ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00384956
Conditions: Myelodysplastic Syndromes
Keywords: MDS either de novo or secondary, fitting any of the WHO classifications.
Sponsor: Washington University School of Medicine
Start date: 2006-08-01; Completion date: 2010-03-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary endpoint of this study is to estimate morphologic complete remission rate. Estimation of response rate is also a secondary objection.

Detailed description:
Myelodysplastic syndrome (MDS) is a hematological disorder characterized by ineffective hematopoiesis. The only known curative treatment for patients with MDS is allogeneic stem cell transplantation. However, only a minority of patients are candidates for this aggressive therapy. DNA hypomethylation agents have been shown to have activity in this disorder and are postulated to work by reversing this epigenetic mechanism of gene-silencing. Recently, 5-azacitidine, administered subcutaneously for seven days, received approval by the FDA for the therapy of MDS based on a randomized trial which demonstrated a diminished risk of leukemic transformation and improved survival when compared to best supportive care.

The subcutaneous route of administration can present challenges to implementing this therapy. In the CALGB studies 8921 and 9221, approximately 23% of patients had significant injection site pain. Moreover, 35 % of patients had injection site bruising which can be extensive in thrombocytopenic patients. Due to limitations on drug concentration and administration volumes for subcutaneous dosing, patients often need to have two or three injections at separate sites each day to meet target dosing. In addition, the schedule of administration is inconvenient in an outpatient setting secondary to the need to schedule administrations over weekends. Therefore, there is great interest in pursuing an abbreviated intravenous route for administration of the drug.

Arms: arm 1: Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
Interventions: intervention 1: Azacitidine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00387335
Conditions: Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma Recurrent Metastatic Squamous Neck Cancer With Occult Primary Recurrent Squamous Cell Carcinoma of the Hypopharynx Recurrent Squamous Cell Carcinoma of the Larynx Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity Recurrent Squamous Cell Carcinoma of the Nasopharynx Recurrent Squamous Cell Carcinoma of the Oropharynx Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity Stage IV Squamous Cell Carcinoma of the Hypopharynx Stage IV Squamous Cell Carcinoma of the Larynx Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IV Squamous Cell Carcinoma of the Nasopharynx Stage IV Squamous Cell Carcinoma of the Oropharynx Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Sponsor: National Cancer Institute (NCI)
Start date: 2006-08-01; Completion date: 2010-03-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well sunitinib works in treating patients with recurrent and/or metastatic head and neck cancer. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description:
OBJECTIVES:

I. Determine the overall response rate of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with sunitinib malate.

II. Determine the toxicity of this drug in these patients. III. Determine the feasibility of administering this drug to patients with ECOG performance status 2 (cohort B).

OUTLINE: This is a multicenter, cohort study.

Patients are assigned to one of two cohorts according to ECOG performance status (ECOG 0-1 \[cohort A\] vs ECOG 2 \[cohort B\]). Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for at least 1 year.

Arms: arm 1: Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: sunitinib malate
Intervention descriptions: intervention 1: Given orally

Protocol documents:
Clinical trial NCT00392197
Conditions: Schizophrenia
Keywords: OPC-14597 Schizophrenia
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2006-11-01; Completion date: 2010-03-01
Enrollment: 111 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to examine the effects of aripiprazole on glucose metabolism in schizophrenic patients without hyperglycemia and diabetes mellitus or any history thereof.

Detailed description:

Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: 1 or 2 times a day, p.o., 6 - 24mg a day

Protocol documents:
Clinical trial NCT00403390
Conditions: Congenital Hypothyroidism Hypothyroidism
Sponsor: Boston Children's Hospital
Start date: 2006-11-01; Completion date: 2010-03-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study compares two different brands of thyroxine (thyroid hormone). Currently, pharmacists may be substituting generic formulations of thyroid hormone without your doctor knowing about this. Although a small difference in thyroid function is not significant in most healthy children, adolescents and adults, in infants and toddlers even a small difference in thyroid function can have important harmful consequences on brain development. The purpose of the present study is to learn whether the difference between brands of thyroid hormone that are currently being substituted is sufficient to cause a difference in thyroid function.

Detailed description:
This study is an unblinded, randomized controlled cross-over study, which involves taking 2 different forms of levothyroxine sequentially over a 16 week period. Subjects will have a total of 3 visits over this time period. At the first visit, subjects are randomized to receive either generic (Sandoz) levothyroxine or Synthroid (Abbott) brand of levothyroxine. Blood is drawn for baseline thyroid function studies and other markers which are influenced by thyroid hormone at each visit. The second visit is the cross-over visit, and the final visit is a close-out visit, after which each subject will resume taking their previous formulation of levothyroxine.

Arms: arm 1: Dose previously demonstrated to normalize thyroid function given daily for 2 months arm 2: Dosage previously determined to normalize thyroid function given daily for 2 months
Interventions: intervention 1: Brand Name Levothyroxine (Synthroid) intervention 2: Generic formulation of Levothyroxine
Intervention descriptions: intervention 1: Randomized crossover study using 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott), then 8 weeks of the generic formulation of levothyroxine (manufactured by Sandoz). The dose of medication does not change throughout the duration of the study. intervention 2: Randomized crossover study using 8 weeks of the generic formulation of levothyroxine (manufactured by Abbott, then 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott). The dose of medication does not change throughout the duration of the study.

Protocol documents:
Clinical trial NCT00404235
Conditions: Melanoma (Skin)
Keywords: stage IV melanoma recurrent melanoma
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2006-10-01; Completion date: 2010-03-01
Enrollment: 76 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as carboplatin and ABI-007, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin together with ABI-007 works in treating patients with stage IV melanoma that cannot be removed by surgery.

Detailed description:
OBJECTIVES:

Primary

* Assess the safety and antitumor activity of carboplatin and paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) in patients with unresectable stage IV melanoma who have not received prior chemotherapy for their metastatic disease. (Cohort 1)
* Assess the safety and antitumor activity of this regimen in patients with unresectable stage IV melanoma who have received prior chemotherapy for their metastatic disease. (Cohort 2)

Secondary

* Describe the impact of this regimen on parameters of immune function and angiogenesis in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy for metastatic disease (yes vs no).

Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.

Blood and tumor tissue samples are collected periodically to evaluate secreted protein acidic and rich in cysteine (SPARC) content of tumor tissue by immunohistochemistry and to explore the impact of therapy on immune homeostasis. Samples are also analyzed by immunoenzyme techniques for angiogenesis markers.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 74 patients will be accrued for this study.

Arms: arm 1: Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.

Blood and tumor tissue samples are collected periodically to evaluate secreted protein acidic and rich in cysteine (SPARC) content of tumor tissue by immunohistochemistry and to explore the impact of therapy on immune homeostasis. Samples are also analyzed by immunoenzyme techniques for angiogenesis markers.

After completion of study treatment, patients are followed periodically for up to 2 years.
Interventions: intervention 1: carboplatin intervention 2: paclitaxel albumin-stabilized nanoparticle formulation
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00410384
Conditions: Systemic Lupus Erythematosus
Keywords: Antibodies Autoimmune Diseases Systemic Lupus Erythematosus SLE Belimumab Lupus
Sponsor: Human Genome Sciences Inc.
Start date: 2006-12-01; Completion date: 2010-03-01
Enrollment: 819 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.

Detailed description:

Arms: arm 1: Placebo arm 2: Belimumab 1 mg/kg arm 3: Belimumab 10 mg/kg
Interventions: intervention 1: Placebo intervention 2: Belimumab 1 mg/kg intervention 3: Belimumab 10 mg/kg
Intervention descriptions: intervention 1: Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks. intervention 2: Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks. intervention 3: Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.

Protocol documents:
Clinical trial NCT00412451
Conditions: Diabetic Macular Edema
Keywords: Diabetic Macular Edema PVD DME Diabetic Retinopathy
Sponsor: ThromboGenics
Start date: 2006-12-01; Completion date: 2010-03-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.

Detailed description:

Arms: arm 1: 25µg ocriplasmin intravitreal injection versus sham injection arm 2: 75µg ocriplasmin intravitreal injection versus sham injection arm 3: 125µg ocriplasmin intravitreal injection versus sham injection arm 4: Sham injection
Interventions: intervention 1: ocriplasmin intervention 2: Sham injection
Intervention descriptions: intervention 1: Intravitreal injection, single administration intervention 2: Sham intravitreal injection

Protocol documents:
Clinical trial NCT00415194
Conditions: Head and Neck Neoplasms
Sponsor: Eli Lilly and Company
Start date: 2006-12-01; Completion date: 2010-03-01
Enrollment: 795 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.

Detailed description:

Arms: arm 1: Pemetrexed 500 milligrams per meter square (mg/m\^2) administered intravenously (IV) plus cisplatin 75 mg/m\^2 IV on Day 1 every 21 days. Pretreatment, Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose. arm 2: Placebo (approximately 100 mL normal saline) administered intravenously (IV) plus cisplatin 75 mg/m\^2 on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
Interventions: intervention 1: pemetrexed intervention 2: cisplatin intervention 3: placebo
Intervention descriptions: intervention 1: 500 mg/m\^2, IV, every 21 days, six 21 day cycles intervention 2: 75 mg/m\^2, administered IV, every 21 days, six 21 day cycles intervention 3: Approximately 100 mL normal saline administered IV, every 21 days, six 21 day cycles

Protocol documents:
Clinical trial NCT00419393
Conditions: Epilepsy
Keywords: Keppra XR Levetiracetam XR long term partial seizures
Sponsor: UCB Pharma
Start date: 2007-12-01; Completion date: 2010-03-01
Enrollment: 190 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in subjects with partial onset seizures.

Detailed description:

Arms: arm 1: 1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
Interventions: intervention 1: Keppra XR (Levetiracetam XR)
Intervention descriptions: intervention 1: 500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years).

Protocol documents:
Clinical trial NCT00420459
Conditions: Fragile X Syndrome
Sponsor: Indiana University School of Medicine
Start date: 2007-04-01; Completion date: 2010-03-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effectiveness and tolerability of aripiprazole in the treatment of children and adolescents with Fragile X Syndrome.

Detailed description:
This 12-week prospective, open-label study design was chosen to gather pilot data for potential future lager scale, double-blind, placebo-controlled studies in Fragile X Syndrome.

We hypothesize that aripiprazole will be effective in decreasing aggression, SIB, agitation, and interfering repetitive behavior commonly observed in individuals with Fragile X Syndrome. We also hypothesize that aripiprazole will be well tolerated.

Arms: arm 1: None
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: All subjects will initially receive 2.5 mg/day of aripiprazole during the first week. The dosage may be increased to a maximum of 20 mg/day over 8 weeks.

Protocol documents:
Clinical trial NCT00424476
Conditions: Systemic Lupus Erythematosus
Keywords: Autoimmune Diseases Lupus SLE Systemic Lupus Erythematosus Belimumab Antibodies
Sponsor: Human Genome Sciences Inc.
Start date: 2007-05-01; Completion date: 2010-03-01
Enrollment: 865 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.

Detailed description:

Arms: arm 1: Placebo arm 2: Belimumab 1 mg/kg arm 3: Belimumab 10 mg/kg
Interventions: intervention 1: Placebo intervention 2: Belimumab 1 mg/kg intervention 3: Belimumab 10 mg/kg
Intervention descriptions: intervention 1: Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48. intervention 2: Belimumab 1 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48. intervention 3: Belimumab 10 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.

Protocol documents:
Clinical trial NCT00446563
Conditions: Hypertension; Hypertrophy, Left Ventricular
Keywords: Left ventricular hypertrophy, hypertension, valsartan, amlodipine
Sponsor: Novartis
Start date: 2007-03-01; Completion date: 2010-03-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of amlodipine plus valsartan in patients with hypertension and left ventricular hypertrophy

Detailed description:

Arms: arm 1: Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication. arm 2: Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
Interventions: intervention 1: Valsartan intervention 2: Amlodipine intervention 3: Hydrochlorothiazide intervention 4: Losartan
Intervention descriptions: intervention 1: 160 mg film coated tablets taken orally once daily in the morning. intervention 2: 5 mg or 10 mg tablets taken orally once daily in the morning. intervention 3: 12.5 mg or 25 mg tablets taken orally once daily in the morning. intervention 4: 100 mg tablets taken orally once daily in the morning.

Protocol documents:
Clinical trial NCT00446992
Conditions: Schizophrenia
Keywords: Schizophrenia Schizoaffective psychosis olanzapine
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2006-04-01; Completion date: 2010-03-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to describe metabolic changes in the first 16 weeks of anti-psychotic treatment in previously drug-naïve patients with psychosis.

We hypothesize that in drug-naive patients, greater insulin resistance prior to treatment predicts a disproportionately greater increase in insulin resistance with olanzapine treatment.

Detailed description:
Antipsychotic medications are associated with an increased risk of diabetes. We focused on a description of early metabolic adverse effects and clinical and biochemical features that might predict these adverse effects.

Arms: arm 1: The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Interventions: intervention 1: Olanzapine
Intervention descriptions: intervention 1: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.

Protocol documents: