ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00384839
Conditions: Prostate Cancer
Sponsor: US Oncology Research
Start date: 2006-04-01; Completion date: 2009-11-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to find out what effects (good and bad) Vidaza has on patients with prostate cancer. This investigational drug is not approved by the Food and Drug Administration (FDA) for the treatment of prostate cancer; however, it is approved in myelodysplastic syndrome - a bone marrow disease. The pharmaceutical company involved in this study, Pharmion Corporation, is the manufacturer of Vidaza.

Detailed description:
This is an open label Phase II study. Patients will receive Vidaza for 5 consecutive days (Days 1- 5) of each 28-day cycle. Complete androgen ablation will be continued. Response will be assessed after a minimum of 2 cycles (evaluable patients). PSA response will be evaluated prior to each cycle and % fetal hemoglobin will be evaluated prior to each odd cycle (excluding Cycle 1). Patients will be treated until clinical progression up to a maximum of 12 cycles. A total of 35 patients with advanced metastatic HRPC will be enrolled in this trial.

Arms: arm 1: azacitidine for injectable suspension
Interventions: intervention 1: azacitidine for injectable suspension
Intervention descriptions: intervention 1: Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.

Protocol documents:
Clinical trial NCT00385671
Conditions: Diabetic Neuropathy, Painful
Sponsor: Eli Lilly and Company
Start date: 2006-09-01; Completion date: 2009-11-01
Enrollment: 407 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin.

Detailed description:

Arms: arm 1: Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \& Germany) or 150 mg BID (Canada), PO for 10 weeks. arm 2: Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks. arm 3: Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
Interventions: intervention 1: duloxetine hydrochloride intervention 2: pregabalin intervention 3: gabapentin
Intervention descriptions: intervention 1: Duloxetine (DLX) once daily (QD), orally (PO) intervention 2: Pregabalin (PGB) orally (PO) intervention 3: Stable Gabapentin (GAB) (participants will remain on the same dose of gabapentin at which they entered the study)

Protocol documents:
Clinical trial NCT00390468
Conditions: Metastatic Cancer Pain Prostate Cancer
Keywords: Tandutinib MLN518 CT53518 pain adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer bone metastases hormone-based castration
Sponsor: National Cancer Institute (NCI)
Start date: 2006-10-01; Completion date: 2009-11-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Tandutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well tandutinib works in treating patients with progressive prostate cancer and bone metastases.

Detailed description:
OBJECTIVES:

Primary

* Determine the time to progression in patients with progressive androgen-independent prostate cancer with bone metastases treated with tandutinib.

Secondary

* Determine the prostate-specific antigen (PSA) decline rate by 50% (PSA response), using the PSA Working Group Criteria, in patients treated with this regimen .
* Evaluate modulation of bone pain and bone markers in patients treated with this regimen.
* Determine the objective tumor response by RECIST (Response Evaluation Criteria In Solid Tumors) criteria in patients treated with this regimen.
* Determine the qualitative and quantitative toxicity of this regimen in these patients.

OUTLINE: Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Bone pain is assessed at baseline, on day 1 of course 3, and at disease progression.

After completion of study treatment, patients are followed for 4 weeks.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Arms: arm 1: 500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases. Tandutinib (MLN518) previously known as CT53518.
Interventions: intervention 1: Tandutinib
Intervention descriptions: intervention 1: 500 mg twice daily every day with doses taken approximately 12 hours apart, 28 day cycle.

Protocol documents:
Clinical trial NCT00406653
Conditions: Crohn's Disease
Sponsor: Bristol-Myers Squibb
Start date: 2006-12-01; Completion date: 2009-11-01
Enrollment: 451 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active Crohn's Disease in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: 4 arms for induction period

2 arms for maintenance period arm 2: 4 arms for induction period

2 arms for maintenance period arm 3: 1 arm for open-label extension phase
Interventions: intervention 1: abatacept intervention 2: placebo intervention 3: abatacept
Intervention descriptions: intervention 1: Dextrose 5% in water, intravenous (IV).

Placebo on days Induction Period (IP)-1, IP-15,IP-29, IP-57;

3 mg/kg on days IP-1, IP-15,IP-29, IP-57;

\~10 mg/kg on days IP-1, IP-15,IP-29, IP-57,

or 30 mg/kg on days IP-1,IP-15 and \~10 mg/kg on days IP-29, IP-57.

Induction Period 3 months

Maintenance Period 12 months intervention 2: Normal saline, IV, 0 mg/kg, every 28 days.

Induction Period 3 months

Maintenance Period 12 months intervention 3: \~10 mg/kg, every 28 days.

Open- Label Extension Period until the drug is marketed for Crohn's Disease (CD)or the CD development program for abatacept is discontinued

Protocol documents:
Clinical trial NCT00406692
Conditions: Alcoholism
Keywords: Zonisamide Alcoholism Alcohol
Sponsor: Boston University
Start date: 2006-11-01; Completion date: 2009-11-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
In this study the influence of zonisamide administration over a 13 week period on alcohol consumption in alcoholic (alcohol dependent) subjects will be examined. The dose of zonisamide given to subjects will be slowly increased over a period of several weeks. They will receive a full dose over a 5 week period. This will be a pilot study in which all of the subjects will only receive zonisamide. A primary objective of this study is to determine the possible size of the effect that zonisamide administration has on drinking (i.e. drinks consumed per day) to allow us to plan for a larger clinical trial of the effects of zonisamide on alcohol dependence.

Detailed description:

Arms: arm 1: In open-label non-placebo controlled trial subjects are treatment with zonisamide 400 mg during the maintenance phase of this study
Interventions: intervention 1: Zonisamide
Intervention descriptions: intervention 1: Week 1 (Wk1) -100 mg daily; Wk 2- 100 mg daily; Wk 3- 200 mg daily; Wk 4- 200 mg daily; Wk 5- 300 mg daily; Wk 6- 300 mg daily; Wk 7-11- 400 mg daily; Wk 12(Days 1-5) 300 mg daily; Wk 12 (Day 6-7) Week 13 (Days 1-3)- 200 mg daily; Week 13 (Days 4-7) - 100 mg daily.

Protocol documents:
Clinical trial NCT00406848
Conditions: Major Depressive Disorder
Sponsor: Eli Lilly and Company
Start date: 2006-11-01; Completion date: 2009-11-01
Enrollment: 370 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of duloxetine 60 mg once daily to placebo on depression in elderly patients (greater than or equal to 65 years of age). Patients who do not respond in the first 13 weeks will be eligible for rescue using pre-defined criteria. Patients randomized to duloxetine 60 mg/day meeting the rescue criteria will be increased to 120 mg/day. Patients randomized to the placebo arm meeting the rescue criteria will be assigned to duloxetine 60 mg/day.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: duloxetine hydrochloride intervention 2: placebo
Intervention descriptions: intervention 1: Placebo for 1 week (double-blind placebo lead-in), then duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity. intervention 2: Placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.

Protocol documents:
Clinical trial NCT00410410
Conditions: Ulcerative Colitis
Sponsor: Bristol-Myers Squibb
Start date: 2006-12-01; Completion date: 2009-11-01
Enrollment: 591 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active ulcerative colitis in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied

Detailed description:
The Induction Period First Cohort (IP1C) arms (30/10 mg/kg and 10 mg/kg) were placebo-controlled arms that were used for the primary endpoint and its analysis. The Induction Period Second Cohort arms (IP2C 30/10 mg/kg and 10 mg/kg) were not placebo-controlled, their sole purpose being to provide sufficient numbers of participants for the maintenance phase. The first cohort (IP1C) was randomized to receive placebo or 1 of 3 doses of abatacept. Following completion of the IP1C randomization, a second cohort (IP2C) was randomized to receive 1 of 2 doses of abatacept. After all participants in the IP1C completed or discontinued, the data was locked and the formal analysis for the Induction Period primary endpoint was performed. Summary tables for the second cohort (IP2C) and the Maintenance and Open-label phases were generated from a second, subsequent data lock.

Arms: arm 1: Induction Period; 3 arms for Cohort 1: ABA 30/\~10 mg/kg (ABA administered at 30 mg/kg followed by ABA at \~10 mg/kg), ABA \~10 mg/kg, ABA 3 mg/kg

Induction Period; 2 arms for Cohort 2: ABA 30/\~10 mg/kg and Second Cohort ABA \~10 mg/kg

1 arm for maintenance period (ABA \~10 mg/kg) arm 2: 1 arm for induction period

1 arm for maintenance period arm 3: 1 arm for open-label extension phase (ABA \~10 mg/kg)
Interventions: intervention 1: abatacept (ABA) intervention 2: placebo intervention 3: abatacept
Intervention descriptions: intervention 1: Dextrose 5% in water, IV. Placebo on days IP-1, IP-15,IP-29, IP-57; 3 mg/kg on days IP-1, IP-15,IP-29, IP-57; 10 mg/kg on days IP-1, IP-15,IP-29, IP-57; or 30 mg/kg on days IP-1,IP-15 and \~10 mg/kg on days IP-29, IP-57 (ABA 30/\~10 mg/kg Group).

Induction Period 3 months

Maintenance Period 12 months intervention 2: Normal saline, IV, 0 mg/kg, every 28 days.

Induction Period 3 months

Maintenance Period 12 months intervention 3: \~10 mg/kg, once monthly

Open- Label Extension Period until the drug is marketed for UC or the UC development program for abatacept is discontinued

Protocol documents:
Clinical trial NCT00415584
Conditions: Secondary Hyperparathyroidism Hypercalcemia
Keywords: hypercalcemia transplant
Sponsor: Montefiore Medical Center
Start date: 2007-02-09; Completion date: 2009-11-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Secondary hyperparathyroidism can persist following successful renal transplantation and can cause high blood calcium, kidney dysfunction or failure and excessive bone loss among other problems. If the condition does not resolve, surgery is frequently required to remove the parathyroid glands, with all the inherent risks of surgery. Cinacalcet, a medicine used to treat secondary hyperparathyroidism in patients with kidney disease, may be effective in treating this condition in renal transplant recipients. The investigator team will study the effect of cinacalcet on calcium, bone and renal function in a 6 month treatment protocol.

Detailed description:
Secondary Hyperparathyroidism in the renal transplant recipient can cause abnormal bone and mineral metabolism, resulting in hypercalcemia that is detrimental to renal function, causing renal dysfunction and calcinosis. These patients often require parathyroidectomy to correct the hypercalcemia. Surgery is not without significant risk to the patient. Risks include vocal cord paralysis, protracted hypocalcemia, cardiac arrhythmias, muscle cramps. In addition, parathyroidectomy has been associated with subsequent renal impairment.

Cinacalcet is a calcimimetic agent that is very effective in the treatment of secondary hyperparathyroidism in patients with renal failure as well as in hypercalcemia of parathyroid cancer. There have been reports of short term Cinacalcet use in renal transplant recipients. Serum calcium was improved in these patients.

However, little is known about the effect of cinacalcet on bone activity and turnover. It is not known whether Cinacalcet causes low turnover bone activity with adynamic bone disease. It is known that low turnover bone disease in renal patients can by itself cause hypercalcemia as the bone becomes static and unable to respond to everyday calcium loads.

Studies have shown that adynamic bone can develop in renal transplant recipients under a variety of conditions. It is not known what effect, if any, cinacalcet has on the bone activity of renal transplant recipients with persistent secondary hyperparathyroidism.

The purpose of the study is to determine the effect of Cinacalcet on serum calcium, renal function and bone histology in renal transplant recipients.

This is a prospective, open-label study. Protocol procedures will include baseline and 6 month measurements of bone mineral density, bone biochemical parameters, glomerular filtration rate, anterior iliac crest bone biopsy. Subjects will start cinacalcet after the first biopsy. The medication will be titrated to normalize serum calcium. Medication will be supplied by the study. Serum electrolytes will be monitored as indicated.

Arms: arm 1: None
Interventions: intervention 1: Cinacalcet HCl
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00416520
Conditions: Chronic Kidney Disease Hyperphosphatemia
Keywords: Chronic Kidney Disease Dialysis Hyperphosphatemia Phosphate binder
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2007-06-01; Completion date: 2009-11-01
Enrollment: 336 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, randomised, parallel group, flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) intervention 2: Placebo intervention 3: Another phosphate binder (Sevelamer)
Intervention descriptions: intervention 1: 3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind intervention 2: 3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind intervention 3: Current approved dosing recommendations for 12 weeks

Protocol documents:
Clinical trial NCT00419952
Conditions: Asthma
Keywords: Moderate Asthma Severe Asthma
Sponsor: AstraZeneca
Start date: 2007-02-01; Completion date: 2009-11-01
Enrollment: 742 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration, FDA) in the African American population.

Detailed description:

Arms: arm 1: Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID) arm 2: Budesonide HFA pMDI 160 ug x 2 actuations BID
Interventions: intervention 1: Budesonide/formoterol (SYMBICORT) pMDI intervention 2: Budesonide HFA pMDI
Intervention descriptions: intervention 1: Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID) intervention 2: Budesonide HFA pMDI 160 ug x 2 actuations BID

Protocol documents:
Clinical trial NCT00423098
Conditions: Lupus Nephritis
Keywords: Lupus Nephritis enteric-coated mycophenolate sodium EC-MPS Myfortic
Sponsor: Novartis Pharmaceuticals
Start date: 2007-02-01; Completion date: 2009-11-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will investigate the efficacy and safety of enteric-coated mycophenolate sodium in combination with two different corticosteroid (CS) regimes for the induction of remission of a lupus nephritis flare. Patients will be randomly allocated to standard CS regimen (group I) or to a reduced dose CS regimen (group II)

Detailed description:

Arms: arm 1: Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of Prednisone was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks. arm 2: Mycophenolate sodium was administered in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of Prednisone was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Interventions: intervention 1: Mycophenolate sodium intervention 2: Prednisone intervention 3: Methylprednisolone
Intervention descriptions: intervention 1: Mycophenolate sodium as administered orally for 2 weeks at 1440mg daily and then increased to 2160mg daily for 22 weeks. intervention 2: Oral prednisone or prednisone equivalent was started on Day 4 and subsequently tapered every 2 weeks according to the patient's weight. intervention 3: All patients received bolus therapy with 0.5 g of intravenous Methylprednisolone per day for 3 consecutive days.

Protocol documents:
Clinical trial NCT00429104
Conditions: Breast Cancer
Keywords: Breast Cancer Carcinoma of the Breast HER-2/neu Overexpression Herceptin Trastuzumab GM-CSF Sargramostim Leukine
Sponsor: M.D. Anderson Cancer Center
Start date: 2002-08-01; Completion date: 2009-11-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objectives:

1. To determine the patient's tumor response rate that this protocol will produce.
2. To determine the 1 year progression-free survival that this protocol will produce.

Secondary Objective:

1\. To determine whether antibody-dependent cell-mediated cytotoxicity (ADCC) is the mechanism of overcoming Herceptin-resistance by use of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF).

Detailed description:
GM-CSF stimulates the immune system and may increase the effectiveness of Herceptin.

Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete medical history and physical exam. This includes blood tests (about 2 tea spoons), and x-rays. Women who are able to have children must have a negative blood or urine pregnancy test.

If you are found to be eligible to take part in this study, you will receive trastuzumab through a vein (IV) every week until the disease gets worse. GM-CSF will be injected under the skin at least once a day until the white blood cell count is stable. GM-CSF will also continue during the course of study until the disease progresses.

You will have further evaluation of your disease by computed tomography-CT scan, bone scan, chest X-ray, etc. at 2, 4, 6, 9, 12, 18, and 24 months after the start of treatment. You will have blood tests (about 2 tea spoons) at least twice a week until the appropriate dose of GM-CSF is found. The dose may increase or decrease depending on the blood test.

You will have blood (about 2 tablespoons) drawn before treatment at the 2nd and 4th month, and if the disease gets worse.

You will be removed from the study if the disease is progressing or severe side effects occur.

This is an investigational study. The FDA has approved trastuzumab and GM-CSF, but their use in this study is experimental. A total of 36 patients will take part in this study. All will be enrolled at UT MD Anderson Cancer Center.

Arms: arm 1: Herceptin 4 mg/kg IV Over 90 Minutes + GM-CSF 250 mcg/m\^2 subcutaneously
Interventions: intervention 1: Herceptin intervention 2: GM-CSF
Intervention descriptions: intervention 1: 4 mg/kg IV Over 90 Minutes intervention 2: 250 mcg/m\^2 Subcutaneously

Protocol documents: