ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00551174
Conditions: Post-Menopausal Osteoporosis
Sponsor: Hoffmann-La Roche
Start date: 2004-10-01; Completion date: 2008-11-01
Enrollment: 781 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ibandronate [Bonviva/Boniva] intervention 2: ibandronate [Bonviva/Boniva]
Intervention descriptions: intervention 1: 3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day). intervention 2: 2 mg IV every 2 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).

Protocol documents:
Clinical trial NCT00559962
Conditions: Hyperlipidemia
Keywords: LDL hepatic fat
Sponsor: Aegerion Pharmaceuticals, Inc.
Start date: 2007-10-01; Completion date: 2008-11-01
Enrollment: 260 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine safety and effectiveness of low-dose therapeutic AEGR-733 +/- atorvastatin, ezetimibe or fenofibrate (compared to placebo) on liver fat accumulation measured by Magnetic Resonance Spectroscopy

Detailed description:
The goal within the current development program and this study is to investigate whether lower doses of AEGR-733 can result in significant reductions in LDL-C and TGs while providing fewer gastrointestinal adverse events and less hepatic fat accumulation than seen in studies with higher doses. The potential for atorvastatin, ezetimibe or the PPAR-alpha agonist (fenofibrate) to ameliorate any hepatic fat accumulation will also be investigated. The twelve week dosing schedule allows us to demonstrate the longer term effects of lower doses of MTP-I on hepatic fat accumulation.

Arms: arm 1: Placebo arm 2: 2.5 mg AEGR-733 arm 3: 5 mg AEGR-733 arm 4: 7.5 mg AEGR-733 arm 5: 10 mg AEGR-733 arm 6: 5 mg AEGR-733 + 20 mg atorvastatin arm 7: 5 mg AEGR-733 + 145 mg fenofibrate arm 8: 5 mg AEGR-733 + 10 mg ezetimibe
Interventions: intervention 1: AEGR-733 intervention 2: placebo intervention 3: AEGR-733 intervention 4: AEGR-733 intervention 5: AEGR-733 intervention 6: AEGR-733 and atorvastatin intervention 7: AEGR-733 and fenofibrate intervention 8: AEGR-733 and ezetimibe
Intervention descriptions: intervention 1: 3 capsules each evening for each 4-week period intervention 2: 3 capsules each evening for each 4-week period intervention 3: 3 capsules each evening for each 4-week period intervention 4: 3 capsules each evening for each 4-week period intervention 5: 3 capsules each evening for each 4-week period intervention 6: 3 capsules each evening for each 4-week period intervention 7: 3 capsules each evening for each 4-week period intervention 8: 3 capsules each evening for each 4-week period

Protocol documents:
Clinical trial NCT00561392
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease Rivastigmine Patch
Sponsor: Novartis
Start date: 2007-11-01; Completion date: 2008-11-01
Enrollment: 208 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluated the safety and efficacy of 10 cm\^2 rivastigmine patch in patients with Alzheimer Disease (MMSE 10-26). The primary objective was the percentage of patients who stayed on the target size of 10 cm\^2 for at least 8 weeks. This proportion was then compared to historical data of the percentage of patients who could reach a rivastigmine capsule target dose of 12 mg and stay on it at least 8 weeks.

Detailed description:

Arms: arm 1: For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability.
Interventions: intervention 1: Rivastigmine 5 and 10 cm^2 patch
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00568685
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Start date: 2007-11-01; Completion date: 2008-11-01
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to provide information regarding the relative effectiveness of three different atomoxetine doses in the treatment of Korean children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD)

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Atomoxetine Hydrochloride intervention 2: Atomoxetine hydrochloride intervention 3: Atomoxetine hydrochloride
Intervention descriptions: intervention 1: Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period intervention 2: Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period intervention 3: Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days.

Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days

Protocol documents:
Clinical trial NCT00571922
Conditions: Methamphetamine Dependence, Treatment Seeking
Keywords: methamphetamine, crystal, treatment
Sponsor: NYU Langone Health
Start date: 2007-07-01; Completion date: 2008-11-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial will compare 10 week treatment with acamprosate (2 gr/day) versus placebo, combined with weekly abstinence oriented individual counseling, in methamphetamine dependent patients, 72 subjects will be enrolled, with an interim analysis scheduled after 36 enrolled. Primary outcome is methamphetamine absitience over the 10 week treatment period, and the last 2 weeks of treatment. Abstinence is defined on a weekly basis as no urine positive of methamphetamine (or amphetamine) and self-report of not use for the 7 day period. Secondary measures include treatment retention, drug craving, mood, and safety.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Acamprosate intervention 2: placebo
Intervention descriptions: intervention 1: 2 gr/day (333 mg, TID) intervention 2: matching placebo

Protocol documents:
Clinical trial NCT00577824
Conditions: Type 2 Diabetes
Keywords: diabetes exenatide LY2148568 Byetta Lilly Amylin
Sponsor: AstraZeneca
Start date: 2008-01-01; Completion date: 2008-11-01
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: exenatide intervention 2: exenatide intervention 3: placebo
Intervention descriptions: intervention 1: subcutaneous injection, 5mcg, twice a day intervention 2: subcutaneous injection, 10mcg, twice a day intervention 3: subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day

Protocol documents:
Clinical trial NCT00578929
Conditions: Seasonal Allergic Rhinitis
Keywords: allergic rhinitis allergies seasonal allergies
Sponsor: Alcon Research
Start date: 2007-09-01; Completion date: 2008-11-01
Enrollment: 2388 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal allergic rhinitis.

Detailed description:

Arms: arm 1: Olopatadine HCl 0.6% 1 spray per nostril twice daily arm 2: Vehicle 1 spray per nostril twice daily arm 3: Olopatadine HCl 0.6% 2 sprays per nostril twice daily arm 4: Vehicle 2 sprays per nostril twice daily
Interventions: intervention 1: Olopatadine Hydrochloride Nasal Spray 0.6% intervention 2: Vehicle
Intervention descriptions: intervention 1: Olopatadine HCl 1 or 2 sprays per nostril twice daily intervention 2: Vehicle 1 or 2 sprays per nostril twice daily

Protocol documents:
Clinical trial NCT00585325
Conditions: Burn
Sponsor: University of Wisconsin, Madison
Start date: 2004-10-01; Completion date: 2008-11-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Patients will be randomized prospectively to one of two groups. One group will receive 5 mg/kg of 1% lidocaine, and the other will receive .9 normal saline, instilled into their VAC sponge ½ hour prior to VAC dressing change. All patients will complete a pain assessment tool prior to receiving the instilled lidocaine/placebo, immediately after the procedure and 1 hour after the procedure. Pain scores will then be compared between the lidocaine and placebo groups.

Risks: Lidocaine toxicity is a potential risk, but 5 mg/kg of 1 % Lidocaine is below toxicity thresholds in an adult.

Detailed description:
• All Burn service patients (inpatients and outpatients in burn clinic) who are receiving VAC therapy will be screened for study inclusion criteria. Those with allergies to lidocaine will be excluded. Participants will be enrolled until a sample size of 80 wound VAC changes is achieved. Up to 4 VAC dressing changes can be included in this study per participant. Subjects will be randomized prospectively for each dressing change. Utilizing a randomized bracketed approach, patients will be assigned to one of two groups: Lidocaine group or Placebo group. The Pharmacy Research Center (PRC) will assign patient a study Identification (ID) number and record it along with their medical record number on the Master Study ID List. They will then randomize the participants by drawing randomly shuffled green vs white index cards. (40 white card = 0.9 normal saline and 40 green card = 5 mg/kg of 1% Lidocaine). They will draw up the appropriate amount of medication to be used, label it with the patients Medical Record (MR) #, date, and administration instructions and deliver it to the nurse who is doing the VAC dressing change. They will keep the Master Randomization Data Collection Tool in a locked drawer in her office.

Arms: arm 1: 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change arm 2: receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change
Interventions: intervention 1: Instilled 1% Lidocaine intervention 2: Placebo (0.9% Normal Saline)
Intervention descriptions: intervention 1: 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change intervention 2: .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change

Protocol documents:
Clinical trial NCT00590122
Conditions: Parkinson's Disease
Keywords: Parkinson's disease time to "on" delayed on
Sponsor: Baylor College of Medicine
Start date: 2006-10-01; Completion date: 2008-11-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.

Detailed description:
This is a study to compare orally dissolving levodopa (Parcopa) to the conventional immediate release oral levodopa. This is a single-dose, double-blind, placebo controlled crossover trial in participants with Parkinson disease.

Arms: arm 1: Parcopa at equivalent dosage to subjects current stable dose arm 2: Carbidopa-levodopa (Sinemet)at subjects current stable dose
Interventions: intervention 1: Parcopa intervention 2: carbidopa-levodopa (Sinemet)
Intervention descriptions: intervention 1: at subjects current stable dose of comparator intervention 2: at subjects current stable dose

Protocol documents:
Clinical trial NCT00592475
Conditions: Liver Cirrhosis
Keywords: conivaptan Liver Cirrhosis Hypertension, Portal
Sponsor: Cumberland Pharmaceuticals
Start date: 2007-12-01; Completion date: 2008-11-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety of IV conivaptan in stable euvolemic or hypervolemic cirrhotic patients, and to characterize the effects of IV conivaptan on the hepatic hemodynamic response in patients with cirrhosis.

Detailed description:

Arms: arm 1: Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours arm 2: Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours arm 3: Placebo continuous intravenous infusion over 6.5 hours
Interventions: intervention 1: conivaptan intervention 2: Placebo
Intervention descriptions: intervention 1: IV intervention 2: IV

Protocol documents:
Clinical trial NCT00594165
Conditions: Early-Stage Parkinson's Disease
Keywords: Rotigotine
Sponsor: UCB Pharma
Start date: 2002-06-01; Completion date: 2008-11-01
Enrollment: 217 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic Parkinson's disease.

Detailed description:
This is the open-label extension to the randomized, double-blind, placebo-controlled SP512 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease.

Arms: arm 1: Rotigotine
Interventions: intervention 1: Rotigotine
Intervention descriptions: intervention 1: Rotigotine trans-dermal patches:

10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)

Optimal dosing:

During the first year:

The maximum Rotigotine dose allowed is 6 mg/24 hours.

After the first year: allowed dose increase of Rotigotine up to a maximum of 16 mg/24 hours.

Protocol documents:
Clinical trial NCT00595075
Conditions: Healthy
Keywords: sleep performance night shift Ramelteon Healthy Individuals
Sponsor: Brigham and Women's Hospital
Start date: 2007-12-01; Completion date: 2008-11-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Night shift-workers are often advised to take a prophylactic nap prior to starting the shift in order to improve alertness and performance. However, individuals often report difficulty initiating and maintaining sleep at that time of the day secondary to the alerting influence of the near-24 hour circadian rhythm (biological clock). A sleep-promoting medication may improve the quality of an evening nap and subsequent alertness and performance during a night shift. We will use Ramelteon, a melatonin agonist that is FDA approved for insomnia, in order to test the following hypotheses:

1. ramelteon, compared with placebo, will significantly increase sleep efficiency during a 2-hour nap;
2. sleep inertia, as assessed by neurobehavioral tests and subjective and objective sleepiness assessments will not be significantly increased after ramelteon treatment compared with placebo treatment; and
3. neurobehavioral performance, subjective and objective sleepiness, and subjective mood during a simulated 8-hour night shift will be significantly improved when ramelteon is given prior to a prophylactic nap compared to a prophylactic nap with placebo.

Detailed description:

Arms: arm 1: Ramelteon 8 mg will be given once prior to a 2-hour nap arm 2: Placebo will be given once prior to a 2-hour nap
Interventions: intervention 1: Ramelteon intervention 2: placebo
Intervention descriptions: intervention 1: Ramelteon 8 mg tablet by mouth x 1 dose intervention 2: placebo identical in appearance to active experimental drug x 1 dose

Protocol documents:
Clinical trial NCT00598559
Conditions: Acute Pain Fever
Keywords: Acute pain Fever IV Acetaminophen Analgesic
Sponsor: Mallinckrodt
Start date: 2008-01-01; Completion date: 2008-11-01
Enrollment: 213 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will be investigating safety and efficacy administration of repeated dose of IV Acetaminophen (IV APAP) over five days for the treatment of acute pain or fever in adult patients.

Detailed description:
• To assess the safety of IV Acetaminophen when used over five days for the treatment of acute pain or fever in adult inpatients

Secondary Objectives:

* To compare the efficacy of IV Acetaminophen 650 milligram (mg) every four (q4) hours vs. 1 gram (g) every 6 (q6) hours over 5 days of treatment
* To compare the safety of IV Acetaminophen 650 mg q4 hours vs. 1 g q6 hours over 5 days of treatment
* To compare the safety of IV Acetaminophen vs. standard of care (SOC) treatment over 5 days of treatment
* To compare the efficacy of IV Acetaminophen vs. standard of care treatment over 5 days of treatment

Arms: arm 1: 1 g q6h IV Acetaminophen arm 2: 650 mg q4h IV Acetaminophen arm 3: The standard of care treatments were defined as any medication the investigator deemed appropriate to treat the subject, including products containing acetaminophen but excluding IV acetaminophen.
Interventions: intervention 1: IV Acetaminophen
Intervention descriptions: intervention 1: Arm 1: 1 g IV Acetaminophen every 6 hours administered for five days. Arm 2: 650 mg IV Acetaminophen every 4 hours administered for five days. Arm 3: The standard of care treatments were defined as any medication the investigator deemed appropriate to treat the subject, including products containing acetaminophen but excluding IV acetaminophen.

Protocol documents:
Clinical trial NCT00599924
Conditions: Colorectal Neoplasms Neoplasms
Keywords: advanced solid tumors, colorectal cancer, sunitinib (SUTENT), FOLFOX
Sponsor: Pfizer
Start date: 2005-09-01; Completion date: 2008-11-01
Enrollment: 53 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study determined the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with FOLFOX \[Leucovorin + Fluorouracil (5-FU) + Oxaliplatin\]. Three different dosing regimens with starting doses of sunitinib at 37.5 mg/day (Schedule 2/2, Schedule 4/2, and Continuous Dosing) were tested in patients with advanced solid tumors, including colorectal cancer.

Detailed description:
Study Design: Treatment, Single Group Assignment (7 cohorts), Open Label, Non-Randomized, Safety Study.

Arms: arm 1: SU011248 \[sunitinib\] in combination with FOLFOX; FOLFOX is a chemotherapy regimen that combines oxaliplatin and leucovorin with bolus and infusion 5-FU. The modified FOLFOX 6 (mFOLFOX6) regimen is one of several different regimens of FOLFOX used in clinic, according to different dosages of the 4 drugs. mFOLFOX6 was administered every 2 weeks on Days 1 and 2 of each cycle.

25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in three different dosing regimens: schedule 2/2 (2 weeks on, 2 weeks off), schedule 4/2 (4 weeks on, 2 weeks off), and continuous daily dosing (every day); FOLFOX will be administered every 2 weeks, using the modified FOLFOX 6 (mFOLFOX6) regimen, consisting of: oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 as a 2-hr IV infusion; 5-FU 400 mg/m2 IV bolus, followed by - 5-FU 2400 mg/m2 as a 46-hr IV infusion
Interventions: intervention 1: sunitinib + FOLFOX intervention 2: sunitinib + FOLFOX intervention 3: sunitinib + FOLFOX intervention 4: sunitinib + FOLFOX intervention 5: sunitinib + FOLFOX intervention 6: sunitinib + FOLFOX intervention 7: sunitinib + FOLFOX
Intervention descriptions: intervention 1: 37.5 mg sunitinib + modified FOLFOX6 (Schedule 2/2) intervention 2: 50 mg sunitinib + modified FOLFOX6 (Schedule 2/2) intervention 3: 50 mg sunitinib + modified FOLFOX6 ( CRC, only Schedule 2/2) intervention 4: 37.5 mg sunitinib + modified FOLFOX6 (Schedule 4/2) intervention 5: 50 mg sunitinib + modified FOLFOX6 (Schedule 4/2) intervention 6: 37.5 mg sunitinib + modified FOLFOX6 (Continuous Dosing) intervention 7: 25 mg sunitinib + modified FOLFOX6 (Continuous Dosing)

Protocol documents:
Clinical trial NCT00600067
Conditions: Diabetes
Keywords: Diabetes Type 2 Diabetes Diabetes Mellitus Metabolic Diseases Glucose Metabolism Disorders Glycemic Control
Sponsor: VIVUS LLC
Start date: 2008-01-01; Completion date: 2008-11-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the long-term safety and efficacy of VI-0521 (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2 diabetic adults. Continuation of initial 6 month trial.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Phentermine/Topiramate intervention 2: Placebo
Intervention descriptions: intervention 1: phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks intervention 2: Oral placebo capsules, once daily, 28 weeks

Protocol documents:
Clinical trial NCT00603278
Conditions: Asthma
Keywords: Adolescents Adults Pharmacokinetics Asthma GW685698X Pharmacogenetics
Sponsor: GlaxoSmithKline
Start date: 2007-12-01; Completion date: 2008-11-01
Enrollment: 622 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

Detailed description:
A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma Symptomatic on Low-Dose ICS Therapy

Arms: arm 1: None arm 2: None
Interventions: intervention 1: GW685698X intervention 2: placebo
Intervention descriptions: intervention 1: GW685698X intervention 2: placebo

Protocol documents: