ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00116649
Conditions: Keratosis
Keywords: actinic keratosis lesions large head torso extremities actinic keratosis
Sponsor: Graceway Pharmaceuticals, LLC
Start date: 2005-06-01; Completion date: 2007-05-01
Enrollment: 551 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The purpose of this study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso, and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The secondary objective is to evaluate the effectiveness of treatment with imiquimod in people with large surface areas of AK.

Detailed description:
This was a Phase 4, open-label, single-arm, multicenter study in male and female subjects aged 18 years or older with clinically diagnosed AK lesions, conducted at 31 investigational sites in the United States.

This study assessed the safety of imiquimod as a treatment for AK applied in doses ranging from one packet 12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles, depending upon treatment success and AK lesion recurrence. Eligible subjects applied imiquimod 5% cream prior to normal sleeping hours 2 days per week to at least 4 clinically typical, visible, discrete, nonhypertrophic AK lesions in contiguous or noncontiguous treatment areas totaling greater than 25 cm2 at baseline. Multiple treatment areas could be exposed (i.e., head, torso and/or extremities), with the number of packets determined by the investigator but not to exceed one packet for each 25 cm2 treatment area, up to a maximum of 6 packets per dose. In each treatment cycle, dosing was to continue for 16 weeks (approximately 4 months), as instructed by the investigator, followed by a 2-month, treatment-free follow-up period.

Arms: arm 1: Aldara® (imiquimod) cream, 5% supplied in 250 mg single-use packets.
Interventions: intervention 1: imiquimod cream
Intervention descriptions: intervention 1: imiquimod 5% cream applied in doses ranging from one packet (12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles

Protocol documents:
Clinical trial NCT00124020
Conditions: Bacterial Pneumonia
Sponsor: Cumberland Pharmaceuticals
Start date: 2005-01-01; Completion date: 2007-05-01
Enrollment: 771 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Telavancin intervention 2: Vancomycin
Intervention descriptions: intervention 1: Telavancin 10 mg/kg/day IV for up to 21 days intervention 2: Vancomycin 1 Gm administered every 12 hrs IV for up to 21 days

Protocol documents:
Clinical trial NCT00134784
Conditions: Parkinson Disease
Keywords: parkinson brain imaging
Sponsor: Institute for Neurodegenerative Disorders
Start date: 2000-04-01; Completion date: 2007-05-01
Enrollment: 142 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this project is to assess the change in dopamine transporter density in Parkinson's disease subjects during a sixty month period including a nine month treatment trial of levodopa. Dopamine transporter will be assessed using \[123I\]ß-CIT SPECT (single photon emission computed tomography) imaging, a marker of dopamine terminal integrity and of clinical disease state.

Detailed description:
All subjects will be imaged at the Institute for Neurodegenerative Disorders.

Subjects will be evaluated sequentially with \[123I\]ß-CIT SPECT and standardized clinical rating scales during a sixty month period. The subjects involved in this study will have had \[123I\]ß-CIT and SPECT scans at baseline and return for scanning at week 40 following the start of their participation in the ELLDOPA study.

Before each SPECT procedure subjects will be tested to ensure eligibility for the study. They will also have a neurological evaluation including tests of motor function, thinking, memory and handwriting. Some of these tests will be given with the aid of a computer.

On the first day participants are injected with \[123I\]ß-CIT, an investigational radioactive material that localizes in the brain. Study participants will also have a thorough neurologic examination and standard neuropsychological testing, including testing of memory, concentration, abstraction and visual spatial functions.

Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure will be used to obtain SPECT (single photon emission computed tomography) images of the brain.

Arms: arm 1: To assess\[123I\]B-CIT SPECT imaging in early Parkinson's disease subjects on placebo compared to early verses later Levodopa. Subjects on Levodopa 150mg/day, Levodopa 300 mg/day, and Levodopa 600 mg/day will be assessed.
Interventions: intervention 1: [123I]B-CIT SPECT imaging
Intervention descriptions: intervention 1: To assess \[123I\]B-CIT SPECT imaging

Protocol documents:
Clinical trial NCT00134901
Conditions: Cocaine-Related Disorders
Keywords: Cocaine dependence treatment memantine
Sponsor: New York State Psychiatric Institute
Start date: 2003-03-01; Completion date: 2007-05-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Cocaine is one of the most widely abused drugs in the United States. Memantine is a type of drug called an NMDA receptor antagonist. It works by decreasing normal excitement in the brain. NMDA receptor antagonists have shown to reduce cocaine-induced dopamine release in animal models, as well as lessen conditioned cocaine cues. The purpose of this study is to determine the effectiveness of memantine in preventing relapse to cocaine use in cocaine dependent individuals. In addition, this study will determine whether memantine produces better results than a placebo in decreasing cocaine craving, psychological symptoms, functional impairment, and discontinuation of treatment in cocaine dependent individuals.

Detailed description:
Memantine is a non-competitive NMDA receptor antagonist that works by decreasing normal excitement in the brain. Dopamine plays a role in the rewarding and addictive properties of cocaine, however, past clinical studies have not been successful in using dopamine agonists in treating cocaine dependent individuals. Non-competitive NMDA receptor antagonists have shown to reduce cocaine-induced dopamine release in animal models and lessen conditioned cocaine cues. This study will evaluate memantine in treating cocaine dependent individuals and its ability to prevent relapse to cocaine use. Specifically, the aim of this study is to determine if memantine is superior to placebo in decreasing cocaine craving, psychological symptoms, functional impairment, and discontinuation of treatment for cocaine abuse.

Participants will enter a 2-week, single-blind, placebo lead-in phase, during which they will visit the clinic three times each week. At each study visit, urine samples and other rating assessments will be collected. In addition, participants will attend weekly therapy sessions. In order to continue in the trial, participants are required to attend at least four out of the first six study visits and both therapy sessions. Eligible participants will then be randomly assigned to receive either memantine or placebo for the duration of the 12-week, double-blind phase of the trial. Study visits will continue to occur three times each week; participants will also receive weekly therapy. Memantine will be taken twice each day. Participants who complete the 12-week trial will enter a 2-week lead-out phase, during which they will be tapered back to a placebo in a single-blind manner. Weekly psychotherapy sessions will continue until the end of Week 14.

Arms: arm 1: Memantine arm 2: Placebo
Interventions: intervention 1: Memantine intervention 2: placebo
Intervention descriptions: intervention 1: Memantine intervention 2: placebo

Protocol documents:
Clinical trial NCT00286429
Conditions: Diabetes Mellitus
Keywords: Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus Lipoatrophic Dyslipidemia Drug Therapy
Sponsor: Takeda
Start date: 2006-02-01; Completion date: 2007-05-01
Enrollment: 390 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and safety of alogliptin, once daily (QD), taken in combination with insulin for the treatment of Type 2 Diabetes.

Detailed description:
There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected.

Takeda is developing alogliptin (SYR-322) for patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes.

The aim of the current study is to evaluate the efficacy of alogliptin in combination with insulin in subjects who are inadequately controlled on insulin alone (with or without metformin). Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center. Study participation is anticipated to be about 34 weeks (or 8.5 months).

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Alogliptin and insulin intervention 2: Alogliptin and insulin intervention 3: Insulin
Intervention descriptions: intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks. intervention 3: Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.

Protocol documents:
Clinical trial NCT00293215
Conditions: Neoplasms
Sponsor: Ludwig Institute for Cancer Research
Start date: 2006-02-01; Completion date: 2007-05-01
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This was a Phase 1 dose-escalation study of CMD-193, a humanized monoclonal antibody linked to the toxin calicheamicin, in subjects with advanced tumors expressing the Lewis-Y antigen. The primary study objective was to determine the biodistribution and pharmacokinetics (PK) of 111-In-CMD-193 (i.e., CMD-193 tagged with a small amount of radioactive Indium \[111-In\]), with secondary objectives of determining changes in tumor metabolism and describing the antitumor responses to CMD-193.

Detailed description:
Subjects received a single infusion of 111-In-CMD-193 on Day 1. Collection of blood for PK and whole body gamma camera imaging for assessment of biodistribution and tumor uptake were performed on Days 1, 2, 3 or 4, 5 or 6, and 7 or 8 following the 111-In-CMD-193 infusion. Subjects were evaluated for safety for 3 hours post-infusion on Day 1 of each cycle, with subsequent safety assessments performed on Days 8 and 15. Blood for human anti-human antibody (HAHA) response was collected pre-infusion, prior to each subsequent cycle (every 3 weeks) and at study discontinuation.

CMD-193 was administered on Day 1 of each subsequent 21-day cycle as a 60 (± 5) minute intravenous (IV) infusion at a dose of 1.0 mg/m\^2 in Cohort 1 and 2.6 mg/m\^2 in Cohort 2. Each subject received up to 6 cycles of CMD-193 (including the initial infusion of 111-In-CMD-193) until disease progression, unacceptable toxicity, or withdrawal of consent. Up to 6 additional cycles of CMD-193 were permitted if approved by the Sponsor in subjects who tolerated CMD-193 treatment and had evidence of response. Pretreatment medications (e.g., paracetamol, promethazine hydrochloride) were to be administered to reduce the incidence and severity of an anticipated infusion syndrome characterized by fever and chills, and less commonly hypotension.

Restaging by computed tomography (CT) scan was performed at the end of Cycles 2, 4, and 6. Assessment of tumor metabolism was performed by positron emission tomography with 18F-labeled fluorodeoxyglucose (18F-FDG-PET) prior to Cycle 1 and at the time of restaging at the end of Cycles 2 and 4.

Arms: arm 1: Subjects received 111-In-CMD-193 on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 1.0 mg/m\^2 on Day 1 of subsequent 21-day cycles. arm 2: Subjects received 111-In-CMD-193 on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 2.6 mg/m\^2 on Day 1 of subsequent 21-day cycles.
Interventions: intervention 1: 111-Indium-CMD-193 intervention 2: CMD-193
Intervention descriptions: intervention 1: 111-In-CMD-193 (3-7 mCi) was administered as an IV infusion over 60 (± 5) minutes. intervention 2: CMD-193 was administered as an IV infusion over 60 (± 5) minutes.

Protocol documents:
Clinical trial NCT00326963
Conditions: HIV Infections
Sponsor: Hoffmann-La Roche
Start date: 2006-03-01; Completion date: 2007-05-01
Enrollment: 142 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new investigational PI will be administered according to the procedures of the early access program in which the patient is enrolled. The anticipated time on study treatment is 3-12 months, and the target sample size is approximately 120 individuals.

Detailed description:

Arms: arm 1: Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½" needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID).
Interventions: intervention 1: Background ARVs intervention 2: PI intervention 3: enfuvirtide [Fuzeon]
Intervention descriptions: intervention 1: As prescribed intervention 2: As prescribed intervention 3: 90mg sc bid

Protocol documents:
Clinical trial NCT00329303
Conditions: Psoriasis
Keywords: Moderate to severe chronic plaque psoriasis anti TNF α CDP 870 Cimzia® certolizumab pegol retreatment
Sponsor: UCB Pharma
Start date: 2006-04-01; Completion date: 2007-05-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to assess differences in PASI scores between Week 12 of Study C87040 \[NCT00245765\] and Week 12 of re-treatment in this study.

Detailed description:

Arms: arm 1: Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter. arm 2: Subcutaneous injections of 400 mg every 2 weeks.
Interventions: intervention 1: Certolizumab Pegol (Cimzia®)
Intervention descriptions: intervention 1: * Pharmaceutical Form: Solution for injection in pre-filled syringe
* Route of Administration: Subcutaneous use
* Dose and Administration details :

  2 x 1 mL Certolizumab Pegol at Week 0, followed by
* 1 x 1 mL Certolizumab Pegol plus 1 x 1 mL Placebo (for blinding reasons) in the Certolizumab Pegol 200 mg arm at Weeks 2, 4, 6, 8 and 10
* 2 x 1 mL Certolizumab Pegol in the Certolizumab Pegol 400 mg arm at Weeks 2, 4, 6, 8 and 10

Protocol documents:
Clinical trial NCT00336544
Conditions: Pneumonia
Keywords: Pneumonia Respiratory Infection Infectious Advanced Life Sciences Lung Pulmonary Cethromycin Clarithromycin Biaxin
Sponsor: Advanced Life Sciences, Inc.
Start date: 2006-06-01; Completion date: 2007-05-01
Enrollment: 522 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of cethromycin to clarithromycin for the treatment of mild to moderate community-acquired pneumonia (CAP).

Detailed description:
Lower respiratory tract infections remain one of the leading causes of death worldwide. Increasing rates of antibiotic resistance and newer, more pervasive pneumonia-causative pathogens contribute to this statistic. Currently available macrolide antibiotics for the treatment of community-acquired pneumonia are slowly losing effectiveness, resulting in the need to develop newer drugs to fight resistant infections. In this study, we compare the safety and efficacy of a common macrolide, clarithromycin, to a new ketolide, cethromycin.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Cethromycin intervention 2: Clarithromycin
Intervention descriptions: intervention 1: Cethromycin 300 mg once per day (QD) for 7 days, administered orally intervention 2: Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally

Protocol documents:
Clinical trial NCT00350636
Conditions: Overactive Bladder
Keywords: OAB, anticholineric, oxybutynin, urge urinary incontinence
Sponsor: Watson Pharmaceuticals
Start date: 2006-06-01; Completion date: 2007-05-01
Enrollment: 789 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.

Detailed description:

Arms: arm 1: Oxybutynin topical gel arm 2: placebo topical gel
Interventions: intervention 1: Oxybutynin topical gel intervention 2: Placebo topical gel
Intervention descriptions: intervention 1: 1 application daily to skin for 12 weeks intervention 2: 1 application daily to skin for 12 weeks

Protocol documents:
Clinical trial NCT00368069
Conditions: Epilepsy
Keywords: Epilepsy Keppra® XR Levetiracetam XR Extended release
Sponsor: UCB Pharma
Start date: 2006-08-01; Completion date: 2007-05-01
Enrollment: 158 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.

Detailed description:

Arms: arm 1: Keppra® extended release formulation -XR arm 2: placebo
Interventions: intervention 1: Keppra® extended release formulation - XR intervention 2: Placebo
Intervention descriptions: intervention 1: 500mg extended release oral tablet, 2 tablets once daily intervention 2: oral tablets, 2 tablets once daily

Protocol documents:
Clinical trial NCT00396383
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma Stem cell mobilization apheresis
Sponsor: Genzyme, a Sanofi Company
Start date: 2004-11-01; Completion date: 2007-05-01
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe and well tolerated in multiple myeloma (MM) patients. In addition, this study determines if plerixafor alone can be used to mobilize peripheral blood progenitor cells (PBPCs) for transplantation in MM patients. The minimum number of CD34+ cells to collect is 2\*10\^6 CD34+ cells/kg and the target is ≧4\*10\^6 CD34+ cells/kg. Success of transplant engraftment will be measured by the number of days to polymorphonuclear leukocytes (PMN) and platelet (PLT) engraftment. Durability of transplant will be assessed for a minimum of one year.

Detailed description:
This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe and well tolerated in multiple myeloma (MM) patients. In addition, this study determines if 240 µg/kg plerixafor alone can be used to mobilize peripheral blood progenitor cells (PBPCs) for transplantation in MM patients. The minimum number of CD34+ cells to collect is 2\*10\^6 CD34+ cells/kg and the target is ≧4\*10\^6 CD34+ cells/kg. Success of transplant engraftment will be measured by the number of days to polymorphonuclear leukocytes (PMN) and platelet (PLT) engraftment. Durability of engraftment will be assessed for a minimum of one year.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Arms: arm 1: Participants with MM who were eligible for autologous peripheral blood stem cell transplantation.
Interventions: intervention 1: plerixafor
Intervention descriptions: intervention 1: Participants were given a 240 µg/kg dose of plerixafor by subcutaneous injection in the morning followed by apheresis 6 hours later. Daily treatment with plerixafor followed by apheresis was administered for up to 4 consecutive days or until 4\*10\^6 CD34+ cells/kg body weight had been collected.

Protocol documents:
Clinical trial NCT00486330
Conditions: HIV Infections
Keywords: HIV Pharmacokinetics Buprenorphine Tipranavir HIV Seronegativity
Sponsor: Yale University
Start date: 2006-05-01; Completion date: 2007-05-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to examine the effect of tipranavir combined with ritonavir, medications for the treatment of HIV-infection, on buprenorphine/naloxone (BUP) in people who have been receiving the same dose of buprenorphine/naloxone for at least 3 weeks before study entry.

Detailed description:
A large number of people with HIV-infection obtained HIV through injection drug use. Some of these people are currently being treated with buprenorphine/naloxone (BUP) for their addiction and with medications for HIV infection. Tipranavir is a medication that was recently approved by the Food and Drug Administration (FDA) for the treatment of HIV-infection. Tipranavir is given in combination with another HIV medication, ritonavir. Tipranavir acts by making it more difficult for the virus that causes AIDS to multiply and cause more damage to the immune system. Ritonavir acts by increasing the amount of tipranavir available to fight HIV.

Earlier studies looking at the combination of BUP and HIV medications have shown that BUP and some HIV medications act differently when taken together. It is important to learn if taking BUP and HIV medications together results in changes in the blood level of either medication. If the HIV medication decreases the level of BUP in the blood, an individual taking BUP and HIV medications may experience symptoms of withdrawal ("dope sickness"), even while taking their usual dose of BUP. On the other hand, if BUP decreases the amount of HIV medication in the blood, then the HIV medication may be less effective in controlling HIV infection. It is therefore important to learn if tipranavir/ritonavir and BUP will affect each other when taken together.

In order to learn about the effects of BUP on tipranavir/ritonavir, we will need to measure the amount of BUP in your blood for 24 hours after you have taken tipranavir/ritonavir and BUP together and then compare that to the amount of BUP in your blood when you are not taking tipranavir/ritonavir.

Arms: arm 1: None
Interventions: intervention 1: Buprenorphine, Tipranavir and ritonavir
Intervention descriptions: intervention 1: After determining buprenorphine/naloxone pharmacokinetics over a 24-hour period, tipranavir/ritonavir and buprenorphine/naloxone will be coadministered for 7 days.

Protocol documents: