title: A Randomized Controlled Multicenter Trial of a Five Day Course of Oral Colistin and Neomycin Followed by Restoration of the Gut Microbiota Using Fecal Transplantation to Eradicate Intestinal Carriage of Extended Spectrum Beta-lactamase or Carbapenemase-producing Enterobacteriaceae in High-risk Patients

acronym: R-GNOSIS WP3

summary: This investigator initiated,international, multicenter open-label, randomized controlled trial aims to assess whether a 5 day course of oral nonabsorbable antibiotics (colistin sulfate 2 million IU per os 4x/day and neomycin sulfate 500 mg (salt) per os 4x/day ) followed by fecal microbiota transplantation (administered either via nasogastric administration or via capsules) is effective at eradicating intestinal carriage of beta-lactamase producing Enterobacteriaceae (ESBL-E) and carbapenemase producing Enterobacteriaceae (CPE). compared to no intervention (current standard of care) in adult non-immunosuppressed patients .

ReferenceCitation: Huttner B, Haustein T, Uçkay I, Renzi G, Stewardson A, Schaerrer D, Agostinho A, Andremont A, Schrenzel J, Pittet D, Harbarth S. Decolonization of intestinal carriage of extended-spectrum β-lactamase-producing Enterobacteriaceae with oral colistin and neomycin: a randomized, double-blind, placebo-controlled trial. J Antimicrob Chemother. 2013 Oct;68(10):2375-82. doi: 10.1093/jac/dkt174. Epub 2013 May 29.

ReferenceCitation: Youngster I, Russell GH, Pindar C, Ziv-Baran T, Sauk J, Hohmann EL. Oral, capsulized, frozen fecal microbiota transplantation for relapsing Clostridium difficile infection. JAMA. 2014 Nov 5;312(17):1772-8. doi: 10.1001/jama.2014.13875. Erratum in: JAMA. 2015 Feb 17;313(7):729.

ReferenceCitation: de Lastours V, Poirel L, Huttner B, Harbarth S, Denamur E, Nordmann P. Emergence of colistin-resistant Gram-negative Enterobacterales in the gut of patients receiving oral colistin and neomycin decontamination. J Infect. 2020 May;80(5):578-606. doi: 10.1016/j.jinf.2020.01.003. Epub 2020 Jan 15.

ReferenceCitation: Huttner BD, de Lastours V, Wassenberg M, Maharshak N, Mauris A, Galperine T, Zanichelli V, Kapel N, Bellanger A, Olearo F, Duval X, Armand-Lefevre L, Carmeli Y, Bonten M, Fantin B, Harbarth S; R-Gnosis WP3 study group. A 5-day course of oral antibiotics followed by faecal transplantation to eradicate carriage of multidrug-resistant Enterobacteriaceae: a randomized clinical trial. Clin Microbiol Infect. 2019 Jul;25(7):830-838. doi: 10.1016/j.cmi.2018.12.009. Epub 2019 Jan 4.

lead_sponsor: Stephen Harbarth

location_country: Netherlands France Switzerland Israel

location_facility: Assistance Publique-Hôpitaux de Paris, Hôpital Beaujon


title: A Non-interventional Prospective Study on Allogeneic Stem Cell Transplantation in Patients With AL Amyloidosis

summary:
Light-chain (AL-) amyloidosis is a very rare monoclonal plasma cell disorder with poor prognosis. Rarity of disease has precluded performance of randomized controlled trials comparing various possible treatment modalities. In general, treatment of AL amyloidosis has been adapted from myeloma (MM) therapy. There is large experience with allo SCT in MM. Based on small series of patients and case reports allogeneic transplant has emerged as potentially effective. However, more formal proof of concept of using allogeneic hematopoietic transplantation for treatment of AL Amyloidosis is lacking.

Therefore, given the limitations of conventionally collected registry data (dubious follow-up information and extreme heterogeneity), we developed the: "EBMT non-interventional prospective study on allogeneic transplantation in AL Amyloidosis" which means that transplant centers that already do perform allogeneic transplants for AL Amyloidosis will be encouraged to register their patients with AL Amyloidosis very timely with the EBMT, followed by mandatory submission of EBMT MedB and follow-up forms. The diagnosis of AL Amyloidosis would be based on uniform criteria. All EBMT centres performing allogeneic transplants for Amyloidosis will be invited to participate in this study and centres will be asked to report all AL Amyloidosis cases referred for transplantation using a simple registration form and then to submit Amyloidosis MED B forms for each transplanted patient and follow-up forms as necessary. In conclusion, it should be possible to largely improve the usual quality of registry-based data and to generate scientifically sound knowledge on HSCT in an orphan disease such as AL Amyloidosis.

status: Completed

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Schönland et al. EBMT retrospective data, Blood 2005.

ReferenceCitation: Schönland et al. DLI data, Haematologica, 2008.

lead_sponsor: European Society for Blood and Marrow Transplantation

location_country: Germany France Switzerland

location_facility:
CHRU Limoges
University Hospital Eppendorf
University of Heidelberg
University Hospital

lead_sponsor_type: industriel

status_simplified: Completed


primary_purpose: Treatment

intervention_type: Drug

title: Clinical Pharmacology, Efficacy and Safety Study of FGTW in Paediatric Patients With Severe Congenital Fibrinogen Deficiency

study_completion_date_type: Actual

lead_sponsor: Laboratoire français de Fractionnement et de Biotechnologies

source: euctr

study_type: Interventional

location_country: Lebanon Morocco France Turkey

location_facility: Faculty Ihsan Dogramaci Children's Hospital

summary: The aim of the study is to evaluate clinical pharmacology, efficacy and safety of FGTW in pediatric patients with congenital fibrinogen deficiency.


type: Other Identifier

title: A Phase 1 Study of Combination Therapy With SAR405838 and Pimasertib in Patients With Advanced Cancer

summary:
Primary Objectives:

To determine the recommended Phase 2 dose of SAR405838 / pimasertib combination therapy in patients with solid tumors.

To assess the anti-tumor activities of SAR405838 / pimasertib in patients with solid tumors.

Secondary Objectives:

To characterize the pharmacokinetic profile of SAR405838 and pimasertib.

To evaluate the pharmacodynamic effect of the SAR405838 and pimasertib.

To characterize genetic status in tumor tissue and circulating tumor DNA.

design_allocation: Non-Randomized

ReferenceType: derived

ReferenceCitation: de Weger VA, de Jonge M, Langenberg MHG, Schellens JHM, Lolkema M, Varga A, Demers B, Thomas K, Hsu K, Tuffal G, Goodstal S, Macé S, Deutsch E. A phase I study of the HDM2 antagonist SAR405838 combined with the MEK inhibitor pimasertib in patients with advanced solid tumours. Br J Cancer. 2019 Feb;120(3):286-293. doi: 10.1038/s41416-018-0355-8. Epub 2018 Dec 26.

lead_sponsor: Sanofi

location_country: Netherlands France

location_facility:
Investigational Site Number 528001
Investigational Site Number 528002
Investigational Site Number 250001
Investigational Site Number 528003


title: Lower Urinary Tract Symptoms in Patients Suffering From Systemic Sclerosis: a Multi-centric Longitudinal Study

summary:
Urinary symptoms must be frequent in Scleroderma. In one hand, mobility limitation by joint stiffness and skin sclerosis, forced diuresis due to heart involvement (cardiomyopathy or pulmonary hypertension), diuretics use and corticoid-induced hyperglycaemia, as well as narcotic medication use, puts patients at higher risk of secondary bladder filling and voiding dysfunction. In another hand, few case report and small sample observational studies have identified a specific sclerosis of the urinary tract. Those two mechanisms must be more frequent in the diffuse cutaneous form of scleroderma (dcSSc) compare to the limited one (lcSSc). But prevalence or incidence is unknown.

Urinary symptoms are seldom reported by those suffering from them and are rarely part of a systemic evaluation. In a threatening disease, urinary symptoms assessment might seem to be of no priority. But LUTS have a real impact on many aspect of everyday living. Furthermore urinary tract involvement might predispose to urinary tract infection due to flow limitation and stagnation. Since it is an inner fibrosis it might be associated with a more aggressive form of disease conferring a greater loss of physical function, higher risk for hospital admission and death.

Thus, identifying urinary symptoms would permit to address specific rehabilitation or medication therapy, in order to minimize the consequences of the bothersome symptoms and identify those subjects at higher risk of urinary infection, aggressive disease/loss of function or death.

This study will also give basement to build an interventional study directed toward LUTS treatment in this population.

In this prospective cohort we would like to:

Compare the prevalence of lower urinary tract symptoms (LUTS) in diffuse and limited forms of systemic sclerosis.
Determine the prevalence (at inclusion) and incidence (in a two years period) of LUTS among patients suffering from systemic sclerosis.
Evaluate the impact of LUTS symptoms on Quality of life.
Compare the discrimination ability of Cochin-hand score and HAQ score to predict incontinence in this population.
Evaluate the association between LUTS symptoms, hospital admission rate, urinary tract infection, mortality and loss of autonomy.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: John G, Avouac J, Piantoni S, Polito P, Fredi M, Cozzi F, Airò P, Truchetet ME, Franceschini F, Allanore Y, Chizzolini C. Prevalence and Disease-Specific Risk Factors for Lower Urinary Tract Symptoms in Systemic Sclerosis: An International Multicenter Study. Arthritis Care Res (Hoboken). 2018 Aug;70(8):1218-1227. doi: 10.1002/acr.23454. Epub 2018 Jun 19.

ReferenceCitation: John G, Allanore Y, Polito P, Piantoni S, Fredi M, Avouac J, Franceschini F, Truchetet ME, Cozzi F, Airo P, Chizzolini C. The limited cutaneous form of systemic sclerosis is associated with urinary incontinence: an international multicentre study. Rheumatology (Oxford). 2017 Nov 1;56(11):1874-1883. doi: 10.1093/rheumatology/kex230.

lead_sponsor: University Hospital, Geneva

location_country: France Switzerland Italy

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

lead_sponsor_type: academique

status_simplified: Unknown


type: EudraCT Number

title: A Phase 1b, Multi-center, Open-label, Dose Escalation Study of GSK2256098 (FAK Inhibitor) in Combination With Trametinib (MEK Inhibitor) in Subjects With Advanced Solid Tumors

summary: The purpose of this study is to assess the safety of combination treatment of GSK2256098 and trametinib in mesothelioma subjects and subjects with other selected tumor types. Also, the study will identify a maximum tolerated combination dose of GSK2256098 and trametinib. This study is a Phase I, open-label, dose-escalation study to determine maximal tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) and regimens for oral MEK inhibitor trametinib (once daily [OD]dosing) and the oral FAK inhibitor GSK2256098 (twice daily [BID] dosing). The synergy of the combination was observed over a wide range of concentrations and results in several-fold reduction in compound concentration to achieve equivalent biological responses compared to either single agent. The dose and schedule of dosing may be modified based on emerging safety, pharmacokinetic (PK), and pharmacodynamic (PD) data. The study will be conducted in two parts; Part 1 Dose Escalation to determine the MTD and RP2D and Part 2 Expansion Cohort to further evaluate the safety and tolerability of trametinib and GSK2256098 at the RP2D and determine clinical activity. Additionally, in Part 1 Dose Escalation, additional subjects with malignant pleural mesothelioma (MPM) will be recruited at doses that are considered tolerable in order to assess PD in MPM subjects at each dose (the Pharmacodynamic Cohort). The Expansion Cohort will be limited to subjects with MPM who have progressed or are intolerant to first-line therapy.

study_start_date_type: Actual

design_allocation: Randomized

ReferenceCitation: Mak G, Soria JC, Blagden SP, Plummer R, Fleming RA, Nebot N, Zhang J, Mazumdar J, Rogan D, Gazzah A, Rizzuto I, Greystoke A, Yan L, Tolson J, Auger KR, Arkenau HT. A phase Ib dose-finding, pharmacokinetic study of the focal adhesion kinase inhibitor GSK2256098 and trametinib in patients with advanced solid tumours. Br J Cancer. 2019 May;120(10):975-981. doi: 10.1038/s41416-019-0452-3. Epub 2019 Apr 17.

ipd_sharing: Yes

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
France
United Kingdom


title: Xarelto (Rivaroxaban) Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages

summary: This cross-sectional epidemiologic study measured physician and patient awareness and understanding of the key messages in the Xarelto prescriber guide and Xarelto patient alert card.

time_perspective: Cross-Sectional

lead_sponsor: Bayer

location_country:
Germany
France
Spain
United Kingdom

intervention_type: Behavioral


title: Retrospective Collection of Effectiveness and Safety Data From Patients Treated With Liraglutide or DPP-4 Inhibitor in Primary Care in Europe

summary: This study is conducted in Europe. The aim of this study is to demonstrate the clinical effectiveness and safety of liraglutide and dipeptidyl peptidase-4 (DPP-4) inhibitor therapy in routine primary care in Europe.

time_perspective: Retrospective

lead_sponsor: Novo Nordisk A/S


title: A Non-interventional Study to Evaluate the Use of Pliaglis in Daily Practice

summary: A multe-center, non-interventional study in Europe to evaluate Pliaglis in daily practice

ReferenceCitation: Jain R, Arias GM, Naranjo P, Murison M, López Estebaranz JL, Fratila A, Prager W, Barona CG, Weidmann M, Dahan S, Cartier H, Sattler G, Podda M. The Use of a Self-Occluding Topical Anasthetic in Daily Practice: A Non-Interventional Study. J Drugs Dermatol. 2018 Apr 1;17(4):413-418.

lead_sponsor: Galderma R&D

location_facility:
Centre Médical Saint-Jean
Clínica Dermatológica Dr. Guillén
Swansea Laser Clinic
Klinikum Darmstadt Hautklinik


title: A Phase 1, Multi-center, Non-randomized, Open Label, Dose Escalation Design Study of Sorafenib (BAY43-9006) in Combination With Eribulin in Subjects With Advanced, Metastatic or Refractory Solid Tumors

summary:
This Phase 1 study will be conducted in an open-label, non-randomized, dose-escalation design in subjects with advanced, metastatic or refractory solid malignancy who are not candidates for standard therapy. The study drugs are sorafenib and eribulin mesylate.

Up to 24 subjects with solid tumors will participate in the dose escalation part of the study, and once the maximum tolerated dose is defined, up to 30 subjects with advanced, metastatic or refractory solid tumors will participate in the expansion phase of the study.

Eribulin (mesylate) will be administered intravenously at a fixed dose of 1.4 mg/m2 on Days 1 and 8 of 21-day Cycles.

The starting sorafenib dose (Dose Level 1) is 200 mg twice daily. Sorafenib is given orally, continuously on days 11 to 21 of Cycle 1, and from Day 1 to Day 21 of all subsequent cycles. If 200 mg sorafenib twice daily is tolerated with eribulin, the sorafenib dose will be escalated sequentially to 200 mg morning dose and 400 mg evening dose (Dose Level 2) in a new cohort. If Dose Level 2 is tolerated, a second dose escalation to 400 mg twice daily (Dose Level 3) will be studied in a new cohort. If the starting dose of sorafenib is not tolerated with eribulin, the sorafenib dose will be de-escalated to 200 mg once daily in a new cohort. Subjects will need to receive two cycles of eribulin plus sorafenib therapy and safety data for the first and second cycle needs to be available before the start of the next cohort.

location_country: Germany France


summary: This study is a multicenter, prospective, observational study to evaluate the long-term safety of OZURDEX® in patients with macular oedema following central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) or patients with non-infectious posterior segment uveitis in real-world clinical practice.

lead_sponsor: Allergan


title: An Open-label, Non-randomized, Dose Escalation, Safety and Pharmacokinetic Phase I Study of Ombrabulin (AVE8062) in Combination With Bevacizumab Administered by Intravenous Infusion Every 3 Weeks in Patients With Advanced Solid Tumors.

summary:
Primary Objective:

- To determine the maximum administered dose (MAD) and the maximum tolerated dose (MTD) of ombrabulin in combination with best tolerated dose of bevacizumab based on the incidence of related Dose Limiting Toxicities (DLTs).

Secondary Objectives:

To assess the overall safety profile of the combination
To characterize the pharmacokinetic (PK) profile of both ombrabulin and bevacizumab when given in combination
To evaluate preliminary evidence of anti-tumor activity
To assess the pharmacodynamic effect using (Dynamic Contrast Enhanced Ultra-Sound) DCE-US, measuring biomarkers

location_country:
France
United Kingdom
Italy

location_facility:
Investigational Site Number 826001
Investigational Site Number 380001
Investigational Site Number 250001
Investigational Site Number 380002


title: A Multiple-Dose Study To Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted RO5190591 in Combination With Peginterferon Alfa-2a Plus Ribavirin in Patients With Chronic Hepatitis C Genotype 1

summary: This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. Patients in cohorts will be randomized to receive either oral doses of danoprevir, or danoprevir plus ritonavir, or placebo plus ritonavir. All patients will receive Pegasys (180mcg sc once weekly) plus ribavirin (1000-1200mg/day po), with the option to continue this treatment after completion of study drug treatment. Anticipated time on study treatment is up to 12 weeks.

ReferenceCitation: Gane EJ, Rouzier R, Wiercinska-Drapalo A, Larrey DG, Morcos PN, Brennan BJ, Le Pogam S, Nájera I, Petric R, Tran JQ, Kulkarni R, Zhang Y, Smith P, Yetzer ES, Shulman NS. Efficacy and safety of danoprevir-ritonavir plus peginterferon alfa-2a-ribavirin in hepatitis C virus genotype 1 prior null responders. Antimicrob Agents Chemother. 2014;58(2):1136-45. doi: 10.1128/AAC.01515-13. Epub 2013 Dec 2.

ReferenceCitation: Morcos PN, Chang L, Kulkarni R, Giraudon M, Shulman N, Brennan BJ, Smith PF, Tran JQ. A randomised study of the effect of danoprevir/ritonavir or ritonavir on substrates of cytochrome P450 (CYP) 3A and 2C9 in chronic hepatitis C patients using a drug cocktail. Eur J Clin Pharmacol. 2013 Nov;69(11):1939-49. doi: 10.1007/s00228-013-1556-y. Epub 2013 Jul 20.

ReferenceCitation: Gane EJ, Rouzier R, Stedman C, Wiercinska-Drapalo A, Horban A, Chang L, Zhang Y, Sampeur P, Nájera I, Smith P, Shulman NS, Tran JQ. Antiviral activity, safety, and pharmacokinetics of danoprevir/ritonavir plus PEG-IFN α-2a/RBV in hepatitis C patients. J Hepatol. 2011 Nov;55(5):972-9. doi: 10.1016/j.jhep.2011.01.046. Epub 2011 Feb 24.

lead_sponsor: Hoffmann-La Roche

location_country:
New Zealand
Poland
France


title: A Phase 1, Randomized, Single-Blind, Placebo-Controlled, Dose Escalation Trial to Evaluate the Safety and Tolerability of a Single Dose of Intravenous ALN-TTR01 in Patients With TTR Amyloidosis

summary: The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of ALN-TTR01 in patients with transthyretin (TTR) mediated amyloidosis (ATTR).

ReferenceCitation: Coelho T, Adams D, Silva A, Lozeron P, Hawkins PN, Mant T, Perez J, Chiesa J, Warrington S, Tranter E, Munisamy M, Falzone R, Harrop J, Cehelsky J, Bettencourt BR, Geissler M, Butler JS, Sehgal A, Meyers RE, Chen Q, Borland T, Hutabarat RM, Clausen VA, Alvarez R, Fitzgerald K, Gamba-Vitalo C, Nochur SV, Vaishnaw AK, Sah DW, Gollob JA, Suhr OB. Safety and efficacy of RNAi therapy for transthyretin amyloidosis. N Engl J Med. 2013 Aug 29;369(9):819-29. doi: 10.1056/NEJMoa1208760.

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Sweden
France
Portugal
United Kingdom


title: Prospective, International Multi-centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-term Performance of the DePuy PROXIMA™ Hip in Subjects With Indications Suitable for a Primary Total Hip Arthroplasty

summary: The purpose of this study is to monitor the performance of the DePuy PROXIMA™ hip in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.

status: Terminated

lead_sponsor: DePuy International

location_country:
France
Portugal
Spain
United Kingdom

location_facility:
Hospital Belle Isle
Hospital de Santo Antonio
Pilgrim Hospital
Hospital Clinic Barcelona

intervention_type: Device


title: A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine Fibroids

summary:
The first magnetic resonance-guided focused ultrasound (MRgFUS) treatment of uterine fibroid using the ExAblate 2000 system was performed in 2001. Since then, more than 5000 treatments were done in more than 60 different hospitals around the world. The experience accumulated in this novel treatment was collected by InSightec and implemented into software and hardware updates, clinical tips and guidelines, all aimed to improve the clinical results and their durability, while maintaining a high level of safety.

Based on extensive clinical experience and our internal research and development effort goals toward continuous improvement in ExAblate treatment safety and performance, limited changes have been made to the current ExAblate system. This modified ExAblate system version is designated as the ExAblate 2100 UF V2 system.

The modifications are believed to improve system's friendliness to the user, without introducing new risks or other issues of safety of the device, and should not have any negative impact on the safety or technical efficacy of the treatments for patients.

lead_sponsor: InSightec

location_country:
Russian Federation
France
Israel
United Kingdom

location_facility: Research Centre of Obstetric / Gynaecology & Perinatology


title: A Randomized, Placebo-Controlled, Double-blind, Parallel Group, Multi-centre Phase II Dose-Finding Study of M516102 in the Treatment of Pruritus Associated With Atopic Dermatitis

summary: This study is to investigate the efficacy and safety of M516102 and to evaluate the dose response relationship of M516102 and placebo, in the treatment of pruritus associated with atopic dermatitis.

lead_sponsor: Maruho Co., Ltd.

location_country:
Germany
Poland
France
United Kingdom

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1


title: An Open-label Extension to a 52-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study in Patients With Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106

summary: This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with Alzheimer's disease.

ReferenceCitation: Farlow MR, Andreasen N, Riviere ME, Vostiar I, Vitaliti A, Sovago J, Caputo A, Winblad B, Graf A. Long-term treatment with active Aβ immunotherapy with CAD106 in mild Alzheimer's disease. Alzheimers Res Ther. 2015 Apr 27;7(1):23. doi: 10.1186/s13195-015-0108-3. eCollection 2015.

lead_sponsor: Novartis

location_country:
Sweden
France
Switzerland
United Kingdom

intervention_type: Biological


title: Acceptability of Long-term Progestin-only Contraception in Europe

summary: The study examines the use of Mirena or Implanon for long-term contraception in women. The duration of therapy use is the key focus of the study. Also, any reasons for discontinuation and the safety profile will be examined. In addition, patients are asked to fill out a short questionnaire about their menstrual bleeding before and during therapy.

location_country:
France
Slovakia
United Kingdom
Ireland


acronym: FACTO

title: A PHASE 4, MULTINATIONAL, MULTICENTRE, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, PARALLEL GROUP, CONTROLLED CLINICAL STUDY OF FIXED COMBINATION BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg pMDI WITH HFA-134A PROPELLANT (CHF1535, FOSTER®) VERSUS FLUTICASONE 250 µg PLUS SALMETEROL 50 µg DPI (SERETIDE® DISKUS®) AS MAINTENANCE TREATMENT IN CONTROLLED ASTHMATIC PATIENTS.

lead_sponsor: Chiesi Farmaceutici S.p.A.

ReferenceType: result

ReferenceCitation: Barnes N, van Noord JA, Brindicci C, Lindemann L, Varoli G, Perpiña M, Guastalla D, Casula D, Patel S, Chanez P; FACTO (Foster® As Complete Treatment Option) Study Group. Stepping-across controlled asthmatic patients to extrafine beclometasone/formoterol combination. Pulm Pharmacol Ther. 2013 Oct;26(5):555-61. doi: 10.1016/j.pupt.2013.01.011. Epub 2013 Mar 22.

location_country: Germany France Netherlands Spain

location_facility: Allergologie imUmkreis der Praxis Pneumologie

summary: Double blind, multinational, multicentre, randomised, 2 arm parallel group study


title: Two-arm, Randomized, Open-label, Phase IIIb Study Investigating the Safety of a 3 Hour i.p. Infusion of Catumaxomab With and Without Prednisolone Premedication in Patients With Malignant Ascites Due to Epithelial Cancer

acronym: CASIMAS

summary:
This is a randomized phase IIIb study investigating the treatment of malignant ascites due to epithelial cancer (carcinomas) with the trifunctional antibody catumaxomab. In order to make the catumaxomab treatment more convenient for the patient and the hospital praxis the tolerability of 3 hour infusions of catumaxomab with and without premedication of prednisolone is evaluated.

A total of 208 patients with malignant ascites due to epithelial cancer will be allocated to two treatment groups in a 1:1 ratio.

ReferenceCitation: Lordick F, Ott K, Weitz J, Jäger D. The evolving role of catumaxomab in gastric cancer. Expert Opin Biol Ther. 2008 Sep;8(9):1407-15. doi: 10.1517/14712598.8.9.1407 . Review.

ReferenceCitation: Burges A, Wimberger P, Kümper C, Gorbounova V, Sommer H, Schmalfeldt B, Pfisterer J, Lichinitser M, Makhson A, Moiseyenko V, Lahr A, Schulze E, Jäger M, Ströhlein MA, Heiss MM, Gottwald T, Lindhofer H, Kimmig R. Effective relief of malignant ascites in patients with advanced ovarian cancer by a trifunctional anti-EpCAM x anti-CD3 antibody: a phase I/II study. Clin Cancer Res. 2007 Jul 1;13(13):3899-905.

ReferenceCitation: Shen J, Zhu Z. Catumaxomab, a rat/murine hybrid trifunctional bispecific monoclonal antibody for the treatment of cancer. Curr Opin Mol Ther. 2008 Jun;10(3):273-84.

ReferenceCitation: Fossati M, Buzzonetti A, Monego G, Catzola V, Scambia G, Fattorossi A, Battaglia A. Immunological changes in the ascites of cancer patients after intraperitoneal administration of the bispecific antibody catumaxomab (anti-EpCAM×anti-CD3). Gynecol Oncol. 2015 Aug;138(2):343-51. doi: 10.1016/j.ygyno.2015.06.003. Epub 2015 Jun 3.

lead_sponsor: Neovii Biotech

location_country: Germany France Spain Italy

location_facility:
Study site
Study Site


title: A Randomised, Double-Blind, Multicentre Study to Compare the Efficacy and Tolerability of Oral Ivermectin to Malathion 0.5% Lotion in the Treatment of Head Lice Infestation

summary: The purpose of this study is to compare 2 single doses of ivermectin as tablets with 2 single applications of malathion 0.5% lotion (Days 1 and 8) in clearing head lice, in patients who have recently used standard head lice treatments without success.

ReferenceCitation: Chosidow O, Giraudeau B, Cottrell J, Izri A, Hofmann R, Mann SG, Burgess I. Oral ivermectin versus malathion lotion for difficult-to-treat head lice. N Engl J Med. 2010 Mar 11;362(10):896-905. doi: 10.1056/NEJMoa0905471. Erratum in: N Engl J Med. 2010 Apr 29;362(17):1647.

lead_sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

location_country:
France
Israel
United Kingdom
Ireland

location_facility:
Shandon Clinic
Chaim Sheba Medical Centre
Hopital Avicenne
Synexus Clinical Research Centre


title: A Twenty-four Week, Open-label, Non-comparative, Multi-center Study to Assess the Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension.

summary: This study will assess the efficacy of an aliskiren based treatment regimen in reaching blood pressure (BP) target in patients with mild to moderate hypertension. (defined as mean sitting Systolic Blood Pressure [msSBP] ≥ 140 mmHg and < 180 mmHg and/or mean sitting Diastolic Blood Pressure [msDBP] ≥ 90 and <110 mmHg).

location_country: Hungary France Slovakia Romania


title: Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation

summary: This study is being conducted on the Vanguard™ Deep Dish Rotating Platform (DD RP) to evaluate the clinical efficacy of the DDRP components.

ipd_sharing: No

lead_sponsor: Zimmer Biomet

location_country:
Netherlands
France
United Kingdom

location_facility: Zuyderland Medisch Centrum Sittard-Geleen


title: A 52-week,Multi-center,Randomized,Double-blind,Placebo-controlled,Parallel Group Study in Patients With Mild Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106

summary: This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mild Alzheimer's disease.

location_facility: Centre Hospitalier Universitaire Pellegrin


title: An Observational, Prospective Evaluation of the Trifecta™ Valve

summary: This trial is designed to confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by New York Heart Association (NYHA) functional classification, hemodynamic performance, and hematology analysis.

lead_sponsor: Abbott Medical Devices

location_country: Germany France Netherlands

location_facility:
Hôpital de Pontchaillou
Universitat Herzzentrum Leipzig GmbH
Deutsches Herzzentrum München
Onze Lieve Vrouwe Gasthuis


title: A Prospective, Single-arm, Multicenter 2-phase Feasibility Study to Assess the TAXUS Petal Paclitaxel-Eluting Bifurcation Coronary Stent System (TAXUS Petal)for the Treatment of de Novo Atherosclerotic Bifurcation Lesions

summary: The purpose of this study is to determine the safety and feasibility of use in humans of the TAXUS Petal Paclitaxel-Eluting Bifurcation Coronary Stent System in the treatment of de novo lesions in native coronary arteries involving a major side branch. The TAXUS® Petal™ is an investigational device with an indication of improving coronary artery luminal diameter while maintaining side branch access in subjects with symptomatic ischemic disease due to discrete atherosclerotic bifurcation lesions

ReferenceCitation: Ormiston JA, Lefèvre T, Grube E, Allocco DJ, Dawkins KD. First human use of the TAXUS Petal paclitaxel-eluting bifurcation stent. EuroIntervention. 2010 May;6(1):46-53. doi: 10.4244/.

lead_sponsor: Boston Scientific Corporation

location_country:
New Zealand
Germany
France

location_facility: Institut Hospitalier Jacques Cartier-ICPS, 6, Avenue du Noyer Lambert

location_facility: Mercy Angiography Unit, 98 Mountain Road, First Floor

location_facility: Auckland City Hospital, Cardiac Investigations Unit, Park Road

location_facility: HELIOS Klinikum Siegburg, Ringstrasse 49


title: A 4-year Extension to a Phase II a Multicenter Study Evaluating Long-term Safety, Tolerability, Pharmacokinetics and Effects on Liver Iron Concentration of Repeated Doses of 10 mg/kg/Day of Deferasirox in Pediatric Patients With Transfusion Dependent β-thalassemia Major.

summary: In this 4-year extension study the safety, efficacy and and pharmacokinetics of deferasirox in regularly transfused pediatric patients with β-thalassemia major was assessed. Patients who successfully completed the main 1 year trial (NCT00390858) were eligible to continue in this extension trial and receive chelation therapy with deferasirox for up to 4 years.

lead_sponsor: Novartis Pharmaceuticals

location_country: France Italy


summary:
The primary objective of this trial is to demonstrate the equivalence, in terms of immunogenicity, of three different industrial lots of the investigational vaccine thereby supporting consistency of the manufacturing process.

Secondary Objectives:

Immunogenicity

To demonstrate that the investigational vaccine induces an immune response at least as good as the one induced by the reference vaccine, in terms of antibody titers.

To assess the immunogenicity of the investigational vaccine using parameters defined in the European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96).

Safety:

To demonstrate that the investigational vaccine is at least as well tolerated as the reference vaccine, in terms of defined safety profile.

To describe the safety profile after vaccination.

Comfort of the vaccination assessment:

To assess the pain immediately after the injection using a Verbal Rating Scale. To describe the vaccination comfort after the injection using a -Patient-Reported Outcome questionnaire: the Vaccination Comfort Questionnaire.

primary_purpose: Prevention

ReferenceCitation: Arnou R, Eavis P, Pardo JR, Ambrozaitis A, Kazek MP, Weber F. Immunogenicity, large scale safety and lot consistency of an intradermal influenza vaccine in adults aged 18-60 years: Randomized, controlled, phase III trial. Hum Vaccin. 2010 Apr;6(4):346-54. Epub 2010 Apr 15.

ReferenceCitation: Chevat C, Viala-Danten M, Dias-Barbosa C, Nguyen VH. Development and psychometric validation of a self-administered questionnaire assessing the acceptance of influenza vaccination: the Vaccinees' Perception of Injection (VAPI) questionnaire. Health Qual Life Outcomes. 2009 Mar 4;7:21. doi: 10.1186/1477-7525-7-21.

lead_sponsor: Sanofi Pasteur, a Sanofi Company

location_country:
Lithuania
France
Spain
United Kingdom


title: An Open-Label Study to Investigate the Efficacy and Safety of AF37702 Injection in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients With Chronic Kidney Disease

summary: The purpose of this study is to evaluate the ability of peginesatide (AF37702) to increase and maintain increased hemoglobin levels in participants with chronic kidney disease (CKD) (either not on dialysis, receiving regular hemodialysis or peritoneal dialysis, or following renal transplant) with confirmed antibody-mediated pure red cell aplasia (PRCA).

ReferenceCitation: Macdougall IC, Rossert J, Casadevall N, Stead RB, Duliege AM, Froissart M, Eckardt KU. A peptide-based erythropoietin-receptor agonist for pure red-cell aplasia. N Engl J Med. 2009 Nov 5;361(19):1848-55. doi: 10.1056/NEJMoa074037.

lead_sponsor: Takeda

location_country:
Germany
France
United Kingdom


title: A Phase II Open-Label Clinical Trial of Recombinant Human Alpha-L-iduronidase (Aldurazyme®) to Evaluate the Safety and Pharmacokinetics in Mucopolysaccharidosis I (MPS I) Patients Less Than 5 Years Old

summary: The main objectives of this study are to evaluate the safety and pharmacokinetics (PK) of enzyme replacement therapy with recombinant human alpha-L-iduronidase [Aldurazyme® (laronidase)] in mucopolysaccharidosis I (MPS I) patients less than 5 years old. Efficacy measurements will also be evaluated in this study.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Germany
France
Netherlands
United Kingdom

location_facility: Willink Biochemical Genetics Unit Royal Hospital for Children


title: Nephroblastoma (Wilms Tumour) Clinical Trial And Study

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy before surgery may shrink the tumor so it can be removed during surgery. Giving more chemotherapy after surgery may kill any remaining tumor cells. It is not yet known which chemotherapy regimen after surgery is most effective in treating Wilm's tumor.

PURPOSE: Phase III trial to study the effectiveness of chemotherapy before and after surgery in treating children who have Wilm's tumor.

ReferenceCitation: Warmann SW, Nourkami N, Frühwald M, Leuschner I, Schenk JP, Fuchs J, Graf N. Primary lung metastases in pediatric malignant non-Wilms renal tumors: data from SIOP 93-01/GPOH and SIOP 2001/GPOH. Klin Padiatr. 2012 Apr;224(3):148-52. doi: 10.1055/s-0032-1304600. Epub 2012 Apr 18.

ReferenceCitation: Furtwängler R, Nourkami N, Alkassar M, von Schweinitz D, Schenk JP, Rübe C, Siemer S, Leuschner I, Graf N. Update on relapses in unilateral nephroblastoma registered in 3 consecutive SIOP/GPOH studies - a report from the GPOH-nephroblastoma study group. Klin Padiatr. 2011 May;223(3):113-9. doi: 10.1055/s-0031-1275293. Epub 2011 Apr 20.

ReferenceCitation: van den Heuvel-Eibrink MM, van Tinteren H, Rehorst H, Coulombe A, Patte C, de Camargo B, de Kraker J, Leuschner I, Lugtenberg R, Pritchard-Jones K, Sandstedt B, Spreafico F, Graf N, Vujanic GM. Malignant rhabdoid tumours of the kidney (MRTKs), registered on recent SIOP protocols from 1993 to 2005: a report of the SIOP renal tumour study group. Pediatr Blood Cancer. 2011 May;56(5):733-7. doi: 10.1002/pbc.22922. Epub 2010 Dec 22.

ReferenceCitation: Warmann SW, Furtwängler R, Blumenstock G, Armeanu S, Nourkami N, Leuschner I, Schenk JP, Graf N, Fuchs J. Tumor biology influences the prognosis of nephroblastoma patients with primary pulmonary metastases: results from SIOP 93-01/GPOH and SIOP 2001/GPOH. Ann Surg. 2011 Jul;254(1):155-62. doi: 10.1097/SLA.0b013e318222015e.

ReferenceCitation: Szavay P, Luithle T, Graf N, Furtwängler R, Fuchs J. Primary hepatic metastases in nephroblastoma--a report of the SIOP/GPOH Study. J Pediatr Surg. 2006 Jan;41(1):168-72; discussion 168-72.

ReferenceCitation: Smets AM, van Tinteren H, Bergeron C, De Camargo B, Graf N, Pritchard-Jones K, de Kraker J. The contribution of chest CT-scan at diagnosis in children with unilateral Wilms' tumour. Results of the SIOP 2001 study. Eur J Cancer. 2012 May;48(7):1060-5. doi: 10.1016/j.ejca.2011.05.025. Epub 2011 Jun 22.

ReferenceCitation: Williams RD, Al-Saadi R, Chagtai T, Popov S, Messahel B, Sebire N, Gessler M, Wegert J, Graf N, Leuschner I, Hubank M, Jones C, Vujanic G, Pritchard-Jones K; Children's Cancer and Leukaemia Group; SIOP Wilms' Tumour Biology Group. Subtype-specific FBXW7 mutation and MYCN copy number gain in Wilms' tumor. Clin Cancer Res. 2010 Apr 1;16(7):2036-45. doi: 10.1158/1078-0432.CCR-09-2890. Epub 2010 Mar 23.

ReferenceCitation: Messahel B, Williams R, Ridolfi A, A'hern R, Warren W, Tinworth L, Hobson R, Al-Saadi R, Whyman G, Brundler MA, Kelsey A, Sebire N, Jones C, Vujanic G, Pritchard-Jones K; Children's Cancer and Leukaemia Group (CCLG). Allele loss at 16q defines poorer prognosis Wilms tumour irrespective of treatment approach in the UKW1-3 clinical trials: a Children's Cancer and Leukaemia Group (CCLG) Study. Eur J Cancer. 2009 Mar;45(5):819-26. doi: 10.1016/j.ejca.2009.01.005. Epub 2009 Feb 21.

lead_sponsor: University of Leicester

location_facility: Academisch Medisch Centrum at University of Amsterdam


title: Clinical Validation Study for EDIT-B Test: an Aid for Differential Diagnosis of Bipolar Disorder, Based on RNA Editing Blood Biomarkers

acronym: EDIT-B

summary:
Differentiation between major depressive disorder (MDD) and bipolar disorder (BD) as soon as possible in the patient journey represents a major clinical issue. When the patient is in a depressive phase, the symptoms are similar between the two pathologies and the current clinical scales fail in distinguishing them. Physicians often report this difficulty and as a consequence, the mean time from onset to bipolar disorder diagnosis is currently 7.5 years. These diagnostic delays and misdiagnosis lead to damaging consequences for patients and their loved ones: worsening of symptoms, comorbidities, suicide risk and inadequate care resulting in severe impairment in social and occupational functioning. Faced with these high expectations for accurate diagnostic methods for an earlier management of psychiatric patients, the combination of relevant clinical features and biomarkers could stand for a solution, leading to a personalised approach in patients with mood disorders.

In a first clinical discovery study, a panel of RNA biomarkers in the blood of patients with a major depressive episode (MDE) has been identified, allowing to differentiate bipolar disorder from MDD (unipolar depression). These biomarkers are based on RNA modifications, namely RNA editing, that could be identified using molecular biology, NGS and artificial intelligence. This panel constitutes EDIT-B test, which is based on Alcediag's proprietary and patented biomarkers and algorithms.

The present study aims to validate the biomarker signatures proposed by Alcediag by measuring the association between the modifications of the RNA editing and major depressive disorder/ bipolar disorder diagnosis, in patients with a MDE in real-life setting pilot centres.

status: Recruiting

ReferenceCitation: Salvetat N, Checa-Robles FJ, Patel V, Cayzac C, Dubuc B, Chimienti F, Abraham JD, Dupré P, Vetter D, Méreuze S, Lang JP, Kupfer DJ, Courtet P, Weissmann D. A game changer for bipolar disorder diagnosis using RNA editing-based biomarkers. Transl Psychiatry. 2022 May 4;12(1):182. doi: 10.1038/s41398-022-01938-6.

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ReferenceCitation: Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978 Nov;133:429-35.

ReferenceCitation: Kim SH, Kim HJ, Lee SI, Jo MW. Comparing the psychometric properties of the EQ-5D-3L and EQ-5D-5L in cancer patients in Korea. Qual Life Res. 2012 Aug;21(6):1065-73. doi: 10.1007/s11136-011-0018-1. Epub 2011 Sep 23.

ReferenceCitation: Hawass NE. Comparing the sensitivities and specificities of two diagnostic procedures performed on the same group of patients. Br J Radiol. 1997 Apr;70(832):360-6.

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ReferenceCitation: Merikangas KR, Jin R, He JP, Kessler RC, Lee S, Sampson NA, Viana MC, Andrade LH, Hu C, Karam EG, Ladea M, Medina-Mora ME, Ono Y, Posada-Villa J, Sagar R, Wells JE, Zarkov Z. Prevalence and correlates of bipolar spectrum disorder in the world mental health survey initiative. Arch Gen Psychiatry. 2011 Mar;68(3):241-51. doi: 10.1001/archgenpsychiatry.2011.12.

ReferenceCitation: Carvalho AF, Solmi M, Sanches M, Machado MO, Stubbs B, Ajnakina O, Sherman C, Sun YR, Liu CS, Brunoni AR, Pigato G, Fernandes BS, Bortolato B, Husain MI, Dragioti E, Firth J, Cosco TD, Maes M, Berk M, Lanctôt KL, Vieta E, Pizzagalli DA, Smith L, Fusar-Poli P, Kurdyak PA, Fornaro M, Rehm J, Herrmann N. Evidence-based umbrella review of 162 peripheral biomarkers for major mental disorders. Transl Psychiatry. 2020 May 18;10(1):152. doi: 10.1038/s41398-020-0835-5. Review.

ReferenceCitation: Carvalho AF, Firth J, Vieta E. Bipolar Disorder. N Engl J Med. 2020 Jul 2;383(1):58-66. doi: 10.1056/NEJMra1906193. Review.

ReferenceCitation: Fiedorowicz JG, He J, Merikangas KR. The association between mood and anxiety disorders with vascular diseases and risk factors in a nationally representative sample. J Psychosom Res. 2011 Feb;70(2):145-54. doi: 10.1016/j.jpsychores.2010.07.010. Epub 2010 Sep 18.

ReferenceCitation: Pan JX, Xia JJ, Deng FL, Liang WW, Wu J, Yin BM, Dong MX, Chen JJ, Ye F, Wang HY, Zheng P, Xie P. Diagnosis of major depressive disorder based on changes in multiple plasma neurotransmitters: a targeted metabolomics study. Transl Psychiatry. 2018 Jul 10;8(1):130. doi: 10.1038/s41398-018-0183-x.

ReferenceCitation: Kessing LV. Course and cognitive outcome in major affective disorder. Dan Med J. 2015 Nov;62(11):B5160.

ReferenceCitation: Giridharan VV, Sayana P, Pinjari OF, Ahmad N, da Rosa MI, Quevedo J, Barichello T. Postmortem evidence of brain inflammatory markers in bipolar disorder: a systematic review. Mol Psychiatry. 2020 Jan;25(1):94-113. doi: 10.1038/s41380-019-0448-7. Epub 2019 Jun 27.

ReferenceCitation: Maes M, Carvalho AF. The Compensatory Immune-Regulatory Reflex System (CIRS) in Depression and Bipolar Disorder. Mol Neurobiol. 2018 Dec;55(12):8885-8903. doi: 10.1007/s12035-018-1016-x. Epub 2018 Apr 2. Review.

ReferenceCitation: Mannion NM, Greenwood SM, Young R, Cox S, Brindle J, Read D, Nellåker C, Vesely C, Ponting CP, McLaughlin PJ, Jantsch MF, Dorin J, Adams IR, Scadden AD, Ohman M, Keegan LP, O'Connell MA. The RNA-editing enzyme ADAR1 controls innate immune responses to RNA. Cell Rep. 2014 Nov 20;9(4):1482-94. doi: 10.1016/j.celrep.2014.10.041. Epub 2014 Nov 13.

ReferenceCitation: Lamers MM, van den Hoogen BG, Haagmans BL. ADAR1: "Editor-in-Chief" of Cytoplasmic Innate Immunity. Front Immunol. 2019 Jul 25;10:1763. doi: 10.3389/fimmu.2019.01763. eCollection 2019. Review.

ReferenceCitation: Rosenthal JJ, Seeburg PH. A-to-I RNA editing: effects on proteins key to neural excitability. Neuron. 2012 May 10;74(3):432-9. doi: 10.1016/j.neuron.2012.04.010. Review.

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ReferenceCitation: Yang W, Wang Q, Kanes SJ, Murray JM, Nishikura K. Altered RNA editing of serotonin 5-HT2C receptor induced by interferon: implications for depression associated with cytokine therapy. Brain Res Mol Brain Res. 2004 Apr 29;124(1):70-8.

ReferenceCitation: Chimienti F, Cavarec L, Vincent L, Salvetat N, Arango V, Underwood MD, Mann JJ, Pujol JF, Weissmann D. Brain region-specific alterations of RNA editing in PDE8A mRNA in suicide decedents. Transl Psychiatry. 2019 Feb 15;9(1):91. doi: 10.1038/s41398-018-0331-3. Erratum in: Transl Psychiatry. 2019 Mar 14;9(1):112.

ReferenceCitation: Weissmann D, van der Laan S, Underwood MD, Salvetat N, Cavarec L, Vincent L, Molina F, Mann JJ, Arango V, Pujol JF. Region-specific alterations of A-to-I RNA editing of serotonin 2c receptor in the cortex of suicides with major depression. Transl Psychiatry. 2016 Aug 30;6(8):e878. doi: 10.1038/tp.2016.121.

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ReferenceCitation: Salvetat N, Van der Laan S, Vire B, Chimienti F, Cleophax S, Bronowicki JP, Doffoel M, Bourlière M, Schwan R, Lang JP, Pujol JF, Weissmann D. RNA editing blood biomarkers for predicting mood alterations in HCV patients. J Neurovirol. 2019 Dec;25(6):825-836. doi: 10.1007/s13365-019-00772-9. Epub 2019 Jul 22.

ReferenceCitation: Salvetat N, Chimienti F, Cayzac C, Dubuc B, Checa-Robles F, Dupre P, Mereuze S, Patel V, Genty C, Lang JP, Pujol JF, Courtet P, Weissmann D. Phosphodiesterase 8A to discriminate in blood samples depressed patients and suicide attempters from healthy controls based on A-to-I RNA editing modifications. Transl Psychiatry. 2021 Apr 30;11(1):255. doi: 10.1038/s41398-021-01377-9.

ReferenceCitation: Wang P, Yu S, Liu J, Zhang D, Kang X. Seven novel mutations of ADAR in multi-ethnic pedigrees with dyschromatosis symmetrica hereditaria in China. Mol Genet Genomic Med. 2019 Oct;7(10):e00905. doi: 10.1002/mgg3.905. Epub 2019 Aug 18.

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lead_sponsor: Alcediag

location_country: Denmark France Spain

location_facility:
Parc Sanitari Sant Joan de Déu
Hospital Clínic de Barcelona
GHU Paris Psychiatrie & Neurosciences
The Capital Region of Denmark

status_simplified: Ongoing


title: Prospective Multicenter Clinical Study on the Visual and Refractive Outcomes and Safety Outcomes Following Implantation of an AddOn Intraocular Lens in Previously Pseudophakic Eyes

summary: The purpose of this prospective multicenter clinical study is to evaluate the visual and refractive outcomes and safety outcomes following bilateral implantation of trifocal and/or trifocal toric 1stQ AddOn (Medicontur) intraocular lenses (IOLs) to correct residual refractive errors, astigmatism, and presbyopia in previously pseudophakic eyes.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Medicontur Medical Engineering Ltd

location_country:
United Kingdom
France
Spain
Belgium

location_facility: Institut Ophtalmologique de l'Ouest Jules Verne


title: Development and External Validation of an International, Multicenter Machine Learning Algorithm for Prediction of Outcome After Lumbar Spinal Fusion for Degenerative Disease: The FUSE-ML Study

acronym: FUSE-ML

summary: The aim of the FUSE-ML study is to develop and externally validate a robust ML-based prediction tool based on multicenter data from a range of international centers that will provide individualized risk-benefit profiles tailored to each patient undergoing lumbar spinal fusion for degenerative disease. Data will be collected by a range of international centers.

lead_sponsor: Bergman Clinics

location_country: Austria Netherlands France

location_facility: Department of Neurosurgery, Bergman Clinics

intervention_type: Procedure


title: Evaluation of the SENSEI® Laparoscopic Tethered Gamma Probe for 99mTc-nanocolloid Sentinel Lymph Node Biopsy in Prostate Cancer

summary:
This study is a prospective, open label, single-arm study to examine the performance and safety of the SENSEI® laparoscopic tethered gamma probe in patients undergoing 99mTc-nanocolloid SLNB for prostate cancer (PCa) during RP and ePLND surgery.

Patients scheduled for RP and ePLND using the standard treatment pathways at each centre will have preoperative 99mTc-nanocolloid imaging. RP and ePLND will be conducted as standard of care, with SLNB guided by the SENSEI® laparoscopic tethered gamma probe carried out after RP and prior to ePLND. The first 2 patients per site (N = 10 in total) are considered to be sufficient to enable further familiarisation with the procedure and use of the probe in addition to the usability work and training that the sites did prior to the start of this study. Subsequent patients will be evaluable for the PP population. The primary analysis of diagnostic performance will be performed using the PP population of patients with SLN identified on preoperative imaging

primary_purpose: Diagnostic

lead_sponsor: Lightpoint Medical Limited

location_country: Germany France Spain Belgium

location_facility:
Hospital del Mar
University Hospital Essen
UZ Leuven
Institute Paoli-Calmettes


title: Hypophosphatemia in the ICU - A One-day Point Prevalence Survey

acronym: HYPO-P-ICU

summary: The point prevalence survey aims at defining the until now unknown real prevalence of hypophosphatemia (defined as blood phosphate value < 0.8 mmol/l) in international critical care settings

ReferenceCitation: Berger MM, Appelberg O, Reintam-Blaser A, Ichai C, Joannes-Boyau O, Casaer M, Schaller SJ, Gunst J, Starkopf J; ESICM-MEN section. Prevalence of hypophosphatemia in the ICU - Results of an international one-day point prevalence survey. Clin Nutr. 2021 May;40(5):3615-3621. doi: 10.1016/j.clnu.2020.12.017. Epub 2020 Dec 29.

ipd_sharing_description: Data will be collected in central REDCap database. No individual patient data will be made available

lead_sponsor: Centre Hospitalier Universitaire Vaudois

location_country: Estonia France Switzerland

location_facility:
Hôpital de Nyon
Hôpital Pasteur 2
Lausanne University Hospital
Tartu University Hospital

intervention_type: Dietary Supplement


title: An Open-Label Safety, Tolerability, and Efficacy Study of Eteplirsen in Patients With Duchenne Muscular Dystrophy Who Have Completed Study 4658-102

lead_sponsor: Sarepta Therapeutics, Inc.

location_country:
France
Italy
United Kingdom
Belgium

location_facility: Fondazione Policlinico Universitario Agostino Gemelli, UOC Neuropsichiatria Infantile

location_facility: UCL Great Ormond Street Institute of Child Health, Dubowitz Neuromuscular Centre

summary: The purpose of this extension study is to evaluate the ongoing safety and tolerability of additional treatment with eteplirsen administered once weekly by intravenous (IV) infusion in male participants with DMD who have successfully completed the 96-week eteplirsen Study 4658-102.


title: A Multicenter Prospective Cohort Study on Persona Total Knee System

summary:
In this project the investigators wish to:

Evaluate intra-operative and postop complications, longer term survivorship and patient reported outcome measures (PROMs) following primary total knee replacement using Persona Total Knee system.

This project is carried out as prospective cohort study. Recruitment of participants to this project is expected to begin in October 2016 or as soon as permission from the Regional Ethics Committee and the local Data Protection Agency is obtained as required. A total of 700 participants (including 155 participants from a randomized controlled trial (RCT) investigating the Persona and the Nexgen total knee systems, which is separately submitted to the ethics committee) are to be included at several centers in the nordic region. Recruitment is expected complete after a period of 1,5 years per site. The patient follow-up visits are expected to be completed 2 years after recruitment of the last participant. Survivorship will be collected until 10 years after the recruitment of the last participant.

Participants are seen on an outpatient basis at 3 months and 1 and 2 years postoperatively. After the 2 year follow-up visit the patients will be followed for survivorship through the National Knee Arthroplasty Registries at 5, 7 and 10 years postoperatively.

location_country: Norway Denmark France Sweden

location_facility: Ortopedic Clinic, Motala Specialist Care Capio AB

location_facility: Copenhagen University Hospital, Hvidovre


title: Phase I/II Gene Transfer Clinical Trial of rAAV9.CMV.hNAGLU for Mucopolysaccharidosis (MPS) IIIB

acronym: MPSIIIB

summary: Open-label, dose-escalation clinical trial of rAAV9.CMV.hNAGLU injected intravenously through a peripheral limb vein

ReferenceCitation: Fu H, Dirosario J, Killedar S, Zaraspe K, McCarty DM. Correction of neurological disease of mucopolysaccharidosis IIIB in adult mice by rAAV9 trans-blood-brain barrier gene delivery. Mol Ther. 2011 Jun;19(6):1025-33. doi: 10.1038/mt.2011.34. Epub 2011 Mar 8.

ReferenceCitation: Truxal KV, Fu H, McCarty DM, McNally KA, Kunkler KL, Zumberge NA, Martin L, Aylward SC, Alfano LN, Berry KM, Lowes LP, Corridore M, McKee C, McBride KL, Flanigan KM. A prospective one-year natural history study of mucopolysaccharidosis types IIIA and IIIB: Implications for clinical trial design. Mol Genet Metab. 2016 Nov;119(3):239-248. doi: 10.1016/j.ymgme.2016.08.002. Epub 2016 Aug 18.

ReferenceCitation: Neufeld EF, Cantz MJ. Corrective factors for inborn errors of mucopolysaccharide metabolism. Ann N Y Acad Sci. 1971 Jul 6;179:580-7.

ReferenceCitation: Weber B, Guo XH, Kleijer WJ, van de Kamp JJ, Poorthuis BJ, Hopwood JJ. Sanfilippo type B syndrome (mucopolysaccharidosis III B): allelic heterogeneity corresponds to the wide spectrum of clinical phenotypes. Eur J Hum Genet. 1999 Jan;7(1):34-44.

ReferenceCitation: Wijburg FA, Węgrzyn G, Burton BK, Tylki-Szymańska A. Mucopolysaccharidosis type III (Sanfilippo syndrome) and misdiagnosis of idiopathic developmental delay, attention deficit/hyperactivity disorder or autism spectrum disorder. Acta Paediatr. 2013 May;102(5):462-70. doi: 10.1111/apa.12169. Epub 2013 Feb 6. Review.

ReferenceCitation: de Ruijter J, Valstar MJ, Wijburg FA. Mucopolysaccharidosis type III (Sanfilippo Syndrome): emerging treatment strategies. Curr Pharm Biotechnol. 2011 Jun;12(6):923-30. doi: 1389-2010/11 $58.00+.00. Review.

ReferenceCitation: Murrey DA, Naughton BJ, Duncan FJ, Meadows AS, Ware TA, Campbell KJ, Bremer WG, Walker CM, Goodchild L, Bolon B, La Perle K, Flanigan KM, McBride KL, McCarty DM, Fu H. Feasibility and safety of systemic rAAV9-hNAGLU delivery for treating mucopolysaccharidosis IIIB: toxicology, biodistribution, and immunological assessments in primates. Hum Gene Ther Clin Dev. 2014 Jun;25(2):72-84. doi: 10.1089/humc.2013.208. Epub 2014 Apr 10.

ReferenceCitation: Ribera A, Haurigot V, Garcia M, Marcó S, Motas S, Villacampa P, Maggioni L, León X, Molas M, Sánchez V, Muñoz S, Leborgne C, Moll X, Pumarola M, Mingozzi F, Ruberte J, Añor S, Bosch F. Biochemical, histological and functional correction of mucopolysaccharidosis type IIIB by intra-cerebrospinal fluid gene therapy. Hum Mol Genet. 2015 Apr 1;24(7):2078-95. doi: 10.1093/hmg/ddu727. Epub 2014 Dec 18.

ReferenceCitation: Hamano K, Hayashi M, Shioda K, Fukatsu R, Mizutani S. Mechanisms of neurodegeneration in mucopolysaccharidoses II and IIIB: analysis of human brain tissue. Acta Neuropathol. 2008 May;115(5):547-59. Epub 2007 Dec 4.

ReferenceCitation: Tamagawa K, Morimatsu Y, Fujisawa K, Hara A, Taketomi T. Neuropathological study and chemico-pathological correlation in sibling cases of Sanfilippo syndrome type B. Brain Dev. 1985;7(6):599-609.

ReferenceCitation: Mingozzi F, High KA. Immune responses to AAV in clinical trials. Curr Gene Ther. 2011 Aug;11(4):321-30. Review.

ReferenceCitation: Saeki I, Tokunaga S, Matsuura T, Hayashida M, Yanagi Y, Taguchi T. A formula for determining the standard liver volume in children: a special reference for neonates and infants. Pediatr Transplant. 2012 May;16(3):244-9. doi: 10.1111/j.1399-3046.2011.01624.x. Epub 2011 Dec 12.

ReferenceCitation: Schlesinger AE, Edgar KA, Boxer LA. Volume of the spleen in children as measured on CT scans: normal standards as a function of body weight. AJR Am J Roentgenol. 1993 May;160(5):1107-9.

ReferenceCitation: Malm G, Månsson JE. Mucopolysaccharidosis type III (Sanfilippo disease) in Sweden: clinical presentation of 22 children diagnosed during a 30-year period. Acta Paediatr. 2010 Aug;99(8):1253-7. doi: 10.1111/j.1651-2227.2010.01800.x. Epub 2010 Mar 14.

ReferenceCitation: Dale DC, Fauci AS, Guerry D IV, Wolff SM. Comparison of agents producing a neutrophilic leukocytosis in man. Hydrocortisone, prednisone, endotoxin, and etiocholanolone. J Clin Invest. 1975 Oct;56(4):808-13.

ReferenceCitation: Summers C, Rankin SM, Condliffe AM, Singh N, Peters AM, Chilvers ER. Neutrophil kinetics in health and disease. Trends Immunol. 2010 Aug;31(8):318-24. doi: 10.1016/j.it.2010.05.006. Review.

ReferenceCitation: McCurdy VJ, Johnson AK, Gray-Edwards HL, Randle AN, Bradbury AM, Morrison NE, Hwang M, Baker HJ, Cox NR, Sena-Esteves M, Martin DR. Therapeutic benefit after intracranial gene therapy delivered during the symptomatic stage in a feline model of Sandhoff disease. Gene Ther. 2021 Apr;28(3-4):142-154. doi: 10.1038/s41434-020-00190-1. Epub 2020 Sep 3.

ipd_sharing_description: There is no plan to share data

lead_sponsor: Abeona Therapeutics, Inc

location_country:
Germany
United States
Spain
France

location_facility: Hospital Clinico Universitario de Santiago


acronym: Riociguat in patients with operable CTEPH prior to pulmonary endarterectomy

title: A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Multicentre, Prospective Study to Assess Efficacy of Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy With High Preoperative Pulmonary Vascular Resistance

lead_sponsor: International CTEPH Association

ipd_sharing_description: IPD sharing is not foreseen

location_country:
Germany
United States
United Kingdom
France

location_facility:
Papworth Hospital
Hopital de Bicêtre
Kerckhoff-Klinik GmbH
UC San Diego

summary: This is a randomised, double-blind, placebo-controlled, multicentre, multinational, prospective study in patients with operable chronic thromboembolic pulmonary hypertension (CTEPH) prior to pulmonary endarterectomy (PEA) with high preoperative pulmonary vascular resistance (PVR). Patients will be randomised in a 1:1 ratio to receive riociguat or matching placebo for 3 months before undergoing PEA. The primary objective of this study is to assess the efficacy of riociguat on preoperative PVR compared to placebo in patients with operable CTEPH.


title: An Open-Label Safety, Tolerability, and Pharmacokinetics Study of Eteplirsen in Young Patients With Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

location_facility: UCL Great Ormond Street Institute of Child Health

location_facility: Site Fondazione Policlinico Universitario Agostino Gemelli

summary: This is a multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, and PK of once-weekly IV infusions of eteplirsen in approximately 12 male participants, ages 6 months to 48 months (inclusive), who have genotypically confirmed DMD with a deletion mutation amenable to exon 51 skipping.


title: A Clinical Trial to Investigate Biomarker Effects of Pre-Surgical Treatment With DDR Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC) Who Are Planned to Undergo Surgery That is Likely to be Followed by Radiotherapy and/or Chemotherapy.

summary: This biomarker study has been designed to assess the effects of different agents in both tumour tissue and peripheral samples to help inform the best combinations of DDR agents with immuno-oncology (IO) therapies. In the first instance 2 DDR agents will be assessed separately as monotherapy. Additional arms may be added later to evaluate other DDR agents and/or DDR and immunotherapy agents in combination or in sequence. The primary objective of the study is to investigate immune activation due to DDR inhibition by assessing tumour and blood samples of patients treated with study investigational agent(s).

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

lead_sponsor: AstraZeneca

location_country:
United States
Taiwan
France


summary: The purpose of this study is to assess the performance and safety of T4020 versus saline solution.

primary_purpose: Other

lead_sponsor: Laboratoires Thea

location_country: Turkey Bulgaria Spain France

location_facility:
CHU
Hospital
Erciyes Üniversitesi Tıp Fakültesi


title: Mitral Valve Replacement With the MValve Dock and A Percutaneous Transcatheter Heart Valve

acronym: DOCK 1

summary: This study evaluates the MValve mitral prosthesis in conjunction with a Lotus transcatheter heart valve (THV) for mitral valve replacement in subjects at high risk for conventional mitral valve replacement or repair surgery.

lead_sponsor: MValve Technologies Ltd

location_country: Germany Poland France Brazil

location_facility: University of Bonn - Medizinische Klinik und Poliklinik II


title: An Open-Label, Multicenter, Dose-Escalation Phase I Study of RO6874813, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors

summary: This first-in-human study consists of three parts. The primary purpose of Part 1 is to characterize the safety and tolerability of RO6874813 in participants with locally advanced and/or metastatic solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. In addition, the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) will be determined. In Part 2 the safety and tolerability of RO6874813 will continue to be characterized in participants with locally advanced and/or metastatic solid tumors known to be fibroblast activation protein-alpha positive (FAP+). In addition, treatment-induced efficacy of RO6874813 will be assessed by functional imaging and paired tumor biopsies. The primary purpose of Part 3 is to demonstrate anti-tumor activity of RO6874813 in participants with recurrent or metastatic FAP+ sarcomas.

lead_sponsor: Hoffmann-La Roche

location_country:
United States
Spain
France

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Centre Leon Berard; Departement Oncologie Medicale


title: Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC): Open, Non-Randomised, Uncontrolled, Multicentre, Dose Escalation, First-in-man Study With a Dose Expansion

acronym: DUALIDES

summary: The purpose of this first-in-man study is to evaluate safety, tolerability and pharmacokinetics of ODM-204 in patients with metastatic castration-resistant prostate cancer.

lead_sponsor: Orion Corporation, Orion Pharma

location_country:
Finland
Latvia
United Kingdom
France

location_facility: P. Stradins Clinical University Hospital


title: A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies

summary:
The goal of this laboratory research study is to learn if using molecular information (matched therapy) or not using molecular information and having the study doctor choose the therapy based on your past experience are more effective ways to choose the best cancer treatment for you.

This is an investigational study.

Up to 200 participants will take part in this study. Up to 50 will be enrolled at MD Anderson.

lead_sponsor: M.D. Anderson Cancer Center

location_country:
United States
Israel
Spain
France

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Chaim Sheba Medical Center at Tel Hasomer

intervention_type: Other


title: A Prospective, Randomized-controlled Evaluation of Biomet 3i's T3 Implant System for Integration Success and the Preservation of Crestal Bone

acronym: OAK

summary: This study evaluates the T3 implant system for the preservation of alveolar crestal bone and the establishment of initial integration. The new surface-treated features of the implant may contribute to improved soft and hard tissue healing. The success rate of the T3 implant will be no different than that of the control implant, which possess similar geometry but different surface treatments.

lead_sponsor: ZimVie

location_country:
Germany
France
United Kingdom
Belgium

location_facility:
Dr. Felix Hanssler
Dr. Tommie VanDeVelde
Dr. Dominique Caspar
Dr. Nicholas Lewis


title: Phase 1 Dose Escalation Study of LY2334737 Using 2 Dosing Regimens in Patients With Advanced and/or Metastatic Solid Tumors

summary: The purpose of this study is to evaluate two different dosing regimens of LY2334737 in participants with cancer that is advanced and/or has spread to other parts of the body. Information about side effects will be collected.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
United States
France

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


title: A Randomized, Double-blind, Placebo Controlled, Parallel Group, Proof of Concept Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of QGE031 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis

summary: The study will assess the safety and efficacy of QGE031 in the treatment of moderate to severe atopic dermatitis patients. In addition, QGE031 levels in the blood will be measured and the effect of QGE031 on markers in the blood and skin will be evaluated. Comparisons of the effect of QGE31 will be made with placebo and also cyclosporine, a treatment already established as being effective in atopic dermatitis.

lead_sponsor: Novartis Pharmaceuticals

location_country: Austria Germany France


title: An Open-Label Study Study of Sipuleucel-T in European Men With Metastatic, Castrate Resistant Prostate Cancer

summary: To demonstrate that sipuleucel-T can be successfully manufactured for subjects with metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.

lead_sponsor: Dendreon

location_country:
Austria
Netherlands
France
United Kingdom

location_facility: Ludwig Boltzmann-Institute for Applied Cancer Research

location_facility: Barts Cancer Institute - a Cancer Research UK Centre of Excellence, Queen Mary University of London

location_facility: Radboud University Nijmegen; UMC St Radboud Hospital; Faculteit der Medische Wetenschappen, Urologie

location_facility: Department of Cancer Medicine and Genitourinary Oncology Group Institut Gustave Roussy (IGR) Département de médicine


title: Treatment of Patients With Posttransplant Lymphoproliferative Disorder (PTLD) With a Sequential Treatment Consisting of Anti-CD20 Antibody Rituximab and CHOP+GCSF Chemotherapy (Including 1st+2nd Amendment)

summary: Post-transplantation lymphoproliferative disorder (PTLD) develops in one to ten per cent of transplant recipients and can be EBV-associated. To improve long-term efficacy after rituximab monotherapy and to avoid the toxicity of CHOP seen in first-line treatment, the investigators initiated an international multicentre phase II trial to test whether the subsequent application of rituximab and four courses of three-weekly CHOP would improve the outcome of patients with PTLD: PTLD-1, sequential treatment (ST).

ReferenceCitation: Trappe RU, Dierickx D, Zimmermann H, Morschhauser F, Mollee P, Zaucha JM, Dreyling MH, Dührsen U, Reinke P, Verhoef G, Subklewe M, Hüttmann A, Tousseyn T, Salles G, Kliem V, Hauser IA, Tarella C, Van Den Neste E, Gheysens O, Anagnostopoulos I, Leblond V, Riess H, Choquet S. Response to Rituximab Induction Is a Predictive Marker in B-Cell Post-Transplant Lymphoproliferative Disorder and Allows Successful Stratification Into Rituximab or R-CHOP Consolidation in an International, Prospective, Multicenter Phase II Trial. J Clin Oncol. 2017 Feb 10;35(5):536-543. doi: 10.1200/JCO.2016.69.3564. Epub 2016 Dec 19.

ReferenceCitation: Trappe R, Oertel S, Leblond V, Mollee P, Sender M, Reinke P, Neuhaus R, Lehmkuhl H, Horst HA, Salles G, Morschhauser F, Jaccard A, Lamy T, Leithäuser M, Zimmermann H, Anagnostopoulos I, Raphael M, Riess H, Choquet S; German PTLD Study Group; European PTLD Network. Sequential treatment with rituximab followed by CHOP chemotherapy in adult B-cell post-transplant lymphoproliferative disorder (PTLD): the prospective international multicentre phase 2 PTLD-1 trial. Lancet Oncol. 2012 Feb;13(2):196-206. doi: 10.1016/S1470-2045(11)70300-X. Epub 2011 Dec 13.

lead_sponsor: Charite University, Berlin, Germany

location_country: Australia France Germany Sweden

location_facility: Sahlgrens hospital, Department of Hematology

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Hematology and Oncology, Augustenburger Platz 1

location_facility: Hôpital Pitié-Salpétrière, Department of Hematology, 47-83 Boulevard de l'Hopital

location_facility: Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Qld 4102


title: Phase I/II, Multi-center, Open Label, Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti Tumor Activity of ASP9521 in Patients With Metastatic Castrate-resistant Prostate Cancer

summary: The study has three parts. Part 1 is a dose escalation to investigate the safety and tolerability of ASP9521. Part 2 will evaluate the safety and tolerability and initial anti-tumor activity of ASP9521. Part 3 of the study will be a Food Effect study.

ReferenceCitation: Loriot Y, Fizazi K, Jones RJ, Van den Brande J, Molife RL, Omlin A, James ND, Baskin-Bey E, Heeringa M, Baron B, Holtkamp GM, Ouatas T, De Bono JS. Safety, tolerability and anti-tumour activity of the androgen biosynthesis inhibitor ASP9521 in patients with metastatic castration-resistant prostate cancer: multi-centre phase I/II study. Invest New Drugs. 2014 Oct;32(5):995-1004. doi: 10.1007/s10637-014-0101-x. Epub 2014 Apr 27.

lead_sponsor: Astellas Pharma Inc

location_country:
France
United Kingdom
Belgium

location_facility:
Site:109
Site 131
Site: 101
Site: 121


title: A Multi-Center Prospective Study to Evaluate the Safety and Effectiveness of Arcuate Incisions Performed With the IntraLase iFS Femtosecond Laser System

summary: To determine if arcuate incisions performed with the iFS femtosecond laser are safe and effective in reducing corneal astigmatism.

lead_sponsor: Abbott Medical Optics

location_facility: Paracelsus Medizinische Privat-Universitat, PMU


title: Open-label, Combined Dose-finding (Phase I) and Efficacy-finding (Phase II) Study of RO5323441 in Combination With Bevacizumab for Patients With Recurrent Glioblastoma

summary: This open-label, multicenter study will evaluate the safety and efficacy of RO5323441 in combination with Avastin (bevacizumab) in patients with recurrent glioblastoma. In the dose-finding part, patients will receive intravenous escalating doses of RO5323441 in combination with 10 mg/kg Avastin once every two weeks. In the efficacy-finding part, patients will be randomized to receive the established dose (from the dose-finding part) of RO5323441 plus Avastin or Avastin alone. Patients in the dose-finding part may continue treatment with RO5323441 and Avastin on the study until evidence of progressive disease or unacceptable adverse events happen. In the efficacy-finding part, patients will receive study treatment until disease progression or death.

location_country:
Denmark
France
Switzerland
United Kingdom


title: A Double-blind Placebo-controlled Study of the Application of the SCIO Universal Electrophysiological Biofeedback System for Statistical Evaluation of the SCIO's Ability to Increase Body Wellness After One 45-minute Session

summary: The objective of the study is to determine if one 45-minute treatment with the SCIO (Scientific Consciousness Interface Operations System) biofeedback device would show a change, and hopefully an improvement, on a person's Body Wellness indicators (Quality of Life Questionnaire, Energy Index Factor, Strength, Oxidation, Flexibility, Memory, pH, and VARHOPE scores (V=voltage, A=amperage, R=resistance, H=hydration, O=oxygenation, P=proton pressure and E=electron pressure), electrical measures within the device. For subjects in the control group, it is expected that there will likely be an improvement of approximately 5% in measured variables. That is, subjects in the control group will likely report some of the positive changes listed above for test group subjects. However, on average, any positive change in post-treatment measures for control subjects is expected to occur to a significantly lesser degree than for subjects in the test group.

lead_sponsor: Maitreya Kft.

location_country:
Germany
United States
Romania
France

location_facility:
Annex of Quantum Northwest Presents
CFI Centrum für Integrative Medizin
Annex of Hexagram SARL
Centrul de Biorezonanţă Dr. Băcean


title: A Randomized Controlled Trial Comparing Transoral Incisionless Fundoplication (TIF) Using EsophyX With Sham Procedure for the Treatment of PPI Dependent GERD: the TIF vs. Sham Study

summary: The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure.

ReferenceCitation: Håkansson B, Montgomery M, Cadiere GB, Rajan A, Bruley des Varannes S, Lerhun M, Coron E, Tack J, Bischops R, Thorell A, Arnelo U, Lundell L. Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD. Aliment Pharmacol Ther. 2015 Dec;42(11-12):1261-70. doi: 10.1111/apt.13427. Epub 2015 Oct 13.

lead_sponsor: EndoGastric Solutions

location_country: Sweden France Belgium

location_facility: Karolinska University, Huddinge Hospital


title: A Phase I Study to Evaluate the Safety and Tolerability of the Histone Deacetylase Inhibitor, CHR-2845, in Patients With Advanced or Treatment Refractory Haematological Diseases or Lymphoid Malignancies

summary: The purpose of this study is to determine whether the histone deacetylase inhibitor CHR-2845 is tolerated in patients with haematological diseases and lymphoid malignancies.

ReferenceCitation: Ossenkoppele GJ, Lowenberg B, Zachee P, Vey N, Breems D, Van de Loosdrecht AA, Davidson AH, Wells G, Needham L, Bawden L, Toal M, Hooftman L, Debnam PM. A phase I first-in-human study with tefinostat - a monocyte/macrophage targeted histone deacetylase inhibitor - in patients with advanced haematological malignancies. Br J Haematol. 2013 Jul;162(2):191-201. doi: 10.1111/bjh.12359. Epub 2013 May 7.

lead_sponsor: Chroma Therapeutics

location_country: Netherlands France Belgium

location_facility:
Institut Paoli-Calmettes
ZNA Stuivenberg
VU University Medical Center
Erasmus University Medical Center


title: EFFECT OF THE CONSUMPTION OF FERMENTED DAIRY DRINK ON COMMON INFECTIONS IN SHIFT-WORKERS

summary: This clinical study plans to investigate the effect of the consumption of a fermented dairy drink on the occurrence of common infections. This study will be performed in a healthy adult population of shift workers.

lead_sponsor: Danone Research

location_country:
United Kingdom
France
Spain
Belgium

location_facility:
SGS
VEEDA
Therapharm
Hospital de la Santa Creu


title: Dose Finding and Randomized, Multicenter, Placebo-Controlled, Phase 2 Study of Enzastaurin and Sunitinib Versus Placebo and Sunitinib in Patients With Metastatic Renal Cell Carcinoma

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country: Austria Poland France Italy

summary: This study will compare the effects of Enzastaurin plus Sunitinib versus Sunitinib alone in metastatic Renal Cell Cancer.


title: Study of Efficacy and Safety of Rasburicase for the Treatment/Prevention of Hyperuricemia Related to Tumor Lysis Syndrome in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma, Previously Treated or Not With Urate Oxidase Presenting With Hyperuricemia and/or Bulky Disease

summary:
The primary objective was to evaluate the efficacy of rasburicase in terms of prevention and treatment of hyperuricemia related to Tumor Lysis Syndrome (TLS) in 2 populations of adult patients, previously treated or not with urate oxidase, with relapsing aggressive non-Hodgkin's lymphoma (NHL) and at risk of TLS, presenting with hyperuricemia and/or bulky disease at diagnostic of relapse.

The secondary objectives were to :

evaluate the efficacy of rasburicase in terms of renal protection,
evaluate the safety of rasburicase in the two cohorts of patients,
correlate efficacy and safety results with antibodies generation/level.

lead_sponsor: Sanofi

location_country: Germany France Italy Belgium

location_facility:
Sanofi-Aventis Administrative Office
Sanofi- Aventis Administrative Office


summary: This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.

lead_sponsor: Allergan

location_country:
Germany
United States
Portugal
France


title: A Phase III Randomized Study Comparing A Chemotherapy With Cisplatin And Etoposide To A Etoposide Regimen Without Cisplatin For Patients With Extensive Small-Cell Lung Cancer

summary: The purpose of this study is to determine if a cisplatin-etoposide regimen improves survival in comparison to a regimen containing etoposide and without platinum derivative.

ReferenceCitation: Berghmans T, Scherpereel A, Meert AP, Giner V, Lecomte J, Lafitte JJ, Leclercq N, Paesmans M, Sculier JP; European Lung Cancer Working Party (ELCWP). A Phase III Randomized Study Comparing a Chemotherapy with Cisplatin and Etoposide to a Etoposide Regimen without Cisplatin for Patients with Extensive Small-Cell Lung Cancer. Front Oncol. 2017 Sep 19;7:217. doi: 10.3389/fonc.2017.00217. eCollection 2017.

lead_sponsor: European Lung Cancer Working Party

location_country: France Spain Greece Belgium

location_facility: Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

location_facility: Hellenic Cancer Institute - St Savas Oncology Hospital


title: The Effects of Fx-1006A on Transthyretin Stabilization and Clinical Outcome Measures in Patients With Non-V30M Transthyretin Amyloidosis

summary:
This is an open-label, multicenter, international study designed to determine TTR stabilization as well as Fx-1006A safety and tolerability, and its effects on clinical outcomes in patients with non-V30M TTR amyloidosis.

Strong pre-clinical and clinical evidence support a daily dose of 20 mg of Fx-1006A to be the optimum dose to achieve stabilization of tetrameric TTR in ATTR-PN patients. Since disease presentation is similar between V30M and non-V30M TTR mutations associated with ATTR-PN and Fx-1006A has been shown to stabilize wild-type and V30M TTR in vitro and ex vivo, the present study is being conducted to determine the effects of Fx-1006A on TTR stabilization in ATTR-PN patients with TTR mutations other than V30M. Safety and exploratory efficacy of Fx-1006A administered once daily for 12 months will also be evaluated in this patient population.

This is an open-label, multicenter, international study designed to determine TTR stabilization as well as Fx-1006A safety and tolerability, and its effects on clinical outcomes in patients with non-V30M TTR amyloidosis. The study will be conducted in two parts. Part 1 will include a six-week dosing period during which all enrolled patients will receive oral Fx-1006A 20 mg soft gelatin capsules once daily for six weeks. At Week 6, blood samples will be collected from each patient to determine TTR stabilization. Patients who complete the Week 6 visit will continue receiving daily oral Fx-1006A 20 mg for up to a total of 12 months during Part 2 of this study. If it is determined that a patient is not stabilized at Week 6, the patient will be discontinued from the study.

During Part 2, clinical outcomes will be measured at Months 6 and 12, based on NIS, Norfolk QOL-DN, mBMI, NCS, HRDB, SF-36, Karnofsky score, and echocardiography; NT-pro-BNP and troponin I levels will be measured at Baseline, Weeks 2 and 6, and Months 3, 6, and 12.

Pharmacokinetic measurements will be made using samples collected at Baseline, Week 6, and Months 6 and 12.

Safety and tolerability will be assessed throughout the study based on vital signs, physical examinations, ECG, echocardiography, 24-hour Holter monitoring, clinical laboratory tests (hematology, serum chemistry, and urinalysis), and monitoring adverse events and concomitant medication use.

Day 1 will be defined as administration of the first dose of study drug. Clinic Visits will be conducted during Screening (Days -30 to -1) and at Baseline (Day 0), and Week 2, and Week 6, and Months 3, 6, and 12 (± 2 weeks of the scheduled date for post-Baseline visits). Monthly telephone contacts (+ 1 week of the scheduled date) will be made during months in which no investigative site visits are scheduled (Months 4, 5, 7, 8, 9, 10, and 11) for assessment of adverse events and concomitant medications. A final telephone contact to assess adverse events and concomitant medication usage will be made 30 days after the last dose of study drug.

Patients who discontinue from the study at any time following enrollment will have a final visit performed, including all safety assessments, at the time of discontinuation. Any patient discontinuing after the Month 6 visit will also have all exploratory assessments performed.

ReferenceCitation: Merlini G, Coelho T, Waddington Cruz M, Li H, Stewart M, Ebede B. Evaluation of Mortality During Long-Term Treatment with Tafamidis for Transthyretin Amyloidosis with Polyneuropathy: Clinical Trial Results up to 8.5 Years. Neurol Ther. 2020 Jun;9(1):105-115. doi: 10.1007/s40120-020-00180-w. Epub 2020 Feb 27.

ReferenceCitation: Huber P, Flynn A, Sultan MB, Li H, Rill D, Ebede B, Gundapaneni B, Schwartz JH. A comprehensive safety profile of tafamidis in patients with transthyretin amyloid polyneuropathy. Amyloid. 2019 Dec;26(4):203-209. doi: 10.1080/13506129.2019.1643714. Epub 2019 Jul 27.

ReferenceCitation: Gundapaneni BK, Sultan MB, Keohane DJ, Schwartz JH. Tafamidis delays neurological progression comparably across Val30Met and non-Val30Met genotypes in transthyretin familial amyloid polyneuropathy. Eur J Neurol. 2018 Mar;25(3):464-468. doi: 10.1111/ene.13510. Epub 2017 Dec 26.

ReferenceCitation: Merlini G, Planté-Bordeneuve V, Judge DP, Schmidt H, Obici L, Perlini S, Packman J, Tripp T, Grogan DR. Effects of tafamidis on transthyretin stabilization and clinical outcomes in patients with non-Val30Met transthyretin amyloidosis. J Cardiovasc Transl Res. 2013 Dec;6(6):1011-20. doi: 10.1007/s12265-013-9512-x. Epub 2013 Oct 8.

lead_sponsor: Pfizer

location_country:
Germany
United States
Italy
France

location_facility: Centro per lo Studio e la Cura delle Amiloidosi Sistemiche

location_facility: Universitatsklinikum Munster, Transplant Hepatology


title: A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer

summary: The purpose of this study is to determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced NSCLC


title: A Multi-Center, Randomized, Double-Blind, Placebo- and Positive-Control, Double-Dummy, 3 Parallel Cohort, Two-Way Crossover Single Oral Dose Study in GERD (Gastro Esophageal Reflux Disease) Patients to Evaluate the Effects of AFQ056 and Baclofen (Positive Control) on the Incidence of Meal-Induced Gastro Esophageal Reflux Events

summary: This study will assess the safety and tolerability of oral single dose applications of AFQ056 in GERD patients.

lead_sponsor: Novartis

location_country: Germany France Switzerland Belgium

location_facility:
Novartis Investigative Site
Novartis Investigative site


summary:
Vaccination against influenza is a high priority for the elderly population who present the highest morbidity and mortality rate. However, due to their weak antibody response an improvement of the immune response to influenza vaccination remains an unmet medical need. The purpose of an investigational influenza vaccine candidate administered by an alternate route is to improve immune responses to the vaccine in the elderly population, which could provide additional reductions in influenza-associated morbidity and mortality in this population.

Primary Objective:

To demonstrate that the investigational vaccine induces a better immunogenicity than the reference vaccine in terms of seroprotection rate after the first vaccination.

Secondary Objectives:

Immunogenicity:

To describe the antibody persistence induced by both vaccines at 3, 6, and 12 months after the first vaccination in a subset of subjects.

To describe the immunogenicity of the investigational vaccine after each vaccination using parameters defined in the European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96) specific to elderly subjects.

Safety:

To demonstrate the tolerance of the investigational vaccine after the first vaccination, in terms of pre-defined solicited systemic reactions.

To describe the safety profile after each vaccination. To describe the effect of repetitive injections on the safety profile.

ReferenceCitation: Chevat C, Viala-Danten M, Dias-Barbosa C, Nguyen VH. Development and psychometric validation of a self-administered questionnaire assessing the acceptance of influenza vaccination: the Vaccinees' Perception of Injection (VAPI) questionnaire. Health Qual Life Outcomes. 2009 Mar 4;7:21. doi: 10.1186/1477-7525-7-21.

lead_sponsor: Sanofi Pasteur, a Sanofi Company

location_country: Lithuania France Italy Belgium


title: A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With and Without Ribavirin (Copegus®) in Subjects With Hepatitis C

summary: Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels

ReferenceCitation: Hézode C, Forestier N, Dusheiko G, Ferenci P, Pol S, Goeser T, Bronowicki JP, Bourlière M, Gharakhanian S, Bengtsson L, McNair L, George S, Kieffer T, Kwong A, Kauffman RS, Alam J, Pawlotsky JM, Zeuzem S; PROVE2 Study Team. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med. 2009 Apr 30;360(18):1839-50. doi: 10.1056/NEJMoa0807650.

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
Austria
Germany
France
United Kingdom

location_facility:
Call For Information
Call for Information


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalation, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion.

summary:
The study is designed to assess the efficacy of an investigational drug called SR121463B (vasopressin receptor antagonist) in the treatment of low levels of sodium in the blood associated with the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH).

This double blind period study is followed by 2 open label extension studies with flexible doses of satavaptan.

location_country: Hungary Germany France Belgium


title: An International Field Study of the Reliability and Validity of a Disease-Specific Questionnaire Module (the QLQ-OV28) in Assessing the Quality of Life of Patients With Ovarian Cancer

summary:
RATIONALE: Quality-of-life assessment in patients undergoing cancer treatment may help determine the intermediate- and long-term effects of treatment.

PURPOSE: This clinical trial studies the quality of life in patients with ovarian cancer.

ReferenceCitation: Chie WC, Tsai CJ, Chiang C, Lee YC. Quality of life of patients with oesophageal cancer in Taiwan: validation and application of the Taiwan Chinese (Mandarin) version of the EORTC QLQ-OES18: a brief communication. Qual Life Res. 2010 Oct;19(8):1127-31. doi: 10.1007/s11136-010-9675-8. Epub 2010 May 22.

ReferenceCitation: Cull A, Howat S, Greimel E, Waldenstrom AC, Arraras J, Kudelka A, Chauvenet L, Gould A; EORTC Quality of Life Group [European Organization for Research and Treatment of Cancer]; Scottish Gynaecological Cancer Trials Group. Development of a European Organization for Research and Treatment of Cancer questionnaire module to assess the quality of life of ovarian cancer patients in clinical trials: a progress report. Eur J Cancer. 2001 Jan;37(1):47-53.

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

location_country:
Austria
France
Spain
United Kingdom


title: InteGRAtive Analysis of tuMor, Microenvironment, immunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer

acronym: GRAMMY

summary: Multicentric, exploratory, non-pharmacologic, retrospective/prospective, translational study aiming to identify the molecular, cellular and psychological-sociological variables predictive of response to chemotherapy in gastric cancer patients.

status: Active, not recruiting

time_perspective: Other

lead_sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

location_country: France Italy Greece

location_facility: Centre Hospitalier Regional et Universitaire (CHRU)

location_facility: 1st Department of Propaedeutic Surgery, National & Kapodistrian University of Athens (NKUA)


title: Phase 2 Study of Daratumumab Monotherapy in Previously Untreated Patients With Stage 3B Light Chain (AL) Amyloidosis

lead_sponsor: European Myeloma Network

location_country: Netherlands France Italy Greece

location_facility: National and Kapodistrian University of Athens, School of Medicine

summary: This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed stage 3B light chain (AL) amyloidosis.


title: Lumenate Observational Vasospasm Interventional Trial (LOVIT)

acronym: LOVIT

summary: The LOVIT study is a European prospective, multi-center, open-label, single-arm feasibility trial designed to determine the safety and angiographic effectiveness through 30 days post treatment with Lumenate Intraluminal Device in the treatment of symptomatic vasospasm.

lead_sponsor: Neurvana Medical

location_country: Hungary Germany France Sweden

location_facility:
Foundation Adolphe de Rothschild
Hospital Purpan
National Institute of Neurosciences
Karolinska Universitetssjukhuset
Uniklinik RWTH Aachen


title: Prospective Validation of the ROX Index Utility in Predicting Failure of HFNC Treatment in Patients With Acute Respiratory Failure

summary: We recently described the ROX index, defined as the ratio of SpO2/FIO2 to respiratory rate that outperformed the diagnostic accuracy of the two variables separately. Patients who had a ROX index ≥4.88 after 12 hours of HFNC therapy were less likely to be intubated, even after adjusting for potential covariates. Like any other scoring system, an independent validation of the score in a different population is necessary. We therefore undertook a multicenter, prospective study to validate the ROX index's diagnostic accuracy for determining which patients will fail on HFNC and will need to be intubated.

ReferenceCitation: Roca O, Messika J, Caralt B, García-de-Acilu M, Sztrymf B, Ricard JD, Masclans JR. Predicting success of high-flow nasal cannula in pneumonia patients with hypoxemic respiratory failure: The utility of the ROX index. J Crit Care. 2016 Oct;35:200-5. doi: 10.1016/j.jcrc.2016.05.022. Epub 2016 May 31.

ReferenceCitation: Frat JP, Ragot S, Coudroy R, Constantin JM, Girault C, Prat G, Boulain T, Demoule A, Ricard JD, Razazi K, Lascarrou JB, Devaquet J, Mira JP, Argaud L, Chakarian JC, Fartoukh M, Nseir S, Mercat A, Brochard L, Robert R, Thille AW; REVA network. Predictors of Intubation in Patients With Acute Hypoxemic Respiratory Failure Treated With a Noninvasive Oxygenation Strategy. Crit Care Med. 2018 Feb;46(2):208-215. doi: 10.1097/CCM.0000000000002818.

ReferenceCitation: Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Béduneau G, Delétage-Métreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

ReferenceCitation: Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernández G, García-de-Acilu M, Frat JP, Masclans JR, Ricard JD. An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1368-1376. doi: 10.1164/rccm.201803-0589OC.

lead_sponsor: Hospital Universitari Vall d'Hebron Research Institute

location_country: France Spain

location_facility: Hôpital Antoine Béclère, Service de Réanimation polyvalente et surveillance continue

location_facility: Hôpital Louis Mourier, Service de Réanimation Médico-Chirurgicale

location_facility: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona


title: Clinical Trial Evaluating the Effects on Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula Compared to a Cow's Milk Extensively Hydrolysed Protein Formula in Infants With Cow's Milk Protein Allergy

summary: This is a multicenter, controlled, randomized, prospective, non-inferiority, double blind intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of Cow's Milk Protein Allergy (CMPA).

lead_sponsor: Laboratorios Ordesa

location_facility: Hospital Universitari i Politècnic La Fe


title: Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range

acronym: FIRST

summary:
The aim of this study is to assess subjects' satisfaction linked to the pan facial management of rejuvenation with injections of Azzalure® and Restylane® fillers.

This will be an open, multi-centre study.

lead_sponsor: Galderma R&D

location_country:
France
Spain
United Kingdom


title: A Clinical Evaluation of Different Device Parameters for the Management of Patients With Treatment Resistant Major Depressive Disorder, Single or Recurrent Episode, With Deep Brain Stimulation

summary: To evaluate the effects of two different programming settings of deep brain stimulation (DBS) in the subgenual white matter (Brodmann Area 25 WM) as an adjunctive treatment for TR-MDD, single or recurrent episode on mood as measured by the MADRS.

lead_sponsor: Abbott Medical Devices

location_country:
France
Israel
United Kingdom

location_facility: National Hospital for Neurology and Neurosurgery - UCL

location_facility: Hadassah-Hebrew University Medical Center