab plus EMD 1201081 or cetuximab alone. The study will be conducted as a multicenter study in several European Union (EU) member states and the Unites States.

EMD 1201081 in combination with cetuximab will be evaluated for antitumor activity in subjects by examining its effects on accepted clinical endpoints. Progression-free survival (PFS) will be evaluated in subjects treated with EMD 1201081 plus cetuximab compared to cetuximab alone in cetuximab-naïve subjects with R/M SCCHN who have progressed on a cytotoxic therapy.

Cetuximab, approved in colorectal cancer and SCCHN in combination with platinum-based chemotherapy and SCCHN in combination with radiotherapy in the EU, will be provided as investigational medicinal product (IMP) in this study. Commercially available Cetuximab will be provided in the United States.

ReferenceCitation: Ruzsa A, Sen M, Evans M, Lee LW, Hideghety K, Rottey S, Klimak P, Holeckova P, Fayette J, Csoszi T, Erfan J, Forssmann U, Goddemeier T, Bexon A, Nutting C; NA EMD 1201081 Study Group. Phase 2, open-label, 1:1 randomized controlled trial exploring the efficacy of EMD 1201081 in combination with cetuximab in second-line cetuximab-naïve patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). Invest New Drugs. 2014 Dec;32(6):1278-84. doi: 10.1007/s10637-014-0117-2. Epub 2014 Jun 4.

family: Ruzsa

full_name: A. Ruzsa

given: A.

family: Sen

full_name: M. Sen

given: M.

family: Evans

full_name: M. Evans

full_name: L. W. Lee

given: L. W.

family: Hideghety

full_name: K. Hideghety

given: K.

family: Rottey

full_name: S. Rottey

given: S.

family: Klimak

full_name: P. Klimak

given: P.

family: Holeckova

full_name: P. Holeckova

family: Fayette

full_name: J. Fayette

given: J.

family: Csoszi

full_name: T. Csoszi

given: T.

family: Erfan

full_name: J. Erfan

family: Forssmann

full_name: U. Forssmann

given: U.

family: Goddemeier

full_name: T. Goddemeier

family: Bexon

full_name: A. Bexon

family: Nutting

full_name: C. Nutting

given: C.

journal_name: Investigational New Drugs

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: EMD Serono

location_country:
United Kingdom
France
Poland
Slovakia
Hungary
Belgium
United States
Czech Republic

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: SPZOZ Centrum Onkologi Liemi Lubelskiej, II Odzial Radioterapiii z pododdzialem Chemioterpii

location_facility: Szegedi Tudomayegyetem Altalanos Orvostudomanyi Kar Onkoterapias Klinika

location_facility: University of Kentucky, Markey Cancer Center

location_facility: Centrum Onkologi - Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworow Glowy i Szyi (NCI)

location_facility: Zala Megyei Kohaz Kulsokorhaz Onkologia Osztaly

location_facility: Ustav radiacni onkologie Fakultni nemacnice Na Bulovce

location_facility: Zaklad Opleki Zdrowotnej MSWIA z Warminsko-Mazurskim Centrum Onkologil, Oddziat Chemioterapli

location_facility: Southampton University Hospitals NHS Trust


ReferenceCitation: Dal Negro RW, Wedzicha JA, Iversen M, Fontana G, Page C, Cicero AF, Pozzi E, Calverley PMA; RESTORE group; RESTORE study. Effect of erdosteine on the rate and duration of COPD exacerbations: the RESTORE study. Eur Respir J. 2017 Oct 12;50(4). pii: 1700711. doi: 10.1183/13993003.00711-2017. Print 2017 Oct.

family: Dal Negro

full_name: Roberto W. Dal Negro

given: Roberto W.

family: Wedzicha

full_name: Jadwiga A. Wedzicha

given: Jadwiga A.

family: Iversen

full_name: Martin Iversen

given: Martin

family: Fontana

full_name: Giovanni Fontana

given: Giovanni

family: Page

full_name: Clive Page

given: Clive

family: Cicero

full_name: Arrigo F. Cicero

given: Arrigo F.

family: Pozzi

full_name: Edoardo Pozzi

given: Edoardo

family: Calverley

full_name: Peter M.A. Calverley

given: Peter M.A.

journal_name: European Respiratory Journal

oa_colors: green hybrid

evidence: open (via free pdf)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Florence - Florence Research

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

status: Unknown status

lead_sponsor: Edmond Pharma

location_country:
Italy
United Kingdom
France
Bulgaria
Poland
Slovakia
Romania
Belgium
Denmark
Czech Republic

acronym: RESTORE

location_facility: Clinica Pneumologie I, Spitalul Clinic Judetean Mureş

location_facility: Department of Respiratory Medicine, Faculty Hospital

location_facility: Katedra i klinika Pulmonologii, Uniwersytet Medyczny

location_facility: Campus Gasthuisberg Dep.t Longfunctiemetingen

location_facility: Ospedale Careggi, Malattie dell'Apparato Respiratorio

location_facility: Specializovana NemocnicaSvorada Zobor n.o.

location_facility: Service de Pneumologie, Hopital Bois-Guillaume

location_facility: Spitalul de Pneumoftiziologie "Leon Daniello"

location_facility: Regional Respiratory Centre, Belfast City Hospital

location_facility: Department of Respiratory Diseases, Copenhagen University Hospital

location_facility: Clinic for emergency Medicine and Intensive care, Pneumology and Physiatry

location_facility: Ospedale San Carlo Borromeo, Dipartimento Broncocardiopneumologico

location_facility: UOC di Pneumologia-Ospedale Mater Salutis

location_facility: Klinika Pulmonologii II Katedry, Collegium Medicum Uniwersytetu

location_facility: UOC di Pneumologia- Ospedale Civile di Massa e Carrara

location_facility: Katedra i Klinika Pneumonologii, Warszawski Uniwersytet Medyczny

location_facility: Nemocnica s Poliklinicou "Svateho Jakuba"n.o.

location_facility: Institutul de Pneumoftiziologie "Marius Nasta"

location_facility: Katedra Pulmunologii i Alergologii, Klinika Gruźlicy Uniwersytetu Medycznego

location_facility: Aintree Chest Centre, University Hospital Aintree

location_facility: Cardiovascular and Respiratory Studies Department

location_facility: Spitalul de Pneumoftiziologie "Victor Babes"

location_facility: Clinic of Pulmonary Disease-Military Medical Academy

title: The Efficacy and Safety of Erdosteine in the Long-term Therapy of Chronic Obstructive Pulmonary Disease (COPD). A 12-month, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study

summary: The aim of the study is to evaluate the effect of erdosteine, compared to placebo, on exacerbation rate over a 12-month treatment period in patients with moderate-to-severe COPD. Moreover, the effects of erdosteine on pulmonary function parameters, clinical symptoms and quality of life, and the long-term safety of the drug will be assessed.


title: A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma (TIVO-1)

summary: This is an open-label, randomized, controlled, multi-national, multi-center, parallel-arm trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health outcome measurements of tivozanib and sorafenib.

lead_sponsor: AVEO Pharmaceuticals, Inc.

location_country:
Italy
United States
Chile
India
Serbia
France
Bulgaria
Czechia
Poland
Romania
Hungary
Argentina
Russian Federation
Canada
United Kingdom
Ukraine

location_facility:
Site 421
Site 170
Site 411
Site 482
Site 466
Site 180
Site 110
Site 403
Site 156
Site 152
Site 173
Site 154
Site 151
Site 102
Site 130
Site 490
Site 443
Site 459
Site 150
Site 481
Site 453
Site 462
Site 435
Site 441
Site 404
Site 461
Site 431
Site 440
Site 494
Site 187
Site 458
Site 436
Site 121
Site 157
Site 483
Site 153
Site 401
Site 423
Site 133
Site 495
Site 191
Site 444
Site 455
Site 402
Site 496
Site 424
Site 454
Site 400
Site 185
Site 422
Site 172
Site 432
Site 433
Site 430
Site 442
Site 184
Site 158
Site 460
Site 463
Site 160
Site 123
Site 452
Site 186
Site 457
Site 468
Site 480
Site 492
Site 465
Site 155
Site 491
Site 122
Site 434
Site 498
Site 497
Site 161
Site 467
Site 451
Site 464
Site 159
Site 484
Site 162
Site 493
Site 450
Site 182
Site 456
Site 190


ReferenceCitation: Powell JS, Pasi KJ, Ragni MV, Ozelo MC, Valentino LA, Mahlangu JN, Josephson NC, Perry D, Manco-Johnson MJ, Apte S, Baker RI, Chan GC, Novitzky N, Wong RS, Krassova S, Allen G, Jiang H, Innes A, Li S, Cristiano LM, Goyal J, Sommer JM, Dumont JA, Nugent K, Vigliani G, Brennan A, Luk A, Pierce GF; B-LONG Investigators. Phase 3 study of recombinant factor IX Fc fusion protein in hemophilia B. N Engl J Med. 2013 Dec 12;369(24):2313-23. doi: 10.1056/NEJMoa1305074. Epub 2013 Dec 4.

family: Powell

full_name: Jerry S. Powell

given: Jerry S.

family: Pasi

full_name: K. John Pasi

given: K. John

family: Ragni

full_name: Margaret V. Ragni

given: Margaret V.

family: Ozelo

full_name: Margareth C. Ozelo

given: Margareth C.

family: Valentino

full_name: Leonard A. Valentino

given: Leonard A.

family: Mahlangu

full_name: Johnny N. Mahlangu

given: Johnny N.

family: Josephson

full_name: Neil C. Josephson

given: Neil C.

family: Perry

full_name: David Perry

given: David

family: Manco-Johnson

full_name: Marilyn J. Manco-Johnson

given: Marilyn J.

family: Apte

full_name: Shashikant Apte

given: Shashikant

family: Baker

full_name: Ross I. Baker

given: Ross I.

family: Chan

full_name: Godfrey C. Chan

given: Godfrey C.

family: Novitzky

full_name: Nicolas Novitzky

given: Nicolas

family: Wong

full_name: Raymond S. Wong

given: Raymond S.

family: Krassova

full_name: Snejana Krassova

given: Snejana

family: Allen

full_name: Geoffrey Allen

given: Geoffrey

family: Jiang

full_name: Haiyan Jiang

given: Haiyan

family: Innes

full_name: Alison Innes

given: Alison

family: Li

full_name: Shuanglian Li

given: Shuanglian

family: Cristiano

full_name: Lynda M. Cristiano

given: Lynda M.

family: Goyal

full_name: Jaya Goyal

given: Jaya

family: Sommer

full_name: Jurg M. Sommer

given: Jurg M.

family: Dumont

full_name: Jennifer A. Dumont

given: Jennifer A.

family: Nugent

full_name: Karen Nugent

given: Karen

family: Vigliani

full_name: Gloria Vigliani

given: Gloria

repository_institution: Queen Mary University of London - Queen Mary Research Online

title: Phase 3 Study of Recombinant Factor IX Fc Fusion Protein in Hemophilia B

location_country:
Italy
United States
Brazil
South Africa
India
Sweden
Hong Kong
Germany
France
Japan
Poland
Belgium
Australia
Russian Federation
China
Canada
United Kingdom

location_facility:
Research site
Ressearch Site
Research Site

title: B-LONG: An Open-Label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant, Long-acting Coagulation Factor IX Fc Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia B

summary: The primary objectives of the study were: to evaluate the safety and tolerability of rFIXFc; to evaluate the efficacy of rFIXFc in all treatment arms; to evaluate the effectiveness of prophylaxis over on-demand (episodic) therapy by comparing the annualized number of bleeding episodes between participants receiving rFIXFc on each prevention (prophylaxis) regimen and participants receiving rFIXFc on an episodic regimen. The secondary objectives of the study were: to evaluate and assess the pharmacokinetic (PK) parameter estimates of rFIXFc and rFIX (BeneFIX®) at baseline in the Sequential PK subgroup as well as rFIXFc at Week 26 (±1 week); to evaluate participants' response to treatment; to evaluate rFIXFc consumption.


ReferenceCitation: Seibyl J, Catafau AM, Barthel H, Ishii K, Rowe CC, Leverenz JB, Ghetti B, Ironside JW, Takao M, Akatsu H, Murayama S, Bullich S, Mueller A, Koglin N, Schulz-Schaeffer WJ, Hoffmann A, Sabbagh MN, Stephens AW, Sabri O. Impact of Training Method on the Robustness of the Visual Assessment of 18F-Florbetaben PET Scans: Results from a Phase-3 Study. J Nucl Med. 2016 Jun;57(6):900-6. doi: 10.2967/jnumed.115.161927. Epub 2016 Jan 28.

family: Seibyl

full_name: John Seibyl

given: John

family: Catafau

full_name: Ana M. Catafau

given: Ana M.

family: Barthel

full_name: Henryk Barthel

given: Henryk

family: Ishii

full_name: Kenji Ishii

given: Kenji

family: Rowe

full_name: Christopher C. Rowe

given: Christopher C.

family: Leverenz

full_name: James B. Leverenz

given: James B.

family: Ghetti

full_name: Bernardino Ghetti

given: Bernardino

family: Ironside

full_name: James W. Ironside

given: James W.

family: Takao

full_name: Masaki Takao

given: Masaki

family: Akatsu

full_name: Hiroyasu Akatsu

given: Hiroyasu

family: Murayama

full_name: Shigeo Murayama

given: Shigeo

family: Bullich

full_name: Santiago Bullich

given: Santiago

family: Mueller

full_name: Andre Mueller

given: Andre

family: Koglin

full_name: Norman Koglin

given: Norman

family: Schulz-Schaeffer

full_name: Walter J. Schulz-Schaeffer

given: Walter J.

family: Hoffmann

full_name: Anja Hoffmann

given: Anja

family: Sabbagh

full_name: Marwan N. Sabbagh

given: Marwan N.

family: Stephens

full_name: Andrew W. Stephens

given: Andrew W.

family: Sabri

full_name: Osama Sabri

given: Osama

journal_name: Journal of Nuclear Medicine

oa_colors: green other

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repository_institution: Indiana University - IUScholarWorks

version: submittedVersion

ReferenceCitation: Sabri O, Sabbagh MN, Seibyl J, Barthel H, Akatsu H, Ouchi Y, Senda K, Murayama S, Ishii K, Takao M, Beach TG, Rowe CC, Leverenz JB, Ghetti B, Ironside JW, Catafau AM, Stephens AW, Mueller A, Koglin N, Hoffmann A, Roth K, Reininger C, Schulz-Schaeffer WJ; Florbetaben Phase 3 Study Group. Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: phase 3 study. Alzheimers Dement. 2015 Aug;11(8):964-74. doi: 10.1016/j.jalz.2015.02.004. Epub 2015 Mar 28.

name: Department of Nuclear Medicine University of Leipzig  Leipzig Germany

name: Banner Sun Health Research Institute  Sun City AZ USA

name: Molecular Neuroimaging LLC  New Haven CT USA

name: Department of Community‐based Medicine Nagoya City University Graduate School of Medical Sciences  Nagoya City Aichi Japan

name: Department of Neurology Nagoya City University Graduate School of Medical Sciences  Nagoya City Aichi Japan

name: Department of Biofunctional Imaging Medical Photonics Research Center Hamamatsu University School of Medicine  Hamamatsu Japan

name: Department of Neurology and Neuropathology Tokyo Metropolitan Geriatric Hospital & Institute of Gerontology  Tokyo Japan

name: Tokyo Metropolitan Institute of Gerontology  Tokyo Japan

name: Department of Molecular Imaging, Austin Health University of Melbourne  Melbourne VIC Australia

name: VA‐Puget Sound Health Care System and University of Washington  Seattle WA USA

name: Department of Pathology and Laboratory Medicine Indiana University School of Medicine  Indianapolis IN USA

name: Centre for Clinical Brain Sciences University of Edinburgh  Edinburgh Scotland

name: Department of Neuropathology University Medical Center Göttingen  Göttingen Germany

title: Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: Phase 3 study

location_country:
United States
France
Japan
Australia
Germany

acronym: Safety and efficacy of positron emission tomography imaging with BAY 94-9172 (ZK 6013443)

title: An Open-label, Non-randomized Study to Evaluate the Efficacy and Safety of BAY94-9172 (ZK 6013443) Positron Emission Tomography (PET) Imaging for Detection/Exclusion of Cerebral Beta-amyloid When Compared to Postmortem Histopathology

summary: To determine the sensitivity and specificity of the visual assessment of tracer uptake in the Florbetaben PET images compared to histological verification of the presence or absence of cerebral β-amyloid in the respective histopathologic post mortem specimens as the standard of truth


title: Care for Late Stage Parkinsonism

acronym: CLaSP

summary: The aim of this project is to evaluate the needs and provision of care for patients in the late stages of Parkinsonism and their carers in several European countries, to compare the effectiveness of different health and social care systems, and to lay the foundation for improved outcomes in this population. The investigators will undertake an in-depth assessment of patients and their care arrangements in a population recruited through networks in six European countries. The systems and procedures that are used in the provision of care will be reviewed through a systematic literature review, interviews and assessments of patients, carers and health care providers, and through a trial comparing assessment by a specialist with management suggestions, guidance and access to telephone advice to that of usual care. Through interviews, questionnaire assessment and review of current health-care and social care arrangement, the investigators will assess the needs, provision of care and use of health-care resources, and their impact on patient and carer outcomes in different countries. National and regional databases will also be interrogated to identify current practice and use of healthcare resources and drug usage. A systematic literature review of the evidence for effective management strategies, analysis of the study data, and evaluation of change in outcomes following specialist review will provide the basis for recommendations in the management of late stage Parkinsonism. The investigators will also evaluate potentially useful outcome measures for use in this patient group. In addition to charting the needs and current care provision for late stage Parkinsonism in different European countries, its cost and effectiveness, and an analysis of health-care and social care predictors of improved outcome, the project will produce a platform for the assessment of patients with late stage Parkinsonism, their current treatment and care provision, as well as guidelines on the management of this late disease phase.

ReferenceCitation: Kruse C, Kretschmer S, Lipinski A, Verheyen M, Mengel D, Balzer-Geldsetzer M, Lorenzl S, Richinger C, Schmotz C, Tönges L, Woitalla D, Klebe S, Schrag A, Dodel R. Resource Utilization of Patients with Parkinson's Disease in the Late Stages of the Disease in Germany: Data from the CLaSP Study. Pharmacoeconomics. 2021 May;39(5):601-615. doi: 10.1007/s40273-021-01011-y. Epub 2021 Mar 19.

family: Kruse

full_name: Christopher Kruse

given: Christopher

family: Kretschmer

full_name: Sabrina Kretschmer

given: Sabrina

family: Lipinski

full_name: Anna Lipinski

given: Anna

family: Verheyen

full_name: Malte Verheyen

given: Malte

family: Mengel

full_name: David Mengel

given: David

family: Balzer-Geldsetzer

full_name: Monika Balzer-Geldsetzer

given: Monika

family: Lorenzl

full_name: Stefan Lorenzl

given: Stefan

family: Richinger

full_name: Carmen Richinger

given: Carmen

family: Schmotz

full_name: Christian Schmotz

given: Christian

family: Tönges

full_name: Lars Tönges

given: Lars

family: Woitalla

full_name: Dirk Woitalla

given: Dirk

family: Klebe

full_name: Stephan Klebe

given: Stephan

family: Schrag

full_name: Anette Schrag

given: Anette

family: Dodel

full_name: Richard Dodel

given: Richard

journal_name: PharmacoEconomics

evidence: open (via crossref license)

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_institution: University College London - UCL Discovery

title: Resource Utilization of Patients with Parkinson’s Disease in the Late Stages of the Disease in Germany: Data from the CLaSP Study

ReferenceCitation: Balzer-Geldsetzer M, Ferreira J, Odin P, Bloem BR, Meissner WG, Lorenzl S, Wittenberg M, Dodel R, Schrag A. Study protocol: Care of Late-Stage Parkinsonism (CLaSP): a longitudinal cohort study. BMC Neurol. 2018 Nov 5;18(1):185. doi: 10.1186/s12883-018-1184-3.

apc_source: openAPC

family: Ferreira

full_name: Joaquim Ferreira

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

location_country:
Sweden
Netherlands
France
Portugal
Germany
United Kingdom

location_facility:
University of Marburg
Radboud university medical center
Instituto de Medicina Molecular
University of Bordeaux
University College London
University of Munich
Lund University


title: The EUROpean and Asian Cardiac and Renal Remote Ischemic Pre-conditioning Study : A Prospective, Randomized Control Trial

acronym: EUROCRIPS

summary: The purpose of the present study is to determine if remote ischemic preconditioning reduces incidence of acute kidney injury in patients with reduced kidney function undergoing Percutaneous Coronary Intervention.

ReferenceCitation: D'Ascenzo F, Femminò S, Ravera F, Angelini F, Caccioppo A, Franchin L, Grosso A, Comità S, Cavallari C, Penna C, De Ferrari GM, Camussi G, Pagliaro P, Brizzi MF. Extracellular vesicles from patients with Acute Coronary Syndrome impact on ischemia-reperfusion injury. Pharmacol Res. 2021 Aug;170:105715. doi: 10.1016/j.phrs.2021.105715. Epub 2021 Jun 7.

family: D’Ascenzo

full_name: Fabrizio D’Ascenzo

given: Fabrizio

family: Femminò

full_name: Saveria Femminò

given: Saveria

family: Ravera

full_name: Francesco Ravera

given: Francesco

family: Angelini

full_name: Filippo Angelini

given: Filippo

family: Caccioppo

full_name: Andrea Caccioppo

given: Andrea

family: Franchin

full_name: Luca Franchin

given: Luca

family: Grosso

full_name: Alberto Grosso

given: Alberto

family: Comità

full_name: Stefano Comità

given: Stefano

family: Cavallari

full_name: Claudia Cavallari

given: Claudia

family: Penna

full_name: Claudia Penna

family: De Ferrari

full_name: Gaetano Maria De Ferrari

given: Gaetano Maria

family: Camussi

full_name: Giovanni Camussi

given: Giovanni

family: Pagliaro

full_name: Pasquale Pagliaro

given: Pasquale

family: Brizzi

full_name: Maria Felice Brizzi

given: Maria Felice

journal_name: Pharmacological Research

repository_institution: University of Turin - Institutional Research Information System University of Turin

ReferenceCitation: Moretti C, Cerrato E, Cavallero E, Lin S, Rossi ML, Picchi A, Sanguineti F, Ugo F, Palazzuoli A, Bertaina M, Presbitero P, Shao-Liang C, Pozzi R, Giammaria M, Limbruno U, Lefèvre T, Gasparetto V, Garbo R, Omedè P, Sheiban I, Escaned J, Biondi-Zoccai G, Gaita F, Perl L, D'Ascenzo F. The EUROpean and Chinese cardiac and renal Remote Ischemic Preconditioning Study (EURO-CRIPS CardioGroup I): A randomized controlled trial. Int J Cardiol. 2018 Apr 15;257:1-6. doi: 10.1016/j.ijcard.2017.12.033.

family: Moretti

full_name: Claudio Moretti

given: Claudio

family: Cerrato

full_name: Enrico Cerrato

given: Enrico

family: Cavallero

full_name: Erika Cavallero

given: Erika

family: Lin

full_name: Song Lin

given: Song

lead_sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Unità Operativa di Cardiologia Presidio Ospedaliero Misericordia Via Senese 161 58100 Grosseto

location_facility: Institut Cardiovasculaire Paris Sud Hôpital Jacques Cartier


title: A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Patients With Advanced Solid Malignancies

summary: This study is primarily designed to assess the safety and tolerability of AZD4547 at increasing doses in patients with advanced solid malignancies and for whom no standard medication options are available. It also assesses the blood levels and action of AZD4547 in the body over a period of time.

location_country:
Italy
United States
Netherlands
France
Spain
Germany
United Kingdom


ReferenceCitation: Poewe W, Seppi K, Fitzer-Attas CJ, Wenning GK, Gilman S, Low PA, Giladi N, Barone P, Sampaio C, Eyal E, Rascol O; Rasagiline-for-MSA investigators. Efficacy of rasagiline in patients with the parkinsonian variant of multiple system atrophy: a randomised, placebo-controlled trial. Lancet Neurol. 2015 Feb;14(2):145-52. doi: 10.1016/S1474-4422(14)70288-1. Epub 2014 Dec 8.

family: Poewe

full_name: Werner Poewe

given: Werner

family: Seppi

full_name: Klaus Seppi

given: Klaus

family: Fitzer-Attas

full_name: Cheryl J Fitzer-Attas

given: Cheryl J

family: Wenning

full_name: Gregor K Wenning

given: Gregor K

family: Gilman

full_name: Sid Gilman

given: Sid

family: Low

full_name: Phillip A Low

given: Phillip A

family: Giladi

full_name: Nir Giladi

given: Nir

family: Barone

full_name: Paolo Barone

given: Paolo

family: Sampaio

full_name: Cristina Sampaio

given: Cristina

family: Eyal

full_name: Eli Eyal

given: Eli

family: Rascol

full_name: Olivier Rascol

given: Olivier

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Italy
Austria
Netherlands
Spain
Germany
France
Israel
Hungary
Portugal
United States
United Kingdom
Canada

location_facility:
Teva Investigational Site 1005
Teva Investigational Site 8003
Teva Investigational Site 3203
Teva Investigational Site 3801
Teva Investigational Site 3305
Teva Investigational Site 3204
Teva Investigational Site 8002
Teva Investigational Site 1061
Teva Investigational Site 3201
Teva Investigational Site 1006
Teva Investigational Site 1002
Teva Investigational Site 3004
Teva Investigational Site 3202
Teva Investigational Site 3802
Teva Investigational Site 1109
Teva Investigational Site 3205
Teva Investigational Site 1108
Teva Investigational Site 3206
Teva Investigational Site 1012
Teva Investigational Site 1001
Teva Investigational Site 1110
Teva Investigational Site 1009
Teva Investigational Site 5103
Teva Investigational Site 3006
Teva Investigational Site 3101
Teva Investigational Site 3102
Teva Investigational Site 3402
Teva Investigational Site 8004
Teva Investigational Site 3401
Teva Investigational Site 1011
Teva Investigational Site 3005
Teva Investigational Site 1111
Teva Investigational Site 3403
Teva Investigational Site 3502
Teva Investigational Site 3103
Teva Investigational Site 1007
Teva Investigational Site 1014
Teva Investigational Site 1003
Teva Investigational Site 3503
Teva Investigational Site 1013
Teva Investigational Site 1010
Teva Investigational Site 3603
Teva Investigational Site 1004
Teva Investigational Site 3304
Teva Investigational Site 5101
Teva Investigational Site 1008
Teva Investigational Site 5102

title: A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients With Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)

summary: To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype.


title: A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine as Compared With the Combination of Insulin Glargine and Preprandial Lispro Insulin in Subjects With Type 2 Diabetes Mellitus

summary: This study will examine the safety and efficacy of albiglutide in combination with insulin glargine as compared with the combination of insulin glargine and preprandial lispro insulin in subjects with type 2 diabetes.

ReferenceCitation: Rosenstock J, Fonseca VA, Gross JL, Ratner RE, Ahrén B, Chow FC, Yang F, Miller D, Johnson SL, Stewart MW, Leiter LA; Harmony 6 Study Group. Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial insulin lispro. Diabetes Care. 2014 Aug;37(8):2317-25. doi: 10.2337/dc14-0001. Epub 2014 Jun 4.

family: Rosenstock

full_name: Julio Rosenstock

given: Julio

family: Fonseca

full_name: Vivian A. Fonseca

given: Vivian A.

family: Gross

full_name: Jorge L. Gross

given: Jorge L.

family: Ratner

full_name: Robert E. Ratner

given: Robert E.

family: Ahrén

full_name: Bo Ahrén

given: Bo

family: Chow

full_name: Francis C.C. Chow

given: Francis C.C.

family: Yang

full_name: Fred Yang

given: Fred

family: Miller

full_name: Diane Miller

given: Diane

family: Johnson

full_name: Susan L. Johnson

given: Susan L.

family: Stewart

full_name: Murray W. Stewart

given: Murray W.

family: Leiter

full_name: Lawrence A. Leiter

given: Lawrence A.

journal_name: Diabetes Care

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Advancing Basal Insulin Replacement in Type 2 Diabetes Inadequately Controlled With Insulin Glargine Plus Oral Agents: A Comparison of Adding Albiglutide, a Weekly GLP-1 Receptor Agonist, Versus Thrice-Daily Prandial Insulin Lispro

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Brazil
Peru
South Africa
India
Hong Kong
Mexico
Philippines
Germany
France
Spain
United States
United Kingdom
Korea, Republic of
Taiwan