ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00115336
Conditions: Hematologic Diseases Anemia, Sickle Cell
Keywords: Blood Diseases Sickle Cell Anemia
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2005-01-01; Completion date: 2008-12-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare ketorolac, a potent, non-steroidal anti-inflammatory drug (NSAID), with ibuprofen, a commonly used NSAID, for the treatment of the painful crisis of sickle cell disease (SCD).

Detailed description:
BACKGROUND:

SCD is a common disorder among African Americans and other minority groups. It is characterized by chronic anemia and episodic vaso-occlusive crises. The most common of these crises is the painful crisis. Current treatment of the painful crisis includes rest, hydration, and analgesic medication. Morphine is the most commonly prescribed analgesic medication for moderate to severe painful episodes, but there are several side effects associated with its use, including somnolence, respiratory depression, constipation, dysphoria, and pruritus. Other analgesic medications, including NSAIDs, may improve pain control and decrease the need for morphine and other opioid drugs; however, more research is needed to confirm the benefits in individuals with SCD.

DESIGN NARRATIVE:

This study will enroll 120 children who will receive standard opioid and supportive therapy. In addition to this care, participants will be randomly assigned to receive one of the following: 1) intravenous ketorolac and oral placebo; or 2) intravenous placebo and oral ibuprofen. Outcome assessments will include the duration of hospitalization for opioid therapy; the degree of pain intensity and relief determined by validated pain scales; and the utilization of opioid medications during hospitalization. All participants will be monitored for potential adverse effects of the study medications by laboratory measurements and clinical assessments. Additionally, participants will self-report pain levels using the Oucher pain scale. Participants will be monitored for the development of adverse events, including gastrointestinal symptoms and deterioration of kidney function, as determined by daily kidney function tests including BUN, creatinine, and hematuria.

Arms: arm 1: Intravenous ketorolac and oral placebo arm 2: Intravenous placebo and oral ibuprofen
Interventions: intervention 1: Intravenous Ketorolac intervention 2: Ibuprofen
Intervention descriptions: intervention 1: Intravenous ketorolac intervention 2: Ibuprofen, taken orally

Protocol documents:
Clinical trial NCT00118742
Conditions: Liver Transplantation
Sponsor: Hoffmann-La Roche
Start date: 2005-08-01; Completion date: 2008-12-01
Enrollment: 293 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant. Patients will be randomized to receive either CellCept 1-1.5 g twice daily (BID) + tacrolimus + cyclosporine, or CellCept 1-1.5 g BID + sirolimus. The anticipated time on study treatment is 1 to 2 years, and the target sample size is 100 to 500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: mycophenolate mofetil [CellCept] intervention 2: Tacrolimus intervention 3: Cyclosporine intervention 4: Sirolimus
Intervention descriptions: intervention 1: 1-1.5 g orally or intravenously twice daily intervention 2: As prescribed, for 12 months intervention 3: As prescribed, for 12 months intervention 4: 2-4 mg orally once daily for 9-11 months

Protocol documents:
Clinical trial NCT00121836
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2005-06-01; Completion date: 2008-12-01
Enrollment: 109 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was until disease progression or unacceptable toxicity. The target sample size was \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Capecitabine intervention 2: Bevacizumab
Intervention descriptions: intervention 1: 1000 mg/m² PO BID on Days 1-15 of each 3-week cycle intervention 2: 15 mg IV on Day 1 of each 3-week cycle

Protocol documents:
Clinical trial NCT00125931
Conditions: Bipolar Disorder
Keywords: bipolar disorder mania manic state opiate kappa
Sponsor: Mclean Hospital
Start date: 2005-09-01; Completion date: 2008-12-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The opiate neurotransmitter system is thought to be involved in many abnormal mood states. Some researchers have suggested that changes in this system may trigger the switch to/from manic and depressive states in bipolar disorder. One problem with most of the currently available opiate medications is that they can produce addiction/dependence. A particular kind of opiate medication known as kappa-opiates may be able to produce changes in this system with much less risk of addiction. This study looks at Talwin (a combination of pentazocine and naloxone), a medication which affects the kappa and mu opiate systems. The study will examine whether two doses of Talwin affect manic symptoms in people who have been admitted to the hospital. This study will give more information about the involvement of the opiate system in bipolar disorder, and give important information for use in developing new treatments.

Detailed description:
Opiates have a long history of treating mood disorders. Some researchers have suggested that changes in this system may trigger the switch to/from manic and depressive states in bipolar disorder. The clinical use of opiate medications has been limited by their abuse/dependence potential. Studies of opiate receptor subtypes have raised the possibility that medications targeting the kappa/dynorphin system could be used to target mood symptoms with reduced/limited addiction potential. Rodent studies at Mclean indicate that kappa-agonists have pro-depressant effects and kappa-antagonists have anti-depressant effects. In addition, antimanic/antipsychotic medications regulate the activity of dynorphin cells. This study is a pilot open-label investigation using Talwin, a combination of pentazocine and naloxone. Pentazocine is a kappa agonist and mixed mu agonist. Two doses of Talwin will be given to acutely manic inpatients in a cumulative-dosing strategy. Measurements of manic symptoms will be conducted before, during, and after administration. This study will determine whether pentazocine has an immediate or sustained impact on acute mania symptoms.

Arms: arm 1: Talwin NX
Interventions: intervention 1: Talwin Nx
Intervention descriptions: intervention 1: Talwin NX 50mg po twice

Protocol documents:
Clinical trial NCT00126425
Conditions: Heart Failure, Congestive
Keywords: Heart Failure nuclear cardiology sympathetic innervation 123I-mIBG
Sponsor: GE Healthcare
Start date: 2005-07-01; Completion date: 2008-12-01
Enrollment: 587 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to predict cardiac outcomes in subjects with heart failure and in comparison to subjects without cardiovascular disease.

Detailed description:

Arms: arm 1: Single dose
Interventions: intervention 1: 123I-mIBG (meta-iodobenzylguanidine)
Intervention descriptions: intervention 1: Single dose

Protocol documents:
Clinical trial NCT00127218
Conditions: Atherosclerosis Cardiovascular Disease
Keywords: atherosclerotic plaque MRI inflammatory markers statins
Sponsor: Johns Hopkins University
Start date: 2003-09-01; Completion date: 2008-12-01
Enrollment: 145 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the added benefits of increased high-density lipoprotein (HDL) cholesterol serum levels over and above those achieved by lipid lowering therapy guided by current guidelines, in older individuals with cardiovascular disease.

Detailed description:
The hypothesis being tested is that the current standard lipid lowering therapy, combined with a 20 percent or greater increase in serum HDL induced by long-acting niacin, reduces plaque size in older individuals with cardiovascular disease. The specific aims of testing this hypothesis are:

1. to determine the effects of statin plus placebo vs. statin plus niacin therapy on plaque size and composition,
2. to determine whether alterations of inflammatory markers of atherosclerosis induced by lipid lowering therapy parallel alterations of plaque architecture and composition in older patients with cardiovascular disease,
3. to determine the effects of these interventions on the incidence of cardiovascular and cerebrovascular events.

The results of the trial will be directly applicable to developing strategies for plaque stabilization in the elderly who suffer the most from the severe complications of advanced cardiovascular atherosclerosis.

A total of 144 participants aged 65 and older with cardiovascular or cerebrovascular disease will be recruited. Participants will be randomized to receive either statin plus niacin or statin plus a placebo for 18 months. Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis, or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily, simvastatin 20 mg daily, atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily. Ten visits are expected, initially every 4 weeks for dose adjustment. Then visits will be every 6 months; MRI, Inflammatory Markers tests, and other lab tests will be done at baseline and the visits at months 6, 12, and 18.

Arms: arm 1: any statin plus niacin arm 2: any statin plus placebo
Interventions: intervention 1: any statin intervention 2: niacin intervention 3: Placebo
Intervention descriptions: intervention 1: Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis, or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily, simvastatin 20 mg daily, atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily for 18 months intervention 2: long-acting niacin daily for 18 months intervention 3: matching placebo pill daily for 18 months

Protocol documents:
Clinical trial NCT00136916
Conditions: Diabetes Mellitus
Sponsor: Pfizer
Start date: 2002-06-01; Completion date: 2008-12-01
Enrollment: 635 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to find out the good and bad effects of inhaled insulin that is used by oral inhalation, to adult males and females with type 2 diabetes mellitus. The other name for this inhaled insulin is Exubera®.

This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.

Detailed description:
Pfizer announced in October 2007 that it would stop marketing Exubera. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171029 was terminated on June 9, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Arms: arm 1: Inhalable short-acting insulin arm 2: None
Interventions: intervention 1: Inhaled Insulin intervention 2: Subcutaneous insulin
Intervention descriptions: intervention 1: Inhaled insulin with dose adjusted according to premeal blood glucose intervention 2: Subcutaneous insulin with dose adjusted according to premeal blood glucose

Protocol documents:
Clinical trial NCT00137046
Conditions: Diabetes Mellitus, Type 1
Sponsor: Pfizer
Start date: 2002-05-01; Completion date: 2008-12-01
Enrollment: 582 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to find out the good and bad effects of a drug that is not approved for sale and the effects if any on measures of pulmonary function in adult males and females with type 1 diabetes mellitus. The drug is called EXUBERA (inhaled insulin).

This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.

Detailed description:
Pfizer announced in October 2007 that it would stop marketing Exubera. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171022 was terminated on June 9, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Subcutaneous Insulin intervention 2: Inhaled Insulin
Intervention descriptions: intervention 1: Subcutaneous insulin with dose adjusted according to premeal blood glucose intervention 2: Inhaled insulin with dose adjusted according to premeal blood glucose

Protocol documents:
Clinical trial NCT00138203
Conditions: Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-06-01; Completion date: 2008-12-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the response of non-small cell lung cancer to SAHA in the second line setting by applying RECIST criteria.

SECONDARY OBJECTIVES:

I. To estimate the time to progression and overall survival in this patient population.

II. To examine the toxicity profile of SAHA.

TERTIARY OBJECTIVES:

I. To evaluate the molecular activity of SAHA by evaluating its effect on histone acetylation, upregulation of target genes, generation of reactive oxygen species, apoptosis and correlation with P53 status.

II. To explore gene expression profiles that predict response to SAHA.

OUTLINE: This is a multicenter study.

Patients receive oral suberoylanilide hydroxamic acid once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 1 month and then every 3 months for 1 year or until disease progression.

Arms: arm 1: Patients receive oral suberoylanilide hydroxamic acid once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: vorinostat intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00143455
Conditions: Small Cell Lung Carcinoma
Sponsor: Pfizer
Start date: 2002-06-01; Completion date: 2008-12-01
Enrollment: 485 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the effects of irinotecan hydrochloride with cisplatin to the "standard" regimen etoposide plus cisplatin on overall survival, in chemotherapy-naive patients with newly diagnosed Extensive Disease-Small Cell Lung Cancer (ED-SCLC).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Etoposide + cisplatin intervention 2: Irinotecan + cisplatin
Intervention descriptions: intervention 1: etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle intervention 2: irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle

Protocol documents:
Clinical trial NCT00145496
Conditions: Schizophrenia
Sponsor: Organon and Co
Start date: 2004-12-01; Completion date: 2008-12-01
Enrollment: 468 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as olanzapine, has shown improvement in the treatment of negative symptoms in acute trials. The purpose of this study is to compare an investigational compound (asenapine) with a marketed agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of schizophrenia for 6 months. Patients completing this study may be eligible to participate in an extension 6 months of treatment. Patients are required to have stable symptoms prior to entry into study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Asenapine intervention 2: Olanzapine
Intervention descriptions: intervention 1: 5-10 mg sublingually twice daily for up to 26 weeks intervention 2: 5-20 mg by mouth once daily for up to 26 weeks

Protocol documents:
Clinical trial NCT00159822
Conditions: Aspergillosis
Sponsor: Pfizer
Start date: 2005-07-01; Completion date: 2008-12-01
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the efficacy of voriconazole (VFend(R)) as first line treatment for proven chronic bronchopulmonary aspergillosis, in minimally immunocompromised or non-immunocompromised patients after 6 months of treatment i.e. chronic necrotizing pulmonary

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Voriconazole
Intervention descriptions: intervention 1: Voriconazole oral : loading dose on day 1 : 400mg/12 hours; maintenance dose 200 mg /12 hours for 6 to 12 months depending on clinical response.

Alternatively, patients may start on Voriconazole, IV, for 7 days loading dose, 6mg/Kg/12 hours on day one and maintenance dose 4 mg/Kg/12 hours

Protocol documents:
Clinical trial NCT00167206
Conditions: Fanconi Anemia
Keywords: Stem Cell Transplant Thymic Shielding Total Body Irradiation Chemotherapy
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2004-03-01; Completion date: 2008-12-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether thymic shielding during total body irradiation can be given and whether it will reduce the risk of infections in Fanconi Anemia patients undergoing alternate donor (not a matched sibling) stem cell transplants.

Detailed description:
All subjects will be given the same treatment regimen of total body irradiation (TBI), Fludarabine, Cyclophosphamide, and anti-thymocyte globulin (ATG), followed by an alternate donor stem cell transplant. Since this treatment regimen has been given before, without thymic shielding, we will compare the outcomes of these patients with the historical data from subjects who did not receive thymic shielding.

Arms: arm 1: Patients who received total body irradiation (450 cGy \[centigray\]) with thymic shielding prior to chemotherapy regimen and Hematopoietic Stem Cell Transplant (HSCT)
Interventions: intervention 1: Hematopoietic Stem Cell Transplant intervention 2: Thymic Shielding During Radiation intervention 3: Total Body Irradiation intervention 4: Cyclophosphamide, Fludarabine
Intervention descriptions: intervention 1: Bone marrow failure may be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. intervention 2: protecting the thymus during total body radiation (450 cGy administered) intervention 3: Six days before the stem cells are given (day -6), subjects will receive total body irradiation with thymic shielding. Thymic shielding is done by placing a piece of lead on the chest during the irradiation treatment so that the irradiation beams do not go to the thymus. intervention 4: Day -5 through Day -2, subjects will receive a chemotherapy regimen of Fludarabine, Cyclophosphamide via central line

Protocol documents:
Clinical trial NCT00167934
Conditions: Schizophrenia
Keywords: Diabetes Metabolic
Sponsor: Washington University School of Medicine
Start date: 2004-12-01; Completion date: 2008-12-01
Enrollment: 164 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the metabolic processes responsible for high levels of blood glucose, metabolism disorders, and weight gain in people with schizophrenia who have been treated with antipsychotic medications in combination with valproate.

Detailed description:
This project aims to study the whole-body metabolic processes responsible for hyperglycemia, dyslipidemia and increased adiposity in schizophrenia patients treated with antipsychotic medications in combination with valproate. The project hypothesizes that combined treatment with valproate and antipsychotic medications will decrease insulin sensitivity at the level of skeletal muscle, liver and adipose tissue, in comparison to antipsychotic monotherapy. The decrease in insulin sensitivity is hypothesized to be associated with defects in glucose and lipid metabolism and increased adiposity

Treatment effects of antipsychotic/valproate combination therapy on different components of insulin secretion and action, and treatment effects on abdominal versus peripheral adiposity, are unknown despite the availability of gold-standard methods and the prognostic significance of these issues. Relevant data are needed to target basic research, to identify the potential for acute and long-term complications, and to plan therapeutic interventions. The following specific aims will be addressed in non-diabetic schizophrenia patients treated with atypical antipsychotics who will be randomized to open label treatment with either valproate or no adjuvant. Evaluations are performed at baseline and 3 months of treatment.

Arms: arm 1: 50% of participants will receive placebo arm 2: 50% of participants will receive Depakote ER
Interventions: intervention 1: Valproate intervention 2: Placebo
Intervention descriptions: intervention 1: Depakote ER 500 mg to 3000 mg taken every night intervention 2: Placebo given at same frequency as Valproate

Protocol documents: