lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).

ReferenceCitation: Paul C, Reich K, Gottlieb AB, Mrowietz U, Philipp S, Nakayama J, Harfst E, Guettner A, Papavassilis C; CAIN457A2211 study group. Secukinumab improves hand, foot and nail lesions in moderate-to-severe plaque psoriasis: subanalysis of a randomized, double-blind, placebo-controlled, regimen-finding phase 2 trial. J Eur Acad Dermatol Venereol. 2014 Dec;28(12):1670-5. doi: 10.1111/jdv.12359. Epub 2014 Jan 7.

publisher_dissemination: Wiley

title: A Randomized, Double-blind, Placebo Controlled, Multicenter Regimen Finding Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

location_country:
Germany
France
Norway
Japan
United States
Iceland
Israel


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: UCB BIOSCIENCES, Inc.

summary: SP848 is an open-label study to evaluate long-term safety, tolerability, and efficacy in children with epilepsy treated with Lacosamide (LCM) oral solution (syrup) or LCM tablets as adjunctive therapy.

status: Completed

title: An Open-Label Study To Determine Safety, Tolerability And Efficacy Of Long -Term Oral Lacosamide (LCM) As Adjunctive Therapy In Children With Epilepsy

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

study_completion_date_type: Actual

location_country:
Germany
Italy
Poland
Hungary
Japan
Mexico
Belgium
United States
China
Ukraine
France

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


lead_sponsor: Shire

summary: This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.

ReferenceType: background

ReferenceCitation: Jeppesen PB, Sanguinetti EL, Buchman A, Howard L, Scolapio JS, Ziegler TR, Gregory J, Tappenden KA, Holst J, Mortensen PB. Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like peptide 2 analogue, improves intestinal function in short bowel syndrome patients. Gut. 2005 Sep;54(9):1224-31. doi: 10.1136/gut.2004.061440.

ReferenceType: derived

ReferenceCitation: Pape UF, Iyer KR, Jeppesen PB, Kunecki M, Pironi L, Schneider SM, Seidner DL, Lee HM, Caminis J. Teduglutide for the treatment of adults with intestinal failure associated with short bowel syndrome: pooled safety data from four clinical trials. Therap Adv Gastroenterol. 2020 Apr 20;13:1756284820905766. doi: 10.1177/1756284820905766. eCollection 2020.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: SAGE Publications

sponsor_collaborators:
Shire
Nycomed Germany GmbH

location_facility: Med. Klinik m.S. Hepatologie und Gastroenterologie

location_facility: Azienda Universitaria Policlinico Federico II

location_facility: Universitaetsklinikum Tuebingen Medizinische Klinik I

location_facility: Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego

location_facility: University Health Network - Toronto General Hospital

title: A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
United States
Spain
Canada
France


intervention_type: Biological

lead_sponsor: Amgen

summary: This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new or worsening lens opacifications in men with non-metastatic prostate cancer receiving denosumab for bone loss due to androgen deprivation therapy.

title: A Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifications in Subjects With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss Due to Androgen-Deprivation Therapy

primary_purpose: Supportive Care

design_allocation: Randomized

location_country:
Slovenia
Poland
India
New Zealand
Slovakia
Hungary
Australia
Mexico
United States
Latvia
Greece
South Africa
Czechia
Ukraine
Bulgaria
Canada
Russian Federation
France


type: Other Identifier

title: A Phase Ib/II, Open-label Study of the Safety, Tolerability, and Efficacy of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab

summary: This was a multi-institutional, multinational, open-label, single-arm Phase Ib/II study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of trastuzumab emtansine (trastuzumab-MCC-DM1) administered by intravenous (IV) infusion in combination with pertuzumab in patients with human epidermal growth factor receptor-2 (HER2)-positive locally advanced or metastatic breast cancer who had previously received trastuzumab.

design_allocation: Non-Randomized

ReferenceCitation: Miller KD, Dieras V, Harbeck N, Andre F, Mahtani RL, Gianni L, Albain KS, Crivellari D, Fang L, Michelson G, de Haas SL, Burris HA. Phase IIa trial of trastuzumab emtansine with pertuzumab for patients with human epidermal growth factor receptor 2-positive, locally advanced, or metastatic breast cancer. J Clin Oncol. 2014 May 10;32(14):1437-44. doi: 10.1200/JCO.2013.52.6590. Epub 2014 Apr 14.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Hoffmann-La Roche

sponsor_collaborators:
Hoffmann-La Roche
Roche Pharma AG

location_country:
Germany
Italy
Belgium
United States
Spain
Canada
France


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel, Dose-Ranging Study to Evaluate The Efficacy, Safety, Tolerability, and Pharmacodynamics of NBI-6024 In Adult and Adolescent Patients With New Onset Type 1 Diabetes Mellitus

summary:
This was a study designed to evaluate the efficacy of multiple doses of an investigational drug, NBI-6024, in adult (18 to 35 years of age) and adolescent (10 to 17 years of age) patients with new onset type 1 diabetes mellitus, on endogenous insulin production.

A total of 188 patients were enrolled in the study. The study was divided into three periods: screening, treatment (comprising an induction phase and maintenance phase), and follow-up.

NBI-6024 was generally well tolerated and exhibits a benign safety profile, as there were no significant safety issues with NBI-6024 treatment. In summary, NBI-6024 did not demonstrate statistically significant efficacy compared with placebo.

primary_purpose: Basic Science

ReferenceCitation: Walter M, Philotheou A, Bonnici F, Ziegler AG, Jimenez R; NBI-6024 Study Group. No effect of the altered peptide ligand NBI-6024 on beta-cell residual function and insulin needs in new-onset type 1 diabetes. Diabetes Care. 2009 Nov;32(11):2036-40. doi: 10.2337/dc09-0449. Epub 2009 Aug 18.

lead_sponsor: Neurocrine Biosciences

location_country:
Finland
Germany
United Kingdom
Spain
South Africa
Canada
Czech Republic
France

location_facility: Diabetes Center for Children and Adolescents

location_facility: University Hospital and School of Medicine

location_facility: Center Hospitalier Universitaire de Sherbrooke


title: Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction

summary: Prospective, non-interventional, multi-center study. Each subject will be followed for up to twelve months during the treatment with oral hormonal contraceptives(Qlaira ® or a Progestin Only Pill). For each subject demographic data and medical history will be documented at Visit 1: (Baseline). Bleeding profile, subjective assessment of study treatment (satisfaction and wellbeing) and adverse events including unintended pregnancies will be documented at Visit 2 (Month 3-5) and Visit 3 (Month 6-12). Data audit/monitoring will be done.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Bayer

location_country:
Germany
Italy
Slovakia
Hungary
Israel
United Kingdom
Sweden
Greece
Czech Republic
Russian Federation
France


title: A Randomised Double-blind Study to Compare the Analgesic Efficacy and Safety Profiles of M6G and Morphine, as a Loading Dose Followed by PCA, in Patients Suffering Moderate to Severe Post-operative Pain Requiring PCA for at Least 24 Hours

summary: To compare the incidence and severity of nausea in the study treatment groups, during the 18-hour period starting 6 hours after titration to pain relief; following confirmation of the assumption of non-inferiority between the two groups of pain relief over the 24 hour post-operative period. Pain relief and nausea will be determined by measuring the areas under the curves of pain intensity and nausea verbal rating scale scores.

lead_sponsor: Paion UK Ltd.

collaborators:
Chiltern International Ltd.
HFL Ltd.

sponsor_collaborators:
Paion UK Ltd.
Chiltern International Ltd.
HFL Ltd.

location_country:
Germany
Poland
United Kingdom
Netherlands
Czechia
France

location_facility: Teaching Hospital Bulovka, Department of Urology

location_facility: Universitätsklinikum Bonn, Klinik und Poliklinik f. Anaesthesiologie

location_facility: Anaesthetisia - Resuscitation Department, Tenon Hospital

location_facility: Department of Anaesthesiology, Leiden University Medical Centre

location_facility: Intensive Care Unit, Level 5, Western Infirmary,


title: Phase 2 Study of Pemetrexed in Combination With Cisplatin and Cetuximab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

summary: The purpose of this trial is to estimate progression free survival in patients with recurrent or metastatic head and neck cancer that have not received chemotherapy in this setting.

ReferenceCitation: Cristy M, Eckerman KF. 1987. Specific absorbed fractions of energy at various ages from internal sources: I. methods. Prepared by the Oak Ridge National Laboratory, Oak Ridge, Tenn.

ReferenceCitation: Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

ReferenceCitation: Vermorken JB, Licitra L, Stohlmacher-Williams J, Dietz A, Lopez-Picazo JM, Hamid O, Hossain AM, Chang SC, Gauler TC. Phase II study of pemetrexed in combination with cisplatin and cetuximab in recurrent or metastatic squamous cell carcinoma of the head and neck. Eur J Cancer. 2013 Sep;49(13):2877-83. doi: 10.1016/j.ejca.2013.05.002. Epub 2013 May 30.

oa_host_type: closed

publisher_dissemination: Elsevier

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Italy
United Kingdom
Belgium
Spain
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 Study of the AeriSeal System for Lung Volume Reduction in Patients With Advanced Emphysema

summary: The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced emphysema.

ReferenceCitation: Magnussen H, Kramer MR, Kirsten AM, Marquette C, Valipour A, Stanzel F, Bonnet R, Behr J, Fruchter O, Refaely Y, Eberhardt R, Herth FJ. Effect of fissure integrity on lung volume reduction using a polymer sealant in advanced emphysema. Thorax. 2012 Apr;67(4):302-8. doi: 10.1136/thoraxjnl-2011-201038. Epub 2012 Feb 28.

lead_sponsor: Aeris Therapeutics

location_country: Germany Israel Austria France

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice

location_facility: Otto Wagner Spital Wien Interne Lungenabteilung

location_facility: Medizinische Klinik und Poliklinik Klinikum Großhadern

intervention_type: Device


summary: This study will assess the pharmacokinetics/pharmacodynamics and safety of oseltamivir [Tamiflu] therapy in infants less than 1 year of age with influenza diagnosed in the 96 hours prior to the first dose. Patients age 3-12 months will receive 3 mg/kg, 1-3 months will receive 2.5 mg/kg, and birth to 1 month will receive 2 mg/kg twice a day for a total of 10 doses. Patients positive for influenza virus on Day 6 will be eligible to receive continued study treatment for an additional 10 doses (5 days). The anticipated time on study treatment is 4 weeks, and the target sample size is 65-85 male and female infants.

ReferenceCitation: Rath BA, Brzostek J, Guillen S, Niranjan V, Chappey C, Rayner CR, Clinch B. Safety, virology and pharmacokinetics of oseltamivir in infants with laboratory-confirmed influenza: a Phase I/II, prospective, open-label, multicentre clinical trial. Antivir Ther. 2015;20(8):815-25. doi: 10.3851/IMP2967. Epub 2015 May 27.

location_facility: Zespol Opieki Zdrowotnej Debica; Oddzial Dzieciecy

location_facility: Fondazione Ospedale Maggiore Policlinico

location_facility: Onkologische Schwerpunktpraxis Dr. Med. O. Burkhard & B. Reimann

location_facility: CAMPUS VIRCHOW-KLINIKUM CharitéCentrum 17 Klinik f.Pädiatrie Abt.Pneumologie u.Immunologie

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Intermedios y Urgencias Pediatricas

location_facility: Hospital Universitario de Getafe; Servicio de Pediatria

location_facility: Samodzielny Publiczny Zakład Opieki; Wcześniaków I Intensywnej Terapii

location_facility: Hôpital Femme Mère Enfant; Service de rhumatologie pédiatrique

title: An Open Label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Oseltamivir (Tamiflu®) in the Treatment of Infants 0 to <12 Months of Age With Confirmed Influenza Infection

location_country: Germany Italy Poland Belgium Spain France


title: CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients

summary:
The aim of this study is to obtain data from hospitalized Community Acquired Pneumonia (CAP) patients on the disease including disease severity, clinical signs and symptoms and measures used for diagnosis in daily routine practice as well as data on Avelox® including information on the use, effectiveness, treatment outcome, safety and tolerability.

As this is a non-interventional observational study, routine clinical practice is observed. The application of medications follows the normal routines and is decided by the treating physician under recognition of the package insert.

ReferenceType: result

ReferenceCitation: Kuzman I, Bezlepko A, Kondova Topuzovska I, Rokusz L, Iudina L, Marschall HP, Petri T. Efficacy and safety of moxifloxacin in community acquired pneumonia: a prospective, multicenter, observational study (CAPRIVI). BMC Pulm Med. 2014 Jun 30;14:105. doi: 10.1186/1471-2466-14-105.

license: cc-by

license_normalized: cc-by

version: acceptedVersion

repositories_concat: PubMed Central;medlib.mef.hr

publisher_dissemination: Springer

location_country: Macedonia, The Former Yugoslav Republic of


title: A Randomized, 6-Week, Double-Blind, Placebo- Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression

summary: This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I depression.

ReferenceCitation: Loebel A, Cucchiaro J, Silva R, Kroger H, Sarma K, Xu J, Calabrese JR. Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):169-77. doi: 10.1176/appi.ajp.2013.13070985.

publisher_dissemination: American Psychiatric Association Publishing

ReferenceCitation: Sajatovic M, Forester BP, Tsai J, Kroger H, Pikalov A, Cucchiaro J, Loebel A. Efficacy of Lurasidone in Adults Aged 55 Years and Older With Bipolar Depression: Post Hoc Analysis of 2 Double-Blind, Placebo-Controlled Studies. J Clin Psychiatry. 2016 Oct;77(10):e1324-e1331. doi: 10.4088/JCP.15m10261.

publisher_dissemination: Physicians Postgraduate Press, Inc

ReferenceCitation: Rajagopalan K, Bacci ED, Ng-Mak D, Wyrwich K, Pikalov A, Loebel A. Effects on health-related quality of life in patients treated with lurasidone for bipolar depression: results from two placebo controlled bipolar depression trials. BMC Psychiatry. 2016 May 23;16:157. doi: 10.1186/s12888-016-0865-y.

publisher_dissemination: Springer-Nature

ReferenceCitation: Chapel S, Chiu YY, Hsu J, Cucchiaro J, Loebel A. Lurasidone Dose Response in Bipolar Depression: A Population Dose-response Analysis. Clin Ther. 2016 Jan 1;38(1):4-15. doi: 10.1016/j.clinthera.2015.11.013. Epub 2015 Dec 22.

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

lead_sponsor: Sumitomo Pharma America, Inc.

location_country:
Germany
Poland
India
Romania
United States
South Africa
Ukraine
Czech Republic
Russian Federation
France

location_facility: Albuquerque Neuroscience Inc.,101 Hospital Loop, Suite 209

location_facility: Mental Illness Treatment Rehabilitation Foundation (MITR)

location_facility: Reg. Clinic Psych. Hosp., Dept 11, DNMU n.a.M. Gorkiy

location_facility: Spitalul Clinic Judetean de Urgenta Cluj

location_facility: Spitalul Clinic de Urgenta Militar Central "Prof. Dr. Carol" Psihiatrie

location_facility: Hopital Caremeau, Service de Psychiatrie A

location_facility: Spitalul Clinic de Neuropsihiatrie Craiova

location_facility: City Psychiatric Hospital #2 of St. Nikolay Chudotvorets

location_facility: Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM

location_facility: LLC International Medical Centre "SOGAZ"

location_facility: University of California at Irvine Medical Center

location_facility: Odesa Regional Psychoneurological Dispensary

location_facility: Depression and Anxiety Disorders Research Institue

location_facility: American Medical Research, Inc., 1200 Harger Road Suite 415

location_facility: Lake Charles Clinical Trials LLC,700 Spring Forest Road

location_facility: Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry

location_facility: Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia

location_facility: Spitalul Judetean de Urgenta Pitesti Sectia de Psihiatric

location_facility: Vijayawada Institute of Mental Health and Neurosciences, Psychiatry

location_facility: CRI"Cl. Psych.Hosp.#1, Fem Psych.Dept.#2, Male Psych.Dept.#1

location_facility: Bekhterev Scientific Research Psychoneurological Institute

location_facility: Collaborative Neuroscience Network Inc.,12772 Valley View Street

location_facility: Capital Clinical Research,5515 Security Lane, Suite 525

location_facility: Moscow Medical Academy named I.M. Sechenov

location_facility: Richard H. Weisler , M.D., PA.,& Associates, 700 Spring Forest Road, Suite 125

location_facility: Sheppard Pratt Health System,6501 North Charles Street

location_facility: CNRI - Los Angeles LLC,8309 Telegraph Road

location_facility: Reg. Psych. Hosp. n.a. O.Yuschenko, Dept. #21, VNMUn.a.M. Pirog

location_facility: R.K. Yadav Memorial Mental Health & De-Addiction Hospital

location_facility: Spitalul Clinic de Neurologie si Psihiatrie Oradea

location_facility: FutureSearch Clinical Trials, LLC., 4200 Marathon Blvd., Suite 200

location_facility: American Medical Research Inc.,1200 Harger Road Suite 415

location_facility: Midwest Clinical research Center, One Elizabeth Place, Suite G-3


title: An Open-label, Multicenter Phase II Extension of Study 28063 (ATAMS) to Obtain Long-term Follow-up Data in Subjects With Relapsing Multiple Sclerosis Treated With Atacicept for up to 5 Years (ATAMS-Extension)

acronym: ATAMS ext

summary:
This study (28851) is a long-term follow-up study of subjects enrolled in ATAMS study 28063 (NCT00642902). The aim of this study is to monitor the safety and tolerability of atacicept administered for up to 5 years to subjects with relapsing multiple sclerosis (RMS).

This extension study consists of two parts. Part A will be double blind and Part B will be open label. During Part A, subjects initially randomized to atacicept will continue to receive the atacicept dose to which they have been randomized in study 28063 (ATAMS) once a week subcutaneously (under the skin). Subjects randomized to placebo in ATAMS will receive atacicept at 150 mg once a week subcutaneously during Part A. Once the results of ATAMS are available and the atacicept dose with the best benefit / risk ratio has been identified, all subjects will be switched to this dose and will continue the extension study open-label (Part B). Throughout the study, subjects and investigators will remain blinded with respect to initial and part A treatment allocation/dose.

status: Terminated

ReferenceCitation: Kappos L, Hartung HP, Freedman MS, Boyko A, Radu EW, Mikol DD, Lamarine M, Hyvert Y, Freudensprung U, Plitz T, van Beek J; ATAMS Study Group. Atacicept in multiple sclerosis (ATAMS): a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Neurol. 2014 Apr;13(4):353-63. doi: 10.1016/S1474-4422(14)70028-6. Epub 2014 Mar 6.

lead_sponsor: EMD Serono

sponsor_collaborators:
EMD Serono
Merck KGaA, Darmstadt, Germany

location_country:
France
Germany
Lithuania
United Kingdom
Australia
Sweden
Netherlands
Lebanon
Belgium
Switzerland
United States
Spain
Ukraine
Canada
New Caledonia
Russian Federation
Czech Republic

status_simplified: Unknown


title: Model 4396 Left Ventricular Lead Study

summary: This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe and effective. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Italy
Denmark
Australia
Austria
United States
Saudi Arabia
Canada
France


acronym: DIONE

lead_sponsor: Tibotec Pharmaceuticals, Ireland

summary: The purpose of this study is to evaluate pharmacokinetics (what body does to medication), safety, tolerability, and efficacy (effectiveness) of darunavir with low-dose ritonavir (DRV/rtv) administered once daily, in combination with an investigator-selected background regimen consisting of other antiretrovirals (ARVs) ie, 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), in treatment-naive (never treated before) HIV-1 infected adolescents aged from 12 to <18 years and weighing at least 40 kg.

sponsor_collaborators:
Tibotec Pharmaceuticals, Ireland
Tibotec Pharmaceutical Limited

title: A Phase II, Open-Label Trial, to Evaluate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Drv/Rtv Once Daily in Treatment-Naive HIV-1 Infected Adolescents Aged Between 12 and < 18 Years

location_country:
Ireland
United Kingdom
United States
Spain
Ukraine
France


summary: This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in patients <18 years of age who have relapsed or refractory acute leukemias that may benefit from administration of midostaurin, including MLL-rearranged ALL and FLT3 positive AML.

location_facility: Seattle Children's Hospital CPKC412A2114

title: A Phase I/II, Open-label, Dose-escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Twice Daily Oral Midostaurin and to Evaluate the Preliminary Clinical and Pharmacodynamic Response in Pediatric Patients With Relapsed or Refractory Leukemia

location_country:
France
Italy
Netherlands
United States
Sweden


title: A Prospective, Multi-center Study to Evaluate the Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse

summary: The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.

ReferenceCitation: Milani AL, Hinoul P, Gauld JM, Sikirica V, van Drie D, Cosson M; Prolift+M Investigators. Trocar-guided mesh repair of vaginal prolapse using partially absorbable mesh: 1 year outcomes. Am J Obstet Gynecol. 2011 Jan;204(1):74.e1-8. doi: 10.1016/j.ajog.2010.08.036. Epub 2010 Oct 20.

lead_sponsor: Ethicon, Inc.

location_country: Germany Netherlands Belgium France

location_facility:
Kreiskrankenhaus
Sint Lodewijkstraat 78
Martin Luther University
Reinier de Graaf Gasthuis
St. Marien-Hospital
DRT Krankenhaus
CHRU de Lille
Universitatsklinik Tubingen


title: International Randomized Study to Compare CyberKnife® Stereotactic Radiotherapy With Surgical Resection in Stage I Non-small Cell Lung Cancer

acronym: STARS

summary: Lung cancer remains the most frequent cause of cancer death in both men and women in the world. Surgical resection using lobectomy with mediastinal lymph node dissection or sampling has been a standard of care for operable early stage NSCLC. Several studies have reported high local control and survival using SBRT in stage I NSCLC patients. SBRT is now an accepted treatment for medically inoperable patients with stage I NSCLC and patients with operable stage I lung cancer are entered on clinical protocols. The purpose of this study is to conduct a phase III randomized study to compare CyberKnife SBRT with surgery, the current standard of care for stage I operable NSCLC.

ReferenceCitation: Park S, Kim HJ, Park IK, Kim YT, Kang CH. Stereotactic ablative radiotherapy versus surgery in older patients with stage I lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):74-80. doi: 10.1093/ejcts/ezab045.

publisher_dissemination: Oxford University Press

ReferenceCitation: Chang JY, Senan S, Paul MA, Mehran RJ, Louie AV, Balter P, Groen HJ, McRae SE, Widder J, Feng L, van den Borne BE, Munsell MF, Hurkmans C, Berry DA, van Werkhoven E, Kresl JJ, Dingemans AM, Dawood O, Haasbeek CJ, Carpenter LS, De Jaeger K, Komaki R, Slotman BJ, Smit EF, Roth JA. Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: a pooled analysis of two randomised trials. Lancet Oncol. 2015 Jun;16(6):630-7. doi: 10.1016/S1470-2045(15)70168-3. Epub 2015 May 13. Erratum In: Lancet Oncol. 2015 Sep;16(9):e427.

oa_host_type: repository

unpaywall_oa_status: green

lead_sponsor: Accuray Incorporated

sponsor_collaborators:
Accuray Incorporated
M.D. Anderson Cancer Center

location_country:
United States
China
Taiwan
France

location_facility: CyberKnife Center of WanFang Medical Hospital

intervention_type: Procedure


acronym: REFLEXION

lead_sponsor: Merck KGaA, Darmstadt, Germany

summary: REFLEXION is a double blind extension of the study 27025 (NCT00404352) (REFLEX). The purpose of the study is to obtain long-term follow-up data in subjects with clinically definite multiple sclerosis (MS) and subjects with a first demyelinating event at high risk of converting to MS, treated with fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF).

ReferenceCitation: Comi G, De Stefano N, Freedman MS, Barkhof F, Uitdehaag BM, de Vos M, Marhardt K, Chen L, Issard D, Kappos L. Subcutaneous interferon beta-1a in the treatment of clinically isolated syndromes: 3-year and 5-year results of the phase III dosing frequency-blind multicentre REFLEXION study. J Neurol Neurosurg Psychiatry. 2017 Apr;88(4):285-294. doi: 10.1136/jnnp-2016-314843. Epub 2016 Dec 30.

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: University of Oxford - Oxford Academic Notes & Queries

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery;open-archive.highwire.org

publisher_dissemination: British Medical Journal

location_facility:
Research Site
Reserch Site

title: Double-blind Extension of the Study 27025 (REFLEX) to Obtain Long-term Follow-up Data in Patients With Clinically Definite MS and Patients With a First Demyelinating Event at High Risk of Converting to MS, Treated With Rebif® New Formulation (REFLEXION)

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


title: Prognostic Significance and Longitudinal Assessment of Patient-reported Quality of Life and Symptoms in Myelodysplastic Syndromes. A Large-scale International, Observational Study: PROMYS Study

acronym: PROMYS

summary:
RATIONALE: Gathering information about quality of life, fatigue, and other symptoms from patients with myelodysplastic syndromes may help doctors learn more about the disease and may help plan treatment.

PURPOSE: This clinical trial is studying quality of life and symptoms in patients with newly diagnosed myelodysplastic syndromes.

status: Unknown status

study_completion_date_type: Anticipated

ReferenceCitation: Efficace F, Gaidano G, Sprangers M, Cottone F, Breccia M, Voso MT, Caocci G, Stauder R, Di Tucci AA, Sanpaolo G, Selleslag D, Angelucci E, Platzbecker U, Mandelli F. Preference for involvement in treatment decisions and request for prognostic information in newly diagnosed patients with higher-risk myelodysplastic syndromes. Ann Oncol. 2014 Feb;25(2):447-54. doi: 10.1093/annonc/mdt557.

ReferenceCitation: Caocci G, Voso MT, Angelucci E, Stauder R, Cottone F, Abel G, Nguyen K, Platzbecker U, Beyne-Rauzy O, Gaidano G, Invernizzi R, Molica S, Criscuolo M, Breccia M, Lubbert M, Sanpaolo G, Buccisano F, Ricco A, Palumbo GA, Niscola P, Zhang H, Fenu S, La Nasa G, Mandelli F, Efficace F. Accuracy of physician assessment of treatment preferences and health status in elderly patients with higher-risk myelodysplastic syndromes. Leuk Res. 2015 Aug;39(8):859-65. doi: 10.1016/j.leukres.2015.05.012. Epub 2015 Jun 12.

ReferenceCitation: Efficace F, Gaidano G, Breccia M, Criscuolo M, Cottone F, Caocci G, Bowen D, Lubbert M, Angelucci E, Stauder R, Selleslag D, Platzbecker U, Sanpaolo G, Jonasova A, Buccisano F, Specchia G, Palumbo GA, Niscola P, Wan C, Zhang H, Fenu S, Klimek V, Beyne-Rauzy O, Nguyen K, Mandelli F. Prevalence, severity and correlates of fatigue in newly diagnosed patients with myelodysplastic syndromes. Br J Haematol. 2015 Feb;168(3):361-70. doi: 10.1111/bjh.13138. Epub 2014 Oct 1.

ReferenceCitation: Efficace F, Gaidano G, Breccia M, Voso MT, Cottone F, Angelucci E, Caocci G, Stauder R, Selleslag D, Sprangers M, Platzbecker U, Ricco A, Sanpaolo G, Beyne-Rauzy O, Buccisano F, Palumbo GA, Bowen D, Nguyen K, Niscola P, Vignetti M, Mandelli F. Prognostic value of self-reported fatigue on overall survival in patients with myelodysplastic syndromes: a multicentre, prospective, observational, cohort study. Lancet Oncol. 2015 Nov;16(15):1506-1514. doi: 10.1016/S1470-2045(15)00206-5. Epub 2015 Sep 21.

ReferenceCitation: Efficace F, Cottone F, Abel G, Niscola P, Gaidano G, Bonnetain F, Anota A, Caocci G, Cronin A, Fianchi L, Breccia M, Stauder R, Platzbecker U, Palumbo GA, Luppi M, Invernizzi R, Bergamaschi M, Borin L, Di Tucci AA, Zhang H, Sprangers M, Vignetti M, Mandelli F. Patient-reported outcomes enhance the survival prediction of traditional disease risk classifications: An international study in patients with myelodysplastic syndromes. Cancer. 2018 Mar 15;124(6):1251-1259. doi: 10.1002/cncr.31193. Epub 2017 Dec 12.

ReferenceCitation: Efficace F, Cottone F, Oswald LB, Cella D, Patriarca A, Niscola P, Breccia M, Platzbecker U, Palumbo GA, Caocci G, Stauder R, Ricco A, Petranovic D, Caers J, Luppi M, Fianchi L, Frairia C, Capodanno I, Follini E, Sarlo C, Fazi P, Vignetti M. The IPSS-R more accurately captures fatigue severity of newly diagnosed patients with myelodysplastic syndromes compared with the IPSS index. Leukemia. 2020 Sep;34(9):2451-2459. doi: 10.1038/s41375-020-0746-8. Epub 2020 Feb 21.

lead_sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

location_country:
Germany
Italy
United Kingdom
Brazil
Austria
Belgium
United States
China
Croatia
Taiwan
Czechia
France

location_facility: Università degli Studi - Policlinico di Tor Vergata

location_facility: Saint - Cloud Medecin des CLCC Hematologie Service E Hopital ReneHuguenin - Institut Curie

location_facility: Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova - Irccs - Sc Ematologia

location_facility: Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

location_facility: ASL N.8 - Ospedale "A. Businco" - Unità Operativa di Ematologia e Trapianto di Midollo

location_facility: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

location_facility: Aou Città Della Salute E Della Scienza - Ospedale S. Giovanni Battista Molinette

location_facility: AZ Sint-Jan AV, Department of Hematology

location_facility: Divisione di Ematologia Ospedale "Santa Maria Goretti"

location_facility: Divisione Ematologia - Azienda Ospedaliera Universitaria "San Martino""

location_facility: Purpan Hospital - Internal Medicine Department

location_facility: Divisione Ematologia - Università Campus Bio-Medico

location_facility: Complesso Ospedaliero S. Giovanni Addolorata

location_facility: ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia

location_facility: Asst Di Monza - Ospedale S. Eugenio - Uo Ematologia E Cta

location_facility: Ematologia - Dipartimento di Medicina Clinica e Sperimentale

location_facility: SOS Dipartimento di Oncoematologia Osp. Rovigo

location_facility: Università degli Studi "La Sapienza" - Dip. Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia

location_facility: Curitiba Unidade de Hematologia - Hemoterapia e Oncologia. Setor de Transplante de Medula Ossea. Complexo Hospital de Clinicas da Universidade Federal do Parana (CHC-UFPR)

location_facility: Aou Arcispedale Sant'Anna - Uoc Ematologia E Fisiopatologia Della Coagulazione

location_facility: Asl Di Asti - Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia

location_facility: Memorial Sloan-Kettering Cancer Center (MSKCC)

location_facility: Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST

location_facility: Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo

location_facility: U.O.A. di Medicina Trasfusionale e DH di Ematologia - ASL TO 4 Ospedale di Ivrea

location_facility: Hematology - Clinical Hospital Centre Rijeka - Faculty of Medicine - University of Rijeka

location_facility: UO Ematologia - AOU Policlinico di Modena

location_facility: Asl Di Piacenza - Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti

location_facility: U.O. Ematologia e Trapianto di Midollo - Ist. Scientifico Ospedale San Raffaele

location_facility: Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo

location_facility: The University of Texas, MD Anderson Cancer Center

location_facility: Unità Operativa Ematologia 1 - Università degli Studi di Bari

location_facility: S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

location_facility: Department of Hematology - Universitatsklinikum Carl Gustav Carus

intervention_type: Other


title: A Multicenter, Multinational, Longitudinal Clinical Assessment Study of Subjects With Mucopolysaccharidosis IVA (Morquio Syndrome)

summary: This multicenter, multinational, longitudinal study will quantify endurance and respiratory function in subjects diagnosed with MPS IVA and will better characterize the spectrum of symptoms and biochemical abnormalities in MPS IVA disease over time.

ReferenceCitation: Martell LA, Cunico RL, Ohh J, Fulkerson W, Furneaux R, Foehr ED. Validation of an LC-MS/MS assay for detecting relevant disaccharides from keratan sulfate as a biomarker for Morquio A syndrome. Bioanalysis. 2011 Aug;3(16):1855-66. doi: 10.4155/bio.11.172.

lead_sponsor: BioMarin Pharmaceutical

location_country:
Germany
Italy
United Kingdom
Argentina
Brazil
Netherlands
United States
Taiwan
Canada
France


lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study was to determine the efficacy and safety of twice daily (bid) oral midostaurin in patients with Aggressive Systemic Mastocytosis (ASM) or Mast Cell Leukemia (MCL) with or without an Associated Hematological clonal Non-Mast cell lineage Disease (AHNMD).

ReferenceCitation: Hartmann K, Gotlib J, Akin C, Hermine O, Awan FT, Hexner E, Mauro MJ, Menssen HD, Redhu S, Knoll S, Sotlar K, George TI, Horny HP, Valent P, Reiter A, Kluin-Nelemans HC. Midostaurin improves quality of life and mediator-related symptoms in advanced systemic mastocytosis. J Allergy Clin Immunol. 2020 Aug;146(2):356-366.e4. doi: 10.1016/j.jaci.2020.03.044. Epub 2020 May 11.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

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

ReferenceCitation: Gotlib J, Kluin-Nelemans HC, George TI, Akin C, Sotlar K, Hermine O, Awan FT, Hexner E, Mauro MJ, Sternberg DW, Villeneuve M, Huntsman Labed A, Stanek EJ, Hartmann K, Horny HP, Valent P, Reiter A. Efficacy and Safety of Midostaurin in Advanced Systemic Mastocytosis. N Engl J Med. 2016 Jun 30;374(26):2530-41. doi: 10.1056/NEJMoa1513098.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

location_facility: Oregon Health and Science University Dept. Hematologic Malignancies

location_facility: Stanford University Medical Center Stanford University 2

location_facility: Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia

location_facility: Memorial Sloan Kettering Cancer Center Dept. of MSKCC (2)

location_facility: University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(3)

location_facility: University of California at Los Angeles Dept. of Hematology Clinic

location_facility: Dana Farber Cancer Institute Hematology / Oncology

title: A Single Arm, Phase II, Open-Label Study to Determine the Efficacy of 100mg Twice Daily Oral Dosing of Midostaurin Administered to Patients With Aggressive Systemic Mastocytosis or Mast Cell Leukemia +/- an Associated Hematological Clonal Non-Mast Cell Lineage Disease

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Germany
Poland
Norway
United Kingdom
Australia
Netherlands
Austria
Belgium
United States
Turkey
Canada
France

ipd_sharing: Undecided


title: Comparison of Three Therapeutic Strategies for Treating Type 2 Diabetes Mellitus Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs

acronym: OSIRIS

summary:
Primary objectives :

To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin combined with 3 bolus of insulin glulisine (Arm 1), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs.
To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin and insulin secretagogue (sulfonylurea or glinide) combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 3), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs.

Secondary objectives :

To compare between the 3 treatment groups: evolution of HbA1c over time, percentage of subjects with HbA1c <= 7% at the end of the study, evolution of blood glucose profiles, incidence of hypoglycemia, insulin doses, evolution of body weight and treatment satisfaction.

lead_sponsor: Sanofi

location_country:
Germany
Ireland
Italy
Lithuania
Poland
Hungary
United Kingdom
Sweden
Netherlands
Mexico
Belgium
Korea, Republic of
Spain
Greece
Turkey
Taiwan
Russian Federation
France


title: Phase 2 Study of Weekly Oxaliplatin and Capecitabine (XELOX) in Combination With Preoperative Radiotherapy in Patients With MRI Defined Locally Advanced Rectal Cancer

summary:
Primary objective:

Pathological complete response (ypT0N0) rate

Secondary objectives:

Histopathological R0 resection rate
Pathological downstaging (ypT0-T2N0) rate
One month surgical complication rate
Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes
Safety
Local and distant recurrence rates
Progression-free survival
Overall survival

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
Spain
France


title: Randomized Clinical Trial Comparing Surveillance and Selective Surgical Treatment for Abdominal Aortic Aneurysms Less Than 5.5 cm in Diameter Versus Early Endovascular Treatment

acronym: CAESAR

summary: Objective of the present study is to compare endovascular repair versus surveillance and, eventually delay treatment in patients with small abdominal aortic aneurysms (AAA), with respect to patient survival, AAA rupture and AAA related death risks.

ReferenceCitation: Alcorn HG, Wolfson SK Jr, Sutton-Tyrrell K, Kuller LH, O'Leary D. Risk factors for abdominal aortic aneurysms in older adults enrolled in The Cardiovascular Health Study. Arterioscler Thromb Vasc Biol. 1996 Aug;16(8):963-70. doi: 10.1161/01.atv.16.8.963.

ReferenceCitation: Scott RA, Wilson NM, Ashton HA, Kay DN. Is surgery necessary for abdominal aortic aneurysm less than 6 cm in diameter? Lancet. 1993 Dec 4;342(8884):1395-6. doi: 10.1016/0140-6736(93)92756-j.

ReferenceCitation: United Kingdom Small Aneurysm Trial Participants; Powell JT, Brady AR, Brown LC, Fowkes FG, Greenhalgh RM, Ruckley CV, Thompson SG. Long-term outcomes of immediate repair compared with surveillance of small abdominal aortic aneurysms. N Engl J Med. 2002 May 9;346(19):1445-52. doi: 10.1056/NEJMoa013527.

ReferenceCitation: Mortality results for randomised controlled trial of early elective surgery or ultrasonographic surveillance for small abdominal aortic aneurysms. The UK Small Aneurysm Trial Participants. Lancet. 1998 Nov 21;352(9141):1649-55.

ReferenceCitation: Lederle FA, Wilson SE, Johnson GR, Reinke DB, Littooy FN, Acher CW, Ballard DJ, Messina LM, Gordon IL, Chute EP, Krupski WC, Busuttil SJ, Barone GW, Sparks S, Graham LM, Rapp JH, Makaroun MS, Moneta GL, Cambria RA, Makhoul RG, Eton D, Ansel HJ, Freischlag JA, Bandyk D; Aneurysm Detection and Management Veterans Affairs Cooperative Study Group. Immediate repair compared with surveillance of small abdominal aortic aneurysms. N Engl J Med. 2002 May 9;346(19):1437-44. doi: 10.1056/NEJMoa012573.

ReferenceCitation: EVAR trial participants. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomised controlled trial. Lancet. 2005 Jun 25-Jul 1;365(9478):2179-86. doi: 10.1016/S0140-6736(05)66627-5.

ReferenceCitation: De Rango P, Verzini F, Parlani G, Cieri E, Romano L, Loschi D, Cao P; Comparison of surveillance vs. Aortic Endografting for Small Aneurysm Repair (CAESAR) Investigators. Quality of life in patients with small abdominal aortic aneurysm: the effect of early endovascular repair versus surveillance in the CAESAR trial. Eur J Vasc Endovasc Surg. 2011 Mar;41(3):324-31. doi: 10.1016/j.ejvs.2010.11.005. Epub 2010 Dec 9.

ReferenceCitation: Cao P, De Rango P, Verzini F, Parlani G, Romano L, Cieri E; CAESAR Trial Group. Comparison of surveillance versus aortic endografting for small aneurysm repair (CAESAR): results from a randomised trial. Eur J Vasc Endovasc Surg. 2011 Jan;41(1):13-25. doi: 10.1016/j.ejvs.2010.08.026. Epub 2010 Sep 25.

lead_sponsor: University Of Perugia

sponsor_collaborators:
University Of Perugia
William Cook Europe

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Netherlands
Spain
Czech Republic
France

location_facility: Chirurgia Vascolare, Ospedale San Donato

location_facility: Klinik Fuer Gefasschirurgie st.Franziskus Hospital

location_facility: Chirurgia Vascolare Ospedale San Giovanni di Dio

location_facility: S.C. Chirurgia Vascolare Az Osp. S.Maria Nuova

location_facility: Vitkovice Hospital Ostrava and University Hospital Ostrava - Poruba

location_facility: Naczyniowej i Transplantacyjnej Akademii Medycznej

location_facility: S.C. Chirurgia Vascolare - Università di Perugia

location_facility: Azienda Ospedaliera "Antonio Cardarelli"

location_facility: Policlinico Le Scotte - U.O. Chirurgia Vascolare

location_facility: Institute of Cardiovascular Disease Hospital Clinic University of Barcelona

location_facility: Klinika Chirurgii ogolnej i Chorob Klatki Piersiowej Warsaw

lead_sponsor_type: academique


acronym: COMPLEMENT 1

summary: The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.

ReferenceCitation: Tausch E, Beck P, Schlenk RF, Jebaraj BJ, Dolnik A, Yosifov DY, Hillmen P, Offner F, Janssens A, Babu GK, Grosicki S, Mayer J, Panagiotidis P, McKeown A, Gupta IV, Skorupa A, Pallaud C, Bullinger L, Mertens D, Dohner H, Stilgenbauer S. Prognostic and predictive role of gene mutations in chronic lymphocytic leukemia: results from the pivotal phase III study COMPLEMENT1. Haematologica. 2020 Oct 1;105(10):2440-2447. doi: 10.3324/haematol.2019.229161.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: Max-Delbrueck-Center for Molecular Medicine - MDC Repository

repositories_concat: LIRIAS (KU Leuven);PubMed Central;archive.ugent.be;edoc.mdc-berlin.de;eprints.whiterose.ac.uk

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Hillmen P, Robak T, Janssens A, Babu KG, Kloczko J, Grosicki S, Doubek M, Panagiotidis P, Kimby E, Schuh A, Pettitt AR, Boyd T, Montillo M, Gupta IV, Wright O, Dixon I, Carey JL, Chang CN, Lisby S, McKeown A, Offner F; COMPLEMENT 1 Study Investigators. Chlorambucil plus ofatumumab versus chlorambucil alone in previously untreated patients with chronic lymphocytic leukaemia (COMPLEMENT 1): a randomised, multicentre, open-label phase 3 trial. Lancet. 2015 May 9;385(9980):1873-83. doi: 10.1016/S0140-6736(15)60027-7. Epub 2015 Apr 14.

ReferenceCitation: Jewell RC, Laubscher K, Lewis E, Fang L, Gafoor Z, Carey J, McKeown A, West S, Wright O, Sedoti D, Dixon I, Hottenstein CS, Chan G. Assessment of the effect of ofatumumab on cardiac repolarization. J Clin Pharmacol. 2015 Jan;55(1):114-21. doi: 10.1002/jcph.376. Epub 2014 Aug 21.

title: A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Added to Chlorambucil Versus Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia

location_country:
Germany
Ireland
Italy
Poland
India
United Kingdom
Brazil
Netherlands
Sweden
Belgium
United States
Spain
Greece
Czechia
Canada
Russian Federation
France

ipd_sharing: Yes


title: An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving HERCEPTIN-Containing Regimens

summary: This study was designed to determine the efficacy of an oral dual kinase inhibitor for the treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a refractory patient population.

lead_sponsor: GlaxoSmithKline

location_country:
Argentina
United Kingdom
Germany
France


title: A Prospective Randomised Controlled Trial Of Hyperfractionated Versus Conventionally Fractionated Radiotherapy In Standard Risk Medulloblastoma

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy in different ways with combination chemotherapy may kill any remaining tumor cells following surgery. It is not yet known which radiation therapy regimen combined with combination chemotherapy is more effective in treating medulloblastoma.

PURPOSE: Randomized phase III trial to compare different radiation therapy regimens plus combination chemotherapy in treating children who have undergone surgery for medulloblastoma.

enrollment_type: Anticipated

lead_sponsor: University of Leicester

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
Belgium
Spain
France

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Royal Liverpool Children's Hospital, Alder Hey


title: A Multi-National Randomized Phase-III GCIG Intergroup-Study Comparing 1st-line Chemotherapy With Gemcitabine/Paclitaxel/Carboplatin vs Paclitaxel/Carboplatin In Previously Untreated Patients With Epithelial Ovarian Cancer FIGO Stages I-IV

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel combined with gemcitabine is more effective than carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel combined with gemcitabine to see how well it works compared to paclitaxel and carboplatin alone in treating patients who have undergone surgery for ovarian epithelial or fallopian tube cancer.

ReferenceCitation: du Bois A, Herrstedt J, Hardy-Bessard AC, Muller HH, Harter P, Kristensen G, Joly F, Huober J, Avall-Lundqvist E, Weber B, Kurzeder C, Jelic S, Pujade-Lauraine E, Burges A, Pfisterer J, Gropp M, Staehle A, Wimberger P, Jackisch C, Sehouli J. Phase III trial of carboplatin plus paclitaxel with or without gemcitabine in first-line treatment of epithelial ovarian cancer. J Clin Oncol. 2010 Sep 20;28(27):4162-9. doi: 10.1200/JCO.2009.27.4696. Epub 2010 Aug 23.

ReferenceCitation: Machelon V, Gaudin F, Camilleri-Broet S, Nasreddine S, Bouchet-Delbos L, Pujade-Lauraine E, Alexandre J, Gladieff L, Arenzana-Seisdedos F, Emilie D, Prevot S, Broet P, Balabanian K. CXCL12 expression by healthy and malignant ovarian epithelial cells. BMC Cancer. 2011 Mar 16;11:97. doi: 10.1186/1471-2407-11-97.

lead_sponsor: AGO Study Group

collaborators: Nordic Society of Gynaecological Oncology - Clinical Trials Unit

collaborators: GERCOR - Multidisciplinary Oncology Cooperative Group

location_country: Germany Denmark Norway France

location_facility: Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen

location_facility: University Hospital Schleswig-Holstein - Kiel Campus

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen

location_facility: Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

location_facility: Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe - Universitaetsklinikum Muenster

location_facility: Herlev Hospital - University Hospital of Copenhagen

location_facility: Staedtische Kliniken Frankfurt am Main - Hoechst


lead_sponsor: Pfizer

summary: The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer

ReferenceCitation: Finn RS, Rugo HS, Gelmon KA, Cristofanilli M, Colleoni M, Loi S, Schnell P, Lu DR, Theall KP, Mori A, Gauthier E, Bananis E, Turner NC, Dieras V. Long-Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow-Up. Oncologist. 2021 May;26(5):e749-e755. doi: 10.1002/onco.13684. Epub 2021 Mar 10.

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_institution: University of Melbourne - Minerva Access

ReferenceCitation: Finn RS, Boer K, Bondarenko I, Patel R, Pinter T, Schmidt M, Shparyk YV, Thummala A, Voitko N, Bananis E, McRoy L, Wilner K, Huang X, Kim S, Slamon DJ, Ettl J. Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first-line treatment of ER+/HER2- advanced breast cancer (PALOMA-1, TRIO-18). Breast Cancer Res Treat. 2020 Sep;183(2):419-428. doi: 10.1007/s10549-020-05755-7. Epub 2020 Jul 18.

repository_institution: Technische Universität München - mediaTUM Gesamtbestand

repositories_concat: PubMed Central;mediatum.ub.tum.de

ReferenceCitation: Ettl J, Im SA, Ro J, Masuda N, Colleoni M, Schnell P, Bananis E, Lu DR, Cristofanilli M, Rugo HS, Finn RS. Hematologic adverse events following palbociclib dose reduction in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: pooled analysis from randomized phase 2 and 3 studies. Breast Cancer Res. 2020 Mar 12;22(1):27. doi: 10.1186/s13058-020-01263-0.

repository_institution: Technical University Munich - mediaTUM – the media and publications repository of the Technical University Munich

repository_institution: Seoul National University - Seoul National University Open Repository

ReferenceCitation: Rugo HS, Turner NC, Finn RS, Joy AA, Verma S, Harbeck N, Masuda N, Im SA, Huang X, Kim S, Sun W, Iyer S, Schnell P, Bartlett CH, Johnston S. Palbociclib plus endocrine therapy in older women with HR+/HER2- advanced breast cancer: a pooled analysis of randomised PALOMA clinical studies. Eur J Cancer. 2018 Sep;101:123-133. doi: 10.1016/j.ejca.2018.05.017. Epub 2018 Jul 25.

ReferenceCitation: Dieras V, Rugo HS, Schnell P, Gelmon K, Cristofanilli M, Loi S, Colleoni M, Lu DR, Mori A, Gauthier E, Huang Bartlett C, Slamon DJ, Turner NC, Finn RS. Long-term Pooled Safety Analysis of Palbociclib in Combination With Endocrine Therapy for HR+/HER2- Advanced Breast Cancer. J Natl Cancer Inst. 2019 Apr 1;111(4):419-430. doi: 10.1093/jnci/djy109.

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;escholarship.org

repositories_institution: California Digital Library - eScholarship

ReferenceCitation: Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

ReferenceCitation: Bell T, Crown JP, Lang I, Bhattacharyya H, Zanotti G, Randolph S, Kim S, Huang X, Huang Bartlett C, Finn RS, Slamon D. Impact of palbociclib plus letrozole on pain severity and pain interference with daily activities in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer as first-line treatment. Curr Med Res Opin. 2016 May;32(5):959-65. doi: 10.1185/03007995.2016.1157060. Epub 2016 Mar 2.

ReferenceCitation: Finn RS, Crown JP, Lang I, Boer K, Bondarenko IM, Kulyk SO, Ettl J, Patel R, Pinter T, Schmidt M, Shparyk Y, Thummala AR, Voytko NL, Fowst C, Huang X, Kim ST, Randolph S, Slamon DJ. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015 Jan;16(1):25-35. doi: 10.1016/S1470-2045(14)71159-3. Epub 2014 Dec 16.

location_facility: Frauenklinik und Poliklinik Klinikum rechts der Isar, Technische Universitaet Muenchen

location_facility: Fovarosi Onkormanyzat Uzsoki Utcai Korhaz

location_facility: Universitaetsklinik und Poliklinik fuer Gynaekologie, Martin-Luther-Universitaet Halle-Wittenberg

location_facility: Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic

location_facility: TORI Central Administration (Regulatory Management)

location_facility: National Cancer Center, Center for Breast Cancer

location_facility: Mutterhaus der Borromaeerinnen, Innere Medizin I

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: Department of Oncotherapy, National Hospital

location_facility: Drug Management Only: UCLA West Medical Pharmacy

location_facility: TORI Central Administration (Regulatory Managment Only)

location_facility: UCLA West Medical Pharmacy (Drug Management Only)

location_facility: Regulatory Office: Comprehensive Cancer Centers of Nevada

location_facility: Central Hematology Oncology Medical group Inc.

location_facility: Unita' Operativa di Oncologia, Ospedale Civile di Lugo

location_facility: Orszagos Onkologiai Intezet, Kemoterapia B

location_facility: Hospital General Universitario Vall D'Hebron

location_facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

location_facility: Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe Universitaetsklinik Mainz

location_facility: Markusovszky Egyetemi Oktatokorhaz, Onkoradiologiai Osztaly

location_facility: Gwinnett Hospital System Inc.-d/b/a-The Center for Cancer Care

location_facility: Nationales Centrum fuer Tumorerkrankungen

location_facility: TORI -US Central Administration (Regulatory Management)

location_facility: Sansum Santa Barbara Medical Foundation Clinic

location_facility: Texas Oncology-Dallas Presbyterian Hospital

location_facility: Lviv State Oncologic Regional Treatment and Diagnostic Centre

location_facility: State Budgetary Healthcare Institution "Samara Regional Clinical Oncology Dispensary"

location_facility: Petz Aladar Megyei Oktato Korhaz, Onkoradiologia

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz és Egyetemi Oktato Korhaz, Onkologia

location_facility: Santa Monica-UCLA Medical Center and Orthopaedic Hospital

location_facility: M.O. di Oncologia - Azienda USL di Rimini - Ospedale "Cervesi"

location_facility: Westwood Bowyer Clinic, Peter Morton Medical Building

location_facility: CSSS Champlain-Charles-Le Moyne Local HS-0054

location_facility: Municipal clinical treatment-and-propyilactic institution "Donetsk regional oncology center',

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es

location_facility: Central Coast Medical Oncology Corporation

location_facility: North Shore Oncology-Hematology Associates

location_facility: Gemeinschaftspraxis, Onkologischer Schwerpunkt am Oskar-Helene-Heim

location_facility: Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates

location_facility: US Oncology Research and Clinical Pharmacy

location_facility: Central Hematology Oncology Medical Group, Inc

location_facility: Department of Oncology and Medical Radiology, SI "DMA of MOH, Ukraine, "MI "Dnipropetrovsk City

location_facility: Municipal Treatment-and-Prophylactic Institution 'Donetsk City Oncological Dispensary' Radiology dep

location_facility: Frauenaerzte Pruener Gang Abts & Partner

location_facility: Ospedale Civile di Faenza Centro Oncologico

location_facility: UCLA Hematology/Oncology - Santa Clarita

location_facility: Federal State Budgetary Scientific Institution

location_facility: Divisione Oncologia Medica Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRST

location_facility: Azienda Unita Sanitaria Locale di Rimini, U.O. di Oncologia ed Oncoematologia Ospedale degli Infermi

title: PHASE 1/2, OPEN-LABEL, RANDOMIZED STUDY OF THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF LETROZOLE PLUS PD 0332991 (ORAL CDK 4/6 INHIBITOR) AND LETROZOLE SINGLE AGENT FOR THE FIRST-LINE TREATMENT OF ER POSITIVE, HER2 NEGATIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Germany
Ireland
Italy
Hungary
United States
Korea, Republic of
Spain
South Africa
Canada
Ukraine
Russian Federation
France


title: A Multi-center, Multi-regional Observational Study to Test the Responsiveness of the Validated MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Instrument to EDSS Status Changes in Any Form of Multiple Sclerosis (MS) in Patients With or Without Treatment

acronym: MusiQoL

summary:
This is a multi-center, multi-regional observational,24 month study.

Health-related quality of life data from the MusiQoL instrument and SF-36 instrument will be collected at baseline, M6, M12, M18 and M24 in patients with MS. In addition, physical health outcomes such as expanded disability status scores (EDSS) will be collected every 6 months.

ReferenceCitation: Auquier P, et al. Responsiveness of the Multiple Sclerosis International Quality of Life(MusiQoL) questionnaire to changes in disability in subjects with multiple sclerosis: 12-month results. Eur J Neurol 2010;17(Suppl 3):486

ReferenceCitation: Auquier P, et al. Responsiveness of the Multiple Sclerosis International Quality of Life and Short Form-36 questionnaires to Expanded Disability Status Scale score changes in subjects with multiple sclerosis: 12-month results of an international observational study. 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS): 13-16 October 2010, Gothenburg, Sweden; P650

ReferenceCitation: Auquier P, et al. Responsiveness of the Multiple Sclerosis International Quality of Life questionnaire to Expanded Disability Status Scale score changes in subjects with Multiple Sclerosis: Month 12 results from an international observational study. 13th Annual ISPOR Annual European Congress: November 2010, Prague, Czech Republic; P25667

ReferenceCitation: Baumstarck K, Pelletier J, Boucekine M, Auquier P; MusiQoL study group. Predictors of quality of life in patients with relapsing-remitting multiple sclerosis: a 2-year longitudinal study. Rev Neurol (Paris). 2015 Feb;171(2):173-80. doi: 10.1016/j.neurol.2014.09.005. Epub 2015 Jan 2.

ReferenceCitation: Boucekine M, Loundou A, Baumstarck K, Minaya-Flores P, Pelletier J, Ghattas B, Auquier P. Using the random forest method to detect a response shift in the quality of life of multiple sclerosis patients: a cohort study. BMC Med Res Methodol. 2013 Feb 15;13:20. doi: 10.1186/1471-2288-13-20.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repository_normalized: HAL

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

location_country:
Germany
Italy
Israel
Argentina
Norway
Australia
United Kingdom
Austria
United States
Spain
Turkey
France

location_facility:
Reseach site
Reseach Site
Research Site


title: Randomized, Controlled, Double-blind Multicenter Safety Study to Evaluate the Safety and Immunogenicity of Subcutaneous EPO HEXAL vs. ERYPO® in the Treatment of Anemia Associated With Chronic Renal Insufficiency in Predialysis Patients

summary:
This is a randomized, controlled, double-blind, multicenter multinational safety study involving about 300 predialysis patients aged 18 years or above suffering from anemia.

Symptomatic anemia will be corrected by s.c. application of EPO HEXAL or ERYPO® in order to achieve a hemoglobin target range of 10.0 -12.0 g/dL.

lead_sponsor: Sandoz

location_country:
Germany
Poland
India
Slovakia
Romania
Austria
Czechia
Bulgaria
Russian Federation
France

location_facility: State Educational Institution of Higher Professional Education "St. Petersburg State Medical Academy named after I.I. Mechnikov of Roszdrav"

location_facility: Wojewodzki Szpital Specjalistyczny nr. 1 im. Jozefa Gasinskiego

location_facility: Sozialmedizinisches Zentrum Ost Donauspital

location_facility: Dialyseplaxis DR. Rieck, DR. Göbel, DR. Wagner

location_facility: State Health Care Institution City Clinical Hospital named after SP Botkin

location_facility: Gemeinschaftspraxis Dr. Kirchner und Dr. Menge

location_facility: Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel

location_facility: State Healthcare Institution "Reoublic Hospital named after VA Baranov"

location_facility: State Educational Institution of Higher Professional Education "Moscow State University of Medicine and dentistry of Federal Agency of health Care and Social Development", City Clinical Hospital #23

location_facility: Nephrologische Gemeinschaftspraxis Dr. Rensinghoff & Dr. Becker

location_facility: CHU de Rouen - Hopital de Bois Guillaume

location_facility: Gemeinschaftspraxis Dres. Leistikow, Hafezi und Sandner

location_facility: State Healthcare Institution "Kemerova Regional Clinical Hospital"

location_facility: Russian University of Peoples Frienship (clinical base: City clinical hospital #53)

location_facility: KfH Kuratorium f. Dialyse und Nierentransplantation e.V.

location_facility: Gemeinschaftspraxis Dr. Steffen & Dr. Perino

location_facility: NZOZ NEFROLUX Sp. J. Lucjan Sobieraj, Wojciech Kaminski

location_facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.

location_facility: St. Petersburg State Healthcare Institution "City Mariinsky Hospital"

location_facility: Praxis Dr. Rose, Pohlmeier und Dr. Lammers

location_facility: Szpital Praski p.w. Przemienienia Panskiego II Oddzia Chorob Wewnetrznych

location_facility: Dialysepraxis Dipl. med. Gierak & Dipl. med. Rettig

location_facility: State Healthcare Institution of Yaroslavl region "Regional Clinical Hosptal"

location_facility: Municipal Healthcare Institution "City Clinical Hospital #2"

location_facility: KfH Kuratorium für dialyse und Nierentransplantation e.V.

location_facility: State Educational Institution of Higher Professional Education "St. Petersburg State Medical Academy for Postgraduate studies of Roszdrav"

location_facility: Municipal healthcare Institution "City Clinical Hospital #2"

location_facility: State healthcare Institution "Nizhegorodsky Regional Clinical Hospital named after NA Semashko"

location_facility: Institutul National de DiabetNutritie si Boli Metabolice Paulescu

location_facility: State Institution "St. petersburg Clinical research Institute of Emergency Medical Care named after I.I. Dzhanelidze"

location_facility: Pulse Diagnostix Cardiac and Medical Center

location_facility: Gemeinschaftspraxis Dr. med. Gert-Peter Dragoun, Dr. med Günther Hevendehl

location_facility: St. Petersburg State Healthcare Institution "City Outpatient Clinic #17"

location_facility: State Educational Institution of Higher Professional Education "St. Petersburg State Medical Institute named after IP Pavlov of Roszdrav"

location_facility: Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwor (Solumed SC)

location_facility: State Educational Institution of High Professional Education Saratov State Medical University of Roszdrav

location_facility: Schwerpunktpraxis für Diabetologie und Nephrologie

location_facility: Nephrologisches Zentrum an Stadtkrankenhaus

location_facility: State Healthcare Institution "Ryazan Regional Cardiological Dispensary"

location_facility: State Institution Scientific Research Institute of Cardiology of Tomsk Research Center of Siberian Branch of Russian Academy of Medical Sciences

location_facility: Klinik für Nephrologie und Allgemeine Innere Medizin

location_facility: State Educational Institution of Higher Professional Education "Smolensk State Medical Academy of Federal Agency of Health Care and Social Development"

location_facility: Municipal Institution "City Clinical Hospital #40"

location_facility: Municipal medical Institution "City Hospital #1"

location_facility: Centrul Medical de Diagnostic si Tratament Ambulator si Medicina Preventiva Bucuresti

location_facility: Federal State Institution "National Medical Surgery center named after NI Pirogov of Federal Agency of Health Care and Social Development"

location_facility: Studienzentrum Hämatologie / Onkologie / Diabetes

location_facility: State Healthcare Institution "Sverdlovsk Regional Clinical Hospital #1"

location_facility: Diabetes- und Dialysezentrum Merker, Vogt

location_facility: Specjalistyczna Przychodnia Lekarska Medikard


title: A Randomized, Open-label Study to Explore the Correlation of Biomarkers With Response Rate in Chemo-naive Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer Who Receive Treatment With Avastin in Addition to Carboplatin-based Chemotherapy

summary: This study will explore the correlation of biomarkers with response rate, and the overall efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in patients with advanced or recurrent non-squamous non-small cell lung cancer. Patients will be randomized to one of 2 groups, to receive either Avastin 7.5mg/kg iv on day 1 of each 3 week cycle, or Avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
France
Germany
Italy
Poland
Hungary
Hong Kong
Denmark
Australia
United Kingdom
Netherlands
Belgium
Spain
Taiwan
Canada
Russian Federation
Czech Republic


lead_sponsor: Eisai Inc.

summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of donepezil in children with persistent attention impairment that is present at least 12 months after the completion of cancer treatment.

sponsor_collaborators:
Eisai Inc.
Eisai Limited

title: Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment

type: Registry Identifier

location_country:
Germany
United Kingdom
Argentina
Australia
Netherlands
United States
Spain
Chile
Canada
France


title: RFC1 Natural History Study

summary: This international, multi-center, multi-modal and prospective observational study aims to determine the phenotypic spectrum and the natural progression of the RFC1 repeat expansion disease, and to seek and validate digital, imaging, and molecular biomarkers that aid in diagnosis and serve as outcome measures in future clinical trials of this novel, but frequent ataxia with late adult-onset.

status: Recruiting

lead_sponsor: Prof. Dr. Matthis Synofzik

location_country:
Germany
Italy
New Zealand
Australia
Brazil
Turkey
France

location_facility: Service de Neurologie, Hôpitaux Universitaires de Strasbourg

location_facility: Department of Neurology University Hospital Schleswig Holstein

location_facility: German Center for Neurodegenerative Diseases (DZNE)

location_facility: Center for Neurology & Hertie-Institute for Clinical Brain Research, Dept. for Neurodegenerative Diseases

location_facility: Centre of Brain Research Neurogenetics Research Clinic, University of Auckland

location_facility: Department of Neuroscience, Central Clinical School, Monash University

location_facility: Università degli Studi di Napoli 'Federico II', c/o AOU Federico II

location_facility: Department of Neurology, Ataxia Unit, Universidade Federal de São Paulo

status_simplified: Ongoing


title: Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM14 Administered Intravenously to Patients With Advanced Solid Tumors

summary: Despite recent advances in the treatment of solid tumors in general, advanced (metastatic) disease remains mostly incurable and there is an urgent need to develop new therapeutic options for these patients, particularly investigational drugs with novel mechanisms of action. The investigation of new combination regimens of non-crossresistant agents with acceptable-and not completely overlapping-toxicities has been a major way to improve response rate and outcome of patients with advanced solid tumors.

lead_sponsor: PharmaMar

location_country:
United States
Spain
France

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Hospital Universitario Madrid Sanchinarro


title: Efficacy and Safety of Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablets in Patients With Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo With an Additional Reference Arm Evaluating Entocort®EC

summary:
This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment period.

After the screening visit, patients will enter a washout period of 2 days, then they will be randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg), budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and capsules), all administered once a day after breakfast. Hence, each patient will receive, in the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three placebo Entocort® matching capsules.

ReferenceCitation: Travis SP, Danese S, Kupcinskas L, Alexeeva O, D'Haens G, Gibson PR, Moro L, Jones R, Ballard ED, Masure J, Rossini M, Sandborn WJ. Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study. Gut. 2014 Mar;63(3):433-41. doi: 10.1136/gutjnl-2012-304258. Epub 2013 Feb 22.

version: submittedVersion

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

lead_sponsor: Bausch Health Americas, Inc.

sponsor_collaborators:
Bausch Health Americas, Inc.
Cosmo Technologies Ltd

location_country:
France
Italy
Lithuania
Poland
Slovakia
United Kingdom
Romania
Australia
Sweden
Belgium
Latvia
Ukraine
Estonia
Russian Federation
Israel

location_facility: Uzhgorod National University, Hospital surgery chair on the base of Uzhgorod Regional Clinical Hospital

location_facility: Chair of Gastroenterology and therapy of Dnipropetrovsk State Medical Academy based on Institute of gastroenterology

location_facility: Uzhgorod State Medical University, chair of therapy and family medicine, district clinical hospitalof station "Uzhgorod"

location_facility: Box Hill Hospital, Department of Gastroenterology Clive Ward Centre,

location_facility: Divisione di Gastroenterologia - Istituto Clinico Humanitas IRCCS in Gastroenterologia

location_facility: Saint-Petersburg GUZ City polyclinic #38 28

location_facility: Dipartimento di Medicina Interna e Specialità Mediche (DIMI)

location_facility: Gastromed S.C.Maciej Kralisz, Andrzej Penpicki, Jacek Romatowski, Gabinet, Gastrologiczny i Pracownia Endoskopowa

location_facility: Gastroenterologické a Hepatologické centrum

location_facility: GU research educational medical centre of the administration of the affairs of the president of Russian Federation on the basis of State Healthcare Institution "State Clinical Hospital # 51"

location_facility: Paula Stradina Clinical University Hospital

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: GUZ of Moscow "City Clinical Hospital #24"

location_facility: Lviv National Medical University after name Danylo Halytsky based on Communal Clinical City hospital No 5, Department of Propedeutic of Internal Disease

location_facility: Szpital Uniwersytecki w Krakowie,Oddział Kliniczny Kliniki Gastroenterologii Hematologii i Chorób Zakaźnych

location_facility: Centrul de Gastroenterologie Dr. Goldis Adrian

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Kliniki Gastroenterologii, Hepatologii i Chorob Zakaznych,

location_facility: St. Petersburg State Medical Academy n.a. I.I. Mechnikov

location_facility: State Scientific Centre of Coloproctology of the Federal Agency for High-Technology Medical Care

location_facility: Federal State Institution ?National Medical Surgical Center

location_facility: CRO - IRCCS - Struttura Operativa Complessa di Gastroenterologia Oncologica

location_facility: FGU North-West DIstrict Medical Center of Roszdrav

location_facility: University Hospital of Coventry and Warwickshire

location_facility: Spitalul Clinic Colentina Sectia Gastroenterologie

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA

location_facility: FNsP Bratislava, Nemocnica Stare Mesto 1st Internal Clinic Mickiewiczova

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED

location_facility: Vilnius University Hospital Santariskiu Klinikos

location_facility: NZOZ Centrum Leczenia Chorob Cywilizacyjnych, oddzial Gdynia, filia Fikakw

location_facility: FNsP Bratislava, Nemocnica Ruzinov V. Interna klinika, Gastroenterohepatologicke oddelenie Ruzinovska

location_facility: City Clinical Emergency Hospital named after O.I.Meschaninov,

location_facility: Odessa city Polyclinic #20, Therapeutic Dept. 6


title: Central Nervous System Disorders Following Hematopoietic Stem Cell Transplantation: a Prospective Observational Trial From the Infectious Diseases Working Party and the Transplant Complications Working Party of the European Society for Blood and Marrow Transplantation

summary:
All patients undergoing allogeneic or autologous HSCT at the participating centres will be observed. Once a diagnosis of CNS disorder is made, additional data will be reported for these patients.

We will identify clinical and diagnostic characteristics such as cerebrospinal fluid (CSF) and neuroimaging patterns, risk factors, response to treatment (including novel antifungal agents such as isavuconazole) and outcome. In addition, risk factors for CNS disorders after allogeneic and autologous HSCT will be analyzed using a prospectively assessed matched control group. In the future, this study might be the basis for an interventional trial (e.g. using a prophylactic approach).

status: Active, not recruiting

location_country:
Germany
Italy
Poland
Colombia
Hungary
Australia
Tunisia
Spain
Turkey
Russian Federation
France

location_facility: Hacettepe University Children's Hospital

location_facility: Raisa Gorbacheva Research Institute for Oncology

location_facility: University Hospital, Collegium Medicum UMK

location_facility: University Children's Hospital in Krakow


title: SerUM Markers in MERkel Cell Carcinoma Patients: a Longitudinal moniTorIng Study for optiMization of European Guidelines

acronym: SUMMERTIME

summary: Merkel cell carcinoma (MCC) is a rare aggressive skin carcinoma. Approximately 80% of MCC are related to the Merkel Cell Polyomavirus (MCPyV). Although rates of relapse are high, the follow-up strategy lacks consensus. Patients are usually assessed clinically every 3 to 6 months for the first 2-3 years, and every 6 to 12 months thereafter. In the European guidelines, patients with early stages are monitored with clinical examination and ultrasonography of lymph nodes, while whole-body imaging is optional in patients with stage III disease, on a yearly basis for 5 years. Such strategy may prevent the diagnosis of infra-clinical recurrences, whereas patients could still be treated with surgery or radiation therapy. Until 2017, patients with advanced disease were treated with chemotherapies, with no long-term benefit. Immunotherapies with PD-1/PD-L1 inhibitors currently allow durable responses in 50% of such patients. This major change in the management of MCC patients argues for a follow-up strategy that would allow early diagnosis of infra-clinical metastases, when tumoral burden is still low. Given that all patients cannot be monitored by systematic regular imaging, additional non-invasive tools are needed. Blood-based biomarkers as a surrogate of tumor burden are advantageous as they can be repeated over time, providing guidance on when imaging is necessary. The study aims to assess two blood biomarkers, MCPyV T-Ag antibodies and cell-free miR-375, in a prospective fashion from baseline diagnosis, in a cohort of 150 European MCC patients

study_start_date_type: Anticipated

primary_purpose: Other

ReferenceCitation: Fan K, Ritter C, Nghiem P, Blom A, Verhaegen ME, Dlugosz A, Odum N, Woetmann A, Tothill RW, Hicks RJ, Sand M, Schrama D, Schadendorf D, Ugurel S, Becker JC. Circulating Cell-Free miR-375 as Surrogate Marker of Tumor Burden in Merkel Cell Carcinoma. Clin Cancer Res. 2018 Dec 1;24(23):5873-5882. doi: 10.1158/1078-0432.CCR-18-1184. Epub 2018 Jul 30.

ReferenceCitation: Kervarrec T, Tallet A, Miquelestorena-Standley E, Houben R, Schrama D, Gambichler T, Berthon P, Le Corre Y, Hainaut-Wierzbicka E, Aubin F, Bens G, Tabareau-Delalande F, Beneton N, Fromont G, Arbion F, Leteurtre E, Touze A, Samimi M, Guyetant S. Diagnostic accuracy of a panel of immunohistochemical and molecular markers to distinguish Merkel cell carcinoma from other neuroendocrine carcinomas. Mod Pathol. 2019 Apr;32(4):499-510. doi: 10.1038/s41379-018-0155-y. Epub 2018 Oct 22.

ReferenceCitation: Paulson KG, Lewis CW, Redman MW, Simonson WT, Lisberg A, Ritter D, Morishima C, Hutchinson K, Mudgistratova L, Blom A, Iyer J, Moshiri AS, Tarabadkar ES, Carter JJ, Bhatia S, Kawasumi M, Galloway DA, Wener MH, Nghiem P. Viral oncoprotein antibodies as a marker for recurrence of Merkel cell carcinoma: A prospective validation study. Cancer. 2017 Apr 15;123(8):1464-1474. doi: 10.1002/cncr.30475. Epub 2016 Dec 7.

ReferenceCitation: Samimi M, Molet L, Fleury M, Laude H, Carlotti A, Gardair C, Baudin M, Gouguet L, Maubec E, Avenel-Audran M, Esteve E, Wierzbicka-Hainaut E, Beneton N, Aubin F, Rozenberg F, Dupin N, Avril MF, Lorette G, Guyetant S, Coursaget P, Touze A. Prognostic value of antibodies to Merkel cell polyomavirus T antigens and VP1 protein in patients with Merkel cell carcinoma. Br J Dermatol. 2016 Apr;174(4):813-22. doi: 10.1111/bjd.14313. Epub 2016 Feb 3.

lead_sponsor: University Hospital, Tours

collaborators: European Academy of Dermatology and Venerology

location_country:
Finland
Italy
Germany
United Kingdom
Romania
Sweden
Netherlands
Austria
Turkey
France

location_facility: Department of Dermatology, Başkent University Faculty of Medicine

location_facility: Department of Dermatology, Medical University of Vienna

location_facility: Department of Dermatology, Carol Davila University of Medicine and Pharmacy

location_facility: National Tumour Institute "Fondazione G. Pascale" Unit of Melanoma - Cancer Immunotherapy and Innovative therapy

location_facility: Skin Cancer and Surgery Center, Sahlgrenska University Hospital

location_facility: University Hospital of Helsinki, Finland

location_facility: Dermatology Dept, Hospital University of Tours


title: Risk Factors and Treatment Options for Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer: a Multicentric Retrospective Cohort Study (METABREC)

acronym: METABREC

summary:
Esophagectomy is the cornerstone of the curative treatment of esophageal carcinoma. Despite this treatment, patients can suffer from locoregional or distant metastatic disease and only a very selected group of patients can be cured: mostly those with recurrence in one single organ.

Brain metastases are rare after esophagectomy for cancer, but they have a serious impact on survival. Agressive treatment is often moren difficult for brain metastases compared to other metastases and some risk factors have been identified earlier.

There is an impression that the incidence of brain metastases in esophageal cancer patients has increased since the introduction of neoadjuvant treatment schemes. However, this is not clear yet. A potential explanation could be that chemotherapy disturbs the blood-brain-barrier, hereby facilitating the migration of tumor cells to the brain.

The purpose of this study is to retrospectively analyze the incidence and potential risk factors of brain metastases in patients who underwent esophagectomy for esophageal cancer. Patients treated between 2000 and 2019 will be included and outcome parameters are Odds Ratio for brain metastases (comparison between primary surgery and neoadjuvant treatment followed by surgery), time to recurrence and risk factors, number and characteristics of the brain metastases.

time_perspective: Retrospective

lead_sponsor: Universitaire Ziekenhuizen KU Leuven

location_country:
Ireland
Sweden
Netherlands
Belgium
United States
France

location_facility: Centre Hospitalier régional Universitaire de Lille


lead_sponsor: Glycostem Therapeutics BV

summary: WiNK is a Phase I/IIa trial to evaluate the safety and efficacy of oNKord® in 33 adults with acute myeloid leukemia (AML) who are in morphologic complete remission with residual measurable disease and who are currently not proceeding to allogeneic hematopoietic stem cell transplantation.

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: University Hospital Carl Gustav Carus Dresden

title: A Prospective Phase I/IIa, Open-label, Multicenter Trial to Evaluate the Safety and Efficacy of oNKord®, an Off-the-shelf, ex Vivo-cultured Allogeneic NK Cell Preparation, in Subjects With Acute Myeloid Leukemia Who Are in Morphologic Complete Remission With Measurable Residual Disease and Who Are Currently Not Proceeding to Allogeneic Hematopoietic Stem Cell Transplantation

location_country: Germany Switzerland Netherlands Belgium France

ipd_sharing: No


acronym: EMBRACE 1

lead_sponsor: LEO Pharma

summary:
The study will investigate the efficacy and safety compared to placebo and the safety compared to ustekinumab of brodalumab in adolescents with moderate to severe plaque psoriasis. The study will also investigate if brodalumab affects development of vaccination-induced immune responses.

The study will run over 62-64 weeks (including screening, treatment, and safety follow-up) for each participant, but with the primary endpoint measured at Week 12.

location_facility:
LEO Pharm Investigational Site
LEO Pharma Investigational Site

title: A Phase 3, Randomised, Double-blind, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Brodalumab Treatment Compared to Placebo and Ustekinumab in Adolescent Subjects With Moderate-to-severe Plaque Psoriasis

ipd_sharing_description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

location_country: Germany Italy Poland Hungary Belgium Spain Greece France


type: Other Grant/Funding Number

title: Phenotypes, Biomarkers and Pathophysiology in Spastic Ataxias

acronym: SPAX-PBP

summary: The aim of this study is to determine the clinical spectrum and natural progression of Spastic Ataxias (SPAX) and related disorders in a prospective multicenter natural history study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the genetic etiology and molecular mechanisms of these diseases.

lead_sponsor: Dr. Rebecca Schule

collaborators: German Center for Neurodegenerative Diseases (DZNE)

location_country:
Germany
Italy
United Kingdom
Netherlands
Turkey
Canada
France

location_facility: Radboud University Medical Center; Department of Neurology & Donders Institute for Brain, Cognition, and Behaviour

location_facility: Center for Neurology & Hertie-Institute for Clinical Brain Research, Dept. for Neurodegenerative Diseases

location_facility: Department of Clinical Neurosciences, University of Cambridge; John Van Geest Cambridge Centre for Brain Repair

location_facility: Montreal Neurological Institute of McGill University, Department of Neurology and Neurosurgery and Human Genetics

location_facility: Département d'information médicale (DIM); Département de Biostatistique, Santn 3emé Publique et Information Médicale (BIOSPIM)- Bâtiment Mazarie étage; Hôpitaux Universitaires Pitié Salpêtrière

intervention_type: Diagnostic Test


title: Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms

acronym: MPN-DOACs

summary:
Patients with myeloproliferative neoplasms (MPN) are predisposed to have an increased thrombotic and hemorrhagic risk and, in this context, the use of newly approved direct oral anticoagulants (DOACs) may have improved bleeding risk compared to warfarin use. However, the published experience is very limited and does not allow any conclusion. In the cohort of patients with MPN and venous thromboembolism (VTE) of European Leukemia-net, only 3.3% of patients had been treated with DOACs. Similarly, in a recent publication of a series of 760 patients with single-center MPN, only 25 (3.3%) were treated with a DOAC (13 for atrial fibrillation and 12 for thrombotic events).

While it is known that the risk of thrombotic recurrence and haemorrhagic event during warfarin treatment is about 30% at 5 years from the first event, the actual risk of such events in MPN patients is not known.

The aim of the present study is therefore to obtain information on patients with MPN treated with DOAC for atrial fibrillation (AF) and VTE. This is an international multi-center retrospective survey aimed at describing the efficacy / safety of DOAC in the prevention of:

cardioembolic stroke in patients with MPN with AF
recurrent thrombosis in patients with MPN with VTE
major bleeding in all patients with MPN.

The results will allow to design future prospective studies that evaluate the benefit / risk profile of DOAC compared to warfarin in these pathologies characterized by high risk of thrombosis and, in some subgroups, of bleeding.

lead_sponsor: Fondazione per la Ricerca Ospedale Maggiore

location_country:
Germany
Italy
United Kingdom
United States
Spain
Canada
France

location_facility: Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo

location_facility: Divisione Ematologia, Ospedale Borgo Roma

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS UCSC Ematologia

location_facility: Fondazione IRCCS Policlinico San Matteo S.C Ematologia

location_facility: Ospedale San Bortolo di Vicenza - U.O.C di Ematologia

location_facility: ASST MONZA Ospedale San Gerardo Clinica Ematologica


lead_sponsor: Novo Nordisk A/S

summary: This trial is conducted in Europe. The aim of this research is to assess the safety of continuous treatment with insulin detemir following participation in trial NN304-1689 (NCT00435019) on antibody development.

ReferenceCitation: Thalange N, Bereket A, Jensen LB, Hiort LC, Peterkova V. Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2-16 Years. Diabetes Ther. 2016 Dec;7(4):713-724. doi: 10.1007/s13300-016-0196-5. Epub 2016 Sep 6.

title: A 52-Week, Multinational, Multi-Centre, Open-Labelled Extension Trial of Insulin Detemir in Children and Adolescents 3-17 Years With Type 1 Diabetes on a Basal-Bolus Regimen With Insulin Aspart as Bolus Insulin

location_country: Macedonia, The Former Yugoslav Republic of


title: Two-year Study to Determine the Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis for 2 Years Followed by a 2 Year Open Label Study

summary: Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study.

ReferenceCitation: Boonen S, Lorenc RS, Wenderoth D, Stoner KJ, Eusebio R, Orwoll ES. Evidence for safety and efficacy of risedronate in men with osteoporosis over 4 years of treatment: Results from the 2-year, open-label, extension study of a 2-year, randomized, double-blind, placebo-controlled study. Bone. 2012 Sep;51(3):383-8. doi: 10.1016/j.bone.2012.06.016. Epub 2012 Jun 30.

lead_sponsor: Warner Chilcott

sponsor_collaborators:
Warner Chilcott
Sanofi

location_country:
Poland
Hungary
United Kingdom
Australia
Netherlands
Lebanon
Belgium
United States
Czech Republic
France

location_facility:
Research Facility
Research Site


lead_sponsor: Intercept Pharmaceuticals

summary: The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline phosphatase levels in PBC participants, over a 12-week treatment period, as compared to placebo.

ReferenceCitation: Kowdley KV, Luketic V, Chapman R, Hirschfield GM, Poupon R, Schramm C, Vincent C, Rust C, Pares A, Mason A, Marschall HU, Shapiro D, Adorini L, Sciacca C, Beecher-Jones T, Bohm O, Pencek R, Jones D; Obeticholic Acid PBC Monotherapy Study Group. A randomized trial of obeticholic acid monotherapy in patients with primary biliary cholangitis. Hepatology. 2018 May;67(5):1890-1902. doi: 10.1002/hep.29569. Epub 2018 Jan 29.

location_facility: University Medical Centre Hamburg-Eppendorf

location_facility: Centre de Recherche du CHUM / University of Montreal

title: A Study of INT-747 (6-ECDCA) Monotherapy in Patients With Primary Biliary Cirrhosis

location_country:
Germany
United Kingdom
Austria
United States
Spain
Canada
France


title: Open Label, Parallel Group, Multicenter Study of Two Intravenous (IV) Ibandronate Dose Regimens (2 mg Every 2 Months and 3 mg Every 3 Months) in Women With Postmenopausal Osteoporosis Who Completed Trial BM16550

summary: This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.

location_country:
France
Germany
Italy
Poland
Hungary
Norway
Denmark
Australia
United Kingdom
Mexico
Belgium
United States
Spain
South Africa
Czech Republic


title: A Multi-center, Open-label, follow-on Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Including a Double-blind, Randomized Time Point Withdrawal Subtrial.

summary: SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial is to assess safety and tolerability of long-term exposure of lacosamide (previously referred to as SPM 927) in subjects with painful distal diabetic neuropathy.

lead_sponsor: UCB Pharma

location_country:
Finland
Germany
Italy
Poland
Hungary
United Kingdom
Romania
Austria
Belgium
Spain
Czechia
Bulgaria
Serbia
Russian Federation
France


title: A Randomized, Double-Blind, Parallel-Group Multi-Center Comparative Flexible-Dose Study Of Pregabalin Versus Levetiracetam As Adjunctive Therapy To Reduce Seizure Frequency In Subjects With Partial Seizures

summary: This study will compare pregabalin and levetiracetam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.

ReferenceCitation: Zaccara G, Almas M, Pitman V, Knapp L, Posner H. Efficacy and safety of pregabalin versus levetiracetam as adjunctive therapy in patients with partial seizures: a randomized, double-blind, noninferiority trial. Epilepsia. 2014 Jul;55(7):1048-57. doi: 10.1111/epi.12679. Epub 2014 Jun 5.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Germany
Costa Rica
Turkey
Czechia
France
Lithuania
Colombia
India
Belgium
Peru
Philippines
Italy
Venezuela
Mexico
Korea, Republic of
Spain
Greece
Panama
Taiwan
Bulgaria
Russian Federation