ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00818766
Conditions: Antibiotic Prophylaxis
Keywords: Thoracic Surgery Antibiotic Prophylaxis Chest Tube
Sponsor: Brigham and Women's Hospital
Start date: 2008-03-01; Completion date: 2011-04-01
Enrollment: 251 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate if post-operative antibiotic prophylaxis decreases infectious complications when compared to pre-operative antibiotics alone, in patients undergoing elective thoracic surgery requiring tube thoracostomy (chest tube).

Detailed description:
There is currently no evidence-based standard for the extended use of prophylactic antibiotics in patients receiving thoracic surgery that results in the placement of a tube thoracostomy (chest tube). The rationale for this prophylaxis is that antibiotics directed at typical skin flora may reduce the rate of infectious complications, such as surgical site infection and empyema.

Currently, clinicians' approach to post-operative antibiotic prophylaxis in patients undergoing tube thoracostomy associated with thoracic and cardio-thoracic surgery varies widely. While reducing the infectious complications of thoracic surgery is an important goal, it is also important to reduce the use of unnecessary antibiotics. As there is equipoise on the benefit of extended antibiotic prophylaxis for tube thoracostomy, our study will examine two prevailing clinical practices and attempt to determine if one leads to better patient outcomes.

Arms: arm 1: Participants received intravenous (IV) cefazolin or vancomycin (for participants allergic to cephalosporin) immediately following surgery for 48 hours or until all chest tubes were removed, whichever occurred first. arm 2: Participants received IV placebo-matching antibiotics immediately following surgery for 48 hours or until all chest tubes were removed, whichever occurred first.
Interventions: intervention 1: cefazolin or vancomycin intervention 2: Placebo
Intervention descriptions: intervention 1: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were penicillin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first. intervention 2: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.

Protocol documents:
Clinical trial NCT00825825
Conditions: Antidepressant Activity in Healthy Volunteers
Keywords: Citalopram Escitalopram Celexa Lexapro fMRI antidepressant healthy volunteers
Sponsor: Michael Henry, MD
Start date: 2007-05-01; Completion date: 2011-04-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Escitalopram (Lexapro) and citalopram (Celexa) are similar selective serotonin reuptake inhibitors that alter blood flow to the amygdala and other brain structures involved in regulating mood. Escitalopram consists of S-citalopram while citalopram contains both S-citalopram and R-citalopram (racemic citalopram). There is evidence that R-citalopram may block the effects of S-citalopram. The hypothesis being tested is that because of the antagonist effect of R-citalopram, S-citalopram will have a greater effect on the mood circuit than racemic citalopram when equal doses of S-citalopram are administered. The study design consists of a two week medication period followed by blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) while viewing affective visual stimuli.

Detailed description:

Arms: arm 1: One week of escitalopram at 10 mg followed by one week at 20 mg in healthy volunteers. arm 2: One week of citalopram at 20 mg followed by one week at 40 mg in healthy volunteers. arm 3: Two weeks of placebo in healthy volunteers.
Interventions: intervention 1: Escitalopram intervention 2: Citalopram intervention 3: Placebo
Intervention descriptions: intervention 1: One week of escitalopram taken orally at 10 mg followed by one week at 20 mg daily. intervention 2: One week of citalopram taken orally at 20 mg followed by one week at 40 mg daily. intervention 3: Two weeks of placebo taken orally.

Protocol documents:
Clinical trial NCT00831129
Conditions: Pre-diabetes
Sponsor: University of Chicago
Start date: 2006-09-01; Completion date: 2011-04-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to examine if a combination of a cholesterol lowering-drug, simvastatin, with a sugar-lowering drug called rosiglitazone is more effective in improving vascular inflammation (irritation of the vessels that transport your blood) and other cardiovascular risk factors than the taking of simvastatin alone.

Detailed description:
Age 21-75 years Metabolic syndrome (must have 3 of the 5 components) elevated waist circumference \>40inches in men, \>35 inches in women elevated triglycerides \>150mg/dL reduced HDL \<40mg/dL in men\<50 in women elevated blood pressure \>130mmHg systolic, or \>85mmHg diastolic elevated fasting glucose \>100mg/dL

Arms: arm 1: Subjects will receive 40 mg Simvastatin + 1 tab Placebo Rosiglitazone daily arm 2: Subjects will receive 40 mg Simvastatin + 4 mg Rosiglitazone once daily
Interventions: intervention 1: Rosiglitazone intervention 2: Placebo Rosiglitazone intervention 3: Simvastatin
Intervention descriptions: intervention 1: 4 mg daily intervention 2: 1 tab daily intervention 3: 40 mg daily

Protocol documents:
Clinical trial NCT00833053
Conditions: Psoriasis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-10-01; Completion date: 2011-04-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Participants from an ongoing observational study (P05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to their current treatment plan. While receiving infliximab study treatment(s), patients in this study will attend regularly scheduled office visits for various clinical tests for safety and effectiveness evaluations.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Infliximab intervention 2: Infliximab and methotrexate
Intervention descriptions: intervention 1: Infliximab 5 mg/kg body weight intravenous infusion given every 6 weeks intervention 2: Infliximab 5 mg/kg body weight intravenous infusion (given every 8 weeks) plus methotrexate 7.5 mg orally (once weekly)

Protocol documents:
Clinical trial NCT00833469
Conditions: Postpartum Depression
Keywords: women postpartum depression anxiety
Sponsor: Massachusetts General Hospital
Start date: 2009-01-01; Completion date: 2011-04-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether women with postpartum major depressive disorder (MDD) will experience a significant decrease in depressive symptoms from baseline over an eight-week treatment intervention with escitalopram (Lexapro). Also, to determine whether women with postpartum MDD will experience a significant decrease in anxiety symptoms.

Detailed description:

Arms: arm 1: Flexible dose escitalopram 10mg
Interventions: intervention 1: Escitalopram
Intervention descriptions: intervention 1: Once daily by mouth

Protocol documents:
Clinical trial NCT00859339
Conditions: Transitional Cell Carcinoma of the Bladder
Keywords: TCC
Sponsor: Noah Hahn, M.D.
Start date: 2009-03-01; Completion date: 2011-04-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial will investigate the activity of sunitinib combined with cisplatin and gemcitabine followed by radical cystectomy in patients with Transitional Cell Carcinoma (TCC) of the Bladder.

Detailed description:
OUTLINE: This is a multi-center study.

* Gemcitabine ( 1000 mg/m2) IV days 1 and 8
* Cisplatin (70 mg/m2) IV day 1 and
* Sunitinib malate (37.5 mg) oral daily for days 1-14

The treatment regimen will be administered in four, 21-day, cycles followed by radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.

ECOG performance status 0 or 1

Hematopoietic:

* Absolute Neutrophil Count (ANC) \> 1.5 K/mm3 \[(IS): 1.5 x 109/L\]
* Platelets \> 100 K/mm3 \[(IS): 100 x 109/L\]
* Hemoglobin (Hgb) \> 9.0 g/dL \[(IS): 90 g/L\]

Hepatic:

* Total bilirubin \< 1.5 x Upper Limit of Normal (ULN)
* Aspartate aminotransferase (AST) ≤ 2.5 x ULN
* Alanine aminotransferase (ALT) ≤ 2.5 x ULN

Renal:

* Calculated creatinine clearance of \> 60 cc/min

Cardiovascular:

* No uncontrolled angina, congestive heart failure or myocardial infarction or coronary/peripheral artery bypass graft within 6 months prior to registration for protocol therapy.

Arms: arm 1: Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
Interventions: intervention 1: Gemcitabine intervention 2: Cisplatin intervention 3: Sunitinib Malate intervention 4: Radical Cystectomy
Intervention descriptions: intervention 1: Gemcitabine ( 1000 mg/m2) IV days 1 and 8 intervention 2: Cisplatin (70 mg/m2) IV day 1 intervention 3: Sunitinib malate (37.5 mg) oral daily for days 1-14 intervention 4: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.

Protocol documents:
Clinical trial NCT00875433
Conditions: Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2009-03-01; Completion date: 2011-04-01
Enrollment: 60 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A phase II trial to assess the impact of afatinib (BIBW 2992) on the heart (QTcF) and the effectiveness of afatinib (BIBW 2992) in treating certain cancers. Cancers studied will include glioblastoma and cancers which have spread to the brain (metastases).

Detailed description:

Arms: arm 1: BIBW 2992 high dose, once daily, continuous, monotherapy
Interventions: intervention 1: BIBW 2992
Intervention descriptions: intervention 1: patients to receive continuous oral daily dosing of BIBW 2992

Protocol documents:
Clinical trial NCT00895011
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction E.D.
Sponsor: VIVUS LLC
Start date: 2009-04-01; Completion date: 2011-04-01
Enrollment: 298 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to evaluate the safety and efficacy of two doses of avanafil in the treatment of adult males for erectile dysfunction following bilateral nerve-sparing radical prostatectomy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Placebo intervention 2: Avanafil intervention 3: Avanafil
Intervention descriptions: intervention 1: One dose 30 minutes prior to initiation of sexual activity intervention 2: One dose 30 minutes prior to initiation of sexual activity intervention 3: One dose 30 minutes prior to initiation of sexual activity

Protocol documents:
Clinical trial NCT00904423
Conditions: Breast Cancer Bone Diseases
Sponsor: Mark Pegram
Start date: 2009-04-01; Completion date: 2011-04-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Aromatase inhibitors are potent suppressors of breast cancer growth, but side effects include bone loss, fractures, arthralgias and myalgias. We hypothesize vitamin D administration might be beneficial in treating these symptoms and to protect bone.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Vitamin D
Intervention descriptions: intervention 1: up to 2400 mg; oral tablet

Protocol documents:
Clinical trial NCT00909727
Conditions: Cystic Fibrosis
Keywords: Fibrosis Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2009-08-01; Completion date: 2011-04-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic adenosine monophosphate (AMP)-dependent protein kinase A (PKA) activation.

Detailed description:
This is a Phase 3, 2-part, randomized, double-blind, placebo-controlled, parallel group multicenter study of orally administered ivacaftor in subjects with cystic fibrosis (CF) 6 to 11 years of age who have the G551D-CFTR mutation and a forced expiratory volume in 1 second (FEV1) between 90% and 105% predicted (using Knudson standards).

Based on in vitro studies and pharmacologic, pharmacokinetic (PK), and safety profiles, ivacaftor was selected for clinical development as a possible treatment for patients with CF. Patients with the G551D mutation were the targeted population for this study because ivacaftor is a potentiator of the gating effect of the CFTR protein, and the most prevalent mutation with a gating defect in CF is the G551D mutation.

This study was conducted in 2 parts. Part A was conducted to analyze the PK properties of ivacaftor and to determine the most appropriate dose to administer to subjects in Part B of this study. Part B explored the safety and efficacy of ivacaftor over long-term treatment in subjects 6 to 11 years of age.

Arms: arm 1: Subjects who received placebo every 12 hours (q12h) for up to 48 weeks. arm 2: Subjects who received 150 mg of ivacaftor q12h for up to 48 weeks.
Interventions: intervention 1: Ivacaftor intervention 2: Placebo
Intervention descriptions: intervention 1: 150-mg tablet given orally q12h for up to 48 weeks intervention 2: Tablet given orally q12h for up to 48 weeks

Protocol documents:
Clinical trial NCT00910299
Conditions: Coronary Artery Disease (CAD)
Keywords: Clopidogrel VerifyNow PRU Measurements Drug Eluting Stents (DES) Heart Disease Percutaneous Coronary Intervention (PCI) P2Y12 Platelets Platelet Reactivity
Sponsor: Eli Lilly and Company
Start date: 2009-07-01; Completion date: 2011-04-01
Enrollment: 423 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the efficacy of prasugrel versus clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting stents.

To determine the adverse event profile of prasugrel in patients with high platelet reactivity on clopidogrel after implantation of coronary drug-eluting stents.

To determine the effect of prasugrel on inhibition of platelet activation in patients with high platelet reactivity on clopidogrel.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Prasugrel intervention 2: Clopidogrel
Intervention descriptions: intervention 1: One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months. intervention 2: 75 mg oral daily maintenance dose up to 6 months.

Protocol documents:
Clinical trial NCT00914862
Conditions: Insomnia
Keywords: Sleep Initiation and Maintenance Disorders Drug Therapy
Sponsor: Takeda
Start date: 2009-11-01; Completion date: 2011-04-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the pharmacokinetic profile, safety, and tolerability of ramelteon in adolescents with insomnia, children with Attention Deficit Hyperactivity Disorder (ADHD) associated with insomnia and gender- and race-matched healthy adults.

Detailed description:
Ramelteon is a treatment for insomnia approved for use in the United States (US) in July 2005 and in the Philippines and Indonesia in 2008. It is currently under development in the European Union (EU) and Japan. Ramelteon is marketed in the US as ROZEREM® for the treatment of insomnia characterized by difficulty with sleep onset in patients over 18 years of age.

In adolescents, the form of sleep onset and/or sleep maintenance insomnia, defined as psychophysiologic insomnia, is similar to adults, and more appropriate for treatment with pharmacological intervention when compared to insomnia in children younger than 12 years of age. In psychophysiologic insomnia, the individual develops conditioned anxiety around difficulty falling or staying asleep, which leads to heightened physiologic and emotional arousal and further compromises the ability to sleep. In children over the age of 12, insomnia is more likely to be persistent and have identifiable consequences. In addition, there is less variability in normative sleep data for this age group than in younger children.

Sleep disturbances are also common in children. Specifically, insomnia associated with ADHD in children is very common with a reported prevalence of 28% in medication-free children with ADHD.

This study is to characterize the pharmacokinetics (PK) and safety profile of a 4 or 8 mg dose of ramelteon in adolescents who are between 12 to 17 years of age (prior to the 18th birthday) with insomnia characterized by difficulty with sleep initiation, and in pediatrics who are between 6 to 11 years of age who have insomnia associated with ADHD. These profiles will be compared with those of healthy adults aged 18 to 50 years who are matched by race and gender receiving an 8 mg dose of ramelteon. This open-label study is designed in accordance with the recommendations of the FDA and ICH guidances for pediatric PK studies.

Arms: arm 1: Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon. arm 2: Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon. arm 3: Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon. arm 4: Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon. arm 5: Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
Interventions: intervention 1: Ramelteon
Intervention descriptions: intervention 1: Ramelteon tablets, orally for one day only.

Protocol documents:
Clinical trial NCT00917267
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes exenatide once weekly Byetta Amylin Lilly
Sponsor: AstraZeneca
Start date: 2009-07-01; Completion date: 2011-04-01
Enrollment: 691 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. These previous studies of exenatide once weekly have been conducted in non-Asian populations, so this study has been developed to support the local regulatory requirements of China, Korea, Japan, India, and Taiwan.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: exenatide once weekly intervention 2: exenatide twice daily
Intervention descriptions: intervention 1: 2.0mg subcutaneous injection, once a week intervention 2: 5mcg subcutaneous injection twice a day (4 weeks), 10mcg subcutaneous injection twice a day (22 weeks)

Protocol documents:
Clinical trial NCT00923598
Conditions: Total Knee Arthroplasty Knee Pain
Keywords: TKA Bilateral Cleveland Clinic UCSD Catheter Nerve block Postoperative pain Femoral Catheter Bilateral Total Knee Arthroplasty Bilateral Femoral Catheter
Sponsor: University of California, San Diego
Start date: 2009-06-01; Completion date: 2011-04-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, observer-masked, controlled study. Subjects will be patients undergoing bilateral total knee arthroplasty (TKA). One side (left or right) will be randomized to one of two treatment groups: a postoperative ropivacaine concentration of 0.1% or 0.4%. The contralateral side will receive the other possible ropivacaine concentration of 0.1% or 0.4%. The basal rate and patient-controlled bolus volume will depend upon the treatment group, but the total dose of local anesthetic is the same for each. For the duration of the study, all patients will receive the current usual and customary analgesics for bilateral TKA patients. All patients will receive a ropivacaine perineural infusions initiated in the operating room and continued until at least the afternoon of postoperative day (POD) 2, as well as oral acetaminophen, a sustained-release oral opioid; and celecoxib. Rescue opioid and route of administration will be determined by pain severity using a Numeric Rating Scale of 0-10, with 0 equal to no pain and 10 being the worst imaginable pain.

Detailed description:
The investigators propose to test the null hypothesis that differing concentrations of ropivacaine (0.1% vs. 0.4%) at an equal total dose has no impact on quadriceps muscle strength during a continuous femoral nerve block following total knee arthroplasty (TKA). These results will help define the optimal concentration of local anesthetic used for continuous peripheral nerve blocks.

Arms: arm 1: Patients will be randomized ot 0.1% Ropivicaine infusion on the right leg and therefore 0.4% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital. arm 2: Patients will be randomized ot 0.4% Ropivicaine infusion on the right leg and therefore 0.1% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital.
Interventions: intervention 1: 0.1% and 0.4% perineural ropivicaine
Intervention descriptions: intervention 1: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery.

Protocol documents: