title: PET Interest in the Follow Up of Colorectal Cancer Stage II and III: Phase III Randomised Study

summary:
The follow up of colorectal cancer after curative surgery has to find loco-regional relapses or synchronous metastases, and to detect adenomas and new cancer on the rest of the colon.

The increase of survival after relapse of the colorectal cancer depends on the possibility of curative action or after chemotherapy response.

This is a Phase III open-labeled, multicenter, multidisciplinary, randomised study, comparing 2 arms of 188 patients (i.e. 376 total patients).

Study Period (date of first inclusion/last inclusion): 3 years.

Follow Up: 3 years.

The primary objective is the evaluation of PET performance in the earlier relapse detection of the colorectal cancer relapse in comparison with conventional control (including carcinoembryonic [CEA] levels and other classic radiological exams).

ReferenceCitation: Monteil J, Le Brun-Ly V, Cachin F, Zasadny X, Seitz JF, Mundler O, Selvy M, Smith D, Rullier E, Lavau-Denes S, Lades G, Labrunie A, Lecaille C, Valli N, Leobon S, Terrebonne E, Deluche E, Tubiana-Mathieu N. Comparison of 18FDG-PET/CT and conventional follow-up methods in colorectal cancer: A randomised prospective study. Dig Liver Dis. 2021 Feb;53(2):231-237. doi: 10.1016/j.dld.2020.10.012. Epub 2020 Nov 2.

family: Monteil

full_name: Jacques Monteil

given: Jacques

family: Le Brun-Ly

full_name: Valerie Le Brun-Ly

given: Valerie

family: Cachin

full_name: Florent Cachin

given: Florent

family: Zasadny

full_name: Xavier Zasadny

given: Xavier

family: Seitz

full_name: Jean-François Seitz

given: Jean-François

family: Mundler

full_name: Olivier Mundler

given: Olivier

family: Selvy

full_name: Marie Selvy

given: Marie

family: Smith

full_name: Denis Smith

given: Denis

family: Rullier

full_name: Eric Rullier

given: Eric

family: Lavau-Denes

full_name: Sandrine Lavau-Denes

given: Sandrine

family: Lades

full_name: Guillaume Lades

given: Guillaume

family: Labrunie

full_name: Anais Labrunie

given: Anais

family: Lecaille

full_name: Cedric Lecaille

given: Cedric

family: Valli

full_name: Nathalie Valli

family: Leobon

full_name: Sophie Leobon

given: Sophie

family: Terrebonne

full_name: Eric Terrebonne

family: Deluche

full_name: Elise Deluche

given: Elise

family: Tubiana-Mathieu

full_name: Nicole Tubiana-Mathieu

given: Nicole

journal_name: Digestive and Liver Disease

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd


type: Other Identifier

title: Open Multicenter Phase II Study in Second-Line Metastatic Colorectal Cancer Patients: Combination of ALIMTA and Irinotecan Administered Every Two-Weeks

summary: A non-randomized phase II study to determine the efficacy and safety of the combination of Pemetrexed and Irinotecan every two weeks in metastatic colorectal cancer patients.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Louvet C, André T, Gamelin E, Hebbar M, Mabro M, Bennamoun M, Rassam H, de Gramont A. Phase II Study of Biweekly Pemetrexed Plus Irinotecan as Second-Line Therapy for Metastatic Colorectal Cancer. J Oncol. 2010;2010:785934. doi: 10.1155/2010/785934. Epub 2010 Apr 8.

apc_source: doaj

name: Service d'Oncologie, Hôpital Saint-Antoine, 184 rue du Faubourg Saint-Antoine, 75012 Paris, France

family: Louvet

full_name: C. Louvet

given: C.

sequence: first

name: Groupe Hospitalier Pitié Salpétrière, Service d'Hépato-Gastroentérologie, Paris, France

family: André

full_name: T. André

given: T.

sequence: additional

family: Gamelin

full_name: E. Gamelin

given: E.

family: Hebbar

full_name: M. Hebbar

given: M.

family: Mabro

full_name: M. Mabro

name: Centre Hospitalier Intercommunal Le Raincy-Montfermeil, Montfermeil, France

family: Bennamoun

full_name: M. Bennamoun

family: Rassam

full_name: H. Rassam

given: H.

family: de Gramont

full_name: A. de Gramont

given: A.

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Oncology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Hindawi Limited

publisher_dissemination: Hindawi

publisher_group: Hindawi

publisher_normalized: Hindawi

lead_sponsor: Eli Lilly and Company

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.

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Phase II Study Evaluating The Role Of Exemestane On Clinical And Pathologic Response Rates, And Its Aromatase Activity As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients.

summary: To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)

lead_sponsor: Pfizer


title: A Prospective Randomized Multicentric Trial Comparing Amoxicillin/Clavulanate Potassium Therapy to Appendectomy for Acute Non Complicated Appendicitis

summary: The purpose of the study is to demonstrate that antibiotic therapy is as safe and effective as appendectomy for the treatment of acute non complicated appendicitis. Two hundred fifty patients will be included in a prospective multicentric randomized trial. The primary endpoint is the rate of intra abdominal infections in both therapeutic strategies. Other criteria will be studied including duration of hospital stay and absence from work during a follow up period of one year, parietal and abdominal complications and recurrent appendicitis after antibiotic therapy.

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Vons C, Barry C, Maitre S, Pautrat K, Leconte M, Costaglioli B, Karoui M, Alves A, Dousset B, Valleur P, Falissard B, Franco D. Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial. Lancet. 2011 May 7;377(9777):1573-9. doi: 10.1016/S0140-6736(11)60410-8.

family: Vons

full_name: Corinne Vons

given: Corinne

family: Barry

full_name: Caroline Barry

given: Caroline

family: Maitre

full_name: Sophie Maitre

family: Pautrat

full_name: Karine Pautrat

given: Karine

family: Leconte

full_name: Mahaut Leconte

given: Mahaut

family: Costaglioli

full_name: Bruno Costaglioli

given: Bruno

family: Karoui

full_name: Mehdi Karoui

given: Mehdi

family: Alves

full_name: Arnaud Alves

given: Arnaud

family: Dousset

full_name: Bertrand Dousset

given: Bertrand

family: Valleur

full_name: Patrice Valleur

given: Patrice

family: Falissard

full_name: Bruno Falissard

family: Franco

full_name: Dominique Franco

given: Dominique

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hotel Dieu Hospital, Department of Digestive Surgery

location_facility: Lariboisière Hospital, Department of Digestive Surgery

location_facility: Antoine Béclère Hospital - Department of Surgery

location_facility: Cochin Hospital, Department of Digestive Surgery

intervention_type: Procedure

lead_sponsor_type: academique


title: Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel and oxaliplatin and to see how well they work in treating patients with stage III or stage IV ovarian epithelial cancer.

status: Unknown status

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Polyclinique De Courlancy
C.H. Senlis
Hopital Saint Antoine
Intercommunal Hospital
Hopital Tenon

status_simplified: Unknown


title: Phase II Study of Hydroxyurea for the Treatment of Recurrent and/or Nonoperable Meningioma

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of hydroxyurea in treating patients who have recurrent and/or unresectable meningioma.

study_start_date_type: Actual

lead_sponsor: UNICANCER

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours


title: NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™

summary: The purpose of this study is to evaluate outcomes following electromagnetic navigation bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Bowling MR, Folch EE, Khandhar SJ, Kazakov J, Krimsky WS, LeMense GP, Linden PA, Murillo BA, Nead MA, Pritchett MA, Teba CV, Towe CW, Williams T, Anciano CJ. Fiducial marker placement with electromagnetic navigation bronchoscopy: a subgroup analysis of the prospective, multicenter NAVIGATE study. Ther Adv Respir Dis. 2019 Jan-Dec;13:1753466619841234. doi: 10.1177/1753466619841234.

name: Department of Internal Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, Brody School of Medicine, East Carolina University, 521a Moye Boulevard, Greenville, NC 27834, USA

family: Bowling

full_name: Mark R. Bowling

given: Mark R.

name: Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA

family: Folch

full_name: Erik E. Folch

given: Erik E.

name: Inova Health System, Virginia Cancer Specialists, Fairfax, VA, USA

family: Khandhar

full_name: Sandeep J. Khandhar

given: Sandeep J.

name: University Hospitals Cleveland Medical Center and Case Western Reserve School of Medicine, Cleveland, OH, USA

family: Kazakov

full_name: Jordan Kazakov

given: Jordan

name: Medstar Franklin Square Hospital Center, Baltimore, MD, USA

family: Krimsky

full_name: William S. Krimsky

given: William S.

name: Blount Memorial Physicians Group, Maryville, TN, USA

family: LeMense

full_name: Gregory P. LeMense

given: Gregory P.

family: Linden

full_name: Philip A. Linden

given: Philip A.

family: Murillo

full_name: Boris A. Murillo

given: Boris A.

name: University of Rochester Medical Center, Rochester NY, USA

family: Nead

full_name: Michael A. Nead

given: Michael A.

name: Pulmonary Department, Pinehurst Medical Clinic and FirstHealth Moore Regional Hospital, Pinehurst, NC, USA

family: Pritchett

full_name: Michael A. Pritchett

family: Teba

full_name: Catalina V. Teba

given: Catalina V.

family: Towe

full_name: Christopher W. Towe

given: Christopher W.

name: Department of Radiation Oncology, Ohio State University Wexner Medical Center, Columbus OH, USA Brigham and Women’s Hospital, Boston, MA, USA

family: Williams

full_name: Terence Williams

given: Terence

name: East Carolina University, Greenville, NC, USA

family: Anciano

full_name: Carlos J. Anciano

given: Carlos J.

journal_name: Therapeutic Advances in Respiratory Disease

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: East Carolina University - The Scholarship East Carolina University's Institutional Repository

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Khandhar SJ, Bowling MR, Flandes J, Gildea TR, Hood KL, Krimsky WS, Minnich DJ, Murgu SD, Pritchett M, Toloza EM, Wahidi MM, Wolvers JJ, Folch EE; NAVIGATE Study Investigators. Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study. BMC Pulm Med. 2017 Apr 11;17(1):59. doi: 10.1186/s12890-017-0403-9.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

ReferenceCitation: Folch EE, Bowling MR, Gildea TR, Hood KL, Murgu SD, Toloza EM, Wahidi MM, Williams T, Khandhar SJ. Design of a prospective, multicenter, global, cohort study of electromagnetic navigation bronchoscopy. BMC Pulm Med. 2016 Apr 26;16(1):60. doi: 10.1186/s12890-016-0228-y. Review.

location_country:
Italy
Austria
France
Spain
Denmark
United States
United Kingdom

location_facility: Pulmonary Medicine Center of Chattanooga - Memorial Health

location_facility: Pulmonary and Critical Care Associates of Baltimore

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino - IST

location_facility: Gundersen Lutheran Medical Foundation, Inc

location_facility: University of Cincinnati Physicians Company LLC

location_facility: University Hospitals of Case Medical Center

location_facility: University Hospitals of Saint Etienne France


title: A Multicenter, Parallel, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Moderate to Severe Plaque Psoriasis

summary: The primary objective is to assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks.

enrollment_type: Anticipated

ReferenceCitation: Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17.

name: Dermatology Centre; Manchester Academic Health Science Centre; Salford Royal Hospital; University of Manchester; M6 8HD Manchester U.K

family: Griffiths

full_name: C.E.M. Griffiths

family: Christophers

full_name: E. Christophers

given: E.

name: Specialty Care; Pfizer Inc; Collegeville PA U.S.A

family: Szumski

full_name: A. Szumski

given: A.

family: Jones

full_name: H. Jones

given: H.

family: Mallbris

full_name: L. Mallbris

given: L.

journal_name: British Journal of Dermatology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country: Italy Austria Netherlands France Poland Romania Hungary Belgium Spain Germany


type: EudraCT Number

title: A Phase IIIB, Multicentre, Multinational, Randomized, Open-label Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® Day 1 to Day 5 Followed by Pergoveris® Starting Day 6 to Pergoveris® Starting Day 1 in Women Between 36 and 40 Years of Age Undergoing Assisted Reproductive Technique (ART)

acronym: PERSIST

summary:
This is a multicenter, multi-national, randomized, open-label comparative trial. After screening, the subjects will start down-regulation treatment on Day 21-22 of the cycle. Down-regulation treatment will start within 2 months following the screening visit. The routine long luteal phase protocol for gonadotropin-releasing hormone (GnRH) agonist treatment will be followed. Once down-regulation has been confirmed, a pregnancy test will be performed just before randomization and start of recombinant human follicle-stimulating hormone (r-hFSH) treatment to rule out any pre-existing pregnancy. If the result is negative, the subject will be randomly assigned to one of the two treatment arms of the trial:

GONAL-f®: (Liquid Pen; 300 international unit [IU] of per day) stimulation Day 1-5 followed by Pergoveris® (vial/powder, 300 IU per day) from stimulation Day 6 and until required recombinant human chorionic hormone (r-hCG) criterion is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Pergoveris®: (vial/powder, 300 IU per day) from stimulation Day 1 and until required r-hCG criterion is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.

Randomization across the two treatment arms will be kept balanced in a 1:1 ratio. Follicular development will be monitored according to the center's standard practice by ultrasound (US) and/or estradiol (E2) levels, until the protocol r-hCG requirement is met (i.e., at least one follicle greater than or equal to [>=] 18 millimeter [mm] and two follicles >=16 mm). After this, a single injection of r-hCG will be administered in order to induce final oocyte maturation.

At a time of 34-38 hours after r-hCG administration, oocytes will be recovered vaginally under US monitoring. Oocytes will then be fertilized in vitro and embryos replaced 2-5 days after oocyte recovery. Ovum pick up (OPU), in vitro fertilization (IVF), embryo transfer (ET) and luteal support will be performed as per center's standard practice.

A post-treatment safety visit will be performed for all subjects who received r-hCG (pregnant and non- pregnant) on Day 15-20 post-hCG. For subjects who have withdrawn from treatment (i.e. after starting Pergoveris® or Gonal-f® but before hCG is given) this visit will take place 20-30 days after their first Pergoveris® or Gonal-f® treatment injection (excluding pregnancy testing).

ReferenceCitation: H Behre, C Howles, S Longobardi. Luteinizing hormone supplementation from Day 1 versus 6 of ovarian stimulation in women aged 36-40 years: results from an open-label, randomized, multicentre, multinational trial. Human Reproduction. 2013;28(suppl 1)

ReferenceCitation: Behre HM, Howles CM, Longobardi S; PERSIST Study Investigators. Randomized trial comparing luteinizing hormone supplementation timing strategies in older women undergoing ovarian stimulation. Reprod Biomed Online. 2015 Sep;31(3):339-46. doi: 10.1016/j.rbmo.2015.06.002. Epub 2015 Jun 15.

family: Behre

full_name: Hermann M. Behre

given: Hermann M.

family: Howles

full_name: Colin M. Howles

given: Colin M.

family: Longobardi

full_name: Salvatore Longobardi

given: Salvatore

bso_classification: Biology (fond.)

journal_name: Reproductive BioMedicine Online

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country:
Italy
Netherlands
Finland
France
Poland
Greece
Slovakia
Russian Federation
Denmark
Germany
United Kingdom


title: A Prospective, Randomized, Controlled, Stratified Study of InductOs in Subjects With Open Diaphyseal Tibia Fractures Treated With Reamed Locked Intramedullary Nail Fixation

summary: Demonstrate a larger proportion of subjects with healed fractures among subjects treated with InductOs and reamed, locked intramedullary nailing compared to subjects treated with reamed, locked intramedullary nailing alone.

location_country:
Italy
South Africa
Netherlands
Finland
France
Poland
Norway
Romania
Belgium
Spain
Germany
United Kingdom


title: A Prospective, Multicentre, International, Post-marketing, Longitudinal, Observational Cohort Study to Monitor the Performances of GMK Sphere Cementless Knee Prosthesis

summary: This is a Post-Marketing Surveillance study of GMK Sphere cementless knee prosthesis.

status: Recruiting

study_completion_date_type: Anticipated

lead_sponsor: Medacta International SA

location_country: France Switzerland

location_facility:
Hôpitaux Civils de Colmar
Clinique Saint Vincent de Paul
Hôpital de la Tour
Clinique des Acacias
Clinique du Parc

intervention_type: Device

status_simplified: Ongoing


title: Study of the Impact of DPD Activity on the Efficacy of Capecitabine

acronym: DPDMAX

summary: This study evaluates the Impact of DihydroPyrimidine Dehydrogenase (DPD) activity on the efficacy of Capecitabine in patients with metastatic breast cancer. The DPD phenotype before the initiation of treatment will be assess and then the patient will be follow up during the treatment with Capecitabine up to 24 month.

primary_purpose: Other

ipd_sharing: No

lead_sponsor: Centre Antoine Lacassagne

location_country: Monaco France

location_facility:
Clinique St Georges
Centre Antoine Lacassagne
Centre Azuréen de Cancérologie
Clinique Saint Jean
Hôpital Princesse Grâce

intervention_type: Other


title: A Prospective, Multicenter, Randomised Study to Evaluate the Fixation of Cemented and Cementless Design of GMK-UNI Anatomical Knee Prosthesis.

summary: Unicompartmental knee arthroplasty (UKA) is the principal surgical alternative to the total knee arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current comparative randomized study aims to evaluate the fixation of cemented and cementless designs of GMK-UNI unicompartmental knee prosthesis over a 5-year time period.

ipd_sharing: Undecided

location_facility:
Clinique du Mail
CHP Saint-Grégoire
Centre Orthéo, Espace Fauriel
Dr. Näder Helmy
Clinique Saint Vincent de Paul


type: Registry Identifier

title: Measurement of Pharyngeal Sensitivity With the SENSITEST Device: Validation of the Diagnosis Algorithm for Sleep Disordered Breathing

acronym: SENSITEST

summary: Pharyngeal sensitivity is a determinant parameter of pharyngeal functioning, particularly regarding protective dilator reflexes of upper airway. Preliminary results have suggested that the use of this parameter in diagnosis algorithm such as linear discriminant analysis and random forest could predict the presence of sleep apnea syndrome in almost 98% of patients. Our study aims at validating a new diagnosis method of sleep disordered breathing which will be compared with nocturnal polysomnography, the reference method to diagnose sleep disordered breathing. Pharyngeal sensitivity will be measured using the SENSITEST device which allows an automatic measurement of the pharyngeal sensation. The use of this parameter in diagnosis algorithm will be compared with polysomnographic results.

primary_purpose: Diagnostic

ReferenceType: background

ReferenceCitation: Dematteis M, Lévy P, Pépin JL. A simple procedure for measuring pharyngeal sensitivity: a contribution to the diagnosis of sleep apnoea. Thorax. 2005 May;60(5):418-26.

ReferenceCitation: Larsson H, Carlsson-Nordlander B, Lindblad LE, Norbeck O, Svanborg E. Temperature thresholds in the oropharynx of patients with obstructive sleep apnea syndrome. Am Rev Respir Dis. 1992 Nov;146(5 Pt 1):1246-9.

ReferenceCitation: Kimoff RJ, Sforza E, Champagne V, Ofiara L, Gendron D. Upper airway sensation in snoring and obstructive sleep apnea. Am J Respir Crit Care Med. 2001 Jul 15;164(2):250-5.

ReferenceCitation: Guilleminault C, Li K, Chen NH, Poyares D. Two-point palatal discrimination in patients with upper airway resistance syndrome, obstructive sleep apnea syndrome, and normal control subjects. Chest. 2002 Sep;122(3):866-70.

ReferenceCitation: Woodson BT, Garancis JC, Toohill RJ. Histopathologic changes in snoring and obstructive sleep apnea syndrome. Laryngoscope. 1991 Dec;101(12 Pt 1):1318-22.

ReferenceCitation: Friberg D. Heavy snorer's disease: a progressive local neuropathy. Acta Otolaryngol. 1999;119(8):925-33.

ReferenceCitation: Boyd JH, Petrof BJ, Hamid Q, Fraser R, Kimoff RJ. Upper airway muscle inflammation and denervation changes in obstructive sleep apnea. Am J Respir Crit Care Med. 2004 Sep 1;170(5):541-6. Epub 2004 May 19.

ReferenceCitation: Mayer P, Dematteis M, Pépin JL, Wuyam B, Veale D, Vila A, Lévy P. Peripheral neuropathy in sleep apnea. A tissue marker of the severity of nocturnal desaturation. Am J Respir Crit Care Med. 1999 Jan;159(1):213-9.

ReferenceCitation: Deegan PC, McNicholas WT. Pathophysiology of obstructive sleep apnoea. Eur Respir J. 1995 Jul;8(7):1161-78. Review.

ReferenceCitation: Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5.

lead_sponsor: University Hospital, Grenoble

location_facility:
Annemasse-Bonneville Hospital
University Hospital of Grenoble
Clinic of Louvière
University Hospital of Geneva
Poitiers University Hospital


title: A Placebo-controlled, Single-blind, Multi-center Study to Explore the Photoparoxysmal Response in Photosensitive Epileptic Subjects After One Single Oral Dose of Brivaracetam in Capsules.

summary: to assess the effect of brivaracetam on the photoparoxysmal EEG response in photosensitive epileptic subjects

lead_sponsor: UCB Pharma

location_country: Germany France


title: Persona Outcomes Led Assessment Research in Total Knee Arthroplasty (POLAR - TKA)

summary:
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona knee implants used in primary total knee arthroplasty. The assessment will include:

Implant survivorship based on removal of a study device.
Safety based on incidence and frequency of adverse events.
Clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.

ReferenceCitation: Mathijssen NMC, Verburg H, London NJ, Landsiedl M, Dominkus M. Patient reported outcomes and implant survivorship after Total knee arthroplasty with the persona knee implant system: two year follow up. BMC Musculoskelet Disord. 2019 Mar 4;20(1):97. doi: 10.1186/s12891-019-2470-y.

family: Mathijssen

full_name: N. M. C. Mathijssen

given: N. M. C.

family: Verburg

full_name: H. Verburg

family: London

full_name: N. J. London

given: N. J.

family: Landsiedl

full_name: M. Landsiedl

given: M.

family: Dominkus

full_name: M. Dominkus

currency_apc_doaj: GBP

journal_name: BMC Musculoskeletal Disorders

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Zimmer, GmbH

location_country:
Austria
Netherlands
France
Spain
Germany
United Kingdom

location_facility: Stichting Research Orthopedie & Reinier de Graaf Groep

location_facility: Centre Hospitalier régional Universitaire de Montpellier


title: Phase IV, Multi-center, Randomized, Cross-over Study to Demonstrate the Efficacy of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder

acronym: ACCEPTANCE

summary: The study is designed to demonstrate that treatment with low level stimulation of the bladder muscles reduces symptoms of urinary incontinence in comparison with no stimulation.

status: Terminated

lead_sponsor: MedtronicNeuro

location_country:
Italy
Netherlands
France
Belgium
Germany
United Kingdom

location_facility: Marienhospital Herne, Klinikum der Ruhr-Universitaet Bochum

location_facility: National Hospital for Neurology and Neurosurgery

location_facility: Centre Hospitalier Universitaire de Lyon-Sud


title: Comparison Between MostCare and Echo-Doppler for Cardiac Output Measurement: an Observational Study

acronym: PRAM

summary: Recently, an uncalibrated minimally invasive Pulse-code Modulator (PCM) has been developed: the MostCare system. This monitoring system is powered by Pressure Recording Analytical Method (PRAM), which is based on the mathematical analysis of the arterial pressure profile changes. It allows beat-to-beat Stroke Volume (SV) assessment from the pressure signal recorded invasively in radial, brachial, or femoral arteries. The most innovative features of this method are: 1) the lack of a calibration requirement, 2) the analysis of the arterial wave signal is performed at 1000 Hz, 3) a dedicated arterial catheter-transducer is unnecessary. MostCare is powered by PRAM (Pressure Recording Analytical Method) algorithm. The investigators primary end-point was to evaluate the relationship between Cardiac Output (CO) measured by MostCare with CO calculated with Echo-Doppler in Intensive Care Unit (ICU) patients under different clinical conditions. As a secondary end-point the investigators evaluated the relationship between CO measured by MostCare with CO obtained with thermodilution techniques (standard bolus thermodilution or transpulmonary thermodilution, i.e. PiCCO system). This is a prospective multicentre observational study.

lead_sponsor: Azienda Ospedaliera Universitaria Senese

location_country:
Italy
United Kingdom
France
Spain

location_facility: Cardiovascular Anesthesia, Policlinico Umberto I°

location_facility: Intensive Care Unit, Santa Maria Annunziata Hospital

location_facility: of Anesthesia, Critical Care and Pain Medicine, Hospital Universitario de la Ribera

location_facility: Cardio-Thoracic-Vascular Anaesthesia and Intensive Care, San Raffaele University Hospital

location_facility: Department of Cardiovascular Anesthesia and Intensive Care, Careggi University Hospital, Italy

location_facility: Department of Anaesthesia and Intensive Care, Torrette University Hospital

location_facility: Department of Anaesthesia and Intensive Care, Pisa University Hospital

location_facility: Department of Anesthesiology & Intensive Care - Lariboisière University Hospital University Paris 7 Diderot. France

location_facility: Anaesthesia and Intensive Care Unit, S. Giovanni di Dio - Torregalli Hospital

location_facility: (Cardiothoracic Anaesthesia, Heart and Lung Centre, New Cross Hospital

location_facility: Department of Anaesthesia and Intensive Care, Siena University Hospital

location_facility: Department of Anaesthesia and Intensive Care, Ospedali Riuniti Foggia University Hospital


title: A Muliticenter, Open Label Safety Study of 2 Doses of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed GERD

summary: The purpose of this study is to provide additional information on safety and tolerability after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this study.

location_country:
Italy
United States
South Africa
Switzerland
Netherlands
Germany
France
Poland
Belgium
Australia
Canada


title: A Multicenter, Randomized, Double-Blind, Comparison Study of the Safety and Efficacy of a Once-Daily Dose of Tigecycline Versus Ertapenem for the Treatment of Foot Infections in Subjects With Diabetes

summary: The purpose of this study was to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections. The co-primary efficacy endpoints were not met.

ReferenceCitation: Lauf L, Ozsvár Z, Mitha I, Regöly-Mérei J, Embil JM, Cooper A, Sabol MB, Castaing N, Dartois N, Yan J, Dukart G, Maroko R. Phase 3 study comparing tigecycline and ertapenem in patients with diabetic foot infections with and without osteomyelitis. Diagn Microbiol Infect Dis. 2014 Apr;78(4):469-80. doi: 10.1016/j.diagmicrobio.2013.12.007. Epub 2013 Dec 16.

family: Lauf

full_name: Laszlo Lauf

given: Laszlo

family: Ozsvár

full_name: Zsófia Ozsvár

given: Zsófia

family: Mitha

full_name: Ismael Mitha

given: Ismael

family: Regöly-Mérei

full_name: Janos Regöly-Mérei

given: Janos

family: Embil

full_name: John M. Embil

given: John M.

family: Cooper

full_name: Angel Cooper

given: Angel

family: Sabol

full_name: Mary Beth Sabol

given: Mary Beth

family: Castaing

full_name: Nathalie Castaing

given: Nathalie

family: Dartois

full_name: Nathalie Dartois

family: Yan

full_name: Jean Yan

given: Jean

family: Dukart

full_name: Gary Dukart

given: Gary

family: Maroko

full_name: Robert Maroko

given: Robert

journal_name: Diagnostic Microbiology and Infectious Disease

oa_host_type: publisher

location_country:
Peru
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
India
Croatia
France
Lithuania
Panama
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Turkey
Colombia
South Africa
Chile
Sweden
Switzerland
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Spain
Estonia
Latvia


title: A Multicenter, Open-Label, PK, PD and Safety Study of Pantoprazole Delayed-Release Granules Administered as a Suspension in Neonates and Preterm Infants With a Clinical Diagnosis of GERD

summary: The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.


title: The Bacteriuria in Renal Transplantation (BiRT) Study: A Prospective, Randomized, Parallel-group, Multicenter, Open-label, Superiority Trial Comparing Antibiotics Versus no Treatment in the Prevention of Symptomatic Urinary Tract Infection in Kidney Transplant Recipients With Asymptomatic Bacteriuria

acronym: BiRT

summary: The purpose of this study is to compare antibiotics versus no-treatment in kidney transplant recipients with asymptomatic bacteriuria.

lead_sponsor: Erasme University Hospital

location_country: Belgium France

location_facility: Department of Kidney Transplantation, Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Saint-Étienne

location_facility: Centre Hospitalier Universitaire Rangueil

location_facility: Universitair Ziekenhuis Brussel - Vrije Universiteit Brussel

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Groupe Henri Mondor-Albert Chenevier, Assistance Publique-Hôpitaux de Paris

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Hôpital Tenon, Assistance Publique-Hôpitaux de Paris

location_facility: Centre Hospitalier Universitaire de Charleroi


title: A Phase I/IIa Study of Intra-tumoral BT-001 (TG6030) Administered Alone and in Combination With Pembrolizumab in Patients With Cutaneous or, Subcutaneous Lesions or Easily Injectable Lymph Nodes of Metastatic/Advanced Solid Tumors.

summary: This is a Phase I/IIa, multicenter, open-label, consecutive cohorts, dose-escalation study of BT-001 with repeated IT administrations alone and in combination with IV infusions of pembrolizumab.

lead_sponsor: Transgene

location_facility:
Centre Léon Bérard
Institut Bergonié
Clinique Universitaire Saint-Luc
Hôpital Saint-Louis AP-HP
Institut Gustave Roussy

intervention_type: Biological


title: Study Assessing Efficacy and Safety of NFL-101 as a Tobacco Cessation Therapy

summary:
CESTO 2 is a 318 participants, 3-arm, multicentric, randomized, double-blind, placebo-controlled Phase II clinical trial.

The main objectives are to select the most efficient dose and to assess long-term efficacy of NFL-101 compared to placebo, for abrupt cessation and for reduction before cessation.

lead_sponsor: NFL Biosciences SAS

location_country: Australia France

location_facility: Centre d'Investigation Clinique de Poitiers (CIC 1402)

location_facility: Centre d'Investigation Clinique de Rennes

location_facility: Centre d'Investigation Clinique de Bordeaux

location_facility: College of Health and Medicine, University of Tasmania


title: Automatic Oxygen Administration in Early and Late Postoperative Hypoxaemia Prevention After Major Abdominal and Thoracic Surgery

summary:
The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in the post anesthesia care unit in a patient population admitted for major abdominal and thoracic surgery.

The investigators' hypothesis is that FreeO2 system will provide a better control of the oxygen saturation and reduce postoperative hypoxaemia.

ReferenceCitation: L'Her E, Jaber S, Verzilli D, Jacob C, Huiban B, Futier E, Kerforne T, Pateau V, Bouchard PA, Consigny M, Lellouche F. Automated closed-loop versus standard manual oxygen administration after major abdominal or thoracic surgery: an international multicentre randomised controlled study. Eur Respir J. 2021 Jan 5;57(1). pii: 2000182. doi: 10.1183/13993003.00182-2020. Print 2021 Jan.

family: L'Her

full_name: Erwan L'Her

given: Erwan

family: Jaber

full_name: Samir Jaber

given: Samir

family: Verzilli

full_name: Daniel Verzilli

given: Daniel

family: Jacob

full_name: Christophe Jacob

given: Christophe

family: Huiban

full_name: Brigitte Huiban

given: Brigitte

family: Futier

full_name: Emmanuel Futier

given: Emmanuel

family: Kerforne

full_name: Thomas Kerforne

given: Thomas

family: Pateau

full_name: Victoire Pateau

given: Victoire

family: Bouchard

full_name: Pierre-Alexandre Bouchard

given: Pierre-Alexandre

family: Consigny

full_name: Maëlys Consigny

given: Maëlys

family: Lellouche

full_name: François Lellouche

given: François

journal_name: European Respiratory Journal

oa_host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Bretagne Occidentale

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

ReferenceCitation: L'her E, Jaber S, Verzilli D, Jacob C, Huiban B, Futier E, Kerforne T, Pateau V, Bouchard PA, Gouillou M, Nowak E, Lellouche F. Automated oxygen administration versus conventional oxygen therapy after major abdominal or thoracic surgery: study protocol for an international multicentre randomised controlled study. BMJ Open. 2019 Jan 17;9(1):e023833. doi: 10.1136/bmjopen-2018-023833.

family: L’her

full_name: Erwan L’her

location_facility:
CHU Poitiers
CHU Clermont-Ferrand
Hôpital Laval - Québéc
CHU Montpellier
Brest, University Hospital


title: FL-2000 Study for Newly Diagnosed Follicular Lymphoma Patients With a High Tumor Burden

summary: The purpose of this study is to assess in a prospective multicentric study (Phase III) the introduction of a monoclonal antibody directed against B-cells associated with a standard therapy including chemotherapy and alpha-interferon in first line treatment of patients with a large tumor burden follicular lymphoma.

ReferenceCitation: Solal-Celigny P, Lepage E, Brousse N, Reyes F, Haioun C, Leporrier M, Peuchmaur M, Bosly A, Parlier Y, Brice P, et al. Recombinant interferon alfa-2b combined with a regimen containing doxorubicin in patients with advanced follicular lymphoma. Groupe d'Etude des Lymphomes de l'Adulte. N Engl J Med. 1993 Nov 25;329(22):1608-14.

ReferenceCitation: McLaughlin P, Grillo-López AJ, Link BK, Levy R, Czuczman MS, Williams ME, Heyman MR, Bence-Bruckler I, White CA, Cabanillas F, Jain V, Ho AD, Lister J, Wey K, Shen D, Dallaire BK. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998 Aug;16(8):2825-33.

ReferenceCitation: Salles G, Mounier N, de Guibert S, Morschhauser F, Doyen C, Rossi JF, Haioun C, Brice P, Mahé B, Bouabdallah R, Audhuy B, Ferme C, Dartigeas C, Feugier P, Sebban C, Xerri L, Foussard C. Rituximab combined with chemotherapy and interferon in follicular lymphoma patients: results of the GELA-GOELAMS FL2000 study. Blood. 2008 Dec 15;112(13):4824-31. doi: 10.1182/blood-2008-04-153189. Epub 2008 Sep 17.

name: Hospices Civils de Lyon and Université Lyon 1, Lyon, France;

family: Salles

full_name: Gilles Salles

given: Gilles

name: Centre Hospitalier Universitaire de Nice, Nice, France;

family: Mounier

full_name: Nicolas Mounier

given: Nicolas

name: Centre Hospitalier Universitaire de Rennes, Rennes, France;

family: de Guibert

full_name: Sophie de Guibert

given: Sophie

name: Centre Hospitalier Universitaire de Lille, Lille, France;

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

name: Cliniques Universitaires (UCL) de Mont-Godinne, Yvoir, Belgium;

family: Doyen

full_name: Chantal Doyen

given: Chantal

name: Centre Hospitalier Universitaire de Montpellier, Montpellier, France;

family: Rossi

full_name: Jean-François Rossi

given: Jean-François

name: Hôpital Henri-Mondor, Assistance Publique-Hopitaux de Paris and Université Paris XII, Paris, France;

family: Haioun

full_name: Corinne Haioun

given: Corinne

name: Hôpital Saint-Louis, Assistance Publique-Hopitaux de Paris, Paris, France;

family: Brice

full_name: Pauline Brice

given: Pauline

name: Centre Hospitalier Universitaire de Nantes, Nantes, France;

family: Mahé

full_name: Béatrice Mahé

given: Béatrice

name: Institut Paoli Calmettes, Marseille, Marseille, France;

family: Bouabdallah

full_name: Reda Bouabdallah

given: Reda

name: Centre Hospitalier (CH) de Colmar, Colmar, France;

family: Audhuy

full_name: Bruno Audhuy

given: Bruno

name: Institut Gustave Roussy, Villejuif, France;

family: Ferme

full_name: Christophe Ferme

name: Centre Hospitalier Universitaire de Tours, Tours, France;

family: Dartigeas

full_name: Caroline Dartigeas

given: Caroline

name: Centre Hospitalier Universitaire de Nancy, Nancy, France;

family: Feugier

full_name: Pierre Feugier

given: Pierre

family: Sebban

full_name: Catherine Sebban

given: Catherine

family: Xerri

full_name: Luc Xerri

given: Luc

name: Centre Hospitalier Universitaire d'Angers, d'Angers, France

family: Foussard

full_name: Charles Foussard

given: Charles

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

lead_sponsor: Lymphoma Study Association

location_facility: Groupe d'Etude des Lymphomes de l'adulte

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud


title: An Open Label Study to Determine the Safety and Tolerability of 12 Weeks Treatment With Oral REN001 in Subjects With Fatty Acid Oxidation Disorders (FAOD)

summary: The purpose of this study is to assess REN001 safety in subjects with fatty acid oxidation disorders.

lead_sponsor: Reneo Pharma Ltd

location_country:
United States
France
Spain

location_facility: Division of Medical Genetics, University Utah

location_facility: Neurology department, Raymond-Poincaré Teaching Hospital, Nord/Est/Ile de France Neuromuscular Reference Center

location_facility: Servicio de Neurología - Unidad de Neuromuscular Centro de Referencia Nacional de Enfermedades Neuromusculares raras Instituto de Investigación i+12


title: COVID-19 And Lingering Symptoms In Primary Care Patients

acronym: CALIP

summary: The ongoing corona virus disease 2019 (COVID-19) is a viral acute respiratory tract infection caused by server acute respiratory syndrom coronavirus typ 2 (SARS-CoV-2). The signs and symptom of SARS-CoV-2 infection vary and most people with COVID-19 experience illness of mild or moderate severity and recover with symptomatic treatment outside of hospital. Studies have found that some people experience lingering/long-lasting symptoms and only a minority of patients were completely free from COVID-19 related symptoms after two months. About one third still had up to two residual symptoms and 55% had three or more. As far as we know no study on lingering symptoms has been published in patients after a mild or moderate infection managed in primary care settings. The aim of this study is to explore the course of disease over a one year period and describe lingering symptoms and their impact on well-being and daily activities in adult non-hospitalized patients with previous established COVID-19 infection.

lead_sponsor: Katarina Hedin

location_country:
Italy
Brazil
Sweden
Netherlands
France
Poland
Georgia
Romania
Ireland
Belgium
Australia
Denmark
Germany
United Kingdom
Ukraine

location_facility: Center for General Practice at Aalborg University

location_facility: Département de Santé Publique, Université Côte d'Azur, Centre Hospitalier Universitaire de Nice, Nice, France

location_facility: the Academic Centre for General Practice (ACHG), Department of Public Health and Primary Care, KU Leuven

location_facility: Centre for General Practice, Department of Family Medicine & Population Health (FAMPOP), Faculty of Medicine and Health Sciences, University of Antwerp

location_facility: School of Medicine, National University of Ireland

location_facility: School of Medicine, University of St Andrews North Haugh, St Andrews KY16 9TF

location_facility: Institut für Allgemeinmedizin Universitätsklinikum Würzburg Josef-Schneider-Str. 2/D7 97080 Würzburg

location_facility: Julius Center, University Medical Center Utrecht

location_facility: R. Lugar Center for Public Health Research

location_facility: Covid-19 primary care special unit Sassuolo, Azienda Unità Sanitaria locale di Modena, Modena, Italy

location_facility: Department of General Practice, Melbourne Medical School, University of Melbourne, Vic.

location_facility: CPHC of Mukachevo United Territorial Community, Practice Mukachevo


title: A Phase 1 / 2 Study of CAN04, a Fully Humanized Monoclonal Antibody Against IL1RAP, in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumours

summary: This is a Phase 1/2, open-label, multicentric, non-randomised, parallel-arm study that aims to establish the safety, tolerability, and initial efficacy of CAN04 in combination with 3 SoC chemotherapies (mFOLFOX, DTX, and G/C).

lead_sponsor: Cantargia AB

location_country: France Spain

location_facility: EDOG Institut de Cancerologie de l'Ouest - PPDS


title: A Phase 1B Dose Escalation, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of CC-95775 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-hodgkin's Lymphoma

summary:
CC-95775-ST-001 is an open-label, Phase 1B, dose escalation and expansion study of CC-95775 in subjects with advanced or unresectable solid tumors, including laBCC, and relapsed/ refractory non-Hodgkin's lymphoma (NHL). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-95775 administered on a 4d on/24d off schedule to estimate the MTD of CC-95775. A mTPI-2 will help guide CC-95775 dose escalation decisions with the final decisions made by an SRC. Approximately 20 subjects will be enrolled.

The expansion cohort (Part B) will evaluate the safety, PK, PD safety and preliminary activity of CC-95775 in advanced solid tumors, including laBCC. Approximately 20 subjects will be enrolled.

status: Active, not recruiting

ipd_sharing: Yes

lead_sponsor: Celgene

location_facility:
Centre Eugene Marquis
Hopital Saint Louis
Clinica Universidad de Navarra
Institut Curie
Hospital de Madrid Norte- Sanchinarro


title: A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ADU-1604, an Anti-CTLA-4 Antibody, in Adults With Metastatic Melanoma

summary: This study is a first-in-human, open-label, multicenter, dose-escalation study designed to evaluate the safety, PK, and PD of ADU-1604 and explore initial clinical activity in adults with metastatic melanoma.

lead_sponsor: Aduro Biotech, Inc.

location_facility:
Hospital Universitario Ramon y Cajal
Hôpital de la Timone
Hospital Saint Louis
Hospital Universitario Virgen Macarena
Gustave- Roussy Institute


title: In Situ Immune Parameters and Their Prognostic Role on the Survival of Patients With Glioblastoma

acronym: IMMUNOGLIO

summary:
Glioblastoma (GBM) is the most frequent brain tumor. Currently survival is poor and few treatments are available. Recent data show that there is no immune privilege of the central nervous system (CNS) and that GBM are invaded by effector CD8 T cells, letting us hypothesis that GBM growth is dependent of immunosurveillance.

The aim of this study is to better understand the antitumor immune response against GBM to unravel new effectors and immunosuppressive pathways important for the regulation of anticancer immunity and to discover new immune activating strategies with the objectives to isolate subgroups of GBMs that could benefit from an immunotherapy approach. To achieve this goal, GBM tumor samples and a blood sample will be collected during the initial tumor resection.

The sites involved in the recruitment of the patients will be the neurosurgical teams in Brussel, Dijon, Nantes and Padova.

lead_sponsor: Centre Georges Francois Leclerc

location_country: Italy France

location_facility: Azienda Ospedaliera Università di Padova


title: An Open Label, Phase I, Dose Escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Doses of BI 836909 in Relapsed and/or Refractory Multiple Myeloma Patients

summary: The primary objective of this trial is to determine the maximum tolerated dose (MTD) of BI 836909 administered by continuous i.v. infusion in patients with relapsed and/or refractory multiple myeloma. If the MTD is not reached based on safety findings, a recommended dose for further development will be determined. This will depend on the safety data, pharmacokinetic/pharmacodynamics data and potentially preliminary efficacy data. Secondary objectives are to document the safety and tolerability of BI 836909, to perform pharmacokinetic and pharmacodynamic analyses and to evaluate relevant biological effects in terms of parameters of efficacy.

ReferenceCitation: Topp MS, Duell J, Zugmaier G, Attal M, Moreau P, Langer C, Krönke J, Facon T, Salnikov AV, Lesley R, Beutner K, Kalabus J, Rasmussen E, Riemann K, Minella AC, Munzert G, Einsele H. Anti-B-Cell Maturation Antigen BiTE Molecule AMG 420 Induces Responses in Multiple Myeloma. J Clin Oncol. 2020 Mar 10;38(8):775-783. doi: 10.1200/JCO.19.02657. Epub 2020 Jan 2.

name: Department of Internal Medicine II, University Hospital Würzburg, Würzburg, Germany

family: Topp

full_name: Max S. Topp

given: Max S.

family: Duell

full_name: Johannes Duell

given: Johannes

name: Amgen Research (Munich), Munich, Germany

family: Zugmaier

full_name: Gerhard Zugmaier

given: Gerhard

name: University of Toulouse, Toulouse, France

family: Attal

full_name: Michel Attal

given: Michel

name: Hematology Department, University Hospital Center of Nantes, Nantes, France

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Langer

full_name: Christian Langer

given: Christian

family: Krönke

full_name: Jan Krönke

given: Jan

name: Regional University Hospital of Lille, Lille, France

family: Facon

full_name: Thierry Facon

given: Thierry

family: Salnikov

full_name: Alexey V. Salnikov

given: Alexey V.

family: Lesley

full_name: Robin Lesley

given: Robin

family: Beutner

full_name: Karl Beutner

given: Karl

family: Kalabus

full_name: James Kalabus

given: James

family: Rasmussen

full_name: Erik Rasmussen

given: Erik

family: Riemann

full_name: Kathrin Riemann

given: Kathrin

family: Minella

full_name: Alex C. Minella

given: Alex C.

family: Munzert

full_name: Gerd Munzert

given: Gerd

family: Einsele

full_name: Hermann Einsele

given: Hermann

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Anti–B-Cell Maturation Antigen BiTE Molecule AMG 420 Induces Responses in Multiple Myeloma

lead_sponsor: Boehringer Ingelheim

location_facility:
Universitätsklinikum Ulm
INS Universitaire du Cancer
Universitätsklinikum Würzburg
HOP Claude Huriez
HOP Hôtel-Dieu


title: LISA Post Market Clinical Follow-Up Study:Post Marketing Prospective Documentation of Clinical Outcomes (Post-operative, Safety and Performance) After Lumbar Dynamic Stabilization Surgery With LISA Implant

acronym: LISA-PMCF

summary:
The study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat lumbar stenosis and chronic back pain due to lumbar degenerative disease, and restore the natural movements of the spine. "Post-market" means the device (i.e. the LISA implant) being used in this study has already obtained CE certification and is commercially available for use in the European market.

The LISA implant consists of a "spacer", a woven polyester band and a titanium blocker. The spacer is placed between the two vertebrae, identified causing back pain and is fastened by the band to these vertebrae. The band is tightened and locked into the spacer. This ensures that there is sufficient stiffness at the concerned segment to protect the disc from extra stress and to restore natural mobility.

Medical Device manufacturers conduct "post-market" clinical studies in order to continuously evaluate the product scientifically and to comply with legal and ethical obligations. With these studies, the long-term safety as well as performance of their medical devices are assessed.

This study, which is initiated and sponsored by BACKBONE (LISA designer, developer, manufacturer and marketer), aims to evaluate the long-term safety and performance of the LISA implant for the treatment of lumbar degenerative disease and to evaluate the treatment.

lead_sponsor: BACKBONE

location_country: Denmark Germany France

location_facility: Pitié-Salpêtrière University Hospital Center

location_facility: Elective Surgery Center, Silkeborg Regional Hospital


title: A First in Human Study to Assess Safety and Performance of the DaVingi™ System in the Treatment of Patients With Functional Tricuspid Regurgitation

summary: The DaVingi™ System is a percutaneous trans-catheter device delivered using right heart catheterization through the right internal jugular vein. The DaVingi™ System is designed for performing ring annuloplasty by using a Ring Delivery System to place a complete, flexible fabric ring around the annulus of the atrial side of the tricuspid valve. Fluoroscopy and echocardiography are used to monitor the ring placement procedure.

primary_purpose: Device Feasibility

lead_sponsor: Cardiac Implants LLC

location_country: Israel France Czechia

location_facility:
Hopital Bichat
Na Homolce Hospital
Rambam Health Care Campus
Clinique Pasteur
Institut Mutualiste Montsouris


title: A Multicenter Double-blind Placebo-controlled Trial of Non-cultured Epidermal Cellular Grafting Versus Hyaluronic Acid for Repigmenting Stable Leukoderma (Vitiligo and Piebaldism)

summary:
The purpose of this study is to assess the efficacy of autologous epidermal cells suspension grafting using a newly developed device named VITICELL® compared to placebo.

The secondary objective is to evaluate safety of VITICELL® and global satisfaction of patient and investigator.

lead_sponsor: Laboratoires Genévrier

location_country: Italy Belgium France

location_facility: Department of Dermatology - Ghent University Hospital


title: A Phase I Dose Escalation Study To Determine The Optimal Biological Dose Of BN83495 - An Oral Steroid Sulphatase Inhibitor - In Postmenopausal Women With Oestrogen-Receptor Positive Breast Cancer Whose Disease Progressed After Prior Therapy For Locally Advanced/Metastatic Disease

summary:
The purpose of this study is to determine the optimal biological dose (OBD) of Irosustat (BN83495) in postmenopausal women with oestrogen receptor (ER) positive locally advanced or metastatic breast cancer with disease progression after prior hormonal therapy.

This study is designed to provide necessary information on safety and dose response of BN83495, when given by repeated once daily oral administration, while achieving a maximal STS inhibition and a maximal reduction in plasma oestradiol (E2) and adiol levels. The data obtained will be used to plan further clinical studies.

lead_sponsor: Ipsen

location_country:
United Kingdom
Belgium
France

location_facility:
Centre Eugène Marquis
Centre Paul Papin
Institut Jules Bordet
Institut Georges François Leclerc
Imperial College Healthcare NHS Trust


type: Other Grant/Funding Number

title: Preimplantation Factor (PIF): Biomarker Detection in Maternal Blood - Correlation With Live Birth.

summary:
PIF: biomarker of pregnancy, miscarriage, premature birth, preeclampsia, placenta accreta.

Except for serum hCG, no pregnancy-complication markers are widely employed to predict the need for medical intervention. Since circulating PIF is present from very early and throughout viable pregnancy, it may represent a specific biomarker candidate. PIF levels will be analyzed in serum of pregnant women in a range of settings: a) following IVF; b) index pregnancy of women with history of recurrent pregnancy loss, c) index pregnancy of women with history of placenta mediated complications such as: intrauterine growth restriction, spontaneous idiopathic preterm delivery, and preeclampsia; and d) index pregnancy in women with evidence of abnormal placentation, namely placenta accreta and related conditions.

lead_sponsor: BioIncept LLC

location_country:
United States
France
Greece

location_facility: Lab Clement - Seine St Denis Hospital, Le Blanc Mesnil

location_facility: Yale Women and Children's Center for Blood Disorders & Yale Fertility Center


title: Preimplantation Factor (PIF): Prognostic Value of a Non-invasive Embryo Viability Biomarker Detection in Culture Media Followed by Single Embryo Transfer - Correlation With Live Birth.

summary: PIF: biomarker of successful implantation To overcome the poor reproductive potential of embryos generated during in vitro fertilization cycles and the lack of markers enabling the identification of the most competent ones, it is common to transfer multiple embryos. However this practice is associated with the risks of multi-fetal pregnancies and high morbidity/mortality. Ideally, the availability of a marker specifically produced by viable embryos would permit the transfer of a single embryo (SET) without affecting the chances of pregnancy and, most importantly, capable to drastically reduce multiple pregnancies after IVF. In preliminary work, we demonstrated that no pregnancy resulted following the transfer of embryos where PIF was undetectable in culture media.(Keramitsoglou, T et al. ASRI Meeting, Hamburg, 2012) Using a non-invasive method of detection of PIF in the media surrounding the embryo will be correlated to live birth following single embryo transfer. By selecting only viable embryos, it will reduce the need for multiple IVF cycles, increase the rate of pregnancy outcome associated with SET, and will minimize multi-fetal pregnancy that has very high medical and societal costs both in pregnancy and after delivery.

location_facility: Lab Clement - Seine St. Denis Hospital, Le Blanc Mesnil


title: Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal

summary:
Hammertoe and ClawToe are ones of the most common foot deformities. The second toe is the most frequently affected, but the other small toes may also be involved. When nonoperative treatment fails, surgery often is recommended. One surgical option is the arthrodesis of the Proximal Interphalangeal (PIP) joint. This arthrodesis is technically demanding, its needs:

Internal fixation;
Interphalangeal Compression;
Anatomic PIP joint plantar flexion angle. The implant Ipp-On has been developed for this specific arthrodesis. The objective of this study is to evaluate the efficacy and safety of the Proximal Interphalangeal Implant: Ipp-On at short term follow up.

The safety of the Ipp-On will be described in terms of rate of device related complications.

The efficacy of the Ipp-On will be described in terms of fusion rate at 6 months.

lead_sponsor: Integra LifeSciences Services

location_country: Belgium France Switzerland

location_facility: Ospedale Regionale di Bellinzona e Valli


title: A Multi-centred, Non-comparative, Non-randomised, Open, Post Marketing Investigation to Look at the Long-term Clinical Efficacy of the Delta Xtend Reverse Total Shoulder Used in the Treatment of Shoulders With Rotator Cuff Deficiencies.

summary: This post-marketing study is designed to collect data relating to the use of the Delta Xtend™ Total Shoulder Replacement System in shoulder with rotator cuff deficiencies. This allows for continued monitoring of the performance and safety of the prosthesis in a broader range of clinical situations.

lead_sponsor: DePuy International

location_country: Germany Belgium France

location_facility:
Universitair Ziekenhuis
Polyclinique de l'Atlantique
CHRU Reims Hôpital Maison Blanche
Clinique Generale D'Annecy
Krankenhaus Munchen Bogenhausen


title: International Collaborative Treatment Protocol for Infants Under One Year With Acute Lymphoblastic or Biphenotypic Leukemia

summary:
RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine, methotrexate, leucovorin, and antithymocyte globulin before and after transplant may stop this from happening. It is not yet known which treatment regimen is most effective in treating acute leukemia.

PURPOSE: This randomized clinical trial is studying how well different therapies work in treating infants with newly diagnosed acute leukemia.

ReferenceCitation: Stutterheim J, van der Sluis IM, de Lorenzo P, Alten J, Ancliffe P, Attarbaschi A, Brethon B, Biondi A, Campbell M, Cazzaniga G, Escherich G, Ferster A, Kotecha RS, Lausen B, Li CK, Lo Nigro L, Locatelli F, Marschalek R, Meyer C, Schrappe M, Stary J, Vora A, Zuna J, van der Velden VHJ, Szczepanski T, Valsecchi MG, Pieters R. Clinical Implications of Minimal Residual Disease Detection in Infants With KMT2A-Rearranged Acute Lymphoblastic Leukemia Treated on the Interfant-06 Protocol. J Clin Oncol. 2021 Feb 20;39(6):652-662. doi: 10.1200/JCO.20.02333. Epub 2021 Jan 6.

name: Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands

family: Stutterheim

full_name: Janine Stutterheim

given: Janine

family: van der Sluis

full_name: Inge M. van der Sluis

given: Inge M.

name: Center of Bioinformatics, Biostatistics and Bioimaging, University of Milano-Bicocca, Monza, Italy

name: Pediatrics, School of Medicine and Surgery, University of Milano-Bicocca, Fondazione MBBM/San Gerardo Hospital, Monza, Italy

family: de Lorenzo

full_name: Paola de Lorenzo

given: Paola

name: Department of Pediatrics, UKSH, Kiel, Germany

family: Alten

full_name: Julia Alten

given: Julia

name: United Kingdom Children Cancer Study Group, London, United Kingdom

family: Ancliffe

full_name: Philip Ancliffe

given: Philip

name: St Anna Children's Hospital, Medical University of Vienna, Vienna, Austria

family: Attarbaschi

full_name: Andishe Attarbaschi

given: Andishe

name: Department of Pediatric Hematology, University Robert Debre Hospital, APHP, Paris, France

family: Brethon

full_name: Benoit Brethon

given: Benoit

family: Biondi

full_name: Andrea Biondi

given: Andrea

name: Chilean National Pediatric Oncology Group, Santiago, Chile

family: Campbell

full_name: Myriam Campbell

given: Myriam

name: Tettamanti Research Center, Pediatrics, School of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy

family: Cazzaniga

full_name: Giovanni Cazzaniga

given: Giovanni

name: German Cooperative Study Group for Childhood Acute Lymphoblastic Leukemia, Hamburg, Germany

family: Escherich

full_name: Gabriele Escherich

given: Gabriele

name: European Organisation for Research and Treatment of Cancer Children Leukemia Group, Brussels, Belgium

family: Ferster

full_name: Alina Ferster

given: Alina

name: Australian and New Zealand Children's Haematology/Oncology Group, Perth Children's Hospital, Perth, Australia

name: Telethon Kids Cancer Centre, Telethon Kids Institute, University of Western Australia, Perth, Australia

family: Kotecha

full_name: Rishi S. Kotecha

given: Rishi S.

name: Department of Pediatrics and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

family: Lausen

full_name: Birgitte Lausen

given: Birgitte

name: The Chinese University of Hong Kong, Shatin, Hong Kong, Special Administrative Region, People's Republic of China

family: Li

full_name: Chi Kong Li

given: Chi Kong

name: Cytogenetic-Cytouorimetric-Molecular Biology Laboratory, Center of Pediatric Hematology Oncology, Azienda Policlinico “G. Rodolico - San Marco,” Catania, Italy

family: Lo Nigro

full_name: Luca Lo Nigro

given: Luca

name: Department of Pediatric Hematology/Oncology, IRCCS Bambino Gesù Children's Hospital, Sapienza, University of Rome, Rome, Italy

family: Locatelli

full_name: Franco Locatelli

given: Franco

name: DCAL, Institute of Pharmaceutical Biology, Goethe-University, Frankfurt am Main, Germany

family: Marschalek

full_name: Rolf Marschalek

given: Rolf

family: Meyer

full_name: Claus Meyer

given: Claus

name: Berlin-Frankfurt-Miünster Group Germany, Kiel, Germany

family: Schrappe

full_name: Martin Schrappe

given: Martin

name: Czech Working Group for Pediatric Hematology, Prague, Czech Republic

family: Stary

full_name: Jan Stary

family: Vora

full_name: Ajay Vora

given: Ajay

name: CLIP, Dept. of Paediatric Haematology and Oncology, Second Faculty of Medicine, Charles University and University Hospital Motol, Prague, Czech Republic

family: Zuna

full_name: Jan Zuna

name: Department of Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands

family: van der Velden

name: Polish Pediatric Leukemia/Lymphoma Study Group, Zabrze, Medical University of Silesia, Katowice, Poland

name: Dutch Childhood Oncology Group, Utrecht, the Netherlands

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Pieters R, De Lorenzo P, Ancliffe P, Aversa LA, Brethon B, Biondi A, Campbell M, Escherich G, Ferster A, Gardner RA, Kotecha RS, Lausen B, Li CK, Locatelli F, Attarbaschi A, Peters C, Rubnitz JE, Silverman LB, Stary J, Szczepanski T, Vora A, Schrappe M, Valsecchi MG. Outcome of Infants Younger Than 1 Year With Acute Lymphoblastic Leukemia Treated With the Interfant-06 Protocol: Results From an International Phase III Randomized Study. J Clin Oncol. 2019 Sep 1;37(25):2246-2256. doi: 10.1200/JCO.19.00261. Epub 2019 Jul 8.

name: Princess Maxima Center for Pediatric Oncology, Utrecht, the Netherlands

name: French Acute Lymphoblastic Leukemia Study Group, Paris, France

name: Istituto di Ricovero e Cura a Carattere Scientifico Bambino Gesù Children’s Hospital, Rome, Italy

name: Seattle Children’s Hospital and Research Institute, Seattle, WA

name: Australian and New Zealand Children’s Haematology/Oncology Group, Perth, Australia

name: University of Western Australia, Perth, Western Australia, Australia

name: Rigshospitalet, University of Copenhagen, Copenhagen, Denmark

name: The Chinese University of Hong Kong, Shatin, Hong Kong, Special Administrative Region, People’s Republic of China

name: St Anna Children’s Hospital, Medical University of Vienna, Vienna, Austria

name: Children Cancer Research Institute, Vienna, Austria

name: St Jude Children’s Research Hospital, Memphis, TN

name: Dana-Farber Cancer Institute, Boston, MA

name: Berlin-Frankfurt-Münster Group Germany, Kiel, Germany

location_country:
Italy
Austria
Netherlands
Germany
France
Czechia
Belgium
United States
United Kingdom

location_facility: Nuovo Ospedale San Gerardo at University of Milano-Bicocca

location_facility: Children's Hospital and Regional Medical Center - Seattle

location_facility: University Medical Center Hamburg - Eppendorf

location_facility: Great Ormond Street Hospital for Children

location_facility: Hopital Universitaire Des Enfants Reine Fabiola

location_facility: M. D. Anderson Cancer Center at University of Texas


title: The Development and Validation of the SWADOC Tool: A Study Protocol for a Multicentric Prospective Cohort Study

summary:
Background: After a period of coma, patients with severe brain injury may present disorders of consciousness (DOC). A wide proportion of these patients also suffer from severe dysphagia. Assessment and therapy of swallowing disabilities of DOC patients are essential because dysphagia has major functional consequences and comorbidities. Dysphagia evaluation in patients with DOC is hampered by the lack of adapted tools. The first aim of the study was to develop a new tool, the SWallowing Assessment in Disorders Of Consciousness (SWADOC), and propose a validation protocol. The SWADOC tool has been developed to help therapists to apprehend components related to swallowing in patients with DOC. The second aim is to appreciate the relationship between patients' level of consciousness and SWADOC items and scores.

Method/design: In this multicentric prospective cohort, 104 patients with DOC will be tested three times during two consecutive days with the SWADOC tool. Statistical analyses will focus on the reliability and validity of the SWADOC tool, especially the intra and inter-rater reliability, internal consistency, measures of dispersion and concurrent validity with the FOTT Swallowing Assessment of Saliva (FOTT-SAS). The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorders (SECONDs) and the Coma Recovery Scale-Revised (CRS-R)

Discussion: The assessment of swallowing abilities among patients with DOC is the first necessary step towards the development of an individualized dysphagia care plan. A validated scoring tool will be essential for clinicians to better apprehend dysphagia in DOC patients and to document the evolution of their disorders.

ReferenceCitation: Mélotte E, Maudoux A, Delhalle S, Lagier A, Thibaut A, Aubinet C, Kaux JF, Vanhaudenhuyse A, Ledoux D, Laureys S, Gosseries O. Swallowing in individuals with disorders of consciousness: A cohort study. Ann Phys Rehabil Med. 2021 Jul;64(4):101403. doi: 10.1016/j.rehab.2020.04.008. Epub 2020 Jul 18.

ReferenceCitation: Sanz LRD, Aubinet C, Cassol H, Bodart O, Wannez S, Bonin EAC, Barra A, Lejeune N, Martial C, Chatelle C, Ledoux D, Laureys S, Thibaut A, Gosseries O. SECONDs Administration Guidelines: A Fast Tool to Assess Consciousness in Brain-injured Patients. J Vis Exp. 2021 Feb 6;(168). doi: 10.3791/61968.

ReferenceCitation: Mortensen J, Jensen D, Kjaersgaard A. A validation study of the Facial-Oral Tract Therapy Swallowing Assessment of Saliva. Clin Rehabil. 2016 Apr;30(4):410-5. doi: 10.1177/0269215515584381. Epub 2015 Apr 28.

ReferenceCitation: Bicego A, Lejoly K, Maudoux A, Lefebvre P, Laureys S, Schweizer V, Diserens K, Faymonville ME, Vanhaudenhuyse A. [Swallowing in disorders of consciousness]. Rev Neurol (Paris). 2014 Oct;170(10):630-41. doi: 10.1016/j.neurol.2014.04.004. Epub 2014 Jun 18. Review. French.

ReferenceCitation: Wannez S, Gosseries O, Azzolini D, Martial C, Cassol H, Aubinet C, Annen J, Martens G, Bodart O, Heine L, Charland-Verville V, Thibaut A, Chatelle C, Vanhaudenhuyse A, Demertzi A, Schnakers C, Donneau AF, Laureys S. Prevalence of coma-recovery scale-revised signs of consciousness in patients in minimally conscious state. Neuropsychol Rehabil. 2018 Dec;28(8):1350-1359. doi: 10.1080/09602011.2017.1310656. Epub 2017 Apr 11.

ReferenceCitation: Mélotte E, Belorgeot M, Herr R, Simon J, Kaux JF, Laureys S, Sanz LRD, Lagier A, Morsomme D, Pellas F, Gosseries O. The Development and Validation of the SWADOC: A Study Protocol for a Multicenter Prospective Cohort Study. Front Neurol. 2021 Apr 29;12:662634. doi: 10.3389/fneur.2021.662634. eCollection 2021.

family: Mélotte

full_name: Evelyne Mélotte

given: Evelyne

family: Belorgeot

full_name: Marion Belorgeot

given: Marion

family: Herr

full_name: Roxanne Herr

given: Roxanne

family: Simon

full_name: Jessica Simon

given: Jessica

family: Kaux

full_name: Jean-François Kaux

given: Jean-François

family: Laureys

full_name: Steven Laureys

given: Steven

family: Sanz

full_name: Leandro R. D. Sanz

given: Leandro R. D.

family: Lagier

full_name: Aude Lagier

given: Aude

family: Morsomme

full_name: Dominique Morsomme

given: Dominique

family: Pellas

full_name: Frederic Pellas

given: Frederic

family: Gosseries

full_name: Olivia Gosseries

given: Olivia

journal_name: Frontiers in Neurology

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

repository_institution: University of Liège - Open Repository and Bibliography

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

lead_sponsor: University of Liege

location_facility: Centre Hospitalier Neurologique William Lennox (UCL)

location_facility: Cliniques de Soins Spécialisés Valdor-Pèrî

location_facility: Fontfroide functional re-education centre

location_facility: Centre du Cerveau², University Hospital of Liège

location_facility: Centre neurologique et de réadaptation fonctionnelle de Fraiture-en-Condroz

location_facility: Centre de Traumatologie et de Réadaptation de Jette (Erasme, ULB)

intervention_type: Behavioral


title: A Phase I, Open Label, Study to Assess Safety, Tolerability, Biodistribution, Radiation Dosimetry and SPECT/CT Imaging Characteristics of Intravenous 111In-IPN01087 in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma or Colorectal Cancer.

summary: 111Indium-labelled IPN01087 (111In-IPN01087) is developed as a radioactive diagnostic imaging agent in patients with colorectal or pancreatic cancer. It is used with single-photon emission computed tomography (SPECT) for the identification of tumours that overexpress the neurotensin receptor-1 (NTSR1). The purpose of this study is to assess how well 111In-IPN01087 is tolerated and what the most suitable amount to be injected is to obtain good quality images. The study will also look at how 111In-IPN01087 is distributed throughout the body and what the optimal time for doing the scans will be after it has been given as a single intravenous injection.

study_start_date_type: Anticipated

status: Withdrawn

ipd_sharing_description: Where patient data can be anonymised, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.

location_facility:
UZ Leuven
Centre Léon Bérard
CHRU de Nancy - Hôpital de Brabois
Institut Jules Bordet
CHU de Nantes - Hôpital Hôtel Dieu


title: A Phase II, Randomized, Double-blind, Parallel Group Dose Finding Study of Single Oral Doses of Moxidectin in Adults With Scabies

summary: The effective dose of moxidectin to treat human scabies is not known. This study aims to provide proof of concept that a single dose of moxidectin is effective in eliminating the scabies parasite in humans and to enable the determination of an optimal dose of moxidectin for treatment of scabies for further clinical studies.

lead_sponsor: Medicines Development for Global Health

location_country: Austria Australia France

location_facility:
Medizinischen Universität Wien
CHU Nice Hopital Archet 2
Hopital Henri Mondor AP-HP
CHU Saint-Etienne Hopital Nord
Royal Darwin Hospital


title: An Open-label, Dose-escalation Phase I/Ib Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of AsiDNA, a DNA Repair Inhibitor Administered Intravenously, as Single Agent and to Assess the Safety and the Efficacy of AsiDNA in Combination With Carboplatin With or Without Paclitaxel, in Patients With Advanced Solid Tumors

summary:
The aim of the study is to assess:

Part A: the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of AsiDNA in patients with advanced solid tumors.
Part B: the safety and preliminary efficacy of AsiDNA in combination with Carboplatin with or without Paclitaxel in patients with Advanced solid tumors.

ReferenceCitation: Le Tourneau C, Delord JP, Kotecki N, Borcoman E, Gomez-Roca C, Hescot S, Jungels C, Vincent-Salomon A, Cockenpot V, Eberst L, Molé A, Jdey W, Bono F, Trochon-Joseph V, Toussaint H, Zandanel C, Adamiec O, de Beaumont O, Cassier PA. A Phase 1 dose-escalation study to evaluate safety, pharmacokinetics and pharmacodynamics of AsiDNA, a first-in-class DNA repair inhibitor, administered intravenously in patients with advanced solid tumours. Br J Cancer. 2020 Nov;123(10):1481-1489. doi: 10.1038/s41416-020-01028-8. Epub 2020 Aug 25.

family: Le Tourneau

full_name: Christophe Le Tourneau

given: Christophe

family: Delord

full_name: Jean-Pierre Delord

given: Jean-Pierre

family: Kotecki

full_name: Nuria Kotecki

given: Nuria

family: Borcoman

full_name: Edith Borcoman

given: Edith

family: Gomez-Roca

full_name: Carlos Gomez-Roca

given: Carlos

family: Hescot

full_name: Ségolène Hescot

given: Ségolène

family: Jungels

full_name: Christiane Jungels

given: Christiane

family: Vincent-Salomon

full_name: Anne Vincent-Salomon

given: Anne

family: Cockenpot

full_name: Vincent Cockenpot

given: Vincent

family: Eberst

full_name: Lauriane Eberst

given: Lauriane

family: Molé

full_name: Audrey Molé

given: Audrey

family: Jdey

full_name: Wael Jdey

given: Wael

family: Bono

full_name: Françoise Bono

given: Françoise

family: Trochon-Joseph

full_name: Véronique Trochon-Joseph

given: Véronique

family: Toussaint

full_name: Hélène Toussaint

given: Hélène

family: Zandanel

full_name: Christelle Zandanel

given: Christelle

family: Adamiec

full_name: Olga Adamiec

given: Olga

family: de Beaumont

full_name: Olivier de Beaumont

given: Olivier

family: Cassier

full_name: Philippe Alexandre Cassier

given: Philippe Alexandre

journal_name: British Journal of Cancer

location_facility:
Institut Claudius Regaud
Institut Jules Bordet
Institut Curie
Centre Leon Berard
Grand Hôpital de Charleroi


title: Phase 1/2a Study to Evaluate the Safety, Activity, and Pharmacokinetics of Escalating Doses of GNS561 in Patients With Primary and Secondary Liver Cancer

summary: This is a first in human, open-label dose escalation study to investigate the safety, tolerability and pharmacokinetics of GNS561 in patients Primary and Secondary liver cancer

lead_sponsor: Genoscience Pharma

location_country:
United States
Belgium
France

location_facility:
Saint-Joseph Hospital
Memorial Sloan Kettering
CHU Grenoble
Jules Bordet Institute
Croix-Rousse Hospital


title: Phase I Dose-escalation Study of the Orally Administered Selective Bcl-2 Inhibitor S 055746 as Monotherapy for the Treatment of Patients With Acute Myeloid Leukaemia (AML) or High or Very High Risk Myelodysplastic Syndrome (MDS)

summary: The purpose of this study is to determine the safety profile and tolerability of S 055746 in patients with AML, and high or very high risk MDS, in terms of Dose-Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) through safety profile (DLT, MTD), PK profile, PD profile and preliminary efficacy.

ipd_sharing_description:
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

lead_sponsor: Institut de Recherches Internationales Servier

location_facility:
Royal Melbourne Hospital
Hôpital Saint Louis
Centre Hospitalier Lyon Sud
Institut Paoli Calmettes
The Alfred Hospital


status: Approved for marketing

study_type: Expanded Access

lead_sponsor: Alexion Pharmaceuticals

location_country:
United States
France

location_facility:
Hôpital Necker - Enfants Malades
Hôpital des Enfants
Colorado Center for Bone Research
Children's Hospital of Pittsburgh
Hôpital Bicêtre

source: euctr

title: An Open-label, Multicenter, Expanded Access Program for Asfotase Alfa (Human Recombinant Tissue-nonspecific Alkaline Phosphatase Fusion Protein) Treatment for Patients With Infantile- or Juvenile-onset Hypophosphatasia (HPP)

summary: This clinical trial is being conducted in Hypophosphatasia, a bone disorder caused by gene mutation(s) resulting in bone defects. These gene mutations cause low levels of an enzyme needed to harden bone. The purpose of this study is to provide access to treatment in a disease where no approved treatment exists. This is an experimental treatment provided under specific treatment guidelines in which safety endpoints will be collected.


title: Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia: a Multicenter, Open-label Randomized Controlled Clinical Trial

acronym: EMPIRICAL

summary: This trial will evaluate whether empirical treatment against cytomegalovirus and tuberculosis improves survival of HIV-infected infants with severe pneumonia.

ipd_sharing_description: After principal results, addressing primary and secondary objectives will be published. A final repository will be chosen for anonymized data sharing, and transparency after the trial is closed, according to the funder (EDCTP) rules and recommendations, unless national laws impede it.

lead_sponsor: Hospital Universitario 12 de Octubre

location_country:
Italy
Côte D'Ivoire
Zimbabwe
Netherlands
Mozambique
France
Uganda
Spain
Zambia
United Kingdom
Malawi

location_facility: Malawi Liverpool Welcome Trust. Queen Elizabeth Central Hospital College of Medicine

location_facility: Cemtro de Investigaçao em Saúde da Manhiça

location_facility: Stichting Katholieke Universiteit Radboudumc

location_facility: Fundación para la Investigación Biomédica del Hospital 12 de Octubre

location_facility: Programme PACCI. Centre Hospitalier Cocody.

location_facility: University of Zimbabwe Clinical Research Centre


title: The European NAFLD Registry

summary: The European NAFLD Registry is a prospectively recruited, observational study supporting the study of the clinical phenotype, natural history, disease outcomes and pathophysiology of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis. The ultimate goals are to better understand the drivers of interpatient variation in disease pathophysiology and severity and to utilise this information to develop and validate biomarkers that, singly or in combination, enable detection and monitoring of disease progression and/or from NAFL through NASH to fibrosis and cirrhosis.

lead_sponsor: Newcastle University

location_country:
Italy
Sweden
Switzerland
Netherlands
Spain
Finland
France
Greece
Belgium
Portugal
Germany
United Kingdom

location_facility: Royal London Hospital, Barts Health NHS Trust

location_facility: Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière

location_facility: University Hospitals Birmingham Nhs Foundation Trust

location_facility: UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz

location_facility: Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital

location_facility: Department of Medical Sciences University of Torino

location_facility: Le Centre de Recherche Clinique (CRC) du CHU d'Angers

location_facility: Oxford University Hospitals Nhs Foundation Trust

location_facility: The Newcastle Upon Tyne Hospitals Nhs Foundation Trust

location_facility: Marqués de Valdecilla University Hospital


title: Vitamin D3 - Omega3 - Home Exercise - Healthy Ageing and Longevity Trial (Acronym: DO-HEALTH)

acronym: DO-HEALTH

summary:
The European population is aging rapidly which poses a challenge on the individual, the European societies, and health care systems. Among the most promising public health interventions that may extend healthy life expectancy at older age are vitamin D, marine omega-3 fatty acids and physical exercise. However, their individual and combined effects have yet to be confirmed in a clinical trial.

The broad aim of DO-HEALTH is to prolong healthy life expectancy in European seniors. The specific aim is to establish whether vitamin D, omega-3 fatty acids, and a simple home exercise program will prevent disease at older age.

To achieve these aims, DO-HEALTH will enroll 2152 community-dwelling men and women who are 70 years and older, an age when chronic diseases increase substantially. The DO-HEALTH seniors will be recruited from 7 European cities (Zurich, Basel, Geneva, Toulouse, Berlin, Innsbruck and Coimbra) and will be randomized in a 2x2x2 factorial design trial to a simple home exercise program and/or vitamin D, and/or omega-3 fatty acids, over a 3 year period. This will allow to test the individual and the combined benefit of the interventions in the prevention of 5 primary endpoints: incident non-vertebral fractures; functional decline; systolic and diastolic blood pressure change; cognitive decline; and the rate of any infection. Key secondary endpoints include incidence of hip fractures, rate of falls, severity of pain in symptomatic knee osteoarthritis, gastro-intestinal symptoms, mental and oral health, quality of life, and mortality.

All clinical endpoints will be supported by a large DO-HEALTH biomarker study to evaluate the effect of the interventions at the cellular level of multi-organ function. DO-HEALTH will further evaluate reasons why or why not seniors adhere to the 3 interventions, and will assess their cost-benefit in a health economic model based on documented health care utilization and observed incidence of chronic disease.

website DO-HEALTH: http://do-health.eu/wordpress/

primary_purpose: Prevention

ReferenceCitation: Bischoff-Ferrari HA, Vellas B, Rizzoli R, Kressig RW, da Silva JAP, Blauth M, Felson DT, McCloskey EV, Watzl B, Hofbauer LC, Felsenberg D, Willett WC, Dawson-Hughes B, Manson JE, Siebert U, Theiler R, Staehelin HB, de Godoi Rezende Costa Molino C, Chocano-Bedoya PO, Abderhalden LA, Egli A, Kanis JA, Orav EJ; DO-HEALTH Research Group. Effect of Vitamin D Supplementation, Omega-3 Fatty Acid Supplementation, or a Strength-Training Exercise Program on Clinical Outcomes in Older Adults: The DO-HEALTH Randomized Clinical Trial. JAMA. 2020 Nov 10;324(18):1855-1868. doi: 10.1001/jama.2020.16909.

name: Center on Aging and Mobility, University Hospital Zurich, City Hospital Waid & Triemli and University of Zurich, Zurich, Switzerland

name: Department of Geriatric Medicine and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland

name: University Clinic for Acute Geriatric Care, City Hospital Waid & Triemli, Zurich, Switzerland

family: Bischoff-Ferrari

full_name: Heike A. Bischoff-Ferrari

given: Heike A.

name: Gérontopôle de Toulouse, Institut du Vieillissement, Center Hospitalo-Universitaire de Toulouse, Toulouse, France

name: UMR INSERM 1027, University of Toulouse III, Toulouse, France

family: Vellas

full_name: Bruno Vellas

given: Bruno

name: Division of Bone Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland

family: Rizzoli

full_name: René Rizzoli

given: René

name: University Department of Geriatric Medicine Felix Platter and University of Basel, Basel, Switzerland

family: Kressig

full_name: Reto W. Kressig

given: Reto W.

name: Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal

name: Coimbra Institute for Clinical and Biomedical Research (iCBR), Faculty of Medicine, University of Coimbra, Coimbra, Portugal

family: da Silva

full_name: José A. P. da Silva

given: José A. P.

name: Department for Trauma Surgery, Medical University of Innsbruck, Innsbruck, Austria

family: Blauth

full_name: Michael Blauth

given: Michael

name: NIHR Manchester Biomedical Research Center, Manchester University NHS Foundation Trust, Manchester Academic Health Science Center, Manchester, England

name: Rheumatology, Boston University School of Medicine, Boston, Massachusetts

family: Felson

full_name: David T. Felson

given: David T.

name: MRC Arthritis Research UK Center for Integrated Research Into Musculoskeletal Ageing, University of Sheffield, Sheffield, England

name: Academic Unit of Bone Metabolism, Department of Oncology and Metabolism, The Mellanby Center for Bone Research, University of Sheffield, Sheffield, England

family: McCloskey

full_name: Eugene V. McCloskey

given: Eugene V.

name: Department of Physiology and Biochemistry of Nutrition, Max Rubner-Institut, Karlsruhe, Germany

family: Watzl

full_name: Bernhard Watzl

given: Bernhard

name: Center for Healthy Aging, Department of Medicine III Dresden University Medical Center, Dresden, Germany

name: Center for Regenerative Therapies Dresden, Technische Universität Dresden, Dresden, Germany

family: Hofbauer

full_name: Lorenz C. Hofbauer

given: Lorenz C.

name: Center for Muscle and Bone Research, Department of Radiology, Charité Universitätsmedizin Berlin, Berlin, Germany

family: Felsenberg

full_name: Dieter Felsenberg

given: Dieter

name: Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts

name: Department of Nutrition, Harvard T. H. Chan School of Public Health, Boston, Massachusetts

family: Willett

full_name: Walter C. Willett

given: Walter C.

name: Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts

family: Dawson-Hughes

full_name: Bess Dawson-Hughes

given: Bess

name: Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts

family: Manson

full_name: JoAnn E. Manson

given: JoAnn E.

name: Department of Public Health, Health Services Research, and Health Technology Assessment, UMIT–University for Health Sciences, Medical Informatics, and Technology, Hall in Tirol, Austria

name: Center for Health Decision Science, Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Boston, Massachusetts

name: Program on Cardiovascular Research, Institute for Technology Assessment and Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston

family: Siebert

full_name: Uwe Siebert

given: Uwe

family: Theiler

full_name: Robert Theiler

given: Robert

name: Department of Geriatrics, University of Basel, Basel, Switzerland

family: Staehelin

full_name: Hannes B. Staehelin

given: Hannes B.

family: de Godoi Rezende Costa Molino

full_name: Caroline de Godoi Rezende Costa Molino

given: Caroline

family: Chocano-Bedoya

full_name: Patricia O. Chocano-Bedoya

given: Patricia O.

family: Abderhalden

full_name: Lauren A. Abderhalden

given: Lauren A.

family: Egli

full_name: Andreas Egli

given: Andreas

name: Center for Metabolic Diseases, University of Sheffield Medical School, Sheffield, England

name: Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Victoria, Australia

family: Kanis

full_name: John A. Kanis

given: John A.

name: Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts

family: Orav

full_name: Endel J. Orav

location_country: Austria Switzerland France Portugal Germany

location_facility: University of Toulouse - Centre de Recherche - Gérontopôle Hôpital La Grave

location_facility: Centre on Aging and Mobility, University of Zurich and City Hospital Waid

location_facility: University of Coimbra - Clínica Universitária de Reumatologia


title: Standard Craniectomy Against Laparotomy for the Treatment of Traumatic Rise in Intracranial Pressure and the Effect on Long-term Outcome

acronym: SCALPEL

summary: Intractable high intracranial pressures (ICP) are associated with poor functional outcomes and mortality, so the SCALPEL trials aims to evaluate the effect of decompressive craniectomy against decompressive laparotomy to lower those pressures in diffuse TBI. The primary outcome measure for that evaluation is functional outcome after 12 months on the extended Glasgow Outcome Scale (GOS-E).

status: Not yet recruiting

lead_sponsor: Technische Universität München

location_country: Germany France

location_facility: Department of Neurosurgery - Klinikum rechts der Isar


title: Influencia de la Ansiedad en el Aprendizaje Motor de Una Tarea Manual Precisa, en la Memoria a Corto y Largo Plazo y en la Capacidad de Imaginación Motora

summary:
In motor learning, to consider that movements are produced by the cooperation and combination of many brain structures and are influenced by the emotions to which individuals are subjected is essential. Several neural circuits have been identified that closely link the emotional system and the motion control system.

Anxiety is defined by persistent and excessive worries that do not disappear even in the absence of the stressor. Anxiety has been found to produce inefficiencies in information processing, which can result in performance deficits, as well as self-reported anxiety has been linked to poorer working memory performance. In these stress and anxiety contexts, relaxation techniques have been widely used to reduce psychophysiological arousal levels.

Understanding how movement, emotions and interactions are regulated is significant because of the large number of movements humans perform. Of these, manual tasks represent precise movements that require the integration of many elements by the nervous system to perform these tasks successfully. How anxiety influence the way manual tasks are learned is still unknown.

On the other hand, motor imagery (MI) is a cognitive process that is an important contributor to how movements are planned and executed. The use of MI has been recommended to improve movement learning and task execution. Knowing MI capacity is essential for creating effective and individualized MI programs. However, how anxiety can affect our motor imagery ability is still unknown.

The main objective of this study is to determine and quantify the effects of anxiety in the learning of a precise manual task not previously trained on four parameters of fine motor control: time, error, speed, and accuracy. On the other hand, the aim is to determine if the ability of internal visual, external visual, and kinaesthetic imagery varies when the participants are subjected to anxiety.

The investigators expect that participants with anxiety, to whom relaxation is induced, will show better motor performance on the fine motor task and better motor imagery ability. In contrast, the investigators expect that participants with anxiety, to whom relaxation is not induced, will show poorer motor performance on the fine motor task and poorer motor imagery ability.

primary_purpose: Basic Science

ReferenceCitation: Coombes SA, Cauraugh JH, Janelle CM. Emotion and movement: activation of defensive circuitry alters the magnitude of a sustained muscle contraction. Neurosci Lett. 2006 Apr 3;396(3):192-6. Epub 2005 Dec 20.

ReferenceCitation: Moran TP. Anxiety and working memory capacity: A meta-analysis and narrative review. Psychol Bull. 2016 Aug;142(8):831-864. doi: 10.1037/bul0000051. Epub 2016 Mar 10. Review.

ReferenceCitation: Doumas M, Morsanyi K, Young WR. Cognitively and socially induced stress affects postural control. Exp Brain Res. 2018 Jan;236(1):305-314. doi: 10.1007/s00221-017-5128-8. Epub 2017 Nov 14.

ReferenceCitation: MacIntyre TE, Madan CR, Moran AP, Collet C, Guillot A. Motor imagery, performance and motor rehabilitation. Prog Brain Res. 2018;240:141-159. doi: 10.1016/bs.pbr.2018.09.010. Epub 2018 Oct 24. Review.

ReferenceCitation: Schuster C, Hilfiker R, Amft O, Scheidhauer A, Andrews B, Butler J, Kischka U, Ettlin T. Best practice for motor imagery: a systematic literature review on motor imagery training elements in five different disciplines. BMC Med. 2011 Jun 17;9:75. doi: 10.1186/1741-7015-9-75. Review.

ReferenceCitation: Trapero-Asenjo S, Gallego-Izquierdo T, Pecos-Martín D, Nunez-Nagy S. Translation, cultural adaptation, and validation of the Spanish version of the Movement Imagery Questionnaire-3 (MIQ-3). Musculoskelet Sci Pract. 2021 Feb;51:102313. doi: 10.1016/j.msksp.2020.102313. Epub 2020 Dec 9.

ReferenceCitation: Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 1971 Mar;9(1):97-113.

lead_sponsor: Susana Nunez Nagy

location_country: France Spain

location_facility:
University of Alcalá
European University of Madrid
Claude Bernard University Lyon 1
Complutense University of Madrid