AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT02621242 — intervention group
Intervention type: PROCEDURE
Intervention: Upper endoscopy
Description: Upper endoscopy with biopsies
Study NCT02621242 — intervention group
Intervention type: PROCEDURE
Intervention: Anoscopy
Description: Anoscopy with biopsies
Study NCT02621242 — intervention group
Intervention type: DRUG
Intervention: Truvada
Description: Truvada (tenofovir/emtricitabine) daily as HIV pre-exposure prophylaxis. This medication will not be provided by the study.
Study NCT01225575 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: co.don chondrosphere®
Description: co.don chondrosphere® are spheroids in suspension, developed from autologous chondrocytes.~The dose in group A is 3-7 spheroids/cm2 defect, in group B 10-30 spheroids/cm2 defect and in group C 40-70 spheroids/cm2 defect
Study NCT01042704 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bendamustine
Description: Bendamustine is given intravenously (into a vein or IV infusion) on days 1 and 2 of each cycle. Each bendamustine infusion will take 60 minutes
Study NCT01042704 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenalidomide
Description: Lenalidomide is taken orally (by mouth) in the morning on days 1 through 21 of each cycle.
Study NCT01042704 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Dexamethasone is taken orally (by mouth) on days 1, 8, 15, and 22 of each cycle.
Study NCT01042704 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aspirin
Description: All patients will receive enteric coated aspirin, 325 mg, QD while on study. If patient is unable to tolerate aspirin, patient should receive other types of anti-coagulation like Coumadin or low molecular weight heparin.
Study NCT01042704 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prophylaxis
Description: All patients will receive prophylaxis with either an H-2 blocker or proton pump inhibitor (PPI) while on study medications. Suggested medications included ranitidine 150 mg PC BID or omeprazole 20 mg PO QD or equivalent.
Study NCT01042704 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Antibiotic
Description: PCP antibiotic prophylaxis with a Bactrim will be recommended. In case of history of zoster or fungal infection a prophylaxis with Acyclovir or Diflucan should be also considered.
Study NCT01042704 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Biweekly Follow Up
Description: Vital signs (heart rate, breathing rate, blood pressure, and temperature) will be measured, and Blood tests to check CBC, Calcium, Electrolytes, serum, creatinine, and BUN. This follow up will take place at the Hillman Cancer Center, or whichever cancer center in which the subject is treated.
Study NCT01042704 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Cyclical Follow Up
Description: At the beginning of each treatment cycle subjects will undergo a Physical exam, a Performance status check, Recording of any new symptoms or side effects and any new medications, Blood tests (including blood chemistry, organ function and indicators of disease), Urine test, and pregnancy test (if applicable).
Study NCT01042704 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Restaging
Description: Every other cycle subjects' disease will be restaged. This will be accomplished by their treatment physician. Re-staging procedures includes a regular office visit, x-ray, and a bone marrow biopsy. Subjects will spend approximately 4 hours at the Hillman Cancer Center or the UPMC Cancer Center location where they are being treated for this re-staging.
Study NCT01042704 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Post-Treatment Follow Up
Description: After subjects stop receiving the study drugs, they will be followed every 3 months for the first two years, every 6 months for years 2-5, and annually thereafter. The following procedures, which are considered routine for their cancer care, will be done as part of this follow-up:~* Physical exam~* Performance status (check of ability to perform daily functions)~* Recording of any new symptoms and any new medications being taken~* Blood tests to check blood counts (numbers of red and white blood cells and platelets), blood chemistry (to check organ function), and indicators of disease (immunoglobulins)~* Urine test (24hr urine)~* Women who are able to have children will have a pregnancy test (4 weeks after their last dose of lenalidomide).~* A check of the status of disease (includes bone marrow biopsy, skeletal survey, and blood and urine tests). Bone marrow biopsy will be done at the end of treatment, if subjects have a complete response, and their disease gets worse.
Study NCT00159250 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AVI-4658 (PMO)
Description: morpholino antisense oligonucleotide
Study NCT05337215 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: kangaroo father care
Description: The effect of postpartum kangaroo father care on paternal attachment
Study NCT05337215 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: kangaroo father care
Description: The effect of postpartum kangaroo father care on paternal attachment
Study NCT01845337 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Capecitabine
Study NCT01458782 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Treatment of cartilage defects in the knee
Description: Two groups, either ACI or AMIC. ACI includes an arthroscopy for harvesting of cartilage 3-4 weeks prior to the open cartilage surgery. AMIC includes only open surgery at one setting.
Study NCT06509269 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: intraoral scanning
Description: Intraoral Scanning of edentulous Jaw
Study NCT02914210 — intervention group
Intervention type: DEVICE
Group type: OTHER
Intervention: Virtual physical therapy rehabilitation program
Description: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home
Study NCT06509269 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Desktop scanning
Description: Desktop scanning of definitive impression
Study NCT03302988 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Everted closure
Description: Suturing technique to obtain wound eversion. Type of suturing technique at surgeon's discretion
Study NCT03302988 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Planar closure
Description: The planar side will be closed with traditional buried simple closure and running cuticular sutures
Study NCT00654407 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rosuvastatin
Study NCT00654407 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Atorvastatin
Study NCT02914210 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: No intervention
Description: Traditional physical therapy delivered in clinic or via home-health visits
Study NCT02224157 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: budesonide/formoterol 'as needed' + budesonide placebo bid
Description: Symbicort (budesonide/ formoterol) 160/4.5 μg powder for inhalation 'as needed' plus Pulmicort placebo 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment
Study NCT02947880 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bumetanide
Description: For the patient of 25kg and more the bumetanide is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening.
Study NCT02947880 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: For the patient of 25kg and more the placebo is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening.
Study NCT02224157 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: budesonode bid + terbutaline 'as needed'
Description: Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment
Study NCT03630380 — intervention group
Intervention type: OTHER
Intervention: Clinical History
Description: We will collect clinical history for each patient (days of illness, history of fever, cough, difficulty breathing, vomiting, chest pain).
Study NCT03630380 — intervention group
Intervention type: OTHER
Intervention: Physical Exam Findings
Description: We will collect physical exam findings including vital signs, WHO criteria for diagnosing pneumonia, and lung auscultation findings.
Study NCT03630380 — intervention group
Intervention type: OTHER
Intervention: Laboratory Findings
Description: We will collect laboratory findings (white blood cell counts, differential, and c-reactive protein) if ordered by the clinician.
Study NCT03630380 — intervention group
Intervention type: OTHER
Intervention: Lung Ultrasound
Description: We will perform lung ultrasound on all patients.
Study NCT02790645 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Group 2a. Telemedicine program
Description: CSII (Accu-Chek Spirit®) and medical monitoring via telematics application (Emminens Conecta® System, Roche Diagnostics SL) (TM) (6 months).
Study NCT02790645 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Group 1a. Control
Description: Treatment with CSII (Accu-Chek Spirit®) and follow-face doctor visits (conventional treatment -SMC-) (6 months).
Study NCT02790645 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Group 1b.Telemedicine program
Description: After a washout period of 3 months and the crossing, Group 1 begins with medical monitoring via telematics application (Emminens Conecta® System, Roche Diagnostics SL) (TM) (6 months).
Study NCT02790645 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Group 2b. Control
Description: After a washout period of 3 months and the crossing, Group 2 begins with face doctor visits (conventional treatment -SMC-) (6 months) .
Study NCT02151994 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BIA 5-1058
Description: oral administration
Study NCT02151994 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: oral administration
Study NCT01964547 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sativex
Description: Patients self-administered their allocated randomized treatment on an outpatient basis, up to a maximum of 12 sprays to the oral mucosa per day (following an initial titration period).
Study NCT01964547 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Patients self-administered their allocated randomized treatment on an outpatient basis, up to a maximum of 12 sprays to the oral mucosa per day (following an initial titration period).
Study NCT04161716 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: NIRS recording
Description: Patient has a NIRS module during their urodynamic exam.
Study NCT02826954 — intervention group
Intervention type: OTHER
Intervention: Upper airway assessment, including nasal biopsy
Study NCT03266419 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Deep NMB using rocuronium
Description: * Drug: rocuronium~* Bolus dose: 0.7 mg/kg~* Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation.
Study NCT03266419 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Moderate NMB using rocuronium
Description: * Drug: rocuronium~* Bolus dose: none~* Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation.
Study NCT00980616 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ropivacaine, physical serum and adrenalin
Description: A: experimental group: 235 mg of ropivacaine, 5 ml physical serum and 0.5 mg of adrenalin
Study NCT03120936 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Emtricitabine / Tenofovir Disoproxil Oral Tablet
Description: Open-label emtricitabine 200mg/tenofovir 300mg
Study NCT03120936 — intervention group
Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: PrEP support
Description: HIV/STI testing and counseling, adherence counseling, medical exams, safety monitoring, short message system (SMS), ie text message, and peer support, panel management.
Study NCT02674399 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: JointStem
Study NCT02674399 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Synvisc-One
Study NCT04373291 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: BCG-Denmark
Description: Participants randomized to receive BCG will receive one 0.1 ml dose of Mycobacterium bovis BCG live attenuated BCG-Denmark vaccine (AJ Vaccines, Copenhagen, Denmark) by intradermal injection in the left deltoid region.
Study NCT04373291 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Saline
Description: Participants randomized to the control group will receive one 0.1 ml dose sterile 0.9 % NaCl by intradermal injection in the left deltoid region.
Study NCT05435105 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Virtual reality
Description: Distraction method
Study NCT05435105 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Local cold-vibration
Description: Distraction method
Study NCT00346918 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sirolimus
Description: Standard plus Sirolimus
Study NCT00346918 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard
Description: Standard
Study NCT01198132 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Cholecalciferol (Vitamin D3)
Description: Subjects receive Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
Study NCT01198132 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Subjects receive matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
Study NCT01992276 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CR8020
Description: 30 mg/kg administered as a single 2-hour intravenous infusion on Day 1
Study NCT01992276 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CR6261
Description: 30 mg/kg administered as a single 2-hour intravenous infusion on Day 1
Study NCT00654407 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Simvastatin
Study NCT02344680 — intervention group
Intervention type: DRUG
Intervention: Anti-HIV Agents
Study NCT01992276 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Administered as a single 2-hour intravenous infusion on Day 1
Study NCT02590770 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: attention modification
Description: participants will receive gaze-continent feedback according to their viewing patterns
Study NCT02590770 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: participants will receive non-gaze-continent feedback unrelated to their viewing patterns
Study NCT02128893 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Isavuconazole
Description: oral
Study NCT03673150 — intervention group
Intervention type: OTHER
Intervention: non intervention
Description: Observational study / non intervention
Study NCT03863964 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: blood test
Description: 13 blood samples will be drawn: at 3 min, 7 min, 15 min, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, and 5h post-treatment with TXA. Blood samples will be processed for ROTEM® analysis and for plasma concentration of TXA. TXA plasma concentrations will be modeled with a non-linear mixed-effects strategy using Monolix 4.1 and NONMEM(®) 7.2.
Study NCT02128893 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Esomeprazole
Description: oral
Study NCT04267523 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Web parenting intervention
Description: Parents participate in the self-delivered web-based parenting intervention for 6 modules. Treatment includes abilities of psychological flexibility (to be open, aware and active), emotion regulation, and positive parenting strategies.
Study NCT04267523 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Group parenting intervention
Description: Parents participate in face-to-face a weekly 2-hour group for 4 sessions. Treatment includes abilities of psychological flexibility (to be open, aware and active), emotion regulation, and positive parenting strategies.
Study NCT03100929 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Ultrasound
Description: Pre-operational ultrasound for the detection of fetal heart rate, fetal presentation and presence of nuchal cord.
Study NCT02650518 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Short-course Antibiotics
Description: 3 days of amoxicillin/clavulanate, ciprofloxacin, or cotrimoxazole.
Study NCT02650518 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Catheter Change
Description: Urinary catheter change once randomization is complete.
Study NCT00390325 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sorafenib Tosylate
Description: Given PO
Study NCT02382458 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Newsletters on cancer prevention and control
Description: E-mailed or mailed newsletters that provide information on how to prevent cancer
Study NCT02382458 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Behavioral program to reduce inflammation
Description: Group classes which will provide participants with information on achieving a healthy diet, increase physical activity, and manage stress
Study NCT02419742 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carboplatin
Description: TCH regimen: Carboplatin dose = Target Area Under Curve (AUC) (6 milligrams\*milliliter/minute \[mg\*mL/min\]) multiplied by (Glomerular Filtration Rate \[GFR\] + 25). Carboplatin will be administered as IV bolus every 3 weeks for 6 cycles (Cycles 1 to 6).
Study NCT02419742 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: AC-TH regimen: Cyclophosphamide 600 mg/m\^2 IV bolus every 3 weeks for 4 cycles (Cycles 1 to 4).
Study NCT01127737 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Educational Intervention
Description: Mnemonic and a workbook used by kidney transplant recipients to assist with early early detection of SCCs.
Study NCT01127737 — intervention group
Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Completed surveys
Study NCT02419742 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel
Description: AC-TH regimen: Docetaxel 100 mg/m\^2 IV infusion every 3 weeks for 4 cycles (Cycles 5 to 8). TCH regimen: Docetaxel 75 mg/m\^2 IV bolus every 3 weeks for 6 cycles (Cycles 1 to 6).
Study NCT02419742 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: Participants will receive Doxorubicin 60 mg/m\^2 administered as I.V. bolus injection over 5 to 15 minute every 3 weeks for 4 cycles for AC-TH regimen.
Study NCT02419742 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel
Description: AC-TH regimen: Paclitaxel 175 mg/m\^2 IV infusion every 3 weeks for 4 cycles (Cycles 5 to 8).
Study NCT02419742 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Trastuzumab
Description: AC-TH regimen: For weekly administration, 4 milligrams per kilograms (mg/kg) loading dose on Day 1 of Cycle 5, followed by 2 mg/kg on Day 8 of Cycle 5 and 2 mg/kg every week for 4 cycles (up to Cycle 8). For 3 weekly administration, 8 mg/kg loading dose on Day 1 of Cycle 5, followed by 6 mg/kg every 3 for 4 cycles (up to Cycle 8). From Day 1 of Cycle 9, 6 mg/kg will be administered every 3 weeks up to Cycle 22. TCH regimen: For weekly administration, 4 mg/kg loading dose followed by 2 mg/kg weekly from Cycles 1 to Cycle 6. For 3 weekly administration, 8 mg/kg loading dose followed 6 mg/kg every 3 weeks from Cycles 1 to 6. From Cycle 7, 6 mg/kg every 3 weeks up to Cycle 18. All administrations will be intravenous (IV) infusion.
Study NCT01127737 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Placebo
Description: Completed surveys
Study NCT03144596 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Alfuzosin Hydrochloride 10 MG
Description: Alfuzosin hydrochloride Tablet
Study NCT03144596 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tamsulosin Hydrochloride 0.4 MG
Description: Tamsulosin Hydrochloride Tablet
Study NCT01914042 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Morphine
Study NCT01914042 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Milnacipran
Study NCT03768596 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Nudge
Description: Influenza Vaccine Prescription Form accompanied on the back of telephone numbers of occupational health centers of different hospitals where interns are likely to be on probation.
Study NCT03768596 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: vaccination form
Description: a form about vaccination
Study NCT02106325 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ketamine
Description: IV of Ketamine (.25mg/kg)
Study NCT02106325 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Diphenhydramine
Description: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department