AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT01261130 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: 100 μg Na-GST-1/Alhydrogel
Description: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals
Study NCT01261130 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: 10 μg Na-GST-1/ Alhydrogel/GLA-AF
Description: 3 doses 10 μg Na-GST-1/ Alhydrogel/GLA-AF administered at 56 day intervals
Study NCT01261130 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: 30 μg Na-GST-1/Alhydrogel/GLA-AF
Description: 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF administered at 56 day intervals
Study NCT01261130 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: 100 μg Na-GST-1/Alhydrogel/GLA-AF
Description: 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF administered at 56 day intervals
Study NCT01261130 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Butang® hepatitis B vaccine
Description: 3 doses Butang® hepatitis B vaccine administered at 56 day intervals
Study NCT05058105 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FL058 500mg and Meropenem 1000mg（ IV 120min）
Description: D1 qd;~D2\~ D8 q8h;~D9 qd
Study NCT05058105 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FL058 Placebo and Meropenem 1000mg（ IV 120min）
Description: D1 qd;~D2\~ D8 q8h;~D9 qd
Study NCT01779739 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Perineorrhaphy
Description: Procedure to build up the vaginal opening
Study NCT01067456 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Comprehensive Cardiothoracic CT arm
Description: Subjects in this arm will receive the comprehensive cardiothoracic CT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan.
Study NCT01151644 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Anti-pandemic H1N1 influenza vaccine
Description: inactivated, NON-adjuvanted pandemic H1N1 influenza vaccine (A/California/7/2009)
Study NCT02197507 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Digitized sensor
Description: Measure of grip strength of the dominant hand
Study NCT04128384 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR
Description: For the purpose of obtaining intracardiac measurements, the quadripolar diagnostic catheter used as temporary pacemaker wire (5F, Woven, Boston Scientific) during TAVR was retracted from the apex and positioned at the His bundle to measure HV- and AH-intervals.
Study NCT03518073 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zagotenemab
Description: Administered IV
Study NCT03518073 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Administered IV
Study NCT02890706 — intervention group
Intervention type: DEVICE
Group type: OTHER
Intervention: Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed Tomography
Description: Compare two techniques of the CT scanner
Study NCT04566081 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: iTALKbetter: deterministic
Description: A word retrieval therapy application
Study NCT04566081 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: iTALKbetter: reactive
Description: A word retrieval therapy application
Study NCT01725438 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: sample blood
Study NCT01391767 — intervention group
Intervention type: DEVICE
Intervention: NuOss XC
Description: NuOss XC is a bone grafting material that will be placed in extraction socket site.
Study NCT00951132 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: rosuvastatin
Description: 10mg tablets, once daily in three months
Study NCT03785665 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: MDI
Description: Capsule MD1 (Motility dummy 1)
Study NCT02985307 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Short Message Text Service
Description: A service designed by professionals inside the National Health Service (NHS) to provide support and advice for participants to manage weight loss. It combines the expertise of the healthcare team and the convenience of the participant's own mobile phone to give prompts and advice to act on. It makes use of the familiar and convenient mobile phone text service 'SMS' to communicate directly with participants.
Study NCT00951132 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: tablet, once daily, three months
Study NCT04510324 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Red meat patties group
Description: 1. Baseline Visit: day -7 before randomization~* Clinical history~* Refrain from seafood, eggs, fish or meat, for 7-day (washout) prior to Day 1. 2. Day 1 Randomization~* Randomization to 1 of 2 interventions: plant-based or meat burgers~* 6 days-worth of burgers will be delivered to the participant's house 3. Day 1-6:~* The participant will be asked to eat a specific randomized diet for 6 days 5. Days 7~* Physical exam (weight, BP, HR)~* Food questionnaire~* Blood draw: Circulating TMAO, Total, LDL, and HDL cholesterol, Creatinine, High-sensitivity c-reactive protein~* Urine Collection - TMAO 6. Day 7-14: Washout 7. Day 14: Patties delivery 8. Day 14-20: Assigned diet for 6 days 9. Days 20: Same as day 7
Study NCT04510324 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Plant-based patties group
Description: Same as above
Study NCT00491101 — intervention group
Intervention type: OTHER
Intervention: Polish Version of PAQLQ(S) by Juniper
Description: Polish Version of PAQLQ(S) by Juniper
Study NCT03971227 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Acuity 100 (Hexafocon A) contact lens
Description: Daily wear rigid gas permeable contact lens
Study NCT04945499 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: d-glucose
Description: using d-glucose as an contrast agent on CEST MR Imaging
Study NCT02842333 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Additional biological samples
Description: Blood samples
Study NCT01603615 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Botulinum Toxin Type A
Description: Participants received intramuscular injections of botulinum Toxin Type A in the upper and/or lower limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.
Study NCT02985307 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Standard Weight Management Group
Description: A standard Lothian NHS group programme facilitated by a Dietitian
Study NCT02990065 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: PROTEIN SUPPLEMENTATION
Study NCT01738763 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Pinitol
Description: Three doses of Fruit Up® (diluted with mineral water to a final volume of 330 ml) were evaluated, and were equivalent to an intake of 2.5, 4.0 and 6.0 g of pinitol. The placebo beverage contained equal amounts of non-polyol carbohydrates with similar macronutrient composition and energy intake as that those obtained through the pinitol beverage, but excluding pinitol.
Study NCT00491101 — intervention group
Intervention type: OTHER
Intervention: spirometry
Description: spirometry
Study NCT02843932 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: functional brain MRI
Description: functional imagery during motor-perception tasks
Study NCT01034462 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Levomilnacipran ER
Description: Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. Study drug is to be given orally, in capsule form, once daily, for 8 weeks
Study NCT03708029 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Revita Allograft
Description: Human placental allograft
Study NCT00361907 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Effect of Pulsatile IV insulin on diabetic pt blood markers
Description: Diabetic patients are given pulsatile intravenous insulin on a weekly basis determined by weekly physician order based on pt response and insulin resistance.
Study NCT00361907 — intervention group
Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Effect of Pulsatile IV Insulin on blood markers
Description: Circulating blood markers are performed at baseline and every twelve months to compare and measure against diabetic patients receiving pulsatile intravenous insulin.
Study NCT05058105 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FL058 1000mg（ IV 120min）
Description: D1 qd;
Study NCT00361907 — intervention group
Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Effect of Pulsatile IV insulin on diabetic pt blood markers
Description: Blood markers will be performed on diabetic patients enrolled as control patients at baseline and every twelve months to measure and compare against diabetic patients treated with Pulsatile intravenous insulin therapy
Study NCT06494566 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Omega-3
Description: Omega-3 capsule
Study NCT02114359 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Capecitabine/cisplatin
Description: Capecitabine/cisplatin (XP) : cisplatin 50mg/m2 (80% dose of 60mg/2m) iv over 15min D1, capecitabine 1000mg/m2 (80% dose of 1250mg/m2) po bid D1-14, q 3wks
Study NCT06494566 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Mineral Oil
Description: Mineral Oil Capsule
Study NCT03942575 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Negative pressure wound therapy
Description: Wound dressing with negative pressure on closed incisions
Study NCT00838994 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Acupuncture
Description: Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
Study NCT00838994 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Acupuncture
Description: Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
Study NCT00838994 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Acupuncture
Description: Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
Study NCT01057082 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Juven
Description: Participants in the treatment arm will be asked to consume 2 packets of Juven drink mix each day for a period of six months.
Study NCT02114359 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: S-1/cisplatin
Description: S-1/cisplatin (SP) : cisplatin 50mg/m2 (80% dose of 60mg/2m) iv ov 15min D1, S-1 30mg/m2 (80% dose of 40mg/m2) po bid D1-14, q3wks
Study NCT02114359 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Capecitabine/oxaliplatin
Description: Capecitabine+oxaliplatin (XELOX): oxaliplatin 100mg/m2 (80% dose of 130mg/m2)iv ov 120min D1, capecitabine 800mg/m2 (80% dose of 1000mg/m2) po bid D1-14, q3wks
Study NCT02114359 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5-fluorouracil/oxaliplatin
Description: 5-fluorouracil/oxaliplatin (FOLFOX): oxaliplatin 80mg/m2 (80% dose of 100mg/m2) iv ov 120min, leucovorin 80mg/m2 (80% dose of 100mg/m2) iv ov 120min, 5-fluorouracil 1900mg/m2 (80% dose of 2400mg/m2) iv ov 46h D1, q 2wks
Study NCT02114359 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Capecitabine
Description: Capecitabine : 1250mg/m2 po bid D1-14 q3wks (if Ccr \<60ml/min, 1000mg/m2 po bid)
Study NCT02114359 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: S-1
Description: S-1 : 40mg/m2 po bid D1-14 q3wks (if Ccr \<60ml/min, 30mg/m2 po bid)
Study NCT02114359 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 5-fluorouracil
Description: 5-fluorouracil (FL) : leucovorin 100mg/m2 iv ov 2h, 5-fluorouracil 2400mg/m2 iv ov 46h D1, q2wks
Study NCT00440232 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Frovatriptan
Description: Frovatriptan 5.0 mg orally one time at the start of the 20 hour fast
Study NCT00440232 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Inert tab identical in appearance to Frovatriptan
Study NCT02924766 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Niraparib
Description: Participants will start with niraparib 200 mg once daily.
Study NCT05058105 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FL058 Placebo （ IV 120min）
Description: D1 qd;
Study NCT05058105 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Meropenem 1000 mg （ IV 120min）
Description: D4 qd;
Study NCT01057082 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Juven
Description: Participants in the placebo arm will be asked to consume two packets of an orange-flavored drink mix each day for a period of six months.
Study NCT01190852 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azelastine, Fluticasone
Description: TEST = MP29-02 = Combination product Azelastine Hydrochloride and Fluticasone Propionate nasal spray
Study NCT05058105 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Meropenem Placebo （ IV 120min）
Description: D4 qd;
Study NCT01190852 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Azelastine mono
Description: REF = AZE mono Azelastine Hydrochloride nasal spray (= essentially combination product formulation without any FLU; US AZE mono formulation as used in pivotal studies)
Study NCT01190852 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Azelastine
Description: COMP = Astelin® Nasal Spray = AZE mono Azelastine Hydrochloride nasal spray (= US marketed product)
Study NCT02245529 — intervention group
Intervention type: DRUG
Intervention: Tamsulosin
Study NCT00349206 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: sorafenib tosylate
Description: Given orally
Study NCT01034462 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
Study NCT00349206 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: temsirolimus
Description: Given IV
Study NCT02425150 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Corneal reshaping/crosslinking (CRXL)
Description: The keratoconus cornea is treated with epithelial debridement in local anesthesia, is soaked in Riboflavin by repeated topical application during 30 minutes. A flat, rigid contact lens is sutured to the cornea and the cornea and is then irradiated with ultraviolet light 5.4 J/cm2 during 30 minutes.
Study NCT02425150 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Corneal Crosslinking (CXL)
Description: The keratoconus cornea is treated with epithelial debridement in local anesthesia, is soaked in Riboflavin by repeated topical application during 30 minutes. The cornea and is then irradiated with ultraviolet light 5.4 J/cm2 during 30 minutes.
Study NCT05058105 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FL058 1000mg and Meropenem 1000mg （ IV 120min）
Description: D7 qd;~D8\~ D14 q8h;~D15 qd;
Study NCT05058105 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FL058 Placebo and Meropenem 1000mg （ IV 120min）
Description: D7 qd;~D8\~ D14 q8h;~D15 qd;
Study NCT05058105 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FL058 1000mg and Meropenem 2000mg （ IV 120min）
Description: D1 qd;~D2\~ D8 q8h;~D9 qd
Study NCT00911495 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GMI-1070
Description: Intravenous GMI-1070 given as two doses over the course of one day
Study NCT04332354 — intervention group
Intervention type: OTHER
Intervention: routine care. No intervention
Description: no intervention
Study NCT00708162 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Elvitegravir
Description: Elvitegravir (EVG) tablet administered orally once daily with food
Study NCT00708162 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Raltegravir
Description: Raltegravir tablet administered orally twice daily according to prescribing information
Study NCT00708162 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: EVG placebo
Description: Placebo to match elvitegravir administered orally once daily
Study NCT00708162 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RAL placebo
Description: RAL placebo administered orally twice daily.
Study NCT00708162 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Background regimen
Description: Background Regimen (administered according to prescribing information) contains 1 fully-active ritonavir-boosted protease inhibitor (PI/r) plus 1 or 2 additional agents. The ritonavir-boosted PIs include either ATV, darunavir, fosamprenavir, LPV (Kaletra®), or tipranavir; the additional agents include abacavir (ABC), Combivir® (lamivudine (LAM)/zidovudine (ZDV) coformulated), didanosine, emtricitabine (FTC), enfuvirtide, Epzicom® (ABC/LAM coformulated), etravirine, LAM, maraviroc, tenofovir disoproxil fumarate (TDF), Truvada®, (FTC/TDF coformulated), and/or ZDV.
Study NCT00708162 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Background regimen
Description: Background Regimen (administered according to prescribing information) contains 1 fully-active ritonavir-boosted protease inhibitor (PI/r) plus 1 or 2 additional agents. The ritonavir-boosted PIs include either ATV, darunavir, fosamprenavir, LPV (Kaletra®), or tipranavir; the additional agents include abacavir (ABC), Combivir® (lamivudine (LAM)/zidovudine (ZDV) coformulated), didanosine, emtricitabine (FTC), enfuvirtide, Epzicom® (ABC/LAM coformulated), etravirine, LAM, maraviroc, tenofovir disoproxil fumarate (TDF), Truvada®, (FTC/TDF coformulated), and/or ZDV.
Study NCT03367481 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Toothbrush type
Description: In this cross-over study, the participants will use either a soft brush (control) and the medium brush (test).
Study NCT03367481 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Toothbrush type
Description: In this cross-over study, the participants will use either a soft brush (control) and the medium brush (test).
Study NCT02175888 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days
Study NCT02175888 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 days
Study NCT03582202 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Nutritional assessment and therapy
Description: Nutritional screening, nutritional plan, follow-up and instructions on discharge
Study NCT03582202 — intervention group
Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Standard care
Description: Nutritional handling by nurse
Study NCT04474067 — intervention group
Intervention type: OTHER
Intervention: No intervention
Description: This is an observational study, with no intervention.
Study NCT00065507 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Entecavir (ETV)
Description: Tablets, Oral, 1 mg once daily, 96 weeks from the time the last patient is randomized
Study NCT00065507 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Adefovir (ADV)
Description: Tablets, Oral, 10 mg, once daily, 96 weeks from the time the last patient is randomized
Study NCT03635957 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Pegloticase
Description: pegloticase administered intravenously (IV)
Study NCT03635957 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate (MTX)
Description: oral MTX
Study NCT03635957 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Standard Gout Flare Prophylaxis
Description: It is required that before a subject begins the Pegloticase + IMM Period, he or she has been taking at least one protocol standard gout flare prophylaxis regimen (i.e. colchicine and/or nonsteroidal anti-inflammatory drugs and/or low-dose prednisone ≤10 mg/day) for ≥1 week before the first dose of pegloticase and continues flare prophylaxis per American College of Rheumatology guidelines \[Khanna D et al.2012\] for the greater of 1) 6 months, 2) 3 months after achieving target serum urate (sUA \< 6 mg/dL) for patients with no tophi detected on physical exam, or 3) 6 months after achieving target serum urate (sUA \< 5 mg/dL) for patients with one or more tophi detected on initial physical exam that have since resolved.
Study NCT03635957 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Infusion Reaction (IR) Prophylaxis
Description: For IR prophylaxis, fexofenadine (60 mg or 180 mg orally based on the Principal Investigator's discretion) will be taken the day before each infusion; fexofenadine (60 mg or 180 mg orally based on the Principal Investigator's discretion) and acetaminophen (1000 mg orally) will be taken the morning of each infusion; and methylprednisolone (125 mg IV) given over the infusion duration 10-30 minutes (recommended) or hydrocortisone (200 mg IV) will be administered immediately prior to each infusion.
Study NCT03960957 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AbobotulinumtoxinA
Description: Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA