ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01207453
Conditions: Arthritis, Rheumatoid
Keywords: Arthritis, Rheumatoid Milnacipran Pain
Sponsor: Brigham and Women's Hospital
Start date: 2011-01-01; Completion date: 2013-11-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether milnacipran reduces widespread, non-joint pain in patients with rheumatoid arthritis (RA). The investigators will conduct a double-blind randomized crossover trial in subjects with RA to test the hypothesis that milnacipran improves widespread, non-joint pain. The investigators will also use data from the trial to determine whether response to milnacipran is associated with pain-modulating mechanisms from the central nervous system. The investigators hypothesize that response to milnacipran will be greater among patients with impaired central pain mechanisms than among patients with intact central pain modulating mechanisms.

Detailed description:
Despite the development of effective medications to treat inflammation, pain remains a priority for rheumatoid arthritis (RA) patients. The pain that persists despite anti-inflammatory treatment is usually widespread and non-articular; it may lead to diminished quality of life and high medical, psychological and social costs. To develop better treatments for pain and prevent disability, it is critical to obtain a better understanding of widespread, non-joint pain in RA.

Milnacipran is a selective serotonin-norepinephrine reuptake inhibitor (SNRI). No studies have examined the effect of SNRIs on pain in RA. However, several studies have examined the role of SNRIs in fibromyalgia and related pain conditions. Treatment with milnacipran has been associated with improvements in clinical pain severity in Phase 2 and Phase 3 randomized placebo-controlled trials of fibromyalgia patients. In animal models, milnacipran appears to moderate the pain-inducing effects of inflammation and central sensitization. Thus milnacipran may be an ideal drug to treat pain in RA.

A clinical trial of an SNRI in the treatment of widespread, non-joint pain in RA will provide more information regarding pain mechanisms and may lead to more targeted, effective ways of treating pain in RA.

Arms: arm 1: This arm of the study will contain half the study population after randomization. The participants in this arm will receive milnacipran for 6 weeks. They will undergo a one-week taper and a two week washout period and then crossover to a placebo for 6 weeks. arm 2: This arm of the study will contain half the study population after randomization. The participants in this arm will receive placebo for 6 weeks. They will undergo a one-week "taper" and a two week "washout" period and then crossover to milnacipran for 6 weeks.
Interventions: intervention 1: Milnacipran intervention 2: Placebo
Intervention descriptions: intervention 1: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily. intervention 2: None

Protocol documents:
Clinical trial NCT01218516
Conditions: Adenocarcinoma of the Lung
Sponsor: Morphotek
Start date: 2011-06-27; Completion date: 2013-11-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the effect of farletuzumab versus placebo in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum agent (carboplatin or cisplatin) with pemetrexed followed by farletuzumab or placebo on investigator-assessed progression free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 or definitive clinical disease progression (eg, new occurrence of positive fluid cytology) in chemotherapy naive participants with folate receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.

Detailed description:

Arms: arm 1: During Combination Therapy, farletuzumab will be given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Participants who experience clinical benefit from the Combination Therapy will enter the Monotherapy Phase and receive farletuzumab as monotherapy until disease progression. arm 2: During Combination Therapy, placebo will be given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Participants who experience clinical benefit from the Combination Therapy will enter the Monotherapy Phase and receive placebo as monotherapy until disease progression.
Interventions: intervention 1: Farletuzumab intervention 2: Placebo intervention 3: Carboplatin intervention 4: Paclitaxel intervention 5: Pemetrexed intervention 6: Cisplatin
Intervention descriptions: intervention 1: Combination Therapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, farletuzumab (7.5 mg/kg) will be administered intravenously on Week 1 of all additional cycles.

Monotherapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Week 1 of every 3-week cycle until disease progression. intervention 2: Combination Therapy: Placebo will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, placebo will be administered IV on Week 1 of all additional cycles.

Monotherapy: Placebo will be administered intravenously on Week 1 of every 3-week cycle until disease progression. intervention 3: Carboplatin will be administered intravenously to achieve area under the serum concentration-time curve of 5 to 6 mg/mL\^min \[AUC5-6\]. intervention 4: Paclitaxel 200 mg/m\^2 will be administered intravenously. intervention 5: Pemetrexed 500 mg/m\^2 will be administered intravenously. intervention 6: Cisplatin 75 mg/m\^2 will be administered intravenously.

Protocol documents:
Clinical trial NCT01232569
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2011-03-01; Completion date: 2013-11-01
Enrollment: 656 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.

Detailed description:

Arms: arm 1: Patients will receive tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks. arm 2: Patients will receive placebo subcutaneously (sc) every 2 weeks for 24 weeks.
Interventions: intervention 1: Tocilizumab 162 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Tocilizumab will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection. intervention 2: Placebo will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.

Protocol documents:
Clinical trial NCT01235897
Conditions: Advanced Solid Tumors Tumors Cancer
Keywords: Neoplasms Paclitaxel Trastuzumab
Sponsor: University of California, San Francisco
Start date: 2011-03-01; Completion date: 2013-11-01
Enrollment: 17 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test the safety and safest highest dose of an investigational drug called MK-2206 when given in combination with paclitaxel and trastuzumab in patients with Human Epidermal growth factor Receptor 2 (HER2)-overexpressing solid tumor malignancies.

Detailed description:
The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of MK-2206 in combination with paclitaxel and trastuzumab when given to patients with HER2-overexpressing solid tumor malignancies. MK-2206 is an oral drug (taken by mouth) that turns off a protein called AKT inside cancer cells. This could be helpful in treating treatment-resistant cancers, because AKT allows cells to survive despite active anticancer treatment. In the case of HER2-positive cancers, laboratory studies suggest that the drug combination of MK-2206 and paclitaxel and trastuzumab may be effective.

Arms: arm 1: None
Interventions: intervention 1: MK-2206 intervention 2: Paclitaxel intervention 3: Trastuzumab
Intervention descriptions: intervention 1: Different dose levels of MK-2206 will studied, and co-administered with paclitaxel and trastuzumab. MK-2206 will be given orally with a starting dose of 135 mg weekly intervention 2: 80 mg/m2 weekly - paclitaxel intervention 3: 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab

Protocol documents:
Clinical trial NCT01254227
Conditions: Cardiac Iron Overload
Keywords: Cardiac iron overload, deferasirox, deferoxamine
Sponsor: Novartis Pharmaceuticals
Start date: 2011-01-01; Completion date: 2013-11-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of deferasirox in combination with deferoxamine followed be deferasirox monotherapy in patients with severe iron overload due to chronic blood transfusions.

Detailed description:

Arms: arm 1: Deferoxamine combination followed by Deferasirox monotherapy
Interventions: intervention 1: Deferasirox and Deferoxamine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01259466
Conditions: Smoking Cessation Overweight Obesity
Keywords: Smoking cessation Overweight Obesity Internet treatment
Sponsor: Yale University
Start date: 2010-07-01; Completion date: 2013-11-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This project will be a randomized clinical trial testing the efficacy of an internet-administered smoking cessation treatment for overweight and obese smokers. Research on internet-administered behavioral treatments for smoking cessation has found that compared to control treatments (e.g., self-help materials), cessation rates in internet-administered treatments are significantly higher. Research testing the applicability of these treatments to overweight and obese individuals has not yet been conducted. Given that a substantial portion of smokers are also overweight and at elevated cardiovascular risk, there is a need for directed treatment efforts for this group. The current trial proposes to be the first to test the effectiveness of internet-administered smoking cessation treatment for overweight and obese (BMI≥25) smokers. Adult participants will be randomized to receive 12 weeks of internet-administered treatment consisting of either: a) standard smoking cessation treatment with general health education, or b) standard smoking cessation treatment with cognitive behavioral therapy (CBT) for weight concerns. Participants in both conditions will receive open-label treatment with the 21 mg transdermal nicotine patch.

Detailed description:

Arms: arm 1: Cognitive Behavioral Therapy + Nicotine Replacement Patch arm 2: Health Education + Nicotine Replacement Patch
Interventions: intervention 1: Nicotine patch
Intervention descriptions: intervention 1: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks

Protocol documents:
Clinical trial NCT01267266
Conditions: Hormone-resistant Prostate Cancer Recurrent Prostate Cancer Stage IV Prostate Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2010-12-01; Completion date: 2013-11-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II clinical trial is studying how well saracatinib works in treating patients with prostate cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine if AZD0530 (saracatinib) increases time to radiographic progression in men with CRPC compared to placebo.

SECONDARY OBJECTIVES:

I. Describe the adverse events related to AZD0530 in this population. II. Explore the role of FYN and other SRC kinase expression as a predictor of response to AZD0530.

OUTLINE: This is a multicenter study.

LEAD-IN PHASE: Patients receive oral saracatinib once daily during for 8 weeks. Patients who achieve disease regression or a PSA decrease of \> 50% continue to receive open-label saracatinib. Patients who do not show radiographic evidence of new metastases on bone scan and CT, disease regression, or a \> 50% decrease in PSA continue on to the randomized phase.

RANDOMIZED PHASE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive oral placebo once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Upon progression, patients may crossover to arm I.

Tissue samples may be collected for correlative studies. After completion of study treatment, patients are followed up for 12 months.

Arms: arm 1: Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive oral placebo once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Upon progression, patients may crossover to arm I.
Interventions: intervention 1: saracatinib intervention 2: hydrocortisone/placebo
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents:
Clinical trial NCT01287754
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2011-10-01; Completion date: 2013-11-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally until disease progression or unacceptable toxicity occurs.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: erlotinib [Tarceva]
Intervention descriptions: intervention 1: 150 mg daily orally

Protocol documents:
Clinical trial NCT01304706
Conditions: Diabetic Macular Edema
Sponsor: Alimera Sciences
Start date: 2011-04-01; Completion date: 2013-11-01
Enrollment: 120 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the safety and utility of the new inserter for the administration of ILUVIEN in subjects with diabetic macular edema.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Fluocinolone Acetonide
Intervention descriptions: intervention 1: 0.2 μg/day

Protocol documents:
Clinical trial NCT01317472
Conditions: Laryngopharyngeal Reflux
Keywords: laryngopharyngeal reflux, acid reflux, throat reflux
Sponsor: Indiana University
Start date: 2011-03-01; Completion date: 2013-11-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Recent studies have demonstrated that patients with throat-related reflux often require twice daily proton pump inhibitor therapy to attain significant symptomatic improvement, with once daily therapy offering little relief. As dexlansoprazole is a twice-daily release proton pump inhibitor requiring only once-daily dosing, it may provide laryngopharyngeal reflux (LPR) symptomatic relief comparable to that of twice daily dosing, yet be more readily approved by third party payers because of its once daily dosing requirements. It is hypothesized that, in patients with pharyngeal-probe proven throat reflux, there will be significantly greater improvement in symptoms and pharyngeal probe findings in those patients receiving dexlansoprazole than those receiving placebo alone.

Detailed description:
The aim of the study is to compare outcomes, based on RSI-based symptomatic improvement and pharyngeal probe results, after LPR patients are treated for two months with once-daily (QAM) Kapidex versus placebo.Forty patients with pharyngeal pH probe-documented LPR and an elevated reflux symptom index (RSI) (≥14) will be enrolled into a double-blinded placebo controlled study. Twenty patients will receive Kapidex once daily, while twenty receive placebo. Patients will return at two months for evaluation with repeat RSI documentation and repeat pharyngeal pH probe testing. Student t-test will be used to determine if the change in RSI and pH-probe results differs between the study and placebo group.

Arms: arm 1: Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC). arm 2: Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC) or 1 tablet of placebo QAM (1 hour AC).
Interventions: intervention 1: dexlansoprazole intervention 2: Placebo
Intervention descriptions: intervention 1: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months intervention 2: 1 tablet of placebo QAM (1 hour AC) for 2 months

Protocol documents:
Clinical trial NCT01320202
Conditions: Renal Failure Chronic Requiring Hemodialysis
Keywords: End Stage Renal Disease Hemodialysis SFP Hemodialysis-dependent chronic renal failure
Sponsor: Rockwell Medical Technologies, Inc.
Start date: 2011-03-01; Completion date: 2013-11-01
Enrollment: 305 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to confirm the safety and efficacy of Soluble Ferric Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy will be measured primarily by the change from baseline in hemoglobin (Hgb).

Detailed description:
Screening: 2-3 weeks prior to enrollment in Stage 1.

Stage 1 (Run-In): 1-4 weeks depending on qualification for Stage 2.

Stage 2 (Randomized Blinded Treatment): 12 months unless withdrawn prematurely.

Stage 3 (Open-Label Treatment): The duration of Stage 2 plus Stage 3 is intended to be 18 months regardless of treatment assignment in Stage 2.

Arms: arm 1: 11 micrograms (µg) of iron / deciliter (dL) of dialysate. arm 2: 0 micrograms (µg) of iron / deciliter (dL) of dialysate.
Interventions: intervention 1: Soluble Ferric Pyrophosphate (SFP) intervention 2: Standard dialysate
Intervention descriptions: intervention 1: Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months. intervention 2: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week.

Protocol documents:
Clinical trial NCT01323920
Conditions: Leukemia Lymphoma Myelodysplastic Syndrome
Keywords: Stem Cell Transplant Allogeneic Transplant Donors
Sponsor: Dana-Farber Cancer Institute
Start date: 2011-05-01; Completion date: 2013-11-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A common problem after stem cell transplant is graft-versus-host-disease (GVHD). GVHD is a complication of transplantation where the donor graft attacks and damages some of your tissues. After stem cell transplant, all patients receive prophylactic medications against GVHD.

In this research study, we are studying the safety and effectiveness of a bortezomib based GVHD prophylaxic drug combination in participants after myeloablative allogeneic stem call transplantation from a matched unrelated donor, mismatched related or unrelated donor.

Detailed description:
Before your transplant you will receive conditioning therapy with fludarabine and busulfan given 7, 6, 5, and 4 days before your transplant. On day 0, you will receive selected blood cells taken from your sibling or unrelated donor.

You will receive 3 drugs for your GVHD prophylaxis:

Tacrolimus will be started 3 days before your transplant. It will be given intravenously and later by mouth. You will continue to take tacrolimus for 3 to 6 months after transplant.

Methotrexate will be given intravenously 1, 3, 6 and 11 days after your transplant.

Bortezomib will be given intravenously 1, 4, and 7 days after your transplant. On days 1, 4, 7, 30 and 3, 6 and 12 months after your transplant you will have a physical exam, blood work, and be asked to complete a questionnaire.

Arms: arm 1: Drug: Bortezomib. Other Names: Velcade. Bortezomib 1.3 mg/m\^2 IV

Drug: Tacrolimus. Tacrolimus 0.05 mg/kg PO bid

Drug: Methotrexate. Methotrexate 15 mg/m\^2 IV
Interventions: intervention 1: Bortezomib intervention 2: Tacrolimus intervention 3: Methotrexate
Intervention descriptions: intervention 1: Bortezomib 1.3 mg/m\^2 IV intervention 2: Tacrolimus 0.05 mg/kg PO bid intervention 3: Methotrexate 15 mg/m\^2 IV

Protocol documents:
Clinical trial NCT01336959
Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury Cardiopulmonary Bypass CABG Cardiac Surgery
Sponsor: Mereo BioPharma
Start date: 2011-09-01; Completion date: 2013-11-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of BCT197 on acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass.

Detailed description:

Arms: arm 1: 10mg single dose of BCT197 arm 2: Single dose of 50mg BCT197 arm 3: Single dose of matching placebo to 50mg BCT197
Interventions: intervention 1: BCT197 Part A intervention 2: Placebo intervention 3: BCT197 Part B
Intervention descriptions: intervention 1: open label single dose administration of 10mg BCT197, 2 hours prior to surgery intervention 2: Single dose matching placebo administered 2 prior to surgery intervention 3: BCT197 50mg single dose administered 2 hours prior to surgery

Protocol documents: