ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00819637
Conditions: Acute Asthma
Keywords: Acute asthma Arformoterol Long acting beta agonists
Sponsor: Henry Ford Health System
Start date: 2009-01-01; Completion date: 2009-11-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the best dose of nebulized arformoterol, a quick onset but long acting beta agonist, for use in treating acute bronchospasm in asthmatics presenting to the the Emergency Department. Also this study will evaluate the side effect and safety profile of arformoterol when used in this situation.

Detailed description:
Acute bronchospasm associated with exacerbations of asthma is a common problem. Currently the mainstay of treatment is inhalation albuterol, either levalbuterol or racemic mixture, in repetitive fashion depending on the resolution of the airways obstruction. Formoterol is a long-acting (\>12 hours) selective beta2-agonist that has a very rapid onset of bronchodilatation (\<3 minutes and thus similar to that produced by albuterol). Patients with acute bronchospasm could benefit from the prn use of formoterol as they would receive acute relief of their symptoms and this would last for a prolonged time period. Additionally formoterol has been reported to be 28-109 times as potent as albuterol and safe at doses of 54ug in healthy subjects and asthmatics. Racemic formoterol structurally has 2 chiral centers and thus is composed of 4 enantiomers. The RR form (or arformoterol) is the active bronchodilator and it is not clear what the physiologic actions of the other 3 enantiomers are. This study is the first to evaluate nebulized arformoterol solution for therapy of acute asthmatics presenting to the Emergency Department.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: arformoterol (RR formoterol) intervention 2: placebo intervention 3: levalbuterol
Intervention descriptions: intervention 1: Group 1 will receive nebulized arformoterol 15 ug every 20 minutes for 3 doses.

Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses. intervention 2: Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses. intervention 3: Group 3 will receive nebulized levalbuterol 1.25 mg every 20 minutes for 3 doses.

Protocol documents:
Clinical trial NCT00819741
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2009-02-01; Completion date: 2009-11-01
Enrollment: 433 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of repaglinide plus metformin as initial treatment compared to repaglinide alone in Chinese subjects with type 2 diabetes having an HbA1c (glycosylated haemoglobin A1c) over 8.5 % and who never have taken oral sugar-lowering drugs before. The associated unfavourable events including low blood sugar episodes between the two treatments are also compared.

Detailed description:

Arms: arm 1: Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. arm 2: Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
Interventions: intervention 1: repaglinide intervention 2: metformin intervention 3: repaglinide
Intervention descriptions: intervention 1: The dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily intervention 2: The dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily intervention 3: The dose was started from repaglinide 1 mg three times daily. During the dose titration period, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose.

Protocol documents:
Clinical trial NCT00820534
Conditions: Cold Sore
Keywords: cold sore
Sponsor: Novartis
Start date: 2008-12-01; Completion date: 2009-11-01
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Comparison of the efficacy of penciclovir 10 mg/g (1%) cream with that of vehicle at 72 hours in preventing the appearance of classical lesions following prodromal symptoms (tingling or burning sensation) based on thermographic assessment among recurrent cold sore sufferers.

Detailed description:

Arms: arm 1: Penciclovir arm 2: Placebo
Interventions: intervention 1: Penciclovir intervention 2: Placebo
Intervention descriptions: intervention 1: Penciclovir every 2 hours during waking hours for 96 hours intervention 2: Placebo every 2 hous during waking hours for 96 hours

Protocol documents:
Clinical trial NCT00825630
Conditions: Helicobacter Pylori Infection
Keywords: HP UBT PPI
Sponsor: Meridian Bioscience, Inc.
Start date: 2008-11-01; Completion date: 2009-11-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Approximately 200 patients with suspected H.pylori will be tested with a 13C-Urea Breath Test (UBT) to ascertain H.pylori positive. 100 H.Pylori positive patients will tested before and after prescribed with one of the four selected Proton Pump Inhibitors (PPIs); 25 patients in each arm. This will provide information on the influence of PPIs on the UBT (Urea Breath Test). The aim of the trial is to observe the effect of different PPIs on the breath test and choose the optimal protocol of when to stop PPI. The hypothesis is that there will be a minimal effect on the UBT while using selected PPIs.

Detailed description:
Adult subjects with suspected H pylori infection will be recruited and will undergo a 13C -Urea breath test (including citrica) with the BreathID test device. Those were found positive will undergo selected PPI treatment for 14 days and after 24 or 72 hours from the completion of the two weeks, will undergo a second breath test. Those found to be negative (false negative), will undergo additional breath tests.

* Those subjects that underwent any antibiotic, bismuth or PPI therapy 4 weeks prior to the trial, are to be excluded.
* Furthermore, pregnant or nursing women and subjects with an allergy or sensitivity to one of the tests substrates, will be excluded from the study.

Arms: arm 1: Patients with H.pylori infection will take one tablet a day of 20 mg Lansoprazole for 14 days orally in the morning arm 2: Patients with H.pylori infection will take one tablet of 30 mg a day of Omeprazole for 14 days orally in the morning arm 3: Patients with H.pylori infection will take one tablet a day of 40 mg of Pantoprazole for 14 days orally in the morning arm 4: Patients with H.pylori infection will take one tablet a day of 20 mg Esomeprazole for 14 days orally on the morning
Interventions: intervention 1: Lansoprazole (Lanton) intervention 2: Omeprezole (Losec) intervention 3: Pantoprazole(Controloc) intervention 4: Esomeprazole (Nexium)
Intervention descriptions: intervention 1: Oral administration of Lanzoprazole for 14 days in 25 patients with H.pylori infection intervention 2: Oral administration of Omeprazole for 14 days in 25 patients with H.pylori infection intervention 3: Oral administration of Pantoprazole for 14 days in 25 patients with H.pylori infection intervention 4: Oral administration of Esomeprazole for 14 days in 25 patients with H.pylori infection

Protocol documents:
Clinical trial NCT00827242
Conditions: Benign Prostatic Hyperplasia
Keywords: Signs and Symptoms Prostatic Hyperplasia Hyperplasia Genital Diseases, Male Prostatic Diseases BPH-LUTS
Sponsor: Eli Lilly and Company
Start date: 2009-01-01; Completion date: 2009-11-01
Enrollment: 325 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full, etc.)

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: tadalafil
Intervention descriptions: intervention 1: Following a 4-week placebo lead-in period, subjects received placebo tablet by mouth once daily over a 12-week period. intervention 2: Following a 4-week placebo lead-in period, subjects received tadalafil 5 mg tablet by mouth once daily over a 12-week period.

Protocol documents:
Clinical trial NCT00847938
Conditions: Anesthesia
Keywords: neostigmine neuromuscular blocking agent train of four anesthesia
Sponsor: Centre Hospitalier Departemental Vendee
Start date: 2009-03-01; Completion date: 2009-11-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Neuromuscular blockers (NMB) are currently used in anesthesia. Residual paralysis (RP) due to NMB is responsible for respiratory disorders after extubation. Neuromuscular blockade is monitored by train-of-four (TOF) stimulation at the adductor pollicis. To exclude a RP a mechanomyographic TOF ratio of 0.9 is mandatory. But mecanomyography is not available in clinical routine. Acceleromyography is the most currently monitoring available in daily practice but it has been proved that an acceloromyographic (AMG) TOF ratio of 1.0 is necessary to exclude a RP. The incidence of RP in recovery room is underestimated. So to perform a safe extubation, reversal of the neuromuscular blockade is necessary when an AMG TOF ratio has not reached 1.0. Reversal of neuromuscular blockade is achieved with neostigmine. The recommended dose is 0.04 mg/kg. The administration of neostigmine causes parasympathomimetic effects which has to be reversed with atropine. When neuromuscular blockade is light (AMG TOF ratio of 0.4 which corresponds to the absence of fade at the visual evaluation of the TOF), a low dose of neostigmine might be sufficient with less side effects expected. The goal of the study is to compare the delay between a light neuromuscular block and an AMG TOF ratio of 1.0 for three neostigmine regimens of neostigmine 0.04, 0.02, 0.01 mg/kg with atropine respectively 0.02, 0.01, 0.005 mg/kg and a placebo.

Detailed description:

Arms: arm 1: neostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg arm 2: neostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg arm 3: neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg arm 4: no injection of neostigmine
Interventions: intervention 1: neostigmine intervention 2: neostigmine intervention 3: neostigmine
Intervention descriptions: intervention 1: 0.04 mg/kg IV bolus, injection when the of train of four is \> or = to 40 % intervention 2: 0.02 mg/kg IV bolus, injection when the of train of four is \> or = to 40 % intervention 3: 0.01 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %

Protocol documents:
Clinical trial NCT00849212
Conditions: Refractory Partial Seizures
Keywords: Seizures epilepsy
Sponsor: Eisai Co., Ltd.
Start date: 2009-04-01; Completion date: 2009-11-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to explore the maximum tolerated dose of E2007 in Japanese patients with refractory partial seizures which are uncontrolled with other anti-epileptic drugs (AEDs). Thirty patients will receive E2007 (dose escalating to the maximum of 12 mg per day). The dose of E2007 will be adjusted during 6 weeks. Subsequently, the dose will be fixed and maintained during 4 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: E2007
Intervention descriptions: intervention 1: The dose of E2007 will start from 2 mg and will be increased by 2 mg every week up to 12 mg (the maximum dose). The dose will be adjusted during 6 weeks (i.e., titration period). Subsequently, the dose will be fixed and maintained during 4 weeks (Maintenance period). Patients must visit study site at Weeks -4, 1, 2, 3, 4, 5, 6, 8, 10 and 14 to confirm.

Protocol documents:
Clinical trial NCT00880100
Conditions: Cystic Fibrosis Pancreatic Insufficiency
Keywords: Steatorrhea Malabsorption of fat Pancreatic enzymes Abdominal pain Greasy stools
Sponsor: Forest Laboratories
Start date: 2009-04-01; Completion date: 2009-11-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Multicenter, explorative, phase IIIb, open-label study to assess the efficacy and safety of Ultrase® MT12, in the control of steatorrhea and clinical signs and symptoms of malabsorption in CF children with pancreatic insufficiency (PI). This study is sponsored by Aptalis Pharma (formerly Axcan).

Detailed description:
This is a multicenter, explorative, phase IIIb, open-label study in patients with CF and PI. The study consists of a screening visit (visit 1), followed by a baseline phase of 9 days (plus a 5-day window if necessary) during which the regular pancreatic enzyme will be maintained and 10 stool samples will be collected over 5 days, for baseline evaluation of steatorrhea. Afterward, a treatment phase of 19 days (plus a 5-day window if necessary) with Ultrase® MT12 will follow (the usual pancreatic enzyme will be replaced by Ultrase® MT12). Over the last 5 days of the treatment phase, 10 additional stool samples will be collected, for evaluation of steatorrhea.

Arms: arm 1: None
Interventions: intervention 1: Ultrase® MT12
Intervention descriptions: intervention 1: Ultrase® MT12 capsules will be given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose not to exceed 10,000 lipase units/kg/day.

Protocol documents:
Clinical trial NCT00890682
Conditions: Bunion Hallux Valgus
Keywords: Bunion Bunionectomy Osteotomy
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2009-04-01; Completion date: 2009-11-01
Enrollment: 193 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
After undergoing bunion surgery, patients are given a pain medicine injection that may last for up to several days or a placebo. Their pain and pain medicine use is then monitored.

Detailed description:
Following drug study administration, safety and efficacy assessments were conducted

Arms: arm 1: Injection of Study Drug arm 2: Injection of study drug
Interventions: intervention 1: SKY0402 intervention 2: Placebo
Intervention descriptions: intervention 1: Local infiltration of 8cc SKY0402 intervention 2: Local infiltration of 8cc Placebo

Protocol documents:
Clinical trial NCT00890721
Conditions: Hemorrhoid
Keywords: Hemorrhoid Hemorrhoidectomy Postoperative pain Analgesia
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2009-05-01; Completion date: 2009-11-01
Enrollment: 189 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients will get an injection of either SKY0402 or placebo during hemorrhoid surgery, and their pain and pain medicine use will be monitored.

Detailed description:

Arms: arm 1: During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound. arm 2: During the hemorrhoidectomy, 30cc Placebo injected into the wound.
Interventions: intervention 1: SKY0402 intervention 2: Placebo
Intervention descriptions: intervention 1: During the operation, 30cc of SKY0402 are injected into the wound. intervention 2: During the hemorrhoidectomy, 30cc Placebo injected into the wound.

Protocol documents:
Clinical trial NCT00895830
Conditions: Postoperative Nausea and Vomiting
Sponsor: Acacia Pharma Ltd
Start date: 2009-05-01; Completion date: 2009-11-01
Enrollment: 257 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy and safety of different doses of APD405 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.

Detailed description:

Arms: arm 1: None arm 2: 0.3mg dose level arm 3: 1mg dose level arm 4: 2mg dose level arm 5: 3mg dose level
Interventions: intervention 1: APD405 intervention 2: Placebo
Intervention descriptions: intervention 1: IV intervention 2: IV

Protocol documents:
Clinical trial NCT00902161
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-05-01; Completion date: 2009-11-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will assess the effect of combined treatment with MK0893 plus propranolol versus placebo plus propranolol on hypoglycemia.

Detailed description:

Arms: arm 1: Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893-matched placebo was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a single dose of MK0893 on Day 21 (Visit 8). arm 2: Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893 was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a single dose of MK0893-matched placebo on Day 21 (Visit 8).
Interventions: intervention 1: MK0893 intervention 2: MK0893-matched Placebo intervention 3: Propranolol Hydrochloride (HCL)
Intervention descriptions: intervention 1: Single dose of MK0893 1000 mg (ten 100 mg tablets) intervention 2: Single dose of placebo to MK0893 (ten tablets) intervention 3: Propranolol tablets titrated up to 80 mg three times daily over a four week period. Total treatment was approximately 7 weeks.

Protocol documents:
Clinical trial NCT00911157
Conditions: Thrombosis, Venous
Keywords: Pulmonary thromboembolism contrast-enhanced MDCT Deep Vein Thrombosis Fondaparinux sodium
Sponsor: GlaxoSmithKline
Start date: 2008-06-01; Completion date: 2009-11-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism \[VTE\] (i.e., Pulmonary thromboembolism \[PE\] and Deep Vein Thrombosis \[DVT\])) and safety of GSK576428 as the initial treatment in subjects with acute symptomatic DVT in an open-label design.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Fondaparinux sodium intervention 2: unfractionated heparin (UFH)
Intervention descriptions: intervention 1: The dose of Fondaparinux will be determined based on a subject's body weight (\< 50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection. intervention 2: UFH therapy will be started on Day 1 while adjusting activated partial thromboplastin time (aPTT) to maintain aPTT 1.5 to 2.5 times control.

Protocol documents:
Clinical trial NCT00924729
Conditions: Cataract Extraction
Sponsor: Johns Hopkins University
Start date: 2009-09-01; Completion date: 2009-11-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after pre-operative topical administration in subjects undergoing cataract surgery.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Moxifloxacin 0.5% ophthalmic solution intervention 2: Besifloxacin 0.6% ophthalmic suspension
Intervention descriptions: intervention 1: Administer moxifloxacin study drug prior to cataract surgery. intervention 2: Administer besifloxacin study drug prior to cataract surgery.

Protocol documents:
Clinical trial NCT00930943
Conditions: Chronic Pain
Keywords: opioid tolerant chronic pain
Sponsor: MedVadis Research Corporation
Start date: 2009-05-01; Completion date: 2009-11-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to determine whether extended-release oxymorphone hydrochloride taken orally with a high-fat meal, generating an approximately 50% higher Cmax, impacts cognitive functioning, using Cambridge Neuropsychological Test Automated Battery (CANTAB) tests, to a greater extent than when taking under conditions of fasting.

Detailed description:
Oxymorphone 40 mg ER affects cognitive performance similarly within 3 hours post dose, whether given on an empty stomach or after a high-fat meal, suggesting that the altered pharmacokinetics, fed versus fasting and as described above, is not relevant for the medication's impact on cognition. Hence, the direction for oxymorphone ER to be dosed at least 1 hour before or 2 hours after eating, at least from a cognitive perspective, may be without merit.

Arms: arm 1: Participants received 40 mg oxymorphone ER after a high-fat meal of approximately 1,010 kCal arm 2: Participants received 40 mg oxymorphone ER after fasting for 8-12 hours
Interventions: intervention 1: Oxymorphone ER
Intervention descriptions: intervention 1: 40 mg qd twice

Protocol documents: