In February 2022, civil servants from the UK's Department for Levelling Up, Housing and Communities were found to have used Wikipedia for research in the drafting of the Levelling Up White Paper after journalists at The Independent noted that parts of the document had been lifted directly from Wikipedia articles on Constantinople and the list of largest cities throughout history.[462]
To explain this unusual epidemiology, two potential hypotheses are feasible which are not mutually exclusive. First, that infections of intestinal schistosomiasis were not locally acquired and were contracted elsewhere, e.g. around Blantyre, which might explain why mothers were at greater risk owing to longer peripatetic history than their child. Second, that local transmission of intestinal schistosomiasis occurs but intermittently through time, e.g. shortly after periods of prior flooding. Populations of Biomphalaria are typically restricted to parts of Africa where thermal maxima are not as extreme [2] but could potentially colonize Chikhwawa when washed-in during local flooding. Nevertheless the prevalence of schistosomiasis reported here is much higher than that reported previously by Bowie et al.[54] in surveys of SAC using standard parasitological sampling.
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He was a kind man, and also deeply troubled. The troubled part often leads to musical genius, as a way to transcendently channel pain, but the kindness was just him, shown by how Mary and crew stuck by him, and still do, even so long after his death.
Layout table for study information Study Type : Interventional (Clinical Trial) ActualEnrollment : 1074 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Masking Description: Only Arm B and C will be masked to all (Double-blind). Primary Purpose: Treatment Official Title: A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer. Actual Study Start Date : September 30, 2020 Estimated Primary Completion Date : April 30, 2024 Estimated Study Completion Date : November 18, 2025 Resource links provided by the National Library of Medicine MedlinePlus Genetics related topics: Lung cancer Drug Information available for: Osimertinib Amivantamab U.S. FDA Resources Arms and Interventions Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Arm Intervention/treatment Experimental: Treatment Arm A (Open-label): Amivantamab and LazertinibParticipants will receive amivantamab 1050 milligram (mg) intravenously (IV) for body weight less than (=) 80 kg in 28-day cycles: once weekly in Cycle 1 (with a split dose on Days 1-2), and then every 2 weeks in subsequent cycles. Lazertinib will be administered 240 mg (80*3) orally once daily. Drug: AmivantamabParticipants will receive amivantamab intravenously.Other Name: JNJ-61186372 Drug: LazertinibParticipants will receive lazertinib tablets orally.Other Name: JNJ-73841937 and YH-25448 Active Comparator: Treatment Arm B (Double-blind): Osimertinib+Placebo LazertinibParticipants will receive osimertinib 80 mg orally once daily plus matching placebo of lazertinib 240 mg (80*3) orally once daily. Drug: OsimertinibParticipants will receive osimertinib capsules orally. Drug: PlaceboParticipants will receive matching placebo orally. Experimental: Treatment Arm C (Double-blind): Lazertinib+Placebo OsimertinibParticipants will receive lazertinib 240 mg (80*3) orally once daily plus matching placebo of osimertinib 80 mg orally once daily. Drug: LazertinibParticipants will receive lazertinib tablets orally.Other Name: JNJ-73841937 and YH-25448 Drug: PlaceboParticipants will receive matching placebo orally. Outcome Measures Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Primary Outcome Measures : Progression-Free Survival (PFS) According to RECIST v1.1 by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 42 months ]PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occurred first, based on BICR using response evaluation criteria in solid tumors (RECIST) v1.1. Secondary Outcome Measures : Overall Survival (OS) [ Time Frame: Up to approximately 60 months (time from the date of randomization until the date of death due to any cause) ]Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause. Objective Response Rate (ORR) [ Time Frame: Up to approximately 42 months ]ORR is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) as defined by BICR using RECIST v1.1 criteria. Duration of Response (DOR) [ Time Frame: Up to approximately 42 months ]DOR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, only for participants who achieve CR or PR as determined by the investigator using RECIST v1.1 criteria. Progression-Free Survival After First Subsequent Therapy (PFS2) [ Time Frame: Up to approximately 42 months ]The PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent anticancer therapy, based on investigator assessment (after that used for PFS) or death, whichever comes first. Time to Symptomatic Progression (TTSP) [ Time Frame: Up to approximately 42 months ]TTSP is defined as the time from randomization to documentation in the electronic case report form (eCRF) of any of the following (whichever occurs earlier): onset of new symptoms or symptom worsening that is considered by the investigator to be related to lung cancer and requires either a change in anticancer treatment and/or clinical intervention to manage symptoms. Intracranial PFS [ Time Frame: Up to approximately 42 months ]Intracranial PFS is defined as the time from randomization until the date of objective intracranial disease progression or death, whichever comes first, based on BICR using RECIST v1.1. Incidence and Severity of Adverse Events (AEs) [ Time Frame: Up to approximately 60 months ]Incidence and severity of treatment emergent adverse events (TEAEs) will be reported. Any adverse event occurring at or after the initial administration of study treatment through the day of last dose plus 30 days, or until the start of subsequent anticancer therapy (if earlier), is considered to be treatment emergent. Number of Participants with Clinical Laboratory Abnormalities [ Time Frame: Up to approximately 60 months ]Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation, and urine samples) will be reported. Number of Participants with Vital Signs Abnormalities [ Time Frame: Up to approximately 60 months ]Number of participants with vital signs abnormalities (temperature, heart rate, respiratory rate, oxygen saturation, blood pressure) will be reported. Number of Participants with Physical Examination Abnormalities [ Time Frame: Up to approximately 60 months ]Number of participants with physical examination abnormalities will be reported. Serum Concentration of Amivantamab [ Time Frame: Up to approximately 42 months ]Serum samples will be analyzed to determine concentrations of amivantamab. Plasma Concentration of Lazertinib [ Time Frame: Up to approximately 42 months ]Plasma samples will be analyzed to determine concentrations of lazertinib. Number of Participants with Anti-Amivantamab Antibodies [ Time Frame: Up to approximately 42 months ]Number of participants with antibodies to amivantamab will be reported. Change from Baseline in Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NCSLC-SAQ) [ Time Frame: Baseline Up to approximately 42 months ]The NSCLC-SAQ contains 7 items that assess cough, pain, dyspnea, fatigue, and poor appetite over a 7-day recall period. Each multi-item scale and individual item will be summarized using count and percent by visit. Change from Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) [ Time Frame: Baseline Up to approximately 42 months ]EORTC-QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. Eligibility CriteriaGo to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: 2ff7e9595c
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