title: HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib

summary: This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) . Participants with histologically confirmed, hormone receptor positive, HER-2 negative, metastatic breast cancer (MBC) or metastatic cervical cancer (MCC) are eligible for screening at 6 months intervals, or if disease progression is suspected/confirmed. Blood samples will be collected from eligible participants and ctDNA will be extracted and sequenced at a central laboratory, using a HER2-targeted next generation sequencing (NGS) test. A certified molecular test report will be issued from the central laboratory and provided to the investigators and the study sponsor. Participants who are identified with HER2 mutations by this screening protocol will subsequently have access to an appropriate neratinib treatment protocol, pending medical eligibility.

ipd_sharing_description:
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

lead_sponsor: Puma Biotechnology, Inc.

location_country:
Italy
Serbia
France
Israel
Ireland
Spain
United States

location_facility: Beaumont Hospital, Cancer Clinical Trials & Research Unit

location_facility: Hospital Universitario Quirónsalud Madrid

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

location_facility: START Madrid, Hospital Universitario Fundacion Jimenez Diaz

location_facility: Rabin Medical Center, Davidoff Cancer Center

location_facility: Institute for Oncology and Radiology of Serbia

location_facility: University Hospital Waterford, Department of Medical Oncology

location_facility: Fundación Instituto Valenciano de Oncológia

location_facility: Mater Misericordiae University Hospital, Institute for Cancer Research

location_facility: Instituto Oncológico Dr. Rosell, Hospital Universitario Quirón Dexeus

intervention_type: Diagnostic Test


type: Other Identifier

title: A Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Extended-Release Paliperidone as Maintenance Treatment After an Acute Manic or Mixed Episode Associated With Bipolar I Disorder

summary: The purpose of this study is to evaluate the effectiveness and safety of oral extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence of mood symptoms in patients with Bipolar I Disorder who initially respond to treatment of an acute manic or mixed episode with paliperidone ER. Olanzapine was included as an active control arm, although the study is not designed to allow for a direct comparison of olanzapine with paliperidone.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Berwaerts J, Melkote R, Nuamah I, Lim P. A randomized, placebo- and active-controlled study of paliperidone extended-release as maintenance treatment in patients with bipolar I disorder after an acute manic or mixed episode. J Affect Disord. 2012 May;138(3):247-58. doi: 10.1016/j.jad.2012.01.047. Epub 2012 Feb 27.

family: Berwaerts

full_name: Joris Berwaerts

given: Joris

sequence: first

family: Melkote

full_name: Rama Melkote

given: Rama

sequence: additional

family: Nuamah

full_name: Isaac Nuamah

given: Isaac

family: Lim

full_name: Pilar Lim

given: Pilar

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Affective Disorders

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
South Africa
India
Costa Rica
Serbia
Germany
France
Bulgaria
Malaysia
Panama
Poland
Romania
Russian Federation
China
Turkey
United States
Ukraine

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Clinical Study on Tacrolimus Ointment Over the Long-term. "CONTROL Study - Adults"

summary: Long-term tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice daily treatment and subsequent twice weekly prophylactic application can effectively treat active lesions of atopic dermatitis and prevent delay & reduce flares

ReferenceType: background

ReferenceCitation: Wollenberg A, Reitamo S, Girolomoni G, Lahfa M, Ruzicka T, Healy E, Giannetti A, Bieber T, Vyas J, Deleuran M; European Tacrolimus Ointment Study Group. Proactive treatment of atopic dermatitis in adults with 0.1% tacrolimus ointment. Allergy. 2008 Jul;63(7):742-50.

ReferenceCitation: Wollenberg A, Sidhu MK, Odeyemi I, Dorsch B, Koehne-Volland R, Schaff M, Ehlken B, Berger K. Economic evaluation of maintenance treatment with tacrolimus 0.1% ointment in adults with moderate to severe atopic dermatitis. Br J Dermatol. 2008 Dec;159(6):1322-30. doi: 10.1111/j.1365-2133.2008.08807.x. Epub 2008 Sep 6.

lead_sponsor: Astellas Pharma Inc

location_country:
Italy
Austria
Switzerland
Netherlands
Spain
United Kingdom
Finland
France
Belgium
Portugal
Denmark
Germany
Czech Republic


lead_sponsor: Bayer

location_country:
Switzerland
Netherlands
Spain
France
Poland
Israel
Hungary
Belgium
Russian Federation
Portugal
Germany
Czech Republic
Canada

type: EudraCT Number

source: euctr

title: Randomized, Double-blind, Placebo-controlled, Parallel Group Study of Vardenafil 10 mg Twice Daily to Assess the Effect on Urodynamics in Patients With Overactive Bladder (Detrusor Overactivity)

summary: The purpose of this study is to assess if the study drug, Vardenafil (approved by Health Authorities is available on the market for treatment of erectile dysfunction) has an effect on bladder function and micturition frequency. The study drug is to be taken in the form of tablets twice a day, one tablet in the morning and one tablet in the evening. A non-active treatment (placebo), a sugar pill, will be used as a comparator to see if the new study drug works better than no drug. The timing of visits for the study is as follows: the 1st visit (screening visit) at beginning of run-in-assessment with qualifying tests for patients: electrocardiogram (ECG), safety laboratory and residual urine (by ultrasonography: a non-invasive examination using ultrasound for the assessment of the bladder). 2nd visit (randomization visit). During visit this should be performed: urodynamic measurements (filling cystometry and pressure flow investigations), ECG and safety laboratory. 3rd visit (safety visit) takes place at two up to three weeks of randomized treatment. 4th visit (final visit)-following test should be done: urodynamic measurements (filling cystometry and pressure flow investigations), ECG, safety laboratory and residual urine (by ultrasonography); A phone call 24 hours after visit 4 to assess any SAEs.


type: Other Grant/Funding Number

title: A Randomised Phase III Study of Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast

acronym: DCIS

summary:
Hypotheses:

The addition of tumour bed boost after BCS in women with non-low risk DCIS reduces the risk of local recurrence (invasive or intraductal recurrence in the ipsilateral breast).
The risk of local recurrence in the shorter fractionation arm is not worse than that for the standard fractionation arm.
A molecular signature predictive of invasive recurrence of DCIS will be detectable and the molecular signature may eventually have clinical utility for therapy individualization.

Overall Objectives:

To improve the outcome of women with non-low risk DCIS treated with breast conserving therapy.
To individualize treatment selection for women with DCIS to achieve long term disease control with minimal toxicity.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: King MT, Link EK, Whelan TJ, Olivotto IA, Kunkler I, Westenberg AH, Gruber G, Schofield P, Chua BH; BIG 3-07/TROG 07.01 trial investigators. Quality of life after breast-conserving therapy and adjuvant radiotherapy for non-low-risk ductal carcinoma in situ (BIG 3-07/TROG 07.01): 2-year results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2020 May;21(5):685-698. doi: 10.1016/S1470-2045(20)30085-1. Epub 2020 Mar 20.

family: King

full_name: Madeleine T King

given: Madeleine T

family: Link

full_name: Emma K Link

given: Emma K

family: Whelan

full_name: Tim J Whelan

given: Tim J

family: Olivotto

full_name: Ivo A Olivotto

given: Ivo A

family: Kunkler

full_name: Ian Kunkler

given: Ian

family: Westenberg

full_name: Antonia Helen Westenberg

given: Antonia Helen

family: Gruber

full_name: Guenther Gruber

given: Guenther

family: Schofield

full_name: Penny Schofield

given: Penny

family: Chua

full_name: Boon H Chua

given: Boon H

family: Phillips

full_name: Claire Phillips

given: Claire

family: Bryant

full_name: Guy Bryant

given: Guy

full_name: Helen Westenberg

given: Helen

family: Purohit

full_name: Om Pra-Kesh Purohit

given: Om Pra-Kesh

family: Ahern

full_name: Verity Ahern

given: Verity

family: Graham

full_name: Peter Graham

given: Peter

family: Akra

full_name: Mohamed Akra

given: Mohamed

family: McArdle

full_name: Orla McArdle

given: Orla

family: O'Brien

full_name: Peter O'Brien

family: Ludbrook

full_name: Jane Ludbrook

given: Jane

family: Harvey

full_name: Jennifer Harvey

given: Jennifer

location_country:
Italy
Switzerland
Netherlands
France
Singapore
Ireland
Belgium
Australia
New Zealand
Canada
United Kingdom

location_facility: Thunder Bay Regional Health Sciences Centre

location_facility: Cancer Institute Antoni Van Leeuwenhoekziekenhuis

location_facility: Sandwell and West Birmingham Hospitals NHS Trust

location_facility: Centro Di Riferimento Oncologico - Aviano

location_facility: Maastricht Radiation Oncology Maastro Clinic

location_facility: Genesis Cancer Care (previously Premion) - Tugun

location_facility: AZ Groeninghe - Campus Maria's Voorzienigheid

location_facility: McGill University Department of Oncology

location_facility: Imperial College Healthcare Charing Cross

location_facility: Barwon Health - Andrew Love Cancer Care Centre, Geelong Hospital

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: William Buckland Radiotherapy Centre, Alfred Hospital

location_facility: Gloucestershire Royal & Cheltenham General Hospitals

location_facility: Genesis Cancer Care (previously Premion) - Nambour

location_facility: The Shrewsbury and Telford Hospital NHS Trust


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Treatment-withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophageal Reflux (GERD) in Infants Aged 1 to 11 Months, Inclusive

summary: The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind treatment withdrawal phase. The screening phase ensures the patient eligibility. No study medication is dispensed during the screening phase. During the open-label phase, patients are administered esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase, the patients are administered either his/her open-label dose or placebo. Double-blind means neither the physician, parent, or patient will know if patient is taking esomeprazole or placebo. The patient will have an equal chance of receiving esomeprazole or placebo.

ReferenceCitation: Winter H, Gunasekaran T, Tolia V, Gottrand F, Barker PN, Illueca M. Esomeprazole for the Treatment of GERD in Infants Ages 1-11 Months. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S9-15. doi: 10.1097/MPG.0b013e3182496b35.

family: Winter

full_name: Harland Winter

given: Harland

family: Gunasekaran

full_name: Thirumazhisai Gunasekaran

given: Thirumazhisai

family: Tolia

full_name: Vasundhara Tolia

given: Vasundhara

family: Gottrand

full_name: Frederic Gottrand

given: Frederic

family: Barker

full_name: Peter N. Barker

given: Peter N.

family: Illueca

full_name: Marta Illueca

given: Marta

journal_name: Journal of Pediatric Gastroenterology & Nutrition

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Esomeprazole for the Treatment of GERD in Infants Ages 1–11 Months

ReferenceCitation: Winter H, Gunasekaran T, Tolia V, Gottrand F, Barker PN, Illueca M. Esomeprazole for the treatment of GERD in infants ages 1-11 months. J Pediatr Gastroenterol Nutr. 2012 Jul;55(1):14-20. doi: 10.1097/MPG.0b013e3182496b35.


design_allocation: Non-Randomized

lead_sponsor: Novartis Pharmaceuticals

location_country:
France
Russian Federation
Denmark
United States
Canada

title: A Combined Phase 1 and 2 Study Investigating the Combination of RAD001 and Erlotinib in Patients With Advanced NSCLC Previously Treated Only With Chemotherapy

summary: This study aims to assess the value of combined treatment with RAD001 and erlotinib in patients with advanced Non Small Cell Lung Cancer treated only with chemotherapy as systemic therapy.


title: A Randomized Phase II Biomarker Neoadjuvant Study of Sequential AC Followed by Ixabepilone Compared to Sequential AC Followed by Paclitaxel in Women With Early Stage Breast Cancer

summary: The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin plus cyclophosphamide in patients with early stage breast cancer. In addition the study will verify predefined biomarkers as well as discover new biomarkers that could identify patients who are more likely to respond to ixabepilone than standard paclitaxel based therapy.

ReferenceCitation: Abdel-Fatah TMA, Agarwal D, Liu DX, Russell R, Rueda OM, Liu K, Xu B, Moseley PM, Green AR, Pockley AG, Rees RC, Caldas C, Ellis IO, Ball GR, Chan SYT. SPAG5 as a prognostic biomarker and chemotherapy sensitivity predictor in breast cancer: a retrospective, integrated genomic, transcriptomic, and protein analysis. Lancet Oncol. 2016 Jul;17(7):1004-1018. doi: 10.1016/S1470-2045(16)00174-1. Epub 2016 Jun 14.

family: Abdel-Fatah

full_name: Tarek M A Abdel-Fatah

given: Tarek M A

family: Agarwal

full_name: Devika Agarwal

given: Devika

family: Liu

full_name: Dong-Xu Liu

given: Dong-Xu

family: Russell

full_name: Roslin Russell

given: Roslin

family: Rueda

full_name: Oscar M Rueda

given: Oscar M

full_name: Karen Liu

given: Karen

family: Xu

full_name: Bing Xu

given: Bing

family: Moseley

full_name: Paul M Moseley

given: Paul M

family: Green

full_name: Andrew R Green

given: Andrew R

family: Pockley

full_name: Alan G Pockley

given: Alan G

family: Rees

full_name: Robert C Rees

given: Robert C

family: Caldas

full_name: Carlos Caldas

given: Carlos

family: Ellis

full_name: Ian O Ellis

given: Ian O

family: Ball

full_name: Graham R Ball

given: Graham R

family: Chan

full_name: Stephen Y T Chan

given: Stephen Y T

journal_name: The Lancet Oncology

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: University of Nottingham - Nottingham ePrints

version: acceptedVersion

repository_institution: Nottingham Trent Repository - Nottingham Trent University's Institutional Repository

repository_institution: University of Nottingham - Repository@Nottingham

version: submittedVersion

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
Peru
India
Philippines
Germany
France
Singapore
Argentina
Russian Federation
Spain
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: Northwest Oncology & Hematology Associates


title: A Randomized Phase 3 Study of Pemetrexed in Combination With Cisplatin Versus Cisplatin Monotherapy in Patients With Recurrent or Metastatic Head and Neck Cancer

summary: This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.

lead_sponsor: Eli Lilly and Company

location_country:
Romania
Belgium
Russian Federation
Denmark
Taiwan
India
France
Poland
Argentina
Korea, Republic of
South Africa
Netherlands
Hungary
Puerto Rico
China
Germany
United States
Italy
Brazil
Mexico
Spain

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections

summary: The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.

study_start_date_type: Actual

ReferenceCitation: Kullberg BJ, Viscoli C, Pappas PG, Vazquez J, Ostrosky-Zeichner L, Rotstein C, Sobel JD, Herbrecht R, Rahav G, Jaruratanasirikul S, Chetchotisakd P, Van Wijngaerden E, De Waele J, Lademacher C, Engelhardt M, Kovanda L, Croos-Dabrera R, Fredericks C, Thompson GR. Isavuconazole Versus Caspofungin in the Treatment of Candidemia and Other Invasive Candida Infections: The ACTIVE Trial. Clin Infect Dis. 2019 May 30;68(12):1981-1989. doi: 10.1093/cid/ciy827.

name: Radboud Center for Infectious Diseases, and Department of Medicine, Radboud University Medical Center, Nijmegen, The Netherlands

family: Kullberg

full_name: Bart Jan Kullberg

given: Bart Jan

name: Dipartimento di Scienze della Salute, University of Genova

name: Ospedale Policlinico San Martino, Genova, Italy

family: Viscoli

full_name: Claudio Viscoli

given: Claudio

family: Pappas

full_name: Peter G Pappas

given: Peter G

name: Medical College of Georgia/Augusta University

family: Vazquez

full_name: Jose Vazquez

given: Jose

family: Ostrosky-Zeichner

full_name: Luis Ostrosky-Zeichner

given: Luis

name: University Health Network, University of Toronto, Ontario, Canada

family: Rotstein

full_name: Coleman Rotstein

given: Coleman

name: Wayne State University, Detroit, Michigan

family: Sobel

full_name: Jack D Sobel

given: Jack D

name: Hôpitaux Universitaires de Strasbourg and Université de Strasbourg, Inserm, UMR-S1113/IRFAC, France

family: Herbrecht

full_name: Raoul Herbrecht

given: Raoul

name: Sheba Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Israel

family: Rahav

full_name: Galia Rahav

given: Galia

family: Jaruratanasirikul

full_name: Sutep Jaruratanasirikul

given: Sutep

name: Srinagarind Hospital, Khon Kaen University, Thailand

family: Chetchotisakd

full_name: Ploenchan Chetchotisakd

given: Ploenchan

family: Van Wijngaerden

full_name: Eric Van Wijngaerden

given: Eric

family: De Waele

full_name: Jan De Waele

given: Jan

name: Astellas Pharma Global Development, Inc, Northbrook, Illinois

family: Lademacher

full_name: Christopher Lademacher

given: Christopher

name: Basilea Pharmaceutica International Ltd., Basel, Switzerland

family: Engelhardt

full_name: Marc Engelhardt

given: Marc

family: Kovanda

full_name: Laura Kovanda

given: Laura

family: Croos-Dabrera

full_name: Rodney Croos-Dabrera

given: Rodney

family: Fredericks

full_name: Christine Fredericks

given: Christine

name: Department of Medicine, University of California Davis

family: Thompson

full_name: George R Thompson

given: George R

suffix: III

journal_name: Clinical Infectious Diseases

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

version: publishedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

ReferenceCitation: McCormack PL. Isavuconazonium: first global approval. Drugs. 2015 May;75(7):817-22. doi: 10.1007/s40265-015-0398-6. Review.

title: Isavuconazonium: First Global Approval

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Malaysia
Belgium
Australia
Russian Federation
India
France
Thailand
Argentina
Canada
South Africa
Chile
Switzerland
Philippines
Singapore
Hungary
China
Germany
United States
Italy
Brazil
Lebanon
Mexico
Israel
New Zealand
Spain

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: De La Salle Health Sciences Institute- DLSUMC

location_facility: S.I. Russian Oncological Research Center n.a. N.N. Blokhin

location_facility: Hospital General de Agudos Dr. Carlos G. Durand

location_facility: Apollo Hospitals Educational & Research Foundation

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Hospital Civil de Guadalajara Dr Juan I Menchaca

location_facility: University Health Network - Toronto General Hospital

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Ma

location_facility: Hospital General de Agudos Dr. Cosme Argerich

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Hospital das Clinicas da Universidade Federal de Minas Gerai

location_facility: Regional Infection Diseases Infusion Center Inc.

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: University of Maryland School of Medicine

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Universidade Federal de Sao Paulo - UNIFESP

location_facility: Azienda Ospedaliera di Verona-Ospedale Civile Maggiore

location_facility: Hospital Universitario Clementino Fraga Filho

location_facility: University of California Davis Health System

location_facility: Hamilton Health Sciences - Henderson Site

location_facility: State Institution "Hematology Research Center" RAMS

location_facility: Hadassah Universtiy Hospital - Ein Kerem

location_facility: Pusat Perubatan Universiti Kebangsaan Malaysia

location_facility: West China Hospital of Sichuan University

location_facility: Kasturba Medical College K. M. C. Hospital

location_facility: University of California at San Francisco


title: A Randomized Phase II/III Trial of Doxycycline vs. Standard Supportive Therapy in Newly-diagnosed Cardiac AL Amyloidosis Patients Undergoing Bortezomib-based Therapy

summary:
Systemic amyloidoses are rare diseases affecting approximately 1 in 100,000 persons each year.

In systemic amyloidoses abnormal proteins deposit in bodily organs and severely impair their function, causing death if not treated effectively. Light chain (AL) amyloidosis is caused by a usually small population of plasma cells (the cells that produce antibodies). These cells produce part of antibodies, the light chains (LC) that form amyloid deposits. Almost every organ, with the exception of the brain, can be affected by AL amyloidosis. The heart is involved in three fourths of patients and is responsible for almost all the deaths occurring in the first 6 months after diagnosis. Current therapy of AL amyloidosis is based on drugs targeting the plasma cells producing the amyloid-forming LC. At present, most patients receive a powerful anti-plasma cell drug, bortezomib, as part of their initial treatment. However, bortezomib-based therapy, can improve heart involvement only in less than one third of patients with AL amyloidosis, and many patients (approximately one third) still die within 12 months from diagnosis. Early cardiac deaths remain an acute unmet need and the major determinant of overall outcome in this disease. Thus, there is the need of alternative means to treat heart involvement in AL amyloidosis. Doxycycline is a widely used, well tolerated, antibiotic that has been marketed for decades and used to treat a number of different infectious diseases caused by bacteria. This molecule has been extensively studied in the laboratory, in animal models and, more recently, in small studies involving patients, for its potential of improving cardiac damage in amyloidosis. These studies showed that doxycycline disrupts amyloid deposits, reduces the amyloid load in a mouse model, and counteracts the toxicity exerted by amyloid-forming LCs on C. elegans, a worm whose pharynx is used as a model resembling human heart. In a small clinical study, doxycycline was given to patients with cardiac AL amyloidosis during treatment for their underlying plasma cell disease. This resulted in a remarkable improvement of survival compared to "matched historical controls" (i.e. similar patients who had received only anti-plasma cell therapy without doxycycline in the past). Based on these promising preliminary results, we designed the present clinical trial to assess whether the addition of doxycycline to anti-plasma cell therapy can improve survival in patients with cardiac AL amyloidosis who were not previously treated. The rate of survival at 12 months will be compared in patients receiving doxycycline and in controls receiving standard antibiotic therapy, together with anti-plasma cell therapy. Patients will be assessed for parameters of plasma cell disease, heart involvement and possible involvement of other organs, as well as for quality of life. To make sure that patients who will receive doxycycline and those who will not have comparable severity of cardiac disease, patients will be stratified according to the stage of cardiac involvement. Patients with very advanced heart dysfunction will not be enrolled in the trial, because preliminary data indicate that doxycycline is of little or no benefit in these subjects. Patients will be randomized to receive doxycycline or standard antibiotics in combination with anti-plasma cell therapy. Bortezomib-based treatment directed against plasma cells will be delivered according to each participating institutions' guidelines. Doxycycline will be administered at a dosage of 100 mg two times a day, which is usual in the treatment of bacterial diseases. Standard antibiotics will be delivered according to each participating institutions' guidelines (provided that drugs of the same class as doxycycline are not administered) in the control arm. Patients will be provided a diary to record possible adverse events and will be instructed accordingly. Patients will be evaluated at trial centers every 2 months for treatment efficacy and toxicity. In case of unsatisfactory response second-line therapy will be initiated. In the absence of unacceptable toxicity, doxycycline administration will be continued for the entire duration of follow-up (12 months).

status: Recruiting

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: IRCCS Policlinico S. Matteo

location_country:
Italy
France
Greece
Spain
Turkey
Germany
United Kingdom
Canada

location_facility: Cross Cancer Insititue, University of Alberta

location_facility: University College London Medical School and Royal Free Hospital

location_facility: Istanbul University Cerrahpasa Faculty of Medicine

status_simplified: Ongoing


ReferenceCitation: Horneff G, Seyger MMB, Arikan D, Kalabic J, Anderson JK, Lazar A, Williams DA, Wang C, Tarzynski-Potempa R, Hyams JS. Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease. J Pediatr. 2018 Oct;201:166-175.e3. doi: 10.1016/j.jpeds.2018.05.042. Epub 2018 Jul 25.

family: Horneff

full_name: Gerd Horneff

given: Gerd

family: Seyger

full_name: Marieke M.B. Seyger

given: Marieke M.B.

family: Arikan

full_name: Dilek Arikan

given: Dilek

family: Kalabic

full_name: Jasmina Kalabic

given: Jasmina

family: Anderson

full_name: Jaclyn K. Anderson

given: Jaclyn K.

family: Lazar

full_name: Andreas Lazar

given: Andreas

family: Williams

full_name: David A. Williams

given: David A.

family: Wang

full_name: Chen Wang

given: Chen

family: Tarzynski-Potempa

full_name: Rita Tarzynski-Potempa

given: Rita

family: Hyams

full_name: Jeffrey S. Hyams

given: Jeffrey S.

journal_name: The Journal of Pediatrics

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

ReferenceCitation: Ruemmele FM, Rosh J, Faubion WA, Dubinsky MC, Turner D, Lazar A, Eichner S, Maa JF, Alperovich G, Robinson AM, Hyams JS. Efficacy of Adalimumab for Treatment of Perianal Fistula in Children with Moderately to Severely Active Crohn's Disease: Results from IMAgINE 1 and IMAgINE 2. J Crohns Colitis. 2018 Nov 9;12(10):1249-1254. doi: 10.1093/ecco-jcc/jjy087.

name: Université Sorbonne Paris Cité, Paris Descartes, APHP Hôpital Necker-Enfants Malades, Paris, France

family: Ruemmele

full_name: Frank M Ruemmele

given: Frank M

name: Goryeb Children’s Hospital/Atlantic Health, Morristown, NJ, USA

family: Rosh

full_name: Joel Rosh

given: Joel

family: Faubion

full_name: William A Faubion

given: William A

name: Icahn School of Medicine at Mount Sinai, New York, NY, USA

family: Dubinsky

full_name: Marla C Dubinsky

given: Marla C

name: Shaare Zedek Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel

family: Turner

full_name: Dan Turner

given: Dan

name: AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany

family: Eichner

full_name: Samantha Eichner

given: Samantha

family: Maa

full_name: Jen-Fue Maa

given: Jen-Fue

family: Alperovich

full_name: Gabriela Alperovich

given: Gabriela

family: Robinson

name: Connecticut Children’s Medical Center, Hartford, CT, USA

title: Efficacy of Adalimumab for Treatment of Perianal Fistula in Children with Moderately to Severely Active Crohn’s Disease: Results from IMAgINE 1 and IMAgINE 2

ReferenceCitation: Hyams JS, Griffiths A, Markowitz J, Baldassano RN, Faubion WA Jr, Colletti RB, Dubinsky M, Kierkus J, Rosh J, Wang Y, Huang B, Bittle B, Marshall M, Lazar A. Safety and efficacy of adalimumab for moderate to severe Crohn's disease in children. Gastroenterology. 2012 Aug;143(2):365-74.e2. doi: 10.1053/j.gastro.2012.04.046. Epub 2012 May 2.

title: Safety and Efficacy of Adalimumab for Moderate to Severe Crohn's Disease in Children

location_country:
United States
United Kingdom
Netherlands
France
Poland
Belgium
Canada
Czech Republic

location_facility:
Site Reference ID/Investigator# 4285
Site Reference ID/Investigator# 5904
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title: A Multi-Center, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease

summary: The purpose of this study is to determine Efficacy, Pharmacokinetics, and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease


title: A Double-Masked, Placebo-Controlled, Multi-Center, Parallel-Group, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Clinically Quiescent Sight Threatening, Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis

acronym: LUMINATE

summary: The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious uveitis

lead_sponsor: Lux Biosciences, Inc.

location_country:
Austria
India
Germany
France
United States
United Kingdom
Canada

location_facility: Hôpital Pitié Salpétrière, Service d'Ophtalmologie

location_facility: Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences

location_facility: Klinik für Augenheilkunde, Dept. of Ophthalmology

location_facility: Consultant, Retina and Vitreous Services, Bhubaneswar L V Prasad Eye Institute

location_facility: Department of Opthalmology, Sankara Nethralaya, Medical Research Foundation,

location_facility: Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology

location_facility: Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER)

location_facility: Center Hospitalier Universitaire d' Angers, Service d'Opthalmologie

location_facility: Bristol Eye Hospital and University of Bristol

location_facility: UMDNJ-New Jersey Medical School, Ophthalmology Dept.

location_facility: Massachusetts Eye Research and Surgery Institute

location_facility: Vittala International Institute of Ophthalmology


title: A Double-Masked, Placebo-Controlled, Parallel Group, Multi-Center, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis

summary: The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious uveitis


title: Phase II of Immunotherapy Plus Local Tumor Ablation (RFA or Stereotactic Radiotherapy) in Patients With Colorectal Cancer Liver Metastases

acronym: ILOC

summary:
This is a single-arm, open-label, multi-center early phase II study. This proof of concept study will investigate whether the combined use of local tumor ablation/radiation plus immunomodulating drugs may induce a significant immune response in patient with incurable liver metastases from colorectal cancer (CRC) (+/- limited extrahepatic disease) being stable or in partial remission after completion of 4-6 months first line systemic therapy.

The primary objective of the study is to show an overall response rate of lesions not treated by ablation/radiotherapy including the extrahepatic lesions (according to iRECIST criteria) higher than 10%. With the continuation of first line systemic treatment, no further responses are expected.

Secondary objectives are:

To establish the feasibility and safety of the combined treatment modalities;
To study the impact of the local technique (RFA/Radiotherapy) on the results;
To investigate biomarkers to predict response to the combined treatment

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

location_country: Austria Sweden Switzerland Netherlands France Germany

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Karolinska University Hospital - Karolinska Institutet - Danderyds Hospital

location_facility: Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie

location_facility: Medical University Vienna - General Hospital AKH

location_facility: Radboud University Medical Center Nijmegen

intervention_type: Other


ReferenceCitation: Freedman MS, De Stefano N, Barkhof F, Polman CH, Comi G, Uitdehaag BM, Casset-Semanaz F, Hennessy B, Lehr L, Stubinski B, Jack DL, Kappos L. Patient subgroup analyses of the treatment effect of subcutaneous interferon β-1a on development of multiple sclerosis in the randomized controlled REFLEX study. J Neurol. 2014 Mar;261(3):490-9. doi: 10.1007/s00415-013-7222-6. Epub 2014 Jan 12.

family: Freedman

full_name: Mark S. Freedman

given: Mark S.

family: De Stefano

full_name: Nicola De Stefano

given: Nicola

family: Barkhof

full_name: Frederik Barkhof

given: Frederik

family: Polman

full_name: Chris H. Polman

given: Chris H.

family: Comi

full_name: Giancarlo Comi

given: Giancarlo

family: Uitdehaag

full_name: Bernard M. J. Uitdehaag

given: Bernard M. J.

family: Casset-Semanaz

full_name: Florence Casset-Semanaz

given: Florence

family: Hennessy

full_name: Brian Hennessy

given: Brian

family: Lehr

full_name: Lorenz Lehr

given: Lorenz

family: Stubinski

full_name: Bettina Stubinski

given: Bettina

family: Jack

full_name: Dominic L. Jack

given: Dominic L.

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

journal_name: Journal of Neurology

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: De Stefano N, Comi G, Kappos L, Freedman MS, Polman CH, Uitdehaag BM, Hennessy B, Casset-Semanaz F, Lehr L, Stubinski B, Jack DL, Barkhof F. Efficacy of subcutaneous interferon β-1a on MRI outcomes in a randomised controlled trial of patients with clinically isolated syndromes. J Neurol Neurosurg Psychiatry. 2014 Jun;85(6):647-53. doi: 10.1136/jnnp-2013-306289. Epub 2013 Nov 29.

full_name: N. De Stefano

given: N.

full_name: G. Comi

given: G.

full_name: L. Kappos

given: L.

full_name: M. S. Freedman

given: M. S.

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

repository_institution: University of Oxford - Oxford Academic Notes & Queries

title: Efficacy of subcutaneous interferon -1a on MRI outcomes in a randomised controlled trial of patients with clinically isolated syndromes

ReferenceCitation: Comi G, De Stefano N, Freedman MS, Barkhof F, Polman CH, Uitdehaag BM, Casset-Semanaz F, Hennessy B, Moraga MS, Rocak S, Stubinski B, Kappos L. Comparison of two dosing frequencies of subcutaneous interferon beta-1a in patients with a first clinical demyelinating event suggestive of multiple sclerosis (REFLEX): a phase 3 randomised controlled trial. Lancet Neurol. 2012 Jan;11(1):33-41. doi: 10.1016/S1474-4422(11)70262-9. Epub 2011 Dec 4. Erratum in: Lancet Neurol. 2012 Feb;11(2):125.

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Czech Republic
Morocco
Croatia
France
Poland
Slovakia
Argentina
Canada
Turkey
Saudi Arabia
Bulgaria
Portugal
Germany
Italy
Austria
Serbia
Lebanon
Israel
Spain
Estonia
Latvia

title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial of Rebif New Formulation (44 Microgram [Mcg] Three Times Weekly [Tiw] and 44 Mcg Once Weekly [ow]) in Subjects at High Risk of Converting to Multiple Sclerosis (REFLEX)

summary:
The study is a 24 months randomized, double-blind, Placebo-controlled, multi-center clinical trial with an optional 12 months open label extension.

The primary objective of the study is to evaluate the effect of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN] beta-1a (RNF) 44 microgram (three times weekly and once weekly) versus placebo on the time to conversion to McDonald multiple sclerosis (MS) criteria (2005) in subjects with a first clinical demyelinating event at high risk of converting to MS.

The main secondary objective of study is to evaluate the effect of RNF 44 microgram (three times weekly and once weekly) versus placebo on the "Time to conversion to clinically definite MS (CDMS)" in subjects with a first clinical demyelinating event at high risk of converting to MS.

At the end of 24 month double-blind core REFLEX trial, subjects who will not convert to CDMS and decide to receive open-label (OL) treatment will be enrolled into an open-label, 12 month extension period to evaluate the effect of RNF 44 mcg three times weekly treatment on the time to conversion to McDonald MS and time to conversion to CDMS.


title: Diagnostic Accuracy of On-line Quantitative Flow Ratio. Functional Assessment by Virtual Online Reconstruction (The FAVOR II Europe-Japan Study)

acronym: FAVOR II EJ

summary: Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is assessed by calculation of the pressure in the vessel based on two angiographic projections. The purpose of the FAVOR II study is to evaluate the diagnostic accuracy of on-line QFR compared to 2D Quantitative Coronary Angiography (QCA) with FFR as gold standard.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013.

ReferenceCitation: Westra J, Andersen BK, Campo G, Matsuo H, Koltowski L, Eftekhari A, Liu T, Di Serafino L, Di Girolamo D, Escaned J, Nef H, Naber C, Barbierato M, Tu S, Neghabat O, Madsen M, Tebaldi M, Tanigaki T, Kochman J, Somi S, Esposito G, Mercone G, Mejia-Renteria H, Ronco F, Bøtker HE, Wijns W, Christiansen EH, Holm NR. Diagnostic Performance of In-Procedure Angiography-Derived Quantitative Flow Reserve Compared to Pressure-Derived Fractional Flow Reserve: The FAVOR II Europe-Japan Study. J Am Heart Assoc. 2018 Jul 6;7(14). pii: e009603. doi: 10.1161/JAHA.118.009603.

name: Department of Cardiology Aarhus University Hospital Skejby Denmark

family: Westra

full_name: Jelmer Westra

given: Jelmer

family: Andersen

full_name: Birgitte Krogsgaard Andersen

given: Birgitte Krogsgaard

name: Cardiovascular Institute Azienda Ospedaliero‐Universitaria di Ferrara Cona Italy

name: Maria Cecilia Hospital GVM Care and Research Cotignola (RA) Italy

family: Campo

full_name: Gianluca Campo

given: Gianluca

name: Department of Cardiovascular Medicine Gifu Heart Center Gifu City Japan

family: Matsuo

full_name: Hitoshi Matsuo

given: Hitoshi

name: Department of Cardiology Medical University of Warsaw Warszawa Poland

family: Koltowski

full_name: Lukasz Koltowski

given: Lukasz

family: Eftekhari

full_name: Ashkan Eftekhari

given: Ashkan

name: Department of Cardiology Hagaziekenhuis The Hague The Netherlands

family: Liu

full_name: Tommy Liu

given: Tommy

name: Division of Cardiology Department of Advanced Biomedical Sciences University of Naples Federico II Naples Italy

family: Di Serafino

full_name: Luigi Di Serafino

given: Luigi

name: Azienda Ospedaliera Sant'Anna e San Sebastiano Caserta Italy

family: Di Girolamo

full_name: Domenico Di Girolamo

given: Domenico

name: Hospital Clinico San Carlos IDISSC Complutense University Madrid Spain

family: Escaned

full_name: Javier Escaned

given: Javier

name: Department of Cardiology and Angiology University of Giessen Giessen Germany

family: Nef

full_name: Holger Nef

given: Holger

name: Klinik für Kardiologie und Angiologie Essen Germany

family: Naber

full_name: Christoph Naber

given: Christoph

name: Emodinamica Aziendale AULSS 3 Serenissima Ospedale Dell'Angelo Mestre Italy

family: Barbierato

full_name: Marco Barbierato

given: Marco

name: School of Biomedical Engineering Shanghai Jiao Tong University Shanghai China

family: Tu

full_name: Shengxian Tu

given: Shengxian

family: Neghabat

full_name: Omeed Neghabat

given: Omeed

name: Department of Clinical Epidemiology Aarhus University Hospital Skejby Denmark

family: Madsen

full_name: Morten Madsen

given: Morten

family: Tebaldi

full_name: Matteo Tebaldi

given: Matteo

family: Tanigaki

full_name: Toru Tanigaki

given: Toru

family: Kochman

full_name: Janusz Kochman

given: Janusz

family: Somi

full_name: Samer Somi

given: Samer

family: Esposito

full_name: Giovanni Esposito

given: Giovanni

family: Mercone

full_name: Giuseppe Mercone

given: Giuseppe

family: Mejia‐Renteria

full_name: Hernan Mejia‐Renteria

given: Hernan

name: The Lambe Institute for Translational Medicine and Curam National University of Ireland Galway Galway Ireland

journal_name: Journal of the American Heart Association

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

title: Diagnostic Performance of In‐Procedure Angiography‐Derived Quantitative Flow Reserve Compared to Pressure‐Derived Fractional Flow Reserve: The FAVOR II Europe‐Japan Study

location_country:
Italy
Netherlands
France
Japan
Denmark
Germany
United Kingdom

location_facility: Azienda Ospedaliero-Universitaria di Ferrara, University of Ferrara

location_facility: Institut Cardiovasculaire Paris Sud Massy

location_facility: Azienda ospedaliera Sant'Anna e S. sebastiano di Caserta


title: An Open-Label, Multicenter, Phase 1 Study With Expansion Cohorts of Ramucirumab or Necitumumab in Combination With Osimertinib in Patients With Advanced T790M-Positive EGFR-Mutant Non-Small Cell Lung Cancer After Progression on First-Line EGFR TKI Therapy

summary: The main purpose of this study is to evaluate the safety of ramucirumab or necitumumab in combination with osimertinib in participants with non-small cell lung cancer (NSCLC).

ReferenceCitation: Yu HA, Paz-Ares LG, Yang JC, Lee KH, Garrido P, Park K, Kim JH, Lee DH, Mao H, Wijayawardana SR, Gao L, Hozak RR, Chao BH, Planchard D. Phase I Study of the Efficacy and Safety of Ramucirumab in Combination with Osimertinib in Advanced T790M-positive EGFR-mutant Non-small Cell Lung Cancer. Clin Cancer Res. 2021 Feb 15;27(4):992-1002. doi: 10.1158/1078-0432.CCR-20-1690. Epub 2020 Oct 12.

family: Yu

full_name: Helena A. Yu

given: Helena A.

family: Paz-Ares

full_name: Luis G. Paz-Ares

given: Luis G.

family: Yang

full_name: James Chih-Hsin Yang

given: James Chih-Hsin

family: Lee

full_name: Ki Hyeong Lee

given: Ki Hyeong

family: Garrido

full_name: Pilar Garrido

given: Pilar

family: Park

full_name: Keunchil Park

given: Keunchil

family: Kim

full_name: Joo-Hang Kim

given: Joo-Hang

full_name: Dae Ho Lee

given: Dae Ho

family: Mao

full_name: Huzhang Mao

given: Huzhang

family: Wijayawardana

full_name: Sameera R. Wijayawardana

given: Sameera R.

family: Gao

full_name: Ling Gao

given: Ling

family: Hozak

full_name: Rebecca R. Hozak

given: Rebecca R.

family: Chao

full_name: Bo H. Chao

given: Bo H.

family: Planchard

full_name: David Planchard

given: David

journal_name: Clinical Cancer Research

publisher: American Association for Cancer Research (AACR)

title: Phase I Study of the Efficacy and Safety of Ramucirumab in Combination with Osimertinib in Advanced T790M-positive EGFR-mutant Non–small Cell Lung Cancer

location_country:
France
Spain
United States
Korea, Republic of
Taiwan

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: A Phase III, Randomized, Double Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients With Active Systemic Lupus Erythematosus.

summary: The purpose of this study is to evaluate the safety and efficacy of Epratuzumab with standard treatments for patients with SLE.

status: Terminated

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

name: Dermatologist, Masters of Public Health Program; Harvard School of Public Health; Boston Massachusetts USA

family: Hannon

full_name: Cora W Hannon

given: Cora W

name: Department of Dermatology; Royal Victoria Hospital; Belfast UK

family: McCourt

full_name: Collette McCourt

given: Collette

name: Department of Dermatology, Clinical Unit for Research Trials and Outcomes in Skin (CURTIS); Massachusetts General Hospital; Boston Massachusetts USA

family: Lima

full_name: Hermenio C Lima

given: Hermenio C

name: Emory University Hospital; Emory Healthcare; Atlanta Georgia USA

family: Chen

full_name: Suephy Chen

given: Suephy

name: Office of Research and Innovation; Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn; Dublin Ireland

family: Bennett

full_name: Cathy Bennett

given: Cathy

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: UCB Pharma

location_country:
Italy
Brazil
United States
United Kingdom
Netherlands
Germany
France
Belgium
Spain
Canada
Czech Republic

status_simplified: Unknown


title: A Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic Systems

summary: Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments

status: Withdrawn

location_country:
Italy
Brazil
United States
United Kingdom
Netherlands
Germany
France
Slovakia
Hungary
Belgium
Spain
Canada
Czech Republic


title: Evaluation of Virtual Touch Tissue Imaging Quantification (VTIQ - 2D-SWE) in the Assessment of BI-RADS® 3 and 4 Lesions: Can Patient Selection for Biopsy be Improved? - A Confirmatory Multi-Center-Study

summary: The primary aim of this study is to evaluate if VTIQ in addition to BI-RADS® categorization can improve the diagnostic accuracy with respect to detection of malignancies, in particular for BI-RADS® categories 3 and 4a. The idea of the study is to restage all patients in categories 3 and 4a according to a predefined VTIQ cut-off value of ≥ 3.5 m/s (37 kPa).

primary_purpose: Diagnostic

ReferenceCitation: Barr RG, Zhang Z. Shear-wave elastography of the breast: value of a quality measure and comparison with strain elastography. Radiology. 2015 Apr;275(1):45-53. doi: 10.1148/radiol.14132404. Epub 2014 Nov 24.

ReferenceCitation: Barr RG, Zhang Z. Effects of precompression on elasticity imaging of the breast: development of a clinically useful semiquantitative method of precompression assessment. J Ultrasound Med. 2012 Jun;31(6):895-902.

ReferenceCitation: Golatta M, Schweitzer-Martin M, Harcos A, Schott S, Junkermann H, Rauch G, Sohn C, Heil J. Normal breast tissue stiffness measured by a new ultrasound technique: virtual touch tissue imaging quantification (VTIQ). Eur J Radiol. 2013 Nov;82(11):e676-9. doi: 10.1016/j.ejrad.2013.06.029. Epub 2013 Aug 8.

ReferenceCitation: Golatta M, Schweitzer-Martin M, Harcos A, Schott S, Gomez C, Stieber A, Rauch G, Domschke C, Rom J, Schütz F, Sohn C, Heil J. Evaluation of virtual touch tissue imaging quantification, a new shear wave velocity imaging method, for breast lesion assessment by ultrasound. Biomed Res Int. 2014;2014:960262. doi: 10.1155/2014/960262. Epub 2014 Mar 31.

ReferenceCitation: Tozaki M, Saito M, Benson J, Fan L, Isobe S. Shear wave velocity measurements for differential diagnosis of solid breast masses: a comparison between virtual touch quantification and virtual touch IQ. Ultrasound Med Biol. 2013 Dec;39(12):2233-45. doi: 10.1016/j.ultrasmedbio.2013.07.012. Epub 2013 Sep 21.

ReferenceCitation: Barr RG, Nakashima K, Amy D, Cosgrove D, Farrokh A, Schafer F, Bamber JC, Castera L, Choi BI, Chou YH, Dietrich CF, Ding H, Ferraioli G, Filice C, Friedrich-Rust M, Hall TJ, Nightingale KR, Palmeri ML, Shiina T, Suzuki S, Sporea I, Wilson S, Kudo M. WFUMB guidelines and recommendations for clinical use of ultrasound elastography: Part 2: breast. Ultrasound Med Biol. 2015 May;41(5):1148-60. doi: 10.1016/j.ultrasmedbio.2015.03.008. Epub 2015 Mar 18. Review.

ReferenceCitation: Cosgrove DO, Berg WA, Doré CJ, Skyba DM, Henry JP, Gay J, Cohen-Bacrie C; BE1 Study Group. Shear wave elastography for breast masses is highly reproducible. Eur Radiol. 2012 May;22(5):1023-32. doi: 10.1007/s00330-011-2340-y. Epub 2011 Dec 31.

family: Cosgrove

full_name: David O. Cosgrove

given: David O.

family: Berg

full_name: Wendie A. Berg

given: Wendie A.

family: Doré

full_name: Caroline J Doré

given: Caroline J

family: Skyba

full_name: Danny M. Skyba

given: Danny M.

family: Henry

full_name: Jean-Pierre Henry

given: Jean-Pierre

family: Gay

full_name: Joel Gay

given: Joel

family: Cohen-Bacrie

full_name: Claude Cohen-Bacrie

given: Claude

journal_name: European Radiology

license: cc-by-nc

license_normalized: cc-by-nc

license: implied-oa

license_normalized: implied-oa

ReferenceCitation: Balleyguier C, Canale S, Ben Hassen W, Vielh P, Bayou EH, Mathieu MC, Uzan C, Bourgier C, Dromain C. Breast elasticity: principles, technique, results: an update and overview of commercially available software. Eur J Radiol. 2013 Mar;82(3):427-34. doi: 10.1016/j.ejrad.2012.03.001. Epub 2012 Mar 24. Review.

ReferenceCitation: Barr RG, Destounis S, Lackey LB 2nd, Svensson WE, Balleyguier C, Smith C. Evaluation of breast lesions using sonographic elasticity imaging: a multicenter trial. J Ultrasound Med. 2012 Feb;31(2):281-7.

ReferenceCitation: Barr RG. Sonographic breast elastography: a primer. J Ultrasound Med. 2012 May;31(5):773-83. Review.

ReferenceCitation: Evans A, Whelehan P, Thomson K, Brauer K, Jordan L, Purdie C, McLean D, Baker L, Vinnicombe S, Thompson A. Differentiating benign from malignant solid breast masses: value of shear wave elastography according to lesion stiffness combined with greyscale ultrasound according to BI-RADS classification. Br J Cancer. 2012 Jul 10;107(2):224-9. doi: 10.1038/bjc.2012.253. Epub 2012 Jun 12.

lead_sponsor: Heidelberg University

location_country:
United States
Netherlands
France
Japan
Portugal
Germany

location_facility: Universitätsmedizin Greifswald, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Institut Gustave Roussy, Service de Radiologie, Villejuif Cedex

location_facility: Centro Hospitalar e Universitário de Coimbra, Departamento de Radiologia

location_facility: Universitätsklinikum Marburg, Klinik für Gynäkologie, gyn. Endokrinologie und Onkologie Senologische Diagnostik & Gynäkologischer Ultraschall

intervention_type: Device

lead_sponsor_type: academique


title: A Multi-centre Randomized, Placebo-controlled Trial of Mirabegron, a New beta3-adrenergic Receptor Agonist on Left Ventricular Mass and Diastolic Function in Patients With Structural Heart Disease

summary:
This study will assess the efficacy of mirabegron, a new beta3-adrenergic receptor in the prevention of heart failure. This is a two armed, prospective, randomized, placebo-controlled, multi-centric european phase IIb trial with placebo and mirabegron distributed in a 1:1 fashion. The patients enrolled will have cardiac structural remodeling with or without symptoms of heart failure (maximum NYHA II).

Patients will be monitored for change in left ventricular mass (assessed by cardiac MRI) and/or changes in diastolic function (assessed by echocardiography) after 12 months of treatment.

ReferenceCitation: Belge C, Hammond J, Dubois-Deruy E, Manoury B, Hamelet J, Beauloye C, Markl A, Pouleur AC, Bertrand L, Esfahani H, Jnaoui K, Götz KR, Nikolaev VO, Vanderper A, Herijgers P, Lobysheva I, Iaccarino G, Hilfiker-Kleiner D, Tavernier G, Langin D, Dessy C, Balligand JL. Enhanced expression of β3-adrenoceptors in cardiac myocytes attenuates neurohormone-induced hypertrophic remodeling through nitric oxide synthase. Circulation. 2014 Jan 28;129(4):451-62. doi: 10.1161/CIRCULATIONAHA.113.004940. Epub 2013 Nov 4.

ReferenceCitation: Balligand JL. beta(3)-Adrenoceptor stimulation on top of beta(1)-adrenoceptor blockade "Stop or Encore?". J Am Coll Cardiol. 2009 Apr 28;53(17):1539-42. doi: 10.1016/j.jacc.2009.01.048.

ReferenceCitation: Dessy C, Balligand JL. Beta3-adrenergic receptors in cardiac and vascular tissues emerging concepts and therapeutic perspectives. Adv Pharmacol. 2010;59:135-63. doi: 10.1016/S1054-3589(10)59005-7. Review.

lead_sponsor: Jean-Luc Balligand

location_country:
Italy
France
Poland
Greece
Belgium
Portugal
Germany
United Kingdom

location_facility: Center for Cardiovascular Research Berlin (CCR/Charité)

location_facility: Association for Research and Development of the Faculty of Medicine (AIDFM)

location_facility: University of Oxford - Division of Cardiovascular Medicine (UOXF)

location_facility: Department of Heart Diseases at Wroclaw Medical University (UMW)

location_facility: University Medical Center Göttingen (UMG-GOE)

intervention_type: Radiation


ReferenceCitation: Monagle P, Lensing AWA, Thelen K, Martinelli I, Male C, Santamaría A, Samochatova E, Kumar R, Holzhauer S, Saracco P, Simioni P, Robertson J, Grangl G, Halton J, Connor P, Young G, Molinari AC, Nowak-Göttl U, Kenet G, Kapsa S, Willmann S, Pap AF, Becka M, Twomey T, Beyer-Westendorf J, Prins MH, Kubitza D; EINSTEIN-Jr Phase 2 Investigators. Bodyweight-adjusted rivaroxaban for children with venous thromboembolism (EINSTEIN-Jr): results from three multicentre, single-arm, phase 2 studies. Lancet Haematol. 2019 Oct;6(10):e500-e509. doi: 10.1016/S2352-3026(19)30161-9. Epub 2019 Aug 13.

family: Monagle

full_name: Paul Monagle

given: Paul

family: Lensing

full_name: Anthonie W A Lensing

given: Anthonie W A

family: Thelen

full_name: Kirstin Thelen

given: Kirstin

family: Martinelli

full_name: Ida Martinelli

given: Ida

family: Male

full_name: Christoph Male

given: Christoph

family: Santamaría

full_name: Amparo Santamaría

given: Amparo

family: Samochatova

full_name: Elena Samochatova

given: Elena

family: Kumar

full_name: Riten Kumar

given: Riten

family: Holzhauer

full_name: Susanne Holzhauer

given: Susanne

family: Saracco

full_name: Paola Saracco

given: Paola

family: Simioni

full_name: Paolo Simioni

given: Paolo

family: Robertson

full_name: Jeremy Robertson

given: Jeremy

family: Grangl

full_name: Gernot Grangl

given: Gernot

family: Halton

full_name: Jacqueline Halton

given: Jacqueline

family: Connor

full_name: Phillip Connor

given: Phillip

family: Young

full_name: Guy Young

given: Guy

family: Molinari

full_name: Angelo C Molinari

given: Angelo C

family: Nowak-Göttl

full_name: Ulrike Nowak-Göttl

given: Ulrike

family: Kenet

full_name: Gili Kenet

given: Gili

family: Kapsa

full_name: Stefanie Kapsa

given: Stefanie

family: Willmann

full_name: Stefan Willmann

given: Stefan

family: Pap

full_name: Akos F Pap

given: Akos F

family: Becka

full_name: Michael Becka

given: Michael

family: Twomey

full_name: Teresa Twomey

given: Teresa

family: Beyer-Westendorf

full_name: Jan Beyer-Westendorf

given: Jan

location_country: Italy Austria France Israel Spain Turkey Germany

title: 7-day Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children From Birth to Less Than 6 Months With Arterial or Venous Thrombosis

summary: The purpose of this study is to find out whether rivaroxaban is safe and effective to use in children age newborn to less than 6 months and how long it stays in the body and how it is used in the body. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.


title: Prospective, International, Multi-centre Study on ASAS Classification Criteria for SpA

summary:
Background:

Existing criteria for AS/SpA such as mod. New York, ESSG, or Amor criteria for classification and/or diagnosis of spondyloarthritis have limitations when applied to early disease. Moreover, MRI is not part of any of the established criteria and the precise role of MRI in early axial disease has not been fully defined yet. Even less is known about sacroiliac (SI) changes in SpA patients with peripheral symptoms. A pilot study using data from 'paper patients' led to new candidate criteria for early spondyloarthritis. Subsequently, the members of the ASAS International Working Group decided to conduct a prospective multi-centre study to evaluate (validate) the new candidate criteria, and to assess their performance as diagnostic criteria.

Aims of the study:

To evaluate the new candidate criteria for axial SpA in a multi-centre setting.
To assess the potential role of the new candidate criteria to be used as diagnostic criteria. To accomplish this, inclusion of consecutive and undiagnosed patients is mandatory as are longer periods of follow-up .
To compare criteria encompassing the whole group of SpA such as ESSG and Amor criteria against criteria which are tailored to either predominant axial disease or predominant peripheral disease. To accomplish this, both patients with predominant axial disease (back pain) but also patient with predominant peripheral disease (arthritis/enthesitis) will be included.

status: Unknown status

ReferenceCitation: Rudwaleit M, Metter A, Listing J, Sieper J, Braun J. Inflammatory back pain in ankylosing spondylitis: a reassessment of the clinical history for application as classification and diagnostic criteria. Arthritis Rheum. 2006 Feb;54(2):569-78.

ReferenceCitation: Rudwaleit M, Sieper J. Positive and negative predictive values from published studies can be misleading for decision-making in clinical practice. Rheumatology (Oxford). 2006 Jun;45(6):779-80; author reply 780-1. Epub 2006 Apr 4.

ReferenceCitation: Rudwaleit M, van der Heijde D, Landewé R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan MA, Kirazli Y, Maksymowych WP, Mielants H, Sørensen IJ, Ozgocmen S, Roussou E, Valle-Oñate R, Weber U, Wei J, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17. Erratum in: Ann Rheum Dis. 2019 Jun;78(6):e59.

family: Rudwaleit

full_name: M Rudwaleit

given: M

family: van der Heijde

full_name: D van der Heijde

given: D

family: Landewe

full_name: R Landewe

given: R

family: Listing

full_name: J Listing

given: J

family: Akkoc

full_name: N Akkoc

given: N

family: Brandt

full_name: J Brandt

family: Braun

full_name: J Braun

family: Chou

full_name: C T Chou

given: C T

family: Collantes-Estevez

full_name: E Collantes-Estevez

given: E

family: Dougados

full_name: M Dougados

family: Huang

full_name: F Huang

given: F

family: Gu

full_name: J Gu

family: Khan

full_name: M A Khan

given: M A

family: Kirazli

full_name: Y Kirazli

given: Y

family: Maksymowych

full_name: W P Maksymowych

given: W P

family: Mielants

full_name: H Mielants

given: H

family: Sorensen

full_name: I J Sorensen

given: I J

family: Ozgocmen

full_name: S Ozgocmen

given: S

family: Roussou

full_name: E Roussou

family: Valle-Onate

full_name: R Valle-Onate

family: Weber

full_name: U Weber

given: U

family: Wei

full_name: J Wei

family: Sieper

full_name: J Sieper

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

location_country:
Italy
Brazil
United States
Switzerland
Mexico
Netherlands
Germany
Spain
Indonesia
France
Hungary
Belgium
Ireland
China
Turkey
Denmark
Canada
United Kingdom
Taiwan
Colombia

location_facility: Universitaetsmedizin Berlin, Charité Campus Benjamin-Franklin, Med. Clinic I, Rheumatology, Hindenburgdamm 30

location_facility: Hvidovre Hospital, University of Copenhagen

location_facility: Case Western Reserve University at MetroHealth Medical Centre

location_facility: Third Affiliated Hospital of Sun Yat-sen University

location_facility: Glasgow Royal Infirmary, Queen Elizabeth Building


title: Long-term Bosentan Open Label Extension of the AC-052-331 Study in Systemic Sclerosis Patients With Ischemic Digital Ulcers

acronym: RAPIDS 2 OL

summary: The aim of the study is to collect long-term efficacy, tolerability and safety data of bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DUs).

lead_sponsor: Actelion

location_country:
Italy
Austria
Switzerland
Germany
France
United States
United Kingdom
Canada

location_facility:
Howard Kenney, MD
Maureen Mayes, MD
Barri Fessler, MD
Edwin Smith, MD
Bashar Kahaleh, MD
Jerry Molitor, MD
Frederick Wigley, MD
Freeman Hospital
Universitatsklinikum
Murray Baron, MD
Eric Rich, MD
Peter Lee, MD
Mary Ellen Csuka, MD
Thomas Medsger, MD
Thomas Osborn, MD
Ospedale Maggiore
Peter Merkel, MD
David Collier, MD
Centre Hospitalier Universitaire
Universitatsklinik
Royal Free Hospital
Naomi Rothfield, MD
Avram Goldberg, MD
Janet Pope, MD
Policlinico Umberto 1
AKH Universitatsklinik
Inselspital, Universitatspital Bern
Vivien Hsu, MD - UMDNJ
Medical Universtiy of South Carolina
Mittie Doyle, MD
Nadera Sweiss, MD
CHRU Claude Huriez
Selly Oak Hospital
Instituto di Clinica, Villa Monna Tessa
Daniel Furst, MD


title: Long-term Open-label Extension Study in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Who Completed Protocol AC-052-366 (BENEFIT, NCT00313222)

acronym: BENEFIT OL

summary: The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.

location_country:
Italy
Austria
United States
United Kingdom
Netherlands
Germany
France
Poland
Australia
Belgium
Spain
Canada
Czech Republic

location_facility: Charles University, Internal Medicine Department, (PAH unit)

location_facility: Centre de Pneumologie de L'Hopital Laval

location_facility: Mayo Clinic, Division of Cardiovascular Diseases and Internal Medicine


title: Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

summary: The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH), to patients suffering from inoperable chronic thromboembolic pulmonary hypertension (CTEPH) because of (i) peripheral localization of thrombotic material or (ii) persistent or recurrent pulmonary hypertension after pulmonary endarterectomy.

ReferenceCitation: Jaïs X, D'Armini AM, Jansa P, Torbicki A, Delcroix M, Ghofrani HA, Hoeper MM, Lang IM, Mayer E, Pepke-Zaba J, Perchenet L, Morganti A, Simonneau G, Rubin LJ; Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension Study Group. Bosentan for treatment of inoperable chronic thromboembolic pulmonary hypertension: BENEFiT (Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension), a randomized, placebo-controlled trial. J Am Coll Cardiol. 2008 Dec 16;52(25):2127-34. doi: 10.1016/j.jacc.2008.08.059.

family: Jaïs

full_name: Xavier Jaïs

given: Xavier

family: D'Armini

full_name: Andrea M. D'Armini

given: Andrea M.

family: Jansa

full_name: Pavel Jansa

given: Pavel

family: Torbicki

full_name: Adam Torbicki

given: Adam

family: Delcroix

full_name: Marion Delcroix

given: Marion

family: Ghofrani

full_name: Hossein A. Ghofrani

given: Hossein A.

family: Hoeper

full_name: Marius M. Hoeper

given: Marius M.

family: Lang

full_name: Irene M. Lang

given: Irene M.

family: Mayer

full_name: Eckhard Mayer

given: Eckhard

family: Pepke-Zaba

full_name: Joanna Pepke-Zaba

given: Joanna

family: Perchenet

full_name: Loïc Perchenet

given: Loïc

family: Morganti

full_name: Adele Morganti

given: Adele

family: Simonneau

full_name: Gérald Simonneau

given: Gérald

family: Rubin

full_name: Lewis J. Rubin

given: Lewis J.

journal_name: Journal of the American College of Cardiology

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: Bosentan for Treatment of Inoperable Chronic Thromboembolic Pulmonary Hypertension

location_facility: Toronto General Hospital Pulmonary & Critical Care Medicine

location_facility: Centre de Pneumonologie de L'Hospital Laval


title: A Randomised Study Examining the Effect of Different Diuretics on Fluid Balance in Diabetics Treated With Avandia

summary: Study examining the effect of different diuretics on fluid retention in diabetics treated with rosiglitazone.

ReferenceType: result

ReferenceCitation: Karalliedde J. Abstract (oral presentation). Management of Rosiglitazone Related Fluid Retention. Diabetes 2005; Vol 54, (suppl 1):Abstract number 81-OR

ReferenceCitation: Karalliedde J, Buckingham R, Starkie M, Lorand D, Stewart M, Viberti G; Rosiglitazone Fluid Retention Study Group. Effect of various diuretic treatments on rosiglitazone-induced fluid retention. J Am Soc Nephrol. 2006 Dec;17(12):3482-90. Epub 2006 Nov 8.

ipd_sharing: Yes

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:
Italy
Netherlands
Germany
France
Poland
Greece
Israel
Slovakia
Norway
Belgium
Spain
Denmark
Canada
United Kingdom


title: A Phase 2B, Randomized, Multicenter, Dose-Ranging Study Assessing the Safety and Efficacy of PD 0348292 in the Prevention of Venous Thromboembolic Events (VTE) in Subjects Undergoing an Elective, Unilateral Total Knee Replacement

summary: To study the safety and effectiveness of several doses of PD 0348292 compared to enoxaparin in preventing blood clots in the lungs or deep leg veins of patients after knee surgery

primary_purpose: Prevention

lead_sponsor: Pfizer

location_country:
Italy
United States
Chile
South Africa
United Kingdom
Spain
France
Poland
Slovakia
Australia
Russian Federation
Portugal
Denmark
Canada
Czech Republic
Colombia


title: A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients With Bladder Cancer Undergoing Radical or Total Cystectomy.

summary: The purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during your surgery, is safe and can help reduce the need for a blood transfusion during bladder surgery.

location_country:
United States
Sweden
Netherlands
France
Belgium
Germany
United Kingdom


title: A Phase IIB Study to Assess the Efficacy of GSK 249553 as Adjuvant Therapy Given to MAGE-3-Positive Patients With Non-Small-Cell Lung Cancer in Stage IB (T2/N0) or II (T1/N1 or T2/N1 or T3/N0), Who Have Had Complete Surgical Resection

summary: Patients will receive injections of GSK 249553 vaccine . Appropriate tests will be performed to assess the safety of the treatment and its ability to induce an immune response.

ReferenceCitation: Passlick B et al. MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) as adjuvant therapy in resected stage IB/II Non-Small Cell Lung Cancer (NSCLC): from proof-of-concept to Phase III trial (MAGRIT). Abstract presented at the European Multidisciplinary Conference in Thoracic Oncology (EMCTO), Lugano, Switzerland. 1-3 May 2009; 64 (suppl. 1):S45 (102PD).

ReferenceCitation: Vansteenkiste J et al. Activity of MAGE-A3 cancer immunotherapeutic as adjuvant therapy in stage IB/II Non-Small Cell Lung Cancer (NSCLC): Final results of a multi-center, double-blind, randomized, placebo-controlled Phase II study. Abstract presented at the 12th Conference on Lung Cancer (WCLC), Seoul, Korea. 2-6 September 2007.

ReferenceCitation: Vansteenkiste J et al. Adjuvant therapy in stage IB/II Non-Small Cell Lung Cancer (NSCLC): Final results of a multi-center, double-blind, randomized, placebo-controlled Phase II study evaluating the MAGE-A3 cancer immunotherapeutic. Abstract presented at The 14th European Cancer Conference (ECCO) (formerly ECCO14/ESTRO 26), Barcelona, Spain. 23-27 September 2007.

ReferenceCitation: Vansteenkiste J et al. Multi-center, double-blind, randomized, placebo-controlled Phase II study to assess the efficacy of recombinant MAGE-A3 vaccine as adjuvant therapy in stage IB/II MAGE-A3-positive, completely resected, Non-Small Cell Lung Cancer (NSCLC). Abstract presented at the 43rd Annual Meeting American Society of Clinical Oncology (ASCO), Chicago, IL. 1-5 June 2007.

ReferenceCitation: Vansteenkiste J et al. Multi-center, double-blind, randomized, placebo-controlled phase II study to assess the efficacy of recombinant MAGE-A3 vaccine as adjuvant therapy in stage IB/II MAGE-A3-positive, completely resected, non-small-cell lung cancer (NSCLC). Abstract presented at the 42nd Annual Meeting American Society of Clinical Oncology (ASCO), Atlanta, GA. 2-6 June 2006.

ReferenceCitation: Vansteenkiste J et al. Phase II randomized study of MAGE-A3 immunotherapeutic as adjuvant therapy in stage IB/II Non-Small Cell Lung Cancer (NSCLC): 44 month follow-up, humoral and cellular immune response data. European Society for Medical Oncology (IASLC-ESMO) Abstract presented at the 1st European Lung Cancer Conference (ELCC), Geneva, Switzerland. 23-26 April 2008; 3 (4 suppl.1):S55-56.

ReferenceCitation: Zielinski M et al. MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) as adjuvant therapy in resected stage IB/II Non-Small Cell Lung Cancer (NSCLC): from proof-of-concept to Phase III trial (MAGRIT). Abstract presented at the 17th European Conference on General Thoracic Surgery (ECGTS), Krakow, Poland. 31 May-3 June 2009.

ReferenceCitation: Vansteenkiste J, Zielinski M, Linder A, Dahabreh J, Gonzalez EE, Malinowski W, Lopez-Brea M, Vanakesa T, Jassem J, Kalofonos H, Perdeus J, Bonnet R, Basko J, Janilionis R, Passlick B, Treasure T, Gillet M, Lehmann FF, Brichard VG. Adjuvant MAGE-A3 immunotherapy in resected non-small-cell lung cancer: phase II randomized study results. J Clin Oncol. 2013 Jul 1;31(19):2396-403. doi: 10.1200/JCO.2012.43.7103. Epub 2013 May 28.

name: Johan Vansteenkiste, University Hospital KU Leuven, Leuven; Marc Gillet, Frédéric F. Lehmann, and Vincent G. Brichard, GlaxoSmithKline Biologicals, Rixensart, Belgium; Marcin Zielinski, Pulmonary Hospital, Zakopane; Wojciech Malinowski, Szpital Kopernika, Tusznin; Jacek Jassem, Medical University of Gdansk, Gdansk, Poland; Albert Linder, LungenKlinik, Hemer; Jakub Perdeus, Asklepios Fachkliniken Muenchen-Gauting, Gauting; Reiner Bonnet, Zentralklinikum Bad Berka, Bad Berka; Bernward Passlick, University...

family: Vansteenkiste

full_name: Johan Vansteenkiste

given: Johan

family: Zielinski

full_name: Marcin Zielinski

given: Marcin

family: Linder

full_name: Albert Linder

given: Albert

family: Dahabreh

full_name: Jubrail Dahabreh

given: Jubrail

family: Gonzalez

full_name: Emilio E. Gonzalez

given: Emilio E.

family: Malinowski

full_name: Wojciech Malinowski

given: Wojciech

family: Lopez-Brea

full_name: Marta Lopez-Brea

given: Marta

family: Vanakesa

full_name: Tonu Vanakesa

given: Tonu

family: Jassem

full_name: Jacek Jassem

given: Jacek

family: Kalofonos

full_name: Haralabos Kalofonos

given: Haralabos

family: Perdeus

full_name: Jakub Perdeus

given: Jakub

family: Bonnet

full_name: Reiner Bonnet

given: Reiner

family: Basko

full_name: Jazeps Basko

given: Jazeps

family: Janilionis

full_name: Richard Janilionis

given: Richard

family: Passlick

full_name: Bernward Passlick

given: Bernward

family: Treasure

full_name: Tom Treasure

given: Tom

family: Gillet

full_name: Marc Gillet

given: Marc

family: Lehmann

full_name: Frédéric F. Lehmann

given: Frédéric F.

family: Brichard

full_name: Vincent G. Brichard

given: Vincent G.

journal_name: Journal of Clinical Oncology

title: Adjuvant MAGE-A3 Immunotherapy in Resected Non–Small-Cell Lung Cancer: Phase II Randomized Study Results

ReferenceCitation: Ulloa-Montoya F, Louahed J, Dizier B, Gruselle O, Spiessens B, Lehmann FF, Suciu S, Kruit WH, Eggermont AM, Vansteenkiste J, Brichard VG. Predictive gene signature in MAGE-A3 antigen-specific cancer immunotherapy. J Clin Oncol. 2013 Jul 1;31(19):2388-95. doi: 10.1200/JCO.2012.44.3762. Epub 2013 May 28.

name: Fernando Ulloa-Montoya, Jamila Louahed, Benjamin Dizier, Olivier Gruselle, Bart Spiessens, Frédéric F. Lehmann, and Vincent G. Brichard, GlaxoSmithKline Vaccines, Rixensart; Stefan Suciu, European Organisation for Research and Treatment of Cancer Headquarters, Brussels; Johan Vansteenkiste, University Hospital Leuven/KU Leuven, Leuven, Belgium; Wim H.J. Kruit, Erasmus Medical Center, Rotterdam, the Netherlands; and Alexander M.M. Eggermont, Institut Gustave Roussy, Villejuif, France.

family: Ulloa-Montoya

full_name: Fernando Ulloa-Montoya

given: Fernando

title: Predictive Gene Signature in MAGE-A3 Antigen-Specific Cancer Immunotherapy

ipd_sharing_description: IPD is available via the Clinical Study Data Request site (click on the link provided below)

location_country:
Italy
United Kingdom
Netherlands
Finland
France
Poland
Greece
Lithuania
Norway
Belgium
Spain
Estonia
Germany
Latvia


title: A Randomized, Controlled, Parallel-Group, Multicenter Study of Extracorporeal Photoimmune Therapy With THERAKOS* UVADEX* for the Treatment of Patients With Newly Diagnosed Acute Graft Versus-Host Disease

summary: The purpose of this study is to compare the safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in the treatment of patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT.

lead_sponsor: Mallinckrodt

location_country:
Italy
Austria
United States
Switzerland
Netherlands
Germany
France
Australia
Belgium
Canada
United Kingdom

location_facility: Centre Hospitalier Universitaire Hospital Bordeaux

location_facility: Weill Medical College of Cornell University

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Leukemia and Bone Marrow Transplant Center - Avera Cancer Institute

location_facility: Klinikum der Universitat Erlangen-Nurnberg

location_facility: Universita di Siena Policlinico Le Scotte

location_facility: Stammzelltransplantationzentrum der Universitat Wurzbrug

location_facility: Centre Hopitalier Universitaire Sart Tilman Liege

intervention_type: Procedure


title: MVP Trial (Managed Ventricular Pacing ("MVP") Versus Backup Ventricular Pacing at a Rate of 40 Beats Per Minute ("VVI 40") Pacing Trial)

acronym: MVP

summary: The purpose of the study is to compare two device settings (sets of instructions) used by the ICD. The Implantable Cardiac Defibrillator ("ICD") can be set to use one wire (top or bottom of the heart) or two wires (top and bottom). The study will compare how much time either ICD wire is used by the ICD and the status of congestive heart failure.

ReferenceCitation: Sweeney MO, Ellenbogen KA, Tang AS, Whellan D, Mortensen PT, Giraldi F, Sandler DA, Sherfesee L, Sheldon T; Managed Ventricular Pacing Versus VVI 40 Pacing Trial Investigators. Atrial pacing or ventricular backup-only pacing in implantable cardioverter-defibrillator patients. Heart Rhythm. 2010 Nov;7(11):1552-60. doi: 10.1016/j.hrthm.2010.05.038. Epub 2010 Jun 4.

family: Sweeney

full_name: Michael O. Sweeney

given: Michael O.

family: Ellenbogen

full_name: Kenneth A. Ellenbogen

given: Kenneth A.

family: Tang

full_name: Anthony S.L. Tang

given: Anthony S.L.

family: Whellan

full_name: David Whellan

given: David

family: Mortensen

full_name: Peter T. Mortensen

given: Peter T.

family: Giraldi

full_name: Francesco Giraldi

given: Francesco

family: Sandler

full_name: David A. Sandler

given: David A.

family: Sherfesee

full_name: Lou Sherfesee

given: Lou

family: Sheldon

full_name: Todd Sheldon

given: Todd

journal_name: Heart Rhythm

title: Atrial pacing or ventricular backup–only pacing in implantable cardioverter-defibrillator patients

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Italy
Austria
Switzerland
Germany
France
Israel
Norway
Spain
Denmark
United States
United Kingdom
Canada


title: A Study to Compare the Efficacy of AZD2171 in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) and the Efficacy of Bevacizumab in Combination With FOLFOX in the Second-line Treatment of Patients With Metastatic Colorectal Cancer

acronym: HORIZON I

summary: The primary purpose of this study is to compare the efficacy of AZD2171 in combination with FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line treatment of patients with metastatic colorectal cancer

lead_sponsor: AstraZeneca

location_country:
Italy
Austria
United Kingdom
Germany
France
Belgium
Spain
Canada
Czech Republic

location_facility:
Ressearch Site
Research Site


title: A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas

summary: Open-label, non-randomized trial to assess the effectiveness of PXD101 in patients with recurrent or refractory cutaneous or peripheral and other types of T-cell lymphomas. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Patients are treated with belinostat(PXD101) 1000 mg/m2 on days 1-5 of a 21 day cycle.

ReferenceCitation: Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben-Yehuda D, Beylot-Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma. Br J Haematol. 2015 Mar;168(6):811-9. doi: 10.1111/bjh.13222. Epub 2014 Nov 17.

family: Foss

full_name: Francine Foss

given: Francine

family: Advani

full_name: Ranjana Advani

given: Ranjana

name: M.D. Anderson Cancer Center; Houston TX USA

family: Duvic

full_name: Madeleine Duvic

given: Madeleine

name: Cancer Institute; New York University; New York NY USA

family: Hymes

full_name: Kenneth B. Hymes

given: Kenneth B.

name: Department of Medicine; Chulalongkorn Hospital; Bangkok Thailand

family: Intragumtornchai

full_name: Tanin Intragumtornchai

given: Tanin

name: Department of Medicine; Songlanagarind Hospital; Songkhla Thailand

family: Lekhakula

full_name: Arnuparp Lekhakula

given: Arnuparp

name: Haematology; Rabin Medical Centre; Beilinson Hospital; Davidoff Cancer Centre and Sackler School of Medicine; Tel Aviv University; Petach Tikva Israel

family: Shpilberg

full_name: Ofer Shpilberg

given: Ofer

family: Lerner

full_name: Adam Lerner

given: Adam

name: Kansas City Cancer Center; Kansas City MO USA

family: Belt

full_name: Robert J. Belt

given: Robert J.

name: Dana-Farber Cancer Institute; Boston MA USA

family: Jacobsen

full_name: Eric D. Jacobsen

given: Eric D.

family: Laurent

full_name: Guy Laurent

given: Guy

name: Division of Haematology; Hadassah-Hebrew University Medical Centre; Jerusalem Israel

family: Ben-Yehuda

full_name: Dina Ben-Yehuda

given: Dina

name: Hopital du Haut-Leveque; Universite Bordeaux; Pessac France

family: Beylot-Barry

full_name: Marie Beylot-Barry

given: Marie

name: Universitatsklinikum Essen; Essen Germany

family: Hillen

full_name: Uwe Hillen

given: Uwe

family: Knoblauch

full_name: Poul Knoblauch

given: Poul

family: Bhat

full_name: Gajanan Bhat

given: Gajanan

family: Chawla

full_name: Shanta Chawla

given: Shanta

family: Allen

full_name: Lee F. Allen

given: Lee F.

name: Hematologic Oncology and Blood Disorders; Cleveland Clinic Taussig Cancer Institute; Cleveland OH USA

family: Pohlman

full_name: Brad Pohlman

given: Brad

journal_name: British Journal of Haematology

lead_sponsor: Onxeo

location_country:
United States
Thailand
France
Israel
Germany

location_facility: Songklanagarind Hospital, Prince of Songkla University


title: An International, Multicenter, Randomized, Placebo-controlled, Parallel-group, 1 Year Treatment, Integrated Biomarkers and Imaging Study in Subjects With Angiographically Documented Coronary Heart Disease (CHD) to Examine the Effects of the Novel Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Inhibitor SB-480848 on Intermediate Cardiovascular Endpoints, Patient Safety and Tolerability

summary: IBIS-2 is a study using SB-480848 versus placebo in subjects with angiographically documented coronary heart disease. Endpoints include coronary imaging, endothelial function, biomarkers, safety and tolerability.

ReferenceCitation: Serruys PW, García-García HM, Buszman P, Erne P, Verheye S, Aschermann M, Duckers H, Bleie O, Dudek D, Bøtker HE, von Birgelen C, D'Amico D, Hutchinson T, Zambanini A, Mastik F, van Es GA, van der Steen AF, Vince DG, Ganz P, Hamm CW, Wijns W, Zalewski A; Integrated Biomarker and Imaging Study-2 Investigators. Effects of the direct lipoprotein-associated phospholipase A(2) inhibitor darapladib on human coronary atherosclerotic plaque. Circulation. 2008 Sep 9;118(11):1172-82. doi: 10.1161/CIRCULATIONAHA.108.771899. Epub 2008 Sep 1.

location_country: Austria Switzerland Netherlands France Czechia Poland Norway Belgium Spain Denmark Germany


title: Clinical Investigation of the Nucleus® CI532 Cochlear Implant

summary:
The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant and to demonstrate the atraumatic nature of the electrode design.

Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea through a straightening sheath.

ReferenceCitation: Hey M, Wesarg T, Mewes A, Helbig S, Hornung J, Lenarz T, Briggs R, Marx M, Ramos A, Stöver T, Escudé B, James CJ, Aschendorff A. Objective, audiological and quality of life measures with the CI532 slim modiolar electrode. Cochlear Implants Int. 2019 Mar;20(2):80-90. doi: 10.1080/14670100.2018.1544684. Epub 2018 Nov 22.

name: Universitätsklinikum Schleswig-Holstein, Kiel, Germany

family: Hey

full_name: Matthias Hey

given: Matthias

name: University of Freiburg, Freiburg, Germany

family: Wesarg

full_name: Thomas Wesarg

given: Thomas

family: Mewes

full_name: Alexander Mewes

given: Alexander

name: Klinikum der J. W. Goethe-Universität, Frankfurt, Germany

family: Helbig

full_name: Silke Helbig

given: Silke

name: Universitätsklinikum Erlangen, Erlangen, Germany

family: Hornung

full_name: Joachim Hornung

given: Joachim

name: Medizinische Hochschule Hannover, Hannover, Germany

family: Lenarz

full_name: Thomas Lenarz

name: University of Melbourne, Melbourne, VIC, Australia

family: Briggs

full_name: Robert Briggs

given: Robert

name: Centre Hospitalier Universitaire de Toulouse, Toulouse, France

family: Marx

full_name: Mathieu Marx

given: Mathieu

name: Complejo Hospitalario Universitario Insular Materno Infantil, Las Palmas, Spain

family: Ramos

full_name: Angel Ramos

given: Angel

family: Stöver

full_name: Timo Stöver

given: Timo

family: Escudé

full_name: Bernard Escudé

given: Bernard

family: James

full_name: Chris J. James

given: Chris J.

family: Aschendorff

full_name: Antje Aschendorff

given: Antje

journal_name: Cochlear Implants International

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Cochlear

location_country: Germany Australia France Spain

location_facility: Klinikum der J. W. Goethe-Universität Frankfurt

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Kiel

location_facility: Service d' ORL et d'Otoneurochirurgie, CHU Toulouse Purpan

location_facility: Ear, Nose and Throat Department, University of Freiburg

location_facility: Ear, Nose and Throat Department, Medizinische Hochschule

location_facility: Ear, Nose and Throat Department, Universitätsklinikum Erlangen


title: A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease Who Have Completed the MT 1303-E13 Study

summary:
The primary objectives of the study are:

-To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD）

lead_sponsor: Mitsubishi Tanabe Pharma Corporation

location_country: Italy Netherlands France Czechia Japan Israel Poland Slovakia Hungary Germany Ukraine


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

summary:
The primary objectives of the study are:

To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD）
To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active CD.

location_country:
Italy
Netherlands
France
Japan
Poland
Israel
Slovakia
Hungary
Germany
Czech Republic
Ukraine

location_facility:
Investigational site
Investigational Site


title: A Phase II, Multicenter, Randomized, Double-blind, "Sham" Pheresis-controlled, Study of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis in Patients Who Have an Inadequate Response to Disease Modifying Antirheumatic Drugs and Biological Agents

summary:
Rheumatoid arthritis (RA) is a systemic autoimmune inflammatory disorder that can cause substantial pain and joint tenderness, significant joint damage, and serious disability. The treatment goals are minimization of the signs and symptoms of the disease, and the reduction of irreversible joint damage.

As the understanding of the pathophysiological mechanisms underlying RA is elucidated, the opportunity to target specific inflammatory processes with new therapies has improved. Rheumatoid arthritis is a T cell-mediated autoimmune disease and there are various therapies, including newer experimental therapies, which target either the activation of T cells or the neutralization of their effector mechanisms. These newer therapies have shown benefit in human and animal models of RA. Extracorporeal photoimmune therapy (ECP) has been shown to be safe and effective in the palliative treatment of the skin manifestations of cutaneous T cell lymphoma. Experimental studies have also demonstrated activity of ECP treatment in several T cell mediated diseases including graft versus-host disease, rejection after organ transplantation, and selected autoimmune diseases.

This study will evaluate a cell-based therapy (ECP) in patients who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs) and biological agents to determine if ECP treatment can reduce the signs and symptoms of RA in this refractory patient population.

location_country:
Italy
Austria
United States
South Africa
Mexico
Germany
France
Slovakia
Australia
Belgium
Canada

location_facility: Medizinische Klinik des Evangelischen Kranken

location_facility: D6 Rheumatology Clinic and E5 Hematology Unit

location_facility: Carroll County Arthritis and Osteoporosis Center

location_facility: Universita de Genova - Ospedale S. Martino

location_facility: OPD- Hospital Civil "Dr. Jaun I. Menchaca"

location_facility: Benaroya Research Institute at Virginia Mason

location_facility: Arthritis and Osteoporosis Center of South Texas

location_facility: Abt. Rheumatologie und Klinische Immunologie

location_facility: University of Charite Clinic for Rheumatology and Immunology


title: A Phase 2b, Multi-Centre, Double-Blind, Placebo-Controlled, Parallel Group Dose Response Study To Assess The Efficacy and Safety Of Oral UK390,957 In Men With Premature Ejaculation

summary: Assessment of efficacy and safety UK-390,957.

location_country:
Italy
Austria
Sweden
Netherlands
Germany
France
Poland
Israel
Norway
Australia
Spain
Turkey
Canada
Czech Republic


summary: The objectives of this program are: to further characterize the natural progression of MPS VI disease; to generate and disseminate information on the care and management of MPS VI patients to clinical and medical professionals; to provide a resource to physicians and patients by providing information for optimizing patient care based on aggregate data; to characterize the clinical response to long-term Naglazyme® (galsulfase) treatment; to further characterize the long-term safety of Naglazyme® treatment.

ReferenceCitation: Solanki GA, Sun PP, Martin KW, Hendriksz CJ, Lampe C, Guffon N, Hung A, Sisic Z, Shediac R, Harmatz PR; CSP Study Group. Cervical cord compression in mucopolysaccharidosis VI (MPS VI): Findings from the MPS VI Clinical Surveillance Program (CSP). Mol Genet Metab. 2016 Aug;118(4):310-8. doi: 10.1016/j.ymgme.2016.06.001. Epub 2016 Jun 3.

family: Solanki

full_name: Guirish A. Solanki

given: Guirish A.

family: Sun

full_name: Peter P. Sun

given: Peter P.

family: Martin

full_name: Kenneth W. Martin

given: Kenneth W.

family: Hendriksz

full_name: Christian J. Hendriksz

given: Christian J.

family: Lampe

full_name: Christina Lampe

given: Christina

family: Guffon

full_name: Nathalie Guffon

given: Nathalie

family: Hung

full_name: Annie Hung

given: Annie

family: Sisic

full_name: Zlatko Sisic

given: Zlatko

family: Shediac

full_name: Renée Shediac

given: Renée

family: Harmatz

full_name: Paul R. Harmatz

given: Paul R.

journal_name: Molecular Genetics and Metabolism

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

repository_institution: University of Pretoria - UpSpace Institutional Repository

lead_sponsor: BioMarin Pharmaceutical

location_country:
Italy
Austria
Sweden
Netherlands
Germany
France
Lithuania
Ireland
Australia
Belgium
Portugal
United States
United Kingdom

location_facility: Great Ormond Street Hospital For Children, NHS Foundation Trust

location_facility: Universitatsklinikum Freiburg, Klinik II

location_facility: Ann and Robert H. Lurie Children's Hospital of Chicago

location_facility: Sioux Valey Children's Speciality Clinics

location_facility: Rotterdam University Hospital - Sophia's Children's Hospital

location_facility: Università Milano Bicocca, Resp. Centro "Fondazione Mariani"

location_facility: Hospital de Sao Joao, Unidae de Doencas Metabolicas

location_facility: Queen Elizabeth Hospital, University Hospitals Birmingham NHS

location_facility: University of Minnesota - Fairview University Medical Center

location_facility: St Mary's Hospital, Willink Biochemical Genetics Unit

location_facility: Children's Hospital and Research Center Oakland

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

location_facility: Institute of Pathology and Genetics, Metabolic Unit

location_facility: Department of Woman's and Child's Health

location_facility: Johns Hopkins Univeristy School of Medicine

location_facility: Vilnius University Hospital, Santariskiu Klinikos

location_facility: Birmingham Children's Hospital, Steelhouse