ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00549549
Conditions: Arthritis, Gouty
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-02-01; Completion date: 2009-12-01
Enrollment: 402 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, double-blind, double-dummy, randomized, active-controlled study that will include an 8-day treatment period followed by a 1-week follow-up period in patients experiencing symptoms of an acute exacerbation of gouty arthritis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Indomethacin intervention 2: Celecoxib intervention 3: Celecoxib intervention 4: Celecoxib
Intervention descriptions: intervention 1: indomethacin 50 mg three times a day (TID) for 8 days. intervention 2: An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg two times a day (BID) for 7 days. intervention 3: An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later (celecoxib 400/200 mg regimen) and continuing 200 mg two times a day (BID) for 7 days. intervention 4: Celecoxib 50 mg two times a day (BID) for 8 days

Protocol documents:
Clinical trial NCT00549939
Conditions: Neurogenic Urinary Bladder
Keywords: child bladder neuropathic alpha blockers
Sponsor: Sanofi
Start date: 2007-10-01; Completion date: 2009-12-01
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to evaluate the efficacy of Alfuzosin in comparison to Placebo on the detrusor Leak Point Pressure (LPP) in children and adolescents 2-16 years of age with elevated detrusor LPP of neuropathic etiology and detrusor LPP ≥ 40 cm H2O.

Secondary objectives were:

* To investigate the safety and tolerability of two doses of Alfuzosin in comparison to Placebo in children and adolescents,
* To evaluate the effects of the two doses of Alfuzosin in comparison to Placebo on:

  * Detrusor compliance,
  * Urinary tract infection,
* To investigate the pharmacokinetics of Alfuzosin (population kinetics),
* To evaluate the 12-month long-term safety of Alfuzosin 0.1 mg/kg/day and 0.2 mg/kg/day.

The study consisted of 2 periods:

* a 12-week double blind treatment period where patients were to receive either Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day or placebo then,
* a 40-week open label extension treatment period where patients were to receive either Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day.

Detailed description:
Patients who met the study entry criteria were randomized (2:1:2:1) to one of the 4 dosage groups (Alfuzosin 0.1 mg/kg/day, matching placebo 0.1 mg/kg/day, Alfuzosin 0.2 mg/mg/kg, matching placebo 0.2 mg/kg/day).

Patients received their treatment using either solution or tablet formulation depending on age as follows:

* Solution to children 2-7 years of age or, children and adolescents 8-16 years of age if they were unable to swallow tablets or they preferred to take the solution or if they had a body weight \< 30kg. The daily dose was devided in 3 doses given at at breakfast, lunch and dinner.
* Tablet to children and adolescents 8-16 years of age who were able to swallow tablets and had a body weight ≥ 30kg. The daily dose was devided in 2 doses given at at breakfast and dinner.

Patients who have completed the 12-week double-blind phase were offered to continue in the 40-week open-label extension study.

* Patients receiving Alfuzosin continued with their dosing regimen.
* Patients receiving Placebo were switched to Alfuzosin with a dose corresponding to their randomization dose group.

All patients had a one-week follow-up period after last dose intake.

Arms: arm 1: Matching placebo 0.1 mg/kg/day or 0.2 mg/kg/day arm 2: None arm 3: None
Interventions: intervention 1: Alfuzosin intervention 2: Placebo
Intervention descriptions: intervention 1: Form: solution or tablet according to age

Route: oral

Dose: daily dose adjusted to body weight intervention 2: Form: matching solution or matching tablet according to age

Route: oral

Dose: daily dose adjusted to body weight

Protocol documents:
Clinical trial NCT00556998
Conditions: Pharmacokinetics
Keywords: pharmacokinetics and safety data of voriconazole in immunocompromised adolescents
Sponsor: Pfizer
Start date: 2008-06-01; Completion date: 2009-12-01
Enrollment: 26 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to collect additional pharmacokinetic and safety data of voriconazole in immunocompromised adolescents receiving intravenous and oral voriconazole. This will help establish voriconazole dosing recommendations for adolescents.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Voriconazole
Intervention descriptions: intervention 1: Voriconazole will be used for prophylaxis purpose. 6 mg/kg IV q12h on the first day (Day 1) and 4 mg/kg IV q12h for at least 5.5 days. The IV treatment is no more than 20 days. Then switch to 300 mg oral tablets q12h for at least 6.5 days. The total treatment duration is no more than 30 days.

Protocol documents:
Clinical trial NCT00560417
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2007-11-01; Completion date: 2009-12-01
Enrollment: 339 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.

Detailed description:

Arms: arm 1: Insulin Lispro Protamine Suspension (ILPS) arm 2: Insulin Glargine
Interventions: intervention 1: Insulin Lispro Protamine Suspension intervention 2: Insulin Glargine
Intervention descriptions: intervention 1: Administered subcutaneously once a day at bedtime intervention 2: Administered subcutaneously once a day at bedtime

Protocol documents:
Clinical trial NCT00564681
Conditions: Cervical Dystonia
Sponsor: Allergan
Start date: 2007-12-01; Completion date: 2009-12-01
Enrollment: 242 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and placebo.

Detailed description:

Arms: arm 1: Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. arm 2: Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. arm 3: Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments. arm 4: Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
Interventions: intervention 1: botulinum toxin type A intervention 2: botulinum toxin type A Formulation 2 intervention 3: Normal Saline
Intervention descriptions: intervention 1: Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. intervention 2: Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. intervention 3: Intramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1.

Protocol documents:
Clinical trial NCT00565370
Conditions: Advanced Gastric Cancer
Keywords: Gastric cancer capecitabine cisplatin sorafenib phase I phase II
Sponsor: Asan Medical Center
Start date: 2007-11-01; Completion date: 2009-12-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
There is strong scientific rationale for exploring the role of sorafenib with capecitabine and cisplatin (XP) in AGC. XP is a new standard of care in AGC and sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine kinases VEGF-R2 and PDGFR-beta.

Detailed description:

Arms: arm 1: XP+sorafenib arm 2: XP
Interventions: intervention 1: Capecitabine, Cisplatin, Sorafenib
Intervention descriptions: intervention 1: Capecitabine ( ) mg/m2 bid D1-D15 Cisplatin 80 mg/m2 D1 Sorafenib ( ) mg bid PO daily every 3 weeks

Protocol documents:
Clinical trial NCT00566111
Conditions: Bipolar Depression
Keywords: Ceftriaxone Acute Antidepressant Effects Glutamatergic System Double-Blind Mood Disorders Bipolar Disorder Depression Affective Disorders
Sponsor: Yale University
Start date: 2007-09-01; Completion date: 2009-12-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We aim to study the efficacy of intravenous ceftriaxone in a four-week, inpatient, placebo-controlled, double-blind study, as an augmentation therapy in patients with bipolar disorder, currently depressed, who have failed to respond to conventional treatments.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ceftriaxone intervention 2: Saline solution
Intervention descriptions: intervention 1: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks. intervention 2: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.

Protocol documents:
Clinical trial NCT00570713
Conditions: Pancreatic Cancer
Sponsor: Morphotek
Start date: 2007-12-01; Completion date: 2009-12-01
Enrollment: 155 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the activity of MORAb-009 when added to a standard regimen of gemcitabine in patients with previously untreated unresectable stage 3 or 4 pancreatic cancer.

Detailed description:

Arms: arm 1: MORAb-009 plus gemcitabine ('MORAb-009'): MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment. arm 2: Placebo plus gemcitabine ('Placebo') Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
Interventions: intervention 1: MORAb-009 intervention 2: Placebo intervention 3: Gemcitabine
Intervention descriptions: intervention 1: Monoclonal antibody administered once weekly by intravenous injection. intervention 2: As per package insert. intervention 3: Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.

Protocol documents:
Clinical trial NCT00573248
Conditions: ADHD
Keywords: Nicotine ADHD Gender
Sponsor: University of California, Irvine
Start date: 2005-08-01; Completion date: 2009-12-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Attention deficit hyperactivity disorder (ADHD) is characterized by inattention, impulsivity, and hyperactivity that are frequently treated with stimulant medications such as Ritalin. Many people with ADHD smoke. The smoking prevalence rates are estimated to be 40% in adults with ADHD compared to 20% in the general population. People with ADHD have also more difficulty to quit smoking. Only 29% of smokers with ADHD quit smoking compared to 48.5% of smokers in the general population. Nicotine is a stimulant, which may have properties similar to stimulant medications (e.g., Ritalin) used to treat ADHD. Nicotine may increase attention and reduce hyperactivity and impulsivity and, thus, may regulate behavior in individuals with ADHD. Alleviating the symptoms of ADHD and increasing cardiovascular activity through smoking may mimic the effects of stimulant medications and can be a form of self-medication.

The major objective of the study was to examine the effects of nicotine on ADHD symptoms, moods, and cardiovascular activity. The study investigated the effects of nicotine patches on behavioral regulation in adult smokers and nonsmokers with ADHD. Smokers and nonsmokers with ADHD participated in two conditions: (1) nicotine patch and (2) placebo patch. During each condition, symptoms, moods, and side effects were assessed for 2 days during waking hours. An electronic handheld diary, programmed to prompt the participant twice per hour, recorded ADHD symptoms (e.g., difficulty concentrating, impulsivity, etc.), negative moods (e.g., anger, stress), and nicotine side effects (nausea, dizziness). Heart rate and blood pressure were recorded with lightweight ambulatory monitors to indicate cardiovascular activity. Results provided information about the effects of nicotine patches on behavioral regulation in adult smokers and nonsmokers with ADHD.

The inclusion of nonsmokers was important to clarify whether the effects of nicotine on smokers was due to smoking withdrawal. The findings help explain the increased smoking prevalence rates and reduced quit rates associated with ADHD. Knowledge about nicotine's effects on behavioral regulation can help to develop successful smoking cessation programs for individuals with ADHD. The findings on cardiovascular activity may help determine the potential risk for cardiovascular disease in smokers and nonsmokers with ADHD. The study contributed to understanding nicotine's effects on behavioral regulation in a highly vulnerable population such as people with ADHD.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Nicotine intervention 2: Placebo
Intervention descriptions: intervention 1: 21 mg nicotine patches for smokers for 2 days

7 mg nicotine patches for nonsmokers for 2 days intervention 2: Placebo Patch

Protocol documents:
Clinical trial NCT00574197
Conditions: Gastrointestinal Symptoms Heart Transplantation
Keywords: Heart Transplant gastrointestinal Cellcept Myfortic GI GI symptoms with Mycophenolate Mofetil post heart transplant
Sponsor: Cedars-Sinai Medical Center
Start date: 2006-06-01; Completion date: 2009-12-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of mycophenolate mofetil (Cellcept®) which is currently used as therapy for the prevention of transplant rejection. Myfortic® was developed to improve the gastrointestinal tolerability of Cellcept®. The new enteric-coated, Myfortic® is presently FDA approved for the prevention of acute kidney rejection only. There is no clinical data of its use in heart transplant patients.

Detailed description:
This is an open-labeled, prospective, non-randomized pilot-phase study of the enteric-coated, Myfortic® versus the non enteric-coated, Cellcept® in patients who are within 5 years of having undergone heart transplant surgery who are currently taking Cellcept®. After the initial screening, 20 patients who fulfill the inclusion criteria and report symptoms of gastrointestinal side-effects while taking Cellcept will be switched to Myfortic. All 20 patients will be followed closely over a period of 6 months following enrollment. Concomitant immunosuppressive therapy will continue in all patients per standard treatment protocol.

Arms: arm 1: 1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
Interventions: intervention 1: Mycophenolate Sodium
Intervention descriptions: intervention 1: 1440mg/day (720mg by mouth, twice a day)

Protocol documents:
Clinical trial NCT00580788
Conditions: Osteoporosis Humoral Hypercalcemia of Malignancy Hyperparathyroidism
Keywords: Endocrine System Diseases MusculoSkeletal System Diseases Hormones Malignancy Postmenopausal Women Bone metabolism
Sponsor: University of Pittsburgh
Start date: 2008-01-01; Completion date: 2009-12-01
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a dose escalation study to determine the maximum tolerable dose of Parathyroid Hormone-related Protein, PTHrP, that can be given safely over one week. The investigators plan to infuse low doses of intravenous PTHrP to determine if it leads to a sustained and progressive suppression of bone formation as occurs in humoral hypercalcemia of malignancy (HHM) or an increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally, the investigators will assess the direct influence of PTHrp on markers of bone turnover, and plasma 1,25 (OH)2 vitamin D regulation in healthy human volunteers.

Detailed description:
During this research the investigators administer PTHrP to healthy young volunteers in a controlled, continuous intravenous manner. As research subjects complete the week-long study without adverse effects, the dose of PThrP will be increased in later subjects. In the event of a significant adverse effect, immediate action will be taken to reverse it. The investigators want to estimate the effect of a sustainable level of mild hypercalcemia achieved by a week-long intravenous infusion of PTHrP has on vitamin D metabolism, markers of bone turnover and fractional excretion of calcium.

Arms: arm 1: PTHrP(1-36) at 2 picomoles/kg/hr for one week. arm 2: PTHrP(1-36) at 4 picomoles/kg/hr for one week. arm 3: PTHrP(1-36) at 5 picomoles/kg/hr for one week. arm 4: PTHrP(1-36) at 6 picomoles/kg/hr for one week.
Interventions: intervention 1: PTHrP (1-36)
Intervention descriptions: intervention 1: IND # 49,175

Protocol documents:
Clinical trial NCT00586066
Conditions: Bipolar Disorder
Keywords: Bipolar disorder Cognitive dysfunction Memantine NMDA antagonist
Sponsor: Massachusetts General Hospital
Start date: 2005-11-01; Completion date: 2009-12-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see whether memantine improves memory function in participants with bipolar disorder who have minimal symptoms. Secondary analyses will test the role of memantine in improving residual mood symptoms (depression and mania) in participants with bipolar disorder.

We hypothesize that in participants with bipolar disorder who have minimal symptoms memantine will be effective in improving cognitive functions, as measured by the difference in neuropsychological test scores at the beginning and at the end of the trial.

Detailed description:
A large proportion of participants with bipolar disorder experience significant cognitive dysfunction, even when euthymic, after adequate treatment. The cognitive deficits in asymptomatic patients with bipolar disorder are very important for the participant's psychosocial function. In this population, cognitive deficits have been associated with poor psychosocial functioning, such as inability to hold a job. Memantine is a glutamate N-methyl-D-aspartate (NMDA) receptor antagonist which has shown efficacy in cognitive dysfunction due to moderate to severe Alzheimer disease.

Demonstrating the role of memantine in reducing cognitive dysfunction in minimally symptomatic participants with bipolar disorder promises to provide important clinical information, which could lead to improvements in well-being and functional status for large populations of participants with bipolar disorder.

Arms: arm 1: Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12. arm 2: Re-purposed Alzheimer's drug to treat cognitive dysfunction associated with bipolar disorder. Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
Interventions: intervention 1: Memantine intervention 2: Placebo
Intervention descriptions: intervention 1: Week 0: 5 mg memantine or placebo once a day (q.d.) Week 1: 5 mg memantine or placebo twice a day (b.i.d.) Week 2-3: 5 mg memantine or placebo once in the morning (q.a.m.)/10 mg once in the evening (q.p.m.) Week 4-12: 10mg Memantine or placebo b.i.d. intervention 2: Inactive comparator. Placebo-matching memantine tablet.

Protocol documents:
Clinical trial NCT00588406
Conditions: Asthma
Keywords: acute, emergency department
Sponsor: Northwell Health
Start date: 2007-09-01; Completion date: 2009-12-01
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine whether adding nebulized inhaled steroids to the standard care of acutely ill ED patients with refractory acute asthma helps improve forced expiratory volume at one second (FEV1) and decrease the need for hospitalization.

Detailed description:
This is a randomized clinical trial studying the effect of nebulized budesonide (Pulmicort) in acutely ill adults presenting to the Emergency Department with severe asthma. Budesonide is an inhaled steroid FDA approved for the treatment of pediatric chronic asthma. ED entry criteria include hyporesponsiveness to nebulized beta-agonists and an FEV1\<50% predicted. The trial will evaluate the efficacy of multiple doses of nebulized budesonide as an adjunct to a highly regimented standardized treatment protocol; standard care consists of bronchodilators (beta-agonists/anticholinergics), systemic steroids, and intravenous magnesium sulfate (if the FEV1\<25% predicted). The primary efficacy endpoint will be the FEV1 4 hours after administration of the study intervention. An additional safety and efficacy endpoint will take place at 5 hours after study intervention. The treatments will be coupled with a protocol-defined assessment regimen, with endpoints measured before each treatment and on ED disposition (at 5 hours after study intervention).

Arms: arm 1: Budesonide, 2mg, 4 doses, plus standard care arm 2: Placebo plus standard care
Interventions: intervention 1: Budesonide intervention 2: albuterol intervention 3: Ipratropium bromide intervention 4: Prednisone
Intervention descriptions: intervention 1: 2mg/dose by nebulizer, four doses over 3 hours intervention 2: 2.5mg/dose by nebulizer, 7 doses over 6 hours intervention 3: 2.5 mg, one dose intervention 4: 60mg PO

Protocol documents: