ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01142726
Conditions: Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2010-12-01; Completion date: 2014-10-01
Enrollment: 511 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of the protocol is to demonstrate the ability of abatacept plus methotrexate to induce remission in patients with very early rheumatoid arthritis after 12 months of treatment and to maintain remission following 6 months of drug withdrawal.

Detailed description:

Arms: arm 1: Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period arm 2: Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period arm 3: Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
Interventions: intervention 1: Abatacept intervention 2: Methotrexate intervention 3: Abatacept placebo intervention 4: Methotrexate placebo
Intervention descriptions: intervention 1: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months intervention 2: Tablets, oral, 2.5 mg, once weekly, 12 months intervention 3: Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months intervention 4: Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months

Protocol documents:
Clinical trial NCT01716585
Conditions: Chronic Hepatitis C Infection
Keywords: Hepatitis C Virus Hepatitis C Genotype 1 Hepatitis C Treatment-Naïve Interferon-Free Chronic Hepatitis C Viekira Pak ombitasvir paritaprevir dasabuvir
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2012-11-01; Completion date: 2014-10-01
Enrollment: 636 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-naïve adults.

Detailed description:

Arms: arm 1: Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks arm 2: Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Interventions: intervention 1: ABT-450/r/ABT-267, ABT-333 intervention 2: Ribavirin intervention 3: Placebo for ABT-450/r/ABT-267 intervention 4: Placebo for ABT-333 intervention 5: Placebo for ribavirin
Intervention descriptions: intervention 1: ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet intervention 2: Capsule (double-blind treatment period), tablet (open-label treatment period) intervention 3: Tablet intervention 4: Tablet intervention 5: Capsule

Protocol documents:
Clinical trial NCT01730339
Conditions: Reduction of Hypertrophic Skin Scarring
Keywords: Skin scarring cicatrix breast scar hypertrophic scar
Sponsor: Pfizer
Start date: 2012-12-01; Completion date: 2014-10-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
The study will compare how well PF-06473871 works versus placebo in reducing skin scarring after scar revision surgery of existing breast scars. The study will also evaluate the safety of PF-06473871 in healthy adult subjects.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PF-06473871 intervention 2: PF-06473871
Intervention descriptions: intervention 1: Single dose administered by injection four different times intervention 2: Single dose administered by injection three different times

Protocol documents:
Clinical trial NCT01768572
Conditions: Rheumatoid Arthritis
Sponsor: Sanofi
Start date: 2013-03-01; Completion date: 2014-10-01
Enrollment: 202 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.

Detailed description:
Total study duration was up to 34 weeks: Screening up to 28 days, treatment phase of 24 weeks, and post-treatment follow-up of 6 weeks.

After completion of the treatment phase of this study, participants were eligible to enter a long term safety study (LTS11210) for active treatment with SAR153191 (REGN88).

Arms: arm 1: Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) and placebo intravenous (IV) infusion once every 4 weeks (q4w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD), hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. arm 2: Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. arm 3: Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate.
Interventions: intervention 1: sarilumab SAR153191 (REGN88) intervention 2: tocilizumab intervention 3: hydroxychloroquine intervention 4: methotrexate intervention 5: sulfasalazine intervention 6: leflunomide intervention 7: subcutaneous placebo intervention 8: intravenous placebo
Intervention descriptions: intervention 1: Pharmaceutical form: solution Route of administration: subcutaneous intervention 2: Pharmaceutical form: solution Route of administration: intravenous intervention 3: Dispensed according to local practice. intervention 4: Dispensed according to local practice. intervention 5: Dispensed according to local practice. intervention 6: Dispensed according to local practice. intervention 7: Pharmaceutical form: solution Route of administration: subcutaneous intervention 8: Pharmaceutical form: solution Route of administration: intravenous

Protocol documents:
Clinical trial NCT00283244
Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer
Sponsor: UNC Lineberger Comprehensive Cancer Center
Start date: 2006-03-01; Completion date: 2014-10-01
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether gemcitabine and erlotinib are more effective when given alone or together in treating non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying gemcitabine and erlotinib to compare how well they work when given alone or together as first-line therapy in treating older patients with stage IIIB or stage IV non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Compare the progression-free survival rate of older patients with stage IIIB or IV non-small cell lung cancer treated with gemcitabine hydrochloride vs erlotinib hydrochloride vs gemcitabine hydrochloride and erlotinib hydrochloride as first-line therapy.

Secondary

* Determine the response rate in patients receiving these regimens.
* Determine the overall survival rate in patients receiving these regimens.
* Determine the toxicity profile of these regimens in these patients.
* Determine the quality of life of patients receiving these regimens.

OUTLINE: This is a randomized, open-label, controlled, parallel group, multicenter study. Patients are stratified by gender, smoking status (never or light vs current or former), and ECOG performance status (0-1 vs 2). Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive gemcitabine hydrochloride IV on days 1 and 8. Patients with progressive disease may cross over to arm II.
* Arm II: Patients receive oral erlotinib hydrochloride daily on days 1-21.
* Arm III: Patients receive gemcitabine hydrochloride as in arm I and erlotinib hydrochloride as in arm II.

In all arms, treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 2 months for 3 years.

Arms: arm 1: Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B. arm 2: Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21. arm 3: Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
Interventions: intervention 1: erlotinib hydrochloride intervention 2: gemcitabine hydrochloride
Intervention descriptions: intervention 1: given orally intervention 2: given IV

Protocol documents:
Clinical trial NCT00350545
Conditions: Graft vs Host Disease
Sponsor: Stanford University
Start date: 2006-08-01; Completion date: 2014-10-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The addition of rituximab to prednisone for the initial treatment of chronic GVHD will increase the overall response rate, enable a more rapid and effective steroid taper.

Detailed description:
To determine the efficacy of Rituximab as first line of treatment of chronic GVHD. Efficacy will be defined as he ability to taper prednisone to a dose of 0.25 mg/kg per day by 6 months without clinical or GVHD relapse/ recurrence.

Arms: arm 1: Rituximab will be given as an IV fusion as initial treatment, followed by predisone (given during registration) which will be continued through-out trial and tapered off by physician. Cyclosporine A and tacrolimus will be used if chances of new diagnosis of chronic GVHD occur. Both drugs have no interaction with Rituxan, but will be tapered off after predisone is completely tapered.
Interventions: intervention 1: Rituximab intervention 2: Prednisone intervention 3: Cyclosporine A intervention 4: tacrolimus
Intervention descriptions: intervention 1: 375 mg/m2;IV infusion once weekly for four doses (days 1,8,15,22); option for second 4-week course at week 9 intervention 2: 1 mg/kg; po per day with taper intervention 3: trough 200-300 or lower; po intervention 4: trough 5-10 or lower; po

Protocol documents:
Clinical trial NCT00357890
Conditions: Diabetes Mellitus, Insulin-Dependent
Keywords: type 1 diabetes diabetes new onset CSII insulin sensitivity beta cell function beta cell preservation
Sponsor: Nemours Children's Clinic
Start date: 2005-12-01; Completion date: 2014-10-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (MDI) using Lantus insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The study evaluates how these modes of therapy affect insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance testing).

Detailed description:
Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (MDI) using Lantus insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The proposed protocol compares the changes in diabetes control between pump therapy and MDI treatment groups. More importantly, however, the study evaluates how these modes of therapy may affect the honeymoon period and glycemic control, specifically focusing on changes in insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance testing). Demonstrating that pump therapy at the time of diagnosis of type 1 diabetes prolongs the honeymoon phase by improving insulin sensitivity and beta cell function may have important therapeutic implications that could influence the standard of care in pediatric diabetes.

Arms: arm 1: Use of pump therapy arm 2: Use of MDI (basal bolus therapy with glargine)
Interventions: intervention 1: Insulin pump therapy intervention 2: Multiple daily injections using insulin glargine + rapid acting analog
Intervention descriptions: intervention 1: CSII initiated within 1 month of diagnosis intervention 2: MDI as control

Protocol documents:
Clinical trial NCT00448019
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia Fludarabine Cyclophosphamide Rituximab Bevacizumab CLL
Sponsor: M.D. Anderson Cancer Center
Start date: 2007-02-01; Completion date: 2014-10-01
Enrollment: 64 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if the combination of fludarabine, cyclophosphamide, rituximab, and bevacizumab is effective in treating chronic lymphocytic leukemia in patients who have already been treated with chemotherapy. The safety of this treatment will also be studied.

Detailed description:
During the study, you will have up to 6 "cycles" of treatment. A cycle is made up of treatment with the study drugs for 3-4 days and then about 3-1/2 weeks (25 days) of no treatment (about 4 weeks total). Treatment with the study drugs will be given for 4 days in a row on the first cycle, and 3 days in a row on Cycles 2-6. On Day 1 of each cycle, you will receive rituximab through a needle in a vein. On Cycle 1, since it is your first exposure to rituximab, it must be given slowly, so it may take 6-8 hours to complete. On the cycles after that, it can be given more rapidly, over 3-4 hours. Cyclophosphamide and fludarabine will be given separately through a needle in a vein on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2-6. Cyclophosphamide and fludarabine will each be given over 30 minutes. Bevacizumab will be given through a needle in a vein over 90 minutes on Day 3 of Cycle 1. If it is well tolerated, the next dose of Bevacizumab will be given over 60 minutes on Day 2 of Cycle 2. If the Cycle 2 dose is well tolerated, the next doses of Bevacizumab will be given over 30 minutes on Day 2 of Cycles 2-6. In addition to the study drugs, you may also be given fluids by vein to help flush the kidneys, to help prevent possible kidney damage. You may receive up to 6 cycles of treatment. Treatment will be given on an outpatient basis. The injections for each daily treatment visit should take less than 6 hours.

Up to 66 patients will take part in the study. All will be enrolled at M.D. Anderson.

Arms: arm 1: FCR = Fludarabine 25 mg/m\^2 intravenous (IV) , Cyclophosphamide 250 mg/m\^2 IV daily for 3 days, Rituximab 375 mg/m\^2 IV Day 1, followed by 500 mg/m\^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
Interventions: intervention 1: Fludarabine intervention 2: Cyclophosphamide intervention 3: Rituximab intervention 4: Bevacizumab
Intervention descriptions: intervention 1: 25 mg/m\^2 IV over 30 minutes daily for 3 days intervention 2: 250 mg/m\^2 IV over 30 minutes daily for 3 days intervention 3: 375 mg/m\^2 IV on Day 1 by prolonged infusion. All subsequent doses 500 mg/m\^2 IV 30-minute infusion. intervention 4: 10 mg/Kg IV on Day 3, course 1 over 30-90 minutes

Protocol documents:
Clinical trial NCT00457665
Conditions: HIV Infections
Keywords: HIV Lipodystrophy Treatment Experienced
Sponsor: University of Texas Southwestern Medical Center
Start date: 2002-02-01; Completion date: 2014-10-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The metabolic and molecular basis of lipodystrophy syndrome in HIV-infected patients is not known. Whether besides protease inhibitors, other antiretroviral drugs, HIV infection and reduction in viral load contribute to the development of lipodystrophy syndrome is not clear.

The project therefore has the following aims: 1) to characterize metabolic abnormalities and changes in body fat distribution, 2) to develop objective criteria for defining the syndrome and to ascertain prognostic indicators and 3) to elucidate the molecular basis of the lipodystrophy syndrome in HIV-infected patients.

Detailed description:
A 2-year long prospective, randomized, double blind, placebo-controlled study in 200 asymptomatic HIV (+) patients to compare two equally effective antiretroviral regimens, one with and the other without a protease inhibiotor. We will study body fat distribution by anthropometry and magnetic resonance imaging and will measure insulin sensitivity (in a subset of patients), plasma lipoproteins, glucose tolerance and other metabolic variables. We will study expression of an array of adipocyte specific proteins/transcription factors involved in adipocyte differentiation, insulin action and lipoprotein metabolism in fat biopsy samples obtained before and after institution of therapy.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Nelfinavir intervention 2: Efavirenz
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00461045
Conditions: Multiple Myeloma
Keywords: multiple myeloma proteasome inhibitor relapsed refractory
Sponsor: Celgene
Start date: 2007-03-01; Completion date: 2014-10-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 2, open-label, multicenter study examining the safety, pharmacokinetics and pharmacodynamics, and best overall response to escalating doses of the proteasome inhibitor NPI-0052 (also known as marizomib) in patients with relapsed or relapsed/refractory multiple myeloma. NPI-0052 is a novel, second generation proteasome inhibitor that prevents the breakdown of proteins involved in signal transduction which blocks growth and survival in cancer cells. The study is a Phase 2 study and is a 2-stage efficacy design in a selected subgroup of patients (Arm C) treated with the recommended phase 2 dose of NPI-0052, as determined in a previously completed Phase 1 study. The study is to evaluate the safety and any preliminary evidence of efficacy of NPI-0052 in multiple myeloma patients who have previously received carfilzomib (PR-171, Kyprolis™) and subsequently had disease progression.

Detailed description:

Arms: arm 1: Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
Interventions: intervention 1: MRZ 0.5 mg/m^2
Intervention descriptions: intervention 1: NPI-0052 0.5 mg/m2 administered IV over 2 hours on Days 1, 4, 8, and 11 in each 21-day cycle

Protocol documents:
Clinical trial NCT00470470
Conditions: Acral Lentiginous Malignant Melanoma Recurrent Melanoma Stage IIIA Melanoma Stage IIIB Melanoma Stage IIIC Melanoma Stage IV Melanoma
Sponsor: National Cancer Institute (NCI)
Start date: 2007-04-01; Completion date: 2014-10-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well imatinib mesylate works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the overall objective response rate (complete response and partial response) in patients with inoperable stage III or IV melanoma harboring somatic alterations in c-KIT treated with imatinib mesylate.

SECONDARY OBJECTIVES:

I. Determine the time to progression in patients treated with this drug. II. Determine if c-KIT mutational status by DNA sequencing, DNA copy number status by fluorescent in situ hybridization (FISH) or comparative genomic hybridization, and/or protein expression by immunohistochemistry (IHC) can best predict clinical benefit from imatinib mesylate.

TERTIARY OBJECTIVES:

I. To evaluate tumors resistant to small molecule inhibitors of Kit for the development of secondary Kit mutations or for changes in Kit copy number.

II. To evaluate for changes in Ki-67, phospho-Akt, phospho-MEK, phospho-S6, phospho STAT3, cleaved caspase 3, IGF-1R, and Kit expression in paired tumor samples obtained from patients treated with a small molecule inhibitor of Kit.

III. To analyze baseline and post-resistance blood samples for soluble cKIT levels, soluble VEGFR1, soluble VEGFR2, VEGF, PlGF, FGF, and melanoma inhibitory activity (MIA) levels, and circulating tumor cells.

IV. To analyze concomitant samples of blood and tumor for imatinib levels in patients treated with imatinib.

OUTLINE: This is a multi-center study. Patients are stratified according to true amplification of c-KIT by FISH vs mutations by DNA sequencing.

Patients receive oral imatinib mesylate twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.

Tumor tissue samples or unstained tissue slides/paraffin blocks may be collected. c-KIT is evaluated by IHC and comparative genomic hybridization.

After completion of study treatment, patients are followed up periodically.

Arms: arm 1: Patients receive oral imatinib mesylate twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: imatinib mesylate intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies

Protocol documents: