Syndrome myélodysplasique ; Syndrome myélodysplasique Aperçu cartographique; Titre : A Phase 1/2 Study of CPI-0610, a Small Molecule Inhibitor of BET Proteins: Phase 1 (in Patients With Hematological Malignancies) and Phase 2 (Dose Expansion of CPI-0610 With and Without Ruxolitinib in Patients With Myelofibrosis) … The total study duration will be maximum 2 years and 3 months for the participants. �i��k� �y�. \=h�� j�L�CFr�5>?1�Q-���ҐZ�P�w �iſ���vj Listing a study does not mean it has been evaluated by the U.S. Federal Government. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu, https://www.janssen.com/clinical-trials/transparency. Généré le 06 janv. 4 0 obj Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04614948. SARS-CoV-2 binding antibodies as assessed ELISA to measure humoral immune response will be reported. Un homme est en état de mort cérébrale et cinq autres personnes sont hospitalisées ce vendredi à Rennes, suite à l'essai clinique d'un médicament. ... pharmacokinetics and pharmacodynamics of an investigational medicinal product. This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, intensive care unit (ICU) admission, mechanical ventilation, and extracorporeal membrane oxygenation (ECMO), linked to objective measures such as decreased oxygenation, X-ray, computed tomographic [CT] findings) and linked to any molecularly confirmed COVID-19 at least 14 days after the second vaccination will be reported. Participants will receive IM injection of placebo on Day 1 and Day 57. Currently, there are no approved vaccines for the prevention of COVID-19. Ils incluent en général un petit nombre de malades (10 à 40). Placebo will be administered as IM injection on Day 1 and Day 57. <> Part 1 employs a dose-escalation design to determine the recommended phase 2 dose. Evidence before this study. Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance. Psilocybin Delivers ‘Remarkable’ Relief in Severe Depression, Batya Swift Yasgur, 2020. The aim of the COVID-19 vaccine clinical development program is to develop a safe and effective vaccine for the prevention of COVID-19. 2 0 obj Masking: None (Open Label) ... Biopsy is allowed by protocol if no histology or cytology records are available. mITT=modified intention-to-treat. By: ... including the study protocol. Clinical trial protocol Title An Exploratory, Open Label, Non-randomized, Within-patient Multiple Dose- ... Trial phase Phase II Drug EVEROLIMUS International multicenter study ClinicalTrials.gov Identifier: NCT01059318 . Protocole ID COG-AEWS1221 ClinicalTrials.gov ID NCT02306161 Type(s) de cancer Pédiatrique divers Phase Phase III Institution CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE Ville Montréal Investigateur principal Dr Yvan Samson Coordonnateur Martine Therrien 514-345-4931 poste 3396 Statut Fermé 1 0 obj 4. For general information, Learn About Clinical Studies. Routine study visits will not be considered medically-attended visits. Talk with your doctor and family members or friends about deciding to join a study. The EUA request includes safety and efficacy data from an ongoing Phase 3 randomized, double-blinded and placebo-controlled trial of mRNA-1273 in approximately 30,400 participants. We found that 2-year progression-free survival in patients with bladder cancer who had robotic cystectomy was non-inferior to that of patients who had open cystectomy. This ... Microsoft Word - PI_essai_clinique_bial_220116 bis version finale_EN_2.docx This first phase of the registry project will collate clinical and laboratory data from all non-commercial clinical trials for MDS in Europe, retrospectively from 1996, and ... Protocole d’essai clinique Author: Essai Clinique. Titre A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants. Bayern ... multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment (Phase IV) - ES ... ALZIRA. %���� stream In this phase 3 trial, subcutaneous administration of the anti-interleukin-17A monoclonal antibody secukinumab significantly improved the signs and symptoms of psoriatic arthritis versus placebo. Research in context. Ad26.COV2.S, a COVID-19 vaccine based on a human replication-incompetent Ad26 vector, constructed to encode the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus spike (S) protein, is being developed. Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate greater than or equal to (>=) 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of signs and symptoms or severe COVID-19 defined in Food and Drug Administration (FDA) guidance. The viral load of SARS-CoV-2 will be assessed in confirmed COVID-19 cases using RT-PCR. Essai Clinique Généré le 06 janv. Participants receive the treatment determined by randomization for a maximum of 4 years or until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or death (whichever occurs first). A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older: Actual Study Start Date : September 7, 2020: ... -19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of this protocol: fever or chills, … ACR20 response rates at week 24 were better with all secukinumab doses than with placebo. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. x��Z�o�6��A�R��E������f�-��^z���l+�[G��r����|���X��C�X��pf8���w�f�T���o�Xm˵����>�6�z(�?�]U4��Z,������������D�=>��/�?�Q���K�8����|{y�����/���=����;���8OC����c?��X��'�(LxB�`���s�)S����'�h��țE!�rJ�e���ۛ�~�UF��I��E��=���ono`]��{�m��MS?�+4�2b�J� Nasal swabs will be used to detect and/or quantify SARS-CoV-2. Un essai clinique de phase I avec augmentation progressive des doses commence aux États-Unis dans des centres académiques très expérimentés sous le parrainage d'OBT. Molecularly confirmed mild COVID-19 is defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. BOD will be evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate, or severe/critical COVID-19 case. Title: … A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older: Actual Study Start Date : November 15, 2020: Estimated Primary Completion Date : May 10, 2022: Estimated Study Completion Date : May 11, 2023 or Ablation. Fever is defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. The protocol approved by ANSM on June 2015 was subjected to a modification request in October. A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of DCC-2618 vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib: Protocole ID : intrigue (DCC-2618-03-002) ClinicalTrials.gov ID : NCT03673501: Type(s) de cancer : Tumeur stromale gastro-intestinale: Phase : Phase III: Stade À propos de Menarini ... Pnuez Created Date: 04/16/2020 05:40:00 Title: ANX5 2009 - Courrier de demande d’autorisation d’essai clinique (AEC) Last … ClinicalTrials.gov ID NCT03383458. and. Choosing to participate in a study is an important personal decision. Les essais de phase Icorrespondent le plus souvent à la première administration d'un médicament à l'homme. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus [ Time Frame: 1 day after the 1st vaccination (Day 2) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus [ Time Frame: 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline [ Time Frame: 1 day after the 1st vaccination (Day 2) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline [ Time Frame: 14 days after the 1st vaccination (Day 15) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of COVID-19 Requiring Medical Intervention [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants with Molecularly Confirmed, Moderate to Severe/Critical COVID-19 [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of Molecularly Confirmed Mild COVID-19 [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of Molecularly confirmed COVID-19 Defined by the US FDA Harmonized Case Definition [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Serologic Conversion Between Baseline (Day 1) and 14 days, 6 months, and 1 year after the 2nd vaccination Using an Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: Between baseline (Day 1) and 14 days, 6 months, and 1 year after the 2nd vaccination ], Number of Participants with First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 2 years and 3 months ], Number of Participants with Medically-attended Adverse Events (MAAEs) [ Time Frame: 6 months after second vaccination (Up to 34 weeks) ], Number of Participants with Medically-attended Adverse Events (MAAEs) Leading to Study Discontinuation [ Time Frame: Up to 2 years and 3 months ], Number of Participants with Solicited Local Adverse Events (AEs) During 7 Days Following Each Vaccination [ Time Frame: Up to Day 8 (7 days after first vaccination on Day 1), up to Day 64 (7 days after second vaccination on Day 57) ], Number of Participants with Solicited Systemic AEs During 7 Days Following Each Vaccination [ Time Frame: Up to Day 8 (7 days after first vaccination on Day 1), up to Day 64 (7 days after second vaccination on Day 57) ], Number of Participants with Unsolicited Local Adverse Events (AEs) During 28 Days Post-vaccination [ Time Frame: Up to Day 29 (28 days after first vaccination on Day 1), up to Day 85 (28 days after second vaccination on Day 57) ], SARS-CoV-2 Binding Antibodies Assessed by ELISA [ Time Frame: Up to 2 years and 3 months ], SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA) [ Time Frame: Up to 2 years and 3 months ], Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies, All participants of childbearing potential must: have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration, Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine, Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study, Must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment (eCOA) (that is, the coronavirus disease-2019 [COVID 19] signs and symptoms surveillance question, the e-Diary, and the electronic patient-reported outcomes (ePROs), Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (100.4-degree Fahrenheit) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor, Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients, Participant received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine, Participant previously received a coronavirus vaccine, Participant received an investigational drug within 30 days (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or investigational monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine (including investigational Adenoviral-vectored vaccines) within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study. Title: Protocole … OSE Pharma : Protocole d’essai clinique de phase 3 pour OSE-­‐2101 accepté par la FDA et l’EMA OSE Pharma reçoit les avis positifs pour préparer l’essai clinique de phase 3 d’enregistrement pour OSE-­‐2101, son vaccin thérapeutique contre le cancer du poumon « non à petites cellules » (NSCLC) Paris, 23 juin 2014 – OSE Pharma SA, … %PDF-1.5 MPOWERED: A phase 3, randomized, open-label, active controlled, multicenter study to evaluate maintenance of … The results of this study may have important implications for implementing the knowledge on the etiology of DS and may be useful to develop new therapeutic approaches. For Part 2 (Dose Expansion): The participant must have histological or cytological … Subjects with DS, aged between 10 and 15 years will be enrolled in the study. Participants will be instructed on how to record daily temperature using a thermometer provided for home use. Essai Clinique. Serologic conversion between baseline (Day 1) and 14 days, 6 months, and 1 year after the 2nd vaccination using an ELISA and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 nucleocapsid (N) protein will be reported. ... Dr. Said Ghandour, Dept.de Biopathologie et Imagerie de la Myéline, CNRS/ULP, Strasbourg, France. Participants will also be instructed on how to note signs and symptoms in the e-Diary on a daily basis for 7 days post each vaccination (day of each vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia. The only change was the investigator's name, approved by the CPP on November 4, 2015. Greenberg, the principal investigator for the study, brings extensive expertise to the trial. Mild COVID-19 includes: Fever, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, or chills, without shortness of breath or dyspnea. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. 3. b�N�U�@��*_�A�?} Participants will receive intramuscular (IM) injection of Ad26.COV2.S vaccine on Day 1 and Day 57. Asistencia Cientifica de Alta Complejidad S.A.S, Asociacion IPS Medicos Internistas de Caldas, Hospital General de Medellin Luz Castro de Gutierrez E.S.E, Centro de Atencion e Investigacion Medica S.A. - CAIMED, CHU de Grenoble - Hôpital Albert Michallon, Groupe Hospitalier Sud Hôpital Haut-Leveque Service d'hematologie, Centre Hospitalier Universitaire de Tours, West Visayas State University Medical Center, Centre of Tuberculosis Research Innovation, Powys Teaching Local Health Board - Bronllys Hospital, Brighton & Sussex University Hospitals NHS Trust, Cambridge University Hospitals NHS Foundation Trust, Imperial College London and Imperial College Healthcare NHS Trust, Central Manchester University Hospitals NHS Foundation Trust, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom, NE1 4LP, Sheffield Teaching Hospitals NHS Foundation Trust, Janssen Vaccines & Prevention B.V. Clinical Trial.