ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01689363
Conditions: Allergic Skin Reaction
Keywords: hyaluronidase enzymes with tissue spreading activity allergic reaction intradermal skin testing
Sponsor: Amphastar Pharmaceuticals, Inc.
Start date: 2012-09-01; Completion date: 2012-12-01
Enrollment: 253 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers using an intradermal skin test.

Detailed description:

Arms: arm 1: Intradermal injection of Amphadase (hyaluronidase 150 USP units/mL) arm 2: Intradermal injection of Histatrol (histamine base 0.1 mg/mL) arm 3: Intradermal injection of saline (0.02 mL)
Interventions: intervention 1: Hyaluronidase intervention 2: Histamine intervention 3: Saline
Intervention descriptions: intervention 1: Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two random sites on their forearms. intervention 2: Subjects received one intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one random sites on their forearms. intervention 3: Subjects received one intradermal injection of 0.02 mL saline at one random site on their forearm.

Protocol documents:
Clinical trial NCT01694706
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-09-01; Completion date: 2012-12-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this trial is to investigate the effect of food and of gastric pH increase on the relative bioavailability of faldaprevir.

Detailed description:

Arms: arm 1: faldaprevir medium, fasted arm 2: faldaprevir medium, fed arm 3: faldaprevir medium + omeprazole medium
Interventions: intervention 1: faldaprevir intervention 2: faldaprevir intervention 3: omeprazole intervention 4: faldaprevir
Intervention descriptions: intervention 1: medium dose of faldaprevir intervention 2: medium dose of faldaprevir intervention 3: medium dose of omeprazole intervention 4: medium dose of faldaprevir

Protocol documents:
Clinical trial NCT01702025
Conditions: Physiological Function in Low Oxygen Environment
Keywords: Hypoxia Altitude Exercise
Sponsor: Colorado State University
Start date: 2012-06-01; Completion date: 2012-12-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In low oxygen environments, such as altitude, some adults may become ill and suffer from acute mountain sickness. Further, all adults will find that exercising becomes much more difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of this investigation is to study the effects of two drugs that may help people adjust to high-altitude quickly, prevent them from becoming ill and improve their exercise performance. The drugs are Methazolamide and Aminophylline.

Detailed description:

Arms: arm 1: Administer a single dose of placebo (yellow corn meal in a capsule, gelatin ) in Normoxic Conditions.

Following a minimum of 7 days a single dose placebo will be administered (yellow corn meal in a gelatin capsule) in Hypoxic conditions. arm 2: Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Normoxic Conditions.

Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Hypoxic conditions. arm 3: Administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions.

Following a minimum of 7 days administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions. arm 4: Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions.(Aminophylline+Methazolamide)

Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions.
Interventions: intervention 1: Placebo intervention 2: Aminophylline intervention 3: Methazolamide intervention 4: Aminophylline+Methazolamide
Intervention descriptions: intervention 1: Yellow corn meal in gel capsules intervention 2: National Drug Code (NDC) 0143-1020-01 intervention 3: NDC 0781-1072-01 intervention 4: NDC 0143-1020-01 and NDC 0781-1072-01

Protocol documents:
Clinical trial NCT01702532
Conditions: Smoking Cessation
Keywords: provoked craving
Sponsor: GlaxoSmithKline
Start date: 2012-09-01; Completion date: 2012-12-01
Enrollment: 320 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of this study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint nicotine mouth film to nicotine lozenge in light smokers using the provoked craving model. The cues used to provoke a craving episode will be the sight and smell of a lit cigarette and the manipulations required to light a cigarette. The smokers will be denied access to cigarettes for 4 hours prior to the provoked craving session in order to precipitate nicotine withdrawal and an increase level of cigarette craving.

Detailed description:

Arms: arm 1: mint nicotine mouth film, buccal administration arm 2: nicotine lozenge, buccal administration
Interventions: intervention 1: Nicotine
Intervention descriptions: intervention 1: Comparison of different dosage forms of nicotine

Protocol documents:
Clinical trial NCT01708057
Conditions: Chronic Obstructive Pulmonary Disease COPD
Keywords: COPD Chronic obstructive pulmonary disease
Sponsor: AstraZeneca
Start date: 2012-10-01; Completion date: 2012-12-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active comparator.

Detailed description:
A randomised, double-blind placebo- and active-controlled, multi-centre, 6-way cross-over, single-dose phase IIa study to investigate the bronchodilatory and systemic effects of 4 different doses of inhaled AZD8683 in patients with Chronic Obstructive Pulmonary Disease (COPD).

Arms: arm 1: Single dose of AZD8683 50 µg arm 2: Single dose of AZD8683 150 µg arm 3: Single dose of AZD8683 300 µg arm 4: Single dose of AZD8683 900 µg arm 5: Single dose of placebo arm 6: Single dose of tiotropium 18 µg
Interventions: intervention 1: AZD8683 intervention 2: Placebo intervention 3: Tiotropium
Intervention descriptions: intervention 1: AZD8683 administered via inhalation intervention 2: Placebo administered via inhalation intervention 3: Tiotropium administered via inhalation

Protocol documents:
Clinical trial NCT01721070
Conditions: Pharmacokinetics
Keywords: Area under curve, time to maximum concentration
Sponsor: Talphera, Inc
Start date: 2012-11-01; Completion date: 2012-12-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following sublingual administration of sufentanil NanoTab.

Detailed description:

Arms: arm 1: Period 1: One dose of SUF NT 15 mcg administered sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil. arm 2: Ketoconazole 400 mg administered once daily for three days. One dose of SUF NT 15 mcg was co-administered sublingually with the third (last) ketoconazole dose.

Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.
Interventions: intervention 1: Sufentanil NanoTab (SUF NT) 15 mcg intervention 2: Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg
Intervention descriptions: intervention 1: Period 1: One dose of SUF NT 15 mcg administered sublingually intervention 2: Period 2: Ketoconazole 400 mg administered daily for three days, SUF NT 15 mcg co-administered sublingually on the third day

Protocol documents:
Clinical trial NCT01730872
Conditions: Chronic Allergic Conjunctivitis
Sponsor: ORA, Inc.
Start date: 2012-11-01; Completion date: 2012-12-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication,

Prednisolone, assessed by the following measures:

Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival redness

Detailed description:
Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 4 days between Visits 3 and 4.

Prednisolone phosphate Tears Naturale II Ophthalmic Solution (Placebo)

Duration:

Approximately 2 weeks

Controls:

Artificial Tears (Tears Naturale® II)

Arms: arm 1: Prednisolone Sodium Phosphate Ophthalmic Solution, 1% arm 2: Tears Naturale II Ophthalmic Solution, 1%
Interventions: intervention 1: Prednisolone Sodium Phosphate Ophthalmic Solution 1% intervention 2: Tears Naturale II Ophthalmic Solution
Intervention descriptions: intervention 1: One drop in each eye, four times/day for 4 days. intervention 2: one drop in each eye, four times/ day (QID) for 4 days

Protocol documents:
Clinical trial NCT01732588
Conditions: Healthy Volunteers
Keywords: Bioavailability
Sponsor: Medicines for Malaria Venture
Start date: 2012-11-01; Completion date: 2012-12-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the bioavailability of nanoparticulate OZ439 delivered to the proximal small bowel (PSB) via the Enterion™ capsule relative to oral OZ439 suspension (current "powder in bottle" \[PIB\]) and oral nanoparticulate OZ439.

The study will also characterise the plasma concentration time profile of OZ439 when delivered via Enterion capsule to the PSB in comparison with OZ439 PIB formulation delivered orally and nanoparticulate OZ439 delivered orally Safety and tolerability of OZ439 formulations will be determined following delivery to the PSB and administered orally

Detailed description:
Previous clinical studies with OZ439 have shown variable PK and a food effect. One hypothesis is that this may be related to a 'common ion effect' leading to precipitation of the drug as a less soluble hydrochloride salt in the stomach, resulting in variable absorption of the drug. This study is designed to investigate the possibility of improving the PK profile by delivering the drug directly to the PSB, thereby bypassing the stomach. The study will compare a previously dosed PIB formulation with oral delivery of a nanoparticulate as a caplet formulation. The same caplet formulation containing nanoparticulate will be administered to the PSB via the Enterion capsule.

Arms: arm 1: 120mg single dose of OZ439 as powder in bottle (PIB) formulation arm 2: 120 mg single dose of OZ439 immediate release (IR) caplet formulation containing nanoparticulate, administered directly via the oral route arm 3: 120 mg single dose of OZ439 caplet formulation containing nanoparticulate, administered orally via the Enterion capsule and delivered to the proximal small bowel
Interventions: intervention 1: OZ439 120mg PIB intervention 2: 120 mg OZ439 caplet intervention 3: 120mg OZ439 caplet via Enterion capsule
Intervention descriptions: intervention 1: 120mg dose (as free base) of OZ439 as a solution made up from powder in bottle (PIB) intervention 2: 120 mg (as free base) of OZ439 immediate-release (IR) caplet formulation containing nanoparticulate, administered directly via the oral route intervention 3: 120 mg OZ439 (as free base) in an immediate release (IR) caplet formulation containing nanoparticulate,administered orally via the Enterion capsule and delivered directly to the proximal small bowel (PSB)

Protocol documents:
Clinical trial NCT01732757
Conditions: Conjunctivitis, Allergic
Sponsor: Allergan
Start date: 2012-11-01; Completion date: 2012-12-01
Enrollment: 157 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™ (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular itching associated with allergic conjunctivitis.

Detailed description:

Arms: arm 1: One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0. arm 2: One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0. arm 3: One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
Interventions: intervention 1: Alcaftadine 0.25% intervention 2: Olopatadine 0.2% intervention 3: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%
Intervention descriptions: intervention 1: One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0. intervention 2: One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0. intervention 3: One drop of placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.

Protocol documents:
Clinical trial NCT01734902
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-11-01; Completion date: 2012-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the current trial is to establish the bioequivalence of 2 hyoscine butylbromide dose forms following oral administration.

Detailed description:

Arms: arm 1: drops, oral administration with 240 mL water arm 2: sugar coated tablets, oral administration with 240 mL water
Interventions: intervention 1: Hyoscine butylbromide intervention 2: Hyoscine butylbromide
Intervention descriptions: intervention 1: sugar coated tablets for oral administration intervention 2: drops for oral administration

Protocol documents:
Clinical trial NCT01747330
Conditions: Pancreatic Exocrine Insufficiency
Keywords: cystic fibrosis
Sponsor: Abbott Products
Start date: 2012-06-01; Completion date: 2012-12-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of Creon micro in children younger than four years with pancreatic exocrine insufficiency.

Detailed description:
A prospective open-label, multi-center study evaluating safety and tolerability of Creon Micro in pediatric subjects from at least one month to less than four years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis (CF). Referring to the European Medicines Agency (EMEA) pediatric age criteria for the purpose of the study, subjects are categorized as infants and toddlers (\< 2 years) and children, (2 years to \< 4 years). In total, 40 subjects will be enrolled (20 subjects in each age subgroup). Subjects receive their prescribed pancreatic enzyme supplementation at the individual dose until start of treatment with Creon Micro, if the subjects were on pancreatic enzyme supplementation before start of the study. Subjects will be treated with Creon Micro during the study. The treatment duration is 3 months.

Arms: arm 1: None
Interventions: intervention 1: Pancreatin
Intervention descriptions: intervention 1: Doses of Pancreatin \<2500 lipase u/kg/feed or \<4000 lipase U/g fat/intake or \<10000 lipase U/kg/day given orally are used

Protocol documents:
Clinical trial NCT01784965
Conditions: Pre-diabetes Older Adults
Sponsor: Stanford University
Start date: 2009-12-01; Completion date: 2012-12-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this study is to evaluate the hypothesis that the addition of liraglutide, a long-acting glucagon-like peptide 1 (GLP-1) analogue, to a calorie-restricted diet will lead to greater weight loss than will a calorie-restricted diet alone in subjects who are older (50 to 60 years of age), overweight/obese, and prediabetic. These individuals have been selected for study because they are at greatly increased risk to develop type 2 diabetes (2DM) and cardiovascular disease (CVD), and it is hypothesized that the addition of liraglutide to a calorie-restricted diet will significantly decrease risk of these adverse outcomes.

There is considerable evidence that GLP-I compounds, including liraglutide, improve glycemic control in patients with manifest 2DM. However, there is relatively little information as to the potential utility of these compounds in nondiabetic individual at greatly increased risk of 2DM and CVD. This research proposal is aimed at providing some of this information by quantifying the effects of liraglutide, a long-acting GLP-1 analogue, on weight loss, insulin secretion, insulin action, and multiple CVD risk factors in a very high risk group-older, overweight/obese, prediabetic individuals. Furthermore, by using specific methods, not surrogate estimates, and avoiding the confounding effects of glucotoxicity, it will be possible to gain new insights into the effects of GLP-1 on insulin secretion and insulin action.

Detailed description:

Arms: arm 1: Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo arm 2: Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo
Interventions: intervention 1: liraglutide intervention 2: Placebo
Intervention descriptions: intervention 1: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg. intervention 2: Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three.

Protocol documents:
Clinical trial NCT01801124
Conditions: Hernia
Keywords: analgesia hernia repair
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2012-04-01; Completion date: 2012-12-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the Transversus Abdominis Plane (TAP).

Detailed description:
This is a prospective, open-label, non-randomized study evaluating the effectiveness of abdominal analgesia when using 266 mg EXPAREL to infiltrate into the TAP unilaterally.

Arms: arm 1: undiluted EXPAREL 266 mg
Interventions: intervention 1: EXPAREL
Intervention descriptions: intervention 1: single dose 266 mg of undiluted EXPAREL

Protocol documents:
Clinical trial NCT01857583
Conditions: Venous Thromboembolism
Keywords: anticoagulant DU-176b edoxaban factor Xa oral orthopedic surgery of lower limbs severe renal impairment
Sponsor: Daiichi Sankyo Co., Ltd.
Start date: 2012-03-01; Completion date: 2012-12-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the safety and pharmacokinetics of DU-176b administered to patients with severe renal impairment undergoing orthopedic surgery of the lower limbs, compared with DU-176b administered to patients with mild renal impairment (MiRI) undergoing orthopedic surgery of the lower limbs.

For reference, the safety of DU-176b in patients with SRI undergoing orthopedic surgery of the lower limbs will be compared with that of fondaparinux.

Detailed description:

Arms: arm 1: Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days. arm 2: Mild Renal Impairment group orally administered 30mg DU-176b once daily for 14 days. arm 3: Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days. arm 4: Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.
Interventions: intervention 1: 15mg DU-176b intervention 2: 30mg DU-176b intervention 3: Fondaparinux
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02020512
Conditions: Glaucoma, Open-Angle Ocular Hypertension
Sponsor: Allergan
Start date: 2011-07-01; Completion date: 2012-12-01
Enrollment: 87 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate 0.03% bimatoprost in the treatment of primary open angle glaucoma and ocular hypertension.

Detailed description:

Arms: arm 1: 0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
Interventions: intervention 1: 0.03% Bimatoprost
Intervention descriptions: intervention 1: 0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.

Protocol documents:
Clinical trial NCT02021461
Conditions: Epilepsy
Sponsor: Bial - Portela C S.A.
Start date: 2012-12-01; Completion date: 2012-12-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the taste preference in children of 3 different flavours of the ESL oral suspension.

Detailed description:
Children between the age of 5 and \<8 years who are patients of the participating investigators will be screened for participation in the study. This may be at a regularly planned visit or the investigators may invite children who would be suitable candidates. Children who agree to participate will be invited to come back to the clinic on a single Study Day and will be randomised to a particular sequence of flavours. On the Study Day, all children will be given 3 different flavoured samples of Eslicarbazepine acetate (ESL) oral suspension for tasting, in the sequence to which they were randomised, in a double-blind, standardized setting. Each sample will consist of 2.5 mL and is to be given with a spoon in a double-blind manner, and is not to be swallowed. After tasting and spitting out each sample the child will be asked to rate the taste on a 10 cm visual analogue scale incorporating a facial hedonic scale. At the end of the session, the child will also be asked which flavour they thought tasted the best and which tasted the worst, to assess overall taste. A follow-up telephone contact interview will be performed between 1 and 4 days after the Study Day to collect adverse event (AE) data.

Arms: arm 1: Subjects were to be enrolled until there were at least 30 evaluable subjects (of whom at least 60% were \<7 years of age). Evaluable subjects were those who completed 3 Visual analogue scale (VAS), 1 for each of the 3 tasting steps with the 3 flavoured oral suspensions. arm 2: Subjects were to be enrolled until there were at least 30 evaluable subjects (of whom at least 60% were \<7 years of age). Evaluable subjects were those who completed 3 Visual analogue scale (VAS), 1 for each of the 3 tasting steps with the 3 flavoured oral suspensions. arm 3: Subjects were to be enrolled until there were at least 30 evaluable subjects (of whom at least 60% were \<7 years of age). Evaluable subjects were those who completed 3 Visual analogue scale (VAS), 1 for each of the 3 tasting steps with the 3 flavoured oral suspensions.
Interventions: intervention 1: ESL Banana taste intervention 2: ESL Grape taste intervention 3: ESL Tutti-Frutti taste
Intervention descriptions: intervention 1: oral suspension with Banana flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses. intervention 2: oral suspension with Grape flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses. intervention 3: oral suspension with Tutti-Frutti flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.

Protocol documents: