ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00701129
Conditions: Pompe Disease Glycogen Storage Disease Type II
Keywords: Glycogenesis 2 Acid Maltase Deficiency
Sponsor: Genzyme, a Sanofi Company
Start date: 2009-10-01; Completion date: 2013-03-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to evaluate the efficacy, clinical benefits and safety of a prophylactic immunomodulatory regimen given prior to first treatment with alglucosidase alfa (Myozyme®) in patients with infantile-onset Pompe disease.

The objectives were to assess the efficacy of a prophylactic immunomodulatory regimen given prior to first treatment with alglucosidase alfa, as assessed by anti-recombinant human acid alpha-glucosidase (anti-rhGAA) antibody titers, and antibodies that inhibit the activity and/or uptake of alglucosidase alfa; to evaluate the clinical benefit as measured by overall survival, ventilator-free survival, left ventricular mass index (LVMI), gross motor function and development, disability index and the incidence of adverse events (AEs), serious adverse events (SAEs), and clinical laboratory abnormalities.

Detailed description:

Arms: arm 1: Alglucosidase alfa (Myozyme®) 20 milligrams per kilogram (mg/kg) intravenous (IV) infusion every other week (qow) (or optionally 20 mg/kg IV infusion every week \[qw\]) beginning from Day 0 to a minimum of 18 months or if the patient was less than (\<) 6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 milligrams per square meter (mg/m\^2) (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m\^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
Interventions: intervention 1: Alglucosidase Alfa intervention 2: Methotrexate intervention 3: Rituximab
Intervention descriptions: intervention 1: Administered as IV infusion. intervention 2: Administered subcutaneously. intervention 3: Administered as IV infusion.

Protocol documents:
Clinical trial NCT01025817
Conditions: Kidney Transplant
Keywords: Kidney transplant renal transplant immunosuppression mycophenolate mofetil tacrolimus everolimus
Sponsor: Novartis Pharmaceuticals
Start date: 2010-01-01; Completion date: 2013-03-01
Enrollment: 613 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney transplant recipients.

Detailed description:

Arms: arm 1: Everolimus (EVR) and tacrolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was \< 3 ng/mL, or reduced if the trough level was \> 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. arm 2: Mycophenolate mofetil and tacrolimus (MMF) treatment arm: MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. Tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, target level of tacrolimus was reduced to 5 - 8 ng/mL.
Interventions: intervention 1: Everolimus and tacrolimus intervention 2: mycophenolate mofetil and tacrolimus
Intervention descriptions: intervention 1: Everolimus:

* Dosage form: 0.75 mg, 0.25 mg, and 0.5 mg tablets
* Dose: 1.5 mg per day
* Frequency: 0.75 mg twice daily

Tacrolimus:

* Dose adjusted to maintain specific blood levels intervention 2: Mycophenolate mofetil: - Dose form: 250 mg capsule - Dose: 2g per day - Frequency: 1g twice daily Tacrolimus: - Dose adjusted to maintain specific blood levels

Protocol documents:
Clinical trial NCT01197534
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Sponsor: AstraZeneca
Start date: 2010-09-01; Completion date: 2013-03-01
Enrollment: 913 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking disease modifying anti-rheumatic drug (DMARD) but not responding. The study will last for 1 year.

Detailed description:
Sub-study:

Full title: Optional Genetic Research

Date: 18 June 2010

Version: 1

Objectives: To collect and store, with appropriate consent ,DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or methotrexate; and/or susceptibility to, progression of and prognosis of RA

Arms: arm 1: Oral Treatment arm 2: Oral Treatment arm 3: Oral Treatment
Interventions: intervention 1: fostamatinib intervention 2: fostamatinib intervention 3: placebo, fostamatinib
Intervention descriptions: intervention 1: fostamatinib 100 mg twice daily intervention 2: fostamatinib 100 mg twice daily/ 150 mg once daily intervention 3: Placebo for 24 weeks followed by fostamatinib 100 mg twice daily.

Protocol documents:
Clinical trial NCT01427972
Conditions: Chronic Kidney Disease
Sponsor: Eli Lilly and Company
Start date: 2011-09-01; Completion date: 2013-03-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this trial is to investigate the safety and efficacy of LY2623091 in males and females with chronic kidney disease.

Detailed description:
This trial consists of 4 treatment arms: 3 LY2623091 dose levels and eplerenone. Each participant will participate in 2 treatment periods, with a minimum wash-out period of 28 days between dosing in the 2 treatment periods. Dosing days will be numbered 1-21 in each of the 2 treatment periods. Participants will receive different treatments in periods 1 and 2. Participants will be housed as inpatients during the days of the controlled diet administration and the oral potassium challenge and until at least 24 hours after its completion (Days -3 to 1; Days 19 to 22, in each treatment period). Otherwise the study will be done on an outpatient basis, with participants returning to the clinic for evaluations during each treatment period (Days 3 or 4, 7, and 14).

Arms: arm 1: Daily by mouth for 21 days. Days 1-20 administered in the fed state. Day 21 administered in the fasted state. Minimum wash-out period of 28 days between dosing in treatment periods arm 2: Daily by mouth for 21 days. Days 1-20 administered in the fed state. Day 21 administered in the fasted state. Minimum wash-out period of 28 days between dosing in treatment periods arm 3: Daily by mouth for 21 days. Days 1-20 administered in the fed state. Day 21 administered in the fasted state. Minimum wash-out period of 28 days between dosing in treatment periods arm 4: Daily by mouth for 21 days. Days 1-20 administered in the fed state. Day 21 administered in the fasted state. Minimum wash-out period of 28 days between dosing in treatment periods
Interventions: intervention 1: LY2623091 intervention 2: Eplerenone
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT01500200
Conditions: Major Depressive Disorder
Sponsor: Alkermes, Inc.
Start date: 2011-12-01; Completion date: 2013-03-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.

Detailed description:
The study will measure efficacy using the HAM-D-17, the MADRS, and the CGI-S as well as using other scales and assessments.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ALKS 5461 intervention 2: Placebo
Intervention descriptions: intervention 1: Two active tablets, given daily intervention 2: Two placebo tablets, given daily

Protocol documents:
Clinical trial NCT01512446
Conditions: Osteoporosis
Keywords: Osteoporosis Osteoporotic fractures Bisphosphonate Pretreatment with bisphosphonates
Sponsor: Evangelisches Krankenhaus Lutherhaus gGmbH
Start date: 2012-02-01; Completion date: 2013-03-01
Enrollment: 436 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.

Detailed description:
Is a continued treatment with alendronate for another two years after a preceding therapy with bisphosphonates of at least four years able to reduce the incidence of new osteoporotic fractures in patients at high fracture risk compared to a therapy-free interval?

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Alendronate intervention 2: Placebo
Intervention descriptions: intervention 1: 70 mg per week intervention 2: 1 pill per week

Protocol documents:
Clinical trial NCT01605825
Conditions: Ischemic Stroke
Sponsor: Acorda Therapeutics
Start date: 2012-05-01; Completion date: 2013-03-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a multi-center, safety and tolerability study in subjects with chronic stable sensorimotor deficits after ischemic stroke. It has been designed as a double-blind, placebo-controlled, 2-period crossover study.

Detailed description:

Arms: arm 1: Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:

Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36 arm 2: Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:

Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36
Interventions: intervention 1: placebo/dalfampridine-ER intervention 2: dalfampridine-ER/placebo
Intervention descriptions: intervention 1: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart intervention 2: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart

Protocol documents:
Clinical trial NCT00090857
Conditions: Breast Cancer
Keywords: breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer breast cancer in situ ductal breast carcinoma in situ
Sponsor: Dana-Farber Cancer Institute
Start date: 2002-02-01; Completion date: 2013-03-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Letrozole may be effective in preventing the development or recurrence of breast cancer in postmenopausal women who are at increased risk of developing breast cancer because of elevated estradiol levels.

PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women with elevated estradiol levels.

Detailed description:
OBJECTIVES:

Primary

* The primary outcome of the study is the change in bone mineral density following a year on letrozole vs. a year on placebo.

Secondary

* Compare the safety, acceptability, and adherence to letrozole vs placebo in postmenopausal women at increased risk for the development or recurrence of breast cancer based on elevated plasma estradiol levels through evaluation of menopausal symptoms (including hot flushes, weight changes, sexual functioning, and genitourinary effects), blood lipid levels, markers of bone turnover, and multidimensional quality of life.
* Determine the effect of letrozole-induced reduction of plasma estradiol levels on mammographic percent breast density.
* Obtain background information for a future large chemoprevention trial to address the question of whether a reduction in plasma estradiol levels can reduce the risk of breast cancer in postmenopausal women.

OUTLINE: This is a pilot, randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 2:1 (experimental treatment: placebo arms).

PROJECTED ACCRUAL: A total of 110 patients (73 for arm I and 37 for arm II) will be accrued for this study.

Arms: arm 1: Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer. arm 2: Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
Interventions: intervention 1: Letrozole intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00153179
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance insulin signaling endothelium-dependent vasodilation
Sponsor: Brigham and Women's Hospital
Start date: 2005-09-01; Completion date: 2013-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will test the hypothesis that reduction in release of free fatty acids from adipocytes will restore insulin-mediated endothelium-dependent vasodilation and skeletal muscle glucose metabolism in subject with type 2 diabetes.

Detailed description:
During the past two decades, there has been a steady increase in the incidence of diabetes mellitus, such that nearly 17 million people are now afflicted. The vast majority of these have type 2 diabetes. Over the next 40 years, the type 2 diabetic population in the United States is expected to increase to nearly 30 million.

Diabetes substantially increases the risk of atherosclerosis, and thereby, cardiovascular morbidity and mortality. Indeed, cardiovascular disease causes more than 50% of the mortality in patients with diabetes. People with type 2 diabetes manifest two cardinal signs of dysmetabolism: hyperglycemia and insulin resistance. Insulin resistance is a progressive phenomenon that occurs well before the onset of frank diabetes, and results in alterations in insulin signaling. Experimental studies suggest that insulin signaling is required for vascular homeostasis, and its impairment is associated with endothelial dysfunction. In the clinical setting, insulin resistance is associated with atherosclerosis and predicts cardiovascular events independent of hyperglycemia. Therefore, we will study the importance of insulin signaling in endothelial biology in humans and the effects of free fatty acids on endothelial function in people with type 2 diabetes.

Arms: arm 1: Acipimox treatment for 7 days arm 2: placebo treatment for 7 days
Interventions: intervention 1: acipimox intervention 2: placebo
Intervention descriptions: intervention 1: subjects will receive acipimox 250 mg orally every 6 hours (or matching placebo) for 7 days, including a dose at 6am on the morning of the study testing visit intervention 2: matching placebo

Protocol documents:
Clinical trial NCT00159432
Conditions: Colorectal Cancer
Keywords: colorectal cancer
Sponsor: University of Southern California
Start date: 2005-02-01; Completion date: 2013-03-01
Enrollment: 63 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is for people with colorectal cancer, who have tumors that cannot be completely removed by surgery. This study is being done to find out how long it takes tumors to grow after patients receive the drugs capecitabine, oxaliplatin and bevacizumab. Capecitabine (also called Xeloda) is a drug that has been approved by the FDA for treatment of advanced colorectal cancer. Capecitabine prevents some colorectal cancer cancer cells from reproducing, and causes some of them to die. Oxaliplatin (also called Eloxatin) has also been approved by the FDA for treatment of advanced colorectal cancer. Oxaliplatin prevents some colorectal cancer cells from reproducing. Bevacizumab is an investigational drug. Bevacizumab is an antibody (a protein that acts against a specific substance) directed against vascular endothelial growth factor (VEGF). VEGF promotes the growth of blood vessels that bring nutrients to cells. Bevacizumab inhibits the growth of colon cancer cells, by blocking the effects of VEGF. The combination of the drugs used in this study is experimental. The purpose of this study is to see how long it takes patients' tumors to grow when they are taking this combination of drugs.

Detailed description:

Arms: arm 1: oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
Interventions: intervention 1: Oxaliplatin intervention 2: Bevacizumab intervention 3: Capecitabine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00182754
Conditions: Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific malignant ascites
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2005-10-01; Completion date: 2013-03-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Octreotide may be an effective treatment for malignant ascites. It is not yet known whether octreotide is more effective than a placebo in treating malignant ascites.

PURPOSE: This randomized phase III trial is studying octreotide to see how well it works compared to placebo in treating patients with cancer-related malignant ascites.

Detailed description:
OBJECTIVES:

Primary

* Compare the efficacy of octreotide vs placebo, in terms of extending the time-to-paracentesis, in patients with cancer-related symptomatic malignant ascites.

Secondary

* Compare the number of paracenteses in patients treated with these drugs.
* Determine the toxicity of octreotide in these patients.
* Compare the quality of life of patients treated with these drugs.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to anticipated ongoing chemotherapy (yes vs no), frequency of prior paracentesis (never vs other), and prior chemotherapy (never vs only first-line chemotherapy vs second-line chemotherapy vs other). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive octreotide subcutaneously (SC) once on day 1.
* Arm II: Patients receive placebo SC once on day 1. In both arms, treatment with intramuscular octreotide or placebo repeats monthly for up to 2 years in the absence of unacceptable toxicity.

Quality of life is assessed at baseline, 2 weeks, and then monthly for up to 2 years during study treatment.

After completion of study treatment, patients are followed every 6 months for up to 2 years.

Arms: arm 1: Patients receive octreotide subcutaneously (SC) once on day 1. arm 2: Patients receive placebo SC once on day 1.
Interventions: intervention 1: octreotide acetate intervention 2: placebo
Intervention descriptions: intervention 1: Given subcutaneously intervention 2: Given subcutaneously

Protocol documents:
Clinical trial NCT00187096
Conditions: Acute Myeloid Leukemia
Keywords: Leukemia Myeloid Acute
Sponsor: St. Jude Children's Research Hospital
Start date: 2005-09-01; Completion date: 2013-03-01
Enrollment: 49 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and efficacy of infusing natural killer cells from a donor as treatment for patients with acute myeloid leukemia in remission or who have experienced relapse.

Detailed description:
Natural killer (NK) cells extracted from a \[parental\] donor are infused intravenously. Most patients are given a multi-agent chemotherapeutic conditioning regimen prior to the infusion. The conditioning regimen may be omitted for patients who have previously received traditional stem cell transplant.

Details of Treatment Plan:

Stratum 1 (AML in complete remission)

Cyclophosphamide 60 mg/kg IV Day -7 Fludarabine 25 mg/m2/day IV Days -6 through -2 Donor pheresis Day -1 Start IL-2 on Day -1, then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0

Stratum 2 (AML that is refractory or relapsed or AML with increasing minimal residual disease)

Clofarabine 40 mg/m2 IV, days -6 through -2 Etoposide 100 mg/m2 IV, days -6 through -2 Cyclophosphamide 400 mg/m2 IV, days -6 through 02 Donor pheresis Day -1 Start IL-2 Day -1, and then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0.

For patients who have received prior SCT, the conditioning regimen may be omitted if the NK cells are obtained from the original SCT donor.

Cytokine regimen (stratum 1 and 2): 1 million units/m2 of IL-2 given subcutaneously three times per week for two weeks (6 doses) starting on the evening of day -1.

NK Cell Transplantation (stratum 1 and 2): NK cells from haplo-identical family donor will be infused on day 0.

Arms: arm 1: Stratum 1 (AML in complete remission)

Cyclophosphamide 60 mg/kg IV Day -7 Fludarabine 25 mg/m2/day IV Days -6 through -2 Donor pheresis Day -1 Start IL-2 on Day -1, then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0 arm 2: Stratum 2 (AML that is refractory or relapsed or AML with increasing minimal residual disease)

Clofarabine 40 mg/m2 IV, days -6 through -2 Etoposide 100 mg/m2 IV, days -6 through -2 Cyclophosphamide 400 mg/m2 IV, days -6 through 02 Donor pheresis Day -1 Start IL-2 Day -1, and then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0.
Interventions: intervention 1: Cyclophosphamide, Fludarabine, Clofarabine, Etoposide, Interleukin-2 intervention 2: Natural Killer Cell Infusion intervention 3: CliniMACS System
Intervention descriptions: intervention 1: See Detailed Description section for additional details of treatment interventions. intervention 2: See Detailed Description section for additional details of treatment interventions. intervention 3: See Detailed Description section for additional details of treatment interventions.

Protocol documents: