ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01136174
Conditions: Idiopathic Pulmonary Fibrosis
Sponsor: Boehringer Ingelheim
Start date: 2010-05-01; Completion date: 2011-03-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate safety of BIBF 1120 in Japanese patients with idiopathic pulmonary fibrosis (IPF), with and without pirfenidone background treatment.

To assess pharmacokinetics of BIBF 1120 in Japanese patients, with and without pirfenidone background treatment.

To assess pharmacokinetics of pirfenidone in Japanese patients, alone and in combination with BIBF 1120 treatment.

Detailed description:

Arms: arm 1: Low dose for cohort 1 arm 2: Middle dose for cohort 2 arm 3: High dose for cohort 3 arm 4: Placebo for cohort 1,2,3
Interventions: intervention 1: Placebo intervention 2: BIBF 1120 intervention 3: BIBF 1120 intervention 4: BIBF 1120
Intervention descriptions: intervention 1: Placebo BID for cohort 1,2,3 intervention 2: 50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively intervention 3: 50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively intervention 4: 50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively

Protocol documents:
Clinical trial NCT01140061
Conditions: Plaque Psoriasis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-05-01; Completion date: 2011-03-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the incidence of erythema and other local cutaneous irritation after administration of MK-0873 by patch or cream formulation in healthy participants and participants with mild psoriasis. Part I and Part II in healthy participants will be initiated prior to Part III in psoriasis participants. The primary hypotheses of the study are: 1) that MK-0873 is safe and well tolerated in healthy participants and participants with psoriasis and 2) that the maximum plasma concentration of MK-0873 is \<20 nM in healthy participants and participants with psoriasis.

Detailed description:

Arms: arm 1: In Part I, healthy participants received skin patches containing nothing (plain patch), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg of MK- 0873) once daily for 21 days. arm 2: In Part I, healthy participants received skin patches containing nothing (plain patch) or placebo once daily for 10 days. arm 3: In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK- 0873) twice daily for 10 days. arm 4: In Part II, healthy participants received skin application of placebo cream twice daily for 10 days. arm 5: In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days. arm 6: In Part II, healthy participants received skin application of placebo cream once daily for 10 days. arm 7: In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days. arm 8: In Part II, healthy participants received skin application of placebo cream twice daily for 10 days. arm 9: In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days. arm 10: In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
Interventions: intervention 1: MK-0873 Patch intervention 2: MK-0873 Cream intervention 3: Placebo Patch intervention 4: Placebo Cream intervention 5: Plain patch
Intervention descriptions: intervention 1: MK-0873 skin patches containing 0.05%. 0.5%, or 2% MK-0873 intervention 2: MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873 intervention 3: Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches intervention 4: Placebo cream matching MK-0873 0.05%, 0.5%, or 2% intervention 5: Plain patch containing no MK-0873 or placebo

Protocol documents:
Clinical trial NCT01144286
Conditions: Vulvovaginal Candidiasis
Keywords: VVC candidiasis vaginal candidiasis
Sponsor: Ferrer Internacional S.A.
Start date: 2010-06-01; Completion date: 2011-03-01
Enrollment: 229 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will be conducted to compare the therapeutic efficacy, safety and tolerability of three different doses of arasertaconazole nitrate (150 mg, 300 mg or 600 mg, pessaries).

Detailed description:

Arms: arm 1: placebo pessary, single dose arm 2: Arasertaconazole nitrate 150 mg pessary, single dose arm 3: Arasertaconazole nitrate 300 mg pessary, single dose arm 4: Arasertaconazole nitrate 600 mg pessary, single dose
Interventions: intervention 1: arasertaconazole nitrate intervention 2: placebo
Intervention descriptions: intervention 1: Arasertaconazole nitrate pessary, placebo pessary intervention 2: placebo, single dose

Protocol documents:
Clinical trial NCT01145066
Conditions: Diabetes Metabolic Syndrome x
Keywords: diabetes metabolic syndrome inflammation botanical oils
Sponsor: Wake Forest University Health Sciences
Start date: 2009-05-01; Completion date: 2011-03-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare how well a combination of borage and echium oils will reduce inflammation compared to fish oils and placebo oil in subjects that are diabetic or have metabolic syndrome.

Detailed description:

Arms: arm 1: borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA arm 2: Croda 18:12 fish oil arm 3: None
Interventions: intervention 1: borage/echium oil combination intervention 2: fish oil intervention 3: corn oil
Intervention descriptions: intervention 1: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA intervention 2: 1.6g/day EPA and 1.08g/day DHA intervention 3: contains 4.5 g/day linoleic acid

Protocol documents:
Clinical trial NCT01178827
Conditions: Overactive Bladder
Sponsor: Allergan
Start date: 2010-08-01; Completion date: 2011-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR®) and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with overactive bladder and age associated memory impairment.

Detailed description:

Arms: arm 1: Sanctura XR® (trospium chloride), 60mg once daily for 10 days arm 2: Oxybutynin IR (oxybutynin immediate release), 5 mg three times daily for 2 days arm 3: Oxybutynin IR placebo three times daily for 2 days
Interventions: intervention 1: trospium chloride intervention 2: oxybutynin IR intervention 3: oxybutynin IR placebo
Intervention descriptions: intervention 1: trospium chloride (60mg) once daily for 10 days intervention 2: oxybutynin IR (5 mg) three times daily for 2 days intervention 3: oxybutynin IR placebo three times daily for 2 days

Protocol documents:
Clinical trial NCT01184872
Conditions: Infections
Keywords: Skin infection Daptomycin Elderly Gram positive Complicated skin and soft tissue infections
Sponsor: Novartis Pharmaceuticals
Start date: 2010-03-01; Completion date: 2011-03-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to provide data documenting the efficacy of daptomycin in elderly patients aged ≥ 65 years with complicated Skin and Soft Tissue Infections.

Detailed description:

Arms: arm 1: Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.

Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days. arm 2: Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.

Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.
Interventions: intervention 1: Daptomycin intervention 2: Vancomycin or Semi-Synthetic Penicillins (SSPs)
Intervention descriptions: intervention 1: Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.

Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days. intervention 2: Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.

Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.

Protocol documents:
Clinical trial NCT01188928
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2010-09-01; Completion date: 2011-03-01
Enrollment: 1152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension with the active components when used individually as monotherapy in the topical suspension vehicle (betamethasone dipropionate in the topical suspension vehicle, calcipotriol in the topical suspension vehicle) and with the topical suspension vehicle alone in the treatment of psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs) in a large phase 3 study. This comparison will ensure a more informed assessment of the benefit/risk ratio of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension while also establishing the optimal treatment duration in psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs).

Detailed description:

Arms: arm 1: Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension arm 2: Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle arm 3: Calcipotriol 50 mcg/g in the topical suspension vehicle arm 4: The topical suspension vehicle alone
Interventions: intervention 1: Calcipotriol plus betamethasone intervention 2: Betamethasone-17,21-dipropionate intervention 3: Calcipotriene intervention 4: Topical suspension vehicle
Intervention descriptions: intervention 1: Topical suspension once daily for up to 8 weeks. intervention 2: Topical suspension once daily for up to 8 weeks. intervention 3: Topical suspension once daily for up to 8 weeks. intervention 4: Topical suspension once daily for up to 8 weeks.

Protocol documents:
Clinical trial NCT01194804
Conditions: Paroxysmal Nocturnal Hemoglobinuria
Keywords: Hemolytic Paroxysmal Nocturnal Hemoglobinuria Eculizumab PNH
Sponsor: Alexion Pharmaceuticals, Inc.
Start date: 2008-04-01; Completion date: 2011-03-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study was to assess the long-term safety and efficacy of eculizumab in hemolytic PNH patients who completed the 4-week screening and 12-week treatment period of the C07-001 study. In addition, pharmacokinetic and pharmacodynamic assessments of eculizumab were conducted.

Detailed description:

Arms: arm 1: Treatment with eculizumab for patients with PNH who have successfully completed the C07-001 protocol
Interventions: intervention 1: Eculizumab
Intervention descriptions: intervention 1: Each vial contains 30 mL of 10 mg/mL eculizumab; dose of 900 mg intravenous every 14 days.

Protocol documents:
Clinical trial NCT01195103
Conditions: Procedural Sedation Regional Anesthesia Block Orthopedic Surgery
Keywords: Procedural sedation Regional Anesthesia block Orthopedic surgery Lusedra Fospropofol disodium Midazolam
Sponsor: Mayo Clinic
Start date: 2011-02-01; Completion date: 2011-03-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
How does Lusedra compare with current standard of care (midazolam) for minimal to moderate sedation for regional anesthesia blocks prior to orthopedic surgery?

Detailed description:
The study overall is aimed at establishing the superiority of a single intravenous bolus-dose of Lusedra for routine use in preoperative regional blocks that avoids deeper levels of sedation and increased risk of nerve damage in an over-sedated individual. The shorter half-life of Lusedra should also demonstrate a superior recovery profile compared to midazolam when used as a rescue comparator. While this study will only enroll patients undergoing regional blocks prior to orthopedic surgery, the clinical utility and value of the larger initial intravenous dosing for Lusedra may be evident for many different monitored anesthesia care anesthetic management situations requiring rapid and effective onset of effects.

Arms: arm 1: 10 mg/kg Lusedra initial bolus. arm 2: 6.5 mg/kg Lusedra initial bolus. arm 3: Placebo initial bolus with dose of midazolam based on patient's weight
Interventions: intervention 1: Fospropofol disodium intervention 2: Fospropofol disodium intervention 3: Placebo + Midazolam intervention 4: Fentanyl
Intervention descriptions: intervention 1: 10 mg/kg bolus intervention 2: 6.5 mg/kg bolus intervention 3: Placebo bolus plus midazolam. The dose of midazolam will be based on the patient's weight: 1 mg for patients \<60 kg; 1.5 mg for patients ≥60 kg to \<90 kg; or 2 mg for patients ≥90 kg intervention 4: All patients will receive a single dose of IV fentanyl (approximately 1 μg/kg not to exceed: 50 μg for patients \<60 kg; 75 μg for patients ≥90 kg) five minutes prior to the initial dose of sedative.

Protocol documents:
Clinical trial NCT01195636
Conditions: Postherpetic Neuralgia
Keywords: Pain from Shingles, PHN, Postherpetic Neuralgia
Sponsor: Xenon Pharmaceuticals Inc.
Start date: 2010-08-01; Completion date: 2011-03-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this trial is to determine if XPF-002 is safe and effective for the treatment of pain in subjects with Postherpetic Neuralgia

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: XPF-002 intervention 2: Placebo
Intervention descriptions: intervention 1: Twice daily application of XPF-002 ointment which contains 8% of the XPF-002 active ingredient intervention 2: Twice daily application of Placebo ointment

Protocol documents:
Clinical trial NCT01195831
Conditions: Scalp Psoriasis
Sponsor: LEO Pharma
Start date: 2010-09-01; Completion date: 2011-03-01
Enrollment: 244 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the clinical efficacy of once daily treatment for 4 weeks with Xamiol® gel (calcipotriol plus betamethasone) with twice daily treatment for 4 weeks with Calcipotriol Scalp Solution in patients with scalp psoriasis.

Detailed description:

Arms: arm 1: Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate) arm 2: Calcipotriol (as hydrate) 50 mcg/ml
Interventions: intervention 1: Xamiol® gel intervention 2: Calcipotriol scalp solution
Intervention descriptions: intervention 1: Once daily application intervention 2: Twice daily application

Protocol documents:
Clinical trial NCT01213524
Conditions: Tobacco Use Disorder Schizophrenia
Keywords: nicotine craving dual-diagnosis comorbidity
Sponsor: Brown University
Start date: 2005-09-01; Completion date: 2011-03-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to investigate the relative contributions of nicotine replacement and sensorimotor replacement (i.e., smoking denicotinized cigarettes) on abstinence-induced smoking urges, withdrawal-related negative affect, psychiatric symptoms, cognitive task performance and 90-min ad libitum usual-brand smoking behavior in smokers with schizophrenia and non-psychiatric smokers.

Detailed description:
This study used a mixed between- and within-subjects design to investigate the separate and combined effects of sensorimotor replacement for smoking (very low nicotine content \[VLNC\] cigarettes vs. no cigarettes) and transdermal nicotine replacement (42 mg nicotine \[NIC\] vs. placebo \[PLA\] patches) in smokers with schizophrenia and control smokers without psychiatric illness. Each session contained a 5-h controlled administration period in which participants underwent the following conditions, in counterbalanced order: VLNC + NIC, VLNC + PLA, no cigarettes + NIC, no cigarettes + PLA, Usual Brand cigarettes + no patches. Next, participants completed measures of cigarette craving, nicotine withdrawal, smoking habit withdrawal, cigarette subjective effects, psychiatric symptoms and cognitive task performance followed by a 90-min period of ad libitum usual-brand smoking.

Arms: arm 1: 42 mg nicotine replacement plus sensorimotor replacement arm 2: inactive transdermal patches plus sensorimotor replacement arm 3: 42 mg nicotine replacement with no sensorimotor replacement arm 4: Double placebo: No nicotine or sensorimotor replacement arm 5: positive control: usual brand smoking
Interventions: intervention 1: sensorimotor replacement intervention 2: 42 mg transdermal nicotine replacement intervention 3: Placebo transdermal nicotine intervention 4: usual brand smoking
Intervention descriptions: intervention 1: denicotinized cigarettes intervention 2: 2 21-mg nicotine patches intervention 3: 2 placebo patches matched to 21-mg nicotine patches intervention 4: participant smokes usual brand of cigarette

Protocol documents:
Clinical trial NCT01215279
Conditions: Chronic Obstructive Pulmonary Disease Lung Disease
Keywords: Respiratory disease Chronic Obstructive Pulmonary Disease
Sponsor: AstraZeneca
Start date: 2010-10-01; Completion date: 2011-03-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to investigate the tolerability and safety of AZD2423 in Patients with chronic obstructive pulmonary disease.

Detailed description:

Arms: arm 1: AZD2423 Oral Treatment for 28 days arm 2: Oral treatment for 28 days
Interventions: intervention 1: AZD2423 intervention 2: Placebo to AZD2423
Intervention descriptions: intervention 1: 100 mg oral treatment once daily for 28 days intervention 2: Oral treatment once daily for 28 days

Protocol documents:
Clinical trial NCT01233232
Conditions: Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD) Laymen Terminology Chronic Bronchitis and Emphysema
Keywords: Chronic Obstructive Pulmonary Disease, Neutrophil, Respiratory Disease
Sponsor: AstraZeneca
Start date: 2010-11-01; Completion date: 2011-03-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients with Chronic Obstructive Pulmonary Disease

Detailed description:

Arms: arm 1: Placebo dose arm 2: Treatment arm AZD5069 50mg arm 3: Treatment arm AZD5069 80mg
Interventions: intervention 1: Placebo intervention 2: AZD5069 50mg intervention 3: AZD5069 80mg
Intervention descriptions: intervention 1: Oral dose bid intervention 2: Oral dose bid intervention 3: Oral dose bid

Protocol documents:
Clinical trial NCT01247363
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes glucokinase safety
Sponsor: Eli Lilly and Company
Start date: 2010-11-01; Completion date: 2011-03-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Safety study with multiple oral doses of LY2608204 given to patients with type 2 diabetes. Study subjects will receive once daily doses of LY2608204 for a total treatment duration of up to 28 days. In this study, each patient will receive increasing doses of LY2608204 until reaching the highest dose that they can tolerate.

Continuous glucose monitoring devices will be employed for each patient to monitor for hypoglycemia during study treatment. Dose titration and dose reduction is determined for each individual patient based on their safety and glycemic data.

Detailed description:

Arms: arm 1: Oral capsules of LY2608204 given once daily at a starting dose of 160 milligram (mg), which may be titrated in 3 dose escalations to 240 mg, 320 mg and 400 mg, with a 7-day treatment duration at each dose level for up to 28 days total treatment.
Interventions: intervention 1: LY2608204
Intervention descriptions: intervention 1: Administered orally.

Protocol documents:
Clinical trial NCT01248468
Conditions: Pain, Migraine
Keywords: Pain, Migraine
Sponsor: Novartis
Start date: 2010-11-01; Completion date: 2011-03-01
Enrollment: 752 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to compare the efficacy and safety of aspirin, acetaminophen and caffeine (AAC) with sumatriptan and placebo in the acute treatment of migraine.

Detailed description:

Arms: arm 1: AAC: 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets arm 2: 1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets arm 3: 1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Interventions: intervention 1: Aspirin, acetaminophen and caffeine intervention 2: Sumatriptan intervention 3: Placebo
Intervention descriptions: intervention 1: 2 tablets each containing Aspirin (250mg), acetaminophen (250mg) and caffeine (65mg) intervention 2: 100 mg Sumatriptan intervention 3: placebo

Protocol documents:
Clinical trial NCT01250834
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2010-12-01; Completion date: 2011-03-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess if giving LY2189265 at the same time as atorvastatin affects how the body absorbs atorvastatin.

Detailed description:

Arms: arm 1: Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Period 1 and Period 2.

Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
Interventions: intervention 1: Atorvastatin intervention 2: LY2189265
Intervention descriptions: intervention 1: Administered orally. intervention 2: Administered subcutaneously.

Protocol documents:
Clinical trial NCT01257542
Conditions: Common Cold Infections, Upper Respiratory Tract
Keywords: randomized parallel double-blind placebo-controlled cough efficacy safety dextromethorphan
Sponsor: Pfizer
Start date: 2010-12-01; Completion date: 2011-03-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
15 mg dextromethorphan hydrobromide will be better than placebo with respect to reducing the number of coughs over 6 hours and reducing the subjective severity of cough over 6 hours.

Detailed description:
In light of protocol changes required due to methodological and operational issues, including background noise in cough recordings which could impact data interpretation, the study has been terminated.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dextromethorphan intervention 2: Placebo
Intervention descriptions: intervention 1: A single 10 mL dose of Children's Triaminic Syrup (Dextromethorphan Hydrobromide 7.5 mg per 5 mL (total dose of 15 mg) intervention 2: A single 10 mL dose of matching placebo syrup

Protocol documents: