ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00573144
Conditions: Acute Myocardial Infarction
Sponsor: Mayo Clinic
Start date: 2006-09-01; Completion date: 2013-04-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of intravenous human beta natriuretic peptide (BNP, Nesiritide) as compared to placebo to prevent adverse post acute myocardial infarction left ventricular remodeling.

Detailed description:
Post acute myocardial infarction (AMI) left ventricular (LV) remodeling begins within hours of the acute event with permanent consequences. Previous studies have demonstrated that LV remodeling is one of the major determinants of long-term survival post AMI. Recent studies have reported that the cardiac natriuretic peptides, atrial natriuretic peptide (ANP) and BNP have direct anti-fibrotic and anti-proliferative effects on the myocardium. More importantly, it has been reported that in the acute phase of AMI, the secretion of the cardiac natriuretic peptides may be insufficient relative to the chronic phase. Therefore, augmentation of the cardiac natriuretic peptide system, such as by exogenous administration of exogenous peptide may prevent post AMI LV remodeling because of the cardioprotective effects. The objective of this study is to to determine the efficacy of IV human BNP (Nesiritide) as compared to placebo to prevent adverse post AMI LV remodeling. This is a randomized double blinded placebo controlled study to determine efficacy of 72 hours of IV BNP at 0.006µg/Kg/min as compared to placebo in patients with anterior ST-elevation myocardial infarction and successful revascularization. The study population will include 60 patients admitted to the Cardiac Care Unit with a first anterior AMI and successful reperfusion therapy (TIMI grade 3 flow) within 24 hours of onset of chest pain documented by coronary angiography.

Arms: arm 1: Infusion of 72 hours of saline solution (packaged to match active comparator). arm 2: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
Interventions: intervention 1: Nesiritide intervention 2: Placebo
Intervention descriptions: intervention 1: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min. intervention 2: Infusion of 72 hours of saline solution (packaged to match active comparator)

Protocol documents:
Clinical trial NCT00585689
Conditions: Bladder Cancer
Keywords: Locally advanced urothelial carcinoma of the bladder
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2007-12-01; Completion date: 2013-04-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study participants will have been diagnosed with bladder cancer that has invaded the muscle wall of the bladder. Surgery is used to remove cancer when it is in the muscle of the bladder. Unfortunately, approximately 50% of people may have their cancer return in another location. For this reason, researchers are focusing on new chemotherapy regimens to be given before surgery (to remove the bladder) that may decrease the likelihood of cancer spreading.

Paclitaxel, carboplatin and gemcitabine are chemotherapy drugs known to destroy bladder cancer cells.

ABI-007 (brand name Abraxane™) is a form of the chemotherapy drug called paclitaxel. Standard paclitaxel is formulated with ethanol and a substance called Cremophor EL (polyoxyethylated castor oil). However, these additives are felt to contribute to the side effects (possibly severe) associated with paclitaxel. ABI-007 does not contain these additives and may deliver more drug to tumor cells. ABI-007 is approved by the United States Food and Drug Administration (FDA) in the treatment of metastatic (advanced) breast cancer, and is being evaluated in other cancers in research studies.

This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin and gemcitabine in the treatment of bladder cancer prior to surgery to remove the bladder.

Detailed description:

Arms: arm 1: Neoadjuvant ABI-007 (260 mg/m\^2) on day 1, Carboplatin (Target AUC \[Area under the curve\] =5) on day 1, and Gemcitabine (800 mg\^m2) on days 1 and 8, every 21 days.
Interventions: intervention 1: ABI-007 intervention 2: Carboplatin intervention 3: Gemcitabine intervention 4: Radical Cystectomy
Intervention descriptions: intervention 1: ABI-007 will be administered at a dose of 260 mg/m2 over a 30 min IV infusion on day 1 of each 21 day cycle. intervention 2: Carboplatin will be administered at a dose of TARGET AUC=5 over a 15 min IV infusion of day 1 of each 21 day cycle. intervention 3: Gemcitabine will be administered at a dose of 800 mg/m2 over a 30 min IV infusion on days 1 and 8 of each 21 day cycle. intervention 4: None

Protocol documents:
Clinical trial NCT00680121
Conditions: Alcoholism
Keywords: Alcoholism Benfotiamine Thiamine
Sponsor: University of Kansas
Start date: 2008-07-01; Completion date: 2013-04-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
B1AS tests the hypothesis that increased vitamin B1 (thiamine) intake can repair brain systems damaged by alcohol and help people with alcohol problems control their alcohol use. A strong, man-made form of thiamine (Benfotiamine) is used to increase blood thiamine to much higher levels than can be achieved using normal vitamin supplements. Drinking patterns are examined over 6 months of continued supplement use. Men and women with a recent history of alcohol problems are eligible to participate.

Detailed description:
B1AS is a randomized, double-blind placebo-controlled clinical trial of the effectiveness of Benfotiamine at reducing abusive drinking patterns in individuals with recent alcohol problems. Subjects consume 4 tablets of Benfotiamine (600 mg) or placebo daily for 6 months. Monthly follow-ups track alcohol use and alcohol-related problems over the 6 months. Blood tests are also conducted to determine the frequency of an inherited abnormality in thiamine processing that may be related to the risk of developing alcoholism.

Arms: arm 1: Placebo arm 2: Benfotiamine 600 mg
Interventions: intervention 1: Benfotiamine intervention 2: Placebo
Intervention descriptions: intervention 1: Benfotiamine 600 mg intervention 2: Placebo

Protocol documents:
Clinical trial NCT00718861
Conditions: Post-menopausal Osteoporosis
Keywords: Osteoporosis zoledronic acid post-menopausal
Sponsor: Novartis Pharmaceuticals
Start date: 2008-05-01; Completion date: 2013-04-01
Enrollment: 190 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis

Detailed description:

Arms: arm 1: Matching placebo administered intravenously. arm 2: None
Interventions: intervention 1: Placebo intervention 2: Zoledronic acid
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00728507
Conditions: Tuberculosis
Keywords: Tuberculosis Moxifloxacin Rifapentine
Sponsor: Johns Hopkins University
Start date: 2009-11-01; Completion date: 2013-04-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Although effective therapy for tuberculosis is available, TB continues to cause significant problems worldwide, and rates of multi-drug resistant (MDR) TB cases are on the rise. A major obstacle to the control of TB is poor adherence with lengthy (usually 6 months) and complicated treatment regimens. Incomplete TB treatment can lead to serious consequences such as increased severity of illness and death, prolonged infectiousness and transmission in the community, and the development of drug resistance. The development of new treatment strategies with more stronger drugs could lead to shorter and simpler regimens. A TB treatment regimen that allowed treatment duration to be meaningfully decreased would have important public health implications.

This trial will compare the effect and safety of a new oral regimen to that of the standard regimen for the first phase of treatment for pulmonary tuberculosis.

The experimental regimen will consist of the following:

* Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.

The standard control intensive phase regimen will consist of the following:

* Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.

Following intensive phase therapy (the study phase), all patients will be treated with a non-experimental continuation phase regimen.

In mice, the combination of Moxifloxacin and Rifapentine have cured the animals significantly faster than the standard regimen and this study will be the first step to see if the potential is also there in humans.

Detailed description:

Arms: arm 1: Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid. arm 2: Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Interventions: intervention 1: Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid intervention 2: Isoniazid, Rifampin, Pyrazinamide, Ethambutol
Intervention descriptions: intervention 1: Rifapentine:150mg tablets, dose = 300mg for subjects \<= 45kg and 450mg for those \>45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment. intervention 2: Administered per standard of care for TB treatment

Protocol documents:
Clinical trial NCT00729833
Conditions: Advanced Cancer Advanced Solid Tumors
Sponsor: Pfizer
Start date: 2008-09-01; Completion date: 2013-04-01
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study is being conducted to determine the maximum tolerated dose, overall safety and tolerability profile, and pharmacokinetic profile of CP-751,871 and sunitinib when given in combination with advanced solid tumors.

Detailed description:
The study was closed to enrollment on 14 Jan 2011 and terminated secondary to excessive screen failure rate and for business reasons associated with Pfizer's business decision to stop development of the figitumumab compound. Safety concerns did not contribute to the decision to terminate this clinical trial.

Arms: arm 1: Escalating cohorts of CP-751,871 + Sunitinib
Interventions: intervention 1: CP-751,871 intervention 2: Sunitinib
Intervention descriptions: intervention 1: CP-751,871 IV, every 3 weeks intervention 2: Sunitinib - daily dosing

Protocol documents:
Clinical trial NCT00734539
Conditions: Candidiasis
Keywords: Candida Neonate Fluconazole Prophylaxis Colonization Resistance
Sponsor: Daniel Benjamin
Start date: 2008-11-01; Completion date: 2013-04-01
Enrollment: 362 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The most common etiology of infection-related death or neurodevelopmental impairment in neonates with birthweight \<750 g is invasive candidiasis. Over 70% of the premature neonates who develop invasive candidiasis will die or suffer severe, permanent neurologic impairment. Fluconazole has been commonly used off-label in the neonatal intensive care unit, but definitive recommendations for its use in the nursery have been hampered by the limited number of well-designed trials. In neonates weighing \<750 g, appropriate dosing is not known, definitive safety and long-term follow up trials have not been completed, and there have not been well-powered trials conducted to establish the efficacy of the product using mortality as part of the primary endpoint. Three recent proof-of-concept studies suggest that fluconazole will be safe and effective, and a recently completed pharmacokinetic study is providing data to give preliminary dosing guidance. The next logical step in drug development is proposed by this research: to conduct a pivotal trial to determine the safety and efficacy of fluconazole in premature neonates with 2-year neurodevelopmental follow-up assessment.

362 neonates, with a birthweight \<750g, were randomized at 33 US centers, to twice weekly fluconazole (6 mg/kg) or placebo for the first 6 weeks of life. The primary efficacy endpoint will be Candida-free survival at study day 49. The research will establish definitive dosing, safety, and efficacy of fluconazole; it will also provide critical information on the effects of fluconazole on neurodevelopmental impairment and antifungal resistance.

Potential Impact:

Approximately 17,000 neonates are born \<750 grams each year in the United States. Over 5000 will die or develop invasive Candida infections. Demonstrating safety and efficacy of fluconazole in preterm neonates will improve the survivability and long term outcomes for these neonates.

Detailed description:
362 subjects were randomized to the study at 33 US sites. Final study visits of Month 18-22 corrected age long term follow up were completed. Study database is locked.

Arms: arm 1: fluconazole 6mg/kg IV or PO twice weekly for 6 weeks arm 2: Placebo IV or PO twice weekly for 6 weeks
Interventions: intervention 1: fluconazole intervention 2: placebo
Intervention descriptions: intervention 1: 6mg/kg IV/PO twice weekly for a total of up to 12-13 doses intervention 2: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for a total of up to 12-13 doses

Protocol documents:
Clinical trial NCT00738361
Conditions: Intraocular Melanoma
Keywords: ciliary body and choroid melanoma, medium/large size iris melanoma metastatic intraocular melanoma recurrent intraocular melanoma extraocular extension melanoma
Sponsor: Ohio State University Comprehensive Cancer Center
Start date: 2008-08-01; Completion date: 2013-04-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with metastatic melanoma of the eye that cannot be removed by surgery.

Detailed description:
OBJECTIVES:

Primary

* To evaluate the overall response rate of patients with unresectable, metastatic uveal melanoma treated with paclitaxel albumin-stabilized nanoparticle formulation.

Secondary

* To determine the median progression-free survival of patients treated with this regimen.
* To determine the overall survival of patients treated with this regimen.

OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 8 weeks for 1 year.

Arms: arm 1: Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Interventions: intervention 1: nab-paclitaxel
Intervention descriptions: intervention 1: 150 mg/m2 weekly for 3 of 4 weeks every 28 days.

Protocol documents:
Clinical trial NCT00829296
Conditions: Hypertension Diabetes
Keywords: diabetes hypertension aortic impedance
Sponsor: University of Chicago
Start date: 2009-01-01; Completion date: 2013-04-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.

Detailed description:
To determine the effect of nebivolol versus metoprolol in Type 2 hypertensive diabetic patients on systolic blood pressure and diastolic blood pressure.

Arms: arm 1: Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached arm 2: Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached
Interventions: intervention 1: nebivolol intervention 2: Metoprolol
Intervention descriptions: intervention 1: Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached intervention 2: Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached

Protocol documents:
Clinical trial NCT00835120
Conditions: Metabolic Syndrome Bipolar Depression Insulin Resistance
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2009-03-01; Completion date: 2013-04-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study is an open-label 8-week adjunctive trial of pioglitazone for the acute relief of bipolar depression comorbid with metabolic syndrome/insulin resistance. Subjects who experience a partial or full response will have the option of continuing in an acute continuation phase lasting up to 12 weeks. The extension phase will allow assessment of the safety and tolerability of pioglitazone during the acute continuation period.

Detailed description:

Arms: arm 1: Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
Interventions: intervention 1: Pioglitazone
Intervention descriptions: intervention 1: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.

Protocol documents:
Clinical trial NCT00848354
Conditions: Rheumatoid Arthritis
Keywords: enbrel moderate arthritis severe arthritis rheumatoid arthritis
Sponsor: Pfizer
Start date: 2009-06-01; Completion date: 2013-04-01
Enrollment: 429 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this 2 phased, open-label study is to compare the safety and efficacy of etanercept with conventional Disease Modifying Antirheumatic Drug (DMARD) therapy in Latin American subjects with moderate to severe rheumatoid arthritis over 128 weeks. Phase 1 is a randomized 24 week treatment period; Phase 2 is an optional open-label 104 week period that allows the investigator to choose continuation with the phase I treatment or the addition, discontinuation or titration of other DMARD therapy already being utilized for the study.

Detailed description:

Arms: arm 1: Phase 1: Etanercept + methotrexate arm 2: Phase 1: Sulfasalazine (SSZ) + methotrexate (MTX) OR Phase 1: Hydrocholoquine (HCQ) + methotrexate
Interventions: intervention 1: Phase 1: Etanercept intervention 2: Phase 1: Methotrexate intervention 3: Phase 2: Optional ETN, SSZ, HCQ, MTX intervention 4: Phase 1: Methotrexate intervention 5: Phase 1: Conventiaonal DMARD
Intervention descriptions: intervention 1: Phase 1: prefilled syringe 50mg/ml, administered once weekly for study weeks 0 - 24 intervention 2: Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24. intervention 3: Phase 2: All therapies are optional and may include any combination of the following: ETN, SSZ, HCQ, MTX Phase 2: Optional ETN: prefilled syringe 50mg/ml, dose variable after study week 24 to week 128.

Phase 2: Optional SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations after study week 24 to week 128.

Phase 2: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations after study week 24 to week 128.

Phase 2: MTX: oral tablet, 2.5mg dose variable after week 24 to week 128. intervention 4: Phase 1: oral tablet, 2.5mg dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24. intervention 5: Phase 1: SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations. OR Phase 1: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations.

Protocol documents:
Clinical trial NCT00849472
Conditions: Neoplasms, Breast
Keywords: Neoadjuvant Breast Cancer Pazopanib (GW786034) NSABP Foundation, Inc. cyclophosphamide Paclitaxel Doxorubicin
Sponsor: GlaxoSmithKline
Start date: 2009-07-01; Completion date: 2013-04-01
Enrollment: 101 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether the treatment of a doxorubicin in combination with cyclophosphamide followed by a combination of pazopanib in combination with paclitaxel prior to surgery results in a pathological complete response in females with breast cancer.

Detailed description:
This is a phase II non-randomized, multi-center study aimed to evaluate the efficacy and safety of the combination of pazopanib and paclitaxel following treatment with cyclophosphamide and doxorubicin for the treatment of neoadjuvant breast cancer.

Patients will receive standard doses of AC every 21 days for 4 cycles. This will be followed by weekly paclitaxel 80 mg/m2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with pazopanib 800 mg PO daily starting with the first paclitaxel dose and continuing until 7 days before surgery. Clinical complete response rate will be determined by tumor assessments performed by palpation at two time points: following AC (before paclitaxel/pazopanib begins) and 2-4 weeks following the last dose of paclitaxel (before surgery). Following recovery from preoperative therapy, patients will undergo the clinically-indicated surgery. Pazopanib will resume 4-6 weeks after surgery and continue daily for 6 months of postoperative pazopanib therapy.

Arms: arm 1: Preoperative

Cycles 1-4 Doxorubicin 60 mg/m2 IV over 15 minutes + Cyclophosphamide 600 mg/m2 IV over 30 minutes of Day 1 every 21 days

followed by:

Cycles 5-8 Paclitaxel 80 mg/m2 IV over 60 minutes (Days 1, 8, and 15) every 28 days in combination with pazopanib (800 mg) PO once daily (2 tablets taken at the same time each day either 1 hour before or 2 hours after a meal) Daily beginning on Day 1 of the first paclitaxel cycle Until 7 days before surgery

Followed by Surgery

Postoperative Pazopanib 800 mg PO once daily (2 tablets taken at the same time each day either 1 hour before or 2 hours after a meal) Daily beginning 4-6 weeks after surgery 6 months from first postoperative dose
Interventions: intervention 1: doxorubicin + cyclophosphamide intervention 2: paclitaxel + pazopanib intervention 3: surgery intervention 4: pazopanib monotherapy
Intervention descriptions: intervention 1: 4 cycles of doxorubicin + cyclophosphamide followed by 4 cycles of paclitaxel + pazopanib. intervention 2: 4 cycles of paclitaxel + pazopanib intervention 3: neoadjuvant surgery for breast cancer intervention 4: 6 months of treatment with pazopanib monotherapy

Protocol documents: