AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT03440268 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebos
Description: These participants will receive a saline solution in pre operatory with the same volume as the experimental group, and this solution will be administrated in 2 hours. During the surgery they will receive a new solution with the same volume of the experimental group, and this solution will be administrated in 6 hours too. The solutions will be covered by an opaque bag, so the participant will not see what is being administrated
Study NCT00662805 — intervention group
Intervention type: DRUG
Intervention: Salmeterol/Fluticasone propionate
Description: Open label, of Salmeterol/Fluticasone propionate (50/500 μg) twice daily via dry powder inhaler (DPI)
Study NCT01084863 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CT-P6
Description: CT-P6: administered every 3 weeks
Study NCT01084863 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Herceptin
Description: Herceptin: administered every 3 weeks
Study NCT01084863 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel
Description: Paclitaxel: administered every 3 weeks
Study NCT01084863 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Paclitaxel
Description: Paclitaxel: administered every 3 weeks
Study NCT04061213 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: Tc-99m-DPD scintigraphy
Description: Myocardial scintigraphy
Study NCT04433221 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Multiple sarcoma-specific CAR-T cells and sarcoma vaccines
Description: 1 infusion, CART 1x10\^6\~1x10\^7 cells/kg via IV and vaccines 1-5x10\^6 irradiated cells via subcutaneous injection
Study NCT02154243 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Midodrine
Description: 10 mg, p.o., once, on day of surgery after first physical therapy session
Study NCT02154243 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Intravenous fluid bolus
Description: 15 cc/kg, once, on day of surgery after first physical therapy session
Study NCT03931538 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Guidance 4.0 PCR test
Description: All patients will have a urine culture and Guidance 4.0 PCR test run on their urine, but physicians will receive one or the other, or both depending on the treatment arm.
Study NCT03931538 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Urine Culture
Description: All patients will have a urine culture and Guidance 4.0 PCR test run on their urine, but physicians will receive one or the other, or both depending on the treatment arm.
Study NCT03726853 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CKD-497 200mg
Description: CKD-497 200mg
Study NCT03726853 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CKD-497 300mg
Description: CKD-497 300mg
Study NCT03726853 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: CKD-497 placebo
Description: Placebo of CKD-497
Study NCT03726853 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: CKD-497 placebo
Description: Placebo of CKD-497
Study NCT03726853 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Comparator
Description: Comparator
Study NCT00533299 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Hydralazine and magnesium valproate
Description: Hydralazine and valproate will start from seven days before day 1 of chemotherapy until the end of the sixth course. Hydralazine will be administered at 182mg (rapid) or 83mg (slow) according to the acetylator phenotype in a single daily dose and magnesium valproate at an oral dose of 40mg/Kg t.i.d.
Study NCT00533299 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebos will start from seven days before day 1 of chemotherapy until the end of the sixth course. Placebo tablets will be administered in an identical form that experimental drugs.
Study NCT00713284 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: sirolimus
Description: Oral tablet(s) taken daily for 6 months; dose will be based on serum trough levels.
Study NCT00149890 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Basiliximab
Description: Basiliximab (10 mg) was supplied as a lyophilisate in vials with ampoules of sterile water for injection (5 mL) and had to be given of 10 mg (body weight \<35 kg) or 20 mg (body weight ≥35 kg) strength.
Study NCT00149890 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Basiliximab
Description: Basiliximab (10 mg) was supplied as a lyophilisate in vials with ampoules of sterile water for injection (5 mL) and had to be given of 10 mg (body weight \<35 kg) or 20 mg (body weight ≥35 kg) strength.
Study NCT00149890 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclosporine/cyclosporine microemulsion
Description: Cyclosporine/cyclosporine microemulsion had to be started with 100 mg/m²/day intravenous (i.v) (2x4h) for 7 days and was to be continued i.v. or orally from day 8 onwards as per center practice. During the 6 months treatment period Cyclosporine doses had to be adjusted according to Cyclosporine A (CsA)-trough levels.
Study NCT00149890 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cyclosporine/cyclosporine microemulsion
Description: Cyclosporine/cyclosporine microemulsion had to be started with 100 mg/m²/day intravenous (i.v) (2x4h) for 7 days and was to be continued i.v. or orally from day 8 onwards as per center practice. During the 6 months treatment period Cyclosporine doses had to be adjusted according to Cyclosporine A (CsA)-trough levels.
Study NCT00149890 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Steroid
Description: Intravenous prednisolone (loading dose: 300 mg/m2, maximum 500 mg) had to be administered intraoperatively only in treatment arm 1 (day 0). The first dose of steroids in treatment arm 2 (day 0) had to be administered within 8 hours after reperfusion of the graft. Beginning from day 1 to day 6 doses of 15 mg/m2/day had to be given intravenously (i.v.) in both treatment arms. Then, the steroid doses (oral prednisone or its equivalent) were to be decreased from 10 mg/m²/day orally (day 7-13), to 7.5 mg/m²/day orally (day 14-30), to 4 mg/m²/day orally (until end of month 2), to 2.5 mg/m²/day orally (until end of month 3) and to 1 mg/m²/day orally (until end of month 6).
Study NCT00149890 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Steroid
Description: Intravenous prednisolone (loading dose: 300 mg/m2, maximum 500 mg) had to be administered intraoperatively only in treatment arm 1 (day 0). The first dose of steroids in treatment arm 2 (day 0) had to be administered within 8 hours after reperfusion of the graft. Beginning from day 1 to day 6 doses of 15 mg/m2/day had to be given intravenously (i.v.) in both treatment arms. Then, the steroid doses (oral prednisone or its equivalent) were to be decreased from 10 mg/m²/day orally (day 7-13), to 7.5 mg/m²/day orally (day 14-30), to 4 mg/m²/day orally (until end of month 2), to 2.5 mg/m²/day orally (until end of month 3) and to 1 mg/m²/day orally (until end of month 6).
Study NCT01431521 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MK-4074 200 mg
Description: 2 x 100-mg capsules, orally, twice-daily (BID) for 4 weeks
Study NCT01431521 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo for MK-4074
Description: 2 x 100-mg capsules, orally, BID for 4 weeks.
Study NCT01431521 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pioglitazone hydrochloride 30 mg
Description: 1 x 30-mg tablet, orally, once daily for 4 weeks
Study NCT01431521 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo for pioglitazone hydrochloride
Description: 1 x 30-mg tablet, orally, once daily for 4 weeks
Study NCT00952770 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: transradial coronary intervention
Description: percutaneous coronary intervention with transradial approach
Study NCT00952770 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: transradial coronary intervention
Description: percutaneous coronary intervention with transradial approach
Study NCT04124224 — intervention group
Intervention type: OTHER
Intervention: Unidos
Description: The investigators will collaborate with our community partners to implement and evaluate a Community-Clinical Linkage (CCL) model in which Community Health Workers (CHWs) connect individuals to social determinant and community health services and build sociocultural resilience through CHW-facilitated individual and group support. As a public health practice-based study that incorporates evidence-based strategies, the investigators seek to establish Unidos effectiveness in Arizona counties with the highest percentage of Latinos of Mexican origin (Yuma, Pima, Santa Cruz, and Maricopa). Unidos CHWs, based in local health departments, will use evidence-based strategies to address three elements that are important in addressing chronic disease risk: 1) health promotion resources and programs; 2) individual and group-based social support; and 3) leveraging community resources to address social determinants of health.
Study NCT01207869 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ucMSCs
Description: the ucMSCs suspension(3× 106 cells per kg of the patient's weight) will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube
Study NCT01207869 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Normal saline
Description: the same amount of ucMSCs suspension will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube
Study NCT02737293 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Control Diet
Description: 4-week intake of Control Diet 5 day rotating menu
Study NCT02737293 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Med Diet
Description: 4-week intake of Med Diet 5 day rotating menu
Study NCT02737293 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Med Diet + Whole Egg
Description: 4-week intake of Med Diet plus Whole Egg 5 day rotating menu
Study NCT00608244 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LCP Tacro
Description: In the morning of Day 8 (after completing one week treatment with Prograf), all patients will be converted to LCP Tacro QD with a conversion ratio of 0.66-0.8.~LCP-Tacro will be administered for 14 Days with one fixed dose change allowed at Day 15. LCP-Tacro will be administered orally once daily in the morning, with an interval of 24 ± 1 h between doses.~Trough levels were to be maintained within predefined therapeutic ranges of 5 to 15 ng/mL.
Study NCT00608244 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prograf
Description: Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day 0 through Day 7 to maintain target trough levels of 5-12 ng/mL.
Study NCT04332471 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Radial shockwave therapy
Description: Target intensity will be within a range of 3.5-5.0 bar at maximum Hz, titrated up to patient tolerance within 100 pulses. Total of 3000 pulses.
Study NCT04332471 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Focused shockwave therapy
Description: Target intensity will be within a range of 0.15-0.25 mJ/mm2 at maximum Hz, titrated up to patient tolerance within 100 pulses. Total of 3000 pulses.
Study NCT04332471 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Shockwave therapy device
Description: The shockwave therapy device will be used to administer either radial or focused shockwave therapy.
Study NCT00269295 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Ty800
Description: Live attenuated Ty800 S typhi oral vaccine is co-administered with a sodium bicarbonate buffer solution. Dosages: 5 X 10\^7 cfu, 5 X 10\^8 cfu, and 5 X 10\^9 cfu.
Study NCT04332471 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Home therapy
Description: Stretching and ice massage
Study NCT01270776 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 2% aqueous chlorhexidine
Description: A single application of a swabstick impregnated with the antiseptic solution over the desired area. The imparted solution will be allowed to air dry with a minimum time of 30 seconds before intervention.
Study NCT01270776 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 2% Chlorhexidine 70% isopropyl alcohol
Description: single application of a swabstick impregnated with the antiseptic solution over the desired area. The imparted solution will be allowed to air dry with a minimum time of 30 seconds before intervention.
Study NCT02535988 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Radiation therapy
Description: 3.5Gy per fraction to a total dose of 35Gy/10 fractions over 2 weeks with concurrent thymalfasin for metastatic lesions of colorectal cancer.
Study NCT02535988 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Thymalfasin
Description: Patients with metastatic lesions of colorectal cancer receiving 3.5Gy per fraction to a total dose of 35Gy/10 fractions over 2 weeks with concurrent thymalfasin ( given twice a week with an interval of 3-4 days each week).
Study NCT00753415 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: V935
Description: A 0.5 mL vaccine administered IM every 2 weeks as either a LD (1 x 10\^9 vector genomes/mL) or a HD (1 x 10\^11 vector genomes/mL).
Study NCT00753415 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: V934-EP
Description: A 0.5 mL vaccine administered by EP as either a LD (0.5 mg plasmid/mL) or a HD (5.0 mg plasmid/mL).
Study NCT00269295 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 150 mL of the prepared sodium bicarbonate buffer solution. Placebo will look and taste essentially like the study product.
Study NCT01191424 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CHF1535 NEXT DPI
Description: FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER
Study NCT01191424 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: BDP DPI and formoterol DPI
Description: FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI
Study NCT02451865 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Binimetinib
Description: Given PO
Study NCT02451865 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel
Description: Given IV
Study NCT02451865 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies
Study NCT02784808 — intervention group
Intervention type: DRUG
Intervention: Biological DMARDs
Description: Participants will receive biologic DMARDs as per standard of CARE. The choice of specific biologic DMARD will be at the descretion of treating physician.
Study NCT02784808 — intervention group
Intervention type: DRUG
Intervention: Non-Biologic DMARDs
Description: Participants will receive non-biologic DMARDs as per standard of care. The choice of specific non-biologic DMARD will be at the descretion of treating physician.
Study NCT02426437 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Pulmonary Rehabilitation (PR)
Description: Patients enrolled in PR will undergo a 6-8 week rehabilitation program.
Study NCT02426437 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Usual Care
Description: Patients enrolled in usual care will be followed-up by their most responsible physician as determined by the admitting team.
Study NCT03340532 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: THE INFORMATION + APPEARANCE VIDEO
Description: THE INFORMATION + APPEARANCE VIDEO which will include the full information video, along with an additional embedded video segment emphasizing negative appearance consequences of UV exposure.
Study NCT03340532 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Information SunSmart video
Description: The INFORMATION SunSmart video providing basic information about UV risks, including secondary skin cancer and the benefits of SP, as well as specific SP recommendations and steps to integrate SP as part of routine self-care for the healthy cancer survivor
Study NCT03340532 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Sleep hygiene video
Description: Contain information on better sleep hygiene
Study NCT05016440 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Lisinopril
Description: 10mg Lisinopril daily for 6-8 weeks postpartum
Study NCT05016440 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Lisinopril
Description: 10mg Lisinopril daily for 6-8 weeks postpartum
Study NCT04124276 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Lycium barbarum polysaccharide
Description: Experimental groups take Lycium barbarum polysaccharide (LBP) (300mg/day) for 6 weeks
Study NCT04124276 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo control group takes placebo (300mg/day) for 6 weeks.
Study NCT04235114 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 50 mg 89Zr-DFO-Nimotuzumab
Description: A maximum of 2 mCi (range 1 - 2 mCi) 50 mg of 89Zr-DFO-nimotuzumab will be injected intravenously over a period of at 2 - 3 minutes. Injection will be followed by a normal saline flush of 20-30 mL. PET/CT scan will be done at different time points post infusion.
Study NCT01376388 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GSK573719/GW642444 Inhalation Powder
Description: GSK573719/GW642444 inhalation powder inhaled orally once daily for 52 weeks.
Study NCT04235114 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 1 mg 89Zr-DFO-Nimotuzumab
Description: A maximum of 2 mCi (range 1 - 2 mCi) 1 mg of 89Zr-DFO-nimotuzumab will be injected intravenously over a period of at 2 - 3 minutes. Injection will be followed by a normal saline flush of 20-30 mL. PET/CT scan will be done at different time points post infusion.
Study NCT01179568 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Citalopram
Description: 16 weeks of medication provided flexibly up to 40 mg/day. Medication will be administered in a double-blind fashion.
Study NCT01179568 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Complicated Grief Treatment
Description: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
Study NCT01179568 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Placebo
Description: 16 weeks of daily inactive medication. It will be administered in a double-blind fashion.
Study NCT01179568 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 16 weeks of daily inactive medication. It will be administered in a double-blind fashion.
Study NCT04053114 — intervention group
Intervention type: OTHER
Intervention: DNA and RNA extraction from FFPE or frozen tissue sample
Description: Next generation sequencing (NGS)
Study NCT00357968 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Prasugrel
Description: Administered orally
Study NCT00357968 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prasugrel
Description: Administered orally
Study NCT00357968 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Clopidogrel
Description: Administered orally
Study NCT00357968 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Clopidogrel
Description: Administered orally
Study NCT00357968 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo for Prasugrel
Description: Administered orally
Study NCT00357968 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo for Prasugrel
Description: Administered orally
Study NCT00357968 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo for Clopidogrel
Description: Administered orally
Study NCT04140682 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PAV+ mode
Description: PAV+ mode by using Puritan-Bennett 840 ventilator
Study NCT04140682 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: PSV mode
Description: PSV mode by using Puritan-Bennett 840 ventilator
Study NCT00357968 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo for Clopidogrel
Description: Administered orally
Study NCT02396615 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: SATIN pineapple
Description: Active juice with added fibre and ginseng
Study NCT02396615 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: SATIN pineapple control
Description: Control products without active ingredients
Study NCT04753060 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Waxing
Description: Donor sites of patients skin grafts are waxed prior to surgery for donor harvesting.
Study NCT02821988 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: External fetal monitor for Nonstress test
Study NCT00465205 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Valacyclovir
Description: 500mg oral twice daily
Study NCT00465205 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Matching Placebo
Description: 500 mg oral twice daily