ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00398476
Conditions: Rhinitis, Allergic, Perennial
Keywords: taste questionnaire preference attributes odor after taste scent
Sponsor: GlaxoSmithKline
Start date: 2006-12-01; Completion date: 2006-12-04
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objectives of this study are to evaluate and compare patient preference for FF (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of allergic rhinitis following single-dose administration.

Detailed description:

Arms: arm 1: 200 micrograms (mcg); an aqueous suspension of microfine FP arm 2: 110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF
Interventions: intervention 1: fluticasone propionate (FP) intervention 2: fluticasone furoate (FF)
Intervention descriptions: intervention 1: 200 micrograms (mcg); an aqueous suspension of microfine FP intervention 2: 110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF

Protocol documents:
Clinical trial NCT00160654
Conditions: Epilepsy, Partial
Keywords: Epilepsy Partial Onset Seizures Keppra Levetiracetam
Sponsor: UCB Pharma
Start date: 2003-11-24; Completion date: 2006-12-12
Enrollment: 251 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Community based study assessing safety and efficacy of levetiracetam in partial onset seizures.

The optimal dose in daily clinical practice will be used.

Detailed description:

Arms: arm 1: Subjects received open-label Levetiracetam.
Interventions: intervention 1: Levetiracetam
Intervention descriptions: intervention 1: * Pharmaceutical form: oral tablets
* Concentration: 500 mg
* Route of administration: Oral use

Protocol documents:
Clinical trial NCT00156936
Conditions: Alcoholism Opiate Dependence
Sponsor: Alkermes, Inc.
Start date: 2004-08-01; Completion date: 2007-01-01
Enrollment: 108 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®).

Planned treatment duration was up to 3 years. Alkermes terminated the study for business purposes in December 2006. The median duration of treatment among all subjects in this extension study was 43 weeks.

Detailed description:
From the date of successful completion of Study ALK21-006 (base study \[NCT01218997\])), all subjects, including those who received oral naltrexone during the base study, were given the option to enroll in this extension study.

Study investigators ensured that subjects were opioid-free and did not demonstrate evidence of withdrawal prior to administration of VIVITROL therapy. If the investigator suspected recent clinically significant opioid use, a naloxone challenge test was performed. The naloxone challenge was not performed in a subject presenting clinical signs or symptoms of opioid withdrawal or in a subject whose urine contained opioids.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Medisorb naltrexone 380 mg intervention 2: Oral naltrexone to Medisorb naltrexone 380 mg
Intervention descriptions: intervention 1: Administered via intramuscular (IM) injection once every 4 weeks. Subjects in this dosing group also received this treatment throughout the base study. intervention 2: Subjects in this dosing group received oral naltrexone 50 mg in the base study, but received only Medisorb naltrexone 380 mg in this extension study, administered via IM injection once every 4 weeks.

Protocol documents:
Clinical trial NCT00369577
Conditions: Schizophrenia
Keywords: Agitation Schizophrenia
Sponsor: Alexza Pharmaceuticals, Inc.
Start date: 2006-08-01; Completion date: 2007-01-01
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess efficacy and safety of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients. The study will be conducted in 120 agitated schizophrenic patients - either newly admitted to a hospital setting or a research unit for acute agitation or already in hospital for chronic underlying conditions. Patients meeting entry criteria will be randomized to one of two doses of Staccato Loxapine or to Staccato Placebo. Following administration of study drug, assessment of agitation state will be conducted at serial time points using standard agitation scales over a 24 hour period.

Detailed description:

Arms: arm 1: Inhaled Staccato Placebo, single dose arm 2: Inhaled Staccato Loxapine 5 mg, single dose arm 3: Inhaled Staccato Loxapine 10 mg, single dose
Interventions: intervention 1: Inhaled Placebo intervention 2: Inhaled Loxapine 5 mg intervention 3: Inhaled Loxapine 10 mg
Intervention descriptions: intervention 1: Inhaled Placebo, single dose intervention 2: Inhaled Staccato Loxapine 5 mg, single dose intervention 3: Inhaled Staccato Loxapine 10 mg, single dose

Protocol documents:
Clinical trial NCT00944645
Conditions: Dyslipidemia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-10-01; Completion date: 2007-01-01
Enrollment: 188 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.

Detailed description:

Arms: arm 1: MK0524A Source 1 (Phase III manufacturing site) arm 2: MK0524A Source 2 (commercial manufacturing site)
Interventions: intervention 1: niacin (+) laropiprant (Source 1) intervention 2: Comparator: niacin (+) laropiprant (Source 2)
Intervention descriptions: intervention 1: Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods. intervention 2: Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 2 in one of two treatment periods.

Protocol documents:
Clinical trial NCT00106704
Conditions: Diabetes Mellitus, Type 2
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-03-01; Completion date: 2007-01-01
Enrollment: 441 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with Type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: Sitagliptin 10 mg tablet daily for 54 weeks arm 2: Placebo tablet daily for 24 weeks followed by Pioglitazone tablet daily for 30 weeks
Interventions: intervention 1: Comparator: Sitagliptin intervention 2: Comparator: Placebo intervention 3: Comparator: Pioglitazone
Intervention descriptions: intervention 1: sitagliptin 10 mg tablet, once daily for 54 weeks intervention 2: Placebo oral tablet once daily for 24 weeks intervention 3: Pioglitazone 30 mg tablet once daily for 30 weeks

Protocol documents:
Clinical trial NCT00146172
Conditions: Breast Neoplasms
Keywords: Tumors Neratinib HKI-272 Nerlynx
Sponsor: Puma Biotechnology, Inc.
Start date: 2003-11-01; Completion date: 2007-01-01
Enrollment: 73 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to evaluate the safety and tolerability as well as find the maximum tolerated dose (MTD) for HKI-272. In addition, this study will examine the effects of the study drug on your tumor, and how your body uses and eliminates HKI-272.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None
Interventions: intervention 1: neratinib
Intervention descriptions: intervention 1: HKI-272

Protocol documents:
Clinical trial NCT00148759
Conditions: HIV Infections
Keywords: Sex differences Pharmacokinetic Lopinavir/ritonavir Treatment Experienced HIV-infection
Sponsor: Emory University
Start date: 2005-06-01; Completion date: 2007-01-01
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The levels of lopinavir achieved in the blood following oral ingestion of standard doses of Kaletra (lopinavir/ritonavir) in HIV-infected men was compared with those achieved in HIV-infected women receiving the same dose of the drug.

Detailed description:
The association between patient sex and the tolerability of antiretroviral drugs (ARVs) is increasingly being recognized. Several lines of evidence suggest that women are more likely than men to develop side effects to ARVs. On the other hand, it has been generally accepted that the efficacies of the ARVs are similar in both sexes. However, recent studies suggest that this may not always be the case. In addition to these observed sex-related differences in the effects of ARVs, there is growing evidence that the pharmacokinetic profile of some of these drugs may be different among male and female HIV infected patients.

The fact that female sex is a risk factor for enhanced antiretroviral effects (including toxicities) has an important implication, particularly from a global health perspective as women now represent the fastest growing segment of the HIV/AIDS epidemic. Therefore, an understanding of the magnitude, clinical significance, and the mechanisms underlying this phenomenon deserves further study. Knowledge acquired from such studies will likely contribute to improved survival among female HIV-infected patients, through optimization of antiretroviral therapeutic regimens in manners that minimize serious adverse effects and improve adherence.

Similarly, the influence of race on the pharmacological effects of ARVs deserves further investigation. Although, there is no reason to believe based on available evidence that racial differences exist in the pharmacological effects of ARVs, the need however exists to explore the influence of race on ARVs pharmacokinetics and treatment outcomes. This is so because data on race related differences on ARV effects is limited, and in addition, people of ethnic minority have been disproportionately under represented in clinical trials involving these drugs in spite of the fact that they bear a larger burden of the HIV epidemic.

Our study will examine the influence of race and sex on the 24-hr pharmacokinetics of lopinavir/ritonavir (an antiretroviral agent commonly used in naïve patients) following a switch from LPV/r 400/100 mg twice daily to 800/200 mg once daily dosing. Tolerability (measured by toxicity grade of diarrhea) and change in quality of life following switch from twice daily to once daily dosing will also be assessed using appropriate validated measurement tools.

Arms: arm 1: LPV/r 800/200 mg once daily arm 2: LPV/r 800/200 mg once daily
Interventions: intervention 1: LPV/r
Intervention descriptions: intervention 1: LPV/r 800/200 mg once daily

Protocol documents:
Clinical trial NCT00156923
Conditions: Alcoholism
Keywords: Alcohol dependence
Sponsor: Alkermes, Inc.
Start date: 2003-10-01; Completion date: 2007-01-01
Enrollment: 108 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).

Detailed description:
Enrolled subjects continued to receive the same dose strength of Medisorb naltrexone (ie, 190 mg or 380 mg) they had received in Study ALK21-003-EXT (NCT01218971). Assigned dose strength (high or low) was not revealed to the subject, the study investigators, or any blinded member of the clinical study team for the duration of the study period. Placebo was not administered.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Medisorb naltrexone 380 mg intervention 2: Medisorb naltrexone 190 mg
Intervention descriptions: intervention 1: Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years. intervention 2: Administered via IM injection once every 4 weeks for up to 3.5 years.

Protocol documents:
Clinical trial NCT00163657
Conditions: End Stage Liver Disease Hepatitis C
Keywords: Hepatitis C Virus Immunosuppressive Agents
Sponsor: Baylor Research Institute
Start date: 2002-07-01; Completion date: 2007-01-01
Enrollment: 312 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare three treatment regimens in patients who have received a liver transplant for end-stage liver disease caused by Chronic Hepatitis C infection.

Detailed description:
End-stage liver disease due to Hepatitis C virus (HCV) infection is the most common reason for liver transplantation in the United States. Patients who have HCV will always carry the virus in their body. If patients respond to treatment, the virus is no longer active. This means that although the virus is still present, it is not currently causing damage to their liver.

Because recurrence of HCV is virtually universal in HCV positive transplant recipients and is associated with long term, possibly lethal complications, the search for the most appropriate therapies must also include methods to prevent or minimize recurrence or disease progression, if the goal of improving long term outcomes for these patients is to be achieved.

Corticosteroids and high doses of immunosuppressive agents have been associated with increased rates of HCV recurrence. Finding a regimen that provides adequate immunosuppression to prevent early and late rejection episodes, and minimizes steroid usage as well as high doses of other immunosuppressive agents is highly desirable.

This study is being conducted to determine the most effective immunosuppressive regimen that will prevent allograft rejection, minimize adverse events and at the same time, prevent or reduce the incidence of HCV recurrence following liver transplant.

Arms: arm 1: immunosuppressant treatment regimens the intervention is antirejection treatment with the above labeled drugs tacrolimus and cyclosporine arm 2: immunosuppressant treatment regimensthe intervention is antirejection treatment with the above labeled drugs MMF tacrolimus and cyclosporine arm 3: immunosuppressant treatment regimens
Interventions: intervention 1: Daclizumub intervention 2: Tacrolimus intervention 3: Cyclosporine intervention 4: MMF
Intervention descriptions: intervention 1: anti-rejection drug intervention 2: anti rejection drug intervention 3: anti rejection drug intervention 4: anti rejection drug

Protocol documents:
Clinical trial NCT00251693
Conditions: Esophagitis, Reflux Esophagitis, Peptic
Keywords: Erosive Esophagitis
Sponsor: Takeda
Start date: 2005-12-01; Completion date: 2007-01-01
Enrollment: 2038 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.

Detailed description:
This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8-week treatment period. This study will compare the efficacy of dexlansoprazole MR (60 mg QD and 90 mg QD) with that of lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease-related symptoms. The study consists of two periods, a screening period (maximum 21 days) and a treatment period, which will last 8 weeks.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Dexlansoprazole MR intervention 2: Dexlansoprazole MR intervention 3: Lansoprazole
Intervention descriptions: intervention 1: Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks. intervention 2: Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks. intervention 3: Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Protocol documents:
Clinical trial NCT00251719
Conditions: Esophagitis, Reflux Esophagitis, Peptic
Keywords: Erosive Esophagitis
Sponsor: Takeda
Start date: 2005-12-01; Completion date: 2007-01-01
Enrollment: 2054 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole (30 mg daily) in healing subjects with endoscopically proven erosive esophagitis.

Detailed description:
This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8 week treatment period. This study will compare the efficacy of Dexlansoprazole MR (60 mg and 90 mg) with that of Lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease related symptoms. The study consists of two periods, a screening period (maximum 21 days) and a treatment period, which will last up to 8 weeks.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Dexlansoprazole MR intervention 2: Dexlansoprazole MR intervention 3: Lansoprazole
Intervention descriptions: intervention 1: Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks. intervention 2: Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks. intervention 3: Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Protocol documents:
Clinical trial NCT00257322
Conditions: Colon Cancer Rectal Cancer
Keywords: Metastatic colon cancer Metastatic rectal cancer
Sponsor: University of California, Irvine
Start date: 2003-04-01; Completion date: 2007-01-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
While new treatments for metastatic and recurrent colorectal cancer have become available over the past several years, this disease remains incurable with a limited life expectancy from the time of diagnosis. New strategies for treatment of disseminated colorectal cancer are needed. Under this proposal, patients with advanced colorectal cancer will receive Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) to stimulate endogenous dendritic cells and enhance anti-tumor immune mechanisms. This will be combined with standard chemotherapy and patients will be followed for response and overall survival. Detailed correlative laboratory analysis will also be performed to define the extent of dendritic cell and cellular immune system stimulation.

Detailed description:

Arms: arm 1: Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250ug/m\^2 SQ QD with a cap of 500mcg SQ QD
Interventions: intervention 1: GM-CSF
Intervention descriptions: intervention 1: 250ug/m\^2 SQ QD with a cap of 500mcg SQ QD

Protocol documents:
Clinical trial NCT00263887
Conditions: Alpha 1-Antitrypsin Deficiency
Keywords: alpha 1 proteinase inhibitor alpha1 proteinase inhibitor congenital emphysema replacement therapy
Sponsor: Grifols Therapeutics LLC
Start date: 2003-12-01; Completion date: 2007-01-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this trial was to explore the utility of evaluating emphysema progression through CT scans measuring lung density during a 2 year period of weekly infusions of either placebo or human alpha-1-antitrypsin (AAT; Prolastin®). Exacerbation data recorded in patient diaries were also collected. All efficacy data were analyzed for potential use in evaluating Prolastin efficacy in this and other clinical trials.

Detailed description:
This is a one to one randomized, placebo-controlled, clinical, exploratory study with the aim of collecting information on possible clinical endpoints i.e., the progression of emphysema by lung density measurements with CT scan and frequency of exacerbations that could be used for a subsequent placebo controlled clinical trial. Progression of disease will be investigated in 80 patients with alpha-1-antitrypsin deficiency, who will be treated with human alpha-1-antitrypsin (AAT; Prolastin®) or placebo weekly for two years to analyze the effect of treatment on lung density and exacerbations. Targeted augmentation therapy with weekly infusions of Prolastin® will be a dose of 60 mg/kg body weight (range of 51.72 to 71.43 mg per kg body weight).

Therefore, this study focuses on several questions:

* Is the 15th percentile point calculated by analysis of CT lung histograms a useful endpoint for clinical trials in AAT deficiency?
* Is quantitation of exacerbations in AAT-deficient patients a useful endpoint for clinical trials in AAT deficiency?
* Are there significant differences between the treatments in favor of Prolastin®?

Arms: arm 1: Prolastin arm 2: None
Interventions: intervention 1: Alpha1-Proteinase Inhibitor (Human) intervention 2: Albumin (Human) 20%, United States Pharmacopeia (USP)
Intervention descriptions: intervention 1: Weekly infusion of 60 mg/kg body weight for 2 years intervention 2: Weekly infusion for 2 years. Albumin (Human) 20% will be diluted with 5% glucose to a final concentration of 2.0%.

Protocol documents:
Clinical trial NCT00264303
Conditions: Chronic Idiopathic Urticaria
Keywords: Chronic Idiopathic Urticaria CUTE Levocetirizine Xyzal®
Sponsor: UCB Pharma
Start date: 2005-12-01; Completion date: 2007-01-01
Enrollment: 886 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus severity score over the first week of treatment

Detailed description:

Arms: arm 1: Levocetirizine, once daily, 4 week duration arm 2: Desloratadine, once daily, 4 week duration
Interventions: intervention 1: Levocetirizine intervention 2: Desloratadine
Intervention descriptions: intervention 1: 5mg oral capsules, once daily, 4 week duration intervention 2: 5mg oral capsules, once daily, 4 week duration

Protocol documents:
Clinical trial NCT00274716
Conditions: Hypertension
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-11-01; Completion date: 2007-01-01
Enrollment: 249 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety and efficacy of two investigational drugs (MK-0736 and MK-0916) in lowering blood pressure and body weight in patients with hypertension (high blood pressure).

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Detailed description:
Participants enrolled in the study will be separated into 2 strata based on baseline body mass index (BMI) assessments prior to being randomly assigned to study treatment. Study will include a 24-week treatment period comprised of 2 phases, A and B, each of which will 12 weeks in duration.

Arms: arm 1: Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) arm 2: Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) arm 3: Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) arm 4: Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) arm 5: Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) arm 6: Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
Interventions: intervention 1: MK0736 intervention 2: MK0916 intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents: