ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00678470
Conditions: Moderate to Severe Psoriasis
Sponsor: University of California, San Francisco
Start date: 2007-09-01; Completion date: 2011-06-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-center, open-label, pilot study. A total of 18 subjects will be enrolled in this 6 month study to evaluate whether the response to intralesional alefacept injections prior to the standard course of intramuscularly (IM) treatment can predict clinical outcomes in psoriasis patients. One lesion with a psoriasis severity assessment score greater than 3 and an induration score greater than 1 will be identified on each patient. Each lesion will receive only one intralesional alefacept injection during the first three weeks of the study (1 lesion per week). Following a 2 week observation period, subjects will undergo a standard 12 week course of weekly intramuscular alefacept injections. The Psoriasis Area Severity Index (PASI) score will be used to determine the effectiveness of the intramuscular alefacept treatments. An 8 week follow-up period will begin after the last dose of alefacept is administered where safety and efficacy measures will continue to be monitored as outlined in the study procedures. The hypothesis is that the response to intralesional alefacept injections, whether it is positive or no benefit, will predict the clinical response to intramuscular alefacept administration.

Detailed description:
See Brief Summary

Arms: arm 1: Investigational intervention without random assignment
Interventions: intervention 1: Intralesional Alefacept
Intervention descriptions: intervention 1: Patients enrolled in this study will receive intralesional alefacept injections to a single psoriatic plaque at week 0. After a two week observation period, patients will receive 15 mg intramuscular alefacept for 12 weeks.

Protocol documents:
Clinical trial NCT00706355
Conditions: Neoplasms
Sponsor: Pfizer
Start date: 2008-08-01; Completion date: 2011-06-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
PF-04217903 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-04217903 is a new member in a class of drugs called c-Met/hepatocyte growth factor receptor tyrosine kinase inhibitors. This research study is the first time PF-04217903 will be given to patients. PF-04217903 is taken by mouth daily.

Detailed description:
The study was prematurely discontinued due to a strategic development decision by Pfizer on 10FEB2012. The decision to terminate was not based on any safety concerns.

Arms: arm 1: None
Interventions: intervention 1: PF-04217903
Intervention descriptions: intervention 1: Escalating doses of PF-04217903 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 50 mg BID to 1000 mg BID. A cycle is considered to be 21 days

Protocol documents:
Clinical trial NCT00717275
Conditions: Brain Metastases
Keywords: Brain Metastases Temozolomide Temodar TMZ Stereotactic Radiosurgery SRS
Sponsor: University of Florida
Start date: 2008-09-01; Completion date: 2011-06-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if administering temozolomide after completion of stereotactic radiosurgery helps control existing brain metastases and prevents the developement of new brain metastases.

Detailed description:
Brain metastases represent a heterogenous group of system tumors whose presence in the central nervous system result in profound neurological devastation. Existing therapies for brain metastases are focused on improving both neurologic function and survival. Therapies aimed at controlling the tumor both at the site of the brain metastases and the rest of the brain have the potential to improve outcomes and quality of life. The combined use of stereotactic radiosurgery followed by temozolomide may represent such a strategy.

Arms: arm 1: None
Interventions: intervention 1: Temozolomide
Intervention descriptions: intervention 1: 75 mg/m2 taken by mouth once a day for 14 out of 28 consecutive days until progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00745368
Conditions: HIV Infections
Keywords: HIV Raltegravir pharmacokinetics Treatment Experienced
Sponsor: University of Rochester
Start date: 2008-09-01; Completion date: 2011-06-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.

Detailed description:
Although we have many medications to fight the HIV virus, very little is known about how much of these medications get into the genital tract. Raltegravir is a new HIV medication that blocks HIV growth and lowers the amount of virus in the blood in a way that is different than all other currently available HIV medications. Raltegravir was recently approved by the Food and Drug Administration (FDA) for use in HIV infected patients, but there is very little information concerning how much raltegravir will reach the genital tract of men or women. The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.

Arms: arm 1: Raltegravir 400 mg tablets twice daily
Interventions: intervention 1: Raltegravir
Intervention descriptions: intervention 1: 400 mg tablets twice daily during duration of trial

Protocol documents:
Clinical trial NCT00756730
Conditions: HIV Infections
Keywords: lopinavir ritonavir atazanavir fosamprenavir darunavir anti-retroviral AIDS HIV LARD triglyceride protease inhibitors treatment Experienced
Sponsor: Community Research Initiative of New England
Start date: 2008-09-01; Completion date: 2011-06-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
For participants with HIV taking either lopinavir or fosamprenavir who have elevated triglycerides, this trial will study the change in triglycerides after switching protease inhibitors.

Detailed description:
This Phase IV trial will look at lipid and virologic responses after a switch to a more lipid-friendly antiretroviral regimen. Participants will be randomized to receive either boosted atazanavir or boosted darunavir given once daily, along with background NRTIs. This 24-week study will require 4 visits after randomization for evaluation, monitoring, and lab studies.

Arms: arm 1: We designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. For this arm the sbject switched to DRV/r at a dose 800mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study. arm 2: We designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. For this are the subject switched to ATV/r at a dose of 300mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study
Interventions: intervention 1: ATV/r intervention 2: DRV/r
Intervention descriptions: intervention 1: Switch to ATV/r at a dose of 300mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study. intervention 2: We designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. Switch to DRV/r at a dose 800mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.

Protocol documents:
Clinical trial NCT00759408
Conditions: Pulmonary Hypertension
Keywords: primary pulmonary hypertension secondary pulmonary hypertension due to left heart failure secondary pulmonary hypertension due to other causes patients without pulmonary disease or pulmonary hypertension
Sponsor: Brigham and Women's Hospital
Start date: 1999-02-01; Completion date: 2011-06-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is is to determine the effect, on the lung circulation, of BQ-123, an investigational compound which is not approved by the FDA.

Detailed description:
Endothelin levels are increased in patients with pulmonary hypertension. We wish to compare the effect of an endothelin antagonist on pulmonary hypertension due to a variety of causes.

Arms: arm 1: BQ-123
Interventions: intervention 1: BQ-123
Intervention descriptions: intervention 1: 6-120 µg/min

Protocol documents:
Clinical trial NCT00763815
Conditions: Diabetes Mellitus Type 2
Keywords: hyperglycemia GLP-1 pioglitazone
Sponsor: Sanofi
Start date: 2008-09-01; Completion date: 2011-06-01
Enrollment: 484 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to pioglitazone with or without metformin, over a period of 24 weeks of treatment, followed by an extension.

The primary objective is to assess the effects of lixisenatide when added to pioglitazone on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to 6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic model assessment of beta-cell function \[HOMA-beta\]), and on fasting plasma insulin (FPI), to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

Detailed description:
Patients who complete the 24-week main double-blind treatment would undergo a variable double-blind extension treatment, which ends for all patients at approximately the schedule date of Week 76 visit (Visit 25) for the last randomized patients.

Arms: arm 1: 2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment. arm 2: 2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Pen auto-injector intervention 4: Pioglitazone intervention 5: Metformin
Intervention descriptions: intervention 1: Self-administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: Self-administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 3: None intervention 4: Dose to be kept stable. intervention 5: Metformin, if given to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.

Protocol documents:
Clinical trial NCT00772590
Conditions: HIV Infections
Keywords: HIV antiretroviral therapy intensification suboptimal CD4+ T cell response virological suppression bovine colostrum raltegravir
Sponsor: Kirby Institute
Start date: 2009-03-01; Completion date: 2011-06-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
A research study to measure the effect on CD4 counts of adding to current anti-retroviral regimen raltegravir with or without hyper-immune bovine colostrum.

Detailed description:
The primary objective of this study is to measure the effect on CD4+ T cell outcome as measured by the mean time weighted CD4+ T cell count change over 24 weeks of two interventions: (I) cART intensification with raltegravir and (II) cART combined with hyper-immune bovine colostrum in HIV-1 infected individuals who have failed to achieve a CD4+ T cell count greater than 350 cells/µL despite persistent HIV plasma viraemia below 50 copies/mL on cART.

Eligible patients will be randomised to one of four arms. I. Raltegravir + hyper-immune bovine colostrum placebo II. Raltegravir placebo + hyper-immune bovine colostrum III. Raltegravir + hyper-immune bovine colostrum IV. Raltegravir placebo + hyper-immune bovine colostrum placebo

Arms: arm 1: Raltegravir and hyper-immune bovine colostrum arm 2: Hyper-immune bovine colostrum and Raltegravir placebo arm 3: Raltegravir and Hyper-immune Bovine Colostrum Placebo arm 4: Raltegravir placebo and hyper-immune bovine colostrum placebo
Interventions: intervention 1: Raltegravir intervention 2: Hyper-immune Bovine Colostrum intervention 3: raltegravir placebo intervention 4: Hyper-immune Bovine Colostrum placebo intervention 5: raltegravir and hyper-immune bovine colostrum
Intervention descriptions: intervention 1: Tablets, 400mg, twice daily intervention 2: Tablet, 1800mg, twice daily intervention 3: One tablet, twice daily intervention 4: Three tablets twice daily intervention 5: 400mg twice daily raltegravir and 1800mg twice daily of hyper-immune bovine colostrum

Protocol documents:
Clinical trial NCT00775671
Conditions: Metabolic Syndrome
Sponsor: Vanderbilt University
Start date: 2008-10-01; Completion date: 2011-06-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Test the hypothesis that nebivolol treatment improves fibrinolytic balance and insulin sensitivity compared to metoprolol treatment in individuals with metabolic syndrome.

Detailed description:
1. Test the hypothesis that nebivolol treatment decreases PAI-1 antigen and activity and improves fibrinolytic balance compared to metoprolol treatment in individuals with metabolic syndrome.
2. Test the hypothesis that nebivolol treatment improves insulin sensitivity compared to metoprolol treatment in individuals with metabolic syndrome.

Arms: arm 1: Nebivolol 5mg by mouth daily for 12 weeks. arm 2: Metoprolol ER 100mg by mouth daily for 12 weeks.
Interventions: intervention 1: placebo intervention 2: Nebivolol intervention 3: Metoprolol
Intervention descriptions: intervention 1: Placebo pill by mouth daily for 21 days followed by either Nebivolol 5 mg by mouth daily or metoprolol ER 100mg by mouth daily for 12 weeks. intervention 2: Nebivolol 5 mg by mouth daily for 12 weeks. intervention 3: Metoprolol ER 100mg by mouth daily for 12 weeks.

Protocol documents:
Clinical trial NCT00784810
Conditions: Osteoarthritis Back Pain
Keywords: Efficacy, tolerability, moderate/severe, oxycodone/naloxone codeine/paracetamol, chronic low back pain, osteoarthritis
Sponsor: Napp Pharmaceuticals Limited
Start date: 2009-02-01; Completion date: 2011-06-01
Enrollment: 247 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare oxycodone/naloxone combination tablet and codeine/paracetamol tablets in the treatment of moderate to severe chronic low back pain or pain due to osteoarthritis.

Detailed description:
This is a randomised, double-blind, double-dummy, parallel group, 12-week study to assess the efficacy and tolerability of oxycodone/naloxone compared to codeine/paracetamol tablets in the treatment of moderate to severe chronic low back pain or moderate to severe pain due to OA of the hip and /or knee.

The screening period will be 3 - 7 days duration. If a subject meets all the screening criteria they may enter the Run-in Period.

During the screening period subjects will continue to take their pre-study pain medication.

The run-in period will be 7 - 14 days duration. During the run-in period subjects will continue to take their pre-study pain medication.

Visit 3 will occur at the end of the Run-in Period (7-14 days after Visit 2). To qualify for entry into the treatment period of the study, subjects must have uncontrolled pain as shown by average daily pain scores of \>5 on 4 of the last 7 days of the run in period.

Eligible subjects will be randomised to either oxycodone/naloxone or codeine/paracetamol tablets. Subjects will receive double-blind study medication for up to 12 weeks.

Arms: arm 1: Oxycodone/Naloxone combination arm 2: Codeine/Paracetamol combination
Interventions: intervention 1: Oxycodone/Naloxone intervention 2: Codeine/Paracetamol
Intervention descriptions: intervention 1: 5/2.5, 10/5 and 20/10 mg oxycodone/naloxone combination, 12 hourly intervention 2: 15/500 and 30/500 mg codeine/paracetamol tablets, 2 tablets 6 hourly

Protocol documents:
Clinical trial NCT00784849
Conditions: Breast Cancer
Keywords: Breast cancer diagnostic lymph nodes
Sponsor: Louisiana State University Health Sciences Center in New Orleans
Start date: 2004-11-01; Completion date: 2011-06-01
Enrollment: 62 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to develope a one-step procedure to perform a biopsy of axillary lymph nodes on the same side as the breast tumor in women diagnosed with breast cancer.

Detailed description:
This study proposes the use of a newly developed experimental radioactive dye (radiolabeled methylene blue). On the day of surgery, the patient receives a single injection of the experimental radioactive dye after anesthesia. The injection will be in the location around the breast tumor. The surgeon makes a small cut in the armpit on the side of the cancer and is able to locate the lymh nodes that collect drainage from the cancerous area by detecting lymph nodes with higher radioactivity using a hand-held detector (a Geiger counter-like device) and/or visually identifying lymph nodes stained blue by the dye. These lymph nodes are then removed and analyzed by pathologists for the presence of cancer.

Arms: arm 1: One arm diagnostic
Interventions: intervention 1: Methylene blue
Intervention descriptions: intervention 1: 1 mC1

Protocol documents:
Clinical trial NCT00786422
Conditions: Venous Thrombosis Deep Vein Thrombosis
Keywords: Embolism and Thrombosis Pulmonary Embolism Embolism Venous Thrombosis Thrombosis Enzyme Inducers CYP Inducers Cohort Study Pharmacologic Actions Respiratory Tract Diseases Lung Diseases Vascular Diseases Human Immunodeficiency Virus (HIV) Neurologic disease Additional relevant MeSH terms: Fibrin Modulating Agents Anticoagulants Therapeutic Uses Hematologic Agents Enzyme Inhibitors Cardiovascular Diseases Cardiovascular Agents
Sponsor: Bayer
Start date: 2009-05-01; Completion date: 2011-06-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter, cohort study evaluating an adapted rivaroxaban dose regimen in patients with acute, proximal deep-vein thrombosis (DVT) or acute pulmonary embolism (PE) who concomitantly use a strong cytochrome P450 isoenzyme 3A4 (CYP 3A4) inducer for the entire 3-month study duration.

Detailed description:
The following laboratory variables were determined at baseline at the local laboratories: Hemoglobin, platelets, activated partial thromboplastin time (aPTT), international normalized ratio (INR), alanine aminotransferase (ALT), and creatinine.

Arms: arm 1: None
Interventions: intervention 1: Rivaroxaban (Xarelto, BAY59-7939)
Intervention descriptions: intervention 1: Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.

Protocol documents:
Clinical trial NCT00798590
Conditions: Critically Ill Hypoglycemia
Keywords: Intensive insulin therapy (IIT) Insulin infusion Tight glycemic control Intensive Care Units
Sponsor: Johns Hopkins University
Start date: 2008-12-01; Completion date: 2011-06-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this present proposal is to examine the efficacy of GLP-1 administered to control blood glucose in critically ill patients.

Detailed description:
All patients whom on admission to the ICU (surgical, burn, \& cardiac) who are expected to receive intensive insulin therapy for at least 72 hours are eligible to be enrolled. Once enrolled, the patients will be randomized to one of two groups: the experimental (intravenous GLP-1 infusion for 72 hours) or control groups (intravenous 0.9% sodium chloride (NaCl) infusion for 72 hours) in a double masked fashion. While enrolled, all patients will receive standard-of-care insulin therapy. Both groups will be maintained on the standard ICU specific protocol for glucose control.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Glucagon-Like Peptide-1 intervention 2: Saline
Intervention descriptions: intervention 1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours. intervention 2: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.

Protocol documents:
Clinical trial NCT00801723
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Sponsor: Bausch Health Americas, Inc.
Start date: 2008-12-01; Completion date: 2011-06-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized, double-blind, comparative study versus placebo performed in patients from studies CB-01-02/01 (NCT00679432), CB-01-02/02 (NCT00679380), or CB-01-02/06 (NCT01100112) who achieved ulcerative colitis disease activity index (UCDAI) remission after 8 weeks of treatment.

Patients in remission at the End of Study visit will be given the opportunity to enter the 12-month Maintenance Phase study outlined in this protocol (CB-01-02/04). The End of Study visit in studies 01, 02, and 06 will be set as the Visit 1 (Day 0) of this study. There will be no interruption of study treatment between the parent studies and this study.

It is planned that approximately 150 patients will be enrolled in the study. Patients will be randomly assigned to two groups to receive either budesonide MMX 6 mg or placebo irrespective of the treatment assigned in studies 01, 02, or 06. Treatments will be administered once a day after breakfast for a maximum of 12 months or up to the occurrence of the first clinical relapse, where clinical relapse is defined as combined recurrence of rectal bleeding and stool frequency ≥ 1-2 stools/day above normal for the patient (score ≥ 1 in both UCDAI items).

During the study, patients will be assessed for safety and efficacy at Visit 1 and after 1, 3, 6, 9, and 12 months of treatment.

Patients will be contacted by telephone on a monthly basis for safety assessment. In case of occurrence of symptoms suggestive of clinical relapse, patients will attend an unscheduled visit at any time during the study.

Detailed description:

Arms: arm 1: One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast. arm 2: One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Interventions: intervention 1: Budesonide MMX 6 mg Tablet intervention 2: Placebo Tablet
Intervention descriptions: intervention 1: Budesonide MMX 6 mg Tablet once daily. intervention 2: Placebo Tablet once daily.

Protocol documents: