ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00574275
Conditions: Pancreatic Neoplasm
Keywords: metastatic pancreatic cancer angiogenesis inhibitor gemcitabine
Sponsor: Sanofi
Start date: 2007-12-01; Completion date: 2010-11-01
Enrollment: 546 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of the study was to evaluate the effectiveness of aflibercept treatment by comparison to placebo in increasing the overall survival (OS) in participants with metastatic pancreatic cancer, treated with gemcitabine.

The secondary objectives were to evaluate progression free survival, clinical benefit, overall response, safety and immunogenicity of aflibercept, in the two treatment arms (Arm 1: Aflibercept and Gemcitabine; Arm 2: Placebo and Gemcitabine).

The study included an interim analysis of OS. In accordance with the study protocol, an interim analysis was performed for the purpose of futility and overwhelming efficacy. On the basis of the interim analysis, the Data Monitoring Committee (DMC) recommended that this study be terminated for futility based on predefined boundary rules.

Detailed description:
The study included:

* A screening visit of up to 21 days prior to randomization
* Randomization at baseline
* A Treatment period (initiated within 3 days of randomization), which included 28-day treatment cycles in both arms until predefined treatment discontinuation criteria were met
* A follow-up visit 30 days after discontinuation of treatment,
* A post study treatment follow-up period until death or the study cutoff date.

The criteria for treatment discontinuation were:

* Participant (or legal representative) chose to withdraw from treatment
* The investigator thought that continuation of the study would be detrimental to the participants well-being, such as:

  * Disease progression
  * Unacceptable AEs not manageable by symptomatic therapy, dose delay, or dose modification
  * Intercurrent illness that prevented further administration of study treatment
  * Noncompliance with the study protocol
* Participant was lost to follow-up
* Unblinding of the participant's investigational treatment

Arms: arm 1: Participants with metastatic pancreatic cancer administered Placebo and 1000 mg/m\^2 Gemcitabine. arm 2: Participants with metastatic pancreatic cancer administered 4 mg/kg Aflibercept and 1000 mg/m\^2 Gemcitabine.
Interventions: intervention 1: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) intervention 2: Placebo intervention 3: Gemcitabine
Intervention descriptions: intervention 1: 4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle. intervention 2: 4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle intervention 3: 1000 mg/m\^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles.

Protocol documents:
Clinical trial NCT00586729
Conditions: Burns
Keywords: Burn Burn wound management Burn graft
Sponsor: Valleywise Health
Start date: 2009-07-01; Completion date: 2010-11-01
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy, safety, and tolerability of topical Vashe™ Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist versus 5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.

Detailed description:

Arms: arm 1: Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days. arm 2: 5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
Interventions: intervention 1: Vashe intervention 2: Mafenide acetate
Intervention descriptions: intervention 1: Antimicrobial irrigant intervention 2: Antimicrobial solution

Protocol documents:
Clinical trial NCT00606177
Conditions: Bipolar I Disorder
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2008-01-01; Completion date: 2010-11-01
Enrollment: 99 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the safety and efficacy of long-term administration of aripiprazole by performing extended administration of the treatment administered in the preceding multicenter, double-blind, placebo-controlled, parallel group-comparison trial of aripiprazole in patients with bipolar disorder experiencing a manic or mixed episode (Study 031-06-003, hereafter "Study 003") in a double-blind manner to those patients who complete Study 003 and demonstrate drug efficacy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aripiprazole intervention 2: placebo
Intervention descriptions: intervention 1: oral, 24mg(4 tablets)/day intervention 2: oral, 0mg(4tablets)/day

Protocol documents:
Clinical trial NCT00606229
Conditions: Bipolar I Disorder
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2008-01-01; Completion date: 2010-11-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To assess the safety and efficacy of long-term administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner in patients with Bipolar I Disorder experiencing a manic or mixed episode

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: oral, 24mg/day

Protocol documents:
Clinical trial NCT00606281
Conditions: Bipolar I Disorder
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2008-01-01; Completion date: 2010-11-01
Enrollment: 258 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this trial is to evaluate the clinical efficacy and safety of aripiprazole in comparison to placebo in patients with Bipolar I Disorder experiencing a manic or mixed episode.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aripiprazole intervention 2: placebo
Intervention descriptions: intervention 1: oral, 24mg/day intervention 2: oral, 0mg(4tablets)/day

Protocol documents:
Clinical trial NCT00606320
Conditions: Bipolar I Disorder
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2008-01-01; Completion date: 2010-11-01
Enrollment: 59 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To assess the safety and efficacy of long-term administration of aripiprazole by performing extended administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner to those patients who completed the preceding multicenter, double-blind, placebo-controlled, parallel group-comparison trial of aripiprazole in patients with bipolar disorder experiencing a manic or mixed episode (Study 031-06-003, hereafter "Study 003") but whose condition worsened or remained unchanged or who discontinued Study 003 between Day 14 and Day 21 due to lack of drug efficacy.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: oral, 24mg(4 tablets)/day

Protocol documents:
Clinical trial NCT00609167
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: stage II multiple myeloma stage III multiple myeloma
Sponsor: Mayo Clinic
Start date: 2006-12-01; Completion date: 2010-11-01
Enrollment: 63 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy such as cyclophosphamide and dexamethasone work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide and dexamethasone together with bortezomib may kill more cancer cells.

PURPOSE: This phase II trial is studying giving cyclophosphamide and dexamethasone together with bortezomib to see how well it works in treating patients with newly diagnosed multiple myeloma.

Detailed description:
OBJECTIVES:

Primary

\* To evaluate the response rate (complete response \[CR\], near CR \[nCR\], and very good partial response) in patients with newly diagnosed multiple myeloma treated with bortezomib in combination with cyclophosphamide and dexamethasone .

Secondary

* Determine the overall response rate (partial response, PR, or better) in these patients after 4, 8, and 12 courses of this regimen.
* Determine the duration of progression-free and overall survival of patients treated with this regimen.
* To evaluate the toxicity of this regimen in these patients.
* To evaluate the ability to successfully collect peripheral blood stem cells from these patients after 4 months of this regimen.
* To evaluate the CR or nCR rate in these patients after 8 and 12 courses of this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral cyclophosphamide on days 1, 8, 15, and 22; bortezomib IV on days 1, 4, 8 , and 11 OR days 1, 8, 15 and 22; and dexamethasone on days 1-4, 9-12, and 17-20 in courses 1 and 2 and days 1, 18, 15, and 22 in all subsequent courses. Courses repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Interventions: intervention 1: bortezomib intervention 2: cyclophosphamide intervention 3: dexamethasone
Intervention descriptions: intervention 1: First 33 patients: 1.3 mg/m\^2 IV Days 1, 4, 8 \& 11

Remaining 30 patients: 1.5 mg/m\^2 IV Days 1, 8, 15 \& 22 intervention 2: 300mg/m\^2 PO days 1, 8, 15 \& 22 intervention 3: First 33 patients: 40 mg PO Days 1-4, 9-12, 17-20

Remaining 30 patients: 40 mg PO Days 1-4, 9-12, 17-20 for cycles 1-2; Days 1, 8, 15, 22 for cycle 3+2 for cycle 3 and beyond

Protocol documents:
Clinical trial NCT00612066
Conditions: Cushing's Disease
Keywords: ACTH-producing pituitary tumor
Sponsor: Jonsson Comprehensive Cancer Center
Start date: 2007-04-01; Completion date: 2010-11-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Rosiglitazone may help pituitary tumor cells become more like normal cells, and to grow and spread more slowly.

PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients with newly diagnosed ACTH-secreting pituitary tumor (Cushing disease).

Detailed description:
OBJECTIVES:

Primary

* To assess the effect of rosiglitazone on biochemical control in patients with newly diagnosed ACTH-secreting pituitary tumor (Cushing disease).

Secondary

* To assess the effect of this drug on corticotrophin (CRH)-stimulated pituitary tumor ACTH secretion.
* To assess the overall safety and tolerability of this drug in these patients.
* To assess the overall quality of life of patients treated with this drug.
* Percentage of Reduction in 24-hour Urinary-free Cortisol Levels

OUTLINE: This is a multicenter study.

Patients receive oral rosiglitazone once daily for 7 weeks in the absence of disease progression or unacceptable toxicity.

Blood, urine, and saliva samples are collected periodically for laboratory studies. Inflammatory markers (C-reactive protein, interleukin-6 \[IL-6\], serum sialic acid, soluble intracellular and vascular adhesion molecules \[sICAM-1, and sVCAM-1\], and amyloid A) are measured at baseline and at the completion of study treatment; salivary cortisol and 24-hour urinary-free cortisol levels are measured at baseline and weekly during study treatment; dexamethasone suppression tests with serum cortisol and corticotrophin (CRH) stimulation test are performed at baseline and at the completion of study treatment; prolactin, insulin-like growth factor-1 (IGF1), thyroid function, and sex steroid hormones are measured at baseline and at the completion of study treatment; and dynamic pituitary function testing (arginine/growth hormone-releasing hormone \[GHRH\] testing to measure growth hormone secretion) is performed at baseline.

Arms: arm 1: None
Interventions: intervention 1: rosiglitazone maleate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00630786
Conditions: Colon Cancer Colorectal Cancer Rectal Cancer Metastatic Colorectal Cancer Oncology
Sponsor: Amgen
Start date: 2008-01-01; Completion date: 2010-11-01
Enrollment: 53 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an exploratory phase 1b/2, global, multicenter, single-arm, 2-part (phase 1b and 2) study of conatumumab in combination with panitumumab in patients with Metastatic Colorectal Cancer.

Detailed description:
This is an exploratory phase 1b/2, global, multicenter, single-arm, 2-part (phase 1b and 2) study of conatumumab in combination with panitumumab in patients with Metastatic Colorectal Cancer.

The objective for Part 1 is to identify a tolerable dose of conatumumab in combination with panitumumab based on the incidence of dose-limiting toxicities in patients with Metastatic Colorectal Cancer.

The objective for Part 2 is to evaluate the objective response rate stratified by Kirsten Rat Sarcoma Virus Oncogene (KRAS) status (wild-type versus mutant) in patients with Metastatic Colorectal Cancer treated with the combination of panitumumab and conatumumab (tolerable dose identified in part 1).

Arms: arm 1: Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
Interventions: intervention 1: Panitumumab intervention 2: Conatumumab
Intervention descriptions: intervention 1: Administered by intravenous infusion intervention 2: Administered by intravenous infusion

Protocol documents:
Clinical trial NCT00630812
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis mannitol mucoactive
Sponsor: Syntara
Start date: 2008-09-01; Completion date: 2010-11-01
Enrollment: 318 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and quality of life. The results of this study are to further investigate and confirm these findings in addition to examine the effect on antibiotic use and chest infections. It is hypothesised that inhaled mannitol will have beneficial effects compared to a control treatment. An open label phase of 26 weeks duration will follow the blinded 26 week phase. During the open label phase all subjects will receive active treatment.

Detailed description:

Arms: arm 1: active treatment arm 2: None
Interventions: intervention 1: inhaled mannitol intervention 2: Placebo comparator
Intervention descriptions: intervention 1: 400 mg BD for 26 + 26 weeks intervention 2: BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase

Protocol documents:
Clinical trial NCT00635024
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma
Sponsor: Mayo Clinic
Start date: 2008-05-01; Completion date: 2010-11-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Biological therapies, such as anti-thymocyte globulin, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Anti-thymocyte globulin may also make cancer cells more sensitive to melphalan. Giving anti-thymocyte globulin together with melphalan may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with melphalan works in treating patients with relapsed multiple myeloma.

Detailed description:
OBJECTIVES:

Primary

\* To evaluate the hematological response rate of anti-thymocyte globulin given in combination with melphalan in patients with relapsed multiple myeloma.

Secondary

* To assess the toxicity and tolerability of this combination in these patients.
* To assess time to disease progression in patients treated with these drugs.
* To assess survival of patients treated with these drugs. OUTLINE: Patients receive anti-thymocyte globulin IV over 6 hours and melphalan IV on day 1. Treatment repeats every 28 days for 6 courses. Patients then receive melphalan alone as above for another 6 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 2 years.

Arms: arm 1: Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m\^2)
Interventions: intervention 1: anti-thymocyte globulin intervention 2: melphalan
Intervention descriptions: intervention 1: 2.5 mg/kg intervention 2: 16 mg/m\^2

Protocol documents:
Clinical trial NCT00655473
Conditions: Coronary Heart Disease
Sponsor: Hoffmann-La Roche
Start date: 2008-03-01; Completion date: 2010-11-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 100 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dalcetrapib (RO4607381) intervention 2: Placebo
Intervention descriptions: intervention 1: 600mg po daily for 24 months intervention 2: po daily for 24 months

Protocol documents:
Clinical trial NCT00660023
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2008-08-01; Completion date: 2010-11-01
Enrollment: 124 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single-arm study will assess the efficacy and safety of monthly administration of intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of hemoglobin (Hb) levels in participants on dialysis with chronic renal anemia in routine clinical practice in Hungary. Participants currently receiving maintenance treatment with intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the starting dose derived from the erythropoiesis-stimulating agent (ESA) dose they had been receiving.

Detailed description:

Arms: arm 1: Participants with chronic renal anemia previously treated with ESA therapy will receive intravenous Mircera, also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose will be determined by the dose of ESA received prior to administration of study treatment, and subsequent doses will be adjusted to achieve target Hb concentrations.
Interventions: intervention 1: Methoxy polyethylene glycol-epoetin beta
Intervention descriptions: intervention 1: Participants will receive intravenous CERA/Mircera every month, with starting dose based on previous ESA therapy. Treatment will continue for 52 weeks.

Protocol documents:
Clinical trial NCT00664534
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2008-04-01; Completion date: 2010-11-01
Enrollment: 344 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.

Detailed description:

Arms: arm 1: Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs) arm 2: Premixed Insulin Lispro (mid-mixture or low-mixture) 1,2 or 3 injections plus OAMs
Interventions: intervention 1: Insulin Glargine intervention 2: Insulin Lispro Premix (mid-mixture and low-mixture)
Intervention descriptions: intervention 1: patient glucose-level dependent, injection, as needed per patient glucose level, 48 weeks intervention 2: patient glucose level dependent, injection, as needed per patient glucose level, 48 weeks

Protocol documents:
Clinical trial NCT00678418
Conditions: Opiate Dependence
Keywords: Addiction Opiate dependence Inpatient detoxification opioid dependence heroin dependence
Sponsor: Alkermes, Inc.
Start date: 2008-06-01; Completion date: 2010-11-01
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3 multi-center trial designed to evaluate the clinical efficacy and safety of VIVITROL® (Medisorb® naltrexone 380 mg) versus placebo when administered to adults upon discharge from inpatient treatment for opioid dependence.

The study was conducted in 2 parts, Part A and Part B. The clinical portion of both parts has completed. Results for Part B are not yet available.

Detailed description:
Part A was a double-blind, randomized, placebo-controlled assessment of the efficacy and safety of 24 weeks of monthly treatment with VIVITROL compared to placebo in opioid-dependent adults.

Subjects who completed Part A could choose to continue to Part B, which was an open-label extension to assess longer-term safety, durability of effect, health economics, and quality of life (QOL) in the continuing study population for up to 1 year.

At the conclusion of both parts, each completing subject will have received a total of up to 19 injections of study drug over approximately 1.5 years.

Dosing was performed by the principal investigator or designated study staff member.

All subjects received standardized, manual-based psychosocial support at each scheduled visit. Opioid use was tracked through urine drug testing and subjects' self reports. Other evaluations for efficacy and safety, health economics, and quality of life were routinely conducted throughout the study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: VIVITROL® 380 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Administered via intramuscular (IM) injection once every 4 weeks for 24 weeks during Part A, followed by once every 4 weeks for 52 weeks in Part B. intervention 2: Administered via IM injection once every 4 weeks for 24 weeks during Part A, followed by VIVITROL® 380 mg via IM injection once every 4 weeks for 52 weeks in Part B.

Protocol documents: