ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01296191
Conditions: Cataracts
Sponsor: Frank A. Bucci, Jr., M.D.
Start date: 2011-05-01; Completion date: 2013-01-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare drug concentrations in aqueous humor following ocular instillation of Besivance and VIGAMOX in subjects undergoing cataract surgery.

Detailed description:
The objective of this study is to compare drug concentrations in aqueous humor following ocular instillation of Besivance or VIGAMOX in subjects undergoing cataract surgery. The hypothesis of the study is that the aggregate aqueous absorption of Besivance over a six hour period is greater than VIGAMOX because of unique properties of Besivance which promote increased contact time of this antibiotic with the ocular surface.

Subjects with scheduled cataract surgery will be screened during their pre-operative visit. Eligible subjects will be randomized to treatment with Besivance or VIGAMOX. Subjects will self-administer 1 drop of study drug into the operative eye 4 times a day for 3 days prior to surgery.Subjects will have one final drop of study medication on the day of surgery.Immediately prior to beginning the cataract surgery, a sample of aqueous humor will be collected by paracentesis.Concentration of Besivance and VIGAMOX in the aqueous humor will be determined by an independent laboratory using standardized high pressure liquid chromatography and mass spectrometry assays. Pharmacokinetic parameters determined from the aqueous humor concentration-time data will minimally include the area under the curve and the maximum concentration.

Arms: arm 1: Subjects undergoing cataract surgery, randomized to the VIGAMOX group Generic name is moxifloxacin eye drops, drops to be used 1 drop 4 times daily for 3 days prior to surgery and 1 drop on day of surgery. arm 2: Subjects scheduled for cataract surgery, randomized to the Besivance group Generic name is besifloxacin eye drops, drops to be used 1 drop 4 times daily for 3 days prior to surgery and 1 drop on day of surgery.
Interventions: intervention 1: Moxifloxacin intervention 2: besifloxacin
Intervention descriptions: intervention 1: One drop 4 times daily for 3 days and one drop the day of sample collection intervention 2: One drop 4 times daily for 3 days and one drop on day of sample collection

Protocol documents:
Clinical trial NCT01296542
Conditions: Cataracts
Sponsor: Bucci Laser Vision Institute
Start date: 2011-05-01; Completion date: 2013-01-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare antibacterial efficacy of Besivance versus VIGAMOX for decreasing bacteria of the conjunctiva and lid margins in cataract patients prior to surgery after both 1 hour and 3 days of treatment.

Detailed description:

Arms: arm 1: Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection arm 2: Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
Interventions: intervention 1: Moxifloxacin Ophthalmic intervention 2: Besifloxacin Ophthalmic
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01308840
Conditions: Biliary Tract Cancer Gallbladder Cancer
Keywords: Unresectable metastatic biliary tract gallbladder cancer
Sponsor: University of Rochester
Start date: 2010-12-01; Completion date: 2013-01-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine disease response of GEMOX-Panitumumab (GEMOX-P) in KRAS/ BRAF wild-type, Stage IV, biliary tract and gallbladder cancer patients who have previously not received chemotherapy. This study will also examine the potential toxicities, progression-free and overall survival in this population.

Detailed description:

Arms: arm 1: Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)
Interventions: intervention 1: Panitumumab intervention 2: oxaliplatin intervention 3: gemcitabine
Intervention descriptions: intervention 1: Day 1 and 15 = 6 mg/kg IV intervention 2: Days 1 and 15 = 85mg/m2 IV intervention 3: Days 1 and 15 = 1000 mg/m2 IV

Protocol documents:
Clinical trial NCT01309204
Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: open-angle glaucoma ocular hypertension OAG OHT
Sponsor: Alcon Research
Start date: 2011-05-01; Completion date: 2013-01-01
Enrollment: 1184 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine fixed combination in lowering intraocular pressure (IOP) relative to each of its individual active constituents instilled concomitantly (Brinzolamide+Brimonidine) in patients with open-angle glaucoma or ocular hypertension.

Detailed description:
This study consisted of 7 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and a treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6 (or early exit). Following washout of any IOP-lowering medication, subjects who met all inclusion/exclusion criteria at both eligibility visits and who had IOP measurements within the specified range during this period were randomized to 1 of 2 study drug groups: Brinz/Brim or Brinz+Brim.

Arms: arm 1: Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months. arm 2: Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
Interventions: intervention 1: Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension intervention 2: Vehicle intervention 3: Brinzolamide 1% ophthalmic suspension intervention 4: Brimonidine tartrate 0.2% ophthalmic solution
Intervention descriptions: intervention 1: None intervention 2: Inactive ingredients used as a placebo for masking purposes intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01310777
Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Open-Angle glaucoma Ocular Hypertension OAG OHT
Sponsor: Alcon Research
Start date: 2011-05-01; Completion date: 2013-01-01
Enrollment: 771 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components in patients with open-angle glaucoma or ocular hypertension.

Detailed description:
This study consisted of 7 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and a treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6 (or early exit). Following washout of any IOP-lowering medication, subjects who met all inclusion/exclusion criteria at both eligibility visits and who had IOP measurements within the specified range during this period were randomized to 1 of 3 study drug groups: Brinz/Brim, Brinz, or Brim.

Arms: arm 1: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months arm 2: Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months arm 3: Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
Interventions: intervention 1: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension intervention 2: Brinzolamide 1% ophthalmic suspension intervention 3: Brimonidine tartrate 0.2% ophthalmic solution
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01312818
Conditions: Acute Lymphoblastic Leukemia
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2011-06-01; Completion date: 2013-01-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Both of bortezomib and vorinostat have identified Phase II doses for pediatric and adult patients of which no grade 4 dose limiting toxicities have been observed in prior studies. The pre-clinical synergy of these 2 agents when used in combination along with the lack of over-riding toxicities and different mechanisms of action provide strong rationale for a clinical trial investigating bortezomib and vorinostat in combination. This trial will use the identified Phase II dose which is at or below the maximum tolerated dose for both agents which have very acceptable toxicity profiles and such should prove feasible and tolerable in this relapsed/refractory ALL population.

Detailed description:
This is a phase II study of bortezomib 1.3 mg/m\^2 by intravenous pyelogram (IVP) on days 1, 4, 8, and 11, vorinostat 180 mg/m\^2 by mouth (PO) per day (not to exceed 400 mg per day) days 1-14, and dexamethasone 6 mg/m\^2 PO days 4-15 for the treatment of relapsed/refractory acute lymphoblastic leukemia (ALL). No more than 3 treatment courses may be given.

Arms: arm 1: Bortezomib IV Vorinostat PO Dexamethasone PO Intrathecal Methotrexate Imatinib Mesylate PO (for Ph+ ALL patients only)
Interventions: intervention 1: Bortezomib intervention 2: Vorinostat intervention 3: Dexamethasone intervention 4: Methotrexate intervention 5: Imatinib mesylate
Intervention descriptions: intervention 1: 1.3 mg/m\^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11. intervention 2: 180 mg/m\^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14 intervention 3: 6 mg/m\^2 by mouth (PO) divided twice a day (BID) on days 4-15. intervention 4: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only) intervention 5: For Ph+ acute lymphoblastic leukemia (ALL) patients only:

Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for \>18 years on Days 1-16.

Protocol documents:
Clinical trial NCT01334957
Conditions: Pain
Sponsor: Cumberland Pharmaceuticals
Start date: 2011-06-01; Completion date: 2013-01-01
Enrollment: 300 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the preemptive treatment of postoperative pain.

Detailed description:

Arms: arm 1: Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.
Interventions: intervention 1: Intravenous ibuprofen
Intervention descriptions: intervention 1: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes

Protocol documents:
Clinical trial NCT01340885
Conditions: Parkinson's Disease
Keywords: attention mild cognitive impairment dementia
Sponsor: Oregon Health and Science University
Start date: 2011-01-01; Completion date: 2013-01-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the relationship between attention and quality of life and how rivastigmine and atomoxetine alter attention in non-demented persons with Parkinson's disease (PD).

Detailed description:
Cognitive dysfunction can occur in early stage of Parkinson's disease (PD) and increases as PD progresses. Attention deficits in PD patients with dementia strongly predict the impairment of their daily living activities.

Previous studies have shown that atomoxetine improves PD executive dysfunction and rivastigmine improves attention deficits in PD patients with dementia without worsening the motor symptoms.

The aim of this study is to examine the effect of atomoxetine and rivastigmine on attention and quality of life in PD patients without disabling cognitive impairment.

Arms: arm 1: Strattera 10-30 mg b.i.d. arm 2: Exelon 1.5-4.5 mg b.i.d. arm 3: sugar pill
Interventions: intervention 1: Strattera intervention 2: Exelon intervention 3: Placebo
Intervention descriptions: intervention 1: 10-30 mg b.i.d. for 6 weeks intervention 2: 1.5-4.5 mg b.i.d. for 6 weeks intervention 3: 2-6 pills for 6 weeks

Protocol documents:
Clinical trial NCT01347008
Conditions: Scleroderma, Systemic Scleroderma, Diffuse Scleroderma, Limited Raynaud Phenomenon
Keywords: Sildenafil Endothelial Progenitor Cells Laser Doppler Imaging
Sponsor: Federal University of São Paulo
Start date: 2011-04-01; Completion date: 2013-01-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Early phases of systemic sclerosis is characterized by inflammatory and microvasculature alterations. Sildenafil citrate has been shown to have vasodilatory effects and to enhance vasculogenesis. The purpose of this study is to evaluate the effect of sildenafil citrate on hand blood flow of patients with systemic sclerosis, using Laser Doppler Imaging.

Detailed description:
Progressive microangiopathy and endothelial dysfunction are identified in early phases of systemic sclerosis. These alterations may result in progressive reduction of vessel lumen, decreased blood flow, and a state of chronic hypoxia resulting in digital ulcers, digital pitting, and, in more severe cases, gangrene and amputation of the extremities. Few studies aimed to evaluate the effects of Sildenafil on the microcirculatory blood flow in patients with Raynaud's phenomenon secondary to systemic sclerosis (SS). Moreover, no study has evaluated the effect of this drug on the number and function of endothelial progenitor cells in SS patients. The relatively new technique of laser Doppler imaging (LDI) allows an objective measurement of superficial cutaneous microvascular blood flow and constitutes a promising approach in the assessment of the digital microvascular vasoreactivity in response to cold stimulus or in response to treatment in SSc patients.

Arms: arm 1: Oral Sildenafil citrate, 50mg, b.i.d. arm 2: Placebo pill (identical to Sildenafil citrate 50mg), b.i.d.
Interventions: intervention 1: Sildenafil citrate intervention 2: Placebo (Sugar pill)
Intervention descriptions: intervention 1: Oral sildenafil citratre, 50mg b.i.d., 8 weeks intervention 2: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks

Protocol documents:
Clinical trial NCT01355523
Conditions: Breast Cancer Depression
Keywords: Breast cancer surgery Melatonin Depression Anxiety Sleep disturbances Cognitive function
Sponsor: Melissa Voigt Hansen
Start date: 2011-07-01; Completion date: 2013-01-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the effect of 6 mg melatonin daily for 1 week preoperatively to 12 weeks postoperatively on depressive symptoms, anxiety, cognitive function and sleep disturbances in breast cancer patients. Furthermore the investigators will examine whether a specific clock-gene (HPER3) is correlated with an increased risk of depression, sleep disturbances or cognitive dysfunction.

Detailed description:
About 1.4 million women are diagnosed with breast cancer every year. Breast cancer is the most common malignancy among women worldwide constituting about 1/5 of all cancer types. Breast cancer diagnosis and treatment, and the months following primary therapy are stressful times for most women. Aside from the actual "cancer threat" many women experience various degrees of depression, anxiety, sleep disturbances and memory/concentration problems (cognitive dysfunction). Naturally these factors influence the quality of life but also contribute to morbidity and mortality.

Melatonin is a regulatory circadian hormone having, among others, hypnotic, sedative, anxiolytic and possibly anti-depressive effects. It has very low toxicity and very few adverse effects.

The purpose of this project is to test melatonin (6 mg daily for 1 week preoperatively to 12 weeks postoperatively) on breast cancer patients and hopefully hereby be able to prevent depression, anxiety, sleep disturbances and cognitive dysfunction. On an overall perspective this will hopefully contribute to improving the quality of life for these patients and extend their lifetime. Furthermore the investigators will be examining whether a specific gene called a clock-gene (HPER3) is correlated with an increased risk of depression, sleep disturbances or cognitive dysfunction. If this is the case it could become possible to identify women with an increased risk and provide prophylactic treatment for those with a risk of developing a depression, sleep disturbances or cognitive disturbances.

Sample size calculations were based on our primary outcome parameter. Using a conservative estimate for the incidence of depression, the investigators expect to find a reduction from 30% to 15% with melatonin treatment. Sample size is sufficient to include our secondary and tertiary outcome parameters as well. The sample size calculations were calculated with a power of 80%, a type I error of 5% and a type II error of 20%.

Arms: arm 1: 6 mg oral melatonin daily arm 2: 6 mg oral placebo daily
Interventions: intervention 1: Melatonin (N-acetyl-5-methoxytryptamine) intervention 2: Placebo
Intervention descriptions: intervention 1: 6 mg oral melatonin daily 1 hour before bedtime intervention 2: 6 mg oral placebo daily 1 hour before bedtime

Protocol documents:
Clinical trial NCT01357616
Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Glaucoma Open-angle glaucoma Ocular hypertension OAG OH
Sponsor: Alcon Research
Start date: 2010-11-01; Completion date: 2013-01-01
Enrollment: 328 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to compare the intraocular pressure (IOP)-lowering efficacy and safety of AZARGA™ (Brinzolamide 1%/Timolol 0.5% Ophthalmic Suspension), dosed twice daily versus AZOPT® (Brinzolamide 1% Ophthalmic Suspension) and Timolol 0.5% Ophthalmic Solution, each dosed twice daily, in Chinese patients with open-angle glaucoma or ocular hypertension who were insufficiently responsive to monotherapy.

Detailed description:
The study consisted of 2 sequential phases. Phase I was the Screening/Eligibility Phase, with a Screening Visit followed by an Eligibility Visit. Phase II was the treatment phase and included Week 1, Week 2, Week 4, and Week 8 visits. Eligible subjects were randomized in a 1:1 ratio to receive Brinzolamide 1%/Timolol 0.5% or Brinzolamide 1% plus Timolol 0.5% two times a day for 8 weeks.

Arms: arm 1: Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator. arm 2: Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
Interventions: intervention 1: Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension intervention 2: Brinzolamide 1% ophthalmic suspension intervention 3: Timolol 0.5% ophthalmic solution
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01361048
Conditions: Trichomonas Vaginitis
Keywords: trichomonas
Sponsor: University of Alabama at Birmingham
Start date: 2011-12-01; Completion date: 2013-01-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators are trying a combination vaginal product of higher dose metronidazole combined with miconazole to see if it is effective in treating vaginal trichomonas.

Detailed description:

Arms: arm 1: control arm arm 2: neo penotran forte vaginal suppository twice a day for 7 days arm 3: neo penotran forte vaginal suppository once a day for 7 days
Interventions: intervention 1: oral metronidazole intervention 2: neo penotran forte intervention 3: neo penotran forte once a day
Intervention descriptions: intervention 1: 2 gm oral once intervention 2: neo penotran forte intravaginal twice a day for 7 days intervention 3: neo penotran forte intravaginally once a day for 7 days

Protocol documents:
Clinical trial NCT01363843
Conditions: Colon Cancer Rectal Cancer
Keywords: neoadjuvant chemo/radiation rectal cancer rectum cancer colon cancer colorectal cancer
Sponsor: William Sikov MD
Start date: 2010-05-01; Completion date: 2013-01-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out how well patients with cancer of the rectum do if they get all of their other treatment - chemotherapy by itself followed by chemotherapy and radiation together - before surgery. Patients have recently been diagnosed with rectal cancer, and the doctors have recommended neo-adjuvant chemo treatment to try to shrink the cancer before removing it.

Detailed description:
The goals of treatment of locally advanced (T3-4 or N1-2) rectal cancer are to eliminate the primary tumor and any involved adjacent lymph nodes, minimize the risk of distant recurrence, and, when possible, preserve anal sphincter function. Standard treatment consists of surgery, concurrent chemotherapy and radiation (RT) and adjuvant chemotherapy. As the present time, the chemoradiation portion of the treatment is often administered before, as opposed to following, surgical resection. This approach has been associated with tumor down-staging, leading to higher rates of tumor resectability and an increase in the ability to perform sphincter-saving surgeries. (1). However, while advances in treatment of the primary tumor and regional nodes, specifically administration of preoperative chemoradiation and more aggressive surgical approaches, such as total mesorectal excision (TME), have been shown to improve locoregional disease control, toxicities and complications of these treatments may result in delay or omission of adjuvant chemotherapy, which could increase the risk of distant recurrence. In this pilot study, standard adjuvant chemotherapy (8 cycles of modified FOLFOX6) will be administered prior to chemoradiation and definitive surgery, eliminating the need for post-operative systemic therapy. The investigators will evaluate the ability of patients to tolerate this treatment and its impact on achievement of pathologic complete responses (pCRs), negative surgical margins and sphincter preservation.

Arms: arm 1: Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles

Concurrent Chemoradiation

50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)

Surgery
Interventions: intervention 1: FOLFOX6 intervention 2: RT with concurrent chemotherapy intervention 3: Surgery
Intervention descriptions: intervention 1: FOLFOX6 intervention 2: IMRT 50.4Gy with chemotherapy intervention 3: None

Protocol documents: