ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00630344
Conditions: Prostate Cancer
Keywords: RAD001 bicalutamide androgen independent prostate cancer
Sponsor: Dana-Farber Cancer Institute
Start date: 2008-02-01; Completion date: 2012-05-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In the treatment of castration-resistant prostate cancer (CRPC), therapies will long response durations remain elusive as a result of the inherent ability of prostate cancer cells to develop iterative resistance. The goal of this study is to learn if the study drug RAD001 together with Bicalutamide can slow the growth of prostate cancer. The safety of the combination will also be studied.

Detailed description:
Bicalutamide, an androgen receptor (AR) antagonist, is frequently used as the first 'secondary hormonal therapy' in combination with another established agent (LHRH: luteinizing hormone-releasing hormone agonist/antagonist) to treat CRPC. A series of studies have shown that RAD001 through inhibition of mammalian target of rapamycin (mTOR) pathway has antitumor and anti-angiogenic activities. The hypothesis is that the combination of an antiandrogen and mTOR inhibitor would have additive and clinically significant effects in CRPC.

STATISTICAL CONSIDERATIONS:

The regimen will be considered promising if the rate of response/favorable outcome is 40% or greater. A rate of 20% (similar to that observed for bicalutamide alone) will not be considered worthy of further study. 38 patients (of whom 36 are assumed to be eligible) will be accrued to the study. If 11 or more patients have a favorable outcome (stable disease \> 6 months or response), the combination will be considered worthy of further study. Given this design, there is a 9% probability of declaring the combination effective if the true favorable outcome rate is 20% and a 91% probability of declaring the combination effective if the true favorable outcome rate is 40%.

Arms: arm 1: RAD001: once daily dose of 10 mg (5 mg tablets)

Bicalutamide: once daily dose of 50 mg (50 mg tablets)

1 cycle=28 days

Both agents are administered continuously until progression of disease or unacceptable toxicity.
Interventions: intervention 1: RAD001 intervention 2: Bicalutamide
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00636155
Conditions: Lymphoma, Small Lymphocytic Leukemia, Lymphocytic, Chronic
Keywords: Small Lymphocytic Lymphoma Chronic Lymphocytic Leukemia EL625 cenersen
Sponsor: David Rizzieri
Start date: 2008-02-01; Completion date: 2012-05-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to see if the investigational drug EL625, when combined with traditional chemotherapy (rituximab, fludarabine, and cyclophosphamide), is effective in Persistent Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)

Detailed description:
Chronic lymphocytic leukemia (CLL) and small B-cell lymphocytic lymphoma (SLL) are thought to be different manifestations of the same disease. Treatment options for CLL/SLL range from a watch and wait approach to bone marrow transplant. Currently there is no consensus on the best treatment regimen and new approaches to treatment are needed.

EL625 is a 20-mer antisense molecule which binds to a coding region of exon 10 in p53 RNA transcripts. It can bind to both mutant and wild type p53. p53 is involved in regulating apoptosis and DNA repair in cells. When genetic damage occurs p53 is upregulated. As the expression of p53 increases in normal cells they are more likely to undergo apoptosis rather than cell cycle arrest and DNA repair. However in malignant cells, for a given level of DNA damage they are more likely to undergo cell cycle arrest and repair rather than apoptosis. Because EL625 is theorized to increase response to chemotherapy, we propose adding EL625 to a combination of fludarabine, cyclophosphamide and rituximab.

Arms: arm 1: EL625 combined with traditional chemotherapy (rituximab, fludarabine, and cyclophosphamide)
Interventions: intervention 1: cenersen sodium intervention 2: Rituximab intervention 3: Cyclophosphamide intervention 4: Fludarabine
Intervention descriptions: intervention 1: 2.4 mg/kg/day as a continuous infusion over 24 hours starting on day one and ending on day 4 intervention 2: 375 mg/m2 on day 2 intervention 3: 250 mg/m2 on days 2, 3, and 4 intervention 4: 25 mg/m2 on days 2, 3, and 4

Protocol documents:
Clinical trial NCT00662025
Conditions: Advanced/Metastatic Breast Cancer
Sponsor: Pfizer
Start date: 2008-04-01; Completion date: 2012-05-01
Enrollment: 63 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese patients with advanced/metastatic breast cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Capecitabine intervention 2: Sunitinib
Intervention descriptions: intervention 1: Capecitabine 1000 mg/m2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles intervention 2: Sunitinib 37.5 mg daily, continuous dosing

Protocol documents:
Clinical trial NCT00676130
Conditions: Cellulitis
Keywords: Cellulitis Bactrim Trimethoprim Sulfamethoxazole MRSA Methicillin-resistant Staphylococcus aureus
Sponsor: Brigham and Women's Hospital
Start date: 2007-05-01; Completion date: 2012-05-01
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of this study is to quantify the effectiveness of Bactrim as additional therapy for the treatment of uncomplicated cellulitis in adults, by comparing: standard therapy plus Bactrim, versus standard therapy plus placebo.

The primary hypothesis of this study is that, in light of increasing CA-MRSA prevalence, subjects treated with standard therapy plus Bactrim will have higher cure rates than those treated with standard therapy plus placebo.

Detailed description:

Arms: arm 1: cephalexin plus placebo arm 2: cephalexin plus trimethoprim-sulfamethoxazole
Interventions: intervention 1: trimethoprim-sulfamethoxazole intervention 2: Cephalexin
Intervention descriptions: intervention 1: Weight-based dosing in capsule or suspension form according to the following scale:

15-19 kg (33-42 lbs): trimethoprim-sulfamethoxazole 40/200 mg four times daily

20-24 kg (42-53 lbs): trimethoprim-sulfamethoxazole 60/300 mg four times daily

25-29 kg (53-64 lbs): trimethoprim-sulfamethoxazole 72/360 mg four times daily

29-60 kg (64-132 lbs): trimethoprim-sulfamethoxazole 80/400 mg four times daily

60 kg (132 lbs): trimethoprim-sulfamethoxazole 80/400 mg four times daily

60-80 kg (132-176 lbs): trimethoprim-sulfamethoxazole 160/800 mg three times daily

\> 80 kg (176 lbs): trimethoprim-sulfamethoxazole 160/800 mg four times daily intervention 2: Weight-based dosing in capsule or suspension form according to the following scale:

15-19 kg (33-42 lbs): Cephalexin 300 mg four times daily

20-24 kg (42-53 lbs): Cephalexin 400 mg four times daily

25-29 kg (53-64 lbs): Cephalexin 500 mg four times daily

29-60 kg (64-132 lbs): Cephalexin 500 mg four times daily

60-80 kg (132-176 lbs): Cephalexin 1000 mg three times daily

\> 80 kg (176 lbs): Cephalexin 1000 mg four times daily

Protocol documents:
Clinical trial NCT00679341
Conditions: Breast Cancer
Keywords: HER2-positive breast cancer HER2 Herceptin Taxotere MBC Breast cancer TDM1 TDM-1 HER2-positive HER2+ HER2 positive breast cancer HER2+ breast cancer Armed Herceptin Trastuzumab emtansine Trastuzumab DM1
Sponsor: Hoffmann-La Roche
Start date: 2008-09-01; Completion date: 2012-05-01
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a Phase II, randomized, multicenter, international, 2-arm, open-label clinical trial designed to explore the efficacy and safety of trastuzumab emtansine (T-DM1) relative to the combination of trastuzumab and docetaxel in patients with human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally advanced breast cancer and/or metastatic breast cancer who have not received prior chemotherapy for metastatic disease.

Detailed description:

Arms: arm 1: Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle. arm 2: Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m\^2 IV on Day 1 of all subsequent 21-day cycles.
Interventions: intervention 1: Trastuzumab emtansine [Kadcyla] intervention 2: Trastuzumab intervention 3: Docetaxel
Intervention descriptions: intervention 1: The total dose depended on the patient's weight on Day 1 of each cycle. Trastuzumab emtansine was administered every 3 weeks until investigator-assessed radiographic or clinical progressive disease (or until second disease progression for patients who crossed over), unacceptable toxicity, or study closure, whichever occurred first. intervention 2: The dose of trastuzumab was recalculated if body weight changed by more than ±10% from baseline. Trastuzumab was administered every 3 weeks until investigator-assessed radiographic or clinical progressive disease, or unmanageable toxicity. Patients in the trastuzumab + docetaxel arm who discontinued study treatment because of progressive disease were eligible to cross-over to trastuzumab emtansine treatment until a second progressive disease event, clinical deterioration, and/or intolerance. intervention 3: Docetaxel was given at a dose of 75 or 100 mg/m\^2 based on the investigator's decision. Patients in the trastuzumab + docetaxel arm who discontinued study treatment because of progressive disease were eligible to cross-over to trastuzumab emtansine treatment until a second progressive disease event, clinical deterioration, and/or intolerance.

Protocol documents:
Clinical trial NCT00699842
Conditions: Myelodysplastic Syndrome MDS Low to Intermediate-1 MDS Non-deletion 5q
Keywords: Myelodysplastic Syndrome MDS Low to Intermediate-1 MDS Non-deletion 5q Lenalidomide
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Start date: 2008-07-01; Completion date: 2012-05-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Revlimid® (Lenalidomide) is indicated for a type of blood cancer, myelodysplastic syndrome (MDS), at 10mg for a specific type of myelodysplastic syndrome with a genetic abnormality called "deletion 5q" in Low and Intermediate-1 (INT-1) patients (staging system according to International Prognostic Scoring System (IPSS)). The purpose of this Phase I/II study is to determine the optimal dose of Revlimid® (Lenalidomide) in MDS Low and MDS INT-1 patients without deletion 5q by slowly increasing the dose while monitoring blood counts for safety evaluation as well as observe other adverse events. Efficacy will also be observed for the phase II portion of the study.

Detailed description:
There are little options for non deletion 5q Low and INT-1 patients. This study aims to find an early clinical signal for higher activity and better response with lenalidomide in patients with non deletion 5q Low and INT-1 MDS patients. Lenalidomide is an immunomodulatory agent. Thalidomide, the parent compound, has both immunomodulatory and anti-angiogenic properties which could confer anti-tumor and anti-metastatic efforts. Lenalidomide has been demonstrated to possess anti-angiogenic activity through inhibition of basic fibroblast growth factor (bFGF), vascular endothelial growth factor (VEGF) and tumor necrosis factor-alpha (TNF-alpha) induced endothelial cell migration (movement of cells in preparation to form new abnormal blood vessels for cancer cells), due at least in part to inhibition of Akt phosphorylation response to bFGF.

In addition, lenalidomide has a variety of immunomodulatory effects. Lenalidomide stimulates T cell proliferation, and the production of interleukin-2 (IL-2), IL-10 and interferon-gamma (IFN-gamma), inhibits IL-1 beta and IL-6 and modulated IL-12 production.

Although the exact anti-tumor mechanism of action of lenalidomide is unknown, a number of mechanisms are postulated for the activity of Lenalidomide in MDS.

Arms: arm 1: Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Interventions: intervention 1: Lenalidomide
Intervention descriptions: intervention 1: Dose Level Lenalidomide Schedule

1. 15mg/day for d1-21 out of 28 days
2. 20mg/day for d1-21 out of 28 days
3. 25mg/day for d1-21 out of 28 days

Protocol documents:
Clinical trial NCT00709618
Conditions: Neoplasms, Breast
Keywords: Erbb2 MBC First or Second line therapy Metastatic Breast Cancer Vinorelbine Tykerb
Sponsor: GlaxoSmithKline
Start date: 2008-06-01; Completion date: 2012-05-01
Enrollment: 44 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, single-arm, multi-center, Phase II study to determine the activity of vinorelbine plus lapatinib in either first- or second-line setting in women with ErbB2 overexpressing metastatic breast cancer (MBC). Sixty subjects will be enrolled in the study. Subjects will receive vinorelbine intravenously once weekly for 3 weeks, followed by a rest week in a 4-week cycle) plus lapatinib daily. Subjects will receive treatment until disease progression or withdrawal from the study. The primary objective of this study is to evaluate overall tumor response rate of lapatinib in combination with vinorelbine. Secondary objectives include progression-free survival, overall survival, duration of response, time to response and time to progression and safety. Safety and efficacy assessments will be performed at 4, 8 and 12 week intervals, and at the end of treatment.

Subject: Metastatic Breast Cancer, ErbB2, First-line or Second-line therapy, Lapatinib, Vinorelbine

Detailed description:

Interventions: intervention 1: Lapatinib, Vinorelbine
Intervention descriptions: intervention 1: Vinorelbine intravenously once weekly for 3 weeks, followed by a rest week in a 4-week cycle) plus lapatinib daily

Protocol documents:
Clinical trial NCT00796549
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Start date: 2008-12-01; Completion date: 2012-05-01
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the RECIST criteria in patients with EGFR FISH positive advanced NSCLC Stage IIIB or IV, selected according to the following scheme:

* Forty (40) 1st line patients
* Thirty (30) 2nd line patients Patients entered into the trial will be treated and followed until death or lost to follow-up. Additional information will be obtained on the safety profile and PK analysis of BIBW 2992.

Detailed description:

Arms: arm 1: BIBW 2992 in EGFR FISH positive NSCLC patients
Interventions: intervention 1: BiBW 2992
Intervention descriptions: intervention 1: BIBW 2992 in EGFR FISH positive NSCLC patients

Protocol documents:
Clinical trial NCT00807989
Conditions: Epilepsy
Sponsor: Yonsei University
Start date: 2008-03-01; Completion date: 2012-05-01
Enrollment: 207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of usual monotherapy and low dose combination of Lamotrigine and Valproate. Low dose combination may be more effective and tolerable because they are low dose and VPA reduce Lamotrigine metabolism.

Detailed description:
An Open label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies

Arms: arm 1: Carbamazepine arm 2: Lamotrigine and Valproate combination therapy
Interventions: intervention 1: Carbamazepine intervention 2: Lamotrigine/Valproate
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00813865
Conditions: Gaucher Disease Type 1 Gaucher Disease Gaucher Disease, Type 1
Keywords: Amicus Therapeutics AT2101 afegostat tartrate isofagomine tartrate
Sponsor: Amicus Therapeutics
Start date: 2009-05-11; Completion date: 2012-05-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluated the long-term safety and efficacy of afegostat tartrate in participants with Gaucher disease who were enrolled in a previous Phase 2 study of afegostat tartrate.

Detailed description:
This was an open-label, long-term extension study of afegostat tartrate in participants with type 1 Gaucher disease who successfully completed Study GAU-CL-202 (NCT00446550). Participants could enter the study immediately upon completion of participation in the lead-in study GAU-CL-202, or at any later time point. Participants received 225 milligram (mg) afegostat tartrate, administered orally for 30 months, and remained in 1 of the 2 randomized treatment regimens of Study GAU-CL-202: afegostat tartrate once daily (QD) for 3 consecutive days, then no afegostat tartrate for 4 consecutive days (consecutive 3-days-on/4-days-off) or QD for 7 consecutive days, then no afegostat tartrate for 7 days (consecutive 7-days-on/7-days-off). Amendment 2 removed the 7-days-on/7-days-off regimen and added an alternative 3-days-on/4-days-off regimen: afegostat tartrate QD on Monday, Wednesday, and Friday, then no afegostat tartrate on Tuesday, Thursday, Saturday, and Sunday (MWF 3-days-on/4-days-off). Once Amendment 2 was implemented at a site, participants assigned to the 7-days-on/7-days-off regimen switched to a 3-days-on/4-days-off regimen; those on the original 3-days-on/4-days-off regimen could switch to the MWF 3-days-on/4-days-off regimen. Amendment 4 removed the original 3-days-on/4-days-off regimen and any participants still on that regimen switched to the MWF 3-days-on/4-days-off regimen. Study visits occurred every 3 months for 30 months. Participants were contacted approximately 1, 3, and 6 months after the end of treatment (EOT) or early termination for follow-up assessments.

Arms: arm 1: Afegostat tartrate was administered orally at a dose of 225 mg QD for 3 or 7 consecutive days followed by no study medication for 4 or 7 consecutive days (consecutive 3-days-on/4-days-off or 7-days-on/7-days-off, respectively). Amendment 2 added a MWF 3-days-on/4-days-off regimen. After Amendment 2 was implemented, all participants were assigned to one of the two 3-days-on/4-days-off regimens. Amendment 4 removed the consecutive 3-days-on/4-days-off regimen, and all participants were assigned to the MWF 3-days-on/4-days-off regimen. Participants were to receive afegostat tartrate for 30 months and be followed for 6 months after EOT.
Interventions: intervention 1: afegostat tartrate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00834080
Conditions: Opiate Dependence
Keywords: opioid dependence VIVITROL opioid-related disorders
Sponsor: Alkermes, Inc.
Start date: 2009-03-01; Completion date: 2012-05-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Medisorb naltrexone 380 mg
Intervention descriptions: intervention 1: Intramuscular (IM) injection administered once every 4 weeks for up to 2 years

Protocol documents:
Clinical trial NCT00850993
Conditions: Hyperbilirubinemia, Neonatal
Keywords: Hemolysis
Sponsor: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Start date: 2008-08-01; Completion date: 2012-05-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It is a normal process in the human body for red blood cells to die, which makes bilirubin.

Bilirubin is cleared away through the liver.

Some babies are born with livers that don't work well enough yet, or their red blood cells are dying too fast, so the baby looks yellow (jaundice).

This means there is too much bilirubin in the body. It can be dangerous if a baby's bilirubin gets too high.

Phototherapy is what they call the lights they shine on newborn babies to help the liver get rid of bilirubin.

This study tests an experimental drug to see if it can reduce how much bilirubin is being made in the first place.

Detailed description:
The purpose of this study is to determine if an experimental drug, stannsoporfin, is safe and effective in the treatment of hyperbilirubinemia in hemolyzing neonates.

Arms: arm 1: Participants receive a single dose of 1.5 mg/kg by intramuscular (IM) injection, along with PhotoTherapy (PT) if and when needed. arm 2: Participants receive a single dose of 3.0 mg/kg by intramuscular (IM) injection, along with PT if and when needed. arm 3: Participants receive a single dose of 4.5 mg/kg by intramuscular (IM) injection, along with PT if and when needed. arm 4: Participants receive a single dose of placebo (sterile saline solution) by IM injection, along with PT if and when needed.
Interventions: intervention 1: Stannsoporfin intervention 2: Placebo intervention 3: PhotoTherapy (as needed)
Intervention descriptions: intervention 1: Stannsoporfin administered as a single IM injection intervention 2: Placebo (sterile saline solution) administered as a single IM injection intervention 3: PT standard care administered as needed, based on bilirubin levels throughout the treatment period

Protocol documents:
Clinical trial NCT00866359
Conditions: Behcet Syndrome
Sponsor: Amgen
Start date: 2009-08-01; Completion date: 2012-05-01
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess whether Apremilast is safe and effective in the treatment of patients with Behcet Disease.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Apremilast (CC-10004) intervention 2: Placebo
Intervention descriptions: intervention 1: Treatment Phase Days 1-7: Titration from 10 mg BID apremilast tablets arm A (or matching placebo arm B) to 30 mg BID apremilast arm A(or matching placebo arm B) Day 8-84: Maintenance of 30 mg BID apremilast arm A (or matching placebo arm B) Dose reductions to 20 mg BID apremilast arm A (or matching placebo arm B) are permitted.

Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast.

Day 92-169: Maintenance of 30 mg BID apremilast arm A or dose reductions to 20 mg BID apremilast arm A (if not previously down titrated) intervention 2: Treatment Phase Days 1-7: Titration from 10mg BID matching placebo (arm B) to 30mg BID placebo (arm B) Day 8-84: Maintenance of 30mg BID placebo (arm B). Dose reductions to 20 mg BID matching placebo (arm B) are permitted.

Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast.

Day 92-169: Maintenance of 30 mg BID apremilast or dose reductions to 20 mg BID apremilast (if not previously down titrated)

Protocol documents: