ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00471536
Conditions: Distal Urethral Cancer Proximal Urethral Cancer Recurrent Bladder Cancer Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter Recurrent Urethral Cancer Stage IV Bladder Cancer Transitional Cell Carcinoma of the Bladder Urethral Cancer Associated With Invasive Bladder Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2008-08-01; Completion date: 2013-12-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying the side effects and how well pazopanib works in treating patients with metastatic urothelial cancer. Pazopanib 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:
PRIMARY OBJECTIVES:

I. Assess the anti tumor activity and toxicity profile of pazopanib hydrochloride in patients with metastatic urothelial cancer.

SECONDARY OBJECTIVES:

I. Evaluate the pharmacokinetics of pazopanib hydrochloride in these patients. II. Evaluate pre- and post-treatment changes in circulating endothelial cells, monocytes and platelets, and angiogenesis-related factors in these patients.

OUTLINE: This is a multicenter study. Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection periodically for correlative studies and pharmacological studies. Samples are analyzed for vascular endothelial growth factor (VEGF) and soluble VEGF receptor II concentration via ELISA. Circulating endothelial cells are also measured.

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

Arms: arm 1: Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: pazopanib hydrochloride
Intervention descriptions: intervention 1: 800 mg Given orally

Protocol documents:
Clinical trial NCT00477191
Conditions: Psoriasis Metabolic Syndrome Hyperlipidemia Obesity Hypertension
Keywords: psoriasis metabolic syndrome Syndrome X diabetes insulin resistance obesity hypertension hyperlipidemia hypercholesterolemia
Sponsor: Massachusetts General Hospital
Start date: 2007-05-01; Completion date: 2013-12-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
People with psoriasis have significantly higher rates of obesity, diabetes, heart failure and high blood pressure than the general public. The purpose of this study is to determine how substances produced in the fat (inflammatory markers) relate to the risk of heart disease in people with the metabolic syndrome and psoriasis. People with metabolic syndrome have insulin resistance, increased waist size, high blood pressure, or high cholesterol.

Detailed description:
People with psoriasis have significantly higher rates of obesity, diabetes, heart failure and high blood pressure than the general public. The purpose of this study is to determine how substances produced in the fat (inflammatory markers) relate to the risk of heart disease in people with the metabolic syndrome and psoriasis. People with metabolic syndrome have insulin resistance, increased waist size, high blood pressure, or high cholesterol. Insulin resistance means that the body does not respond well to the insulin in your blood. Therefore, both blood levels of insulin and glucose (sugar) are high.

This causes inflammation (irritation) in the body. Inflammation can cause an unhealthy response in your body and blood vessels, and can lead to blockages in the heart and other vessels.

TNF-alpha is a substance made by fat and inflammatory cells that helps cause inflammatory reactions. TNF-alpha is thought to be important in causing psoriasis. The drug Etanercept blocks TNF-alpha's actions, and has been approved by the Food and Drug Administration (FDA) for the treatment of psoriasis. We think that Etanercept may also reduce the inflammation associated with metabolic syndrome and decrease the risk of heart disease. All subjects in this study will receive etanercept.

Arms: arm 1: Etanercept
Interventions: intervention 1: Etanercept
Intervention descriptions: intervention 1: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months.

Protocol documents:
Clinical trial NCT00498927
Conditions: Brain and Central Nervous System Tumors
Keywords: recurrent adult brain tumor adult giant cell glioblastoma adult glioblastoma adult gliosarcoma adult anaplastic astrocytoma adult diffuse astrocytoma adult pilocytic astrocytoma adult subependymal giant cell astrocytoma adult anaplastic ependymoma adult ependymoma adult myxopapillary ependymoma adult subependymoma adult anaplastic oligodendroglioma adult oligodendroglioma adult brain stem glioma adult mixed glioma adult pineal gland astrocytoma
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2007-06-01; Completion date: 2013-12-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as temozolomide, 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 temozolomide works in treating patients with recurrent glioblastoma multiforme or other malignant glioma.

Detailed description:
OBJECTIVES:

Primary

* Determine the progression-free survival rate at 6 months in patients with recurrent glioblastoma multiforme or other malignant glioma treated with temozolomide.

Secondary

* Determine the overall survival of patients treated with this drug.

OUTLINE: Patients receive oral temozolomide once daily in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and every 2 months for 2 years for evaluation of markers of neo-angiogenesis. Samples are analyzed by protein expression, reverse-transcriptase PCR, ELISA, and western blot. (Samples are no longer being collected and tested as of 1/12/09)

Arms: arm 1: Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
Interventions: intervention 1: temozolomide intervention 2: protein expression analysis intervention 3: reverse transcriptase-polymerase chain reaction intervention 4: diagnostic laboratory biomarker analysis intervention 5: immunoenzyme technique
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT00539253
Conditions: Hepatocellular Carcinoma
Keywords: liver cancer transarterial chemoembolization
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2007-09-01; Completion date: 2013-12-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research is being done to find out if using the contrast agent MultiHance can be used to show how a liver tumor responds to the chemotherapy given during Transcatheter Arterial Chemoembolization (TACE).

Detailed description:
MultiHance is approved by the Food and Drug Administration (FDA) for use as a contrast material for Magnetic Resonance Imaging (MRI) scans of the central nervous system. It is believed that using MultiHance may be able to help doctors tell normal liver cells apart from active tumor and from tumor affected by the chemotherapy. In this way, MultiHance may improve the way patients with hepatocellular carcinoma are managed clinically.

We hypothesize that the Multi-Hance contrast material will provide better image definition of treated liver tumor(s) on MRI imaging in comparison to other commercially available contrast agents.

Arms: arm 1: If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study
Interventions: intervention 1: gadobenate dimeglumine (MultiHance)
Intervention descriptions: intervention 1: The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.

Protocol documents:
Clinical trial NCT00556491
Conditions: Kidney Failure, Acute Acute Kidney Insufficiency
Keywords: renal kidney injury acute bypass cardiac minocycline prevention Acute Kidney Failure
Sponsor: Tarek M. El-Achkar
Start date: 2007-12-01; Completion date: 2013-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study proposes to investigate whether treatment with minocycline pre-operatively in patients with mild to moderate chronic kidney disease undergoing cardiac surgery will reduce the occurence of kidney injury.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: minocycline intervention 2: placebo
Intervention descriptions: intervention 1: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses intervention 2: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses

Protocol documents:
Clinical trial NCT00583115
Conditions: Pulmonary Hypertension
Sponsor: Indiana University
Start date: 2007-10-01; Completion date: 2013-12-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out if the drug, Gleevec, is safe and effective in treating children with Pulmonary Hypertension.

Detailed description:
Idiopathic pulmonary artery hypertension (IPAH) is a rare but progressive disease in children and adults with a very high mortality from right heart failure. Platelet derived growth factor (PDGF) has been implicated in the pulmonary artery remodeling and vascular proliferation that is a pathologic hallmark of IPAH. Animal and clinical data support the hypothesis that activation of the PDGF receptor is critical in the development of IPAH, and inhibition of the PDGF signaling pathways may be a potential therapeutic target. Gleevec is a tyrosine kinase inhibitor developed for treatment of certain cancers and inhibits the PDGF receptor. Animal and preliminary clinical data suggest that Gleevec can reverse vascular remodeling and improve right heart failure. A small clinical trial for adults with IPAH is ongoing in Europe, but there are no trials in children where the disease has a worse prognosis. This project is a phase II, single dose pilot study to generate the hypothesis that activation of the PDGF receptor is critical in the development of IPAH, and inhibition of the PDGF signaling pathways is a potential therapeutic target. Five patients between the ages of 8 yr to 18 yr with severe IPAH will be recruited nationally, for a 6 month trial of Imatinib. The Specific Aim of this study is to collect preliminary data on the safety and efficacy of Gleevec in children with IPAH. Results from this study are needed to develop a larger, multi-center trial to determine the efficacy and therapeutic impact of Gleevec in children with IPAH. The long term goal of this work is to develop novel therapeutic strategies for treatment of IPAH in children. This translational study of the inhibition of the PDGF receptor in children with IPAH could provide insights into the etiology of IPAH and have a major impact on the development of new treatment strategies for both children and adults with pulmonary artery hypertension from multiple origins.

Arms: arm 1: Drug taken orally 260mg/M2/day once per day
Interventions: intervention 1: Gleevec
Intervention descriptions: intervention 1: 260 mg/M2/day, given once daily by mouth

Protocol documents:
Clinical trial NCT00588731
Conditions: Schizophrenia Schizoaffective Disorder
Sponsor: Yale University
Start date: 2009-02-01; Completion date: 2013-12-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a six-week, randomized, placebo-controlled, fixed dose trial comparing cannabidiol Vs. placebo added to a stable dose of antipsychotic medications in patients diagnosed with schizophrenia.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Cannabidiol intervention 2: Placebo
Intervention descriptions: intervention 1: Active Cannabidiol daily over 6 weeks intervention 2: Placebo

Protocol documents:
Clinical trial NCT00627523
Conditions: Infant, Small for Gestational Age
Sponsor: Pfizer
Start date: 2008-02-01; Completion date: 2013-12-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate the effect on height and psychomotor development of Growth Hormone treatment in very young children starting at an age of 2 years.

Detailed description:

Arms: arm 1: The active treatment arm arm 2: Control
Interventions: intervention 1: Genotropin (PN-180,307) Somatropin intervention 2: Control-no treatment
Intervention descriptions: intervention 1: Injectable Genotropin intervention 2: Control-no treatment

Protocol documents:
Clinical trial NCT00659711
Conditions: Type 2 Diabetes
Sponsor: University at Buffalo
Start date: 2008-03-01; Completion date: 2013-12-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Sitagliptin is a new oral hypoglycemic anti-diabetic drug used either alone or in combination with metformin or a thiazolidinedione for control of type 2 diabetes mellitus. Sitagliptin has been shown to have fewer side effects in the control of blood glucose values.

Obesity and diabetes are states of increased inflammation and can influence the free radicals and inflammatory markers (chemicals in the blood which increase due to inflammation in the body) and are also major risk factors for atherosclerotic disease. In this study we want to see the effect of sitagliptin on these markers. We believe that Sitagliptin may exert an anti-inflammatory effect in the human. The purpose of this study is to determine if the addition of sitagliptin to diabetic patients will provide added benefit. We believe that sitagliptin provides these added benefits by suppressing free radicals (charged substances that cause damage to the body) and inflammation.

Detailed description:

Arms: arm 1: The first group will be started on 100 mg sitagliptin daily for 12 weeks arm 2: will be placed on a placebo for 12 weeks.
Interventions: intervention 1: Januvia (Sitagliptin) 100 mg intervention 2: Placebo
Intervention descriptions: intervention 1: The first group will be started on 100 mg sitagliptin daily for 12 weeks intervention 2: will be placed on a placebo for 12 weeks.

Protocol documents:
Clinical trial NCT00661661
Conditions: Rheumatoid Arthritis
Keywords: Long term open label study in Japan CP-690 550 tofacitinib
Sponsor: Pfizer
Start date: 2008-04-01; Completion date: 2013-12-01
Enrollment: 487 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are only eligible for this study after they have completed participation in another "qualifying" study of CP-690,550.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: CP-690,550
Intervention descriptions: intervention 1: 5 mg BID up to 10 mg BID until launch

Protocol documents:
Clinical trial NCT00664755
Conditions: Nicotine Dependence
Keywords: Menstrual Cycle effects Cue Reactivity Smoking Cessation Impulsivity
Sponsor: Medical University of South Carolina
Start date: 2007-07-01; Completion date: 2013-12-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a brief smoking cessation trial in women, comparing transdermal nicotine patch (TNP) versus varenicline.

Detailed description:
This component builds directly upon the results of the previously funded project in systematically investigating the impact of short-term ovarian hormone fluctuation on females as they try to quit smoking with the aid of either transdermal nicotine patch (TNP) or varenicline. Each participant will receive a standardized impulsivity evaluation and a laboratory-based cue reactivity assessment before the initiation of smoking cessation. Progesterone and estrogen levels will be measured at each of nine visits, thereby providing an index of reproductive hormone variation over the course of each participant's quit attempt. This novel approach of integrating a human laboratory cue reactivity paradigm directly with a treatment outcome study will permit us to assess whether or not smoking cue reactivity has predictive utility with respect to cessation outcome. Subjects will be randomized to receive one of two active pharmacotherapeutic interventions for smoking cessation: TNP vs. varenicline in a randomized, single-blind, double dummy design. While TNP has demonstrated modest efficacy in improving smoking cessation outcomes, there is some evidence that its efficacy may be more robust in men as compared to women. This project will provide important information about a) the impact of ovarian hormone levels on smoking cessation outcomes, b) the relationship between smoking cue reactivity and smoking cessation, and c) comparison between a new pharmacotherapeutic agent and TNP in women.

Arms: arm 1: Participant randomized to receive active varenicline and placebo transdermal nicotine patch. arm 2: Participant randomized to receive active transdermal nicotine patch and placebo varenicline.
Interventions: intervention 1: varenicline intervention 2: transdermal nicotine patch
Intervention descriptions: intervention 1: Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID

Varenicline is taken for a duration of 4 weeks in this study. intervention 2: Weeks 0-3: 21mg patch

Transdermal nicotine patch is used for a duration of 3 weeks in this study.

Protocol documents:
Clinical trial NCT00673244
Conditions: Acute Kidney Failure
Keywords: Renal Replacement Therapy Dialysis
Sponsor: George Washington University
Start date: 2008-04-01; Completion date: 2013-12-01
Enrollment: 77 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The principal objective is to safely determine if we can identify the severity of Acute Kidney Injury (AKI) early in the course of the disease. Once enrolled, we will draw blood and urine for relevant biomarkers. Our goal is to validate if any of these biomarkers can predict the course of AKI (recovery v. RRT v. death)

Detailed description:
AKI is a very common disease in the intensive care unit. However, despite advances in supportive care, patients with AKI carry a high mortality rate (50% to 70%). The established AKI affects nearly 5 percent of hospitalized persons and as many as 15 percent of critically ill patients. Currently, there are no FDA approved therapeutic agents for the treatment of AKI.

Retrospective studies suggest that the early initiation of renal replacement therapy (RRT) improves outcome. Many clinicians tend to take a "wait and see" approach because they do not want to dialyze a patient who is destined to recover renal function without the need for RRT. Therefore, it is vitally important to know early in the course which patients with AKI are likely to progress to RRT.

Arms: arm 1: None
Interventions: intervention 1: Furosemide
Intervention descriptions: intervention 1: One dose: 1 mg/kg (iv)if the patient is furosemide naive or 1.5 mg/kg (iv) if patient is not furosemide naive.

Protocol documents:
Clinical trial NCT00689572
Conditions: Cocaine Dependence
Keywords: cocaine dependence cocaine abuse cocaine crack
Sponsor: University of Virginia
Start date: 2008-07-01; Completion date: 2013-12-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy of ondansetron compared with placebo in the treatment of cocaine dependence.

Detailed description:
We propose to conduct a 9 week randomized, controlled clinical trial to evaluate the efficacy of ondansetron 4 mg twice daily compared with placebo (total N = 100/group × 2 groups = 200 individuals randomized, 400 total subjects will be consented), provided as an adjunct to manual-driven, structured CBT + BBCET in the treatment of cocaine dependence.

Arms: arm 1: Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy arm 2: Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Interventions: intervention 1: Ondansetron intervention 2: Placebo
Intervention descriptions: intervention 1: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy intervention 2: twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy

Protocol documents:
Clinical trial NCT00698204
Conditions: Oral Mucositis
Keywords: Mucositis Head and Neck Cancer Head and Neck Neoplasms Stomatitis
Sponsor: UConn Health
Start date: 2003-07-01; Completion date: 2013-12-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Oral mucositis refers to ulcerative lesions of the oral mucosa that occur due to radiation therapy given for treatment of head and neck cancer. These lesions are painful, compromise nutrition and quality of life and may necessitate interruptions in radiation therapy, thus adversely affecting cancer therapy outcomes. This study examined the use of an anti-inflammatory medicine to reduce pain and severity of oral mucositis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: celecoxib intervention 2: placebo
Intervention descriptions: intervention 1: Subject was asked to take celecoxib each day that radiation therapy was given. intervention 2: Subject was asked to take placebo each day that radiation therapy was given.

Protocol documents: