Participants should record the temperature in the e-Diary in the evening of the day of each vaccination, and then daily for the next 7 days approximately at the same time each day. 2 0 obj Title: Protocole … If more than 1 measurement is made on any given day, the highest temperature of that day will be recorded in the e-Diary. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. <> Participants will be instructed on how to record daily temperature using a thermometer provided for home use. Routine study visits will not be considered medically-attended visits. Liste complète; Recherche; Vidéos pour les patients . 3. Currently, there are no approved vaccines for the prevention of COVID-19. 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. This is the first phase 3 trial comparing robot-assisted cystectomy with open cystectomy for any urological cancer. u逴��x�k��m?Р�(��� w� ��SX(�l:'.�{��0��� 9Ć\��N%KK�X1v�������c5�F�)�9����f�j���gg�~U��pgc� �:�;��Հ���QՏA�j�������� @ ���xDQ���w����+o�g7R����upH�d�V�ӌ-#Ck�����eH"z��zhb��B2q\8�~��e����M�N�+��ID;���pl4[��h9�$�X;.ȓ6^� Essai Clinique. 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. 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) … 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. 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. MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. The Phase 3 clinical trial's primary efficacy endpoint, a responder analysis evaluating the proportion of participants who experienced a 1.25 points per month improvement in the post-treatment Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) slope, was powered on assumed treatment response rates of 35% on NurOwn versus 15% on Placebo. %���� Participants will receive IM injection of placebo on Day 1 and Day 57. This ... Microsoft Word - PI_essai_clinique_bial_220116 bis version finale_EN_2.docx 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. 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. 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, … 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. Molecularly confirmed moderate and severe/critical COVID-19 defined as a positive 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; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case definition at the time of finalization of this protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea. 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 MPOWERED: A phase 3, randomized, open-label, active controlled, multicenter study to evaluate maintenance of … Essai Clinique Généré le 24 nov. 2020 à partir de Titre A Phase 3, Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation Protocole ID AG-221-AML-004 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. Les essais de phase Icorrespondent le plus souvent à la première administration d'un médicament à l'homme. Choosing to participate in a study is an important personal decision. In its evaluation ANSM, took into account the European recommendation on first-in-man administration. Talk with your doctor and family members or friends about deciding to join a study. Subjects with DS, aged between 10 and 15 years will be enrolled in the study. protocole d’essai clinique de phase iii Version n°3.0 du 27 Septembre 2007 Approuvée par le Ministre de la Santé et de l‘Hygiène Publique de Côte d‘Ivoire, après avis �i��k� �y�. 4 0 obj ... PP=per-protocol. �ў��>+��̗�Qg���弮(4o{����������5�����A�6�H��h�^� �&c�i����O�(��K(],�*c5�d�n @����g/�Rf���@�Z�K���M���x�8 o �)�*a��2� �|��i�7�����j�DH�}M�kZ83���� > essai clinique. 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. For Part 2 (Dose Expansion): The participant must have histological or cytological … The study protocol is available from the funder. Assessments like efficacy (COVID-19 like signs and symptoms, etc), immunogenicity (such as humoral immune responses), and safety (such as AEs monitoring) will be performed throughout the study. The study will consist of: a screening phase (up to 28 days), double-blind study period (60-week), and a long-term follow-up period (1 additional year). SARS-CoV-2 binding antibodies as assessed ELISA to measure humoral immune response will be reported. l C�4�X$~����}i�0�gx��v�τbd=��ȡ���m�ln�N�آȡ�>�S��S�L�VSi���� :y����+��@��W[Ry_W�bHKt-�b�q5����Nh�L\��sv��g����_��8�Oo�Yf�u���_�++��O�H���~��DA�u_�H����:"�մ��| ��aj����Y�gdY�����]>�+�'2���]sc����iM5����Z��x�}�����:֘M �AE��!�� wΣ�F/�l�d�Ɔw�~�8����im�J�HcVΡ��e�!��ԗ�Ͷ@���Ee\ 9y�tj����{�����S�sǼ�=�dV�ב�/�0������$�������^��q��g=����Szg�w�S�"س�A��t��_��_�$�0D�z���ʕ��L����+�����b5�٢�� �������B�76 ܓ\�Y 8A��>�� . (sgRi~�=o��m����l 2021 à partir de. U.S. Department of Health and Human Services. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). �d��%�( S���`&���c_��y1q����h��99��ʑ��E ��X�>�I�[6h=�����_Tkl����^h\������� and. The molecule proved most effective in phase 3, will be tested ‘in vivo’ in order to evaluate its ability to correct the tested molecular aberrations. His history in vaccine development includes serving in Bihar, India for … stream %�o��]��>�Ѐ'j#jKG��c?��� Title: … BOD will be evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate, or severe/critical COVID-19 case. Information provided by (Responsible Party): The study will enroll up to 30,000 participants in order to evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in adult participants.
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