Introduction Inflammation and dysregulated immune responses play a crucial role in atherosclerosis, underlying ischaemic heart disease (IHD) and acute coronary syndromes (ACSs). Immune responses are also major determinants of the postischaemic injury in myocardial infarction. Regulatory T cells (CD4+CD25+FOXP3+; Treg) induce immune tolerance and preserve immune homeostasis. Recent in vivo studies suggested that low-dose interleukin-2 (IL-2) can increase Treg cell numbers. Aldesleukin is a human recombinant form of IL-2 that has been used therapeutically in several autoimmune diseases. However, its safety and efficacy is unknown in the setting of coronary artery disease.
Method and analysis Low-dose interleukin-2 in patients with stable ischaemic heart disease and acute coronary syndromes is a single-centre, first-in-class, dose-escalation, two-part clinical trial. Patients with stable IHD (part A) and ACS (part B) will be randomised to receive either IL-2 (aldesleukin; dose range 0.3–3×106 IU) or placebo once daily, given subcutaneously, for five consecutive days. Part A will have five dose levels with five patients in each group. Group 1 will receive a dose of 0.3×106 IU, while the dose for the remaining four groups will be determined on completion of the preceding group. Part B will have four dose levels with eight patients in each group. The dose of the first group will be based on part A. Doses for each of the subsequent three groups will similarly be determined after completion of the previous group. The primary endpoint is safety and tolerability of aldesleukin and to determine the dose that increases mean circulating Treg levels by at least 75%.
Ethics and dissemination The study received a favourable opinion by the Greater Manchester Central Research Ethics Committee, UK (17/NW/0012). The results of this study will be reported through peer-reviewed journals, conference presentations and an internal organisational report.
Trial registration number NCT03113773; Pre-results.
The double-blind, placebo-controlled design will allow assessment of the safety and efficacy of low-dose interleukin (IL)-2 in patients with stable ischaemic heart disease and in acute coronary syndrome patients, both conditions where it is currently contraindicated.
The adaptive dose design of this study will allow assessment of the potential for low-dose IL-2 to increase mean circulating Treg levels by at least 75%.
Due to its early phase design, this study is not powered to assess any clinical outcome data for patients.
Interleukin-2 (IL-2) plays a key role in Treg cell development, expansion, survival and suppressive function.17 18 Deficiency of either IL-2 or IL-2 receptor in mice greatly compromises Treg development and promotes autoimmune responses.19 Supplementation of IL-2 substantially increases Treg cell levels and significantly limits plaque development and inflammation in mice prone to atherosclerosis.20 21 Treg cells show a much lower threshold response to IL-2 receptor signalling compared with effector T cells. This led to the hypothesis that, in contrast to high-dose IL-2 designed to activate T effector cells in cancer, supplementation with low doses of IL-2 in the setting of T cell-mediated immune diseases could selectively promote the expansion of Treg cells at the expense of T effector cells, thereby limiting harmful immune responses. This hypothesis was initially confirmed in two pilot human clinical studies in two different disease settings: graft-versus-host disease22 23 and in hepatitis C virus-induced vasculitis.24 In both studies, administration of low doses of IL-2 in the form of aldesleukin (daily administration of 0.3×106 to 3.0×106 IU IL-2 per square metre of body surface area for 8 weeks, or repetitive 5-day courses of 1.0×106 to 3.0×106 IU IL-2) led to a rapid and marked expansion of the circulating pool of Treg cells, which were at least doubled without affecting the pool of conventional CD4+ T (ie, T effector) cells. The expanded Tregs retained potent suppressive functions, and the treatment was associated with a reduction in the inflammatory response and a concomitant clinical improvement in a substantial proportion of patients. Treatment with low-dose IL-2 was safe, and no adverse effects were reported. This strategy is currently being adapted and tested in various disease settings, where Treg cell promotion is believed to be of potential therapeutic benefit.23–26 In this trial, we hypothesise that low-dose IL-2 (aldesleukin) can be used in IHD to increase Treg numbers and to rebalance the immune system with the overall goal of decreasing recurrent myocardial infarction and cardiovascular death.
The first report of effective IL-2 therapy in human cancer trials was published in 1985.28 The trial patients in that study were placed on dose-escalated IL-2 regimens, of up to approximately 120 million IU (MIU). Associated with these high IL-2 doses were side effects such as capillary leak syndrome (which is characterised by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space, ultimately resulting in hypotension, tachycardia, dyspnoea and pulmonary oedema) and kidney and liver damage (both characterised by increased serum creatinine and bilirubin levels, respectively) 29.
Nevertheless, IL-2 is contraindicated in patients with a significant history, or current evidence of, severe cardiac disease. Therefore, we sought to determine the safety and efficacy of low-dose aldesleukin in patients with pre-existing cardiac conditions. A detailed and conservative risk mitigation strategy was adopted to ensure patient safety was maintained throughout the conduct of the trial (see online supplementary file 1). We hypothesise that low-dose IL-2, unlike higher doses, can be safely administered and is effective in expanding the Treg population in patients with stable and acute coronary artery disease. In this trial, low-dose IL-2 will initially be administered in patients with stable IHD at escalating doses and, following safety reviews, will be given to patients with ACS. The Treg response data from the ACS population will help select the most appropriate dose to assess efficacy in future clinical trials in ACS.
This is a an academically driven, prospective single-centre, randomised, double-blind, placebo-controlled, phase I/II clinical trial. It will be performed at the National Institute for Health Research/Wellcome Trust Cambridge Clinical Research Centre, Cambridge University Hospitals, Cambridge, UK, with overall study coordination provided by the Cardiovascular Trials Office of the Cambridge Clinical Trials Unit, Cambridge University Hospitals National Health Service (NHS) Foundation Trust. The study is sponsored by Cambridge University Hospitals NHS Foundation Trust.
The trial will be performed in two parts. Part A will include patients with stable IHD aged 18–75 years with a clinical diagnosis of IHD for more than 6 months (ascertained by either having had a previous diagnosis of MI or having symptoms of angina and a coronary angiogram showing obstructive (stenosis >50%) coronary disease). The inclusion and exclusion criteria are detailed in table 1 but, in summary, patients with a myocardial infarction within the last 6 months, cardiogenic shock, hypotension/hypertension, heart failure (ejection fraction (EF) <45%), proarrhythmogenic conditions, renal, hepatic, thyroid or haematological dysfunction, active infection, poorly controlled diabetes, active autoimmune disease, current malignancy, history of seizures or immunosuppression will be excluded from this part of the study.
Part B will be performed after part A and will include patients aged of 18–85 years admitted with a diagnosis of non-ST elevation myocardial infarction. The inclusion and exclusion criteria are detailed in table 1. In brief, patients with cardiogenic shock, hypertension/hypotension, heart failure (EF <35%), long QT or arrhythmias, renal, hepatic, thyroid or haematological dysfunction, active infection, active autoimmune disease, current malignancy, history of seizures or immunosuppression will be excluded from this part of the study.
Patients will be recruited from advertisements, outpatient clinics or research databases. Participants will have at least 24 hours to review the patient information sheet prior to informed consent. Study procedures will only be conducted following formal written consent at the screening visit 1 (V1). Baseline blood tests will consist of electrolytes, renal, liver and thyroid function, full blood count, clotting profile, hepatitis B/C and HIV screening, HbA1c and pregnancy screen (where applicable). Baseline vitals, ECG, echocardiogram, clinical history and physical examination will also be performed. Randomisation will be carried out via a paper-based concealment list generated by a statistician. To maintain the overall quality and legitimacy of the clinical trial, unblinding will only occur in exceptional circumstances when knowledge of the actual treatment is essential for further clinical management of the patient.
The trial design is described in detail in figure 1. In brief, following randomisation at V1, patients will attend five consecutive daily outpatient visits (V2–6) during which blinded subcutaneous injections of aldesleukin or placebo will be administered. At each visit, prior to the study drug administration, the medical history will be obtained/reviewed, along with a physical examination, baseline vitals, safety bloods and a 12-lead ECG. Patients will have continuous cardiac monitoring during each visit for at least 30 min predose and 1.5 hours postdose. After dosing, a series of ECGs will be performed at 15 min, 30 min and 60 min, while vitals will be assessed at 30 min and 60 min. For each dosing visit, serum IL-2 levels will be taken at baseline and at 90 min postdose.
Trial design per patient. Each patient will make a total of eight study visits. IL-2, interleukin; V, visit.
There are two follow-up visits (V7 and V8). Assessments during both visits will include a medical review, physical examination, vitals, ECGs and safety bloods tests. Additionally, at V8, a follow-up thyroid function blood test and echocardiogram will be performed.
In addition, during visits V2 and V7 (figure 1), cardiac biomarkers (high sensitivity C reactive protein (hs-CRP), IL-6, brain-type natriuretic peptide (BNP) and troponin) and lymphocyte subsets (including Treg level, see below) analysis will be performed. During visit V8, cardiac biomarkers will be reaassessed.
A total of 25 patients, five in each of the five dosing groups, will be included in part A (drug:placebo ratio of 3:2). In line with current phase I trial designs, a sentinel dosing approach will be employed whereby the first two patients of each group will be allocated to either aldesleukin or placebo in a random order. After a blinded safety review of these first two patients, the remaining patients will then be dosed (see figure 2).
Trial design for each group in part A. There are a total of five dose levels in part A.
Patients admitted with a primary diagnosis of non-ST elevation myocardial infarction will be recruited from the medical and cardiology wards at Cambridge University Hospitals NHS Foundation Trust. Patients may continue to receive trial treatments if they are transferred to the local interventional centre at Royal Papworth Hospital. Participants will be given at least 24 hours to review the patient information sheet prior to formal consent. Dosing should commence within 8 days of screening. All visits and blinding procedures will be the same as part A. However, in part B, a total of 32 patients will be recruited, eight patients in each of the four dosing groups (drug:placebo ratio of 6:2). A sentinel approach to dosing will also be employed in each group. After a blinded safety review of the first two patients, the remaining cohort will be randomly allocated to study treatments as shown in figure 3. The visit schedule for each patient is the same as part A (figure 1).
Trial design for each group in part B. There are a total of four dose levels in part B.
The first group of patients in part A will receive 0.3×106 IU of aldesleukin daily. Thereafter, a blinded review of patient data by the blinded Trial Management Group (TMG) including review of AEs, blood results, ECGs, clinical records and, where possible, drug pharmacodynamics and pharmacokinetics. The TMG will be composed of an experienced, accredited early phase lead physician (LILACS chief investigator), a research physician/scientist, a research nurse, trial coordinator and an unblinded study statistician (for the purposes of data analysis). All data presented by the unblinded statistician to the TMG will be in an aggregated format to preserve the blind for the other TMG members. This is consistent with the commercial standard for such early phase trials in industry. The dose in the second group will be determined after this review, and the same process will be followed in each of the following groups. The maximum dose increments allowed by the protocol between groups will be double the previous dose and capped to a maximum 3.0×106 IU.
A robust set of specific and general withdrawal criteria, as well as objective stopping criteria have been put into place to maintain the safety:risk benefit, in particular due to the risk of capillary leak syndrome.
Following completion of part A, an unblinded independent Data Monitoring Committee (DMC) will review all available safety data, together with any other analyses that the committee may request. The DMC will be composed of an independent group of clinical researchers with suitable experience in experimental medicine and early phase clinical trials. These researchers are independent from the trial team and have not been involved in the setup or running of this clinical trial. They will determine whether it is safe to progress to part B, based on available safety and pharmacodynamic data provided by the unblinded statistician. After this analysis, the dose in each group will be determined based on the review of ongoing patient data by the TMG, as in part A previously. The protocol mandates that the maximum dose used in part B will not exceed that of part A. DMC will be governed by a charter set up a priori and signed up by all members prior to the commencement of the trial (see supplementary file 2).
A review of AEs and SAEs, and concomitant medications.
Changes in safety bloods (electrolytes (sodium, potassium and urea), bone profile (calcium and phosphate), serum creatinine, liver function tests (alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin and gamma glutamyl transferase (GT)), thyroid function tests (thyroid stimulating hormone), blood glucose, full blood count and differential, and clotting (prothrombin time and activated partial thromboplastin time).
Twelve-lead ECG and cardiac monitoring changes (arrhythmias, ischaemic changes and QTcB).
Vital observations (blood pressure, heart rate, respiratory rate, peripheral oxygen saturation and temperature).
Echocardiogram changes at baseline and follow-up.
Change in the mean circulating Treg level measured by fluorescence activated cell sorting (FACS) analysis following treatment with IL-2, over the 5 days of the treatment period.
Change in cardiac biomarker measurements including hs-CRP, troponin I, IL-6 and b-type natriuretic peptide) from analysed blood samples.
Change in lymphocyte subsets measured by FACS analysis.
Pharmacokinetic analysis of IL-2 levels.
As with part A, the primary endpoint will be safety and tolerability of IL-2. A further primary endpoint will be the change in mean circulating Treg levels and whether IL-2 increases mean circulating Treg levels by at least 75% over the 5 days of the treatment period. Exploratory endpoints are the same as for Part A.
AEs, adverse reactions (ARs), serious AE/ARs (SAEs/SARs) and suspected unexpected SARs will be defined as per the International Conference on Harmonisation definitions. A suitably qualified medical doctor will determine the relationship and causality of each AE to the study drug as either 'related' (defined as having a plausible temporal relation and not judged attributable to other causes) or 'not related'. They will also make an assessment on severity and seriousness. Abnormal or significant changes in laboratory results are only AEs if they are deemed to be of clinical significance or if a medical intervention is required. Whether a patient needs to be withdrawn due to the severity of their AE is left up to the discretion of principal investigator.
Lymphocyte subset analysis will be performed at the Department of Clinical Immunology, Cambridge University Hospitals, Cambridge, UK, within 4 hours of sample collection in EDTA. Laboratory technicians will be blinded to treatment allocation. The antibodies that will be used are anti-CD3 (clone SK7, phycoerythrin (PE)-Cy7 labelled; BD Biosciences), anti-CD4 (clone RPA-T4, fluorescein Isothiocyanate (FITC) labelled; BD Biosciences), anti-CD127 (clone HIL-7R-M21, PE labelled; BD Biosciences), anti-CD25 (clone M-A251 and 2A3, allophycocyanin (APC) labelled; BD Biosciences), anti-CD45RA (clone HI100, APC-Cy7 labelled; BioLegend) and anti-CD62L (clone DREG-56, PerCP/Cy5.5 labelled; BioLegend). Whole blood will be assessed by performing clinical FACS to measure the absolute lymphocyte count, lymphocytes subsets and CD25 expression on Treg cells. Fixed concentrations of fluorescently labelled beads will be added to whole blood to count the absolute number of lymphocytes, CD3+, CD4+ and CD8+ T cells, CD19+ B cells and CD19− CD16+ CD56+ NK. Simultaneous whole blood FACS assay will be performed where a lymphocyte gate is drawn to include all events, while the CD3+, CD4+ T-cell gate excludes CD8+ T cells and B cells. Six standardised beads labelled with different quantities of fluorescent APC are measured by FACS to accurately measure CD25-APC on the surface of Tregs compared with a standardised curve. To minimise interassay variation, mean fluorescence intensity can be read from this curve. Tregs will be defined by CD3+CD4+CD25highCD127low makers and will be separated from non-Tregs and used to calculate the absolute Treg count out of CD3+CD4+ T cells. Among the non-Treg T effector CD43+CD4+ population, we will define effector memory cells by CD45RA−CD62L− markers, effector memory CD45 RA+(TEMRA) cells by CD45RA+CD62L− markers, naïve effectors cells by CD45RA+CD62L+ markers and central memory cells by CD45RA−CD62L+ markers. Total memory effectors are the sum of central memory and effector memory cells.
Blood will be taken in gel serum tubes, and the serum will be banked and analysed at the Core Biochemical Assay Laboratory, Cambridge. Hs-CRP and N-terminal pro brain natriuretic peptide (NT-proBNP) will be measured by immunoassays on the Siemens Dimension EXL autoanalyser. All reagents and calibrators are supplied by Siemens, and assays will be performed according to the manufacturer's instructions.
IL-6 will be measured in duplicate using ultrasensitive electrochemical luminescence immunoassay on the Mesoscale Discovery assay platform and read on the MesoScale Diagnostics Sector Imager 6000. All reagents and calibrators will be supplied by MesoScale Discovery.
QTcB >500 ms (or >530 ms if baseline QTcB=450–480 ms) OR QTcB change from baseline >60 ms (based on an average of triplicate electrocardiogram (ECGs)).
Acute pulmonary oedema or congestive heart failure.
Symptomatic systolic BP <90 mm Hg and/or diastolic blood pressure (BP) <60 mm Hg OR persistent symptomatic systolic BP 80–90 mm Hg for >15 mins OR severe hypertension (as defined by BP >180/120 mm Hg).
Atrial fibrillation with rapid ventricular response >150/min, supraventricular tachycardia or bradycardia that requires treatment or is recurrent or persistent.
Sustained ventricular tachycardia or ventricular fibrillation.
Any patient who develops doubling of creatinine.
Systemic hypersensitivity reaction that cannot be attributed to an identifiable cause.
If a life-threatening infection is confirmed clinically with a positive microbiological test.
Signs suggestive of hepatic failure including encephalopathy, increasing ascites, signs of coagulopathy, liver pain and/or tenderness on palpation, hypoglycaemia presumed to be secondary to liver failure and active GI bleeding. Withdrawal also if alanine aminotransferase (ALT)>3 ULN.
Seizure activity, coma, severe lethargy or somnolence.
Risk of respiratory insufficiency requiring intubation.
Dosing will be immediately discontinued for the patients experiencing the event.
Dosing will be halted for all other patients currently in the treatment period of the trial (ie, patients receiving treatment in the same group).
A safety review by the independent DMC will be conducted to determine how to proceed with the trial.
Any further single instances of the events outlined above for the same group will trigger a further DMC safety review.
Any patients who have their dosing discontinued will be withdrawn from the trial.
Additionally, specific objective stopping criteria are set out in box 1, which may trigger an unscheduled DMC review prior to any further dose escalations. Specific and general withdrawal criteria are also listed in online supplementary file 1.
The TMG and the DMC are independent of each other. The function of the DMC is delineated in the DMC charter (online supplementary file 2). The chief investigator of the trial will report to the DMC on the course of the trial during open sessions of the DMC. All DMC meetings will be held in private without any involvement of the trial team. The unblinded statistician is the only person who reports to the DMC and is part of the TMG. However, any data presented to the TMG are presented in a manner that maintains the blind.
The TMG will assess safety in a blinded manner on an ongoing basis at regular intervals during the course of the trial. Between part A and part B, the DMC will be formally convened to review the unblinded data with the unblinded statistician to determine whether it is reasonable for the trial to progress to the next stage.
This is an exploratory study that is not designed to formally test a hypothesis in a confirmatory fashion. Given that both parts of the trial have clinical safety as primary endpoints, a formal power calculation is not relevant. A sample size of 57 patients is achievable within the proposed time scale, given the size of the targeted patient population at our study site. The frequency of AEs per patient will be summarised for each event based on dose level. Summary statistics of laboratory values by dose and visit will be produced where required. The statistician will use the data from each group to perform a modelling analysis of the effect of aldesleukin based on dose and effect size using a smoothed line plot of the mean and 95% CIs. Generally summary statistics of continuous variables will report mean, median, SD, min and max, although a log-transformed scale may be used where the data are skewed. Binary or categorical variables will be summarised using the p% (x/n) format. The Treg data and other secondary biomarker endpoints will be summarised with individual patient profiles over time, and summary statistics will be broken down by dose and visit. Formal estimates of the differences between doses will be made at each time point with accompanying 95% CIs and p values.
Subjects will be coded by a numeric code to create an anonymous dataset. All data will be transferred into a case report form, which will be coded onto a MACRO database. All data will be anonymised and stored encrypted on a secured computer to ensure patient confidentiality.
Heart attacks are distressing and impacts patients' lives dramatically.35 The aim of this research is to help ameliorate this issue and potentially reduce reoccurrence. Lay members of the ethics committee reviewed this study and made constructive comments, which have been addressed. Patients were not involved in the recruitment to or conduct of the study. All patients provided full informed consent, with at least 24 hours to consider the information and at least two opportunities to discuss the trial in detail with the investigators. The results of the study will be disseminated to all study patients at the end of the trial.
The trial began on the 15May 2017. The anticipated final follow-up visit(s) will be in January 2019. Primary analyses are projected to be completed by February 2019.
JC acknowledges funding support from the National Institute for Health Research (NIHR) Cambridge Comprehensive Biomedical Research Centre. ZM acknowledges funding support from the British Heart Foundation (BHF) for his BHF Chair. JHFR acknowledges funding support from the HEFCE, the NIHR Cambridge Biomedical Research Centre, the British Heart Foundation, the EPSRC and the Wellcome Trust. We acknowledge support from the Cambridge Clinical Research Centre and the Core Biochemistry Assay Laboratory in the conduct of this trial and its endpoints.
Novartis Pharmaceuticals UK Ltd. Proleukin Summary of Product Characteristics Updated. https://www.medicines.org.uk/emc/print-document?documentId=19322 (Updated 20 Jan 2015).
. IL-2 rapidly induces natural killer cell adhesion to human endothelial cells. A potential mechanism for endothelial injury. J Immunol 1988;141:158–63.
. Ultra-Low Dose IL-2 Safely Expands Regulatory T Cells and CD56 NK Cells in Healthy Volunteers: Towards Safer Stem Cell Donors? Blood 2015;120:3283.
Contributors TXZ, MK, SPH, JC and ZM contributed to the writing of this manuscript. TXZ, MK, CG, ELA, AH, FK, JH, JHFR, GW, KB, SB, JC and ZM contributed to the writing of the protocol.
Funding This work was funded by the Medical Research Council, grant number MR/N028015/1 and the British Heart Foundation Cambridge Centre of Excellence (RCAG/521). Setup and running of the study and decision to publish results is independent of the funder.
Ethics approval The study was given a favourable opinion by the Greater Manchester Central Research Ethics Committee, UK (17/NW/0012) and approved by the UK's Health Research Authority. The MHRA formally granted regulatory acceptance on 28 April 2017. All study procedures will be conducted after formal written consent, in accordance with the Declaration of Helsinki. The trial was registered on Clinicaltrials.gov (NCT03113773) prior to trial commencement, and the results of this study will be published in a peer-reviewed journal after completion.


text:
Russian MP dies in India
The politician who was visiting India as a tourist has died after apparently falling from a hotel's third floor, police have said
A Russian regional MP from the central Vladimir Oblast, Pavel Antov, died on Monday, while visiting India as a tourist, Russian and Indian media have reported. The circumstances of his death are still being investigated.
Antov's death was confirmed by the Vladimir Oblast legislature's deputy head, Vyacheslav Kartukhin. He did not provide any details about the incident, which he only described as "tragic circumstances." Kartukhin also referred to Antov as a "successful businessman and a philanthropist." The deceased MP was a member of the 'United Russia' party – the nation's largest political force.
According to India's NDTV, the 65-year-old was found lying in a pool of blood outside a hotel in the eastern Indian city of Rayagada last Saturday. He was traveling with a four-member tourist group and had checked into the hotel last Wednesday.
A senior police officer told NDTV that Antov's death might have been a suicide. The police also said they were investigating all potential versions of the incident, including it being accidental. According to the police officer, the man was "in a depression due to the death of his friend."
READ MORE: Mother kills her kids believing they were possessed by demons – media
Another Russian tourist, Vladimir Bydanov, 61, died in the same hotel last week. According to the Russian Consul-General in India, Aleksey Idamkin, Bydanov suffered a heart attack. He also said that the Russian Consulate is in "constant contact" with the relatives of both men and the police. "The police do not see any criminal aspects in these tragic events," the diplomat said.
Some Russian media also referred to Bydanov, who was a businessman from the Russian central Mari El Republic, as Antov's "friend." The two men were reportedly traveling together.

redpajama_set_name: RedPajamaCommonCrawl


text:
Q: Correlated Query? Update query to make dynamic with dates I initially wrote a with statement to gather my list of client ID's that were contacted by rep on a certain date.
I realize that the query is not dynamic the way it is written. I eventually want to query multiple reps within a date range rather than just one date.
I need the query to look forward 90 days based on the date of the initial call and tell me if a certain action was taken (i.e. purchase)
I think I have to write a correlated query but not sure how to go about it. TIA.
With CSA_CONTACT AS (SELECT part_id
FROM table
WHERE REP_ID = '12345'
AND CALL_DATE = '03-Dec-2020'),
PURCHASE AS (SELECT PART_ID, PURCHASE
FROM PUR_TABLE
WHERE PUR_DATE BETWEEN '03-Dec-2020 AND dateadd(DAY, 90, '03-Dec-2020'))
SELECT C.PART_ID
CASE WHEN P.PURCHASE is not null then 'Y' ELSE 'N' END PURCHASE_IND
FROM CSA_CONTACT C LEFT JOIN PUR_TABLE P WHERE C.PART_ID = P.PART_ID

A: You must be looking for group by solution as follows:
Select t.rep_id, t.part_id,
       Case when dateadd(DAY, 90, min(t.call_date)) > min(p.pur_date)
            then 'Y'
            else 'N'
       end as purchase_ind
  From table t
  Left join pur_table p on p.part_id = t.part_id
 Where t.rep_id in (multiple reps like - 123,456, ...)
 Group by t.rep_id, t.part_id

redpajama_set_name: RedPajamaStackExchange


For more information about writing MobiLink synchronization scripts in Java, see Setting up Java synchronization logic.
For an example illustrating the use of Java synchronization scripts for custom authentication, see Java synchronization example.
For more information about synchronization scripting, see Writing synchronization scripts and Synchronization events.
For an introduction to other methods of synchronization such as timestamp, see Synchronization techniques.


Tumu Narasimha Dasu (1790-1833) belongs to the first category as he was imbued with piety and devotion to Lord Rama and always carried the Lord in his heart and soul. Rama was the object of his yearning, the goal of his actions, the principle of his affections and the governing power of his whole soul. He was always immersed in prayer as he believed that prayer, if not the very gate of heaven, was the key to let him into its holiness and beatitude. Tumu Narasimha Dasu was a great saint-musician-composer. He composed many songs (Kritis) extolling the glory of Bhadradri Rama and attained salvation, thus showing a way for others to cross the hell of mundane life and attain the Bliss Eternal. Like Bhakta Ramadasu, Narasimha Dasu (who is believed to be the reincarnation of the former) strained his every nerve to develop the Bhadradri (Bhadrachala) temple and enhance its sanctity. He travelled across the Indian subcontinent, visiting ever so many pilgrim centers spreading the Bhakti cult among the people. His simple living and high thinking and his principles of human welfare are exemplary. He was a humanitarian to the core. Born as the son of a great Sanskrit scholar Tumu Appayya Dikshit and a pious lady Venkamamba in Guntur town in the South Indian State of Andhra Pradesh, Narasimha Dasu was a precocious boy. The religious fervour of the period made a tremendous impact on his sensitive imagination. Narasimha Dasu belongs to the eminent tradition of saint-poet-musicians like Annamayya, Bhakta Ramadasu, Kshetrayya, and Tyagaraju. He was a contemporary of Tyagaraju. Narasimha Dasu had a younger brother Krishnayya and a sister Rukmabai. His father was also a great devotee of Lord Rama. Naturally his home was suffused with an atmosphere of piety and devotion. For a long time his parents had no issue. By the grace of Mangalagiri Narasimha Swami this boy was born. Hence, he was named Narasimha Dasu. Eminent devotees and other elders, who frequently visited his house, used to bless this prodigy. He had mastered Sanskrit and Andhram languages, besides music and literature. As an extraordinarily precocious child, Narasimha Dasu began to recite poems and songs extempore and sing in a melodious tune enthralling his listeners. He had a superb sense of rhythm (Laya), and he also played on the 'Kanjira' (a small one-sided round drum). He had widely read in theology and theosophy. When he was just eight, Narasimha Dasu's literary and musical talents astounded the people. Endowed with a phenomenal memory power, he remembered most of what he read. His poetic genius manifested itself when he sang extempore at that tender age, a song on Bhadrachala Rama, "Namo Namo, Daasaradhe Namo Namo………" His language drew its basic nourishment from literature, and his literature used language as its vehicle blending devotion harmoniously. At the age of 19 years, Narasimha Dasu's marriage to Lakshmibai was solemnized. With the death of his father Appayya Dikshit in the very next year, his struggle for mundane existence began. He got a job in the Revenue Department as Peshkar at Ponnur in the Guntur Division. As an idealist and a man of principles, and as a diligentworker, Narasimha Dasu acquitted himself creditably in his job. He endeared himself to the people by enquiring about their needs and well-being. During this period, he accepted "Pancha Samskara Deeksha" from a god-man (a divine being in human form) by name Damodaram Kesava Dasu, as a token of embracing Vishishtadwaita (a Vedantic doctrine of Ramanujacharya which treats Brahman and Prakriti as realities, and rejects the doctrine of illusion). Such people wear the mark of Wheel (Vishnu's Sudarshana Chakra) on the right shoulder and the Conch (Shankha) on the left shoulder; and two white vertical lines with a red streak in between on the forehead to indicate that they are the servants of Lord Vishnu. As his devotion to Lord Srirama deepened, he found his job and its attendant responsibilities a big hindrance to his Vaishnavite ministry. Soon, he quit his job. This came as a bolt from the blue to his already poverty-stricken family. In one of his outpourings, he appealed to Lord Rama to listen to the hardships he suffered either financially or from money-lenders or godless and anti- Vaishnavite people. His mundane life was sad, broken and tragic whereas his spiritual life was blissful and filled with literary brilliance. His poverty, however, only seemed to enhance his devotion to Srirama which gladdened and inspired countless people around him. Meticulously following the Vaishnavite tradition, and its rules and regulations, he qualified himself to be called 'Narasimha Dasu'—a servant of Lord Vishnu (Srirama). Strengthened by his utter devotion to the Lord, coupled with his unique trait of philosophical detachment, he weathered the hardships of penury. For him, Lord Srirama was the fountain of all that is virtuous, intelligent and joyous. He spurned the idea of approaching the wealthy people saying, "Should I beg of mean men for a morsel of food, should I bear the insults hurled at me when I am piously chanting your holy name, tell me O Rama!


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Fort Pulaski reopens: Savannah-area site weathered hurricane, and then a tornado
One of the torn and smashed signs that were sent flying (NPS)
Barely two months after Fort Pulaski National Monument returned to full operations following Hurricane Matthew, another storm system came calling on May 23. This time, it was an EF-2 tornado coming from the west, at about 6 p.m.
"If we are talking an hour earlier, I don't want to think about what could have happened," said Joel Cadoff, park spokesman and chief of interpretation. Before 5 p.m., people were still in the fort, on trails or in the visitor's center at the site, which is a dozen miles east of Savannah, Ga.
Two employees hid in this demilune during tornado (NPS)
The twister sent two staffers to shelter in Pulaski's demilune, an earthen fortification between the fort's main walls and the moat. A couple of personal vehicles were lost.
And while it did not cause near the damage as Matthew, the storm slammed a "vulnerable place" – the visitor's center complex. The building suffered extensive roof and ceiling damage. The restroom roof was destroyed (it is still in service). Several historic signs were ripped from their posts and sent flying, one piece landing 1,000 feet away. Trails were temporarily closed.
The park staff – with considerable outside help from other National Park Service entities – toiled to patch things up, clear paths and make the site again safe. The monument reopened on Thursday, about six weeks after the latest weather calamity.
(NPS photos)
Until the visitor's center can be repaired, the staff and bookstore are operating out of a casemate inside the fort.
"It's interesting," Cadoff said in a bit of understatement about two events coming so close together. Matthew caused an estimated $1.8 million in damage and forced a six-month recovery. The tornado's bill is at least $400,000 and repairs continue.
Cadoff said Fort Pulaski benefited from what it learned following Hurricane Matthew. "We were much better prepared in an initial response in getting the right people and right knowledge, to get them here to assist us," he said.
The storms reinforced the need for good shelter points, such as the demilune. The west side of Cockspur Island has a couple World War II-era naval magazines.
Cadoff said visitors can still see some snapped and damaged trees in the marsh. "You can definitely see the (tornado) path."
The staff has had enough excitement for the time being. "We would love a very uneventful hurricane, weather season," he said.
Pieces of wood jammed by twister into trunk (NPS)
Labels: fort pulaski, Georgia, Hurricane Matthew, tornado
At Pea Ridge battlefield, students search for structures, evidence of a hamlet's culture
Student Madison Atchley and archaeologist Jerry Hilliard (U. of Ark.)
University of Arkansas archaeology students learning excavation techniques have identified the remains of at least four structures in a hamlet that was transformed into a Federal field hospital during the Battle of Pea Ridge.
"There is a whole lot more to discover," said Jamie Brandon, a professor and an Arkansas Archeological Survey archaeologist.
Brandon, working with staff and faculty, supervised 10 students in this summer's field school, which concludes Friday.
Excavation of a Leetown kitchen cellar (U. of Ark.)
"We are trying to reconstruct the best we can the footprint of Leetown, this mid-19th century hamlet," he told the Picket by phone this week.
Leetown was only a half mile from the pitched fighting of March 7, 1862. Homes were used for hospitals, woods and fields were filled with battle debris, and the stench of death permeated the air, according to the National Park Service.
Two Confederate generals died near Leetown during assaults after their units were separated during a flanking movement. The Confederates were forced to withdraw.
Unlike the famous Elkhorn Tavern some 2 miles to the east, what's left of Leetown is buried.
Jamie Brandon (second from left) supervises field work. (U. of Ark.)
The Arkansas Archeological Survey, a part of the University of Arkansas system, is in a four-year project examining up to nine areas in Pea Ridge National Military Park. The park, Brandon noted, wants to better interpret to visitors what the village meant to the battle, perhaps through shadow buildings or signs.
Archaeologists want to reconstruct past cultures. "We are interested in how (the fighting) impacted the civilian landscape." The hamlet was largely unoccupied by the early 1880s.
Brandon said students conducted excavations and were washing artifacts this week. They did find evidence of a Union presence (it is unlawful for the public to dig for artifacts on federal property).
Another view of the kitchen cellar
Maps of the area are not exact, but there could be the remnants of eight to 12 buildings, including farmsteads, a store and Masonic lodge. One that was noted this year was a detached kitchen to the Mayfield log cabin.
The Picket has published posts about spring 2016 excavations in Ruddick's Field, a couple miles to the east of Leetown. Archaeologists recovered 540 artifacts – the largest a 6-pound solid artillery shot – from the cornfield and in wooded areas. They will be used to plot locations of artillery pieces.
Foundations are all that remain in Leetown (NPS photo)
Brandon said a report on Ruddick's Field is being prepared for submission in 2019. Archaeologists will return to Leetown next year and a survey of areas on the eastern side of the battlefield – site of an artillery duel -- is planned, Brandon said.
He said this year's exploration at Leetown was an "initial foray." Officials hope they can lead a larger volunteer dig, perhaps as soon as next summer.
Work at Pea Ridge is believed to be the first time large-scale remote sensing has been used on such a battlefield, archaeologists told the Picket.
A workshop put on this year for the National Park Service drew expects from all over the world wanting to know more about the mix of technology, said Brandon.
(University of Arkansas)
Labels: archaeologists, arkansas, battle, Brandon, Civil War, hamlet, Jamie, Leetown, pea ridge, survey
Md. community recalls 1863 skirmish
As bagpipes echoed throughout downtown Westminster, Md., residents who poked their heads out of their windows were greeted with the possibly surprising sight of Union and Confederate soldiers marching together peacefully down the streets Saturday. This weekend, Emerald Hill, the grounds surrounding Westminster City Hall, have been transported to the 1860s, as the Pipe Creek Civil War Roundtable commemorates the Battle of Westminster at their annual Corbit's Charge event, which continues through Sunday. • Article
Labels: Corbit's Charge, maryland, Westminster
Out of the water: CSS Georgia casemate section is remarkably preserved
(Video by Panamerican Consultants Inc., via USACE)
One down, and one much bigger piece to go.
Crews working from barges in Savannah, Ga., on Wednesday evening lifted a 20-foot-by-24-foot piece of casemate that once protected the Confederate ironclad CSS Georgia.
Officials are excited because it includes a corner of the structure
Timbers used to support the armor – which was made from joined railroad iron – were "massive and so impressive," said Jeremy S. Buddemeier, new media and social media manager for the U.S. Army Corps of Engineer's Savannah office.
Stephen James, leader archaeologist with Panamerican Consultants, one of the contractors on site, told the Picket on Thursday afternoon that the wood "is shiny smooth, just like it was cut." The piece was lying in the mud, with the armor up and the wood down.
A bottom timber appears to be a foot in diameter, while the upper layer is about 6 inches in diameter, he said.
Corps senior archaeologist Julie-Morgan Ryan said that a mix of roots, biomass and mussels had covered and preserved the artifact with up to 3 feet of sediment, Buddemeier said. That layer protected the 47-ton casemate from wood-damaging Teredo worms that were evident in 2015 recovery dives.
The Corps is removing the scuttled vessel's wreckage as part of a massive harbor deepening project.
They placed a prefabricated frame under this particular piece of armor, which is called the east casemate because of its position in the debris field.
Section of CSS Georgia casemaste (USACE)
Divers are having to deal with the Savannah River's strong current and are working around "slack tides" that can have them in the water longer. They were able to do three dives Wednesday and the daylight and the tides lined up for the east casemate lift, officials said.
Next up is the west casemate, which is about 68 feet by 24 feet and weighs an estimated 120 tons. Lifting that one intact will be a bigger challenge, requiring beams and two cranes.
The earliest that lift will occur is next weekend, the Corps said. Following that comes the mechanized phase, in which a clamshell device will scoop up remaining artifacts from the river floor.
The U.S. Navy, which owns the shipwreck, would like to see artifacts and a reconstructed section of casemate to be displayed in a museum. James said in order to conserve the two casemate sections, conservators would have to separate the iron and wood.
And while the timbers that came up Wednesday are remarkably preserved, he said, they probably wouldn't hold up in the open air, even after extensive conservation. A display could feature the iron armor and new wood.
The crews will rebury the casemate sections in a secure part of the river until a decision is made on future conservation. For now, the east casemate, resting on a barge, is being kept wet with sprinklers.
Posted by Phil Gast at 12:30 PM 1 comment:
Labels: Civil War, Corps, CSS Georgia, east casemate, ironclad, lift, recovery, savannah
$3 million Lincoln, Civil War collection donated to Mississippi State University
Officials say a large Civil War donation will transform Mississippi State University into one of the nation's leading Civil War research destinations. Former Rhode Island Chief Justice Frank J. Williams, a nationally known authority on Abraham Lincoln, will donate his collection, amassed over the past 50 years. The collection -- valued at nearly $3 million -- features more than 17,000 items, including artifacts, signed documents, books and artwork from the Civil War era. • Article
Labels: collection, lincoln, Mississippi State University, Willliams
CSS Georgia recovery: Crews back on river will try to lift 2 casemate sections intact
(All photos USACE)
Julie Morgan
Two years after the recovery of much of the jumbled remains of the CSS Georgia in Savannah, Ga., divers and crews will be back on the Savannah River starting next week (June 19) to go after two prize casemate sections and more artifacts. The ironclad, which served as a floating battery, was scuttled in December 1864 before Federal forces took the city. Julie Morgan, an archaeologist with the U.S. Army Corps of Engineers, which is overseeing the removal of the CSS Georgia as part of a harbor deepening project, spoke this week about what's new this time around. Update! Casemate section lifted
Will this be as interesting as the 2015 effort?
"It is another chapter. The possibility of seeing these large sections of casemate is pretty exciting. It is the casemate that makes the Georgia pretty unique," said Morgan. "To bring up something this size intact is an amazing engineering feat." She cautions officials may have to go to a Plan B of separating sections if the casemate doesn't have the integrity to be brought up in a single lift. Much of the wood backing has deteriorated. Officials said their hope is to bring up a "corner" of the casemate to demonstrate how the sloped pieces of wood-backed armor were designed and fastened.
What's the importance of the casemate?
It was the protective armor that covered both sides of the Confederate vessel and housed the artillery pieces. What's unusual about the Georgia was instead of rolled plate, the casemate was composed of railroad iron (above) attached to multiple layers of supporting wood. The recovery will be no easy task, and crews did not have the proper equipment (and big enough cranes) to lift the two sections in 2015, Morgan said. The west section, about 68 feet by 24 feet, weighs about 120 tons. The largest piece of the east casemate, at 40 tons, is about 27 feet by 24 feet.
Frame that will be used on east casemate (USACE photo)
What's the approach this summer?
"We are approaching this as an intact recovery," said Morgan. The team will go first after the east casemate and will strap a prefabricated frame beneath to serve as support. For the much larger and heavier west casemate, beams will be used and two cranes will make the lift to a barge.
A 5,000-pound casemate after recovery in 2013.
What else may be recovered?
The project will be done in two phases, with the casemates first. In 2015, the east section was moved and many artifacts beneath were scooped or brought up. But crews couldn't get to the other section, lending a bit of mystery as to what may still be there. "There is no telling. What is under that west casemate won't be discovered until we get it up," said Morgan. The mechanized phase follows. Crews will use a large clamshell device to bring up items from the river floor. All manner of artifacts were brought up that way in 2015.
What has been learned about the gunboat in the past couple years?
"Even from the artifacts we recovered in 2015 it really did verify a lot of the archival accounts of the inadequacies of power and components," said the archaeologist. Conservators have found maker's marks on cannon and gun sights. "She was built underpowered and the rationale for why is an interesting question."
Artist's rendering of the CSS Georgia
What's going to happen to the casemate?
They'll be placed back into the river by the end of this summer's work, in a "secure location" away from the shipping lane. As Morgan explains, there needs to be a spot and plan for conservation before they are taken from the water and exposed to the air, which would hasten corrosion. The CSS Georgia conservation has been going on at Texas A&M University, but it still has many items from 2015.
What is the long-term prospects for displaying CSS Georgia items?
As the Picket has previously reported, the U.S. Navy, which owns the vessel, wants to see artifacts on display somewhere rather than in a conservation lab or warehouse. It is in touch with museums and other venues on the prospects. "A larger collection gives a better story, but I think there's also the possibility of some traveling exhibits to get more exposure, especially throughout the state of Georgia," said Morgan. She understands why it may be difficult to show an entire section of the west casemate. "We are talking about something so large you would almost have to design a building around it."
Posted by Phil Gast at 10:27 AM 3 comments:
Labels: artifacts, casemate, Civil War, Confederate, Corps, CSS Georgia, ironclad, river, savannah
Research shows 51 more USCT troops
When Lexington, Kentucky, began Juneteenth celebrations at African Cemetery No. 2 in 1999, the gathering honored 49 black Civil War veterans whose gravestones were found during a restoration. Saturday, the cemetery will honor 100 men who fought with the United States Colored Troops. Yvonne Giles' research has found more than 51 additional names, and it has revealed some fascinating stories. • Article
Labels: cemetery, Civil War, Juneteenth, lexington, troops, USCT
The death of Solomon Luckie: Lamppost to move, shine new light on arduous lives of free blacks in Civil War South
Ambrotype of Solomon Luckie (Courtesy of Atlanta History Center)
Amid the bustle of Civil War Atlanta, 40 residents were an anomaly. Neither white nor enslaved, they were free blacks -- but they were not free in the fullest sense of the word. The residents toiled under restrictions and were always under a cloud of uncertainty.
And yet some of them thrived, particularly if they were judged more for their business success and property ownership than their place in a racial hierarchy.
Solomon "Sam" Luckie and his wife, Nancy Cunningham, were among the tiny number of free African-Americans in Atlanta. Luckie was a barber at one of a half dozen hotels surrounding Atlanta's railroad lines, which ferried vital supplies and troops for the Confederacy.
Luckie made a good living and is among the city's first successful black entrepreneurs.
"He is prominent enough to have his image taken and that of his wife," said Gordon Jones, senior military historian and curator at the Atlanta History Center. "He is well-dressed and wearing a little pinkie ring."
Lamppost at Underground Atlanta (Picket photo)
Luckie's success story ended on Aug. 9, 1864, when one of thousands of Union artillery shells raining on besieged Atlanta hit a lamppost. Shrapnel struck the businessman, who was conversing with white businessmen at the intersection of Whitehall (Peachtree) and Alabama streets. He died hours later.
This week, the Atlanta City Council voted to donate the 1855 gas lamppost, one of 50 installed in what is now downtown Atlanta, to the history center, which will tell the story when the new Cyclorama wing opens in 2018.
The damaged post – for years located inside Underground Atlanta -- will be relocated this summer to make way for the redevelopment of the moribund shopping and entertainment venue.
Lamppost is in Underground Atlanta, in section below white fence (Picket photo)
"It is a very significant artifact. It tells a great story," said Jones. "It starts out as a damaged lamppost, has the story of Solomon Luckie, a free black barber, and (became) a Lost Cause symbol after that. It was celebrated as what Sherman did to us."
While Luckie had children, it's unknown where he was from, his age at death -- or even where he was buried.
And he's not remembered at the lamppost: A sign and two markers bolted to the post make no mention of Luckie. But his story is about to be retold.
Living in a 'between' space in Southern society
Atlanta was a boom town in the early years of the Civil War. The population more than doubled, from 9,500 in 1861 to 22,000 in 1864.
It wasn't your traditional Southern city. Many businessmen hailed from the North and there was some Unionist sentiment during the 1860 election that put Abraham Lincoln into the White House and further fractured the nation.
Wendy Venet, a history professor at Georgia State University, said Atlanta didn't have a plantation elite – It had a business elite.
Nancy Cunningham, Luckie's wife (Courtesy of AHC)
Sam Luckie worked at the Atlanta Hotel, behind railroad cars (Library of Congress)
Luckie, listed as Solomon Luckey in an 1859 directory, operated the Barber Shop and Bathing Salon out of the Atlanta Hotel. Free people of color and slaves were actively involved in the trade. (The hotel can be seen in a well-known George N. Barnard photograph, taken in September 1864, showing the Atlanta Intelligencer newspaper office and rail cars with Union soldiers sitting on top.)
While the barber's family prospered, living in the city came with a price, said Venet, author of "A Changing Wind: Commerce and Conflict in Civil War Atlanta."
Free people of color faced many restrictions, and there was always the issue of having to prove their status.
"They were required to have a white sponsor. They were charged $1,000 for the right to live in the city, although it is unclear whether efforts were made to enforce this," Venet told the Picket. "They were required to ask permission of the City Council to entertain visitors from out of town. A black businessman was turned down by the City Council when he asked for a permit to vend ice cream in 1856."
"Slaves Without Masters," written by Ira Berlin in 1974, recounts free blacks' struggle for liberty and opportunity amid restrictions.
Atlanta Hotel is the first building on left (Library of Congress)
Why so many lived in the South
Historian Henry Louis Gates Jr., in a 2013 article for The Root, addressed the question of why so many free blacks – more than 200,000 -- lived in the South.
Slave owners sometimes freed slaves by last will and testament. Slaves who accumulated money through trading or by hiring their time sometimes were allowed to purchase their freedom. Some came from other states or countries. One-third of the state's tiny free black population lived in Charleston in 1860, on the eve of the war, says the South Carolina Encyclopedia.
Gates writes of uncertainty on whether life would be better in the North. "But comparative dread was not the only reason that most free blacks remained in the South. At the top of the list was family unity. After all, when a slave family was split up, often the free members remained close, attempting to raise the funds needed to buy the remaining members of the family."
Solomon Luckie's circumstance is unknown.
Map shows Atlanta Hotel center left (Courtesy Georgia Battlefields Assn.)
Gates cites Berlin's research in saying some free blacks stayed for economic opportunity. Among the trades they learned were ones that whites did not want to perform or for which they would accept lower wages. In Richmond, Va., 19 percent of skilled free blacks were barbers, followed by plasterers and carpenters.
As Venet has pointed out, by late in the war African-Americans in the South – freed or enslaved – were pushing boundaries. And the Great Migration north was only a few decades away.
Desperate life in a war zone
But in the summer of 1864, free blacks in Atlanta were literally fighting for survival.
As the war dragged on and Union Maj. Gen. William Sherman tightened his siege on the city, food and supplies became scarce. Terrified citizens dug homemade bomb shelters as Federal forces lobbed 35,000 artillery rounds over one month. Eventually, Confederate troops evacuated Atlanta in early September.
Venet has written about Sam Richards, a British-born bookseller in Atlanta who kept a diary for decades. He estimates about 20 people died from shelling. No one knows the exact number, though Jones believes there were about 50 overall casualties.
Stephen Davis, author of "What the Yankees Did to Us: Sherman's Bombardment and Wrecking of Atlanta," said some of the shells didn't go off and lay among the rubble. "As unexploded shells were being tinkered with by ... kids and adults, they blew up."
By late July, as battles swirled around Atlanta, the populace felt a sense of chaos. "The thing people miss is that most of the residents were already gone," said Jones. "Those who could have done so had already gone."
Damage to lamppost base (Picket photos)
A rush to rescue wounded businessman
Luckie ventured out on August 9, 1864, the worst day of Federal shelling, when an estimated 5,000 rounds were fired on the city. (Jesse Garbowski, Cyclorama digital interactive project manager at the AHC, shared details of that day).
The businessman, perhaps in his 30s, walked about a block from the Atlanta Hotel to Whitehall and Alabama.
As the barber leaned against the cast-iron lamppost in conversation, a shell ricocheted and burst, the fragments likely striking his leg. The base of the post has at least one hole caused by the shell.
Prominent white citizen Thomas Crusselle and one or two others carried the Atlantan into a store. Luckie was taken to the Atlanta Medical College, where Dr. Pierre-Paul Noel D'Alvigny amputated his leg. Luckie, who had been administered morphine, died from shock a few hours later.
His burial location is unknown, but Atlanta historian Franklin Garrett speculated that he is buried in Oakland Cemetery, in one of many unmarked graves. His wife, Nancy, died in 1910 and is buried at South View Cemetery, according to Find a Grave.
Whitehall and Alabama streets (Library of Congress)
Current view south (Jesse Garbowski/AHC)
Barnard took a photograph (above) that shows a lamppost at the corner of Whitehall and Alabama. It's possible this is the same fixture, but it is difficult to discern any damage and Luckie may have been standing at another corner.
'Eternal Flame of the Confederacy'
Venet, the historian and author, has written and lectured about how quickly Atlanta leaders embraced the opportunity to rebuild after the war's end in 1865.
"Atlanta was aided by the conscious decision not to fight federal Reconstruction policies," she told the Saporta Report in 2014. "The city decided the best way was to cooperate rather than fight."
Many whites in the South adopted the "Lost Cause" view, that the conflict wasn't about or mostly about slavery -- but instead a Northern assault on state's rights and liberty. Confederate troops, they reasoned, fought a heroic fight against great odds, defending a way of live. This narrative has been challenged by many historians.
Lamp when it was at street level (Georgia Archives)
The lamppost was kept as a memento of the war and displayed in City Hall until 1880, says the Georgia Archives. It was returned to its original spot and the United Daughters of the Confederacy placed a plaque honoring a general. Another plaque was affixed in 1939 for the premiere of "Gone With the Wind."
The post was designated the "Eternal Flame of the Confederacy." At some point, it was moved a short distance during construction for the Underground Atlanta in the 1960s.
Its bright flame flickers below the original street level, next to escalators and restrooms.
Plaques affixed to lamppost (Picket photos)
Exhibit will open next year
To those who may question why the lamppost is being moved from near its historic location, Jones said it will be more secure at the AHC, which he says has the space and wherewithal to tell the story of Civil War Atlanta.
While the AHC has another lamppost, the Luckie artifact provides a lens into African-American life in Atlanta during the Civil War period, officials say.
"It is a curator's dream," said Jones.
Davis, the historian and author, said Luckie should have been recognized by the city years before -- perhaps with a downtown statue.
Details are still being finalized, but history center officials plan to place the lamppost near the locomotive Texas (famous for the Great Locomotive Chase) and the colossal Atlanta Cyclorama (Battle of Atlanta) painting that is being restored.
Editor's note: Some of you may wonder whether Luckie Street is named for Solomon Luckie. I'm told the downtown street is named for Alexander F. Luckie, who died in 1854.
(Picket photo)
Labels: atlanta, barber, Civil War, free black, Georgia, history center, lamppost, Solomon Luckie, Underground Atlanta
More human remains found in Hunley
More clues of the H.L. Hunley mystery are being revealed during conservation of the Confederate submarine. Researchers in a North Charleston, South Carolina, lab unveiled the crew compartment -- which had been sealed by more than a century of ocean exposure and encrusted sediment. • Article
Labels: Confederate, H.L. Hunley, North Charleston, submarine
Louis Intres thinks you should know about the Sultana disaster. But, first, he aims to raise about $3 million to do it right.
Louis Intres, a retired banker, teaches history in Arkanas
Louis Intres and others who hope to build a permanent museum about the Civil War's Sultana disaster believe they are on a mission to keep a small – but dramatic -- part of American history alive.
"A great story like this can't be allowed to die," said Intres, who has been hired by the city of Marion, Ark., to lead an effort to raise nearly $3 million to build a modern venue.
The steamboat, chugging north on the Mississippi River, exploded and caught fire on April 27, 1865, killing about 1,800 passengers and crew (although some say the figure was lower). Many of those on board were released Union prisoners, many from Andersonville, heading home at war's end.
Marion was the closest community to where the overcrowded 260-foot sidewheeler came to rest and residents – including an ancestor of Mayor Frank Fogleman -- helped rescue those thrown into the chilly waters. (The wreckage is believed to be under a field near the river.)
A couple decades ago, Sultana Disaster Museum supporters were at the starting line in their effort to tell this story and bring some tourism to the town of about 12,500. The disaster was little known, not helped by the fact that it got lost at the time in headlines about the assassination of President Abraham Lincoln.
A book by Memphis attorney Jerry Potter in the early 1990s helped get the ball rolling. Marion, along with a local historical society and the Association of Sultana Descendants and Friends, have since pushed the story of the Sultana with a small temporary museum, special events and participation in anniversary articles and television programs.
"It has been a wonderful sleepy community near Memphis," Intres said of Marion. "It is (now) seeking its own identity, maybe for the first time."
Harper's Weekly illustration of the April 1865 disaster
Intres, 68, faces a daunting challenge, although supporters point to his 38-year banking career, fundraising experience, Sultana knowledge and passion for the project – he's presented exhibits and given talks. Intres, an adjunct history instructor at Arkansas State University, is wrapping up a Ph.D degree in heritage and cultural studies.
A feasibility study, delivered to the city last year, lays out the opportunities and challenges that await in bringing in about 35,000 annual patrons. Officials know they will have to tap into the Memphis tourism market. And many of those 10.5 million annual visitors don't come for history. They are more interested in food, music and the river.
-- The strength of the Sultana Story: It much more than a story about war. It also was the worst maritime disaster in U.S. history.
-- There are a number of tools to spread the word and generate interest among other audiences.
-- The museum will benefit from its proximity to Memphis and the Memphis visitor market.
-- The uniqueness and importance of the venue should garner support at the state level.
-- Getting the word out about Sultana; building brand awareness.
-- Lack of complementary attractions in Marion/Crittenden County.
-- Geographic distribution of the resident market with the majority of the market population on the eastern side of the river (Memphis).
-- Civil War interest peaked during the sesquicentennial. The subject of the war not popular with some demographics.
'It is a story of great magnitude'
(Courtesy of Gene Salecker)
A small temporary museum on Washington Street (above) features a handful of artifacts directly related to the disaster, a 14-foot replica of the steamboat and associated items from survivors, including reunion items from the late 19th and early 20th century. Most were collected by Gene Salecker, a Sultana author and lecturer. The museum has little marketing and draws no more than 100 visitors a month.
"It is totally inadequate to tell the story of the Sultana," said Intres. "It is a fine little community museum. This is a true American story. It is a story of great magnitude."
Haizlip Studio of Memphis designed the proposed $2.8 million permanent museum. The plan features 5,500 square feet for permanent exhibits, plus space for changing attractions.
It features a large model of the steamboat, a movie and several stations, with topics ranging from Civil War prisons, the river, the building of the Sultana and bribery/overcrowding.
(Salecker and Potter have written about a kickback scheme between the vessel's financially-strapped captain and an Army quartermaster, Lt. Col. Reuben B. Hatch. According to Potter, the transport fee was $5 for an enlisted man, $10 for an officer. Mason agreed to take the enlisted men for $3; Hatch kept the $2.)
Intres, who said the museum could open with phase one completed, said the Hatch story is compelling and will be expanded to "show what a scoundrel he truly was."
The story goes that Ozias M. Hatch, his brother, and other Illinois lawyers were close to Abraham Lincoln before he became president. Ines and others believe he often asked for intercession from Lincoln, as president, and others to have corruption allegations against Reuben dropped or to give him job recommendations.
In the end, no one was formally held accountable for putting too many men on the Sultana, despite documented concerns about the safety of one of the boat's boilers.
Courtesy of Haizlip Studio: Concept plan of Sultana Disaster Museum, which is planned to be located in Marion, Ark. Click to enlarge
According to the Evening Times newspaper in Crittenden County, the Marion Advertising and Promotions Commission has agreed to spend $400,000 to help build the museum and another $75,000 a year to help defray operating costs over the next 10 years. Intres said the museum will not take away from city services or be an extra burden on citizens.
He will begin reaching out soon to tourism and historical groups, corporations, foundations and individuals. "My responsibility is to put together to put the fundraising program to prepare the grant applications, as well as put together the promotional packages to go to prospective … contributors to help fund it."
"It will not be built with a thousand small contributions. It will require large contributions that will make sure American history is not lost," said Intres. "We seem to be moving away from patriotism, what our country is, and how it was built."
Everything riding on fundraising campaign
Mayor Fogleman told the Evening Times that Intres, who lives an hour away in Jonesboro, is being "being hired to eat, drink, and sleep Sultana. I expect him to further our cause and make our present effort better and to help further refine what we want to do with the new (museum)."
Intres said he will continue teaching but will work a couple days a week in Marion. "This is something I want to do to finish up my public life. I would like this to be my swansong."
Salecker said Intres is the perfect person for a job that is part cheerleader, part business development director.
Salecker with a model of the Sultana at museum
"I know that the mayor of Marion and the Chamber of Commerce members interviewed a number of people regarding the directorship but Louis was the only one that had the knowledge about the Sultana, plus the banking background and the contacts and experience needed to raise the necessary funds," Salecker said.
Intres said he expects the museum to be built, "but it will be totally contingent on the success of this campaign."
He said the city and chamber are all in, with an agreement to meet every 90 days to make a reality check. "As we go along, we will evaluate our progress."
Back to his passion. Intres is full of stories of what happened to those on the Sultana and survivors who coped with the tragedy.
"You have heroism," he said. "It's got intrigue. It has all the elements of a great, great history story. If a movie could be made by Hollywood in a proper way, the whole story, it would be a blockbuster film."
Previous Sultana coverage:
• Documentary, events mark 150th anniversary
• Descendants drop flowers in memory of the lost
• Model captures every detail of Sultana
• Disaster took lives of those who had endured so much
• Siblings recall learning of disaster
Labels: arkansas, Civil War, disaster, marion, maritime, memphis, museum, steamboat, sultana, U.S. history
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An RVer shows off his small trailer and explains how he lives both frugally and with respect to the environment. Not only will you find this interesting, but during the tour of the man's RV you will learn something about RVs and their systems that you may not have known before, no matter how long you have been RVing. Even though the RV's owner says the RV is 150 square feet, it looks larger than that to us. . . but not by much.


She has corrected me. It was four bloody sacks!
Never underestimate a lady !!
She must have been delighted to find you were amenable to "Correction".
A pleasure so far denied me E-S although I am sure a riding crop must be available.
Number 3 on my Bucket List.
The first time I tasted oxtail was in the Nestor, 1960. I thought it was an unpleasant meal, scant meat but plenty of bone, served with carrots and mashed potato. We got it every week on a fjve month voyage to Oz. Apart from a couple of gannets, the crowd always dumped it in the gash bucket and headed for the toaster. We nicknamed the cook Oxtaill Ollie, he was an Oliver Hardy lookalike and we suspected him of scoffing all the good stuff himself and serving us with the rubbish.


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Niiva Talks New Single "Trigger" & Life Lessons
Bulgarian born, England raised, and now Canadian based, Niiva has found her home with music. The singer/songwriter serves up organic modern-pop hymns wrapped up in a digital bow. Spinning relatable stories with a cool and conversational flow, she delivers a sort of lyrical liquid courage in a defiant yet approachable voice.
Niiva recently released her new single "Trigger" and we had the opportunity to chat with her about music, life lessons and what's next.
Kat: How would you describe your sound? and for those just being introduced to your sound, is there anything you think they should know about your music before getting into it?
Niiva: My sound is throwback R&B vibes wrapped in a digital-pop bow. No prep-work required for new listeners, come as you are and let's talk about people pushing your buttons and being in love with people you maybe shouldn't be.
Kat: You recently released your new single "Trigger". Can you share with us your thought process and inspiration behind the track? and why you felt it was the single you wanted release?
Niiva: I love this song, which may be redundant, but it's true. I love how dark and eerie it is, and I love the attitude it has. It's one of the songs off of my upcoming debut EP (excitement) and it just felt like the snippet I wanted to share next. Essentially I wrote it about my partner pushing my buttons when I'm in a mood, and letting him know it's about to go down. It might have a happy ending for both of us, or you might die, let's find out.
Kat: You've worked alongside some of North-America's top songwriters and producers including Kuya (Alessia Cara, Christina Aguilera), Jimmy Harry (Kelly Clarkson, Britney Spears), and Matt Beckley (Camila Cabello, Avril Lavigne) and have shared the stage with incredible international artists such as Shawn Hook and Ria Mae. What has been a career highlight for you so far? What have you learned along the way?
Niiva: There have been so many highlights that I really try to focus on and celebrate along the way because I believe it's incredibly important to celebrate every win along the way, no matter how big or small. Meeting and working with all of the people you mentioned have all been highlights, and each one of them has taught me something incredible – to not be afraid to jump, to be a better writer, a better singer, a better musician, a better collaborator. If we're talking specific highlights outside of that, my last single "Love Games" just surpassed 200K streams on Spotify, which is a big thing to me. It means a lot to me that people are receiving it so well.
Kat: Do you have any advice for emerging artists? or have you been given any advice that really made an impact?
Niiva: I would say the thing that has made the biggest impact for me is to not let fear keep me from moving forward. I was scared when I thought about moving to Toronto, leaving family and friends, but I said yes despite the fear and it's been the best decision possible. I've had sessions and opportunities where I've been afraid that I would actually have no clue what to do, how to do it, etc. but I said yes anyway, and have surprised myself every single time. As preachy as this might sound, there's so much more within
you, and so much more that you're capable of than your fear will let you believe. Just say yes, and figure it out later, honestly.
Kat: How have you been staying connected during Covid-19? What's next?
Niiva: I'm a pretty social and interactive person naturally, so I feel like I've stayed just as socially connected as before – while staying safe and keeping a distance of course – but it just means that much more now. I've really felt the value in it even more than before. Coming up next is my debut EP NEXT MONTH!!!! This has been a work in the making for a couple of years now and I could not be more excited to finally be sharing it with everyone!
For more on Niiva visit: http://www.itsniiva.com
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Exploratory Grants in Cancer Epidemiology (R21 Clinical Trial Optional)
R21 Exploratory/Developmental Research Grant
Reissue of PA-16-175
October 22, 2019 - Notice of Special Interest (NOSI): Geospatial Approaches in Cancer Control and Population Sciences. See Notice NOT-CA-20-004.
August 23, 2019 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137.
July 26, 2019 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128.
PAR-19-277
This funding opportunity announcement (FOA) encourages the submission of exploratory/developmental research grant (R21) applications for cancer epidemiologic research. The overarching goal is to provide support to promote the early and conceptual stages of research efforts on novel scientific ideas that have the potential to substantially advance population-based cancer research, such as improving data collection methods, developing and validating methods of exposures and biological effects, such as epigenetics and metabolomics, and their application in population-based research, functional assessment of genetic variants, and assessing recruitment methods for understudied populations.
June 7, 2019; October 8, 2019; June 8, 2020; October 8, 2020; June 8, 2021; October 8, 2021 , by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
June 7, 2019; October 8, 2019; June 8, 2020; October 8, 2020; June 8, 2021; October 8, 2021 by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.
October/November 2019; February/March 2020; October/November 2020; February/March 2021; October/November 2021; February/March 2022
January 2020; May 2020; January 2021; May 2021; January 2022; May 2022
March 2020; July 2020; March 2021; July 2021; March 2022; July 2022
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
This funding opportunity announcement (FOA) encourages applications for exploratory research on cancer epidemiology. The overarching goal is to provide support to promote the early and conceptual stages of research efforts on novel scientific ideas that have the potential to substantially advance cancer research, such as improving data collection, validating measurement of exposures in body fluids and tissues, among others. This FOA will utilize the exploratory/developmental research grant (R21) mechanism to foster cancer etiology and epidemiology research. These studies may lead to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of cancer research.
The mission of the Epidemiology and Genomics Research Program (EGRP) is to assess the determinants of cancer and cancer-related outcomes in human populations. This mission includes studies of those at risk of cancer and cancer survivors. Determinants of cancer occurrence and health outcomes include behavioral, environmental, genetic, infectious, medical, social and cultural factors, life events, and other experiences that may have a health impact.
Most cancers are multi-factorial in etiology and require an understanding of how these factors modify and interact with each other in leading to cancer. A mechanism that supports high-risk, high-reward research endeavors is critical to translating paradigms and findings from basic biological sciences into epidemiologic studies and ensuring that epidemiologic findings can be used to identify research directions. EGRP has long funded cancer epidemiology cohorts and case-control studies. Resources and evidence generated by these studies have been useful in providing the basis for the design and testing of many preventive and therapeutic interventions. The data and biospecimens accumulated through these large-scale studies afford opportunities for investigators to examine the factors that lead to cancer and influence cancer outcomes, through smaller exploratory, high-risk/high-reward studies.
Scientific Research Objectives
Scientific emphasis in this funding opportunity announcement reissuance reflects the high-priority areas in cancer epidemiology research. EGRP has several broad areas of interest: development and validation of methods and technologies; identification of modifiable risk factors or host susceptibility factors; and clinical and translational epidemiology. EGRP also has interest in cross-cutting themes, such as geospatial approaches to cancer risk and outcome, assessment of risk factors across the lifespan, and health disparities. Specific topics in each of these research areas represent examples of research that EGRP supports and could be supported through this FOA.
Methods and Technologies Research focuses on development and validation of methods to address epidemiologic data collection, study design and analysis, and modification of technological approaches to assess exposure, biologic effects, and cancer outcomes to be applied in large-scale population-based research.
Environmental Epidemiology Research focuses on exposures to physical and chemical agents; social and built environments; nutritional components; physical activity and energy balance; microbiome; and infectious agents and their interactions with underlying host factors.
Genomic Epidemiology Research focuses on genetic, epigenetic, immunologic factors, biological pathways, and their interactions with environmental factors. Development of new methods and models for genetic epidemiologic studies are encouraged, especially methods to examine gene-gene and gene-environment interactions and integration across multiple -omics data (metabolomics, proteomics, transcriptomics, epigenomics, etc.)
Clinical and Translational Epidemiology Research focuses on clinical, genomic, and lifestyle factors that influence cancer progression, recurrence, survival, adverse events, and other related outcomes among cancer patients and survivors, and on factors associated with cancer risk, development, and detection among individuals with underlying diseases, conditions, and inherited syndromes.
Risk Factor Assessment Research focuses on (1) the development, evaluation, and dissemination of high-quality risk factor metrics, methods, tools, technologies, and resources for use across the cancer research continuum, and (2) the assessment of cancer-related risk factors in the population. Of particular interest are the multivariate exposures of diet and physical activity, and their associated risk factors of weight status and body composition. For all these factors, the assessment of acute, usual, and dynamic valuations can be critical.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The combined budget for direct costs for the two-year project period may not exceed $275,000. No more than $200,000 may be requested in a single year.
The maximum project period is 2 years.
Non-domestic (non-U.S.) Entities (Foreign Institutions)
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Research Strategy: The Research Strategy should clearly describe the following within the appropriate section (i.e., Significance and Approach):
Background and Significance: The application should clearly state how the project will contribute to the understanding of cancer etiology and Epidemiology by stimulating research examining clinical, genomic, lifestyle, and other factors, or models/methods conducting human population studies.
Approach: Describe how the project proposes a credible research strategy which generates data/knowledge/information needed to expand this study to large scale population studies, and how data generated from this research will be integrated into existing epidemiology data.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Only the review criteria described below will be considered in the review process.
Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.
Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
In addition, for applications involving clinical trials:
Specific to this FOA: Do the investigators propose a feasibility study to collect early development or preliminary data which help in understanding cancer etiology?
In addition, for applications involving clinical trials: Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
In addition, for applications involving clinical trials: With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Specific to this FOA: Will this study explore an area of Epidemiology research that has potential to generate enough information which can be applied to identify factors/models/approaches in populations of distinct racial and ethnic groups?
In addition, for applications involving clinical trials: Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Specific to this FOA: Does the project propose a credible research strategy which generates data/knowledge/information needed to expand this study to large scale population studies? Can data generated from this research be integrated into existing epidemiology data?
In addition, for applications involving clinical trials: Does the application adequately address the following, if applicable:
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative, and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
In addition, for applications involving clinical trials: If proposed, are the administrative, data coordinating, enrollment, and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate? If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and (4) operate within the proposed organizational structure?
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by Center for Scientific Review (CSR), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
Mukesh Verma, Ph.D.
Email: vermam@mail.nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Carol Perry
Email: perryc@mail.nih.gov