ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01998919
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2006-08-01; Completion date: 2011-11-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4 week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The anticipated time on study treatment is until disease progression or unacceptable toxicity.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: erlotinib [Tarceva] intervention 2: placebo intervention 3: gemcitabine intervention 4: cisplatin intervention 5: carboplatin
Intervention descriptions: intervention 1: 150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily intervention 2: orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application intervention 3: 1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles intervention 4: 75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin intervention 5: 5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin

Protocol documents:
Clinical trial NCT02034591
Conditions: Healthy Subjects
Sponsor: Bristol-Myers Squibb
Start date: 2011-10-01; Completion date: 2011-11-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the bioavailability of Apixaban oral solution administered through an Nasogastric Tube (NGT) in the presence of Boost® Plus and Apixaban administered as crushed tablet through a nasogastric tube relative to Apixaban solution administered orally in healthy subjects.

Detailed description:

Arms: arm 1: Solution Apixaban 5 mg ( 0.4 mg/ml oral solution x 12.5 ml) through mouth or oral syringe arm 2: Oral Solution Apixaban 5 mg single dose (0.4 mg/mL oral solution x 12.5 mL) after 180 mL of Boost Plus®, followed by 60 mL of Boost Plus® via same NGT arm 3: Single dose crushed Apixaban tablet 5 mg (5 mg tablet crushed and suspended in 60 mL Dextrose 5% in water (D5W)) through NGT
Interventions: intervention 1: Apixaban intervention 2: Boost Plus
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02135848
Conditions: Vascular Disease, Peripheral
Sponsor: GlaxoSmithKline
Start date: 2010-10-15; Completion date: 2011-11-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, randomized, blinded, placebo controlled study to evaluate the safety of GSK1278863 and its acute and short-term (e.g. 14d) effects on calf muscle endurance and walking ability in subjects with PAD and symptomatic claudication.

Detailed description:
This is a multi-center, randomized, blinded, placebo controlled study to evaluate the safety of GSK1278863 and its acute and short-term (e.g. 14d) effects on calf muscle endurance and walking ability in subjects with PAD and symptomatic claudication. Functional assessments will be performed following a single high dose (300mg), a single low dose (15mg), and following 14 days of low dose treatment (15mg q.d.). The objectives of this study are to: 1) Evaluate the safety and tolerability of GSK1278863 administered as a single dose and as sub-chronic low dosing (i.e. 14 days) in subjects with peripheral artery disease; 2) To demonstrate the potential pharmacodynamic effect of GSK1278863 on functional measures of calf muscle endurance and fatigability and timed walking distance following a single high or low dose and after 14 days of multiple low dose administration in subjects with claudication-limited peripheral artery disease. In this hypothesis-generating study, multiple assessments of ambulatory and skeletal muscle function will be made during standardized tests of claudication-limited exercise performance, and 3). Characterize the relationship, if any, between the doses and plasma concentrations of GSK1278863 and the pharmacodynamic effects.

Arms: arm 1: Study Drug arm 2: Placebo
Interventions: intervention 1: GSK1278863 intervention 2: Placebo
Intervention descriptions: intervention 1: GSK1278863 intervention 2: Placebo

Protocol documents:
Clinical trial NCT02778113
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2011-10-01; Completion date: 2011-11-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The main purpose of this study was to evaluate the safety and tolerability of nasal glucagon (NG). The study drug was delivered into the participant's nostril (intranasally) or was given as an injection just under the skin (subcutaneously) once in each of four study periods. The study lasted about 23 days for each participant.

Detailed description:

Arms: arm 1: Ng dose at 0.5 milligram (mg) administered once in one of four study periods. arm 2: Ng dose at 1.0 milligram (mg) administered once in one of four study periods. arm 3: Ng dose at 2.0 milligram (mg) administered once in one of four study periods. arm 4: Subcutaneous (SC) glucagon dose of 1 mg, in one of four study periods.
Interventions: intervention 1: Nasal Glucagon intervention 2: Glucagon
Intervention descriptions: intervention 1: Administered intranasally. intervention 2: Administered SC.

Protocol documents:
Clinical trial NCT01141075
Conditions: Amino Acid Metabolism, Inborn Errors
Sponsor: PTC Therapeutics
Start date: 2010-07-19; Completion date: 2011-11-03
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Methylmalonic acidemia (MMA) is a rare genetic disorder caused by mutations in the gene for mitochondrial enzyme methylmalonyl-CoA mutase (MCM) or in one of the genes for adenosylcobalamin (AdoCbl). Lack of these proteins causes toxic elevations of methylmalonic acid (MMacid) in blood, urine, and other tissues. A specific type of mutation, called a nonsense (premature stop codon) mutation, is the cause of the disease in approximately 5% to 20% of participants with mutations in the MCM gene, and approximately 20% to \>50% of participants with mutations in one of the AdoCbl genes. Ataluren is an orally delivered, investigational drug that acts to overcome the effects of the premature stop codon, potentially enabling the production of functional MCM/AdoCbl. This study is a Phase 2a trial evaluating the safety and activity of ataluren in participants with MMA due to a nonsense mutation. The main purpose of this study is to understand whether ataluren can safely decrease MMacid levels.

Detailed description:
In this study, participants with MMA due to a nonsense mutation will be administered an investigational drug called ataluren. Evaluation procedures to determine if a participant qualifies for the study will be performed within 14 days prior to the start of drug administration. Eligible participants who elect to enroll in the study will then participate in 2 drug administration and follow-up periods. Within the first period, ataluren will be taken 3 times per day with meals for 28 days at doses of 5 milligrams/kilograms (mg/kg) (morning), 5 mg/kg (midday), and 10 mg/kg (evening); there will then be an interval of approximately 21 days without ataluren. Within the second period, ataluren will be taken 3 times per day with meals for 28 days at doses of 10 mg/kg (morning), 10 mg/kg (midday), and 20 mg/kg (evening); there will then be an interval of approximately 14 days without ataluren. During the study, ataluren activity, safety, and pharmacokinetics will be evaluated, and MMacid levels in blood and urine will be measured periodically.

Arms: arm 1: Cycle 1: Ataluren treatment will be taken 3 times per day with meals for 28 days at doses of 5 mg/kg (morning), 5 mg/kg (midday), and 10 mg/kg (evening); there will then be an interval of 21 up to 42 days without treatment.

Cycle 2: Ataluren treatment will be taken 3 times per day with meals for 28 days at doses of 10 mg/kg (morning), 10 mg/kg (midday), and 20 mg/kg (evening); there will then be an interval of 14 days without treatment.
Interventions: intervention 1: Ataluren
Intervention descriptions: intervention 1: Ataluren will be provided as a vanilla-flavored powder to be mixed with water.

Protocol documents:
Clinical trial NCT01097629
Conditions: Primary Insomnia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-05-03; Completion date: 2011-11-08
Enrollment: 1020 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep.

Detailed description:

Arms: arm 1: Drug arm 2: Drug arm 3: Placebo Comparator
Interventions: intervention 1: Suvorexant High Dose (HD) intervention 2: Suvorexant Low Dose (LD) intervention 3: Comparator: Placebo
Intervention descriptions: intervention 1: Suvorexant 40 mg + placebo matching suvorexant 20 mg for participants \<65 years old; Suvorexant 30 mg + placebo matching suvorexant 15 mg for participants ≥65 years old; all study drug is tablet for oral administration, taken once daily at bedtime. Participants receive this dose during the 3-month Treatment (TRT) Phase. During the 1-week double-blind (DB) Run-out (RO) following the TRT phase, participants in this study arm receive the noted suvorexant dose or placebo, in a 1:1 ratio. During the 2-week single-blind Run-in period prior to randomization all participants receive placebo to suvorexant once daily at bedtime. intervention 2: Suvorexant 20 mg + placebo matching suvorexant 40 mg for participants \<65 years old; Suvorexant 15 mg + placebo matching suvorexant 30 mg for participants ≥65 years old; all study drug is tablet for oral administration, taken once daily at bedtime. Participants receive this dose during the 3-month TRT Phase. During the 1-week DB RO following the TRT phase, participants in this study arm receive the noted suvorexant dose or placebo, in a 1:1 ratio. During the 2-week single-blind Run-in period prior to randomization all participants receive placebo to suvorexant once daily at bedtime. intervention 3: Matching placebos to suvorexant 40 mg and 20 mg for participants \<65 years old; matching placebos to suvorexant 30 mg and 15 mg for participants ≥65 years old; all study drug is tablet for oral administration, taken once daily at bedtime. Placebo is a third treatment arm for comparison to the two active (suvorexant) treatment arms during the 3-month TRT Phase. During the 1-week DB RO following the TRT phase, participants in this study arm continue to receive placebo. During the 2-week single-blind Run-in period prior to randomization all participants receive placebo to suvorexant once daily at bedtime.

Protocol documents:
Clinical trial NCT00638157
Conditions: Infective Endocarditis
Keywords: Gram-positive bacterial infections Staph Aureus endocarditis bacteremia methicillin-resistant Staphylococcus aureus (MRSA)
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2009-02-13; Completion date: 2011-11-09
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
multicenter, randomized, double blind study to describe the safety and efficacy of daptomycin (6 mg/kg q24h) with and without concomitant initial gentamicin combination therapy in the treatment of SAIE

Detailed description:
Patients will be randomized to either of the following two treatment arms:

* Arm 1: daptomycin
* Arm 2: daptomycin with initial i.v. gentamicin

Patients who meet all the inclusion criteria and exhibit none of the exclusion criteria may be enrolled. Intravenous drug user (IVDU) patients may be randomized and study drug begun on the basis of two separate peripheral blood cultures positive for S. aureus obtained within 96 hours prior to the first dose of study drug.

The recommended minimum duration of treatment for daptomycin will be 28 days. The duration of treatment for gentamicin will be 3 days.

During study treatment, regular assessments (including weekly safety laboratory testing including CPK) will be performed. An End-of-Therapy (EOT) evaluation will be performed on the day of or 1-2 days after completion of daptomycin study drug or upon early termination (ET). All patients will have a post-therapy visit for Test of Cure (TOC)/Safety performed 21-28 days following the last dose of daptomycin study drug.

Arms: arm 1: daptomycin 6 mg/kg q24h for treatment of right-sided infective endocarditis arm 2: daptomycin 6 mg/kg q24h with concomitant initial gentamicin dosed for the first 2 days of therapy for the treatment of right-sided infective endocarditis
Interventions: intervention 1: daptomycin intervention 2: daptomycin and gentamicin
Intervention descriptions: intervention 1: Intravenous (i.v.) 6 mg/kg q24h intervention 2: i.v. daptomycin 6 mg/kg q24h plus initial i.v. gentamicin

Protocol documents:
Clinical trial NCT01268098
Conditions: Hypoparathyroidism
Keywords: Hypoparathyroidism, rhPTH[1-84], NPSP558
Sponsor: Shire
Start date: 2011-02-09; Completion date: 2011-11-11
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and vitamin D supplements.

Detailed description:
Patients with a history of Hypoparathyroidism will be randomized to receive study drug for 8 weeks, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically calcium levels in blood or urine). In addition, the patients' intake of Vitamin D and Calcium will be measured.

Arms: arm 1: 25 µg arm 2: 50 µg
Interventions: intervention 1: NPSP558
Intervention descriptions: intervention 1: All patients will inject NPSP558 25 or 50 µg SC QD into alternating thighs in the morning via a multidose injection pen device.

Protocol documents:
Clinical trial NCT01301508
Conditions: Dermatitis, Atopic
Keywords: atopic dermatitis
Sponsor: Pfizer
Start date: 2011-05-01; Completion date: 2011-11-11
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether AN2898 and AN2728 ointments are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).

Detailed description:

Arms: arm 1: AN2898 ointment applied twice daily for 6 weeks to one target lesion, and AN2898 ointment vehicle applied twice daily for 6 weeks to a second target lesion.

Treatments will be randomly assigned to target lesions A and B. arm 2: AN2728 ointment applied twice daily for 6 weeks to one target lesion, and AN2728 ointment vehicle applied twice daily for 6 weeks to a second target lesion.

Treatments will be randomly assigned to target lesions A and B.
Interventions: intervention 1: AN2728 ointment, 2% intervention 2: AN2898 ointment, 1% intervention 3: AN2898 ointment vehicle intervention 4: AN2728 ointment vehicle
Intervention descriptions: intervention 1: AN2728 ointment, 2%, applied twice daily for 6 weeks intervention 2: AN2898 ointment, 1%, applied twice daily for 6 weeks intervention 3: AN2898 ointment vehicle applied twice daily for 6 weeks intervention 4: AN2728 ointment vehicle applied twice daily for 6 weeks

Protocol documents:
Clinical trial NCT01232491
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2010-10-29; Completion date: 2011-11-14
Enrollment: 611 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe, and North and South America. The aim of this trial is to investigate if a dietary intervention has an effect on weight when initiating insulin treatment in subjects with type 2 diabetes currently treated with oral antidiabetic drugs (OADs).

Detailed description:

Arms: arm 1: Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted. arm 2: Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
Interventions: intervention 1: Insulin detemir intervention 2: Dietary regimen
Intervention descriptions: intervention 1: Individually adjusted insulin detemir subcutaneously (under the skin) once daily. Subjects continue their pre-trial metformin treatment. intervention 2: Subjects receive dietary consultation by a dietician at six occasions during the trial.

Protocol documents:
Clinical trial NCT01175707
Conditions: Complicated Skin or Skin Structure Infection
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2010-07-15; Completion date: 2011-11-17
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, open-label, multi-center, phase 4 study designed to compare intravenous (IV) daptomycin and IV vancomycin administered in a home infusion setting for the treatment of complicated skin and skin structure infections (cSSSI) due to Gram-positive bacteria in participants who are prescribed vancomycin for 7 to 14 days and who are planning to receive vancomycin in a home-infusion setting.

Detailed description:
This is a randomized, open-label, multi-center, phase 4 study. The overall goals of this study are to compare intravenous (IV) daptomycin and IV vancomycin administered in a home infusion setting for the treatment of cSSSI due to Gram-positive bacteria in participants who are prescribed vancomycin for 7-14 days and who are planning to receive vancomycin in a home infusion setting. Study objectives include evaluation of clinical and resource utilization endpoints and economic analysis from the perspective of the home infusion provider.

Arms: arm 1: 500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted arm 2: Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician
Interventions: intervention 1: Daptomycin intervention 2: Vancomycin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01438957
Conditions: Sedation
Keywords: Dexmedetomidine Sedation Non-intubation epidural anesthesia spinal anesthesia
Sponsor: Pfizer
Start date: 2011-06-03; Completion date: 2011-11-18
Enrollment: 119 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the efficacy and safety of DA-9501 (Dexmedetomidine) in patients who require sedation during the surgery that requires epidural or spinal anesthesia without intubation under monitored sedation care.

Detailed description:
Phase III, randomized, placebo controlled, double blind, parallel comparative study (Therapeutic confirmatory trial), to evaluate the efficacy and the safety of Dexmedetomidine in non-intubated patients who require sedation during surgery with spinal or epidural anesthesia under monitored sedation care

Arms: arm 1: Dexmedetomidine 0 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0 mcg/kg/hr Maintenance dose arm 2: Dexmedetomidine 0.4 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose arm 3: Dexmedetomidine 1.5 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose arm 4: Dexmedetomidine 3 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose arm 5: Dexmedetomidine 6 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose
Interventions: intervention 1: Dexmedetomidine hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: Dexmedetomidine 0.2 to 0.7 mcg/kg/hr intervention 2: None

Protocol documents:
Clinical trial NCT01442688
Conditions: Healthy
Sponsor: Shire
Start date: 2011-10-07; Completion date: 2011-11-20
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a drug interaction study evaluating the pharmacokinetic profiles of amoxicillin administered alone \& in combination with MMX Mesalazine/mesalamine.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Amoxicillin + MMX placebo intervention 2: Amoxicillin + MMX mesalazine/mesalamine
Intervention descriptions: intervention 1: MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4. intervention 2: MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.

Protocol documents:
Clinical trial NCT00128102
Conditions: Mesothelioma Lung Cancer
Keywords: Advanced malignant pleural mesothelioma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-06-30; Completion date: 2011-11-21
Enrollment: 661 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this study is to assess the efficacy and safety of an oral investigational drug suberoylanilide hydroxamic acid (vorinostat, MK-0683) compared to placebo, in the treatment of participants with advanced malignant pleural mesothelioma who have failed at least one prior chemotherapy regimen. The primary hypotheses are the following: (1) vorinostat improves overall survival (OS) compared to placebo (2) vorinostat is generally safe and well tolerated.

Detailed description:
Treatment Extension Phase: Participants in this study will be eligible to enroll in an open-label treatment extension phase if they: a) were originally randomized to the vorinostat arm and have not experienced disease progression; b) were randomized to the placebo arm and meet the "Extension Phase Inclusion Criteria for Participants in the Placebo Arm" below; or c) were originally randomized to the vorinostat arm and discontinued study therapy for reasons other than progression and the investigator believes that it is in the participant's best interest to resume vorinostat treatment.

As specified by the protocol, based on planned extension phase inclusion criteria and pre-specified primary outcome analyses requirements, the extension phase of this study was not conducted.

Arms: arm 1: Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment will continue until disease progression or unacceptable toxicity. arm 2: Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment will continue until disease progression or unacceptable toxicity.
Interventions: intervention 1: Vorinostat intervention 2: Placebo
Intervention descriptions: intervention 1: Vorinostat 100 mg oral capsules intervention 2: Vorinostat-matching placebo oral capsules

Protocol documents: