ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01387464
Conditions: Cataract
Keywords: bromfenac concentrations ISV-303 Bromday
Sponsor: Sun Pharmaceutical Industries Limited
Start date: 2011-07-01; Completion date: 2011-08-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to routine cataract surgery.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ISV-303 intervention 2: Bromday™
Intervention descriptions: intervention 1: 0.075% bromfenac in DuraSite dosed QD intervention 2: 0.09% bromfenac dosed QD

Protocol documents:
Clinical trial NCT01389765
Conditions: Depressive Disorder, Major
Sponsor: Eli Lilly and Company
Start date: 2011-07-01; Completion date: 2011-08-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the effect of food on LY2216684. There will be 2 study periods each lasting up to 5 days. There will be at least 7 days between the two doses and a follow up will occur at least 7 days after the last dose. Screening is required within 30 days prior to the start of the study.

Detailed description:

Arms: arm 1: Period 1: Single 18-mg (milligram) oral dose of LY2216684 administered in fasted state. Period 2: Single 18-mg oral dose of LY2216684 administered in fed state. Periods will be separated by a minimum of 7 days. arm 2: Period 1: Single 18-mg oral dose of LY2216684 administered in fed state. Period 2: Single 18-mg oral dose of LY2216684 administered in fasted state. Periods will be separated by a minimum of 7 days.
Interventions: intervention 1: LY2216684
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT01396265
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-07-01; Completion date: 2011-08-01
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of the current study is to investigate the effect of the P-gp inducer rifampicin on the pharmacokinetics (PK) of afatinib in healthy male volunteers

Detailed description:

Arms: arm 1: Tablet, Oral administration with 240 mL of water arm 2: Tablet, Oral administration with 240 mL of water
Interventions: intervention 1: Afatinib intervention 2: Afatinib intervention 3: Rifampicin
Intervention descriptions: intervention 1: single dose intervention 2: single dose intervention 3: multiple doses

Protocol documents:
Clinical trial NCT01399788
Conditions: Healthy Volunteers
Keywords: Bioequivalence Healthy Volunteers
Sponsor: Pfizer
Start date: 2011-07-01; Completion date: 2011-08-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a bioequivalence trial to evaluate the bioequivalence of Myrin P Forte against reference drug in healthy volunteers.

Detailed description:

Arms: arm 1: Test Myrin P Forte Contains 150mg Rifampicin, 75mg Isoniazid, 275mg Ethambutol, 400mg Pyrazinamide arm 2: Reference Single drug reference preparations contain Rifampicin, Isoniazid, Ethambutol, Pyrazinamide
Interventions: intervention 1: Myrin P Forte intervention 2: Single drug references
Intervention descriptions: intervention 1: Tablet containing Rifampicin, Isoniazid, Ethambutol and Pyrazinamide, given once daily, single dose intervention 2: containing Rifampicin, Isoniazid, Ethambutol and Pyrazinamide as single agents

Protocol documents:
Clinical trial NCT01402427
Conditions: Coronary Disease Verapamil Toxicity
Keywords: Coronary Artery Disease Coronary Angiography Percutaneous Coronary Intervention Transradial Radial Artery Spasm Verapamil Adverse Effects
Sponsor: State Health Center, Hungary
Start date: 2011-03-01; Completion date: 2011-08-01
Enrollment: 591 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Background Verapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm. However, verapamil may have side effects and is contraindicated in some clinical settings.

Methods: During an investigator-initiated, randomized, double-blind trial, we evaluate the need for preventive verapamil administration. After vascular access is established, patients receive either 5 mg verapamil (n=297) or placebo (n=294). We compare the rate of access site conversions as primary end point using a superiority margin of 5%. Occurrence of code breaks (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural and fluoroscopic times, contrast volume, and subjective pain are investigated as secondary end points.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Verapamil intervention 2: Placebo
Intervention descriptions: intervention 1: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL. intervention 2: Intraarterial administration of 10 mL saline.

Protocol documents:
Clinical trial NCT01410799
Conditions: Hormone Deficiency Aging
Keywords: Growth Hormone Releasing Hormone Growth Hormone Insufficiency Aging Growth Hormone Physiologic Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones
Sponsor: University of Pennsylvania
Start date: 2011-05-01; Completion date: 2011-08-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the effect of a naturally occurring hormone, called Growth Hormone Releasing Hormone (GHRH) on the muscle, bone, and fat tissues of the body. GHRH stimulates the production of growth hormone (GH), which regulates the build up of many tissues in the body, including muscles and bones. Many elderly people have low levels of GH. The overall goal of this research is to determine the efficacy of GHRH to raise levels of GH and improve these body tissues. Healthy men and women age 65 and older will receive GHRH in four doses nightly for 12 weeks and assessed for changes in muscle strength, body mass, physical performance, and how the body uses sugar.

Detailed description:
Although multiple factors appear to be associated with the functional deterioration of advanced age, decreases in muscle mass and strength (sarcopenia) are commonly seen in aging subjects and are major risk factors for subsequent disability. There are many potential causes of sarcopenia and functional impairment in the elderly, including medical conditions such as cardiovascular disease, altered mood, and sedentary lifestyle. Hyposomatotropism, or decreased activity of growth hormone (GH), is one factor that has been implicated.

GH is a major anabolic hormone that exerts important stimulatory effects on protein synthesis. Many of the peripheral tissue effects of GH are mediated by insulin-like growth factor 1 (IGF-1) produced systemically by the liver or locally in tissues in response to GH stimulation. IGF-1, in turn, regulates GH secretion by negative feedback mechanisms at the pituitary gland. Several investigators have shown that aging is associated with a decrease in spontaneous GH secretion and IGF-1 levels. GH levels decline by 14% for each decade after puberty. Reduction of GH release in aging is thought to be associated with an increase in somatostatin tone, decrease in hypothalmic GHRH output, and diminished response to GHRH. The fact that aging is accompanied by a decrease in protein synthesis leading to a loss of lean body mass and a gain in body fat suggests that a decrease in GH secretion may contribute to these changes. It has been hypothesized that restoration of GH level in the elderly to the levels observed in younger individuals may lead to improvements in body composition. GH may also increase slow wave (delta or deep) sleep in older adults.

Arms: arm 1: Drug: GHRH
Interventions: intervention 1: Growth Hormone Releasing Hormone (GHRH )
Intervention descriptions: intervention 1: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, and 5:00 AM for 12 weeks

Protocol documents:
Clinical trial NCT01436799
Conditions: Cerebral Ischemia
Keywords: propofol desflurane cerebrovascular circulation sitting
Sponsor: Gachon University Gil Medical Center
Start date: 2011-03-01; Completion date: 2011-08-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesized that both propofol and desflurane would decrease the regional oxygen saturation (rSO2) but propofol is likely to reduce rSO2 more than sevoflurane when patients are raised to the sitting position.

Detailed description:
The investigators hypothesized that both propofol and desflurane would decrease the rSO2 but propofol is likely to reduce rSO2 more than sevoflurane when patients are raised to the sitting position. Therefore, the purpose of this study was to investigate the effect of desflurane and propofol on rSO2 values during the beach chair position for shoulder arthroscopy.

Arms: arm 1: anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane arm 2: anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model
Interventions: intervention 1: propofol intervention 2: Desflurane intervention 3: alfentanil intervention 4: Rocuronium
Intervention descriptions: intervention 1: anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1 mainly. intervention 2: anaesthesia was maintained by desflurane 4-7vol% intervention 3: administration of alfentanil 10 μg kg-1 for anesthetic induction intervention 4: administration of rocuronium 0.6 mg kg-1 for anesthetic induction

Protocol documents:
Clinical trial NCT01536704
Conditions: Smoking Cessation
Keywords: nicotine lozenge nicotine nicotine replacement therapy
Sponsor: GlaxoSmithKline
Start date: 2011-07-01; Completion date: 2011-08-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile.

Detailed description:

Arms: arm 1: 2 mg test nicotine lozenge to be chewed. arm 2: 4 mg test nicotine lozenge to be chewed. arm 3: 2 mg reference nicotine lozenge to be chewed. arm 4: 4 mg reference nicotine lozenge to be chewed.
Interventions: intervention 1: Nicotine (2 mg) intervention 2: Nicotine (4 mg)
Intervention descriptions: intervention 1: 2 mg nicotine lozenge in two formulations intervention 2: 4 mg nicotine lozenge in two formulations

Protocol documents:
Clinical trial NCT01546688
Conditions: Epilepsy
Sponsor: Eisai Limited
Start date: 2008-11-01; Completion date: 2011-08-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A two arm, randomized, double-blind study comparing zonisamide with placebo. The zonisamide arm will consist of 100 subjects and the placebo arm of 50 subjects. Study medication will be administered as an add-on treatment to the subject's current 1 or 2 anti-epileptic (AEDs).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Zonisamide at targeted daily doses of 100-500 mg/day intervention 2: Placebo administered to match targeted daily doses of 100-500 mg/day
Intervention descriptions: intervention 1: Each group received 2 doses a day (in the morning and evening) during the Titration Period, once a day (in the evening) or BID during the Maintenance Phase, comprising 25 mg, 50 mg, or 100 mg of ZNS capsules intervention 2: matching placebo

Protocol documents:
Clinical trial NCT01610791
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2010-03-01; Completion date: 2011-08-01
Enrollment: 121 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This open label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6 infusions).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: 8 mg/kg iv every 4 weeks, total of 6 infusions

Protocol documents:
Clinical trial NCT01615887
Conditions: Multiple Sclerosis
Sponsor: State University of New York at Buffalo
Start date: 2009-11-01; Completion date: 2011-08-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Amphetamines have been shown to improve cognition but its use is limited due to its side effects. Lisdexamfetamine is an amphetamine pro-drug, minimizing these effects and has been safely used in children and adults with Attention Deficit Hyperactivity Disorder (ADHD). The investigators hypothesize that lisdexamfetamine may improve cognitive abilities in MS patients with documented cognitive dysfunction. Because lisdexamfetamine is a stimulant its positive effects should be observed primarily in the domains of processing speed and working memory. The investigators therefore propose a study in which the primary objective will be to assess the efficacy of lisdexamfetamine in improving attention and processing speed in MS. The secondary objectives will be (a) the assessment of the safety and tolerability of lisdexamfetamine in the MS population, and (b) to test for effects of the drug on other cognitive domains, depression, and self and informant reports of cognitive and executive function demanding activities and behaviors.

Detailed description:

Arms: arm 1: 30mg lisdexamfetamine OD, increased to 70mg OD over 4 weeks and continued on 70mg OD for 4 weeks arm 2: Placebo will be administered in the same fashion as the treatment arm
Interventions: intervention 1: lisdexamfetamine sulfate intervention 2: placebo
Intervention descriptions: intervention 1: 30mg lisdexamfetamine OD, increased to 70mg OD over 4 weeks and continued on 70mg OD for 4 weeks intervention 2: sugar pill

Protocol documents:
Clinical trial NCT01640340
Conditions: Malignant Neoplasm
Keywords: ondansetron palonosetron emetogenic chemotherapy HEC
Sponsor: Ohio State University Comprehensive Cancer Center
Start date: 2011-01-01; Completion date: 2011-08-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Palonosetron is different from ondansetron because it stays in the body longer and may prevent nausea and vomiting for a longer period of time than ondansetron. It is standard practice to use dexamethasone and aprepitant with either ondansetron or palonosetron to prevent nausea and vomiting caused by highly emetogenic chemotherapy. Although these combinations are commonly used, they have never been compared to each other. The purpose of this study is to record the amount of nausea and vomiting, and the amount of "rescue" medication that is used with these two different anti-emetic regimens

Detailed description:
PRIMARY OBJECTIVES:

I. The goal of this study is to evaluate the overall complete response rate (CR, no emesis and no use of rescue medication from 0 to 120 hours after chemotherapy) of two different antiemetic regimens (palonosetron + aprepitant + dexamethasone and ondansetron + aprepitant + dexamethasone) for patients undergoing the first cycle of highly emetogenic chemotherapy (HEC).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive palonosetron hydrochloride intravenously (IV) 30 minutes prior to chemotherapy on day 1, aprepitant orally (PO) 60 minutes prior to chemotherapy on days 1-3, and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4.

ARM II: Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and aprepitant and dexamethasone as in Arm I.

After completion of study treatment, patients are followed up for 7 days.

Arms: arm 1: Patients receive palonosetron hydrochloride IV 30 minutes prior to chemotherapy on day 1, aprepitant PO (by mouth) 60 minutes prior to chemotherapy on days 1-3, and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4. arm 2: Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and aprepitant and dexamethasone as in Arm I.
Interventions: intervention 1: aprepitant intervention 2: palonosetron hydrochloride intervention 3: ondansetron intervention 4: dexamethasone
Intervention descriptions: intervention 1: Given by mouth intervention 2: Given IV(intervenous infusion) intervention 3: Given PO intervention 4: Given PO

Protocol documents:
Clinical trial NCT01829919
Conditions: Postmenopausal Symptoms
Keywords: Menopause Hot flashes Vasomotor symptoms Climacteric symptoms perimenopause Mesafem Brisdelle Low-Dose Mesylate salt of Paroxetine (LDMP)
Sponsor: Noven Therapeutics
Start date: 2011-07-01; Completion date: 2011-08-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the pharmacokinetics (absorption, breakdown and elimination from the body), safety and tolerability of Brisdelle (paroxetine mesylate) Capsules 7.5 mg when given as a single dose and multiple doses.

Detailed description:
This study is for research only and is not designed to treat a medical condition.

Arms: arm 1: Brisdelle (paroxetine mesylate) Capsules taken orally with 240 mL of water for 20 days.
Interventions: intervention 1: Brisdelle (paroxetine mesylate)
Intervention descriptions: intervention 1: All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.

Protocol documents:
Clinical trial NCT01983774
Conditions: Cystic Fibrosis
Keywords: CF
Sponsor: Columbia University
Start date: 2008-02-01; Completion date: 2011-08-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Gastroesophageal reflux disease (GERD) is a common problem in cystic fibrosis (CF). It may lead to worsening lung function and more respiratory infections for a person with CF. This study will look at treating GERD with a medication, esomeprazole. The medication stops stomach acid from being made. The study will see if there are fewer respiratory infections and improved lung function in patients with CF when taking esomeprazole.

Detailed description:
This is a randomized, placebo controlled intervention study in patients with CF who have a history of frequent exacerbations. Treatment duration is 6 months.

Arms: arm 1: A matching placebo (sugar pill) to esomeprazole 40mg twice daily arm 2: Esomeprazole 40mg twice daily
Interventions: intervention 1: Esomeprazole intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Sugar pill

Protocol documents:
Clinical trial NCT02034578
Conditions: Healthy Volunteers
Sponsor: Bristol-Myers Squibb
Start date: 2011-07-01; Completion date: 2011-08-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the bioavailability of Apixaban solution administered through NGT and washed with Dextrose 5% in water (D5W) or infant formula relative to Apixaban solution administered orally in healthy subjects

Detailed description:

Arms: arm 1: Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via oral syringe arm 2: Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via nasogastric tube (NGT) immediately followed by 60 mL of D5W via NGT arm 3: Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via NGT immediately followed by 60 mL of infant formula via NGT
Interventions: intervention 1: Apixaban
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00554463
Conditions: Lung Cancer
Keywords: limited stage small cell lung cancer
Sponsor: Radiation Therapy Oncology Group
Start date: 2008-01-01; Completion date: 2011-08-03
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Colony-stimulating factors, such as G-CSF or pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy and radiation therapy.

PURPOSE: This phase II trial is studying G-CSF and pegfilgrastim to see how well they work in treating neutropenia in patients undergoing combination chemotherapy and radiation therapy for limited stage small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* To evaluate the safety and efficacy of filgrastim (G-CSF) in reducing grade 4 neutropenia or grades 3-4 febrile neutropenia in patients with limited stage small cell lung cancer treated with radiotherapy and concurrent chemotherapy comprising cisplatin and etoposide.

Secondary

* To evaluate the safety and efficacy of pegfilgrastim in reducing grade 4 neutropenia or grades 3-4 febrile neutropenia in patients treated with adjuvant chemotherapy comprising cisplatin and etoposide.
* To estimate the incidence of dose modifications or treatment delays in patients treated with this regimen.
* To estimate the incidence of esophagitis, pneumonitis, and other non-hematological adverse events in patients treated with this regimen.
* To estimate the incidence of grade 4 thrombocytopenia in patients treated with this regimen.
* To estimate the median and two-year rate of progression-free and overall survival of patients treated with this regimen.

After completion of study therapy, patients are followed every 3 months for one year, every 6 months for 2-3 years, and then annually for up to 5 years.

Arms: arm 1: Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
Interventions: intervention 1: Filgrastim intervention 2: Pegfilgrastim intervention 3: Etoposide intervention 4: Cisplatin intervention 5: radiation therapy
Intervention descriptions: intervention 1: 5 mcg/kg/day IV (intravenous) days 4-13 and days 25-34 for a total of 20 doses. intervention 2: 6 mg via subcutaneous injection days 46 and 67 intervention 3: Concurrent: 120 mg/m\^2, IV on days 1-3 and days 22-24. Adjuvant: 120 mg/m\^2, IV on days 43-45 and days 65-66. intervention 4: Concurrent: 60 mg/m\^2, IV on days 1 and 22. Adjuvant: 60 mg/m\^2, IV on days 43 and 64. intervention 5: A total of 61.2 Gy in 5 weeks: Once-daily 1.8 Gy fractions for 15 fractions over 3 weeks beginning on day 1 of chemotherapy, then twice-daily 1.8 Gy fractions for 10 fractions over 2 weeks.

Protocol documents: