ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01705691
Conditions: Breast Cancer HER2-negative Breast Cancer
Sponsor: NSABP Foundation Inc
Start date: 2012-09-01; Completion date: 2015-10-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
NSABP FB-9 is a Phase II, multi-center, randomized study of eribulin or weekly paclitaxel followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant therapy for women with HER2-negative, operable and locally advanced breast cancer (stage IIb and III). Patients in the control arm will receive neoadjuvant weekly paclitaxel (WP) followed by AC. The primary aim of the study is to determine the pathologic complete response (ypCR) in breast and axillary lymph nodes following completion of neoadjuvant therapy. The secondary aims include determination of the ypCR in axillary nodes, clinical complete response (ycCR) rate after eribulin or paclitaxel and after completion of neoadjuvant chemotherapy, two-year recurrence-free interval, two-year overall survival, and toxicity of the neoadjuvant regimens.

Detailed description:
Patients will be randomized to one of two neoadjuvant therapy regimens. Patients in Arm 1 will receive WP 80 mg/m2 for 12 doses followed by standard AC every 21 days for 4 cycles. Patients in Arm 2 will receive 4 cycles of eribulin 1.4 mg/m2 on days 1 and 8 of a 21-day cycle followed by standard AC every 21 days for 4 cycles. As soon as possible following recovery from chemotherapy, the patient will have either lumpectomy or mastectomy and axillary staging.

In both arms, clinical response will be assessed by physical exam on day 1 of each study therapy cycle. MRI of the breast is required within 4 weeks prior to randomization and following completion of eribulin or WP (before starting AC). Following recovery from surgery, patients will receive radiation therapy and hormonal therapy as clinically indicated. Other postoperative therapies are prohibited.

Patients will be randomized to the control arm (Arm 1) and to the investigational arm (Arm 2) in a 1:2 ratio. The sample size will be up to 50 patients with about 30 patients in Arm 2 and about half that number in Arm 1. Accrual is expected to occur over 15 months.

Arms: arm 1: Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles arm 2: Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Interventions: intervention 1: Paclitaxel intervention 2: Eribulin intervention 3: Doxorubicin intervention 4: Cyclophosphamide
Intervention descriptions: intervention 1: 80 mg/m2 IV over 60 minutes weekly for 12 weeks intervention 2: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles intervention 3: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles intervention 4: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Protocol documents:
Clinical trial NCT01708603
Conditions: Moderate to Severe Plaque Psoriasis
Keywords: psoriasis, brodalumab, AMG 827
Sponsor: Bausch Health Americas, Inc.
Start date: 2012-08-01; Completion date: 2015-10-01
Enrollment: 1831 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses

Detailed description:
.The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.

Arms: arm 1: Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. arm 2: Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. arm 3: Administered by subcutaneous (SC) injection per the labeled dosing regimen. arm 4: Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
Interventions: intervention 1: 210 mg brodalumab intervention 2: 140 mg brodalumab intervention 3: ustekinumab intervention 4: placebo
Intervention descriptions: intervention 1: 210 mg brodalumab administered SC intervention 2: 140 mg brodalumab administered SC intervention 3: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen. intervention 4: Placebo administered SC

Protocol documents:
Clinical trial NCT01710839
Conditions: Central Retinal, Hemi Retinal & Brach Retinal Vein Occlusions
Keywords: CRVO BRVO HRVO Macular edema vein occlusion
Sponsor: Charles C Wykoff, PhD, MD
Start date: 2012-10-01; Completion date: 2015-10-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To see if Lucentis 0.5mg combined with Targeted Pan Retinal photocoagulation will decrease the total number of intravitreal injections in a year for ischemic central retinal vein occlusion, hemi-retinal vein occlusions and branch retinal vein occlusions compared to standard of care

Detailed description:
The WAVE trial is a phase IV, open label, 12-month trial of intravitreal ranibizumab 0.5 mg in patients (n=30) with ischemic CRVO, HRVO and BRVO who have been previously treated with ranibizumab or any other anti-VEGF intravitreal injection therapy, who are incomplete responders to 2 or more consecutive intravitreal anti-VEGF injections in the past 4 months. Randomization is 1:4, 1=control, ranibizumab only, 4=treatment arm. In total, 6 subjects will be randomized to control and 24 randomized to treatment arm.

Cohort 1- 24 Subjects previously treated Patients will receive 6 doses of ranibizumab 0.5 mg, followed by PRN intravitreal injection of ranibizumab 0.5 mg based on pre-defined retreatment criteria for up to 11 total injections.

Wide field angiography guided peripheral targeted-retinal photocoagulation (TRP), will be divided into 2 sessions if needed, one at the 2 weeks post injection visit and another later at M4/V7, if repeat wide field angiogram indicates areas not sufficiently treated in the first TRP session

Cohort 2- 6 Subjects, previously treated patients will receive 6 doses of ranibizumab 0.5 mg, followed by PRN intravitreal injection of ranibizumab 0.5 mg based on pre-defined retreatment criteria for up to 11 total injections.

Arms: arm 1: Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina. arm 2: Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.
Interventions: intervention 1: 0.5mg Ranibizumab intervention 2: Targeted Pan Retinal Photocoagulation
Intervention descriptions: intervention 1: intravitreal injections intervention 2: Targeted Pan Retinal Photocoagulation based on wide field angiography

Protocol documents:
Clinical trial NCT01711879
Conditions: Neovascular Glaucoma
Sponsor: University of Colorado, Denver
Start date: 2013-01-01; Completion date: 2015-10-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 52 week study will assess the use of intravitreal aflibercept injections in patients with neovascular glaucoma (NVG) compared to standard of care panretinal photocoagulation.

The investigators hypothesize that the neovascularization of the iris and angle present in neovascular glaucoma will resolve more quickly in eye treated with intravitreal aflibercept injection alone and result in increased comfort and preservation of visual field as compared to current standard of care utilizing pan-retinal photocoagulation. The advantages to intravitreal aflibercept injection use could include resolution of NVI/NVA (neovascularization of the iris/neovascularization of the angle) leading to quicker pain relief and quicker lowering of IOP (intraocular pressure).

Detailed description:
The two arms of this study will compare current common practice (initial intravitreal anti-VEGF (vascular endothelial growth factor) to study treatment (VEGF) injection only) for 52 weeks.

This single center study will consist of 20 patients with NVG. Patients will be randomized to:

* Group A: A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks.

or

* Group B: 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.

Clinical assessment will include pain assessment (Universal Pain Scale), best corrected visual acuity (ETDRS), ophthalmic examination, anterior segment assessment including number of clock-hours of NVI/NVA, gonioscopy, anterior segment photography, visual field test (Humphrey SITA- Standard 24-2), optic nerve OCT (Zeiss Cirrus Optic Disc Cube 200x200), macular OCT (Cube scan 512 x 128 and 5 Line Raster), fluorescein angiography (initial iris phase followed by standard retinal angiography), and concurrent medical/ocular medications. Qualitative assessment of neovascularization will be made by the investigator based on comparison to baseline angiography.

Arms: arm 1: A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks arm 2: 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Interventions: intervention 1: Aflibercept
Intervention descriptions: intervention 1: Details covered in arm description

Protocol documents:
Clinical trial NCT01714336
Conditions: Hip Fracture
Keywords: Arbeitsgemeinschaft für Osteosynthesefragen (AO) fracture Orthopaedic Trauma Association (OTA) fracture
Sponsor: Mayo Clinic
Start date: 2012-09-01; Completion date: 2015-10-01
Enrollment: 138 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Does tranexamic acid improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.

Detailed description:
Antifibrinolytic medications such as tranexamic acid, aprotinin, and aminocaproic acid have proven to be useful in decreasing blood loss and the proportion of patients who require transfusion after a number of surgical procedures. In orthopedic surgery, tranexamic acid (TXA) is the best studied of these medications and a recent Cochrane Database review determined that tranexamic acid was effective in decreasing perioperative bleeding and post-operative transfusion after elective hip replacement and knee replacement surgery. At Mayo Clinic Rochester, the routine administration of tranexamic acid has evolved over the past decade to become part of the typical protocol for more than 3,000 elective hip and knee replacement procedures each year. Recent administrative data provides fairly compelling evidence of the efficacy of tranexamic acid in decreasing transfusion at the Mayo Clinic Rochester practice with 2010 data showing 2% and 7% prevalence of transfusion in patients treated with tranexamic acid versus 18% and 33% prevalence in those knee and hip replacement patients, respectively, who were not treated with tranexamic acid. A recent analysis of the Mayo Clinic Rochester orthopedic practice showed that patients treated for hip fracture remain at substantial risk of perioperative transfusion (30% prevalence) after operative management. This raises the question as to whether tranexamic acid could improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.

Arms: arm 1: Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. arm 2: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
Interventions: intervention 1: tranexamic acid intervention 2: placebo
Intervention descriptions: intervention 1: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. intervention 2: A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.

Protocol documents:
Clinical trial NCT01721408
Conditions: Intra-abdominal Infection
Sponsor: Pfizer
Start date: 2012-11-01; Completion date: 2015-10-01
Enrollment: 470 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin in hospitalized patients with a complicated intra-abdominal infection.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tigecycline intervention 2: Imipenem/cilastatin
Intervention descriptions: intervention 1: every 12 hours (an initial intravenous dose of 100 mg followed by 50 mg twice a day approximately every 12 hours) and placebo intravenous doses every 12 hours beginning 6 hours after the initial intravenous dose of tigecycline for at least for 5 days and up to 14 days. intervention 2: every 6 hours intravenously, and the imipenem/cilastatin will be dosed by 500mg/500mg for the subjects with creatinine clearance equal or above 71ml/min/1.73m2 or dose will be adjusted by Schedule of Study Drug Administration for Subjects with Renal Impairment.

Protocol documents:
Clinical trial NCT01722071
Conditions: Focus of Study: Neural Correlates of Oxytocin Administration
Keywords: Oxytocin Functional Magnetic Resonance Imaging Social Motivation
Sponsor: Tiffany Love
Start date: 2012-10-01; Completion date: 2015-10-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The proposed study will investigate the effects of intranasal oxytocin administration on neural activity associated with social and non-social motivation.

Detailed description:
Oxytocin is a well-known social and reproductive hormone demonstrated to have a variety of prosocial effects in humans including enhancing trust and generosity, improving positive communication, increasing eye gaze, and reducing anxiety. Oxytocin is hypothesized to facilitate social behaviors via its modulation of motivational networks. With this study, we will characterize oxytocin's effects on the neural processing of salient stimuli. We will utilize a noninvasive brain imaging technique, functional magnetic resonance imaging (fMRI), to assess brain activity while participants perform tests designed to engage neural circuits associated with the processing of social and non-social stimuli.

Arms: arm 1: Each participant will be studied using fMRI following self-administration of placebo. arm 2: Each participant will be studied using fMRI following self-administration of oxytocin.
Interventions: intervention 1: Placebo intervention 2: Oxytocin
Intervention descriptions: intervention 1: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session. intervention 2: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.

Protocol documents:
Clinical trial NCT01722162
Conditions: Colorectal Neoplasms
Sponsor: Washington University School of Medicine
Start date: 2013-04-01; Completion date: 2015-10-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how giving a drug called levocetirizine to patients with colorectal cancer affects their tumor response to capecitabine and bevacizumab. Capecitabine is a chemotherapy drug that blocks tumor growth by disrupting DNA and RNA synthesis and repair (cell division and survival). Bevacizumab is a monoclonal antibody that blocks the ability of tumors to grow and spread by inhibiting the growth of blood vessels that feed them. Patients with colorectal cancer can develop a resistance to the effects of bevacizumab. Levocetirizine may decrease tumor resistance to bevacizumab. Giving bevacizumab, capecitabine, and levocetirizine dihydrochloride together may be an effective treatment for refractory colorectal cancer.

Detailed description:

Arms: arm 1: Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.

Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.

Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2. arm 2: Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.

Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.

Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2.
Interventions: intervention 1: Bevacizumab intervention 2: Capecitabine intervention 3: Levocetirizine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01725113
Conditions: Kidney Failure Secondary Hyperparathyroidism Hyperphosphatemia Hypercalcemia
Sponsor: Winthrop University Hospital
Start date: 2012-11-01; Completion date: 2015-10-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this non-inferiority study is to compare the safety and effectiveness of a mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol in hemodialysis patients using revised Kidney Disease: Improving Global Outcomes (KDIGO) parathyroid hormone targets.

Detailed description:
Active vitamin D analogs have been the mainstay of treatment for patients on hemodialysis with mineral and bone disease (MBD) for the past decade. Intravenous calcitriol is an active vitamin D analog which is nearly identical to natural 1, 25 Vitamin D3. Calcitriol results from the hydroxylation of previtamin D3 in the liver and kidney. Paricalcitol, 19-nor-1 , 25-dihydroxyvitamin D2, is a newer agent vitamin D analog. This agent is believed to have an effect more specific to the parathyroid gland, and less specific to absorption of calcium and phosphorus from the gut. Although both formulations appear equally effective in suppressing parathyroid hormone (PTH), studies have suggested a greater calcemic effect with intravenous calcitriol as compared to paricalcitol (1). Due to this, paricalcitol is the predominant active vitamin D analog used in hemodialysis patients in the United States. Two recent changes in the management of hemodialysis patients will likely reduce the amount of active vitamin D analogs used in the near future: the liberalization of PTH goals according to international guidelines, (2) and the implementation of bundled payments for dialysis by Medicare. These changes challenge previous studies that have analyzed the safety and efficacy of these medications. The purpose of this prospective, randomized, cross-over study will be to determine whether calcitriol is as safe and effective as paricalcitol in the treatment of MBD in hemodialysis patients using the revised KDIGO parathyroid hormone targets. Our hypothesis is that calcitriol will be as equally safe and effective as paricalcitol in the treatment of MBD in hemodialysis patients.

Arms: arm 1: Patients randomized to an active vitamin D treatment protocol based on IV calcitriol. After 14 weeks, patients cross-over to an active vitamin D protocol based on IV paricalcitol for 14 weeks. arm 2: Patients randomized to an active vitamin D treatment protocol based on IV paricalcitol. After 14 weeks, patients cross-over to an active vitamin D protocol based on IV calcitriol for 14 weeks.
Interventions: intervention 1: Calcitriol intervention 2: Paricalcitol
Intervention descriptions: intervention 1: 3 times weekly intervention 2: 3 times weekly

Protocol documents:
Clinical trial NCT01728623
Conditions: Thyroid Cancer
Keywords: Thyroid cancer
Sponsor: Eisai Co., Ltd.
Start date: 2012-09-03; Completion date: 2015-10-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is to evaluate the safety, efficacy, and pharmacokinetics of E7080 when orally administered once daily (QD) in subjects with advanced thyroid cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: E7080 capsule
Intervention descriptions: intervention 1: E7080 is administered as continuous once daily dosing in an uncontrolled manner

Protocol documents:
Clinical trial NCT01750268
Conditions: Traumatic Brain Injury (TBI) Hazardous and Harmful Alcohol Use
Keywords: TBI hazardous and harmful alcohol use veterans co-occurring disorders pharmacotherapy
Sponsor: University of California, San Francisco
Start date: 2012-11-01; Completion date: 2015-10-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of the proposed project is to improve the treatment of veterans with co-occurring traumatic brain injury (TBI) and hazardous or harmful alcohol use. The PI and coinvestigators will conduct a pilot controlled clinical trial of topiramate for the treatment of these co-occurring disorders.

Detailed description:

Arms: arm 1: Topiramate capsules daily - up to 300 mg arm 2: Placebo capsules daily - up 300 mg
Interventions: intervention 1: Medical Management Counseling intervention 2: Topiramate intervention 3: Placebo
Intervention descriptions: intervention 1: Brief alcohol and medication counseling intervention 2: Experimental medication intervention 3: Placebo comparator

Protocol documents: