title: Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction

acronym: UNTOUCHED

summary: This study assesses the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden cardiac death. Devices are to be programmed with zone cutoffs at 200 bpm and 250 bmp in order to mimic the programming settings for transvenous ICDs in the MADIT RIT study. The incidence of inappropriate S-ICD shocks will be compared to the incidence of inappropriate shocks observed in the MADIT RIT study.

primary_purpose: Supportive Care

ReferenceCitation: Moss AJ, Schuger C, Beck CA, Brown MW, Cannom DS, Daubert JP, Estes NA 3rd, Greenberg H, Hall WJ, Huang DT, Kautzner J, Klein H, McNitt S, Olshansky B, Shoda M, Wilber D, Zareba W; MADIT-RIT Trial Investigators. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med. 2012 Dec 13;367(24):2275-83. doi: 10.1056/NEJMoa1211107. Epub 2012 Nov 6.

ReferenceCitation: Gold MR, Knops R, Burke MC, Lambiase PD, Russo AM, Bongiorni MG, Deharo JC, Aasbo J, El Chami MF, Husby M, Carter N, Boersma L. The Design of the Understanding Outcomes with the S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED). Pacing Clin Electrophysiol. 2017 Jan;40(1):1-8. doi: 10.1111/pace.12994. Epub 2017 Jan 15.

ReferenceCitation: Boersma LV, El-Chami MF, Bongiorni MG, Burke MC, Knops RE, Aasbo JD, Lambiase PD, Deharo JC, Russo AM, Dinerman J, Shaik N, Barr CS, Carter N, Appl U, Brisben AJ, Stein KM, Gold MR. Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results. Heart Rhythm. 2019 Nov;16(11):1636-1644. doi: 10.1016/j.hrthm.2019.04.048. Epub 2019 May 10.

ReferenceCitation: Gold MR, Lambiase PD, El-Chami MF, Knops RE, Aasbo JD, Bongiorni MG, Russo AM, Deharo JC, Burke MC, Dinerman J, Barr CS, Shaik N, Carter N, Stoltz T, Stein KM, Brisben AJ, Boersma LVA; UNTOUCHED Investigators*. Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial. Circulation. 2021 Jan 5;143(1):7-17. doi: 10.1161/CIRCULATIONAHA.120.048728. Epub 2020 Oct 19.

lead_sponsor: Boston Scientific Corporation

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Netherlands
Canada
Switzerland
Puerto Rico
United States
France
Belgium
Germany

location_facility: Sacred Heart Medical Center at Riverbend

location_facility: Northern Indiana Research Alliance - Lutheran Hospital

location_facility: CardioVascular Institute of Michigan P.C.

location_facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Strong Memorial Hospital of the University of Rochester

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Erasmus MC - University Medical Center Rotterdam

location_facility: Huntsville Hospital - The Heart Center, PC

location_facility: Cooper Hospital - University Medical Center

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Virginia Commonwealth University Health System

location_facility: University of Iowa Hospitals and Clinics

location_facility: University of Southern California Hospital

location_facility: Cardiovascular Associates of the Delaware Valley

location_facility: Centralny Szpital Kliniczny Uniwerytetu Medycznego


title: The Efficacy of Minoxidil in Children With Williams-Beuren Syndrome: a Randomized Clinical Trial.

acronym: Williams

summary:
The Williams-Beuren syndrome (WBS) is a sporadic congenital disorder characterized by a multisystem developmental impairment. This syndrome is caused by a microdeletion in chromosome 7q11.23 that encompasses loss of the elastin locus.

Elastin, which is part of the extracellular matrix, controls proliferation of vascular smooth muscle cells (VSMCs) and stabilizes arterial structure. Loss of elastin gene in WBS patients has been claimed to provide a biological basis for the abnormal elastic fibre properties leading to cardiovascular abnormalities like supravalvular aortic stenosis (SVAS), hypertension, arteriosclerosis and stenosis in more than 50% of WBS children.

These cardiovascular pathologies result in important consequences and neither curative nor preventive medicinal treatments exist at this time. Surgery is needed in more than half cases, while it is often leading to complications.

Minoxidil is a well-known antihypertensive drug used in adults and children. Furthermore, according to animal studies, minoxidil seems to increase arterial elastin content by decreasing elastase activity in these tissues. Other data demonstrate that minoxidil specifically stimulate elastin synthesis.

Working Hypothesis:If insufficient elastin synthesis leads to vascular complications and arterial hypertension in children with WBS, restoration of sufficient quantity of elastin should then result in prevention or inhibition of vascular malformations and improvement in arterial tension. Therefore, as a pharmacological agent capable to stimulate elastin expression, minoxidil might be a useful drug for the treatment of abnormal elastin metabolism in WBS children.

Objective:To evaluate the efficacy of minoxidil on cardiovascular structure in children with Williams Beuren syndrome.

Methodology: randomized controlled trial on two parallel group (23 patients in each arm) Main criterion:variation of carotid Intima-media thickness (IMT) before and after 12 months of treatment with Minoxidil versus placebo Secondary intermediate criteria of the vascular properties are arterial stiffness, cardiac and renal stenosis, arterial tension.

Total study duration:30 months including a 12 month-recruitment period

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Kassai B, Bouyé P, Gilbert-Dussardier B, Godart F, Thambo JB, Rossi M, Cochat P, Chirossel P, Luong S, Serusclat A, Canterino I, Mercier C, Rabilloud M, Pivot C, Pirot F, Ginhoux T, Coopman S, Grenet G, Gueyffier F, Di-Fillippo S, Bertholet-Thomas A. Minoxidil versus placebo in the treatment of arterial wall hypertrophy in children with Williams Beuren Syndrome: a randomized controlled trial. BMC Pediatr. 2019 May 28;19(1):170. doi: 10.1186/s12887-019-1544-1.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Cardiologie Infantile, CHU Nancy

location_facility: Service de Néphrologie Pédiatrique, CHRU de Lille

location_facility: Service de Néphrologie Pédiatrique, Hôpital Pellegrin, CHU Bordeaux

location_facility: Service de Cardiologie Pédiatrique, Hôpital Cardiovasculaire L. Pradel

location_facility: Service de Cardiologie, Hôpital Saint-André, CHU Bordeaux

location_facility: Service de Physiologie, Explorations Fonctionnelles, Hôpital Robert Debré

location_facility: Service de Cardiologie - Hôpital des Enfants

location_facility: Service de Néphrologie Pédiatrique - Hôpital des Enfants, CHU Toulouse

location_facility: Département de Pédiatrie, Hôpital Femme Mère Enfant

location_facility: Service de Génétique Médicale, Hôpital Pellegrin, CHU Bordeaux

location_facility: Service de Cardiologie Pédiatrique, CHU Angers

location_facility: Unité de Pharmacologie Clinique, Hôpital Robert Debré

location_facility: Service de Génétique Médicale, CHU La Milétrie

location_facility: Département de Pédiatrie- Service de Cardiologie, CHU Grenoble

location_facility: Service de Cardiologie Pédiatrique, Hôpital Necker Enfants Malades

location_facility: Service des Maladies Cardiovasculaires Infantiles et Congénitales, CHRU Lille

location_facility: Service de Pathologie Cardiaque Congénitale du Fœtus, de l'Enfant et de l'Adulte, Hôpital Haut Lévêque, CHU de Bordeaux

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: Randomised Multicentric Phase III Study Comparing Observation Versus Post-surgery Radiotherapy After Complete Exeresis With Margins Greater Than or Equal to 1 cm in Soft Tissues Members Sarcoma.

summary:
Soft tissue sarcomas represent less than 1% of malignant tumors in adults and sarcomas members represent 60% of them.

These rare tumors involve complex multidisciplinary care better in centers having expertise.

Loco-regional therapy strategies have evaluated over time for tumors of members leading to propose more often the combination of a large conservative tumor excision with radiotherapy. Results have been demonstrated equivalent to those of an amputation in terms of local control and survival.

The local recurrence rate for sarcomas of the members of any kind after surgery with or without radiotherapy in the literature varies from 10 to 30%.

The main objective is to achieve a low recurrence rate while maintaining the function. The question remains the possibility of an absence of irradiation in selected cases in a de-escalation therapy order.

study_start_date_type: Actual

status: Terminated

lead_sponsor: Institut Claudius Regaud

location_facility: Institut de Cancérologie de l'Ouest - Centre Paul Papin

location_facility: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Institut de Cancérologie de l'Ouest - Centre René Gauducheau

intervention_type: Radiation

lead_sponsor_type: industriel

status_simplified: Unknown


acronym: INOVA

title: Efficacy and Safety of Two Neoadjuvant Strategies With Bevacizumab in Locally Advanced Resectable Rectal Cancer: A Randomized, Non-Comparative Phase II Study

lead_sponsor: Hoffmann-La Roche

type: EudraCT Number

source: euctr

ReferenceCitation: Borg C, André T, Mantion G, Boudghène F, Mornex F, Maingon P, Adenis A, Azria D, Piutti M, Morsli O, Bosset JF. Pathological response and safety of two neoadjuvant strategies with bevacizumab in MRI-defined locally advanced T3 resectable rectal cancer: a randomized, noncomparative phase II study. Ann Oncol. 2014 Nov;25(11):2205-2210. doi: 10.1093/annonc/mdu377. Epub 2014 Aug 13.

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale

location_facility: Hopital Saint Louis; Radiotherapie Oncologie

location_facility: Ch Lyon Sud; Radiotherapie Sct Jules Courmont

location_facility: Centre Hospitalier Andre Boulloche; Departement D'Oncologie

location_facility: Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie

location_facility: Ch Pitie Salpetriere; Oncologie Medicale

location_facility: Centre Val Aurelle Paul Lamarque; Radiotherapie

location_facility: Polyclinique Du Parc; Centre De Hautes Energies

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Centre Georges Francois Leclerc; Oncologie 3

summary: This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including bevacizumab in newly diagnosed participants with high risk locally advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A or Arm B).


title: Phase II-III Study Comparing Radiochemotherapy With the FOLFOX Regimen Versus Radiochemotherapy With 5FU-cisplatin (Herskovic Regimen) in First Line Treatment of Patients With Inoperable Oesophageal Cancer.

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This randomized phase II/III trial is studying radiation therapy and two different combination chemotherapy regimens to compare how well they work as first-line therapy in treating patients with esophageal cancer that cannot be removed by surgery.

ReferenceCitation: Winter A, Cuer B, Conroy T, Juzyna B, Gourgou S, Mollevi C, Touraine C. Flexible modeling of longitudinal health-related quality of life data accounting for informative dropout in a cancer clinical trial. Qual Life Res. 2022 Sep 17. doi: 10.1007/s11136-022-03252-6. [Epub ahead of print]

ReferenceCitation: Cuer B, Conroy T, Juzyna B, Gourgou S, Mollevi C, Touraine C. Joint modelling with competing risks of dropout for longitudinal analysis of health-related quality of life in cancer clinical trials. Qual Life Res. 2022 May;31(5):1359-1370. doi: 10.1007/s11136-021-03040-8. Epub 2021 Nov 24.

ReferenceCitation: Cuer B, Mollevi C, Anota A, Charton E, Juzyna B, Conroy T, Touraine C. Handling informative dropout in longitudinal analysis of health-related quality of life: application of three approaches to data from the esophageal cancer clinical trial PRODIGE 5/ACCORD 17. BMC Med Res Methodol. 2020 Sep 3;20(1):223. doi: 10.1186/s12874-020-01104-w.

ReferenceCitation: Conroy T, Galais MP, Raoul JL, Bouché O, Gourgou-Bourgade S, Douillard JY, Etienne PL, Boige V, Martel-Lafay I, Michel P, Llacer-Moscardo C, François E, Créhange G, Abdelghani MB, Juzyna B, Bedenne L, Adenis A; Fédération Francophone de Cancérologie Digestive and UNICANCER-GI Group. Definitive chemoradiotherapy with FOLFOX versus fluorouracil and cisplatin in patients with oesophageal cancer (PRODIGE5/ACCORD17): final results of a randomised, phase 2/3 trial. Lancet Oncol. 2014 Mar;15(3):305-14. doi: 10.1016/S1470-2045(14)70028-2. Epub 2014 Feb 18. Erratum in: Lancet Oncol. 2014 Dec;15(13):e587. Erratum in: Lancet Oncol. 2014 Dec;15(13):e587.

lead_sponsor: UNICANCER

location_facility: Centre Hospital Regional Universitaire de Limoges

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

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc


title: Randomized Open Phase III Trial Testing Efficacy of Gemtuzumab Ozogamycin (MYLOTARG) Associated to Intensive Chemotherapy for Patients Aged Between 18-60 Years and Presenting an Acute Myeloid Leukemia (AML) With Intermediate Risk

lead_sponsor: Nantes University Hospital

location_facility:
CHU Purpan
CH Muller
CHU Robert Debré
CHU Jean Bernard - La Milétrie
CHU Michallon
CHU du Bocage
CHU Pontchaillou
Institut de Cancérologie de la Loire
CHU Hautepierre
CHU Dupuytren
CH Metz Thionvile
CHU Brabois
CHRU Angers
CHU Bretonneau
CHU Hôpital Minjoz
CH La Source
CHU Lapeyronie
CH Pays d'Aix
Institut Paoli Calmette
Hopital Cochin (AP-HP)
CH Avignon
CHU Morvan
CHU Carémeau
CH Louis Pasteur
Centre Hospitalier de la Côte Basque
CHU du Haut Lévèque
CHU Amiens
CHU Hôtel Dieu

summary: The main objective of the study is to improve outcome of younger patients (between 18-60 years) with acute myeloid leukemia and intermediate risk defined by the cytogenetics. In this population, in the absence of bone marrow transplantation, event free survival (EFS) is estimated at 35% after three years of follow-up. Adjunction of gemtuzumab ozogamycin (MYLOTARG®) to standard chemotherapy is supposed to increase EFS up to 50% at 3 years. To test this hypothesis, the Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang (GOELAMS ) sponsored by Nantes University Hospital leads this randomized open phase III trial in 29 French centers.


title: Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis

acronym: CHIC

summary: The purpose of this study is to evaluate 3 imaging techniques and their associations : MRI, CTscanner and enhanced contrast ultrasound for the diagnosis of small (< 3 cm) hepatocellular carcinoma for patients with cirrhosis.

status: Unknown status

primary_purpose: Diagnostic

enrollment_type: Anticipated

ReferenceCitation: Paisant A, Vilgrain V, Riou J, Oberti F, Sutter O, Laurent V, Rodes A, Guiu B, Cassinotto C, Trillaud H, Bricault I, Michalak S, Bruno O, Ronot M, Aubé C. Comparison of extracellular and hepatobiliary MR contrast agents for the diagnosis of small HCCs. J Hepatol. 2020 May;72(5):937-945. doi: 10.1016/j.jhep.2019.12.011. Epub 2019 Dec 21.

ReferenceCitation: Aubé C, Oberti F, Lonjon J, Pageaux G, Seror O, N'Kontchou G, Rode A, Radenne S, Cassinotto C, Vergniol J, Bricault I, Leroy V, Ronot M, Castera L, Michalak S, Esvan M, Vilgrain V; CHIC Group. EASL and AASLD recommendations for the diagnosis of HCC to the test of daily practice. Liver Int. 2017 Oct;37(10):1515-1525. doi: 10.1111/liv.13429. Epub 2017 Apr 26.

lead_sponsor: University Hospital, Angers

location_facility:
Chu
Hôpital de la croix rousse
Hôpital Saint Éloi
hôpital Henri Mondor
Hôpital Brabois
Hôpital Du Bocage
Hôpital Saint Antoine
CHU Angers
hôpital Beaujon
hôpital archet II
Hôpital Haut-Lévèque
Hôpital Nord
CHU
Hôpital Hôtel Dieu
Hôpital Saint-André
Hôpital Pontchaillou
Institut Gustave Roussy
Hôpital E. Herriot
Hôpital Paul Brousse

intervention_type: Other


title: A European Multicenter Open-Label Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients

lead_sponsor: Cephalon

location_country:
Poland
Spain
Italy
Ireland
United Kingdom
France
Germany

summary: Breakthrough cancer pain (BTcP) is a common problem in patients with cancer. Fentanyl Buccal Tablet (FBT) is used for the treatment of BTP in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. FBT treatment should be individually titrated to an effective dose that provides adequate analgesia and minimizes undesirable effects. To reach the safest effective dose for the individual patient as soon as possible, the dose titration process is critical. The aim of this study, conducted under pragmatic conditions in a large-scale population of cancer patients is to compare the proportion of patients reaching an effective FBT dose after titration starting with either a 100 mcg dose or a 200 mcg dose.


ipd_sharing: Yes

intervention_type: Biological

title: Phase II Study Evaluating the Efficacy and Tolerance of Bevacizumab (Avastin) in HER2- Inflammatory Breast Cancer

type: Other Identifier

ReferenceCitation: Bertucci F, Fekih M, Autret A, Petit T, Dalenc F, Levy C, Romieu G, Bonneterre J, Ferrero JM, Kerbrat P, Soulie P, Mouret-Reynier MA, Bachelot T, Lerebours F, Eymard JC, Deblock M, Lortholary A, Hardy-Bessard AC, Barthelemy P, Bonnefoi H, Charafe-Jauffret E, Bidard FC, Viens P, Lemonnier J, Pierga JY. Bevacizumab plus neoadjuvant chemotherapy in patients with HER2-negative inflammatory breast cancer (BEVERLY-1): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2016 May;17(5):600-11. doi: 10.1016/S1470-2045(16)00011-5. Epub 2016 Mar 28.

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported under the following conditions: the data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Centre Hospitalier General Andre Boulloche

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

summary:
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab and radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying giving bevacizumab together with chemotherapy before surgery and bevacizumab and radiation therapy after surgery to see how well it works in treating patients with inflammatory breast cancer.


title: Longitudinal Study in Clinical Isolated Syndrome Patients Treated With Interferon Beta. Correlation With Cognitive Disorders and Quality of Life.

acronym: QUALICIS

summary: The aim of this study is to evaluate the role of cognitive disorders and quality of life in patients with CIS, considered as high risk to develop an MS, treated with interferon Beta. This prospective observational study will include 120 patients, all treated and evaluated annually with neurological extensive examination, ophthalmologic screening (OCT, OF, VEP, VF), auto questionnaire about fatigue (musicol, ELIF), quality of life (SEP-59), and conventional MRI.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: CHU de Montpellier-Nîmes - Hôpital Caremeau


title: A Randomised, Multicenter, Open-label Study Evaluating the Impact on the Fibrosis at Week 52 of an Early Biopsy at (D10) Versus Standard Management in Patients Who Have Undergone de Novo Renal Transplantation and Received a Marginal Organ Transplant

summary: This 2 arm study will evaluate the impact on fibrosis at week 52 of an early biopsy, in patients who have received a kidney transplant from an expanded criteria donor. Patients will be randomized to one of two groups; the first group will have a biopsy at day 10, and the second group will receive standard management. All patients will be given CellCept as standard of care. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.


title: A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer

summary: The primary objective of this trial is to explore the overall objective best response rate and the rate of non-progression at 16 weeks of sequential, alternating weekly administration of BIBF 1120 and BIBW 2992 in patients with metastatic CRC based on the RECIST criteria.

lead_sponsor: Boehringer Ingelheim

location_facility:
1239.2.3301B Hôpital Saint Antoine
1239.2.3303D Institut Gustave Roussy
1239.2.3303F Institut Gustave Roussy
1239.2.3305A clinique Saint Jean
1239.2.3303E Institut Gustave Roussy
1239.2.3301H Hôpital Saint Antoine
1239.2.3305B Cabinet Médical
1239.2.3301I Hôpital Saint Antoine
1239.2.3303C Institut Gustave Roussy
1239.2.3301F Hôpital Saint Antoine
1239.2.3301D Hôpital Saint Antoine
1239.2.3304A Hôpital Robert Debré
1239.2.3301J Hôpital Saint Antoine
1239.2.3301K Hôpital Saint Antoine
1239.2.3301C Hôpital Saint Antoine
1239.2.3302B Hôpital Tenon
1239.2.3301E Hôpital Saint Antoine
1239.2.3302A Hôpital Tenon
1239.2.3304B Hôpital Robert Debré
1239.2.3301G Hôpital Saint Antoine
1239.2.3304C Hôpital Robert Debré
1239.2.3303B Institut Gustave Roussy
1239.2.3301A Hôpital Saint Antoine
1239.2.3303A Institut Gustave Roussy


title: An Open Label Study to Assess the Effect of Avastin (Bevacizumab) Combined With First Line Paclitaxel-carboplatin or Second Line Tarceva (Erlotinib) on Progression-free Survival in Non-squamous Non-small Cell Lung Cancer Patients With Asymptomatic Untreated Brain Metastasis

summary: This study will assess the efficacy and safety of Avastin combined with first li ne paclitaxel-carboplatin (cohort 1) or second line Tarceva (cohort 2) in patien ts with non-squamous non-small cell lung cancer with asymptomatic untreated brai n metastasis. Two cohorts of patients will be studied; the first will receive Av astin 15mg/kg iv every 3 weeks combined with first line paclitaxel 200mg/m2 iv p lus carboplatin AUC6 iv every 3 weeks for a maximum of 6 cycles, and the second cohort will receive Avastin 15mg/kg iv every 3 weeks combined with second line T arceva 150mg/kg po.The anticipated time on study treatment is until disease prog ression, and the target sample size is 100-500 individuals.

design_allocation: Non-Randomized


title: Randomized Phase II/III Adjuvant Trial Evaluating Feasibility of Standard (A) vs. Customized Treatment (B) in Stage II or Stage IIIA Non-N2, Non-squamous Non Small Cell Lung Cancer (NSCLC).

acronym: TASTE

summary:
Our hypothesis is that patients receiving therapy based on their baseline tumor ERCC1 levels and EGFR mutations would attain better disease free survival rates than patients in the control arm receiving noncustomized therapy. Using this selective approach, patients with stage II and IIIA non N2 NSCLC in the genotypic arm with low ERCC1 levels will receive cisplatin plus pemetrexed, and those with high ERCC1 levels will not receive cisplatin-based chemotherapy. If they harbor EGRF mutations they will be treated with erlotinib.

The study will be restricted to non-squamous NSCLC for two mains reasons. First, this will enrich the EGFR mutation rate that is awaited to be higher in these tumors than in squamous cell carcinoma. Second, permetrexed cisplatin combination has a promising efficacy and favorable toxicity profile and is of potential interest in the adjuvant setting of resected non-squamous NSCLC.

ReferenceType: result

ReferenceCitation: Wislez M, Barlesi F, Besse B, Mazières J, Merle P, Cadranel J, Audigier-Valette C, Moro-Sibilot D, Gautier-Felizot L, Goupil F, Renault A, Quoix E, Souquet PJ, Madroszyck A, Corre R, Pérol D, Morin F, Zalcman G, Soria JC. Customized adjuvant phase II trial in patients with non-small-cell lung cancer: IFCT-0801 TASTE. J Clin Oncol. 2014 Apr 20;32(12):1256-61. doi: 10.1200/JCO.2013.53.1525. Epub 2014 Mar 17.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Lyon - Hôpital Louis Pradel (Pneumologie)


title: A Randomized, Double-blind, Placebo-controlled Phase II-III Multi-centre Study to Evaluate the Effect of Adjuvant Pazopanib (GW786034) Versus Placebo on Post-surgical Disease-free Survival in Patients With Stage I Non Small Cell Lung Cancer and Tumor Size Equal or Inferior to 5 cm.

summary: The aim of this study is to evaluate the efficacy and safety of pazopanib compared with placebo in patients with T < or = 5 cm, N0 (stage I according to TNM 2009) completely resected NSCLC.

ReferenceCitation: Besse B, Mazières J, Ribassin-Majed L, Barlesi F, Bennouna J, Gervais R, Moreau L, Berard H, Debieuvre D, Molinier O, Moro-Sibilot D, Souquet PJ, Jacquot S, Petit L, Lena H, Pignon JP, Lacas B, Morin F, Milleron B, Zalcman G, Soria JC; Intergroupe Francophone de Cancérologie Thoracique (IFCT). Pazopanib or placebo in completely resected stage I NSCLC patients: results of the phase II IFCT-0703 trial. Ann Oncol. 2017 May 1;28(5):1078-1083. doi: 10.1093/annonc/mdx070.

location_facility:
Bordeaux - Polyclinique Nord
Lyon Sud
Toulon - HIA
Mantes La Jolie - CH
Le Mans - Centre Hospitalier
Orléans - CH
Moulins - CH
Toulouse - CHU Larrey
Paris - Saint Louis
Villejuif - Institut Gustave Roussy
Boulogne - Ambroise Paré
Montpellier - CHRU
Metz - Clinique Claude Bernard
Mont de Marsan - CH
Lille - Hôpital Calmette
Clamart - Hôpital Percy
CHU
Nevers - CH
Nancy - CHU
Dax - CH
Grenoble - CHU
Bobigny - Hôpital Avicenne
Béziers - CH
Marseille - Hôpital Sainte Marguerite
Reims - CHU
Pau - CH
Vesoul - CHI
Clermont Ferrand - CHU
Centre Catalan d'Onologie
Rennes - CHU
Thonon les bains - CH
Caen - CHU Côte de Nacre
Paris - hôpital Saint-Antoine
Strasbourg - NHC
Annemasse - CH
Colmar - CH
Caen - Centre François Baclesse
Paris - Hopital Tenon
Montpellier - Clinique Clémentville
Nantes - Centre René Gauducheau


title: An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Multiple Solid Tumors

summary: The purpose of this study is to determine the safety and efficacy of belzutifan in combination with pembrolizumab and lenvatinib in multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC), endometrial cancer (EC),and esophageal squamous cell carcinoma (ESCC). There is no formal hypothesis testing in this study.

status: Recruiting

study_completion_date_type: Anticipated

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Spain
Australia
Korea, Republic of
United States
Chile
France
Israel
Belgium
Netherlands

location_facility: University of Florida College of Medicine ( Site 5015)

location_facility: Cabrini Hospital - Malvern-Cabrini Institute ( Site 4000)

location_facility: Hôpital Beaujon-Oncologie Digestive ( Site 1104)

location_facility: Hospital Universitari Vall d'Hebron-Oncology ( Site 1800)

location_facility: Seoul National University Hospital-Internal Medicine ( Site 4103)

location_facility: Leids Universitair Medisch Centrum-Medical Oncology ( Site 1504)

location_facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 4100)

location_facility: Northern Hospital-Department of Medical Oncology ( Site 4003)

location_facility: Institut Régional du Cancer Montpellier ( Site 1106)

location_facility: University of Wisconsin Hospitals and Clinics ( Site 5037)

location_facility: Hadassah Medical Center-Oncology ( Site 1303)

location_facility: City of Hope Comprehensive Cancer Center ( Site 5002)

location_facility: Yale-New Haven Hospital-Yale Cancer Center ( Site 5013)

location_facility: Centre Hospitalier Universitaire de Grenoble-Medical Oncology ( Site 1105)

location_facility: Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - GI and Immunology ( Site 5048)

location_facility: Sheba Medical Center-ONCOLOGY ( Site 1302)

location_facility: Westmead Hospital-Department of Medical Oncology ( Site 4001)

location_facility: Samsung Medical Center-Division of Hematology/Oncology ( Site 4102)

location_facility: Gosford Hospital-Oncology Trials ( Site 4004)

location_facility: Rambam Health Care Campus-Oncology ( Site 1300)

location_facility: Asan Medical Center-Department of Oncology ( Site 4101)

location_facility: Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1103)

location_facility: Hospital Universitario Central de Asturias-Medical Oncology ( Site 1802)

location_facility: Inova Schar Cancer Institute ( Site 5039)

location_facility: University of Texas MD Anderson Cancer Center-Gastrointestinal Medical Oncology ( Site 5049)

location_facility: Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 1003)

location_facility: Sourasky Medical Center-Oncology ( Site 1301)

location_facility: UCSF Medical Center at Mission Bay ( Site 5021)

location_facility: University of Arizona Cancer Center-University of Arizona Cancer Center - North Campus ( Site 5047)

location_facility: Cedars-Sinai Medical Center ( Site 5045)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 5050)

location_facility: Antwerp University Hospital-Oncology ( Site 1002)

location_facility: Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1503)

location_facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1801)

location_facility: CHU Besançon-Medical oncology ( Site 1101)

location_facility: Northwest Medical Specialties, PLLC ( Site 5025)

location_facility: Maastricht UMC+-Medical Oncology ( Site 1501)

location_facility: Centro Investigación del Cáncer James Lind ( Site 3107)

status_simplified: Ongoing


title: Open-Label Study To Evaluate The EULAR-RAID Score, Rheumatoid Arthritis Impact Of Disease Score, In Rheumatoid Arthritis Patients Eligible To Etanercept And Who Will Receive Etanercept

acronym: Rainbow

summary: The Disease Activity Score (DAS) is a system of measurement developed in the 1980s that uses certain criteria, including joint counts and patient perceived disease activity, to measure disease activity in people with Rheumatoid Arthritis . More recently, the European League against Rheumatism (EULAR) has developed a new system of measurement known as the Rheumatoid Arthritis Impact of Disease score, or EULAR-RAID score. The EULAR-RAID score is a composite score based on patient reported outcomes, and includes such criteria as pain, functional disability, fatigue, sleep disturbances, coping, overall assessment of physical well being and overall assessment of psychological well being. The objective of this study is to evaluate the practical modalities and performance of the EULAR- RAID score in patients with rheumatoid arthritis who have been prescribed etanercept as part of usual medical practice.

ReferenceCitation: Duarte C, Santos EJF, Ferreira RJO, Kvien TK, Dougados M, de Wit M, da Silva JAP, Gossec L. Validity and reliability of the EULAR instrument RAID.7 as a tool to assess individual domains of impact of disease in rheumatoid arthritis: a cross-sectional study of 671 patients. RMD Open. 2021 Feb;7(1). pii: e001539. doi: 10.1136/rmdopen-2020-001539.

ReferenceCitation: Dougados M, Brault Y, Logeart I, van der Heijde D, Gossec L, Kvien T. Defining cut-off values for disease activity states and improvement scores for patient-reported outcomes: the example of the Rheumatoid Arthritis Impact of Disease (RAID). Arthritis Res Ther. 2012 May 30;14(3):R129. doi: 10.1186/ar3859.

ReferenceCitation: Dougados M, Ripert M, Hilliquin P, Brocq O, Brault Y, Logeart I. Onset of action of etanercept in rheumatoid arthritis based on patient-reported outcomes. Clin Exp Rheumatol. 2012 Mar-Apr;30(2):266-8. Epub 2012 Apr 13.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country: France Monaco


title: Heparin-Induced Thrombocytopenia : Development and Validation of a Predictive Clinical Score: a Prospective Multicenter Study Under the Auspices of the French Haemostasis and Thrombosis Study Group (GEHT)in Cooperation With the French Association of Regional PharmacoVigilance Center (AFCRPV)

acronym: Score-TIH

summary:
Although Heparin-induced thrombocytopenia (HIT) is a rare complication of heparin treatment, it results in a high rate of morbidity and mortality, the cumulative rate of thrombosis recurrence, amputation and death approaching 52 % at one month if no specific treatment is initiated. It is therefore vital to diagnose HIT as early and as reliably as possible to permit appropriate management of this rare condition.

During the acute phase of HIT, clinicians and biologists can only suspect this complication with a greater or lesser degree of confidence. Clinical data are not sufficiently sensitive or specific to confirm or refute thr diagnosis of HIT.

ReferenceCitation: Tardy-Poncet B, de Maistre E, Pouplard C, Presles E, Alhenc-Gelas M, Lasne D, Horellou MH, Mouton C, Serre-Sapin A, Bauters A, Nguyen P, Mullier F, Perrin J, Le Gal G, Morange PE, Grunebaum L, Lillo-Le Louet A, Elalamy I, Gruel Y, Greinacher A, Lecompte T, Tardy B; GFHT-HIT study group. Heparin-induced thrombocytopenia: Construction of a pretest diagnostic score derived from the analysis of a prospective multinational database, with internal validation. J Thromb Haemost. 2021 Aug;19(8):1959-1972. doi: 10.1111/jth.15344. Epub 2021 Jun 14.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Laboratoire d'hématologie - CHU de Clermont Ferrand

location_facility: HOTEL DIEU - CHU Nantes - Laboratoire d'Hématologie

location_facility: Laboratoire d'hématologie - Hôpital Louis Pradel

location_facility: Hopital Purpan - Laboratoire d'hématologie

location_facility: ETS de Franche Conté - Laboratoire d'Immuno Hématologie

location_facility: CHU Strasbourg Hautepierre Laboratoire d'Hématologie

location_facility: Hôpital Antoine Beclère - Laboratoire d'hématologie

location_facility: Hôpital BICHAT - Service d'hématologie immunologie

location_facility: Hôpital Necker Enfants Malades -Laboratoire d'Hématologie

location_facility: Hôpital Européen Georges Pompidou - Service Hématologie Biologique A

location_facility: Hôpital SAINT ELOI - CHU de Montpellier - Laboratoire d'Hématologie

location_facility: CHU Trousseau - CTH - Service d'Hématologie Hémostase

location_facility: Laboratoire central d'hématologie - Hôpital R. DEBRE

location_facility: CHU Cavale Blanche Laboratoire d'Hématologie

location_facility: G.H. Pitié Salpétrière - Labo Hémostase Pavillon Laveran

location_facility: Laboratoire d'Hématologie - CHU le Bocage

location_facility: Hôpital Cardiologique - Laboratoire d'Hémostase


title: A Phase II Trial With Pemetrexed Plus Cisplatin as First Line Chemotherapy for Advanced Non - Small Cell Lung Cancer (NSCLC) Patients With Measurable Asymptomatic Brain Metastasis (GFPC 07-01/METAL).

summary:
NSCLC patients often have cerebral metastasis : 10% at diagnosis and 40% during disease management. Neurosurgery is not indicated in the majority of cases because of presence of several lesions in the brain, failure of primary tumor control or presence of extra-cerebral metastasis. Cerebral metastasis lead to death in 30 to 50% of these cases. Management of these patients in this situation is based on supportive care and whole-brain radiotherapy. The place of chemotherapy for patients with good performance status was discussed for a long time and it is now admitted. However, the place of new drugs such as pemetrexed, which is currently used as a second line treatment for NSCLC, needs to be further studied. It is known that pemetrexed when added to cisplatin for treatment of NSCLC provides a similar effectiveness when compared to other drugs associations commonly used in this indication. In addition, Cisplatin with Pemetrexed probably present a better safety profile.

The present study is based upon the hypothesis stipulating that the association cisplatin-pemetrexed will be at least as efficient as the others association currently used for treatment of NSCLC and will present a better safety profile. The primary objective of this study is overall response rate on brain metastasis according to RECIST criteria. Secondary judgment criterias are : Overall response rate, PFS after first-line CDDP plus pemetrexed, safety profile, quality of life, neurological symptoms, overall survival.

The trial will enroll up to 45 patients in this single-arm two-stage sequential phase II study with the possibility of stopping the study early because of lack of efficacy.

lead_sponsor: University Hospital, Brest

location_facility: Pneumologie, Centre hôspitalier, DRAGUIGNAN

location_facility: Serv. de Pneumo-Allergo, CH de Martigues

location_facility: Service Pneumologie, Pavillon 1A, CH de Lyon-Sud

location_facility: Centre Hospitalier, Service de Pneumologie

location_facility: Hôpital A. Mignot, Service de Pneumologie

location_facility: CHU brest, institut de cancérologie et d'hématologie

location_facility: Médecine 4, C.H.G. de la Fontonne Antibes

location_facility: Hôpital Pontchailloux, Service de Pneumologie.

location_facility: Centre Hôspitalier du Pays d'Aix, Service des Maladies Respiratoires

location_facility: Centre Hôspitalier, Service de Pneumo-Neuro

location_facility: Centre Hospitalier René Dubos - Pontoise, Service d'Oncologie - Hématologie Clinique

location_facility: Centre Hospitalier Départemental, Service de Pneumologie,

location_facility: CHU de ROUEN, Hôpital Bois Guillaume, Serv. de Pneumo.


title: A Phase III Multicentre Randomised Double-blind Comparative Study of Efficacy and Safety of Lanreotide 30 mg Versus Placebo for Treatment of Patients With Digestive Fistulae

summary: The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae.

ReferenceCitation: Gayral F, Campion JP, Regimbeau JM, Blumberg J, Maisonobe P, Topart P, Wind P; Lanreotide Digestive Fistula. Randomized, placebo-controlled, double-blind study of the efficacy of lanreotide 30 mg PR in the treatment of pancreatic and enterocutaneous fistulae. Ann Surg. 2009 Dec;250(6):872-7.

lead_sponsor: Ipsen

location_country:
Russian Federation
France

location_facility: Institute of Surgery n.a. A.V. Vishnevsky


title: A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02B

summary:
Substudy 02B is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.

The goal of substudy 02B is to evaluate the safety and efficacy of investigational treatment arms in participants with 1L advanced melanoma and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/pembrolizumab monotherapy.

location_country:
Spain
Italy
Australia
Switzerland
United States
Israel
France
South Africa

location_facility: HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 2302)

location_facility: CHUV Centre Hospitalier Universitaire Vaudois ( Site 2602)

location_facility: CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE-Clinical Trials Unit ( Site 2865)

location_facility: West Cancer Center - East Campus ( Site 2014)

location_facility: Rambam Health Care Campus-Oncology ( Site 2704)

location_facility: Hospital Universitario Ramón y Cajal ( Site 2802)

location_facility: The Angeles Clinic and Research Institute ( Site 2009)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 2377)

location_facility: Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2863)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 2108)

location_facility: Rabin Medical Center-Oncology ( Site 2705)

location_facility: A.P.H. Paris, Hopital Saint Louis ( Site 2107)

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 2022)

location_facility: University of Pennsylvania Abramson Cancer Center ( Site 2008)

location_facility: Calvary Mater Newcastle-Medical Oncology ( Site 2404)

location_facility: University of Colorado, Anschutz Cancer Pavilion ( Site 2012)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2399)

location_facility: Inova Schar Cancer Institute ( Site 2011)

location_facility: Hadassah Ein Karem Jerusalem ( Site 2702)

location_facility: Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 2603)

location_facility: Istituto Europeo di Oncologia ( Site 2301)

location_facility: LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 2861)

location_facility: Universitaetsspital Zuerich ( Site 2601)

location_facility: Tasman Oncology Research Pty Ltd ( Site 2403)

location_facility: Oregon Health & Science University ( Site 2013)

location_facility: Istituto Oncologico Veneto IRCCS ( Site 2355)

location_facility: Providence Saint John's Health Center ( Site 2010)

location_facility: Melanoma Institute Australia ( Site 2402)


title: An Open Label Study to Assess the Rate of Pathological Complete Response in Patients With Primary Inflammatory HER2-positive Breast Cancer Treated With Avastin + Herceptin Based Chemotherapy

summary: This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

ReferenceCitation: Pierga JY, Petit T, Delozier T, Ferrero JM, Campone M, Gligorov J, Lerebours F, Roché H, Bachelot T, Charafe-Jauffret E, Pavlyuk M, Kraemer S, Bidard FC, Viens P. Neoadjuvant bevacizumab, trastuzumab, and chemotherapy for primary inflammatory HER2-positive breast cancer (BEVERLY-2): an open-label, single-arm phase 2 study. Lancet Oncol. 2012 Apr;13(4):375-84. doi: 10.1016/S1470-2045(12)70049-9. Epub 2012 Feb 28.


title: Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in ICD Patients

summary: The purpose of this study is to report the incidence of ventricular arrhythmias correlated to the SAS and to focus on the interest of diagnosing Sleep-disorders breathing in ICD patients. This diagnosis will be assessed by an ambulatory nasal pressure recording with portable multi-channel recorder associated to a complete SAS related symptoms questionnaire.This clinical trial will be the first step to gather information about the suspected sleep relation between ventricular arrhythmias and Sleep breathing disorders, in order to improve the management and treatment of such arrhythmias in next generation of defibrillators which will integrate a minute ventilation sensor able to monitor breathing.

lead_sponsor: LivaNova

location_country: Germany France Italy Greece

location_facility:
Osp. Civile
CHRU Hopital de la cavale blanche
CH Pau
Policlinico San Donato
Clinique Bizet
CHR Notre Dame de Bonsecours
CHU Dupuytren
Hopital Saint Joseph et saint Luc
CHU
CHR Cardiologie A
Clinique Pasteur
Instituto di Cura
CHRU Brabois
Hopital cardiologique
Nouvelle Clinique Nantaise
Policlinico de Modenna
CHU Hopital la Milétrie
Ospedale Mellini
Hospitale civile Guglielmo da Saliceto
Clinique Saint gatien
Casa di Cura Montevergine
CH Montpellier
CHRU Hopital Trousseau
Hopital Nord
CHU - Hopital Michallon
CHU Charles Nicolle
Onassis Cardiac Surgery Center
Prof. Frey Praxis Starnberg
Universitatsklinikum Hamburg Eppendorf
Herz-Kreislauf-Klinik Bevensen AG

intervention_type: Device


title: Survey on Time to Lipid-lowering Drug Implementation on Dyslipidemic Patients in General Practice.

acronym: PRYSME

summary: The purpose of this observational study is to describe the time to lipid-lowering drug implementation in the management of dyslipidemic patients, according to the cardiovascular risk level.

time_perspective: Cross-Sectional

lead_sponsor: AstraZeneca


title: Comparison and Description of Coronary Patients Management With or Without Heart Failure in Cardiology Consulting

acronym: COMPAR

summary: The purpose of this observational study is to compare frequency of attainment control goals through the more represented cardiovascular factor risk, dyslipidemia, among coronary patients with or without heart failure in cardiology consulting.


title: National Prospective Survey on Women With a Diagnosis of Infiltrative Breast Cancer

acronym: CSI

summary: The purpose of this observational study is to describe radiological, clinical and histological characteristics of women with infiltrative breast cancer.


title: Evaluation of the Impact of Abdominal Fat on GERD Severity and GERD Frequency in General Practice

acronym: LINEA

summary: The purpose of this observational study is to assess the impact of abdominal fat on severity and frequency of GERD symptoms .


title: Profile of Hypertensive Patients Seen in Hospital Outpatient's Department

acronym: PROPHYL HO

summary: To evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics, health care management) of hypertensive patients seen in hospital out patient's department by a cardiologist or a nephrologists.


title: Profile of Hypertensive Patients Seen in Private Cardiology Consultation

acronym: Prophyl C

summary: To evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics, health care management) of hypertensive patients seen in private cardiology consultation by holding account of type of exercise of the cardiologist (private exclusive or mixed hospital and private).


title: A Phase 1, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Combinations of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Subjects With Locally Advanced or Metastatic Solid Tumors

summary: A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or chemotherapy in participants with selected solid tumors. This study consists of 2 main parts, a dose-escalation phase and a dose-expansion phase. The dose-expansion phase can begin once the recommended phase 2 dose/maximum tolerated dose (RP2D/MTD) is determined in the dose-escalation phase.

ipd_sharing: No

lead_sponsor: AbbVie

location_country:
Taiwan
Spain
Australia
United States
Israel
France

location_facility: Virginia Cancer Specialists - Fairfax /ID# 210671

location_facility: Mary Crowley Cancer Research /ID# 210716

location_facility: National Taiwan University Hospital /ID# 210993

location_facility: China Medical University Hospital /ID# 221090

location_facility: Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072

location_facility: The Chaim Sheba Medical Center /ID# 211699

location_facility: Hospital Universitario HM Sanchinarro /ID# 212805

location_facility: St Jude Hospital dba St Joseph /ID# 211130

location_facility: Highlands Oncology Group, PA /ID# 218863

location_facility: Hospital Universitario Virgen de la Victoria /ID# 221671

location_facility: Carolina BioOncology Institute /ID# 210664

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 212806

location_facility: Hospital Universitario Vall d'Hebron /ID# 212804

location_facility: Washington University-School of Medicine /ID# 221399

location_facility: Institut de Cancérologie de l'Ouest René Gauducheau /ID# 212880

location_facility: AP-HP - Hopital Bichat - Claude-Bernard /ID# 212869

location_facility: Tennessee Oncology-Nashville Centennial /ID# 221400


status: Active, not recruiting

title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

ReferenceCitation: Mendes-Bastos P, Ladizinski B, Guttman-Yassky E, Jiang P, Liu J, Prajapati VH, Simpson EL, Vigna N, Teixeira HD, Barbarot S. Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. J Am Acad Dermatol. 2022 Oct;87(4):784-791. doi: 10.1016/j.jaad.2022.06.012. Epub 2022 Jun 15.

ReferenceCitation: Simpson EL, Papp KA, Blauvelt A, Chu CY, Hong HC, Katoh N, Calimlim BM, Thyssen JP, Chiou AS, Bissonnette R, Stein Gold LF, Wegzyn C, Hu X, Liu M, Liu J, Tenorio AR, Chu AD, Guttman-Yassky E. Efficacy and Safety of Upadacitinib in Patients With Moderate to Severe Atopic Dermatitis: Analysis of Follow-up Data From the Measure Up 1 and Measure Up 2 Randomized Clinical Trials. JAMA Dermatol. 2022 Apr 1;158(4):404-413. doi: 10.1001/jamadermatol.2022.0029.

ReferenceCitation: Guttman-Yassky E, Teixeira HD, Simpson EL, Papp KA, Pangan AL, Blauvelt A, Thaçi D, Chu CY, Hong HC, Katoh N, Paller AS, Calimlim B, Gu Y, Hu X, Liu M, Yang Y, Liu J, Tenorio AR, Chu AD, Irvine AD. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021 Jun 5;397(10290):2151-2168. doi: 10.1016/S0140-6736(21)00588-2. Epub 2021 May 21. Erratum in: Lancet. 2021 Jun 5;397(10290):2150.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Portugal
Austria
Australia
Singapore
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Ireland
New Zealand
Korea, Republic of
France
Netherlands

location_facility: ASST Spedali civili di Brescia /ID# 205927

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 205201

location_facility: Dr. Lyne Giroux Medicine Professional Corporation /ID# 206771

location_facility: Beacon Clinical Research, LLC /ID# 206894

location_facility: Total Skin and Beauty Derm Ctr /ID# 205129

location_facility: SoonChunHyang University Buchon Hospital /ID# 206391

location_facility: Clinical Research of West Florida, Inc /ID# 206146

location_facility: Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 205168

location_facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 205292

location_facility: Dermatologische Gemeinschaftspraxis Mahlow /ID# 205765

location_facility: Midflorida Clinical Research, Inc. /ID# 213700

location_facility: Southern California Derma. Inc /ID# 205734

location_facility: Hospital General Universitario de Valencia /ID# 210565

location_facility: The Royal Melbourne Hospital /ID# 205919

location_facility: Universitair Medisch Centrum Groningen /ID# 205162

location_facility: Sanatorium profesora Arenbergera /ID# 205098

location_facility: Hospital Universitario Reina Sofia /ID# 204712

location_facility: Allergy, Asthma & Immunology Associates, PC /ID# 218169

location_facility: Keck School of Medicine of USC /ID# 206971

location_facility: PMG Research of Wilmington LLC /ID# 205968

location_facility: 251 Airforce General Hospital /ID# 205841

location_facility: KK Women's & Children Hospital /ID# 206693

location_facility: Ideal Clinical Research Inc. /ID# 209880

location_facility: New England Research Associates, LLC /ID# 206896

location_facility: Papageorgiou General Hospital Thessaloniki /ID# 204526

location_facility: Universal Axon Clinical Research /ID# 213703

location_facility: Centro Hospitalar de Leiria, EPE /ID# 209906

location_facility: University Hospital Plymouth NHS Trust /ID# 204649

location_facility: Medical Dermatology Specialist /ID# 205516

location_facility: Epiphany Dermatology - Fort Worth /ID# 210073

location_facility: Chung Shan Medical University Hospital /ID# 205092

location_facility: Universitaetsklinikum St. Poelten /ID# 206909

location_facility: Treasure Valley Medical Research /ID# 210298

location_facility: Duplicate_Summit Medical Group /ID# 213863

location_facility: Advanced Research for Health Improvement /ID# 218003

location_facility: 401 GSNA - 401 Army General Hospital /ID# 205352

location_facility: Velocity Clinical Research Hallandale Beach /ID# 207544

location_facility: CCA Braga - Hospital de Braga /ID# 205854

location_facility: Clinical Research Trials of Florida, Inc. /ID# 206840

location_facility: Taipei Medical University Shuang Ho Hospital /ID# 204804

location_facility: Hospital Infantil Universitario Nino Jesus /ID# 210437

location_facility: Child Hosp of Orange County,CA /ID# 205735

location_facility: Arizona Research Center, Inc. /ID# 205795

location_facility: Poliklinika Vlatka Cavka d.o.o. /ID# 211126

location_facility: Vital Prospects Clinical Research Institute, PC /ID# 205824

location_facility: Azienda Ospedaliero-Universitaria di Modena /ID# 205169

location_facility: IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 205986

location_facility: National University Hospital /ID# 205224

location_facility: Bellingham Asthma Allergy and Immunology Clinic /ID# 210357

location_facility: Georgia Pollens Clinical Research Centers, Inc /ID# 218567

location_facility: Linkou Chang Gung Memorial Ho /ID# 204783

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 205987

location_facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 218072

location_facility: Murdoch Children's Research Institute /ID# 205667

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 204993

location_facility: Hallym University Kangnam Sacred Heart Hospital /ID# 206343

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 205679

location_facility: Miami Dade Medical Research Institute /ID# 209413

location_facility: Clinical Research Solutions, LLC /ID# 218416

location_facility: Skin Laser and Surgery Specialists of NY and NJ /ID# 206754

location_facility: SimcoDerm Medical and Surgical Dermatology Center /ID# 206333

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 207982

location_facility: Sjællands Universitetshospital /ID# 205960

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 206573

location_facility: Military Medical Academy Multiprofile Hospital /ID# 205291

location_facility: Hospital Universitario Infanta Leonor /ID# 204710

location_facility: Haut- und Laserzentrum Hunsrück /ID# 205768

location_facility: University of California Irvine /ID# 205136

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o. z. /ID# 205097

location_facility: Hospital General Universitario Gregorio Maranon /ID# 204380

location_facility: Awasty Research Network, LLC /ID# 206748

location_facility: Hospital Vital Alvarez Buylla /ID# 205770

location_facility: CHRU de Brest - Hopital Morvan /ID# 206555

location_facility: Niakosari Medicine Professional Corporation /ID# 206004

location_facility: University Hospital Waterford /ID# 204266

location_facility: DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 205429

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 205085

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 208281

location_facility: CHP, EPE- Hospital Geral de Sa /ID# 205187

location_facility: General Hospital Andreas Syggros /ID# 204527

location_facility: The Dermatology Clinic of Arkansas /ID# 218749

location_facility: Agile Clinical Research Trials /ID# 218080

location_facility: Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 204938

location_facility: Palmtree Clinical Research Inc. /Id# 206184

location_facility: Dermatology Treatment and Research Center, PA /ID# 205473

location_facility: Innovative Clinical Research - Lafayette /ID# 208400

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 205611

location_facility: Hospital Clinic de Barcelona /ID# 210564

location_facility: National Taiwan University Hospital /ID# 204803

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 206658

location_facility: UBC Department of Dermatology and Skin Science The Skin Care Centre /ID# 207837

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 206895

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 205711

location_facility: Rady Children's Hospital San Diego /ID# 208244

location_facility: Clinical Investigation Specialist, Inc - Kenosha /ID# 215933

location_facility: Korea University Ansan Hospital /ID# 206342

location_facility: Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 205766

location_facility: Chung-Ang University Hostipal /ID# 206397

location_facility: Timber Lane Allergy & Asthma Research, LLC /ID# 206897

location_facility: Advanced Research for Health Improvement /ID# 217987

location_facility: Austin Institute for Clinical Research /ID# 206640

location_facility: Presidio Ospedaliero San Salvatore /ID# 205167

location_facility: Northshore University Health System Dermatology Clinical Trials Unit /ID# 205135

location_facility: Marietta Dermatology Clinical Research /ID# 210317

location_facility: The Education & Research Foundation, Inc. /ID# 206900

location_facility: Dr. Dusan Sajic Medicine Professional Corporation /ID# 206890

location_facility: Hospital Parc de Salut del Mar /ID# 204709

location_facility: Allergy Research Canada Inc. /ID# 213547

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 205767

location_facility: Seoul National University Hospital /ID# 206396

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 205839

location_facility: Clinical Investigation Specialists, Inc. /ID# 206898

location_facility: University of New Mexico School of Medicine /ID# 206756

location_facility: Medical center Sveti Panteleimon /ID# 210414

location_facility: The Guenther Dermatology Research Centre /ID# 206772

location_facility: Derm Clin Res Ctr San Antonio /ID# 205469

location_facility: Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 203448

location_facility: University Hospitals Case Medical Center /ID# 206639

location_facility: Dr. S.K. Siddha Medicine Professional Corporation /ID# 207138

location_facility: Continental Clinical Solutions /ID# 210327

location_facility: South Infirmary Victoria University Hospital /ID# 204265

location_facility: The Catholic University of Korea Incheon St.Mary's Hospital /ID# 206529

summary: The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.


type: Registry Identifier

title: Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib

summary: The primary purpose of this study is to determine the efficacy of brigatinib by confirmed objective response rate (ORR) by response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors [RECIST]), in participants with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.

ReferenceCitation: Kim ES, Barlesi F, Mok T, Ahn MJ, Shen J, Zhang P, Ou SI. ALTA-2: Phase II study of brigatinib in patients with ALK-positive, advanced non-small-cell lung cancer who progressed on alectinib or ceritinib. Future Oncol. 2021 May;17(14):1709-1719. doi: 10.2217/fon-2020-1119. Epub 2021 Feb 11.

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Ariad Pharmaceuticals

location_country:
Taiwan
Hong Kong
Spain
Italy
Austria
Australia
Netherlands
Canada
Sweden
Korea, Republic of
United States
France
China
Japan
Germany

location_facility: Keimyung University Dongsan Medical Center

location_facility: Jilin Provincial Cancer Hospital (Changchun Cancer Hospital)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: Washington University School of Medicine

location_facility: Assistance Publique-Hopitaux de Marseille Hopital Nord

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: The First Affiliated Hospital of Zhejiang University School of Medicine

location_facility: USOR - Virginia Cancer Specialists - Fairfax Office

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Kansai Medical University Hirakata Hospital

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: University of California Irvine Health Chao Family Comprehensive Cancer Center

location_facility: USOR - Rocky Mountain Cancer Centers - Pueblo

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Institut Catala d'Oncologia Badalona - Hospital Germans Trias i Pujol

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Hopital Larrey, CHU de Toulouse, Service de Pneumologie

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Azienda Ospedaliero - Universitaria San Luigi Gonzaga

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: Centre de Lutte Contre le Cancer Centre Leon Berard


title: Multicenter, Open, Randomized Comparative Trial To Compare Bacteriological And Clinical Efficacy Of Azithromycin Versus Amoxicillin In Children With Streptococcus Tonsillitis

summary: The primary objective was to compare the bacteriological efficacy at Day 10 of azithromycin pediatric suspension (20 mg/kg/day once daily for 3 consecutive days) versus amoxicillin pediatric suspension (50 mg/kg/day in 2 doses for 6 consecutive days) in children aged 3-15 years with Group A streptococcal acute pharyngitis/tonsillitis. Secondary objectives were assessments of bacteriological efficacy at Day 30 and clinical efficacy at Day 10 and Day 30.

lead_sponsor: Pfizer


title: A Phase 2, Multicenter, Open-Label, 2-Cohort Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2 Antibody Drug Conjugate (ADC), for HER2-Over-Expressing or -Mutated, Unresectable and/or Metastatic Non Small Cell Lung Cancer (NSCLC) (DESTINY-Lung01)

summary: The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.

ReferenceCitation: Li BT, Smit EF, Goto Y, Nakagawa K, Udagawa H, Mazières J, Nagasaka M, Bazhenova L, Saltos AN, Felip E, Pacheco JM, Pérol M, Paz-Ares L, Saxena K, Shiga R, Cheng Y, Acharyya S, Vitazka P, Shahidi J, Planchard D, Jänne PA; DESTINY-Lung01 Trial Investigators. Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2022 Jan 20;386(3):241-251. doi: 10.1056/NEJMoa2112431. Epub 2021 Sep 18.

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

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Spain
United States
France
Japan
Netherlands

location_facility: University of California San Diego (UCSD)

location_facility: Washington University School of Medicine at St. Louis


title: Velcade®-Melphalan Association as Conditioning Regimen Before Autologous Stem-cell Transplantation in Multiple Myeloma Patients Under 65 Years

summary:
Intensification with autologous stem cell (ASCT) is currently the most effective treatment for subjects under 65 and the essential goal is to achieve complete response (CR) or very good partial response (VGPR= greater than 90% reduction of monoclonal component). However, only 50% of patients achieve this CR/VGPR even with tandem ASCT early in the course of disease.

Optimization of the conditioning regimen could improve this CR/VGPR rate. The combinaison of Velcade and HD Melphalan has never been evaluated. However, at conventional doses, Velcade potentiates the antimyeloma effect of Melphalan without inducing any common toxicity.

This study will be conducted in patients under the age of 65 with de novo multiple myeloma or in first relapse, with Salmon and Durie stage of III, II, I with one symptomatic bone lesion (radiological)and no contraindication to intensification. The primary objective will be to increase the CR/VGPR rate 3 months after autologous peripheral blood stem cell transplantation conditioned by Velcade-Melphalan from 40% to 70%. With alpha=5% and bêta=10%, 61 patients will be included.

Secondary objectives will be to assess the toxicity of the Velcade-Melphalan conditioning regimen, the progression-free survival and the overall survival after intensification. Response rates will be evaluated according to the response criteria defined by. Analysis will be performed on an intention-to-treat basis.

After conventional induction therapy and PBSC collection, patients will be offered this new conditioning regimen. they will be free to refuse this regimen, in which case they will receive standard intensification therapy by Melphalan 200 mg/m² followed by autologous stem cell transplantation.

Evaluation will occur at 3 months post intensification.

ReferenceCitation: Roussel M, Moreau P, Huynh A, Mary JY, Danho C, Caillot D, Hulin C, Fruchart C, Marit G, Pégourié B, Lenain P, Araujo C, Kolb B, Randriamalala E, Royer B, Stoppa AM, Dib M, Dorvaux V, Garderet L, Mathiot C, Avet-Loiseau H, Harousseau JL, Attal M; Intergroupe Francophone du Myélome (IFM). Bortezomib and high-dose melphalan as conditioning regimen before autologous stem cell transplantation in patients with de novo multiple myeloma: a phase 2 study of the Intergroupe Francophone du Myelome (IFM). Blood. 2010 Jan 7;115(1):32-7. doi: 10.1182/blood-2009-06-229658. Epub 2009 Nov 2.

lead_sponsor: University Hospital, Toulouse

location_facility: Service of Hematology - Jean Bernard Hospital

location_facility: Service of Hematology - Claude Hurriez Hospital

location_facility: Service of Hematology -Gustave Roussy Institute

location_facility: Service of Clinical Hematology - Avicenne Hospital

location_facility: Service of Hematology - General Hospital

location_facility: Service of Clinical Hematology - F. Baclesse Center

location_facility: Service of Hematology - A. Michallon Hospital

location_facility: Service of Hematology - Pontchaillou Hospital

location_facility: Service of Clinical Hematology - Bocage Hospital

location_facility: Service of Hematology - Brabois Hospital

location_facility: Service of Clinical Hematology - Archet 1 Hospital

location_facility: Service of Clinical Hematology - Army Instruction Hospital of Percy

location_facility: Service of Clinical Hematology - Minjoz Hospital

location_facility: Service of Hematology - Lyon Sud Hospital

location_facility: Service of Hematology - Edouard Herriot Hospital

location_facility: Service of Blood Deseases - Saint Antoine Hospital

location_facility: Service of Hematology - Hautepierre Hospital

location_facility: Service of Clinical Hematology - A. Morvan Hospital

location_facility: Service of Hematology - R.Debré Hospital

location_facility: Service of Clinical Hematology - Cote Basque Hospital

location_facility: Service of Blood Deseases - UH of Nantes

location_facility: Service of Oncohematology - Louis Pasteur Hospital

location_facility: Service of Hematology - Notre Dame du Bon Secours Hospital

location_facility: Service of Onco-Hematology - Bretonneau Hospital

location_facility: Service of Clinical Hematology - UH of Clermont-Ferrand

location_facility: Service of Hematology - Léon Bérard Center

location_facility: Service of Clinical Hematology - Purpan hospital TSA 40031

location_facility: Service of Hematology -Henri Becquerel Center

location_facility: Service of Hematology - Paoli Calmette Institute

location_facility: Service of Blood Deseases - South Hospital


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Ranolazine on Major Adverse Cardiovascular Events in Subjects With a History of Chronic Angina Who Undergo Percutaneous Coronary Intervention With Incomplete Revascularization

acronym: RIVER-PCI

summary: This study will evaluate the efficacy of ranolazine as compared with placebo when used as part of standard medical therapy in chronic angina subjects with incomplete revascularization post-percutaneous coronary intervention (PCI; formerly known as angioplasty with stent) on the composite of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization.

ReferenceType: background

ReferenceCitation: Weisz G, Farzaneh-Far R, Ben-Yehuda O, Debruyne B, Montalescot G, Lerman A, Mahmud E, Alexander KP, Ohman EM, White HD, Olmsted A, Walker GA, Stone GW. Use of ranolazine in patients with incomplete revascularization after percutaneous coronary intervention: design and rationale of the Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (RIVER-PCI) trial. Am Heart J. 2013 Dec;166(6):953-959.e3. doi: 10.1016/j.ahj.2013.08.004. Epub 2013 Oct 16.

ReferenceCitation: Weisz G, Généreux P, Iñiguez A, Zurakowski A, Shechter M, Alexander KP, Dressler O, Osmukhina A, James S, Ohman EM, Ben-Yehuda O, Farzaneh-Far R, Stone GW; RIVER-PCI investigators. Ranolazine in patients with incomplete revascularisation after percutaneous coronary intervention (RIVER-PCI): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2016 Jan 9;387(10014):136-45. doi: 10.1016/S0140-6736(15)00459-6. Epub 2015 Oct 22.

ReferenceCitation: Alexander KP, Weisz G, Prather K, James S, Mark DB, Anstrom KJ, Davidson-Ray L, Witkowski A, Mulkay AJ, Osmukhina A, Farzaneh-Far R, Ben-Yehuda O, Stone GW, Ohman EM. Effects of Ranolazine on Angina and Quality of Life After Percutaneous Coronary Intervention With Incomplete Revascularization: Results From the Ranolazine for Incomplete Vessel Revascularization (RIVER-PCI) Trial. Circulation. 2016 Jan 5;133(1):39-47. doi: 10.1161/CIRCULATIONAHA.115.019768. Epub 2015 Nov 10.

ReferenceCitation: Fanaroff AC, Prather K, Brucker A, Wojdyla D, Davidson-Ray L, Mark DB, Williams RB, Barefoot J, Weisz G, Ben-Yehuda O, Stone GW, Ohman EM, Alexander KP. Relationship Between Optimism and Outcomes in Patients With Chronic Angina Pectoris. Am J Cardiol. 2019 May 1;123(9):1399-1405. doi: 10.1016/j.amjcard.2019.01.036. Epub 2019 Feb 7.

lead_sponsor: Gilead Sciences

location_country:
Poland
Spain
Italy
Austria
Netherlands
Russian Federation
Canada
Czech Republic
United Kingdom
Sweden
United States
France
Israel
Belgium
Germany

location_facility: Scientific and Research Institution Of Cardiology

location_facility: Cardiology Associates of North Mississippi

location_facility: Cardiology Associates of Southeast Ohio, Inc.

location_facility: Centennial Heart Cardiovascular Consultants, LLC

location_facility: Sentara Cardiovascular Research Institute

location_facility: Penza Regional Clinical Hospital n.a. N.N. Burdenko

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Veterans Affairs San Diego Healthcare System

location_facility: Azienda Ospedaliera "Maggiore della Carita" di Novara

location_facility: City Clinical Hospital # 23 n.a."Medsantrud"

location_facility: National Research Center For Preventive Medicine

location_facility: Complejo Hospitalario Universitario de Vigo, Meixoeiro Hospital

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: 4th Wojskowy Szpital Kliniczny z Poliklinika, Klinika Kardiologii

location_facility: University of Florida Health Sciences Center-Jacksonville

location_facility: Scarborough Cardiology Research Associates

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

location_facility: Federal Center of Heart, Blood and Endocrinology n.a. V.A.Almazov

location_facility: University of Vermont Medical Center, Fletcher Allen Health Care

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Fondazione Centro S. Raffaele del Monte Tabor, Ospedale San Raffaele

location_facility: City Clinical Hospital #15 named after O.M. Filatov

location_facility: Hospital Clínico Universitario Virgen de la Victoria

location_facility: Hospital General Universitario de Alicante

location_facility: Buffalo Cardiology and Pulmonary Associates, PC

location_facility: Spectrum Clinical Research Institute, Inc

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Azienda Ospedaliera S. Sebastiano di Caserta

location_facility: Pepin Heart Hospital and Dr. Kiran C. Patel Research Institute

location_facility: Krankenhaus Der Barmherzigen Brüder Trier

location_facility: Centre Hospitalier Universitaire Sart Tilman Liège

location_facility: Wojewódzki Szpital Zespolony im. Ludwika Rydygiera w Toruniu

location_facility: Northwest Indiana Cardiovascular Physicians

location_facility: Cardiovascular Institute of Northwest Florida

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: SPZOZ, Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: A.R.N.A.S. Civico G. Di Cristina Benfratelli

location_facility: Ashford and Saint Peter's Hospital NHS Trust

location_facility: Samodzielny Publiczny Szpital Kliniczny nr. 1 im. Przemienienia Panskiego

location_facility: SPZOZ, SPSK nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach, Górnoslaskie Centrum Medyczne

location_facility: Volgograd Regional Clinical Cardiological Center

location_facility: Veterans Affairs Medical Center, Duke University Medical Center

location_facility: Oklahoma City Veterans' Affairs Medical Center

location_facility: Research Institute for Complex Issues of Cardiovascular Diseases

location_facility: Cardiology Associates of Fairfield County, PC

location_facility: San Antonio Endovascular and Heart Institute

location_facility: North Texas Healthcare System, Dept. of Veteran's Affairs


title: Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Subjects With Type IIa and IIb Hypercholesterolaemia

acronym: CAP-Chol

summary: The purpose of this study is to evaluate the efficacy and safety of Rosuvastatin 5 mg as an hypercholesterolemia treatment comparatively at 2 other statins: Pravastatin 40 mg and Atorvastatin 10 mg. Treatment efficacy will be evaluated by the percentage of LDL-C variation after 8 weeks of treatment.


title: Interventional, Open-label, Fixed-dose Multiple Administration Study to Evaluate Long-term Treatment With Eptinezumab in Patients With Chronic Cluster Headache

acronym: CHRONICLE

summary: The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.

lead_sponsor: H. Lundbeck A/S

location_country:
Denmark
Spain
Italy
United Kingdom
Netherlands
Finland
United States
France
Germany

location_facility: Michigan Headache and Neurological Institute

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Car...

location_facility: IRCCS Istituto Delle Scienze Neurologiche di Bologna

location_facility: Centre Hospitalier Universitaire de Saint-Étienne

location_facility: New England Institute for Neurology and Headache

location_facility: Cleveland Clinic - Neurological Institute

location_facility: Hospitalsenhed Midt og Regionshospitalet Viborg

location_facility: Ospedale Molinette - Clinica Neurologica II - Centro Cefalee

location_facility: Thomas Jefferson University Hospital - Center City Campus

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS


title: A Phase 3, Open-label, Randomized, Multi-center, Controlled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Edoxaban and to Compare the Efficacy and Safety of Edoxaban With Standard of Care Anticoagulant Therapy in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed Venous Thromboembolism (VTE)

ReferenceCitation: Hokusai-VTE Investigators, Büller HR, Décousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31. Erratum in: N Engl J Med. 2014 Jan 23;370(4):390.

location_country:
Croatia
Serbia
Spain
Ukraine
El Salvador
United States
Romania
Czechia
Portugal
Slovenia
Russian Federation
Argentina
India
Israel
Panama
Turkey
Norway
Malaysia
Singapore
Kenya
Brazil
Lebanon
Canada
Guatemala
Hungary
Germany
Bulgaria
Denmark
Taiwan
Thailand
Korea, Republic of
France
Chile
Netherlands

location_facility: Washington University School of Medicine

location_facility: UNIFESP - Universidade Federal de São Paulo

location_facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

location_facility: Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque

location_facility: Izmir Tepecik Training and Research Hospital

location_facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santa Marta

location_facility: FSBI of Science "Kirov Scientific and Research Institute of Hematology and Blood Transfusion, FMBA"

location_facility: Children's Hospital & Clinics of Minnesota

location_facility: Saint George University Hospital Medical Center

location_facility: Hospital El Carmen Dr. Luis Valentin Ferrada

location_facility: Russian Scientific Center of Radiology and Nuclear Medicine of Ministry of Health of Russian Federation, Department of Pediatric Oncology

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: GRAACC - Grupo de Apoio ao Adolescente e à Criança com Câncer

location_facility: Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Clinical Hospital Centre Cavale Blanche BREST

location_facility: American University of Beirut Medical Center

location_facility: Unidad Nacional de Oncología Pediátrica (UNOP)

location_facility: Instituto de Cardiologia do Rio Grande do Sul

location_facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

location_facility: University of Oklahoma Health Sciences Center

location_facility: University Hospital Centre Zagreb, University of Zagreb School of Medicine

location_facility: M. S. Ramaiah Medical College and Hospital

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: HMCG - Hospital e Maternidade Dr. Christovão da Gama

location_facility: Seoul National University Bundang Hospital

location_facility: University of Szeged, Department of Pediatrics

location_facility: Cukurova University Faculty of Medicine Balcali Hospital Pediatry Department

location_facility: University of Miami Miller School of Medicine

location_facility: IMIP - Instituto de Medicina Integral Professor Fernando Figueira

location_facility: Mother and Child Health Care Institute of Serbia "Dr. Vukan Cupic"

location_facility: Spectrum Health Helen DeVos Children's Hospital Grand Rapids

location_facility: Mersin University Health Research and Practice Hospital

location_facility: Centro Multidisciplinar de Estudos Clínicos - CEMEC

location_facility: Hospital Nacional de Niños Benjamín Bloom

location_facility: Shree Krishna Hospital & Medical Research Centre, H M Patel Centre for Medical Care and Education

location_facility: Semmelweis University 2nd Department of Pediatrics

location_facility: Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University

location_facility: Medical Center for Specialized Ambulatory Medical Assistance for Children's Diseases

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: CI of Healthcare Regional Children CH Gastroenterology Center Kharkiv NMU

location_facility: Ankara Çocuk Sağlığı Ve Hastalıkları Hematoloji Onkoloji Eğitim Araştırma Hastanesi

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: Unidad de Cirugía Cardiovascular de Guatemala (UNICAR)

summary: This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to compare the efficacy and safety of edoxaban against standard of care in pediatric subjects with confirmed VTE.