ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01206777
Conditions: Indolent or Intermediate Grade B-cell Malignancy
Keywords: Hypersensitivity Reactions B-cell malignancies
Sponsor: Ohio State University Comprehensive Cancer Center
Start date: 2010-10-01; Completion date: 2013-04-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the feasibility of a 60 minute rapid infusion rituximab protocol in the institution's outpatient infusion center.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Rituximab
Intervention descriptions: intervention 1: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.

Protocol documents:
Clinical trial NCT01212627
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
Sponsor: Angela Taber MD
Start date: 2010-09-01; Completion date: 2013-04-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to evaluate the best dose, safety and side effects of ridaforolimus when given with cetuximab for patients with head and neck, lung and colon cancer that has progressed after initial therapy. A second purpose of this study is to gain preliminary information on whether the combination of ridaforolimus and cetuximab is helpful in treating patients with advanced head and neck cancer

Detailed description:
Patients with advanced NSCLC, colorectal cancer, and head and neck cancer that progressed after at least 1 prior regimen for metastatic disease were eligible. Wild-type K-ras was required in colon cancer. All patients received cetuximab 400 mg/m2 week 1 followed by 250 mg/m2/week. Four dose levels of ridaforolimus were planned: 10mg, 20mg, 30mg, and 40mg daily, 5 days each week, on a 28-day cycle.

Arms: arm 1: Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression
Interventions: intervention 1: Ridaforolimus
Intervention descriptions: intervention 1: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle

Protocol documents:
Clinical trial NCT01216241
Conditions: Febrile Neutropenia
Sponsor: University of Rochester
Start date: 2011-04-01; Completion date: 2013-04-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the benefits and side effects of daptomycin compared to placebo for the treatment of neutropenic fever.

Detailed description:
To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops is higher when daptomycin compared to placebo is added at the same time as anti gram-negative therapy. The five day time point is selected because it is at this point where it is recommended to add antifungal therapy to the treatment regimen if the patient is still febrile.

Arms: arm 1: Daptomycin intravenous 8mg/kg once per day 5-10 days. arm 2: Saline solution
Interventions: intervention 1: Daptomycin intervention 2: Saline Placebo intervention 3: Daptomycin
Intervention descriptions: intervention 1: 8 MG/KG IV intervention 2: 50 ml normal saline once daily intervention 3: 8 mg/kg once daily

Protocol documents:
Clinical trial NCT01218477
Conditions: Leukemia
Keywords: Leukemia (Chronic Myeloid Leukemia-Chronic Phase and Advanced)
Sponsor: Bristol-Myers Squibb
Start date: 2011-01-01; Completion date: 2013-04-01
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to determine the safety and tolerability of the combination of BMS-833923 plus dasatinib in patients with chronic myeloid leukemia.

Detailed description:

Arms: arm 1: Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with chronic myeloid leukemia \[CML\]-chronic phase; 140 mg for those with CML-advanced phase) arm 2: Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) plus BMS-833923, 50 mg, QD arm 3: Participants received BMS-833923, 100 mg twice daily (BID) for 7 days then once daily (QD) + dasatinib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) arm 4: Participants received BMS-833923, 200 mg twice daily (BID) for 7 days then 200 mg once daily (QD) plus dasatinib, 100 /140 mg QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
Interventions: intervention 1: Dasatinib intervention 2: BMS-833923
Intervention descriptions: intervention 1: Oral tablets, 100-140 mg once daily, depending on cohort (100 mg for those with chronic myeloid leukemia \[CML\]-chronic phase; 140 mg for those with CML-advanced phase) intervention 2: Oral capsules, 50-200 mg, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)

Protocol documents:
Clinical trial NCT01248130
Conditions: Autism Spectrum Disorder (ASD)
Keywords: Omega-3 Fatty Acid Autism Spectrum Disorders Pervasive Developmental Disorders Children Cognitive Functioning
Sponsor: Massachusetts General Hospital
Start date: 2009-11-01; Completion date: 2013-04-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of this study is to examine the efficacy and tolerability of short-term omega-3 fatty acids monotherapy in youth with Autism Spectrum Disorders (ASD). The investigators hypothesize that Omega-3 fatty acids will be efficacious in improving the core and associated features of ASD in youth, and that Omega-3 fatty acids monotherapy will be safe and well tolerated by youth with ASD. The secondary aim of this study is to examine the neuropsychological effect of Omega-3 fatty acids monotherapy in youth with ASD. The investigators hypothesize that omega-3 fatty acids will be efficacious in improving cognitive functions in youth with ASD.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Omega-3 Fatty Acid
Intervention descriptions: intervention 1: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.

Protocol documents:
Clinical trial NCT01252277
Conditions: Breast Cancer
Sponsor: Carol Fabian, MD
Start date: 2010-11-01; Completion date: 2013-04-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to gather information on how the prescription drug Lovaza™ which contains omega-3 fatty acids, affects blood and tissue risk biomarkers for breast cancer. This drug is currently approved by the FDA for reducing blood levels of triglycerides.

Detailed description:
The central hypothesis is that 6 months of administration of high dose omega-3 fatty acid esters \[eicosapentaenoic acid (EPA) 1860 mg, and docosahexaenoic acid (DHA) 1500 mg\] daily in the form of a standard prescription strength dose of Lovaza™ (two 1 gram capsules twice daily) will have a favorable side effect profile and potential efficacy as demonstrated by favorable modulation of one or more blood and breast tissue risk biomarkers for breast cancer in premenopausal women.

Arms: arm 1: Lovaza™ (two 1 gram capsules twice daily) for six months
Interventions: intervention 1: Lovaza™
Intervention descriptions: intervention 1: 4 capsules daily for 6 months

Protocol documents:
Clinical trial NCT01254656
Conditions: HIV-1
Sponsor: Pfizer
Start date: 2011-02-01; Completion date: 2013-04-01
Enrollment: 108 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to assess long-term safety and efficacy of lersivirine in patients who have completed 96 weeks of treatment with lersivirine in studies A5271015 and A5271022.

Detailed description:
The trial was terminated prematurely on January 29, 2013, due to the decision of the sponsor to discontinue development of lersivirine. The decision to terminate the trial was not based on any safety or efficacy concerns.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: lersivirine intervention 2: lersivirine intervention 3: efavirenz intervention 4: lersivirine intervention 5: lersivirine intervention 6: etravirine
Intervention descriptions: intervention 1: Lersivirine 500 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily intervention 2: Lersivirine 750 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily intervention 3: Efavirenz 600 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily intervention 4: Lersivirine 750 mg tablets PO taken once daily + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI intervention 5: Lersivirine 1000 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI intervention 6: Etravirine 200 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules taken twice daily + 1 optimized NRTI

Protocol documents:
Clinical trial NCT01263444
Conditions: Glaucoma Ocular Hypertension
Keywords: AZARGA® Open angle glaucoma Prostaglandin Therapy
Sponsor: Alcon Research
Start date: 2011-03-01; Completion date: 2013-04-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of adding AZARGA® as a single agent to prostaglandin monotherapy in patients with either ocular hypertension or primary open-angle glaucoma.

Detailed description:
This study consisted of 3 study visits (Screening/Baseline, Week 4, and Week 12). Eligible patients self-administered the study medication (AZARGA® Eye Drops), adjunct to their current prostaglandin monotherapy for 3 months.

Arms: arm 1: Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
Interventions: intervention 1: Brinzolamide 1% / timolol 0.5% Fixed Combination intervention 2: Habitual prostaglandin monotherapy
Intervention descriptions: intervention 1: None intervention 2: Topical ocular therapy used daily as prescribed

Protocol documents:
Clinical trial NCT01268293
Conditions: Cancer
Keywords: Cancer
Sponsor: Eisai Co., Ltd.
Start date: 2011-02-01; Completion date: 2013-04-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle) in subjects with solid tumors

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: E7080
Intervention descriptions: intervention 1: This arm will be a dose-escalation evaluation of 9-18 subjects to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle). Administration of the study drug can continue until subjects meet discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent.

Protocol documents:
Clinical trial NCT01270802
Conditions: HIV
Keywords: Endothelial function Vitamin D Efavirenz Raltegravir
Sponsor: Indiana University
Start date: 2011-04-01; Completion date: 2013-04-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efavirenz, a commonly used HIV medication, may cause worsening vascular function and bone problems. The purpose of this study is to determine if switching efavirenz to raltegravir, a newer HIV medication, will improve vascular function and tests of bone health.

Detailed description:
Cardiovascular disease (CVD) is an increasingly important comorbidity in HIV-infected patients. Our preliminary data suggests that efavirenz may worsen endothelial function, which in turn may increase the risk for future CVD events. Efavirenz has also been linked to lower vitamin D levels, which may in turn result in increased bone fragility. Raltegravir is not known to affect either endothelial function or vitamin D levels. Therefore, switching efavirenz to raltegravir in patients with suppressed HIV viremia may lead to improved outcomes.

Arms: arm 1: Tenofovir/emtricitabine/efavirenz arm 2: Tenofovir/emtricitabine/efavirenz is switched to tenofovir/emtricitabine plus raltegravir
Interventions: intervention 1: Tenofovir/emtricitabine intervention 2: Tenofovir/emtricitabine/efavirenz intervention 3: Raltegravir
Intervention descriptions: intervention 1: Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine intervention 2: Continued therapy with tenofovir/emtricitabine/efavirenz intervention 3: Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine

Protocol documents:
Clinical trial NCT01276639
Conditions: Psoriasis
Keywords: Xeljanz tofacitinib chronic Pruritus Itch DLQI severe moderate treatment safety efficacy CP-690,550 Plaque Psoriasis Psoriasis Vulgaris Jax-inhibitor Oral Treatment
Sponsor: Pfizer
Start date: 2011-03-01; Completion date: 2013-04-01
Enrollment: 901 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: Placebo/CP-690,550 intervention 4: Placebo/CP-690,550
Intervention descriptions: intervention 1: 10 mg oral BID, Continuous treatment for 52 Weeks intervention 2: 5 mg oral BID, Continuous treatment for 52 Weeks intervention 3: 0 mg oral BID, Continuous treatment for 16 Weeks; 10 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo) intervention 4: 0 mg oral BID, Continuous treatment for 16 Weeks; 5 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)

Protocol documents:
Clinical trial NCT01278407
Conditions: Dementia With Lewy Bodies (DLB)
Keywords: DLB Dementia with Lewy bodies Lewy Body Disease Dementia E2020 Donepezil Aricept
Sponsor: Eisai Co., Ltd.
Start date: 2011-02-01; Completion date: 2013-04-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with Lewy bodies (DLB).

Detailed description:
This 52-week study consisted of 16-week randomized placebo-controlled (RCT, including 12-week Confirmatory Phase) and 36-week open-label extension phases. Of 142 DLB patients enrolled in the RCT phase (three arms: placebo, 5 mg, and 10 mg), 110 entered the extension phase. The placebo group of the RCT phase initiated active treatment at week 16, and the active groups maintained allocated treatment and dosages until week 24. After week 24, all patients received 10 mg. Dose reduction to 5 mg for safety concerns was allowed.

Arms: arm 1: Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase. arm 2: Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase. arm 3: Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase. arm 4: Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns. arm 5: Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
Interventions: intervention 1: Donepezil 5 mg intervention 2: Donepezil 10 mg intervention 3: Donepezil matched placebo
Intervention descriptions: intervention 1: Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg intervention 2: Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg intervention 3: None

Protocol documents:
Clinical trial NCT01306214
Conditions: Diabetes Mellitus, Type 2 Obesity
Sponsor: Boehringer Ingelheim
Start date: 2011-02-01; Completion date: 2013-04-01
Enrollment: 566 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.

Detailed description:

Arms: arm 1: BI 10773 low dose once daily arm 2: BI 10733 high dose once daily arm 3: Placebo tablets matching BI 10773
Interventions: intervention 1: Placebo intervention 2: Placebo intervention 3: Placebo intervention 4: Placebo intervention 5: BI 10773 intervention 6: BI 10773
Intervention descriptions: intervention 1: Placebo matching BI 10773 low dose intervention 2: Placebo matching BI 10773 low dose intervention 3: Placebo matching BI 10773 high dose intervention 4: Placebo matching BI 10773 high dose intervention 5: BI 10773 low dose once daily intervention 6: BI 10773 high dose once daily

Protocol documents:
Clinical trial NCT01309451
Conditions: Diabetic Macular Edema
Keywords: diabetic macular edema DME
Sponsor: Maturi, Raj K., M.D., P.C.
Start date: 2011-03-01; Completion date: 2013-04-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that a combination treatment with Avastin and Ozurdex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.

Detailed description:

Arms: arm 1: None arm 2: Bevacizumab plus Ozurdex
Interventions: intervention 1: Bevacizumab intervention 2: dexamethasone intravitreal implant
Intervention descriptions: intervention 1: intravitreal, 1.25mg., monthly intervention 2: 0.7mg, intravitreal every 4 months

Protocol documents:
Clinical trial NCT01333098
Conditions: Anxiety Disorders
Keywords: anxiety older adult memory cognitive Saint Louis treatment cognitive impariment
Sponsor: Washington University School of Medicine
Start date: 2012-09-01; Completion date: 2013-04-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study seeks to develop and test a novel, mechanistic treatment for mitigating cognitive impairment in older adults with anxiety disorders. Anxiety disorders are common, severe, and disabling in older adults. One particularly impairing aspect of late-life anxiety disorders is cognitive impairment: impairments in memory and executive function cause disability, impede treatment response to psychotherapy, may lead to dementia, and are not corrected by standard anti-anxiety treatments.

This pilot study will test the glucocorticoid antagonist, mifepristone, for cognitive impairment in late-life anxiety disorders. Mifepristone blocks the effects of elevated cortisol levels on glucocorticoid receptors in the brain; it has been studied preliminarily in various neuropsychiatric disorders, such as psychotic depression and bipolar disorder, with well-documented safety and tolerability.

Detailed description:
Currently, no treatment exists to address cognitive impairment in late-life anxiety disorders. In this study, fifteen patients aged 60+ with an anxiety disorder (current or in partial remission) and subjective and/or objective evidence of cognitive impairment will receive treatment with mifepristone. At the baseline visit participants will be randomized to receive either mifepristone 300mg or a placebo daily for 7 days. Participants will be reassessed after 7 days (week 1 visit) of receiving study medication (mifepristone or placebo). At that time all participants will be provided mifepristone 300mg daily for the remaining 3 weeks of study treatment. The primary outcome measure will be neurocognition, as assessed by a battery of neuropsychological measures focusing on immediate and delayed memory and executive function (administered at baseline, week 1, week 4, and week 12). Saliva samples for cortisol measurement will be collected immediately following the baseline visit and week 4 visit. Secondary outcomes will be self-reported anxiety and depressive symptoms.

Arms: arm 1: 1 week mifepristone or placebo (followed by 3 weeks open label mifepristone)
Interventions: intervention 1: Mifepristone
Intervention descriptions: intervention 1: 300mg per day, by mouth, for 21-28 days

Protocol documents:
Clinical trial NCT01337635
Conditions: Atopic Dermatitis Vitamin D Deficiency
Sponsor: Medical College of Wisconsin
Start date: 2010-11-01; Completion date: 2013-04-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Atopic dermatitis is a chronic skin disease characterized by a defective skin barrier, inflammation, and increased propensity for skin infections. Vitamin D is a fat-soluble vitamin that is primarily acquired through local production in the skin after ultraviolet light exposure but can also be obtained through natural and supplemental dietary sources. This randomized controlled trial will examine the effects of vitamin D repletion on atopic dermatitis severity in patients with diagnosed deficiency. The investigators hypothesize that pediatric patients with moderate or severe atopic dermatitis and vitamin D deficiency will have improved cutaneous disease after treatment with high dose as compared to standard dose vitamin D.

Detailed description:

Arms: arm 1: Treatment with cholecalciferol 400 IU daily at home. arm 2: Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.
Interventions: intervention 1: Vitamin D
Intervention descriptions: intervention 1: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks

Protocol documents: