ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00663403
Conditions: Critically Ill Hemodialysis
Keywords: daptomycin pharmacokinetics renal replacement therapy critical illness intensive care units
Sponsor: University of Michigan
Start date: 2007-02-01; Completion date: 2009-04-01
Enrollment: 8 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Daptomycin is an antibiotic that is affective against many strains of antibiotic resistant microorganisms. This antibiotic would be appropriate for use in the intensive care unit (ICU) considering the severity of illness and high risk for infection within this hospital environment. While in the ICU, patients may develop acute renal failure. Approximately 75% of ICU patients who develop acute renal failure will require some form of renal replacement therapy until their kidneys recover. Continuous hemodialysis is becoming one of the most common forms of dialysis in the ICU as it is a gentle type of dialysis provided over longer periods of time. The current data demonstrating the ability of continuous hemodialysis to remove daptomycin from the body is derived from in-vitro trials. The purpose of this trial is to determine the extent of daptomycin removal from critically ill patients receiving continuous hemodialysis. Findings from this trial will be used to develop new dosing recommendations for daptomycin in continuous hemodialysis.

Detailed description:
Daptomycin is a FDA approved antibiotic. This pharmacokinetic trial will monitor daptomycin drug concentrations during continuous hemodialysis. The daptomycin concentration profiles developed from this study will assist in developing a dose recommendation that will result in daptomycin levels that are safe and within therapeutic ranges, as previously identified, in critically ill patients with acute renal failure treated with continuous hemodialysis.

Interventions: intervention 1: Daptomycin
Intervention descriptions: intervention 1: Daptomcyin 8 mg/kg infused intravenously every 48 hours

Protocol documents:
Clinical trial NCT00666926
Conditions: Head and Neck Neoplasm Prostatic Neoplasm Pancreatic Neoplasm
Keywords: Pancreatic Neoplasm Head and Neck neoplasm Prostatic neoplasms; Focal Adhesion Kinase Phase 1 Pharmacodynamics FDG-PET
Sponsor: Verastem, Inc.
Start date: 2005-12-01; Completion date: 2009-04-01
Enrollment: 99 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase (FAK) inhibitor PF-00562271 in patients with positive Positron Emission Tomography \[PET\] scans due to advanced non-hematologic malignancies, including pancreatic, head and neck, and prostatic neoplasms, and patients with other malignancies appropriate for serial biopsy. Screening consists of a Fluorodeoxyglucose Positron Emission Tomography \[FDG-PET\] and tumor imaging, medical history, physical examination, Eastern Cooperative Oncology Group \[ECOG\] performance status, blood draws, a pregnancy test for female patients of childbearing potential. Treatment consists of PF00562271 tablets continued until progression of disease, unacceptable toxicity, or patient request. Evaluations for bioactivity are measured by serial FDG-PET and blood tests for biomarkers related to FAK and PYK2 kinase activities.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: PF00562271 intervention 2: PF00562271 intervention 3: PF00562271 intervention 4: PF00562271
Intervention descriptions: intervention 1: 125 mg twice daily \[BID\] with food, tablet intervention 2: 125 mg BID with food, tablet intervention 3: 125 mg BID with food, tablet intervention 4: 125 mg BID with food, tablet

Protocol documents:
Clinical trial NCT00669864
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2007-11-01; Completion date: 2009-04-01
Enrollment: 293 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.

Detailed description:

Arms: arm 1: Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
Interventions: intervention 1: biphasic insulin aspart 30 intervention 2: metformin
Intervention descriptions: intervention 1: Subcutaneous (under the skin) injection, twice daily intervention 2: Tablets, 1000 - 2000 mg daily

Protocol documents:
Clinical trial NCT00670241
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2008-04-01; Completion date: 2009-04-01
Enrollment: 458 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare efficacy and safety of once daily treatment of calcipotriol plus betamethasone dipropionate gel (LEO 80185) with tacalcitol ointment and LEO 80185 vehicle alone in subjects with psoriasis vulgaris. Subjects will be treated for up to 8 weeks followed by an observation period of up to 8 weeks to investigate the occurence and the time to relapse and occurence of rebound after discontinuation of the investigational products. Only subjects with "controlled disease" will be considered for this observation phase of the study. "Controlled disease" is defined as "Clear" or "Almost Clear" severity category based on Investigator's global assessment (IGA).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: calcipotriol and betamethasone (LEO 80185 gel) intervention 2: LEO 80185 vehicle intervention 3: Tacalcitol ointment
Intervention descriptions: intervention 1: Once daily application intervention 2: Once daily application intervention 3: Once daily application

Protocol documents:
Clinical trial NCT00677924
Conditions: Colorectal Cancer
Keywords: Colorectal Neoplasms Colorectal Tumors Colorectal Carcinoma
Sponsor: Genmab
Start date: 2008-04-01; Completion date: 2009-04-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to determine the safety and efficacy of Zalutumumab alone or in combination with Irinotecan for the treatment of patients with Colorectal Cancer

Detailed description:

Arms: arm 1: Zalutumumab in combination with Irinotecan arm 2: Zalutumumab in combination with Irinotecan
Interventions: intervention 1: Zalutumumab
Intervention descriptions: intervention 1: Solution for infusion

Protocol documents:
Clinical trial NCT00686543
Conditions: Fungal Infection Acute Myelogenous Leukemia Neutropenia
Keywords: Antifungal Agents Anti-Infective Agents
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-12-01; Completion date: 2009-04-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is: to explore the potential for different dosing strategies of posaconazole oral suspension (POS) to increase plasma levels and to profile the pharmacokinetics of these dosing strategies in patients with compromised gastrointestinal function and at high risk for Invasive Fungal Infection.

Detailed description:

Arms: arm 1: POS 200 mg three times a day (TID) on Days 1-8 followed by continued randomized dosing regimen of POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements. arm 2: POS 200 mg TID on Days 1-8 followed by randomized dosing regimen of POS 400 mg twice a day (BID) on Days 9-15, administered with food or oral nutritional supplements. arm 3: POS 200 mg TID on Days 1-8 followed by randomized dosing regimen of POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements.
Interventions: intervention 1: Posaconazole
Intervention descriptions: intervention 1: Posaconazole will be used for prophylaxis

Protocol documents:
Clinical trial NCT00697593
Conditions: Chronic Plaque Psoriasis
Keywords: Efalizumab Chronic Plaque Psoriasis Transition from systemic therapies on to Efalizumab
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2008-01-01; Completion date: 2009-04-01
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess the safety of transitioning subjects to Raptiva therapy from standard oral systemic or phototherapy by overlapping with Raptiva whilst tapering the initial systemic therapy or phototherapy dose.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)
Intervention descriptions: intervention 1: Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1mg/kg/week for up to 12 weeks.

Protocol documents:
Clinical trial NCT00700440
Conditions: Nasopharyngeal Carcinoma
Keywords: Radiotherapy chemotherapy Drug Targeting loco-regionally advanced nasopharyngeal carcinoma Safety. efficacy
Sponsor: Sun Yat-sen University
Start date: 2008-07-01; Completion date: 2009-04-01
Enrollment: 100 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.

Detailed description:

Arms: arm 1: 400mg/m\^2 intravenous infusion one week before radiotherapy, then 250mg/m\^2 intravenous infusion weekly during radiotherapy
Interventions: intervention 1: C225 (cetuximab)
Intervention descriptions: intervention 1: one week before and then weekly during radiotherapy

Protocol documents:
Clinical trial NCT00705575
Conditions: Hypertension
Keywords: Essential Hypertension Stage II
Sponsor: Novartis
Start date: 2008-06-01; Completion date: 2009-04-01
Enrollment: 688 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients with Stage II hypertension over a period of 12 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg) intervention 2: Aliskiren (300 mg)
Intervention descriptions: intervention 1: During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. intervention 2: During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.

Protocol documents:
Clinical trial NCT00706134
Conditions: Hypertension
Keywords: Hypertension ≥ 65 years aliskiren placebo light meal
Sponsor: Novartis
Start date: 2008-05-01; Completion date: 2009-04-01
Enrollment: 756 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo intervention 2: Aliskiren 75 mg intervention 3: Aliskiren 150 mg intervention 4: Aliskiren 300 mg
Intervention descriptions: intervention 1: Placebo tablet taken once daily in the morning with a light meal. intervention 2: Aliskiren 75 mg tablet taken once daily in the morning with a light meal. intervention 3: Aliskiren 150 mg tablet taken once daily in the morning with a light meal. intervention 4: Aliskiren 300 mg tablet taken once daily in the morning with a light meal.

Protocol documents:
Clinical trial NCT00709852
Conditions: Diagnostic Imaging Central Nervous System Diseases
Keywords: Patients referred for a contrast-enhanced MRI of the CNS CNS Imaging
Sponsor: Bayer
Start date: 2008-06-01; Completion date: 2009-04-01
Enrollment: 402 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called gadobutrol (Gadavist) Injection and ProHance Injection. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the brain and spine. The results of the MRI with gadobutrol Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with ProHance.

Detailed description:
Issues on safety will be addressed in Adverse Events section.

Arms: arm 1: Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) in Period 1 and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 2. arm 2: Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 1 and a single dose of gadobutrol 0.1 mmol/kg bw via i.v. in Period 2.
Interventions: intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875) intervention 2: Gadoteridol (ProHance)
Intervention descriptions: intervention 1: Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) intervention 2: Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.

Protocol documents:
Clinical trial NCT00713544
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis RA AZD5672
Sponsor: AstraZeneca
Start date: 2008-07-01; Completion date: 2009-04-01
Enrollment: 373 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being carried out to investigate if AZD5672 is effective in treating Rheumatoid Arthritis (RA) and if so how it compares to placebo (a substance which does not have any action) and etanercept (a medicine already available to treat Rheumatoid Arthritis) when added to treatment with methotrexate. The purpose of this study is also to find out which dose of AZD5672 is the most effective at treating RA and to find out how well the body tolerates AZD5672 when taken for up to 12 weeks.

Detailed description:

Arms: arm 1: None arm 2: 20mg arm 3: 50mg arm 4: 100mg arm 5: 150mg arm 6: None
Interventions: intervention 1: AZD5672 intervention 2: Etanercept intervention 3: Placebo intervention 4: AZD5672 intervention 5: AZD5672 intervention 6: AZD5672
Intervention descriptions: intervention 1: 20 mg oral, once daily intervention 2: 50 mg, subcutaneous injection, weekly intervention 3: placebo, oral, once daily intervention 4: 50 mg oral, once daily intervention 5: 100 mg oral, once daily intervention 6: 150 mg oral, once daily

Protocol documents:
Clinical trial NCT00755183
Conditions: Meibomian Gland Dysfunction
Keywords: Meibomian Gland Dysfunction Dry Eye Syndrome
Sponsor: ORA, Inc.
Start date: 2008-07-01; Completion date: 2009-04-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the safety and efficacy of testosterone 0.03% ophthalmic solution compared to vehicle for the treatment of meibomian gland dysfunction.

Detailed description:
Meibomian gland secretion plays a crucial role in the health of the ocular surface and function of the tear film. The lipid secreted by the meibomian glands has many crucial roles: 1) to retard evaporation from the preocular surface; 2) lower the surface tension of tears; 3) prevent spill-over of tears from the lid margin; 4) prevent the contamination of the tear film by sebaceous lipids; 5) prevent damage to the skin of the lid margin. In dry eye syndrome, blepharitis, meibomian gland dysfunction, and meibomitis the glands are the central pathophysiology of disease and thus a potential target for therapy.

Arms: arm 1: testosterone ophthalmic solution 0.03% arm 2: vehicle of testosterone ophthalmic solution
Interventions: intervention 1: testosterone ophthalmic solution intervention 2: vehicle of testosterone ophthalmic solution
Intervention descriptions: intervention 1: testosterone ophthalmic solution for 128 days intervention 2: vehicle of testosterone ophthalmic solution for 128 days

Protocol documents:
Clinical trial NCT00760266
Conditions: Hypertension
Keywords: Hypertension older population aliskiren hydrochlorothiazide systolic blood pressure diastolic blood pressure amlodipine, stage 2
Sponsor: Novartis
Start date: 2008-09-01; Completion date: 2009-04-01
Enrollment: 451 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed dose combination of aliskiren Hydrochlorothiazide (HCTZ) compared to Hydrochlorothiazide in older population with Stage 2 systolic hypertension.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aliskiren intervention 2: Hydrochlorothiazide
Intervention descriptions: intervention 1: Aliskiren 150 mg for 1 week, Aliskiren 300 mg (with or without amlodipine)for 7 weeks intervention 2: Hydrochlorothiazide (HCTZ) 12.5 mg for week 1; Hydrochlorothiazide (HCTZ) 25 mg (with or without amlodipine)for 7 weeks

Protocol documents:
Clinical trial NCT00763321
Conditions: Chronic Low Back Pain
Keywords: Effect on sleep interference by pain
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2008-09-01; Completion date: 2009-04-01
Enrollment: 287 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of the study is to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP).

Detailed description:
The study used a randomized withdrawal design with an open label (OL) period prior to a double-blind (DB) period. Participants who were receiving benefit and were tolerating ABT-712 during the OL period were randomized into the DB period. Study drug was given for a total of 8 weeks, which included up to 3 weeks in OL, up to 4 weeks in DB, and a 1-week DB taper. During the OL period, all participants took increasing doses of ABT-712 until they were taking 2 tablets, twice daily. During the DB period, participants in the ABT-712 group took 2 ABT-712 tablets, twice daily throughout the 4 weeks, while participants in the placebo group took 2 placebo tablets twice daily.

Arms: arm 1: 2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period). arm 2: 2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period). arm 3: 2 placebo tablets, twice daily, for 4 weeks (double-blind period).
Interventions: intervention 1: ABT-712 intervention 2: Placebo
Intervention descriptions: intervention 1: ABT-712 extended-release tablet intervention 2: Placebo tablet

Protocol documents:
Clinical trial NCT00766675
Conditions: Pain Fibromyalgia
Keywords: Pain Fibromyalgia Ultracet Tramadol Hydrochloride Acetaminophen
Sponsor: Johnson & Johnson Taiwan Ltd
Start date: 2008-10-01; Completion date: 2009-04-01
Enrollment: 80 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the analgesic effect of combination of tramadol hydrochloride and acetaminophen in participants for treatment of fibromyalgia pain (chronic widespread pain and presence of tender points).

Detailed description:
This is an open-label (all people know the identity of the intervention) and multi-center (conducted in more than one center) study of combination of tramadol hydrochloride and acetaminophen in treatment of participants with pain of fibromyalgia. The duration of this study will be 56 days per participant. The study consists of 2 parts: Screening (that is, 3 weeks before study commences on Day 1) and Treatment (that is, up to Day 56). All the eligible participants will receive oral tablet for combination of tramadol hydrochloride and acetaminophen. Rescue medication (a medication intended to relieve symptoms immediately) of tylenol (500 milligram, up to 6 oral tablets daily) will be permitted throughout the study duration. Efficacy of the participants will primarily be evaluated by Pain Visual Analog Scale. Participants' safety will be monitored throughout the study.

Arms: arm 1: Tramadol hydrochloride/acetaminophen oral tablet will be administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
Interventions: intervention 1: Tramadol hydrochloride intervention 2: Acetaminophen
Intervention descriptions: intervention 1: Tramadol hydrochloride oral tablet will be administered at a dose of 37.5 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56. intervention 2: Acetaminophen oral tablet will be administered at a dose of 325 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.

Protocol documents:
Clinical trial NCT00769119
Conditions: Bronchiectasis
Keywords: bronchiectasis Phase II
Sponsor: AstraZeneca
Start date: 2008-09-01; Completion date: 2009-04-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Bronchiectasis (Brx) and if so how it compares to placebo (a substance which does not have any action).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AZD9668 intervention 2: Placebo
Intervention descriptions: intervention 1: 2 x 30 mg, oral tablet, twice daily for 28 days intervention 2: 2 x Matched placebo, oral tablet, twice daily for 28 days

Protocol documents: