ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00784836
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis - Relapsing
Sponsor: Biogen
Start date: 2008-10-01; Completion date: 2009-02-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study was to evaluate the immunogenicity of Avonex® (interferon beta-1a) 30 mcg when administered subcutaneously (SC) to interferon-naïve participants with relapsing multiple sclerosis. The secondary objective of this study was to evaluate the safety and tolerability of Avonex® 30 mcg when administered SC to interferon-naïve subjects with relapsing MS.

Detailed description:

Arms: arm 1: Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
Interventions: intervention 1: BG9418 (interferon beta 1-a)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00790023
Conditions: Seasonal Allergic Rhinitis
Keywords: SAR
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2008-11-01; Completion date: 2009-02-01
Enrollment: 707 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg) once daily compared to placebo in subjects with SAR.

Detailed description:
This is a randomized, double blind, placebo controlled, parallel group, multicenter study to demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg) once daily compared to placebo in subjects with SAR. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Arms: arm 1: 80 mcg Ciclesonide once daily arm 2: 160 mcg Ciclesonide once daily arm 3: Placebo once daily
Interventions: intervention 1: 80 mcg Ciclesonide intervention 2: 160 mcg Ciclesonide intervention 3: Placebo
Intervention descriptions: intervention 1: 80 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril) intervention 2: 160 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril) intervention 3: Placebo HFA Inhaler once daily (one actuation per nostril)

Protocol documents:
Clinical trial NCT00796224
Conditions: Acute Otitis Media
Keywords: azithromycin, pharmacokinetics, pediatrics
Sponsor: Pfizer
Start date: 2008-12-01; Completion date: 2009-02-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine the pharmacokinetics (PK), safety and clinical response following a single dose of either 30 mg/kg IR (Immediate Release) or 60 mg/kg ER (Extended Release) formulation in pediatric subjects 6 months to 6 years of age inclusive.

Detailed description:

Arms: arm 1: 60 mg/kg azithromycin ER (Extended Release)arm arm 2: 30 mg/kg azithromycin IR (Immediate Release) arm
Interventions: intervention 1: 60 mg/kg azithromycin ER intervention 2: 30 mg/kg azithromycin IR
Intervention descriptions: intervention 1: subjects taken 60 mg/kg azithromycin ER intervention 2: subjects taken 30 mg/kg azithromycin IR (Immediate Release)

Protocol documents:
Clinical trial NCT00796614
Conditions: Bladder, Neurogenic
Keywords: tamsulosin pediatric neurogenic bladder
Sponsor: Boehringer Ingelheim
Start date: 2008-01-01; Completion date: 2009-02-01
Enrollment: 231 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Aim of this study is to evaluate the efficacy and safety of a range of doses of tamsulosin hydrochloride as treatment in children with an elevated detrusor leak point pressure associated with a known neurological deficit

Detailed description:

Arms: arm 1: Participants received matching placebo to tamsulosin hydrochloride via opened capsules every day for 14 weeks arm 2: Participants received 0.001 - 0.002 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks arm 3: Participants received 0.002 - 0.004 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks arm 4: Participants received 0.004 - 0.008 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks
Interventions: intervention 1: tamsulosin hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: Oral intervention 2: Oral

Protocol documents:
Clinical trial NCT00798018
Conditions: Pharyngitis
Keywords: lidocaine tetracaine tracheal intubation pharyngitis
Sponsor: Sichuan University
Start date: 2008-10-01; Completion date: 2009-02-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It has been proven that tracheal tube inflated with lidocaine could decrease the post-intubation sore throat in nitrous oxide anesthesia. In the study, the investigators would like to evaluate the effect of lidocaine inflation in non-nitrous oxide anesthesia and compare the effect of tetracaine, the best mucosal local anesthetics with lidocaine.

Detailed description:
The female patients receiving gynecological surgeries were divided into air, saline and 2% lidocaine and 1% tetracaine groups of 25 each using sealed envelope technique. The cuff of the endotracheal tube was inflated by the inflation medium (with the help of intracuff pressure monitoring device) to occlude the leak around the tube by the Minimal Occlusive Volume Technique. This was done by the same anaesthesiologist in all the patients. The cuff volume and pressure were then recorded. The primary outcome of the study was to evaluate the post-intubation sore throat using the visual analogue scale 6h, 24h and 48h after extubation. The secondary outcomes were incidence of complications during emergence of anesthesia and after extubation. Intra-cuff pressure monitoring was done with a pressure monitor, which consisted of the pressure gauge, three-way stopcock whose one end was attached to the pressure monitoring line. Net volume of the inflation medium was noted. Volume of the inflation medium, intra cuff pressure, duration from intubation to extubation and volume of the inflation medium withdrawn from the cuff was noted. Incidence (Yes/No) of tube intolerance, coughing on tube, restlessness, hoarseness, sore throat, breathlessness and laryngospasm were analyzed by the anaesthesiologist who did not know which group the patient belonged to.

Arms: arm 1: air was used to inflate the cuff. arm 2: Normal saline was used to inflate the cuff. arm 3: 2% lidocaine was used to inflate the cuff. arm 4: 1% tetracaine was used to inflate the cuff.
Interventions: intervention 1: 2% lidocaine intervention 2: placebo intervention 3: 1% tetracaine intervention 4: N.S
Intervention descriptions: intervention 1: lidocaine: 2%, injected into the cuff to seal the space between the trachea and the tube at minimal volume intervention 2: Air injected into the cuff to seal the space between the trachea and the tube at minimal volume intervention 3: tetracaine: 1%, injected into the cuff to seal the space between the trachea and the tube at minimal volume intervention 4: 0.9% Normal saline injected into the cuff to seal the space between the trachea and the tube at minimal volume

Protocol documents:
Clinical trial NCT00798577
Conditions: Bacterial Conjunctivitis
Keywords: Bacterial Conjunctivitis
Sponsor: Alcon Research
Start date: 2008-10-01; Completion date: 2009-02-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to investigate the initial antibiotic effects in the treatment of bacterial conjunctivitis symptoms in subjects one year of age and older.

Detailed description:

Arms: arm 1: Vigamox Ophthalmic Solution (Moxifloxacin 5mg/mL) arm 2: Balanced Salt Solution
Interventions: intervention 1: Vigamox Ophthalmic Solution intervention 2: BSS placebo
Intervention descriptions: intervention 1: Moxifloxacin 5mg/mL 3 times daily for 7 days intervention 2: Balanced Saline Solution for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days

Protocol documents:
Clinical trial NCT00807209
Conditions: Postoperative Pain
Keywords: Pain postoperative thoracotomy
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2008-12-01; Completion date: 2009-02-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To review safety and effectiveness of two doses compared to current standard of care.

Detailed description:
Evaluate the efficacy of intercostal nerve block using SKY0402 compared to epidural bupivacaine HCl in subjects undergoing posterolateral thoracotomy. The primary outcome metric for this will be the amount of rescue PCA fentanyl administered for breakthrough pain during the first 72 hours.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Low Dose SKY0402 intervention 2: High Dose SKY0402 intervention 3: Placebo intervention 4: Fentanyl via PCA intervention 5: Bupivacaine via epidural
Intervention descriptions: intervention 1: Bupivacaine, 15 mg/mL via epidural PLUS single total administration of 75mg SKY0402 (25 mg to each of three segments) in 4 mL volume each for a total of 12 mL via nerve block (intercostal) intervention 2: Bupivacaine, 15 mg/mL via epidural PLUS single total administration of 150 mg (50 mg to each of three segments) in 4 mL volume each for a total of 12 mL via nerve block (intercostal) intervention 3: Bupivacaine, 15 mg/mL per epidural PLUS administration of 4 mL Placebo to each of three nerves for a total of 12 mL (intercostal) intervention 4: Fentanyl via PCA intervention 5: Bupivacaine via epidural

Protocol documents:
Clinical trial NCT00824473
Conditions: Seasonal Allergic Rhinitis
Sponsor: Meda Pharmaceuticals
Start date: 2008-12-01; Completion date: 2009-02-01
Enrollment: 506 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone

Detailed description:

Arms: arm 1: Placebo arm 2: 0.15% azelastine hydrochloride
Interventions: intervention 1: Placebo intervention 2: 0.15% azelastine hydrochloride
Intervention descriptions: intervention 1: Placebo intervention 2: 0.15% azelastine hydrochloride 822 mcg

Protocol documents:
Clinical trial NCT00842023
Conditions: Acute Decompensated Heart Failure
Keywords: Natriuretic peptides BNP Heart Failure Nitoglycerin Biomarkers
Sponsor: Western University of Health Sciences
Start date: 2006-07-01; Completion date: 2009-02-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Nesiritide is more effective than nitroglycerin in modifying inflammatory and neurohormonal biomarkers without renal toxicity when proper infusion duration is administered.

Detailed description:
No additional details provided

Arms: arm 1: Nesiritide: 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours. arm 2: Nitroglycerin was initiated at 10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP\<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
Interventions: intervention 1: Nesiritide intervention 2: Nitroglycerin
Intervention descriptions: intervention 1: Bolus 2 mcg/kg followed by 0.01 mcg/kg/min intervention 2: 5-10 mcg/min titrating per protocol based on blood pressure

Protocol documents:
Clinical trial NCT00858897
Conditions: Diabetes Mellitus, Type 1
Keywords: Glutathione
Sponsor: Nemours Children's Clinic
Start date: 2007-06-01; Completion date: 2009-02-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Glutathione is normally present at high (millimolar) levels in blood and plays an important role in the body's defense against oxidative stress, that is, against the damage caused to the body by reactive oxygen species produced by the metabolism of most nutrients, including glucose. Glutathione is a small peptide made from 3 amino acids, glutamate, cysteine, and glycine.

This study is looking at how blood sugar levels may affect the way glutathione is made and used by the body. Since glutathione is continuously synthesized and broken down, the amount of glutathione present in blood depends on the balance between its rate of synthesis and its rate of use.

In earlier studies, the investigators found that in poorly controlled diabetic teenagers, glutathione was low, not because its production was decreased, but because it was used at an excessive rate. In this study, the investigators want to determine how short-term changes in blood sugar levels affect glutathione levels. This will help improve our understanding of how diabetes affects metabolism.

Detailed description:
Adolescents with uncomplicated T1D will receive two, 5-hour infusions of deuterium-labeled cysteine on 2 separate days, a few weeks apart, while blood glucose will be maintained, using intravenous insulin infusion:

* in the hyper-glycemic range (200-250 mg/dL) on one study day, and
* near normoglycemia (80-140 mg/dL) on the other study day.

The order of the study days will be randomized.

We will determine whether the level of blood glucose at the time of study affects blood glutathione concentration, and, if so, whether this is associated with changes in the fractional rate of glutathione synthesis, as determined from the incorporation of labeled cysteine into blood glutathione over the course of the 5-hr infusion of labeled cysteine.

Arms: arm 1: 80-140 mg/dL arm 2: 200-250 mg/dL
Interventions: intervention 1: Cysteine isotope infusion at normoglycemia vs hyperglycemia intervention 2: Regular Insulin
Intervention descriptions: intervention 1: L-\[3,3-2H2\]cysteine intervention 2: Regular insulin, IV, as needed to maintain blood glucose in near-normoglycemic range (80-140 mg/dL) or hyperglycemic range (200-250 mg/mL) during metabolic studies

Protocol documents:
Clinical trial NCT00859027
Conditions: Prostate Cancer
Keywords: Non-metastatic
Sponsor: UConn Health
Start date: 2003-01-01; Completion date: 2009-02-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Men treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)-agonists such as leuprolide and goserelin for prostate cancer will become hypogonadal due to hormonal suppression and demonstrate increased bone turnover and consequent bone loss at the hip and spine. This bone loss can be prevented by treatment with 35 mg/week of risedronate.

Detailed description:
A 6-month randomized, double-blind, placebo-controlled trial was conducted, including 40 men aged ≥ 55 years receiving LHRH-agonist treatment for 6 months for locally advanced prostate cancer. Bone mineral density (BMD) of the lumbar spine, femoral neck, and total hip was measured every 6 months. In addition, bone turnover markers including N-telopeptide, serum C-telopeptide and procollagen peptide, and 25-OH vitamin D and intact parathyroid hormone were measured at baseline and at 6 months.

Arms: arm 1: 35 mg by mouth every week as directed arm 2: Calcium and vitamin D
Interventions: intervention 1: risedronate intervention 2: Placebo risedronate oral tablet
Intervention descriptions: intervention 1: 35 mg/week by mouth intervention 2: One tablet by mouth every week as directed

Protocol documents:
Clinical trial NCT00870103
Conditions: Cataract
Keywords: Cataract
Sponsor: Alcon Research
Start date: 2008-09-01; Completion date: 2009-02-01
Enrollment: 64 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To demonstrate that the combination formulation of Moxifloxacin/Dexamethasone Eye Drop is effective and safe for the prevention of postoperative inflammation as a consequence of cataract extraction surgery.

Detailed description:

Arms: arm 1: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops
Interventions: intervention 1: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops
Intervention descriptions: intervention 1: 1 drop every 6 hours into the study eye

Protocol documents:
Clinical trial NCT00874120
Conditions: Blood Pressure Human Experimentation
Sponsor: Bayer
Start date: 2008-12-01; Completion date: 2009-02-01
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Randomized, placebo-controlled double-blind, crossover design study; 116 subjects randomized on Day 1 to obtain 98 completed subjects. Study will be composed of a 7-day period of therapy with randomized active or placebo treatment with a subsequent 6-8 day washout period, followed by a second 7-day period of double-blind therapy with the other agent. Ambulatory blood pressure measurement will be performed beginning on Day 7 of each treatment period following administration of the study drug.

Detailed description:

Arms: arm 1: Phenylephrine HCl Extended Release tablets 30 mg arm 2: Placebo
Interventions: intervention 1: Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Phenylephrine HCl Extended-Release tablets 30 mg taken twice daily (12 hours apart) for 7 days. intervention 2: Placebo taken twice daily (12 hours apart) for 7 days.

Protocol documents:
Clinical trial NCT00900237
Conditions: Partial Epilepsy
Keywords: Partial Epilepsy Eslicarbazepine acetate Pharmacokinetics Tolerability
Sponsor: Bial - Portela C S.A.
Start date: 2008-11-01; Completion date: 2009-02-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This purpose of this study is to measure the concentrations of two anti-epileptic drugs (Eslicarbazepine acetate and oxcarbazepine) and their metabolites in the cerebrospinal fluid and blood plasma of healthy subjects and also to assess how these drugs are tolerated.

Detailed description:

Arms: arm 1: Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9 arm 2: Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9
Interventions: intervention 1: Eslicarbazepine acetate intervention 2: Oxcarbazepine
Intervention descriptions: intervention 1: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9 intervention 2: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)

Protocol documents:
Clinical trial NCT00909428
Conditions: Overactive Bladder Syndrome
Keywords: Bladder Urinary Urgency Solifenacin Vesicare(R)
Sponsor: Loyola University
Start date: 2007-01-01; Completion date: 2009-02-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Urinary urgency is a key symptom of overactive bladder syndrome (OAB) and may be more bothersome to a patient than the symptom of urinary frequency. Unfortunately, controversy continues to surround the term 'urgency' and there is no good tool to evaluate the severity of urgency. This fact has constrained the performance of clinical research in this field. The cause of urinary urgency is not fully understood and may vary from patient to patient.

Although clinicians regularly obtain measures of bladder sensation during cystometry, little attention has been paid to the patient experience of urinary urgency. In this study, the researchers will use a non-significant risk device (i.e., an Urgeometer) to measure urinary urgency in women with overactive bladder.

Detailed description:
At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter. As the bladder is filled, the participant is asked to rate their urinary urgency using the Urgeometer. The Urgeometer lever marks a continuous scale from 0 'no urge at all' to 100 'maximum urge which you can tolerate'. The testing is stopped once the bladder is filled. To minimize the chance of infection, participants receive one dose of oral antibiotics prior to the bladder testing.

Following completion of the bladder test, participants will take 10mg solifenacin succinate (VesicareR) daily for 30 days. Afterward, participants repeat the bladder test. The change in participants' maximal tolerated cystometric capacity (MCC) will be measured in milliliters and used to evaluate the effectiveness of the drug.

Arms: arm 1: The intervention for this study is 10mg daily solifenacin. Patients with overactive bladder syndrome will take this study drug for 30 days.
Interventions: intervention 1: Solifenacin Succinate
Intervention descriptions: intervention 1: Participants take 10mg daily solifenacin succinate for 30 days

Protocol documents:
Clinical trial NCT00912808
Conditions: Parkinson's Disease
Keywords: parkinsons disease falling
Sponsor: Oregon Health and Science University
Start date: 2005-10-01; Completion date: 2009-02-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to find out if a medication that increases levels of a brain chemical called acetylcholine will improve balance and reduce falls in patients with parkinson's disease who have the problem of very poor balance and are frequently falling or nearly falling on a daily basis. Donepezil, a drug approved for the treatment of Alzheimer's dementia, will reduce falls in subjects with Parkinson's disease and balance impairment.

Detailed description:
This trial is a double-blinded cross-over design comparing donepezil with placebo in 40 subjects with idiopathic Parkinson's disease who report frequent falls or near falls (\>2/week). The purpose of this study is to find out if a medication that increases levels of a brain chemical called acetylcholine will improve balance and reduce falls in patients with parkinson's disease who have the problem of very poor balance and are frequently falling or nearly falling on a daily basis. Donepezil, a drug approved for the treatment of Alzheimer's dementia, will reduce falls in subjects with Parkinson's disease and balance impairment.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Donepezil intervention 2: Sugar Pill (placebo)
Intervention descriptions: intervention 1: donepezil, 5 mg, capsule, once a day, 3 weeks intervention 2: sugar pill, one capsule, once a day, 3 weeks

Protocol documents:
Clinical trial NCT00929071
Conditions: Aging Pain
Keywords: wrinkles dermal filler collagen soft tissue augmentation lidocaine aesthetic
Sponsor: Weinkle, Susan H., M.D.
Start date: 2009-01-01; Completion date: 2009-02-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study doctor will give EVOLENCE® mixed with Lidocaine to people in this study to see if it effectively reduces pain while injecting and works to correct nasolabial wrinkles.

The product being used in this study is EVOLENCE®, which is currently marketed in the United States for the cosmetic correction of soft tissue contour deficiencies (including wrinkles), and been approved by the U.S. Food and Drug Administration (FDA).

Detailed description:
The aim of this study is to determine if the admixture of lidocaine can effectively be used to mediate pain relief during the injection of EVOLENCE® while achieving cosmetic correction.

Arms: arm 1: Assess injection pain severity for a one time 1.0 mL injection of Evolence with 0.2 ml of topical anesthetic, applied 30 minutes prior to injection, to the left nasolabial fold of each participant . arm 2: Assess injection pain severity for a one time 1.0 mL injection of Evolence mixed with 0.18 mL of 2% lidocaine (0.3% final lidocaine-HCl) in the right nasolabial fold of each participant.
Interventions: intervention 1: Evolence intervention 2: Lidocaine intervention 3: topical anesthetic
Intervention descriptions: intervention 1: Injectable collagen intervention 2: admix anesthetic intervention 3: None

Protocol documents: