ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00502242
Conditions: Kidney Transplant
Sponsor: Pfizer
Start date: 2007-12-01; Completion date: 2013-09-01
Enrollment: 229 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine the efficacy of ramipril in preventing a urinary protein to creatinine ratio (U p/c) greater than 0.5 following conversion to sirolimus from a calcineurin inhibitor (CNI) in maintenance kidney transplant patients.

Detailed description:

Arms: arm 1: Capsule - initial treatment is 5 mg (active)- oral - once per day arm 2: Capsule - initial treatment is 5 mg (placebo) - oral - once per day
Interventions: intervention 1: ramipril intervention 2: ramipril
Intervention descriptions: intervention 1: Capsule - initial treatment is 5 mg (active)- oral - once per day intervention 2: Capsule - initial treatment is 5 mg (placebo) - oral - once per day

Protocol documents:
Clinical trial NCT00512317
Conditions: Epilepsies, Partial
Keywords: partial onset epilepsy adult epilepsy partial seizures anticonvulsant catamenial epilepsy adult partial onset epilepsy
Sponsor: Marinus Pharmaceuticals
Start date: 2007-06-01; Completion date: 2013-09-01
Enrollment: 123 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To allow open-label extension to patients who have completed Protocol 1042-0600.

Detailed description:
This is an open-label study evaluating efficacy and safety of ganaxolone treatment in adults with partial onset epilepsy with or without secondary generalizations.

Arms: arm 1: active experimental drug
Interventions: intervention 1: ganaxolone
Intervention descriptions: intervention 1: liquid suspension dosed tid

Protocol documents:
Clinical trial NCT00813709
Conditions: Multiple Sclerosis Clinically Isolated Syndrome
Keywords: Interferon 1-beta Clinical Definite Multiple Sclerosis
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2008-12-01; Completion date: 2013-09-01
Enrollment: 402 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
REFLEXION is a double blind extension of the study 27025 (NCT00404352) (REFLEX). The purpose of the study is to obtain long-term follow-up data in subjects with clinically definite multiple sclerosis (MS) and subjects with a first demyelinating event at high risk of converting to MS, treated with fetal bovine serum \[FBS\]-free/human serum albumin \[HSA\]-free formulation of interferon \[IFN\]-beta-1a (RNF).

Detailed description:
The objective of the study is to investigate whether RNF treatment initiated after the first clinical event versus delayed treatment results in the prolongation of time to Clinically Definite Multiple Sclerosis (CDMS) conversion up to Month 36 and up to Month 60 since randomization in Study 27025 (REFLEX). Furthermore, the study is intended to explore whether RNF treatment initiated after the first clinical event versus delayed treatment delays disability (including development of secondary progressive MS) and reduces disease activity (including the annual relapse rate \[ARR\]) in the long term (up to Month 36 and up to Month 60 since randomization in Study 27025 (REFLEX). The study will also assess the long-term safety profile of RNF (up to Month 36 and up to Month 60 since randomization in Study 27025 (REFLEX).

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: RNF intervention 2: RNF intervention 3: RNF intervention 4: Placebo
Intervention descriptions: intervention 1: Single dose of RNF will be administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. intervention 2: Single dose of RNF will be administered subcutaneously once weekly at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. intervention 3: Participants who were initially randomized in Study 27025 (REFLEX) to the placebo treatment group will be switched to single dose of RNF administered subcutaneously three times weekly at least 48 hours apart at a dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. intervention 4: Single dose matching placebo will be administered subcutaneously twice weekly. Placebo is supplied as a transparent, sterile solution for injection in pre-filled syringes matching the RNF pre-filled syringes, each containing 0.5 milliliter (mL).

Protocol documents:
Clinical trial NCT00244764
Conditions: Carcinoma, Renal Cell
Keywords: Angiogenesis Renal Cell Carcinoma Solid tumors Pazopanib(GW786034)
Sponsor: GlaxoSmithKline
Start date: 2005-10-01; Completion date: 2013-09-01
Enrollment: 225 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Phase II, multi-center, two-stage study utilising a randomised discontinuation design to evaluate the safety and efficacy of GW786034 (pazopanib) in adult subjects with locally recurrent or metastatic clear-cell Renal Cell Carcinoma (RCC). After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.

Detailed description:

Arms: arm 1: All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib. arm 2: All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.
Interventions: intervention 1: GW786034 intervention 2: Placebo
Intervention descriptions: intervention 1: All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib. intervention 2: All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.

Protocol documents:
Clinical trial NCT00393484
Conditions: Chronic Hepatitis B
Sponsor: Bristol-Myers Squibb
Start date: 2007-02-01; Completion date: 2013-09-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, \<300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100 mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus infection.

Detailed description:

Arms: arm 1: Entecavir + Lamivudine placebo (0-96 weeks)

Entecavir (96-240 weeks) arm 2: Lamivudine + Entecavir placebo (0-96 weeks)

Lamivudine (96-240 weeks)
Interventions: intervention 1: Entecavir intervention 2: Lamivudine Placebo intervention 3: Lamivudine intervention 4: Entecavir Placebo
Intervention descriptions: intervention 1: Tablets, Oral, 0.5 mg, once daily (0-96 weeks) and (96-240 weeks) intervention 2: Capsules, Oral, 0 mg, once daily (0-96 weeks) intervention 3: Capsules, Oral, 100 mg, once daily (0-96 weeks)

Tablets, Oral, 100 mg, once daily (96-240 weeks) intervention 4: Tablets, Oral, 0 mg, once daily (0-96 weeks)

Protocol documents:
Clinical trial NCT00394836
Conditions: Lymphoma, Follicular
Keywords: ofatumumab rituximab NHL CD20 refractory
Sponsor: GlaxoSmithKline
Start date: 2007-05-01; Completion date: 2013-09-01
Enrollment: 116 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A Single-Arm, International, Multi-Center Trial of HuMax-CD20 (Ofatumumab), a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to Rituximab as Monotherapy or in Combination With Chemotherapy

Detailed description:
Patients in the study will be randomized into two dose groups. Patients in each dose group will receive one infusion of 300 mg of HuMax-CD20 followed by 7 weekly infusions of either 500 or 1000 mg of HuMax-CD20. Disease status will be assessed every 3 months until month 24.

Interventions: intervention 1: Ofatumumab intervention 2: Ofatumumab
Intervention descriptions: intervention 1: Eight weekly infusions of ofatumumab. The first infusion of 300mg ofatumunab intervention 2: followed by 7 weekly infusions of 1000mg ofatumumab

Protocol documents:
Clinical trial NCT00455975
Conditions: Renal Cancer Kidney Cancer
Keywords: Kidney Cancer Renal Cancer Clear Cell Carcinoma
Sponsor: SCRI Development Innovations, LLC
Start date: 2007-02-01; Completion date: 2013-09-01
Enrollment: 119 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will examine the effectiveness and the side effects of 2 higher dosing schedules of bevacizumab in patients that have advanced clear cell renal carcinoma.

Detailed description:
Bevacizumab is considered a targeted drug. Targeted drugs act on specific receptors on a cell. Bevacizumab blocks receptors that help cancer cells develop blood supplies so that the cancer can grow. These specific receptors are found in greater numbers in kidney cancer. In that regard bevacizumab will be tested in 2 doses that are higher than non-kidney cancer treatments with bevacizumab.

One group of patients will receive bevacizumab at 15 mg per kg by vein every 2 weeks. A total of 75 patients will be treated with this dose.

If this dose is well tolerated a second group of patients will receive bevacizumab at 15mg per kg by vein weekly.

Arms: arm 1: Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity arm 2: Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity
Interventions: intervention 1: Bevacizumab
Intervention descriptions: intervention 1: Bevacizumab

Protocol documents:
Clinical trial NCT00459979
Conditions: Kidney Cancer
Keywords: clear cell renal cell carcinoma stage III renal cell cancer stage IV renal cell cancer papillary renal cell carcinoma
Sponsor: Case Comprehensive Cancer Center
Start date: 2007-03-01; Completion date: 2013-09-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sunitinib may stop the growth of kidney cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects and how well sunitinib works in treating patients with kidney cancer that cannot be removed by surgery.

Detailed description:
OBJECTIVES:

* To determine the percentage of patients with renal cell carcinoma and unresectable primary tumors who can achieve sufficient tumor response, according to the operating surgeon, to undergo nephrectomy after sunitinib therapy.
* To evaluate the safety of sunitinib in patients with renal cell carcinoma and unresectable primary tumors, including analysis of the morbidity of surgery after sunitinib therapy
* To evaluate the objective response rate of patients with renal cell carcinoma and unresectable primary tumors who receive sunitinib therapy.

OUTLINE: A single arm phase II study of sunitinib in patients with unresectable renal cell carcinoma (RCC) will be conducted, including patients with and without distant metastases.

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity. Surgery is performed if and when primary tumor becomes resectable. Patients with residual and/or metastatic disease may resume sunitinib malate within 8 weeks after surgery.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 31 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: sunitinib malate intervention 2: conventional surgery
Intervention descriptions: intervention 1: Sunitinib will be dosed at 50 mg p.o. daily intervention 2: nephrectomy

Protocol documents:
Clinical trial NCT00482625
Conditions: Intraductal Papillary Mucinous Neoplasm of the Pancreas Recurrent Pancreatic Cancer Stage IA Pancreatic Cancer Stage IB Pancreatic Cancer Stage IIA Pancreatic Cancer Stage IIB Pancreatic Cancer Stage III Pancreatic Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2007-06-01; Completion date: 2013-09-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. This phase II trial is studying how well erlotinib hydrochloride works in treating patients with pancreatic cancer that can be removed by surgery

Detailed description:
PRIMARY OBJECTIVES:

I. To test the hypothesis that the activated epidermal growth factor receptor (EGFR) signal transduction biomarker Mucin 5AC (MUC5AC) protein expression within intraductal pancreatic mucinous neoplasm (IPMN) lesions will have greater than zero absolute mean decrease from baseline comparing pre and post 21-42 days of Erlotinib (erlotinib hydrochloride) administration at 100mg orally (PO) once daily (QD).

SECONDARY OBJECTIVES:

I. To test the hypothesis that other correlative IPMN EGF inducible biomarkers will have greater than zero absolute mean decrease from baseline pre and post Erlotinib 100mg PO QD therapy.

II. Safety of Erlotinib treatment. III. To determine Erlotinib pharmacokinetic concentration in plasma and pancreatic tissue at the 100mg/day dose up to 42 days of therapy.

OUTLINE:

Patients receive erlotinib hydrochloride PO QD for 21-42 days in the absence of disease progression or unacceptable toxicity. Patients then undergo to pancreatectomy.

After completion of study treatment, patients are followed up at 4-20 weeks.

Arms: arm 1: Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.
Interventions: intervention 1: erlotinib hydrochloride intervention 2: conventional surgery intervention 3: immunohistochemistry staining method intervention 4: protein expression analysis intervention 5: biopsy intervention 6: pharmacological study intervention 7: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Undergo pancreatectomy intervention 3: Correlative studies intervention 4: Correlative studies intervention 5: Correlative studies intervention 6: Correlative studies intervention 7: Correlative studies

Protocol documents:
Clinical trial NCT00510887
Conditions: Lymphoma, Follicular
Keywords: follicular lymphoma Velcade VR-FND
Sponsor: Duke University
Start date: 2007-01-01; Completion date: 2013-09-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness and safety of combining bortezomib (Velcade) with rituximab, fludarabine, mitoxantrone, and dexamethasone in treating patients with follicular cell lymphoma.

Detailed description:
This is a phase II study using the combination of bortezomib, rituximab, fludarabine, mitoxantrone and dexamethasone. The combination will given over a 28 day cycle. In addition each patient will receive Pneumocystis carinii Pneumonia (PCP) prophylaxis with Trimethoprim/sulfamethoxazole (TMP/Sulfa) or equivalent agent. On day 4 the physician has the option of starting granulocyte colony-stimulating factor (GCSF), granulocyte macrophage colony-stimulating factor (GMCSF), or pegylated GCSF.

All patients who receive at least one dose of the drug will be evaluated for toxicity. Patients will be treated with the agent for at least 2 cycles to be considered eligible for evaluation of response. The chemotherapy dosing will continue until there is evidence of disease progression, a second recurrence of unacceptable toxicity, or a maximum of 8 courses of therapy.

Arms: arm 1: Bortezomib (VELCADER) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.

Each cycle will be repeated every 28 days for 8 cycles maximum.
Interventions: intervention 1: Bortezomib intervention 2: Rituximab intervention 3: Fludarabine intervention 4: Mitoxantrone intervention 5: Dexamethasone
Intervention descriptions: intervention 1: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle intervention 2: Rituximab 375 mg/m2 IV on day 1 intervention 3: Fludarabine 25 mg/m2 IV on days 1,2,3 intervention 4: Mitoxantrone 10 mg/m2 IV on day 2 intervention 5: Dexamethasone 20 mg orally on days 1,2,3,4,5

Protocol documents:
Clinical trial NCT00548717
Conditions: Graft-vs-Host Disease
Keywords: GVHD Stem cell transplantation Sirolimus
Sponsor: Dana-Farber Cancer Institute
Start date: 2007-10-01; Completion date: 2013-09-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This trial will test the hypothesis that the combination of sirolimus, mycophenolate mofetil, and bortezomib will be effective in preventing both acute and chronic GVHD after reduced intensity allogeneic stem cell transplantation.

Detailed description:
The combination of tacrolimus and methotrexate is standard therapy for prevention of GVHD, however, our recent experience has demonstrated that the substitution of sirolimus for methotrexate provides superior GVHD control with reduced transplant-related toxicity. One limitation to the use of calcineurin inhibitors in GVHD prevention is the disruption in Treg function and proliferation. Based on our evolving understanding of the role of Treg in the development of chronic GVHD, we propose a GVHD prophylactic regimen that is effective in prevention of acute GVHD, but by virtue of the maintenance of Treg activity may be able to prevent chronic GVHD. We hypothesize that the substitution of mycophenolate mofetil for tacrolimus as well as the addition of bortezomib may provide similar protection against acute GVHD and prevent chronic GVHD while minimizing renal toxicity after transplantation.

Arms: arm 1: Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF) arm 2: Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF) Bortezomib (Velcade) \*added with study reopening in 2012
Interventions: intervention 1: Sirolimus intervention 2: Mycophenolate mofetil intervention 3: Bortezomib
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00549822
Conditions: Breast Cancer
Keywords: aromatase inhibitor CA 15-3 Hormone receptor positive
Sponsor: Massachusetts General Hospital
Start date: 2007-10-01; Completion date: 2013-09-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to study the effects of using aromatase inhibitor (AI) therapy intermittently on participants with breast cancer. AIs are a class of drugs used to treat breast cancer in postmenopausal women. They work by decreasing the level of estrogen, which is believed to stimulate the growth of tumor tissue. Breast cancer that progresses despite therapy with an AI is thought to have become resistant to AI therapy. There is scientific evidence to suggest that resistant breast cancer cells learn to grow at the very low levels of estrogen present on AI therapy, and that increasing estrogen levels even slightly by stopping AI therapy may inhibit the breast cancer cells.

Detailed description:
* This study involves treating participants with intermittent AI therapy. The AI will be stopped at the time they enter the study. We plan on monitoring a marker in the participants blood called CA 15-3 (or CA 27.29) every 4 weeks to help us make a decision of when to re-start treatment with letrozole (femara). This marker is known to rise when disease is progressing and drop when the disease is responding to treatment. We will be stopping and re-starting therapy based on the changes of CA 15-3 in the participants blood.
* In addition to bloodwork, the following tests and procedures will be performed on a monthly basis: medical history; physical examination and performance status.
* Every 8 weeks the following will be performed: Tumor assessment by physical exam (if possible); Chest x-ray or CT scan or chest; CT scans of abdomen and pelvis; and bone scan.

Arms: arm 1: Letrozole 2.5 mg administered by mouth daily during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle based on CA 15-3 or CA 27.29 levels. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment.
Interventions: intervention 1: Letrozole
Intervention descriptions: intervention 1: Treatment is intermittent with possible breaks between each 28 day treatment cycle if CA 15-3 or CA 27.29 level that has decreased by at least 50% of that individual patient's baseline or peak level on firstline letrozole or anastrozole therapy or has decreased into the normal reference range per institutional parameters. Letrozole or anastrozole therapy will be interrupted until CA 15-3 or CA 27.29 levels rise by at least 25% above trough CA 15-3 or CA 27.29 level. If the trough level is in the normal reference range then the CA 15-3 or CA 27.29 must rise into the normal reference range.

Protocol documents: