title: A Multi-Center, Prospective, Observational Study to Assess Outcomes for Patients Treated for Lumbar Spinal Conditions Using an OLIF25™ and/or OLIF51™Approach

summary: The purpose of this single-arm observational study is to observe and document clinical outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc disease or degenerative scoliosis, and report the rate of adverse events of interest through the 24 months follow-up visit.

lead_sponsor: Medtronic Spinal and Biologics

location_country:
Portugal
Italy
Puerto Rico
France
United States
Belgium
Czechia

location_facility: Foundation for Orthopaedic Research and Education (FORE)

location_facility: Azienda Ospedaliera - Ospedale Civile di Legnano

location_facility: University of California San Francisco (UCSF)

location_facility: Alleghany Health Network Research Institute


type: EudraCT Number

title: Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects With Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CORRECTION)

summary: A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in participants with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8:CD013751. doi: 10.1002/14651858.CD013751.pub2. Review.

ReferenceCitation: Chertow GM, Pergola PE, Farag YMK, Agarwal R, Arnold S, Bako G, Block GA, Burke S, Castillo FP, Jardine AG, Khawaja Z, Koury MJ, Lewis EF, Lin T, Luo W, Maroni BJ, Matsushita K, McCullough PA, Parfrey PS, Roy-Chaudhury P, Sarnak MJ, Sharma A, Spinowitz B, Tseng C, Tumlin J, Vargo DL, Walters KA, Winkelmayer WC, Wittes J, Eckardt KU; PRO2TECT Study Group. Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD. N Engl J Med. 2021 Apr 29;384(17):1589-1600. doi: 10.1056/NEJMoa2035938.

ipd_sharing: No

lead_sponsor: Akebia Therapeutics

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Australia
New Zealand
Argentina
United Kingdom
Ukraine
Hungary
Korea, Republic of
United States
France
Israel
Puerto Rico
Mexico
South Africa
Malaysia
Bulgaria

location_facility:
Research Site #2
Research Site #1
Research Site
Research Site #3

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Prospective, Multi-center, Post Market Randomized Controlled Trial Comparing VT Ablation Outcomes Using Remote MAGNETIC Navigation Guided Substrate Mapping and Ablation Versus Manual Approach in a Low LVEF Population

acronym: MAGNETIC-VT

summary: The study purpose is to demonstrate that ventricular tachycardia (VT) ablation using the Niobe™ ES system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT in a low ejection fraction population.

status: Terminated

ReferenceCitation: Di Biase L, Tung R, Szili-Torok T, Burkhardt JD, Weiss P, Tavernier R, Berman AE, Wissner E, Spear W, Chen X, Neužil P, Skoda J, Lakkireddy D, Schwagten B, Lock K, Natale A; MAGNETIC VT investigators. MAGNETIC VT study: a prospective, multicenter, post-market randomized controlled trial comparing VT ablation outcomes using remote magnetic navigation-guided substrate mapping and ablation versus manual approach in a low LVEF population. J Interv Card Electrophysiol. 2017 Apr;48(3):237-245. doi: 10.1007/s10840-016-0217-3. Epub 2017 Jan 7.

lead_sponsor: Stereotaxis

location_country:
Denmark
Australia
United States
France
Belgium
Netherlands
Czechia

location_facility: Texas Cardiac Arrhythmia Research Foundation

intervention_type: Device

status_simplified: Unknown


ipd_sharing: Yes

intervention_type: Procedure

title: A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

lead_sponsor: Allergan

source: euctr

ReferenceCitation: Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8:CD003919. doi: 10.1002/14651858.CD003919.pub3. Review.

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

location_country:
Denmark
Poland
Spain
Russian Federation
Australia
Thailand
United States
France
Singapore

location_facility: S. Fyodorov Eye Microsurgery Federal State Institution, Novosibirsk Branch

location_facility: CHU de Bordeaux Hopital Pellegrin Service Ophtalmologie

location_facility: Centrum Diagnostykii Mikrochirurgii Oka LENS ul.

location_facility: Ophthalmic Clinical Hospital V.P. Vyhodtseva

location_facility: Chiang Mai University CMU - Maharaj Nakhon Chiang Mai Hospital

summary: This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in participants with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).


title: Longterm Follow-up of Subjects With Transfusion-Dependent β-Thalassemia Treated With Ex Vivo Gene Therapy Using Autologous Hematopoietic Stem Cells Transduced With a Lentiviral Vector

summary: This is a multi-center, long-term safety and efficacy follow-up study for subjects with transfusion-dependent β-thalassemia (TDT) who have been treated with ex vivo gene therapy drug product in bluebird bio-sponsored clinical studies. After completing the parent clinical study (approximately 2 years), eligible subjects will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in the study.

status: Enrolling by invitation

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceCitation: Magrin E, Semeraro M, Hebert N, Joseph L, Magnani A, Chalumeau A, Gabrion A, Roudaut C, Marouene J, Lefrere F, Diana JS, Denis A, Neven B, Funck-Brentano I, Negre O, Renolleau S, Brousse V, Kiger L, Touzot F, Poirot C, Bourget P, El Nemer W, Blanche S, Tréluyer JM, Asmal M, Walls C, Beuzard Y, Schmidt M, Hacein-Bey-Abina S, Asnafi V, Guichard I, Poirée M, Monpoux F, Touraine P, Brouzes C, de Montalembert M, Payen E, Six E, Ribeil JA, Miccio A, Bartolucci P, Leboulch P, Cavazzana M. Long-term outcomes of lentiviral gene therapy for the β-hemoglobinopathies: the HGB-205 trial. Nat Med. 2022 Jan;28(1):81-88. doi: 10.1038/s41591-021-01650-w. Epub 2022 Jan 24.

lead_sponsor: bluebird bio

location_country:
United Kingdom
Italy
Australia
Thailand
United States
France
Germany

intervention_type: Other


title: A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB067 Administered to Adult Subjects With Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation

acronym: VALOR (Part C)

summary:
The primary objectives of Parts A and B of this study are to evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending doses of BIIB067 (tofersen) in adults with ALS and a documented superoxide dismutase 1 (SOD1) mutation. The primary objective of Part C of this study is to evaluate the clinical efficacy of BIIB067 administered to adults with ALS and a confirmed SOD1 mutation.

The secondary objective of Parts A and B of this study is to evaluate the effects of BIIB067 on levels of total SOD1 protein in the cerebrospinal fluid (CSF). The secondary objectives of Part C are to evaluate the safety, tolerability, pharmacodynamic (PD), and biomarker effects of BIIB067.

ReferenceCitation: Miller TM, Cudkowicz ME, Genge A, Shaw PJ, Sobue G, Bucelli RC, Chiò A, Van Damme P, Ludolph AC, Glass JD, Andrews JA, Babu S, Benatar M, McDermott CJ, Cochrane T, Chary S, Chew S, Zhu H, Wu F, Nestorov I, Graham D, Sun P, McNeill M, Fanning L, Ferguson TA, Fradette S; VALOR and OLE Working Group. Trial of Antisense Oligonucleotide Tofersen for SOD1 ALS. N Engl J Med. 2022 Sep 22;387(12):1099-1110. doi: 10.1056/NEJMoa2204705.

ReferenceCitation: Miller T, Cudkowicz M, Shaw PJ, Andersen PM, Atassi N, Bucelli RC, Genge A, Glass J, Ladha S, Ludolph AL, Maragakis NJ, McDermott CJ, Pestronk A, Ravits J, Salachas F, Trudell R, Van Damme P, Zinman L, Bennett CF, Lane R, Sandrock A, Runz H, Graham D, Houshyar H, McCampbell A, Nestorov I, Chang I, McNeill M, Fanning L, Fradette S, Ferguson TA. Phase 1-2 Trial of Antisense Oligonucleotide Tofersen for SOD1 ALS. N Engl J Med. 2020 Jul 9;383(2):109-119. doi: 10.1056/NEJMoa2003715.

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

lead_sponsor: Biogen

location_country:
Denmark
Poland
United Kingdom
Italy
Australia
Canada
Korea, Republic of
United States
France
Belgium
Japan
Germany

location_facility: Washington University School of Medicine

location_facility: New Orleans Center for Clinical Research/Volunteer Research Group, an AMR Company

location_facility: University of Calgary - Health Sciences Centre

location_facility: University of California San Diego Medical Center

location_facility: ALS Center - Dept. of Neuroscience "Rita Levi Montalcini", University of Turin

location_facility: Northwestern University Feinberg School of Medicine


title: Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension

summary:
The TOPP-2 registry is an international, non-interventional, prospective registry including children and adolescents newly diagnosed with pulmonary hypertension (PH) to gain further insights in the disease course and long-term outcome of PH in childhood.

Patients will undergo clinical assessments and receive standard medical care, as determined by treating physicians in their daily clinical practice. The TOPP-2 registry is specifically designed to capture the variables that have been proposed as treatment goals in PePH and the reasons for changes in treatment strategy.

The TOPP-2 registry uses the new clinical classification of PH as outlined at the 5th World Symposium for Pulmonary Hypertension (WSPH) in Nice 2013 and includes new characterizations for children with PH.

The registry is planned and implemented under the scientific leadership of the Association for Pediatric Pulmonary Hypertension (PePH), independently from the financial sponsors.

All enrolled patients will have a follow-up period of 18 months.

status: Active, not recruiting

location_country:
Poland
Brazil
Saudi Arabia
Italy
Australia
Mexico
Canada
Netherlands
Switzerland
Sweden
Hungary
United States
France
China
Israel
Colombia
Japan
Germany

location_facility: Vanderbilt University Children's Hospital

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Hadassah, Hebrew University Medical Center

location_facility: University of Colorado Denver School of Medicine, Children's Hospital Colorado

location_facility: Beatrix Children's Hospital, University Medical Center Groningen

status_simplified: Ongoing


type: Registry Identifier

title: A Randomised Two Arm Open Label Controlled Trial Comparing Standard Immediate Cord Clamping Versus Deferring Cord Clamping for 60 Seconds or More in Babies Born Less Than 30 Weeks of Gestation to Determine Which Cord Clamping Method Results in Improved Survival and Less Disability.

acronym: APTS

summary: To establish if placental transfusion, using deferred cord clamping for 60 seconds or more while holding the baby at or below the level of the placenta, will improve survival without disability compared with standard early cord clamping in preterm babies less than 30 weeks of gestation.

primary_purpose: Prevention

lead_sponsor: University of Sydney

location_country:
United Kingdom
New Zealand
Australia
Canada
United States
France
Pakistan

location_facility:
Royal Hospital for Women
Monash Medical Centre
Mercy Hospital for Women
Auckland Hospital
Craigavon Area Hospital
Waikato Hospital
Hôpital Antoine-Béclère
Royal Jubilee Maternity Hospital
Flinders Medical Centre
Canberra Hospital
Royal Brisbane and Women's Hospital
John Hunter Hospital
Baylor College of Medicine
Christchurch Hospital
King Edward Memorial Hospital
Dunedin Hospital
Mater Mother's Hospital
Liverpool Hospital
Royal North Shore Hospital
Royal Prince Alfred Hospital
University of Vermont Medical Centre
Townsville Hospital
Nepean Hospital
IWK Health Center
Wellington Hospital
Aga Khan University Hospital

lead_sponsor_type: academique


acronym: SHINE

title: An Open-Label Extension Study for Patients With Spinal Muscular Atrophy Who Previously Participated in Investigational Studies of ISIS 396443

design_allocation: Non-Randomized

location_country:
Hong Kong
Spain
Italy
United Kingdom
Australia
Canada
Sweden
Korea, Republic of
United States
France
Turkey
Belgium
Japan
Germany

location_facility:
Research site
Research Site

summary: The primary objective is to evaluate the long-term safety and tolerability of nusinersen (ISIS 396443) administered by intrathecal (IT) injection to participants with Spinal Muscular Atrophy (SMA) who previously participated in investigational studies of nusinersen. The secondary objective is to examine the long-term efficacy of nusinersen administered by IT injection to participants with SMA who previously participated in investigational studies of nusinersen.


type: Other Identifier

title: An International, Multicenter, Open-label Study to Evaluate Safety, Tolerability, Biodistribution, Dosimetry and Preliminary Efficacy of 177Lu-OPS201 for the Therapy of Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)

summary: The purpose of this clinical phase I/II study is to investigate the safety and tolerability of 177Lu-OPS201 used for the treatment of patients with neuroendocrine tumors (NETs). Secondary objectives of these study are the assessment of biodistribution, dosimetry and preliminary efficacy of 177Lu-OPS201.

lead_sponsor: Ipsen

location_country:
Denmark
United Kingdom
Austria
Australia
Canada
Switzerland
United States
France

location_facility: Ramsay Hollywood Private Hospital, Department of Nuclear Medicine

location_facility: University Hospital Basel, Department of Nuclear Medicine

location_facility: Royal Free Hospital, Department of Nuclear Medicine

location_facility: University Hospital Aarhus, Department of Hepatology and Gastroenterology

location_facility: CHU de Nantes, Hotel Dieu, Service de Medecine Nucleaire

location_facility: Peter MacCallum Cancer Centre, Molecular Imaging and Targeted Therapeutics Laboratory

location_facility: CHU de Quebec - Universite Laval Research Center, Department of Radiology and Nuclear Medicine

location_facility: University Hospital Vienna, Department of Nuclear Medicine

location_facility: MD Anderson Cancer Center, Department of Nuclear Medicine


title: Extension of the CBYM338B2203 Phase IIb/III Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Intravenous BYM338 in Patients With Sporadic Inclusion Body Myositis

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Amato AA, Hanna MG, Machado PM, Badrising UA, Chinoy H, Benveniste O, Karanam AK, Wu M, Tankó LB, Schubert-Tennigkeit AA, Papanicolaou DA, Lloyd TE, Needham M, Liang C, Reardon KA, de Visser M, Ascherman DP, Barohn RJ, Dimachkie MM, Miller JAL, Kissel JT, Oskarsson B, Joyce NC, Van den Bergh P, Baets J, De Bleecker JL, Karam C, David WS, Mirabella M, Nations SP, Jung HH, Pegoraro E, Maggi L, Rodolico C, Filosto M, Shaibani AI, Sivakumar K, Goyal NA, Mori-Yoshimura M, Yamashita S, Suzuki N, Aoki M, Katsuno M, Morihata H, Murata K, Nodera H, Nishino I, Romano CD, Williams VSL, Vissing J, Zhang Auberson L; RESILIENT Study Extension Group. Efficacy and Safety of Bimagrumab in Sporadic Inclusion Body Myositis: Long-term Extension of RESILIENT. Neurology. 2021 Mar 23;96(12):e1595-e1607. doi: 10.1212/WNL.0000000000011626. Epub 2021 Feb 17.

location_country:
Denmark
United Kingdom
Italy
Australia
Switzerland
United States
France
Belgium
Japan
Netherlands

summary:
This extension study will provide data to further evaluate the efficacy, safety, and tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in patients with sporadic inclusion body myositis. The extension study was planned to consist of a Screening epoch (to assess patient eligibility), followed by a Treatment Period 1 epoch (double-blind and placebo-controlled), and a Treatment Period 2 epoch (open-label). A Post-treatment Follow-up (FUP) epoch was also planned for patients who discontinued prematurely. Patients who complete the core study and qualify for this extension study entered Treatment Period 1 and continued on the study drug to which they were randomized in the core study (either to one of the three bimagrumab doses (1 mg/kg, 3 mg/kg, and 10mg/kg) or placebo) during Treatment Period 1. Thus, Treatment Period 1 was double-blind and placebo-controlled. Participants were to continue in Treatment Period 1 until the dose with the best benefit-risk profile was determined from the core study data and selected (duration of Treatment Period 1 was estimated to be between 6 and 8 months). Once the dose with the best benefit-risk profile was selected, all participants (including those who were receiving placebo) were planned to enter Treatment Period 2 and switch to open-label treatment with bimagrumab at the selected dose. The core study has been completed but since the core study did not meet the primary end point (no bimagrumab dose was identified based on the core study efficacy results) the extension study was terminated as per protocol/sponsor's decision; therefore, no patients had entered Treatment Period 2. Instead, all patients were to return for the End of Treatment Period 1 (EOT1) visit at their next scheduled visit. As per protocol, all patients who discontinued study medication during Treatment Period 1 for any reason, including due to the study having been stopped as per protocol/sponsor's decision, were to have entered and complete the 6-month FUP after their EOT1 visit.

Due to the nature of the design of the core and extension studies and termination of study medication in the extension study, the treatment duration for individual patients varied considerably. Consequently, the number of patients contributing data to the efficacy analyses at Week 104 and later timepoints was decreased.


ipd_sharing: Undecided

acronym:
Safety and Efficacy study of QVM149 in asthmatic patients

 Sécurité d'emploi et efficacité du traitement QVM149 chez les patients asthmatiques

title: A Multicenter, Randomized, 52-week, Double-blind, Parallelgroup, Active Controlled Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma

ReferenceCitation: Chapman K, van Zyl-Smit R, Maspero J, Kerstjens HAM, Gon Y, Hosoe M, Tanase AM, Pethe A, Shu X, D'Andrea P. One time a day mometasone/indacaterol fixed-dose combination versus two times a day fluticasone/salmeterol in patients with inadequately controlled asthma: pooled analysis from PALLADIUM and IRIDIUM studies. BMJ Open Respir Res. 2021 Aug;8(1). pii: e000819. doi: 10.1136/bmjresp-2020-000819.

ReferenceCitation: Kerstjens HAM, Maspero J, Chapman KR, van Zyl-Smit RN, Hosoe M, Tanase AM, Lavecchia C, Pethe A, Shu X, D'Andrea P; IRIDIUM trial investigators. Once-daily, single-inhaler mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or twice-daily fluticasone-salmeterol in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled phase 3 study. Lancet Respir Med. 2020 Oct;8(10):1000-1012. doi: 10.1016/S2213-2600(20)30190-9. Epub 2020 Jul 9.

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:
Croatia
Spain
Italy
United Kingdom
Lithuania
Peru
Belgium
Japan
Philippines
Romania
South Africa
Poland
Portugal
Austria
Russian Federation
Argentina
India
Israel
Mexico
Sweden
Slovakia
Lebanon
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Jordan
Greece
Ireland
Estonia
Latvia
Finland
Thailand
Vietnam
France
Chile
Colombia
Netherlands

summary: The purpose of the trial was to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Concept1) over two respective QMF149 doses (QMF149 150/160 μg and QMF149 150/320) μg via Concept1 in poorly controlled asthmatics as determined by pulmonary function testing and effects on asthma control.


title: STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI): A Multi-Centre, Randomized, Controlled Trial (Principal Trial)

summary:
The objectives of this trial are to determine whether, in critically ill patients with severe acute kidney injury (AKI), randomization to accelerated initiation of renal replacement therapy (RRT), compared to standard initiation, leads to:

Improved survival (primary outcome); and
Recovery of kidney function (principal secondary outcome), defined as independence from RRT at 90 days

ReferenceCitation: STARRT-AKI Investigators; Canadian Critical Care Trials Group; Australian and New Zealand Intensive Care Society Clinical Trials Group; United Kingdom Critical Care Research Group; Canadian Nephrology Trials Network; Irish Critical Care Trials Group, Bagshaw SM, Wald R, Adhikari NKJ, Bellomo R, da Costa BR, Dreyfuss D, Du B, Gallagher MP, Gaudry S, Hoste EA, Lamontagne F, Joannidis M, Landoni G, Liu KD, McAuley DF, McGuinness SP, Neyra JA, Nichol AD, Ostermann M, Palevsky PM, Pettilä V, Quenot JP, Qiu H, Rochwerg B, Schneider AG, Smith OM, Thomé F, Thorpe KE, Vaara S, Weir M, Wang AY, Young P, Zarbock A. Timing of Initiation of Renal-Replacement Therapy in Acute Kidney Injury. N Engl J Med. 2020 Jul 16;383(3):240-251. doi: 10.1056/NEJMoa2000741. Erratum in: N Engl J Med. 2020 Jul 15;:.

ReferenceCitation: STARRT-AKI Investigators. Statistical analysis plan for the Standard versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI) trial. Crit Care Resusc. 2019 Sep;21(3):162-170.

ReferenceCitation: STARRT-AKI Investigators. STandard versus Accelerated initiation of Renal Replacement Therapy in Acute Kidney Injury: Study Protocol for a Multi-National, Multi-Center, Randomized Controlled Trial. Can J Kidney Health Dis. 2019 Jun 10;6:2054358119852937. doi: 10.1177/2054358119852937. eCollection 2019.

lead_sponsor: Unity Health Toronto

location_country:
Brazil
United Kingdom
Ireland
Austria
Australia
Italy
Canada
Finland
New Zealand
Switzerland
United States
France
China
Belgium
Germany

location_facility: Eastern Hospital (Box Hill and Maroondah Hospital)

location_facility: Centre Hôspitalier universitaire de Sherbrooke (CHUS)

location_facility: St. Paul's Hospital - Providence Health Care

location_facility: Trillium Health Partners - Credit Valley Hospital

location_facility: Hospital de Clínicas de Porto Alegre - Rio Grande do Sul

location_facility: Centre de sante et de services sociaux de Trois-Rivieres (CIUSSS MCQ)

location_facility: Western Health (Footscray Hospital & Sunshine Hospital)

location_facility: Centre hospitalier de l'université de Montréal (St. Luc)

location_facility: London Health Sciences Centre, University Hospital

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval (IUCPQ)

location_facility: London Health Sciences Centre, Victoria Hospital

location_facility: Centre hospitalier de l'université de Montréal (Notre Dame)

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: The First Affiliated Hospital of Xi'An Jiaotong University

location_facility: Centre Hospitalier Universitaire de Quebec (CHUQ)

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Trillium Health Partners - Mississauga Hospital

location_facility: Xiangya Hospital Central South University

location_facility: Beijing Friendship Hospital, Capital Medical University


acronym: TRITON

title: The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension: A Multi-center, Double-blind, Placebo-controlled, Phase 3b Study

lead_sponsor: Actelion

ReferenceCitation: Chin KM, Sitbon O, Doelberg M, Feldman J, Gibbs JSR, Grünig E, Hoeper MM, Martin N, Mathai SC, McLaughlin VV, Perchenet L, Poch D, Saggar R, Simonneau G, Galiè N. Three- Versus Two-Drug Therapy for Patients With Newly Diagnosed Pulmonary Arterial Hypertension. J Am Coll Cardiol. 2021 Oct 5;78(14):1393-1403. doi: 10.1016/j.jacc.2021.07.057.

location_country:
Denmark
Spain
Ireland
Austria
Australia
Italy
Canada
Netherlands
Switzerland
United Kingdom
Sweden
United States
France
Belgium
Germany

location_facility: Washington University School of Medicine

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec

location_facility: University of Texas Southwestern Medical Center

location_facility: Piedmont Pulmonary and Critical Care Research

summary: The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension.


title: A Phase I, First-Time-in-Human Study of MEDI9197, a TLR 7/8 Agonist, Administered Intratumorally as a Single Agent in Subjects With Solid Tumors or CTCL and in Combination With Durvalumab and/or Palliative Radiation in Subjects With Solid Tumors

summary: To evaluate MEDI9197 when administered by intratumoral injection to subjects with solid tumors and in combination with durvalumab in subjects with solid tumors.

ReferenceCitation: Siu L, Brody J, Gupta S, Marabelle A, Jimeno A, Munster P, Grilley-Olson J, Rook AH, Hollebecque A, Wong RKS, Welsh JW, Wu Y, Morehouse C, Hamid O, Walcott F, Cooper ZA, Kumar R, Ferté C, Hong DS. Safety and clinical activity of intratumoral MEDI9197 alone and in combination with durvalumab and/or palliative radiation therapy in patients with advanced solid tumors. J Immunother Cancer. 2020 Oct;8(2). pii: e001095. doi: 10.1136/jitc-2020-001095.

lead_sponsor: MedImmune LLC

location_country:
United States
Canada
France

intervention_type: Biological


title: A Prospective, Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon Percutaneous Transluminal Angioplasty (PTA) Catheter for Treatment of Below-the-Knee (BTK) Arteries

acronym: BTKRegistry

summary: The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the knee. Subjects will be treated with the Lutonix Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed clinically for a minimum of 2 years.

lead_sponsor: C. R. Bard

location_country:
Portugal
Saudi Arabia
Greece
Austria
Italy
Spain
United Kingdom
Switzerland
France
Belgium
Germany

location_facility: King Faisal Hospital and Medical research Center

location_facility: Universitäts-Herzzentrum Freiburg Bad Krozingen

location_facility: A.O.U. Citta della Salute e della Scienza di Torino

location_facility: Medical University Vienna, Department of Angiology

location_facility: Hospital Santa Marta (C.H.Lisboa Central)

location_facility: Medical University Vienna, Department of Radiodiagnostic


title: An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)

summary: An Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease

lead_sponsor: Sunovion

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

location_facility: Muhammed Ali Parkinson and Movement Disorder Center/Barrow Neurological Institute

location_facility: Centre d'Investigation Clinique, CIC 1436, CHU Purpan

location_facility: Aging Research Center, Ce.S.I. University Foundation, Chieti-Pescara Behavioural Neurology & Movement Disorders Unit

location_facility: Jefferson University Hospital Philadelphia

location_facility: Medical University Innsbruck Neurology Department

location_facility: Parkinson's Disease Treatment Center of Southwest Florida

location_facility: UC Irvine Health Gottschalk Medical Plaza

location_facility: Michigan State University - Dept. of Neurology

location_facility: Bendheim Parkinson's and Movement Disorder Center (Mount Sinai Medical Center)

location_facility: Hospital Universitari General de Catalunya

location_facility: Central DuPage Hospital - Neurodegenerative Clinic - Movement Disorders Center

location_facility: Kings College, The Maurice Wohl Neuroscience Institute

location_facility: Park Nicolet Institute - Stuthers Parkinson's Center

location_facility: USF Parkinson's Disease and Movement Disorder Center

location_facility: Royal Devon & Exeter NHS Foundation Trust

location_facility: Wilhelminenspital Department of Neurology

location_facility: Parkinsons Disease and Movement Disorders Center

location_facility: The Ohio State University Wexner Medical Center

location_facility: Houston Methodist Neurological Institute

location_facility: University of Colorado School of Medicine

location_facility: Emory University Department of Neurology

location_facility: Columbia University Medical Center - Neurological Institute, Movement Disorders

location_facility: Universitätsklinikum Ulm Neurologisches Studienzentrum im RKU

location_facility: The Movement Disorder Clinic of Oklahoma

location_facility: Kansas University Medical Center-Department of Neurology

location_facility: IRCCS San Raffaele Pisana - Clinical Trial Center

location_facility: St. Josef-Hospital, Klinikum der Ruhr-Universitaet-Bochum, Neurologische Klinik

location_facility: SUNY Downstate Medical Center, Department of Neurology

location_facility: University of Miami, Miller School of Medicine

location_facility: The Parkinson's and Movement Disorder Institute

location_facility: Duke University - Movement Disorders Clinic


title: A Prospective, Single Arm, Longitudinal Cohort Study To Assess Biomarkers In Real World Patients With Severe Asthma

summary: Prospective, single-arm, longitudinal, international, multicenter study in a real-world cohort of adult severe asthma participants being conducted to assess the relationships between asthma biomarkers and asthma-related health-outcomes for a period of 52 weeks.

primary_purpose: Health Services Research

lead_sponsor: Hoffmann-La Roche

location_country:
Denmark
Portugal
Spain
Italy
Latvia
Netherlands
Russian Federation
Canada
United Kingdom
Hungary
United States
France
Belgium
Germany
Bulgaria

location_facility: Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología

location_facility: Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie

location_facility: Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V

location_facility: AOU Città della Salute e della Scienza di Torino - Ospedale Le Molinette; SC Pneumologia

location_facility: Freeman Hospital; Respiratory Department; Sir William Leach Lung Research Centre

location_facility: St. Paul's Hospital University of British Colambia Division of Hematology

location_facility: Berks-Schuylkill Respiratory Specialists, Ltd

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie

location_facility: Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Hvidovre Hospital, Lungemedicinsk Afdeling

location_facility: Latvian University postgraduate institute

location_facility: Hospital Clinic I provincial; Servicio de Neumologia

location_facility: SBIH "Clinical dermatovenerologic dispensary " of Ministry of Health of the Krasnodar region

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neumologia

location_facility: North Manchester Hospital; Respiratory Department

location_facility: KPPK Studienzentrum GmbH; Dr. med. A. Kroker, Dr. med. O. Schmidt

location_facility: Clinical Hospital Gailezers; Dept of Pulmonology

location_facility: IRCCS AOU SAN MARTINO - IST;UO ALLERGOLOGIA-IMMUNOPATOLOGIA RESPIRATORIA e TERAPIE BIOTECNOLOGICHE

location_facility: Georgia Pollens Clinical Research Centers

location_facility: FSBI "National Research Center - Institute of Immunology" of FMBA of Russia

location_facility: Szent János Kórház; Tüdőgondozó Intézet és Szűrőállomás

location_facility: Complexo Hospitalario Universitario de Santiago

location_facility: Debrecen Uni Medical School; Dept of Pulmonary Medicine

location_facility: SBHI of NN region "RCH of NN n.a. N.A.Semashko"

location_facility: Jewish General Hospital; Endoscopy Department

location_facility: SBEI HPE "North Ossetian State Medical Academy" of Ministry of Health of Russia

location_facility: Hopital Bichat Claude Bernard ; Service de Pneumologie

location_facility: Centre Hospitalier de l'Université de Montréal (CHUM)

location_facility: City Hospital #40 of Resort Administrative District

location_facility: Clinical Research Center of Alabama, LLC

location_facility: Universitätsklinikum Freiburg, Abteilung Pneumologie

location_facility: Matrai Állami Gyógyintézet ; Bronchológia

location_facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

location_facility: Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde

location_facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

location_facility: Research Institute of Complex Cardiovascular Pathology

location_facility: Policlinico di Modena; Oncologia, Ematologia e Patologie dell'apparato Respiratorio

location_facility: Saratov State Medical University; Chair Of Clinical Allergology

location_facility: Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH

location_facility: Presidio Ospedaliero SS. Annunziata di Chieti ; Dip. Medico-UOSD Allergologia

location_facility: Institut für Allergie- und Asthmaforschung Berlin, IAAB

location_facility: CHVNG/E_Unidade 1; Servico de Pneumologia

location_facility: Hospital de Galdakano; Servicio de Neumologia

location_facility: Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases

location_facility: Lungemedicinsk afd. L, Bispebjerg Hospital

location_facility: A.O. Ospedali Riuniti; Villa Sofia-Cervello di Palermo; U. O. Pneumologia 2 - Padiglione B

location_facility: SBEI APE Russian Medical Academy of Post-graduate Education; Department of Clinical Allergology

location_facility: Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )

location_facility: Riga 1st hospital, outpatient clinic Bruninieks

location_facility: Hospital Universitario Reina Sofia; Servicio de Neumología


title: A Phase 2b/3 Prospective, Randomized, Double-Blind, Sham-Controlled 3-Part Trial of VTS-270 (2-hydroxypropyl-β-cyclodextrin) in Subjects With Neurologic Manifestations of Niemann-Pick Type C1 (NPC1) Disease

summary:
Due to different study designs, the sponsor separated Part C into a separate registration (NCT04958642), leaving Parts A/B here in NCT02534844.

This study is to find out how safe and effective VTS-270 is for patients with Niemann-Pick Type C1 (NPC1) disease who have neurologic symptoms (listed under Keywords).

In Parts A/B, two out of every three patients will receive the study drug. The third patient will receive 1 to 2 small needle pricks at the location where the LP and IT injection is normally made (sham control).

In Part C, all participants will receive study drug, as described in the Part C registration record.

Start date for this record is the first day a participant was enrolled in Parts A/B. The trial is actually continuing until the last primary outcome measure of safety data are collected from Part C participants. The last primary outcome measure of safety, along with final adverse events results will be posted in the separate Part C registration record.

ipd_sharing_description: Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT02534844) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

lead_sponsor: Mandos LLC

location_country:
Spain
United Kingdom
New Zealand
Australia
United States
France
Singapore
Turkey
Germany

location_facility: Multicare Institute for Research and Innovation

location_facility: Dell Children's Medical Center of Central Texas

location_facility: CHU Paris Est - Hospital d'Enfants Armand-Trousseau

location_facility: National University Hospital (Singapore) Pte, Ltd

location_facility: Eunice Kennedy Shriver National Institute of Child Health and Human Development

location_facility: Birmingham Women's and Children's NHS Trust


title: A Phase 2b, Randomized, Controlled Trial Evaluating GS-5806 in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection

summary: The primary objective of this study is to evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.

lead_sponsor: Gilead Sciences

location_country:
United Kingdom
Australia
Netherlands
Canada
United States
France
Belgium
Germany


title: A Phase I, Open-Label Study of GSK3174998 Administered Alone and in Combination With Anticancer Agents Including Pembrolizumab in Subjects With Selected Advanced Solid Tumors

summary:
This is a first time in human (FTIH), open-label, non-randomized, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary clinical activity of GSK3174998 administered intravenously to participants with selected advanced or recurrent solid tumors. This dose-escalation study will assess the safety, activity of GSK3174998 as monotherapy (Part 1), in combination with pembrolizumab (Part 2), and potentially in combination with additional therapies.

The study will be conducted in 2 parts, each part consisting of starting with a dose-escalation phase followed by a cohort expansion phase. GSK3174998 will first be evaluated as monotherapy in escalating doses. Once a dose of GSK3174998 has been identified that is both tolerable and demonstrates pharmacodynamic activity, enrollment of Part 2 may begin. In Part 2, escalating doses of GSK3174998 will be evaluated with fixed doses of pembrolizumab.

The maximum duration of treatment with GSK3174998 and pembrolizumab will be approximately 2 years or 35 cycles, whichever comes first. The follow-up period for safety assessments will be a minimum of 3 months from the date of the last dose. The post-treatment follow-up period will include disease assessments every 12 weeks until documented progressive disease (PD). Approximately 141 participants with selected advanced or recurrent solid tumors will be enrolled.

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

lead_sponsor: GlaxoSmithKline

location_country:
Netherlands
United States
Canada
France


title: A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN

acronym: TANGO

summary: This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.

ReferenceCitation: Markman JD, Schnitzer TJ, Perrot S, Beydoun SR, Ohtori S, Viktrup L, Yang R, Bramson C, West CR, Verburg KM. Clinical Meaningfulness of Response to Tanezumab in Patients with Chronic Low Back Pain: Analysis From a 56-Week, Randomized, Placebo- and Tramadol-Controlled, Phase 3 Trial. Pain Ther. 2022 Dec;11(4):1267-1285. doi: 10.1007/s40122-022-00424-7. Epub 2022 Aug 13.

ReferenceCitation: Markman JD, Bolash RB, McAlindon TE, Kivitz AJ, Pombo-Suarez M, Ohtori S, Roemer FW, Li DJ, Viktrup L, Bramson C, West CR, Verburg KM. Tanezumab for chronic low back pain: a randomized, double-blind, placebo- and active-controlled, phase 3 study of efficacy and safety. Pain. 2020 Sep 1;161(9):2068-2078. doi: 10.1097/j.pain.0000000000001928.

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.

lead_sponsor: Pfizer

location_country:
Denmark
Spain
Canada
Hungary
Korea, Republic of
United States
France
Japan
Sweden

location_facility: Northwestern University, Feinberg School of Medicine, Lavin Pavilion

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: National Clinical Research - Richmond, Inc.

location_facility: Hamamatsu University School of Medicine, University Hospital

location_facility: Fukushima Medical University Aizu Medical Center

location_facility: The Center for Rheumatology and Bone Research

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

location_facility: Professional Research Network of Kansas, LLC

location_facility: Hospital Universitario Quiron-Dexeus. Servicio de Farmacia

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Valley Medical Research/Valley Medical Primary Care

location_facility: National Hospital Organization Beppu Medical Center

location_facility: Lafayette Regional Vein and Laser Center

location_facility: CRU Hungary Ltd., MISEK-Radiology Department

location_facility: Chicago Clinical Research Institute, Inc.

location_facility: CTC Pharmacy, Seoul National University Hospital

location_facility: Collaborative Neuroscience Network, LLC.

location_facility: Georgia Institute for Clinical Research, LLC

location_facility: Hospital Regional Universitario del Malaga

location_facility: Willis-Knighton Physician Network/ Spine and Pain Specialist

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Willis-Knighton Physician Network/WKB Family Medicine Associates

location_facility: Center for Advanced Research & Education

location_facility: New Mexico Clinical Research & Osteoporosis Center, Inc.

location_facility: Tokyo Medical and Dental University Medical Hospital

location_facility: Clinical Investigation Specialists, Inc.

location_facility: Kohno Clinical Medicine Research Institute Daisan Kitashinagawa Hospital

location_facility: Centex Studies, Inc./Clear Lake Family Physicians

location_facility: Charlottesville Medical Research Center, LLC

location_facility: Lowcountry Orthopaedics & Sports Medicine

location_facility: Medical corporate corporation hoshikai Onishi medical clinic

location_facility: Complejo Hospitalario Universitario A Coruna. Servicio de Farmacia

location_facility: Hospital Regional Universitario de Malaga

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.

location_facility: Bekes Megyei Koezponti Korhaz Dr Rethy Pal Tagkorhaz

location_facility: London Road Diagnostic Clinic & Medical Centre

location_facility: G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.

location_facility: Clinical Trial Pharmacy, Samsung Medical Center

location_facility: Tolna Megyei Balassa Janos Korhaz, Ortopediai osztaly

location_facility: CTC (Clinical Trial Center) Sahlgrenska University Hospital

location_facility: Northwestern Memorial Hospital - Arkes Pavilion, Diagnostic Testing Center

location_facility: KLR Business Group dba Arkansas Clinical Research

location_facility: Midland Florida Clinical Research Center, LLC


title: A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: The primary objectives of this study are as follows: 1) To evaluate the efficacy of andecaliximab to induce endoscopy, rectal bleeding, and stool frequency (EBS) clinical remission at Week 8 (Cohort 1); 2) To evaluate the efficacy of andecaliximab to maintain EBS clinical remission at Week 52 (Cohort 2); and 3) To evaluate the safety and tolerability of andecaliximab. The study will consist of 3 parts: Induction Phase (Cohort 1), Maintenance Phase (Cohort 2), and an optional Extended Treatment Phase.

location_country:
United Kingdom
Italy
Ukraine
United States
Romania
South Africa
Belgium
Czechia
Poland
Russian Federation
Australia
Slovakia
Canada
Switzerland
Hungary
Bulgaria
Taiwan
Ireland
Latvia
New Zealand
Korea, Republic of
France
Netherlands


title: A Randomized, Sponsor Open, Site and Subject Double Blind, Parallel Group, Placebo-controlled Study to Evaluate the Safety and Efficacy of LHW090 After 4 Weeks Treatment in Patients With Resistant Hypertension

location_country:
Denmark
Netherlands
Switzerland
United States
France
Germany

summary: The purpose of the present study was to determine whether LHW090 displays the clinical safety and efficacy profile to support further development in patients with resistant hypertension.


acronym: SEPSIS-ACT

title: A Double-blind, Randomised, Placebo-Controlled, Phase 2b/3 Adaptive Clinical Trial Investigating the Efficacy and Safety of Selepressin as Treatment for Patients With Vasopressor-dependent Septic Shock

lead_sponsor: Ferring Pharmaceuticals

ReferenceCitation: Laterre PF, Berry SM, Blemings A, Carlsen JE, François B, Graves T, Jacobsen K, Lewis RJ, Opal SM, Perner A, Pickkers P, Russell JA, Windeløv NA, Yealy DM, Asfar P, Bestle MH, Muller G, Bruel C, Brulé N, Decruyenaere J, Dive AM, Dugernier T, Krell K, Lefrant JY, Megarbane B, Mercier E, Mira JP, Quenot JP, Rasmussen BS, Thorsen-Meyer HC, Vander Laenen M, Vang ML, Vignon P, Vinatier I, Wichmann S, Wittebole X, Kjølbye AL, Angus DC; SEPSIS-ACT Investigators. Effect of Selepressin vs Placebo on Ventilator- and Vasopressor-Free Days in Patients With Septic Shock: The SEPSIS-ACT Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1476-1485. doi: 10.1001/jama.2019.14607. Erratum in: JAMA. 2019 Nov 12;322(18):1830.

ReferenceCitation: Lewis RJ, Angus DC, Laterre PF, Kjølbye AL, van der Meulen E, Blemings A, Graves T, Russell JA, Carlsen JE, Jacobsen K, Yealy DM, Opal SM, Windeløv NA, François B, Perner A, Pickkers P, Berry SM. Rationale and Design of an Adaptive Phase 2b/3 Clinical Trial of Selepressin for Adults in Septic Shock. Selepressin Evaluation Programme for Sepsis-induced Shock-Adaptive Clinical Trial. Ann Am Thorac Soc. 2018 Feb;15(2):250-257. doi: 10.1513/AnnalsATS.201708-669SD.

location_country:
Denmark
United States
France
Belgium
Netherlands

location_facility: Wake Forest University School of Medicine

location_facility: Centre Hospitalier et Universitaire de Limoges (there may be other sites in this country)

location_facility: Radboud University Nijmegen Medical Centre (there may be other sites in this country)

location_facility: Northshore University Healthsystem Research Institute

location_facility: Cliniques Universitaires Saint-Luc (there may be other sites in this country)

location_facility: Aalborg Universitetshospital (there may be other sites in this country)

location_facility: University of Oklahoma Health Sciences Center

summary: This is a double-blind, randomised, placebo-controlled, two-part adaptive clinical trial. The trial is designed to investigate the efficacy and safety of multiple dosing regimens of selepressin and to confirm the efficacy and safety of one dosing regimen in treatment of adult patients with septic shock requiring vasopressor.


title: Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients With Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Etoposide and Carboplatin

summary:
This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and etoposide in first line treatment for patients with newly diagnosed extensive-stage SCLC.

The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 90 patients will be enrolled in the study; 20 patients in the Part 1 and 70 patients in the Part 2 portion.

ReferenceCitation: Hussein M, Maglakelidze M, Richards DA, Sabatini M, Gersten TA, Lerro K, Sinielnikov I, Spira A, Pritchett Y, Antal JM, Malik R, Beck JT. Myeloprotective Effects of Trilaciclib Among Patients with Small Cell Lung Cancer at Increased Risk of Chemotherapy-Induced Myelosuppression: Pooled Results from Three Phase 2, Randomized, Double-Blind, Placebo-Controlled Studies. Cancer Manag Res. 2021 Aug 9;13:6207-6218. doi: 10.2147/CMAR.S313045. eCollection 2021.

ReferenceCitation: Ferrarotto R, Anderson I, Medgyasszay B, García-Campelo MR, Edenfield W, Feinstein TM, Johnson JM, Kalmadi S, Lammers PE, Sanchez-Hernandez A, Pritchett Y, Morris SR, Malik RK, Csőszi T. Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy-induced myelosuppression in patients with small cell lung cancer: Pooled analysis of three randomized phase 2 trials. Cancer Med. 2021 Sep;10(17):5748-5756. doi: 10.1002/cam4.4089. Epub 2021 Aug 18.

ReferenceCitation: Li C, Hart L, Owonikoko TK, Aljumaily R, Rocha Lima CM, Conkling PR, Webb RT, Jotte RM, Schuster S, Edenfield WJ, Smith DA, Sale M, Roberts PJ, Malik RK, Sorrentino JA. Trilaciclib dose selection: an integrated pharmacokinetic and pharmacodynamic analysis of preclinical data and Phase Ib/IIa studies in patients with extensive-stage small cell lung cancer. Cancer Chemother Pharmacol. 2021 May;87(5):689-700. doi: 10.1007/s00280-021-04239-9. Epub 2021 Feb 17.

ReferenceCitation: Lai AY, Sorrentino JA, Dragnev KH, Weiss JM, Owonikoko TK, Rytlewski JA, Hood J, Yang Z, Malik RK, Strum JC, Roberts PJ. CDK4/6 inhibition enhances antitumor efficacy of chemotherapy and immune checkpoint inhibitor combinations in preclinical models and enhances T-cell activation in patients with SCLC receiving chemotherapy. J Immunother Cancer. 2020 Oct;8(2). pii: e000847. doi: 10.1136/jitc-2020-000847.

ReferenceCitation: Weiss JM, Csoszi T, Maglakelidze M, Hoyer RJ, Beck JT, Domine Gomez M, Lowczak A, Aljumaily R, Rocha Lima CM, Boccia RV, Hanna W, Nikolinakos P, Chiu VK, Owonikoko TK, Schuster SR, Hussein MA, Richards DA, Sawrycki P, Bulat I, Hamm JT, Hart LL, Adler S, Antal JM, Lai AY, Sorrentino JA, Yang Z, Malik RK, Morris SR, Roberts PJ, Dragnev KH; G1T28-02 Study Group. Myelopreservation with the CDK4/6 inhibitor trilaciclib in patients with small-cell lung cancer receiving first-line chemotherapy: a phase Ib/randomized phase II trial. Ann Oncol. 2019 Oct 1;30(10):1613-1621. doi: 10.1093/annonc/mdz278.

lead_sponsor: G1 Therapeutics, Inc.

location_country:
Poland
Spain
Georgia
Hungary
United States
France
Moldova, Republic of

location_facility: Oklahoma University - Peggy and Charles Stephenson Cancer Center

location_facility: Samodzielny Publiczny ZespAA GruAicy i ChorAb PA¿uc

location_facility: ARENSIA Exploratory Medicine Phase I Unit, The Institute of Oncology

location_facility: University of Colorado Health, Oncology Clinical Research Northern Region

location_facility: Memorial Hospital - Univ. of Colorado Health

location_facility: Hospital Regional Universitario HRU Carlos Haya Malaga

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

location_facility: Hanna Cancer Associates - University of Tennessee

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Boca Raton Regional Hospital - Lynn Cancer Institute

location_facility: The Oncology Institute of Hope and Innovation

location_facility: UNC - Lineberger Comprehensive Cancer Center

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera

location_facility: Orszagos Koranyi Tbc es Pulmonologiai Intezet, XI. Tudobelosztaly


title: An Observational Study to Evaluate the Effectiveness and Safety of Ipilimumab, Administered During the European Expanded Access Programme in Pretreated Patients With Advanced (Unresectable or Metastatic) Melanoma

summary: Observational study to evaluate the effectiveness and safety of ipilimumab, administered during the European expanded access programme (EAP) in pretreated patients with advanced (unresectable or metastatic) melanoma.

time_perspective: Retrospective

lead_sponsor: Bristol-Myers Squibb

location_country:
Denmark
Spain
Ireland
Austria
Italy
Netherlands
Russian Federation
United Kingdom
Switzerland
Hungary
United States
France
Belgium
Norway
Germany
Czechia

location_facility:
Elbe Klinikum Buxtehude
Local Institution
Outcome Sciences Inc Dba Outcome


title: Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow

summary: The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total Elbow when used in primary or revision total elbow replacement.

status: Recruiting

lead_sponsor: Zimmer Biomet

location_country:
United Kingdom
Italy
Australia
Netherlands
Finland
United States
France
Germany

location_facility: Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)


title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis

acronym: focuSSced

summary: This study will assess the efficacy and safety of tocilizumab compared with placebo in participants with SSc across approximately 120 planned global study sites. The study will consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind treatment with active tocilizumab or matching placebo. In the open-label period, eligible participants from either arm may receive active tocilizumab.

ReferenceCitation: Khanna D, Lin CJF, Furst DE, Wagner B, Zucchetto M, Raghu G, Martinez FJ, Goldin J, Siegel J, Denton CP. Long-Term Safety and Efficacy of Tocilizumab in Early Systemic Sclerosis-Interstitial Lung Disease: Open-Label Extension of a Phase 3 Randomized Controlled Trial. Am J Respir Crit Care Med. 2022 Mar 15;205(6):674-684. doi: 10.1164/rccm.202103-0714OC.

ReferenceCitation: Roofeh D, Lin CJF, Goldin J, Kim GH, Furst DE, Denton CP, Huang S, Khanna D; focuSSced Investigators. Tocilizumab Prevents Progression of Early Systemic Sclerosis-Associated Interstitial Lung Disease. Arthritis Rheumatol. 2021 Jul;73(7):1301-1310. doi: 10.1002/art.41668. Epub 2021 May 25.

ReferenceCitation: Gao X, Jia G, Guttman A, DePianto DJ, Morshead KB, Sun KH, Ramamoorthi N, Vander Heiden JA, Modrusan Z, Wolters PJ, Jahreis A, Arron JR, Khanna D, Ramalingam TR. Osteopontin Links Myeloid Activation and Disease Progression in Systemic Sclerosis. Cell Rep Med. 2020 Nov 17;1(8):100140. doi: 10.1016/j.xcrm.2020.100140. eCollection 2020 Nov 17.

ReferenceCitation: Khanna D, Lin CJF, Furst DE, Goldin J, Kim G, Kuwana M, Allanore Y, Matucci-Cerinic M, Distler O, Shima Y, van Laar JM, Spotswood H, Wagner B, Siegel J, Jahreis A, Denton CP; focuSSced investigators. Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2020 Oct;8(10):963-974. doi: 10.1016/S2213-2600(20)30318-0. Epub 2020 Aug 28. Erratum in: Lancet Respir Med. 2020 Oct;8(10):e75. Lancet Respir Med. 2021 Mar;9(3):e29.

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Romania
Belgium
Japan
Poland
Portugal
Argentina
Puerto Rico
Mexico
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
France
Netherlands

location_facility: Centro de Investigaciones Reumatologicas Tucuman

location_facility: Unidad De Enfermedades; Cronico Degenerativas, SC.

location_facility: Spitalul Judetean Cluj; Sectia de Reumatologie

location_facility: Thomas Jefferson Uni ; Division of Rheumatology

location_facility: Vilnius University Hospital Santariskiu Clinic Public Insti

location_facility: Mount Sinai Hospital; Rebecca Macdonald Centre For Arthritis & Autoimmune Disease

location_facility: Arthritis and Rheumatology; Center of Oklahoma PLLC

location_facility: Aarhus Universitetshospital Skejby, Hud- og Kønssygdomme

location_facility: Bispebjerg Hospital, Dermatologisk afdeling

location_facility: Laiko General Hospital; Dept. of Pathophysiology-Uni of Athens

location_facility: Klaipeda University Hospital; Department of Rheumatology

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Reumatología

location_facility: Uni Hospital Aintree; Academic Rheumatology Unit

location_facility: Hospital of the University of Occupational and Environmental Health,Japan

location_facility: Szpital Specjalistyczny im Jozefa Dietla; Centrum Reumatologii, Immunologii i Rehabilitacji, I Oddzi

location_facility: Universitätsspital Zürich; Klinik für Rheumatologie

location_facility: Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie

location_facility: Universitätsspital Basel; Rheumatologische Poliklinik

location_facility: University Hospital of Patras; Rheumatology

location_facility: Universitätsklinikum Dresden; Technische Universität Dresden; Rheumatologie, Innere Medizin III

location_facility: Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV

location_facility: Univ of Calif., Los Angeles; Rheumatology

location_facility: Royal Free Hospital; Department of Rheumatology

location_facility: Arthritis Associates of Southern California

location_facility: Rheumatology Assoc. of S. Florida - Clinical Research Center

location_facility: Academisch Ziekenhuis Leiden; Dept of Rheumatology

location_facility: Uni ' Cattolica Del Sacro Cuore; Facoltà Di Medicina E Chirurgia A.Gemelli-Clinica Reumatologica

location_facility: National Institute of Rheumatology and Physiology

location_facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob

location_facility: Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Medicina Interna/Reumatologia

location_facility: MHAT St.Ivan Rilski; Rheumtology Department

location_facility: Policlinico Universitario-II Università di Napoli; Reumatologia

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Puerto Rico Clinical & Translational Research Consortium

location_facility: Chapel Allerton Hospital; Leeds Institution of Rheumatology Medicine

location_facility: Hopital Claude Huriez; Internal Medicine

location_facility: Hospital Garcia de Orta; Servico de Reumatologia

location_facility: Pécsi Tudományegyetem Klinikai Központ: Immunológiai és Reumatológiai Klinika

location_facility: St. Paul's Hospital University of British Colambia Division of Hematology

location_facility: SPSK NR 4; Reumatologii i Ukladowych Chorob Tkanki

location_facility: Cantacuzino Hospital; Department of Internal Medicine and Rheumatology

location_facility: Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II

location_facility: Ospedale Maggiore Policlinico; Unità Operativa Complessa di Allergologia e Immunologia Clinica

location_facility: MHAT Sv.Ivan Rilski; Clinic of Rheumatology

location_facility: Ospedale Careggi Villa Monnatessa ; Sezione Di Reumatologia

location_facility: Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán

location_facility: Queen Elizabeth Hospital; Rheumatology Dept.

location_facility: Georgetown Uni. Hosp.; Rheumatology, Immunology and Allergy Dept.

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Chorob Wewnetrznych, Chorob Tkanki Łacznej i Geriatrii

location_facility: Hospital Prof. Dr. Fernando Fonseca; Medicina IV


title: A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

acronym: JULIET

summary: This is a multi-center, phase II study to determine the efficacy and safety of CTL019 in adult patients with relapsed or refractory DLBCL.

ReferenceCitation: Cartron G, Fox CP, Liu FF, Kostic A, Hasskarl J, Li D, Bonner A, Zhang Y, Maloney DG, Kuruvilla J. Matching-adjusted indirect treatment comparison of chimeric antigen receptor T-cell therapies for third-line or later treatment of relapsed or refractory large B-cell lymphoma: lisocabtagene maraleucel versus tisagenlecleucel. Exp Hematol Oncol. 2022 Mar 25;11(1):17. doi: 10.1186/s40164-022-00268-z.

ReferenceCitation: Frigault MJ, Dietrich J, Gallagher K, Roschewski M, Jordan JT, Forst D, Plotkin SR, Cook D, Casey KS, Lindell KA, Depinho GD, Katsis K, Elder EL, Leick MB, Choi B, Horick N, Preffer F, Saylor M, McAfee S, O'Donnell PV, Spitzer TR, Dey B, DeFilipp Z, El-Jawahri A, Batchelor TT, Maus MV, Chen YB. Safety and efficacy of tisagenlecleucel in primary CNS lymphoma: a phase 1/2 clinical trial. Blood. 2022 Apr 14;139(15):2306-2315. doi: 10.1182/blood.2021014738.

ReferenceCitation: Schuster SJ, Tam CS, Borchmann P, Worel N, McGuirk JP, Holte H, Waller EK, Jaglowski S, Bishop MR, Damon LE, Foley SR, Westin JR, Fleury I, Ho PJ, Mielke S, Teshima T, Janakiram M, Hsu JM, Izutsu K, Kersten MJ, Ghosh M, Wagner-Johnston N, Kato K, Corradini P, Martinez-Prieto M, Han X, Tiwari R, Salles G, Maziarz RT. Long-term clinical outcomes of tisagenlecleucel in patients with relapsed or refractory aggressive B-cell lymphomas (JULIET): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1403-1415. doi: 10.1016/S1470-2045(21)00375-2. Epub 2021 Sep 10.

ReferenceCitation: Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9:CD013365. doi: 10.1002/14651858.CD013365.pub2. Review.

ReferenceCitation: Westin JR, Kersten MJ, Salles G, Abramson JS, Schuster SJ, Locke FL, Andreadis C. Efficacy and safety of CD19-directed CAR-T cell therapies in patients with relapsed/refractory aggressive B-cell lymphomas: Observations from the JULIET, ZUMA-1, and TRANSCEND trials. Am J Hematol. 2021 Oct 1;96(10):1295-1312. doi: 10.1002/ajh.26301. Epub 2021 Aug 13. Review.

ReferenceCitation: Schuster SJ, Maziarz RT, Rusch ES, Li J, Signorovitch JE, Romanov VV, Locke FL, Maloney DG. Grading and management of cytokine release syndrome in patients treated with tisagenlecleucel in the JULIET trial. Blood Adv. 2020 Apr 14;4(7):1432-1439. doi: 10.1182/bloodadvances.2019001304.

ReferenceCitation: Maziarz RT, Schuster SJ, Romanov VV, Rusch ES, Li J, Signorovitch JE, Maloney DG, Locke FL. Grading of neurological toxicity in patients treated with tisagenlecleucel in the JULIET trial. Blood Adv. 2020 Apr 14;4(7):1440-1447. doi: 10.1182/bloodadvances.2019001305.

ReferenceCitation: Maziarz RT, Waller EK, Jaeger U, Fleury I, McGuirk J, Holte H, Jaglowski S, Schuster SJ, Bishop MR, Westin JR, Mielke S, Teshima T, Bachanova V, Foley SR, Borchmann P, Salles GA, Zhang J, Tiwari R, Pacaud LB, Ma Q, Tam CS. Patient-reported long-term quality of life after tisagenlecleucel in relapsed/refractory diffuse large B-cell lymphoma. Blood Adv. 2020 Feb 25;4(4):629-637. doi: 10.1182/bloodadvances.2019001026.

ReferenceCitation: Awasthi R, Pacaud L, Waldron E, Tam CS, Jäger U, Borchmann P, Jaglowski S, Foley SR, van Besien K, Wagner-Johnston ND, Kersten MJ, Schuster SJ, Salles G, Maziarz RT, Anak Ö, Del Corral C, Chu J, Gershgorin I, Pruteanu-Malinici I, Chakraborty A, Mueller KT, Waller EK. Tisagenlecleucel cellular kinetics, dose, and immunogenicity in relation to clinical factors in relapsed/refractory DLBCL. Blood Adv. 2020 Feb 11;4(3):560-572. doi: 10.1182/bloodadvances.2019000525.

ReferenceCitation: Bishop MR, Maziarz RT, Waller EK, Jäger U, Westin JR, McGuirk JP, Fleury I, Holte H, Borchmann P, Del Corral C, Tiwari R, Anak Ö, Awasthi R, Pacaud L, Romanov VV, Schuster SJ. Tisagenlecleucel in relapsed/refractory diffuse large B-cell lymphoma patients without measurable disease at infusion. Blood Adv. 2019 Jul 23;3(14):2230-2236. doi: 10.1182/bloodadvances.2019000151.

ReferenceCitation: Schuster SJ, Bishop MR, Tam CS, Waller EK, Borchmann P, McGuirk JP, Jäger U, Jaglowski S, Andreadis C, Westin JR, Fleury I, Bachanova V, Foley SR, Ho PJ, Mielke S, Magenau JM, Holte H, Pantano S, Pacaud LB, Awasthi R, Chu J, Anak Ö, Salles G, Maziarz RT; JULIET Investigators. Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2019 Jan 3;380(1):45-56. doi: 10.1056/NEJMoa1804980. Epub 2018 Dec 1.

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:
Italy
Austria
Australia
Netherlands
Canada
United States
France
Norway
Japan
Germany

location_facility: Mayo Clinic - Arizona Mayo Clinic Building

location_facility: University of California San Francisco SC-4

location_facility: The Ohio State University James Cancer Hospital &

location_facility: University of Chicago Medical Center, Hematology & Oncology

location_facility: Emory University School of Medicine/Winship Cancer Institute

location_facility: The Sidney Kimmel Cancer Center at Johns Hopkins Hospital SC-2


title: Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy (SPYRAL HTN-ON MED)

summary: The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.

ReferenceCitation: Mahfoud F, Kandzari DE, Kario K, Townsend RR, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Dimitriadis K, Choi JW, East C, D'Souza R, Sharp ASP, Ewen S, Walton A, Hopper I, Brar S, McKenna P, Fahy M, Böhm M. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. Lancet. 2022 Apr 9;399(10333):1401-1410. doi: 10.1016/S0140-6736(22)00455-X. Epub 2022 Apr 4.

ReferenceCitation: Kandzari DE, Hickey GL, Pocock SJ, Weber MA, Bohm M, Cohen SA, Fahy M, Lamberti G, Mahfoud F. Prioritised endpoints for device-based hypertension trials: the win ratio methodology. EuroIntervention. 2021 Apr 2;16(18):e1496-e1502. doi: 10.4244/EIJ-D-20-01090.

ReferenceCitation: Kario K, Weber MA, Böhm M, Townsend RR, Mahfoud F, Schmieder RE, Tsioufis K, Cohen SA, Fahy M, Kandzari DE. Effect of renal denervation in attenuating the stress of morning surge in blood pressure: post-hoc analysis from the SPYRAL HTN-ON MED trial. Clin Res Cardiol. 2021 May;110(5):725-731. doi: 10.1007/s00392-020-01718-6. Epub 2020 Aug 1.

ReferenceCitation: Böhm M, Townsend RR, Kario K, Kandzari D, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Hickey GL, Fahy M, DeBruin V, Brar S, Pocock S. Rationale and design of two randomized sham-controlled trials of catheter-based renal denervation in subjects with uncontrolled hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) and presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications: a novel approach using Bayesian design. Clin Res Cardiol. 2020 Mar;109(3):289-302. doi: 10.1007/s00392-020-01595-z. Epub 2020 Feb 7. Erratum in: Clin Res Cardiol. 2020 May;109(5):653.

ReferenceCitation: Kandzari DE, Böhm M, Mahfoud F, Townsend RR, Weber MA, Pocock S, Tsioufis K, Tousoulis D, Choi JW, East C, Brar S, Cohen SA, Fahy M, Pilcher G, Kario K; SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355. doi: 10.1016/S0140-6736(18)30951-6. Epub 2018 May 23.

ReferenceCitation: Kandzari DE, Kario K, Mahfoud F, Cohen SA, Pilcher G, Pocock S, Townsend R, Weber MA, Böhm M. The SPYRAL HTN Global Clinical Trial Program: Rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications. Am Heart J. 2016 Jan;171(1):82-91. doi: 10.1016/j.ahj.2015.08.021. Epub 2015 Sep 11. Review.

lead_sponsor: Medtronic Vascular

location_country:
United Kingdom
Greece
Austria
Australia
Ireland
Canada
United States
France
Japan
Germany

location_facility: University General Hospital of Thessaloniki (AHEPA)

location_facility: Cardiff and Vale University Health Board - University Hospital of Wales

location_facility: Hospital of the University of Pennsylvania

location_facility: University Hospitals Cleveland Medical Center

location_facility: Royal Devon & Exeter NHS Foundation Trust

location_facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH

location_facility: Weill Cornell Medical College/The New York Presbyterian Hospital

location_facility: Oregon Health & Science University Hospital


title: A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive

summary: This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group, multicenter study of tezacaftor in combination with ivacaftor in subjects aged 12 years and older with CF who are heterozygous for the F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive.

ReferenceCitation: McKone EF, DiMango EA, Sutharsan S, Barto TL, Campbell D, Ahluwalia N, Higgins M, Owen CA, Tullis E. A phase 3, randomized, double-blind, parallel-group study to evaluate tezacaftor/ivacaftor in people with cystic fibrosis heterozygous for F508del-CFTR and a gating mutation. J Cyst Fibros. 2021 Mar;20(2):234-242. doi: 10.1016/j.jcf.2020.11.003. Epub 2020 Dec 16.

lead_sponsor: Vertex Pharmaceuticals Incorporated

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


title: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

summary: This Phase Ib, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of the combination of MOXR0916 and atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy; or for which standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care. Participants will be enrolled in two stages: a dose-escalation stage and an expansion stage.

lead_sponsor: Genentech, Inc.

location_country:
Spain
Australia
Canada
Korea, Republic of
United States
France
Belgium

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Yonsei University Health System/Severance Hospital

location_facility: HonorHealth Research Institute - Bisgrove

location_facility: University Of Chicago Medical Center; Section Of Hematology/Oncology

location_facility: Hospital Clinico Universitario de Valencia

location_facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: Hosp de Madrid Norte Sanchinarro; Centro Integral; Onco Clara Campal


title: Open Label, Multi-center, Phase IV Study of Ruxolitinib or Ruxolitinib and Panobinostat Combination, for Patients Who Have Completed Prior Global Novartis or Incyte Sponsored Studies

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
Belgium
Japan
South Africa
Poland
Portugal
Russian Federation
Australia
India
Israel
Turkey
Mexico
Sweden
Slovakia
Lebanon
Hungary
China
Germany
Bulgaria
Denmark
Greece
Thailand
Korea, Republic of
France
Chile

summary: This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study Investigator to benefit from ongoing treatment.


title: Age-adjusted D-dimer Cutoff Levels to Rule Out Deep Vein Thrombosis: a Prospective Outcome Study

acronym: ADJUST-DVT

summary: Prospective validation of an age-adjusted D-dimer cut-off to rule out deep vein thrombosis (DVT)

status: Unknown status

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Geneva

location_country: Canada Switzerland France

location_facility: Thunder Bay regional Health Sciences center


title: A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)

summary: The primary objective of this study is to evaluate the noninferiority of switching to emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) in virologically suppressed HIV-1 infected participants.

ReferenceType: result

ReferenceCitation: Hagins D, Orkin C, Daar ES, Mills A, Brinson C, DeJesus E, Post FA, Morales-Ramirez J, Thompson M, Osiyemi O, Rashbaum B, Stellbrink HJ, Martorell C, Liu H, Liu YP, Porter D, Collins SE, SenGupta D, Das M. Switching to coformulated rilpivirine (RPV), emtricitabine (FTC) and tenofovir alafenamide from either RPV, FTC and tenofovir disoproxil fumarate (TDF) or efavirenz, FTC and TDF: 96-week results from two randomized clinical trials. HIV Med. 2018 Nov;19(10):724-733. doi: 10.1111/hiv.12664. Epub 2018 Aug 12.

ReferenceCitation: Mills A, Brinson C, Martorell C, Crofoot G, Daar E, Osiyemi O, et al. Switching to RPV/FTC/TAF from RPV/FTC/TDF or EFV/FTC/TDF: Week 96 Results. Conference on Retroviruses and Opportunistic Infections,Boston. March 4-7, 2018, Abstract 504.

ReferenceCitation: Arribas JR, Rockstroh J, Post, Yazdanpanah Y, Cavassini, DeJesus E, et al. Bone and renal safety of switching to rilpivirine/emtricitabine/tenofovir alafenamide (RPV/FTC/TAF) from single-tablet regimens (STRs) containing efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) or rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF): Week48 subgroup analysis in patients at risk of or with comorbidities. Abstract accepted for presentation atthe 16th European AIDS Conference, 2017 25-27 October Milan, Italy.

ReferenceCitation: Porter DP, Kulkarni R, Cao H, SenGupta D, White KL. No Emergent Resistance in HIV-1 Virologically-Suppressed Subjects Who Switched to RPV/FTC/TAF [Poster1381]. ID Week™ (Infectious Diseases Society of America) 2017 4-8 October; San Diego, CA.

ReferenceCitation: Wohl D, Kulkarni R, Garner W, White KL, Porter DL. Viral Blips Were Infrequent in HIV1-Infected Virologically-Suppressed Adults Treated with Tenofovir Alafenamide or Tenofovir DF Rilpivirine-Containing Regimens [Poster1384]. ID Week™ (Infectious Diseases Society of America) 2017 4-8 October; San Diego, CA.

ReferenceCitation: DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Molina J-M, et al. Efficacy and Safety of Switching to RPV/FTC/TAF in Older Adults. 8th International Workshopon HIV and Aging 2017 2-3 October, New York, New York.

ReferenceCitation: Molina JM, DeJesus E, Rijnders B, Post FAV, B., Stoeckle M, Thalme A, et al. Efficacy and Odefsey® StudyGS-US-366-1216Final Synoptic Clinical Study Report Final CONFIDENTIAL Page4 30July2019 Safety of Switching From RPV/FTC/TDF or EFV/FTC/TDF to RPV/FTC/TAF in Black Adults [Presentation MOPEB0291]. 9th IAS Conference on HIV Science 2017 23-26 July Paris, France.

ReferenceCitation: Rockstroh J, Orkin C, Yazdanpanah Y, Di Perri GDS, P. E., Arribas JR, Brinkman K, et al. Switching From TDF to TAF Improves Bone and Renal Safety Independent of Age, Sex, Race, or 3rd Agent: Results From Pooled Analysis (N=3816) of Virologically Suppressed HIV-1 Infected Adults [Presentation MOPEB0289]. 9th IAS Conference on HIV Science;2017 23-26July Paris, France.

ReferenceCitation: Orkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Mills A, Vandercam B, de Wet J, Rockstroh J, Lazzarin A, Rijnders B, Podzamczer D, Thalme A, Stoeckle M, Porter D, Liu HC, Cheng A, Quirk E, SenGupta D, Cao H. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. Lancet HIV. 2017 May;4(5):e195-e204. doi: 10.1016/S2352-3018(17)30031-0. Epub 2017 Mar 2.

ReferenceCitation: Majeed SR, Shao Y, Garner W, Scott J, Pérez-Ruixo C, SenGupta D, et al. Evaluation of RPV/FTC/TAF Exposure-Efficacy and Exposure-Safety Relationships [Poster427]. Conference on Retroviruses and Opportunistic Infections (CROI) 2017 13-16 February; Seattle, WA.

ReferenceCitation: Hagins D, Mills A, Martorell C, Walmsley S, Gallant J, Tebas P, et al. Efficacy and Safety of Switching toRPV/FTC/TAF in Women [Abstract12]. 7th International Workshop on HIV & Women; 2017 11-12 February; Seattle, Washington.

ReferenceCitation: Orkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, et al. 48Week Results from two studies: Switching to RPV/FTC/TAF from EFV/FTC/TDF (Study1160) or RPV/FTC/TDF (Study1216) [Presentation]. HIV Glasgow; 2016 23-26 October; Glasgow, United Kingdom.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

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

location_facility: Infectious Disease Specialists of Atlanta

location_facility: University of North Carolina at Chapel Hill

location_facility: Desert Medical Group Inc., dba Desert Oasis Healthcare Medical Group

location_facility: Carolinas Medical Center--Myers Park Infectious Disease Clinic

location_facility: Infectious Disease Research Institute Inc.

location_facility: Trinity Health and Wellness Center/AIDS Arms, Inc.

location_facility: Hôpital Gui de Chauliac - Service Maladies Infectieuses et Tropicales

location_facility: Los Angeles BioMedical Institute at Harbor-UCLA Medical Center

location_facility: North Texas Infectious Diseases Consultants

location_facility: Midway Immunology & Research Center, LLC

location_facility: AIDS Arms, Inc./Trinity Health & Wellness Center

location_facility: Hospital Clínico Universitario San Carlos

location_facility: La Playa Medical Group and Clinical Research

location_facility: The University of Alabama at Birmingham (UAB)

location_facility: Center for HIV and Hepatogastroenterology

location_facility: Hospital General Universitario de Alicante

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: World Health Clinicians' CIRCLE CARE Center

location_facility: AIDS Research & Treatment Center of the Treasure Coast

location_facility: Baystate Infectious Diseases Clinical Research

location_facility: Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)

location_facility: Long Beach Education and Research Consultants

location_facility: Fondazione IRCCS San Raffaele del Monte Tabor

location_facility: Infectious Diseases Associates of NW Florida, P.A.

location_facility: The Hathersage Integrated Contraception, Sexual Health and HIV Service

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH (zibp)


title: A Multicenter Single-arm Extension Study to Characterize the Long-term Safety of Cinacalcet Hydrochloride in the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects With Chronic Kidney Disease on Dialysis

lead_sponsor: Amgen

ReferenceType: background

ReferenceCitation: Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4. Review.

location_country:
Poland
Greece
Italy
Russian Federation
Ukraine
Hungary
France
United States
Belgium
Germany
Czechia

summary: The primary objective of this study was to characterize the long-term safety and tolerability of cinacalcet in pediatric patients with chronic kidney disease (CKD) receiving dialysis.


title: A Multi-Center, Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of 52 Weeks Treatment With QGE031 Subcutaneous (s.c). in Asthma Patients Not Adequately Controlled by Medium- or High-dose Inhaled Corticosteroid (ICS) Plus Long Acting β2-agonist (LABA) With or Without Oral Corticosteroid (OCS)

summary: This study planned to assess the effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. However, this study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data analyses were not performed for this study due to the early termination and the very limited dataset (only 10 participants received study medication of the 440 participants planned).

location_country:
Italy
Netherlands
Canada
Hungary
United States
France
Belgium
Japan
Germany
Slovakia


title: European Registry on the Management of Helicobacter Pylori Infection

summary:
The great diversity of regimens and treatment lines, the different efficacy of these, mostly due to the increase in bacterial antibiotic resistance and regional differences, requires a continuous critical analysis of clinical practice, evaluating systematically the efficacy and safety of the different regimens and the cost-effectiveness of the different diagnostic-therapeutic strategies. This will help in the design of an efficient and optimized treatment that will reduce number of re-treatments, diagnostic tests and the appearance of associated pathologies such as peptic ulcers, gastrointestinal bleeding and, probably, gastric cancers. Therefore, the evaluation of real clinical practice using non-interventionist registries will help to improve the design and organization of European Consensus on the management of H. pylori infection, which is the best way to establish healthcare efficiency.

Primary aim

To obtain a database registering systematically over a year a large and representative sample of routine clinical practice of European gastroenterologists in order to produce descriptive studies of the management of H. pylori infection.

Secondary aims

To evaluate H. pylori infection consensus and clinical guidelines implementation in different countries.
To perform studies focused on epidemiology, efficacy and safety of the commonly used treatments to eradicate H. pylori.
To evaluate accessibility to healthcare technologies and drugs used in the management of H. pylori infection.
To allow the development of partial and specific analysis by the participating researchers after approval by the Registry's Scientific Committee

Methodology Non-interventionist prospective multicentre international registry promoted by the European Helicobacter Study Group. A renowned gastroenterologist from each country was selected as Local Coordinator (30 countries). They will in turn select up to ten gastroenterologists per country that will register the routine clinical practice consultations they receive over 10 years in an electronic Case Report Form (e-CRF). Variables retrieved will include clinical, diagnostic, treatment, eradication confirmation and outcome data. The database will allow researchers to perform specific subanalysis after approval by the Scientific Committee of the study.

ReferenceCitation: Arkkila PE, Seppälä K, Kosunen TU, Sipponen P, Mäkinen J, Rautelin H, Färkkilä M. Helicobacter pylori eradication as the sole treatment for gastric and duodenal ulcers. Eur J Gastroenterol Hepatol. 2005 Jan;17(1):93-101.

ReferenceCitation: Azevedo NF, Huntington J, Goodman KJ. The epidemiology of Helicobacter pylori and public health implications. Helicobacter. 2009 Sep;14 Suppl 1:1-7. doi: 10.1111/j.1523-5378.2009.00703.x. Review. Erratum in: Helicobacter. 2010 Feb;15(1):78.

ReferenceCitation: Broutet N, Tchamgoué S, Pereira E, Lamouliatte H, Salamon R, Mégraud F. Risk factors for failure of Helicobacter pylori therapy--results of an individual data analysis of 2751 patients. Aliment Pharmacol Ther. 2003 Jan;17(1):99-109.

ReferenceCitation: de Vries AC, van Grieken NC, Looman CW, Casparie MK, de Vries E, Meijer GA, Kuipers EJ. Gastric cancer risk in patients with premalignant gastric lesions: a nationwide cohort study in the Netherlands. Gastroenterology. 2008 Apr;134(4):945-52. doi: 10.1053/j.gastro.2008.01.071. Epub 2008 Jan 30.

ReferenceCitation: Ford A, Moayyedi P. How can the current strategies for Helicobacter pylori eradication therapy be improved? Can J Gastroenterol. 2003 Jun;17 Suppl B:36B-40B.

ReferenceCitation: Ford AC, Axon AT. Epidemiology of Helicobacter pylori infection and public health implications. Helicobacter. 2010 Sep;15 Suppl 1:1-6. doi: 10.1111/j.1523-5378.2010.00779.x. Review.

ReferenceCitation: Gisbert JP, Calvet X. Review article: the effectiveness of standard triple therapy for Helicobacter pylori has not changed over the last decade, but it is not good enough. Aliment Pharmacol Ther. 2011 Dec;34(11-12):1255-68. doi: 10.1111/j.1365-2036.2011.04887.x. Epub 2011 Oct 21. Review.

ReferenceCitation: Gisbert JP, Calvet X, O'Connor A, Mégraud F, O'Morain CA. Sequential therapy for Helicobacter pylori eradication: a critical review. J Clin Gastroenterol. 2010 May-Jun;44(5):313-25. doi: 10.1097/MCG.0b013e3181c8a1a3. Review.

ReferenceCitation: Gisbert JP, Calvet X. Review article: non-bismuth quadruple (concomitant) therapy for eradication of Helicobater pylori. Aliment Pharmacol Ther. 2011 Sep;34(6):604-17. doi: 10.1111/j.1365-2036.2011.04770.x. Epub 2011 Jul 11. Review.

ReferenceCitation: Gisbert JP, Khorrami S, Carballo F, Calvet X, Gené E, Dominguez-Muñoz JE. H. pylori eradication therapy vs. antisecretory non-eradication therapy (with or without long-term maintenance antisecretory therapy) for the prevention of recurrent bleeding from peptic ulcer. Cochrane Database Syst Rev. 2004;(2):CD004062. Review.

ReferenceCitation: Graham DY, Rimbara E. Understanding and appreciating sequential therapy for Helicobacter pylori eradication. J Clin Gastroenterol. 2011 Apr;45(4):309-13. doi: 10.1097/MCG.0b013e31820ac05e.

ReferenceCitation: Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut. 2010 Aug;59(8):1143-53. doi: 10.1136/gut.2009.192757. Epub 2010 Jun 4. Review.

ReferenceCitation: Greenberg ER, Anderson GL, Morgan DR, Torres J, Chey WD, Bravo LE, Dominguez RL, Ferreccio C, Herrero R, Lazcano-Ponce EC, Meza-Montenegro MM, Peña R, Peña EM, Salazar-Martínez E, Correa P, Martínez ME, Valdivieso M, Goodman GE, Crowley JJ, Baker LH. 14-day triple, 5-day concomitant, and 10-day sequential therapies for Helicobacter pylori infection in seven Latin American sites: a randomised trial. Lancet. 2011 Aug 6;378(9790):507-14. doi: 10.1016/S0140-6736(11)60825-8. Epub 2011 Jul 21.

ReferenceCitation: Hsu PI, Wu DC, Wu JY, Graham DY. Is there a benefit to extending the duration of Helicobacter pylori sequential therapy to 14 days? Helicobacter. 2011 Apr;16(2):146-52. doi: 10.1111/j.1523-5378.2011.00829.x.

ReferenceCitation: Ikenberry SO, Harrison ME, Lichtenstein D, Dominitz JA, Anderson MA, Jagannath SB, Banerjee S, Cash BD, Fanelli RD, Gan SI, Shen B, Van Guilder T, Lee KK, Baron TH; ASGE STANDARDS OF PRACTICE COMMITTEE. The role of endoscopy in dyspepsia. Gastrointest Endosc. 2007 Dec;66(6):1071-5. Epub 2007 Oct 29.

ReferenceCitation: Maconi G, Sainaghi M, Molteni M, Bosani M, Gallus S, Ricci G, Alvisi V, Porro GB. Predictors of long-term outcome of functional dyspepsia and duodenal ulcer after successful Helicobacter pylori eradication--a 7-year follow-up study. Eur J Gastroenterol Hepatol. 2009 Apr;21(4):387-93. doi: 10.1097/MEG.0b013e3283069db0.

ReferenceCitation: Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084.

ReferenceCitation: McColl KE. Clinical practice. Helicobacter pylori infection. N Engl J Med. 2010 Apr 29;362(17):1597-604. doi: 10.1056/NEJMcp1001110. Review.

ReferenceCitation: McNicholl AG, Linares PM, Nyssen OP, Calvet X, Gisbert JP. Meta-analysis: esomeprazole or rabeprazole vs. first-generation pump inhibitors in the treatment of Helicobacter pylori infection. Aliment Pharmacol Ther. 2012 Sep;36(5):414-25. doi: 10.1111/j.1365-2036.2012.05211.x. Epub 2012 Jul 15.

ReferenceCitation: Moayyedi P. The health economics of Helicobacter pylori infection. Best Pract Res Clin Gastroenterol. 2007;21(2):347-61. Review.

ReferenceCitation: Moayyedi P, Deeks J, Talley NJ, Delaney B, Forman D. An update of the Cochrane systematic review of Helicobacter pylori eradication therapy in nonulcer dyspepsia: resolving the discrepancy between systematic reviews. Am J Gastroenterol. 2003 Dec;98(12):2621-6. Review.

ReferenceCitation: Niv Y, Hazazi R. Helicobacter pylori recurrence in developed and developing countries: meta-analysis of 13C-urea breath test follow-up after eradication. Helicobacter. 2008 Feb;13(1):56-61. doi: 10.1111/j.1523-5378.2008.00571.x.

ReferenceCitation: Oderda G, Shcherbakov P, Bontems P, Urruzuno P, Romano C, Gottrand F, Gómez MJ, Ravelli A, Gandullia P, Roma E, Cadranel S, De Giacomo C, Canani RB, Rutigliano V, Pehlivanoglu E, Kalach N, Roggero P, Celinska-Cedro D, Drumm B, Casswall T, Ashorn M, Arvanitakis SN; European Pediatric Task Force on Helicobacter pylori. Results from the pediatric European register for treatment of Helicobacter pylori (PERTH). Helicobacter. 2007 Apr;12(2):150-6.

ReferenceCitation: Rokkas T, Sechopoulos P, Robotis I, Margantinis G, Pistiolas D. Cumulative H. pylori eradication rates in clinical practice by adopting first and second-line regimens proposed by the Maastricht III consensus and a third-line empirical regimen. Am J Gastroenterol. 2009 Jan;104(1):21-5. doi: 10.1038/ajg.2008.87.

ReferenceCitation: Nyssen OP, Vaira D, Pérez Aísa Á, Rodrigo L, Castro-Fernandez M, Jonaitis L, Tepes B, Vologzhanina L, Caldas M, Lanas A, Lucendo AJ, Bujanda L, Ortuño J, Barrio J, Huguet JM, Voynovan I, Lasala JP, Sarsenbaeva AS, Fernandez-Salazar L, Molina-Infante J, Jurecic NB, Areia M, Gasbarrini A, Kupčinskas J, Bordin D, Marcos-Pinto R, Lerang F, Leja M, Buzas GM, Niv Y, Rokkas T, Phull P, Smith S, Shvets O, Venerito M, Milivojevic V, Simsek I, Lamy V, Bytzer P, Boyanova L, Kunovský L, Beglinger C, Doulberis M, Marlicz W, Goldis A, Tonkić A, Capelle L, Puig I, Megraud F, Morain CO, Gisbert JP; European Registry on Helicobacter pylori Management Hp-EuReg Investigators. Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg). Clin Gastroenterol Hepatol. 2022 Oct;20(10):2243-2257. doi: 10.1016/j.cgh.2021.12.025. Epub 2021 Dec 23.

ReferenceCitation: Nyssen OP, Perez-Aisa A, Tepes B, Castro-Fernandez M, Kupcinskas J, Jonaitis L, Bujanda L, Lucendo A, Jurecic NB, Perez-Lasala J, Shvets O, Fadeenko G, Huguet JM, Kikec Z, Bordin D, Voynovan I, Leja M, Machado JC, Areia M, Fernandez-Salazar L, Rodrigo L, Alekseenko S, Barrio J, Ortuño J, Perona M, Vologzhanina L, Romero PM, Zaytsev O, Rokkas T, Georgopoulos S, Pellicano R, Buzas GM, Modolell I, Gomez Rodriguez BJ, Simsek I, Simsek C, Lafuente MR, Ilchishina T, Camarero JG, Dominguez-Cajal M, Ntouli V, Dekhnich NN, Phull P, Nuñez O, Lerang F, Venerito M, Heluwaert F, Tonkic A, Caldas M, Puig I, Megraud F, O'Morain C, Gisbert JP; Hp-EuReg Investigators. Adverse Event Profile During the Treatment of Helicobacter pylori: A Real-World Experience of 22,000 Patients From the European Registry on H. pylori Management (Hp-EuReg). Am J Gastroenterol. 2021 Jun 1;116(6):1220-1229. doi: 10.14309/ajg.0000000000001246.

ReferenceCitation: Nyssen OP, Perez-Aisa A, Castro-Fernandez M, Pellicano R, Huguet JM, Rodrigo L, Ortuñ J, O, Gomez-Rodriguez BJ, Pinto RM, Areia M, Perona M, Nuñez O, Romano M, Gravina AG, Pozzati L, Fernandez-Bermejo M, Venerito M, Malfertheiner P, Fernanadez-Salazar L, Gasbarrini A, Vaira D, Puig I, Megraud F, O'Morain C, Gisbert JP; Hp-EuReg investigators. European Registry on Helicobacter pylori management: Single-capsule bismuth quadruple therapy is effective in real-world clinical practice. United European Gastroenterol J. 2021 Feb;9(1):38-46. doi: 10.1177/2050640620972615. Epub 2021 Feb 11.

ReferenceCitation: McNicholl AG, Bordin DS, Lucendo A, Fadeenko G, Fernandez MC, Voynovan I, Zakharova NV, Sarsenbaeva AS, Bujanda L, Perez-Aisa Á, Vologzhanina L, Zaytsev O, Ilchishina T, Coba C, Lasala JP, Alekseenko S, Modolell I, Molina-Infante J, Ruiz-Zorrilla Lopez R, Alonso-Galan H, Moreno NF, Hinojosa J, Santaella I, Varela P, Gonzalez-Cordero PL, Barrio J, Dominguez-Jimenez JL, Nuñez O, Alcedo J, Nyssen OP, Caldas M, Donday MG, Shvetz O, Megraud F, O'Morain C, Gisbert JP. Combination of Bismuth and Standard Triple Therapy Eradicates Helicobacter pylori Infection in More than 90% of Patients. Clin Gastroenterol Hepatol. 2020 Jan;18(1):89-98. doi: 10.1016/j.cgh.2019.03.048. Epub 2019 Apr 10.

lead_sponsor: Javier P. Gisbert

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
Romania
Belgium
Czechia
Poland
Portugal
Slovenia
Austria
Russian Federation
Turkey
Norway
Sweden
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
Ireland
Estonia
Latvia
Finland
France
Netherlands

location_facility: Central Scientific Research Institute of Gastroenterology

location_facility: Ferencváros Health Centre, Gaastroenterology

location_facility: Lithuanian university of Health Sciences Hospital

location_facility: Ikazia Ziekenhuis/ Erasmus Medisch Centrum

location_facility: Dokuz Eylul University School of Medicine

location_facility: Departament of Gastroenterology, Medical Centre for Postgraduate Education

location_facility: Gastroenterology Clinic, Henry Dunant Hospital