ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01136746
Conditions: Hyperglycemia
Keywords: Hyperglycemia Diabetes Hospital Diabetic
Sponsor: Eli Lilly and Company
Start date: 2011-03-01; Completion date: 2011-11-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the use of insulin glargine plus insulin lispro to human regular insulin for treatment of hyperglycemia in the hospital setting in patients without known prior history of diabetes.

Detailed description:
This study involves a comparison of 2 methods for administering subcutaneous insulin therapy to non-critically ill adult patients with hyperglycemia and without known history of diabetes who are admitted to non-intensive care unit (ICU) general medical hospital services. Basal-bolus therapy, considered the gold standard for glucose control in patients with known diabetes, will be compared with sliding scale insulin, a commonly used method of glucose control (prevailing standard practice) in hospitalized patients. In this study, basal-bolus therapy will consist of once-daily glargine plus lispro 3 to 4 times daily adjusted to achieve pre-meal capillary plasma glucose \<140 milligrams per deciliter (mg/dL) and bedtime capillary plasma glucose \<180 mg/dL for patients who are eating \[predose plasma glucose \<140 mg/dL for patients with nil per os (NPO) orders\]; sliding scale insulin will be administered using human regular insulin 4 times daily as needed adjusted to achieve predose capillary plasma glucose target \<140 mg/dL in patients who are eating or have NPO orders.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Human regular insulin intervention 2: Insulin lispro intervention 3: Insulin glargine
Intervention descriptions: intervention 1: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization) intervention 2: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization) intervention 3: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)

Protocol documents:
Clinical trial NCT01138501
Conditions: Congenital Bleeding Disorder Haemophilia A
Sponsor: Novo Nordisk A/S
Start date: 2010-06-01; Completion date: 2011-11-01
Enrollment: 65 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This trial is conducted in Asia, Europe, and North and South America. The aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: turoctocog alfa intervention 2: turoctocog alfa
Intervention descriptions: intervention 1: Subjects will be treated 3 times per week or every second day with intravenous injections of turoctocog alfa. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen. intervention 2: Subjects will undergo half-life evaluation of their current factor VIII product and pharmacokinetic session with turoctocog alfa before entering preventive treatment (subjects with available evaluation of terminal half-life within the last year are to be excluded from receiving factor VIII). Intravenous injections. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen.

Protocol documents:
Clinical trial NCT01139294
Conditions: Dehydration Cardiac Output Pediatrics
Keywords: cardiac output dehydration pediatrics
Sponsor: Vanderbilt University Medical Center
Start date: 2010-02-01; Completion date: 2011-11-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to non-invasively study the reflective changes in cardiac output as response to fluid therapy in the pediatric moderate hypovolemia/dehydrated pediatric patients using sub-q rehydration using Hylenex augmented subcutaneous infusion of fluids and electrolytes compared to intravenous methods.

Detailed description:
This is an open-labeled, single-center Phase IV clinical trial. The study will consist of patients with moderate hypovolemia/dehydration requiring parenteral rehydration. It is expected that this study will describe the onset or change in cardiac output using Hylenex augmented subcutaneous rehydration from ages 2 months up to 3 years and at a flow rate satisfying clinical needs, especially in reference to changes in cardiac output observed in standard intravenous rehydration.

Arms: arm 1: control arm of the study arm 2: 1ml subcutaneous with initiation of intravenous fluids then every 24 hours with a maximum dose of 3 injections in 72 hours
Interventions: intervention 1: Hylenex
Intervention descriptions: intervention 1: 1ml subcutaneous with initiation of intravenous fluids then every 24 hrs with a maximum dose of 3 injections in 72 hours

Protocol documents:
Clinical trial NCT01143090
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: Schizophrenia Lurasidone Latuda
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2010-08-01; Completion date: 2011-11-01
Enrollment: 149 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The purpose of this study is to characterize the long-term safety and tolerability of lurasidone in subjects with schizophrenia or schizoaffective disorder and to allow for continued treatment for subjects completing the core study (D1050289-NCT01143077).

Detailed description:

Arms: arm 1: Subjects will continue on treatment with the same dose of lurasidone flexible dosing - 40 mg to 12 mg once daily taken orallay at endpoint of the D1050289 ( NCT01143077) core study.
Interventions: intervention 1: Lurasidone HCl
Intervention descriptions: intervention 1: 40 mg Lurasidone tablets, 40 - 120 mg per day for up to 6 months

Protocol documents:
Clinical trial NCT01154933
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes obesity
Sponsor: University at Buffalo
Start date: 2008-04-01; Completion date: 2011-11-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Exenatide has been shown to result in better glycemic control in type II diabetes patients. Obesity and diabetes are states of increased inflammation; exenatide is expected to lead to decreased inflammation by virtue of better glycemic control and weight loss.

The purpose of this study is to determine if the addition of Exenatide to diabetic patients will reduce the requirements of insulin particularly the short acting insulin. Exenatide may also lead to decreased inflammation by virtue of better glycemic control and weight loss, or an independent effect.

Detailed description:

Arms: arm 1: exenatide 5 mcg arm 2: exenatide 10 mcg arm 3: placebo
Interventions: intervention 1: exenatide 5 mcg intervention 2: exenatide 10 mcg intervention 3: placebo
Intervention descriptions: intervention 1: exenatide 5 mcg intervention 2: exenatide 10 mcg intervention 3: saline sq

Protocol documents:
Clinical trial NCT01157078
Conditions: Major Depressive Disorder Depression
Keywords: Major Depressive Disorder MDD Depression Safety add-on therapy
Sponsor: AstraZeneca
Start date: 2010-06-01; Completion date: 2011-11-01
Enrollment: 319 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

Detailed description:
A multicenter, randomized, double-blind, parallel group, placebo-controlled, phase III efficacy and safety study of TC-5214 (S-mecamylamine) in flexible doses as an adjunct to an antidepressant in patients with major depressive disorder with an inadequate response to antidepressant therapy.

Arms: arm 1: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID arm 2: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
Interventions: intervention 1: TC-5214 intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet, oral, twice daily for 8 weeks intervention 2: Tablet, oral, twice daily for 8 weeks

Protocol documents:
Clinical trial NCT01160289
Conditions: Erectile Dysfunction
Sponsor: Eli Lilly and Company
Start date: 2010-10-01; Completion date: 2011-11-01
Enrollment: 410 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of the study is to compare the efficacy of LY2452473 + tadalafil to tadalafil alone in improving the erectile function (EF) of men with erectile dysfunction (ED) who incompletely respond to tadalafil alone.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: LY2452473 intervention 2: tadalafil intervention 3: placebo (tadalafil) intervention 4: placebo (LY2452473)
Intervention descriptions: intervention 1: Administered orally, once daily for 12 weeks intervention 2: Administered orally, once daily for 12 weeks intervention 3: Administered orally, once daily for 12 weeks intervention 4: Administered orally, once daily for 12 weeks

Protocol documents:
Clinical trial NCT01165554
Conditions: Brain Fibrillarab Levels
Keywords: Amyloid PET-Positron Emission Tomography SUVR-Standard uptake value ratios
Sponsor: GE Healthcare
Start date: 2010-05-01; Completion date: 2011-11-01
Enrollment: 203 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the level of association between quantitative regional estimates of brain uptake of \[18F\]flutemetamol and quantitative immunohistochemical regional estimates of brain levels of amyloid estimated from post-mortem analysis of corresponding brain tissue samples.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: [18F] Flutemetamol
Intervention descriptions: intervention 1: Flutemetamol (18F) Injection, 111 to 370 MBq (3 to 10 mCi), single intravenous injection.

Protocol documents:
Clinical trial NCT01176058
Conditions: Candidemia
Keywords: Phase 3b Efficacy and Safety evaluation of Anidulafungin ICC
Sponsor: Pfizer
Start date: 2010-12-01; Completion date: 2011-11-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In the treatment of patients with candidemia and/or other forms of invasive candidiasis , Anidulafungin is at least as effective and safe as Fluconazole.

Detailed description:
To support anidulafungin NDA in China Due to the challenges in subject recruitment resulting in protracted study course, Pfizer Inc. has decided to terminate trial A8851023 prematurely based on the recommendation by the senior management team on November 8, 2011. The decision to terminate the trial was not based on any safety concerns. All investigators were verbally informed by the study team since November 8, 2011 to stop the subject recruitment as soon as possible. All 17 enrolled subjects have been followed up on safety issues and no safety concerns were present by the data of these subjects.

Arms: arm 1: None
Interventions: intervention 1: Anidulafungin/Fluconazole
Intervention descriptions: intervention 1: Anidulafungin:IV,100 mg daily preceded by an initial 200 mg dose on Day 1, 14 - 42 days Fluconazole: IV/Oral, 400mg,QD,14 - 42 days

Protocol documents:
Clinical trial NCT01194427
Conditions: Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Cancer Invasive Breast Cancer
Keywords: Preoperative Neoadjuvant
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2011-03-01; Completion date: 2011-11-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is designed to look at the effects of the combination of vorinostat (Suberoylanilide Hydroxamic Acid or Zolinza) and tamoxifen on breast cancer tissue. The investigators will do this by comparing tissues from the original breast biopsy to tissues obtained after taking vorinostat and tamoxifen for 2 weeks.

Detailed description:
Key eligibility criteria include:

* Newly diagnosed invasive breast cancer awaiting surgery or neoadjuvant (preoperative) treatment
* No use of hormone contraceptives or replacement therapy within 30 days prior to the diagnostic breast cancer biopsy (unless willing to have an additional biopsy prior to starting the study)
* No prior or current use of any therapy to treat the current breast cancer.

Arms: arm 1: Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
Interventions: intervention 1: Vorinostat and Tamoxifen
Intervention descriptions: intervention 1: vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily for 14 days

Protocol documents:
Clinical trial NCT01203878
Conditions: Actinic Keratosis
Keywords: Imiquimod Photodynamic therapy Actinic keratoses Sequential therapy Therapeutic uses
Sponsor: Tennessee Clinical Research Center
Start date: 2010-09-01; Completion date: 2011-11-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to explore the effect of treating actinic keratoses of the face with imiquimod 3.75% cream followed by photodynamic therapy in comparison to treatment with imiquimod alone

Detailed description:
Actinic keratoses are common skin lesions associated with solar ultraviolet radiation exposure. Some actinic keratoses may develop into skin cancers.

Imiquimod 3.75% cream is an approved treatment for actinic keratoses that utilizes a regimen of application to the entire face or balding scalp of up to 2 packets of cream daily for two 2-week cycles, separated by a 2-week no treatment interval.

Photodynamic therapy with aminolevulinic acid (ALA) 20% topical solution is also an approved treatment for actinic keratoses. ALA is applied to actinic keratoses, and after an incubation period, is excited with light. Although approved as a lesion-directed treatment for actinic keratoses, treatment of a field (e.g. face) with photodynamic therapy is commonly performed.

Treatment with photodynamic therapy followed by imiquimod 5% cream has been reported in patients with actinic keratoses, basal cell carcinoma and Bowen's disease, and treatment with imiquimod 5% cream followed by photodynamic therapy in patients with vulvar intraepithelial neoplasia. There are, however, no prior studies on the safety and/or efficacy of using topical imiquimod 3.75% in conjunction with photodynamic therapy in the treatment of actinic keratoses.

This study will use an open-label parallel cohort design in which all patients will received treatment with imiquimod 3.75% cream, and subsequently will be randomized to either photodynamic therapy or observation.

Arms: arm 1: Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light arm 2: Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
Interventions: intervention 1: Photodynamic therapy intervention 2: Imiquimod
Intervention descriptions: intervention 1: Administered 4 weeks after completion of imiquimod therapy intervention 2: Imiquimod 3.75% cream, up to 2 packets, applied topically daily for two 2-week cycles separated by a no-treatment interval of 2-weeks, followed observation

Protocol documents:
Clinical trial NCT01211873
Conditions: Diagnostic Self Evaluation Central Nervous System Diseases
Keywords: CNS Contrast Agent MRI Dotarem Magnevist
Sponsor: Guerbet
Start date: 2010-09-01; Completion date: 2011-11-01
Enrollment: 416 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.

Detailed description:
This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Dotarem®. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Dotarem® when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Dotarem®.

Arms: arm 1: Dotarem and Magnevist were randomised as 2:1 ratio for adult patients. arm 2: Dotarem and Magnevist were randomised as 2:1 ratio arm 3: Pediatric patients were assigned to Dotarem group only.
Interventions: intervention 1: Dotarem (gadoterate meglumine) intervention 2: Magnevist (gadopentetate dimeglumine)
Intervention descriptions: intervention 1: 0.1 mmol/kg by body weight, single IV injection intervention 2: 0.1 mmol/kg by body weight, single IV injection

Protocol documents:
Clinical trial NCT01212445
Conditions: Constipation
Sponsor: Bayer
Start date: 2010-10-01; Completion date: 2011-11-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to evaluate the proportion of subjects with a bowel movement (BM) without straining or without hard and/or lumpy stool within the first 24 h of treatment for subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus Electrolytes (PEG+E) (13.125 g, 26.25 g, 39.375 g). The doses specified relate to the doses of PEG. Secondary objectives were measured by analysis of a subject diary and self-reported BM data. The secondary objectives included comparisons of PEG+E doses at 24 h for: BM control; relief of gas; relief of bloating; and relief of abdominal discomfort/cramping.

In addition, the proportion of subjects with a BM (without straining and without hard and/or lumpy stool) within the first 24 h of treatment for subjects taking different doses of PEG+E was evaluated for the time to first BM.

Detailed description:

Arms: arm 1: Single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time arm 2: Two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time arm 3: Three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time
Interventions: intervention 1: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)
Intervention descriptions: intervention 1: 13.125 g of PEG 3350 powder with approximately 0.6 g of electrolytes

Protocol documents:
Clinical trial NCT01219855
Conditions: Chronic Kidney Disease Secondary Hyperparathyroidism Vitamin D Insufficiency
Keywords: Parathyroid Diseases Renal Insufficiency Kidney Failure, Chronic Hyperparathyroidism, Secondary Vitamin D Hyperparathyroidism Kidney Diseases Kidney Failure Renal Insufficiency, Chronic
Sponsor: OPKO Health, Inc.
Start date: 2010-10-01; Completion date: 2011-11-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency and secondary hyperparathyroidism (SHPT).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Cohort 1 CTAP101 Capsules- 60µg intervention 2: Cohort 1 CTAP101 Capsules - 90µg intervention 3: Cohort 1 Matching Sugar Capsule intervention 4: Cohort 2 CTAP101 Capsules - 30µg intervention 5: Cohort 2 Matching Sugar Capsule
Intervention descriptions: intervention 1: 60µg of CTAP101 capsules given once daily for 42 days. intervention 2: 90µg of CTAP101 capsules given once daily for 42 days. intervention 3: Placebo capsules given once daily for 42 days. intervention 4: 30µg of CTAP101 capsules given once daily for 42 days. intervention 5: Placebo capsules given once daily for 42 days.

Protocol documents:
Clinical trial NCT01222533
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2010-10-01; Completion date: 2011-11-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is compare the effect of different doses of tiotropium delivered by the HandiHaler and Respimat device on lung function. Additionally, the study will investigate the pharmacokinetic profile of these different doses. Studying the pharmacokinetic profile shows what happens to the medication in the body over a period of hours and provides information on potential effects of the medication.

Detailed description:

Arms: arm 1: Tiotropium inhalation solution low dose arm 2: Tiotropium inhalation solution medium dose arm 3: Tiotropium inhalation solution high dose arm 4: Tiotropium inhalation powder 18mcg arm 5: Placebo inhalation solution
Interventions: intervention 1: Tiotropium medium intervention 2: Tiotropium low intervention 3: Tiotropium high intervention 4: Tiotropium 18mcg intervention 5: Tiotropium placebo
Intervention descriptions: intervention 1: Tiotropium inhalation solution medium dose intervention 2: Tiotropium inhalation solution low dose intervention 3: Tiotropium inhalation solution high dose intervention 4: Tiotropium inhalation powder 18mcg intervention 5: Placebo inhalation solution

Protocol documents:
Clinical trial NCT01222585
Conditions: Serious Systemic Infections Necrotizing Enterocolitis
Keywords: Metronidazole Neonate Premature Sepsis Necrotizing enterocolitis
Sponsor: Michael Cohen-Wolkowiez
Start date: 2011-01-01; Completion date: 2011-11-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Yearly in the United States over 500,000 newborns are delivered prematurely. This population is at high risk of catastrophic bowel disease known as necrotizing enterocolitis. Infants with necrotizing enterocolitis are at high risk of death, and survivors are at increased risk of mental retardation. Metronidazole is an antibiotic that is often administered to infants with suspected or confirmed necrotizing enterocolitis. Unfortunately, the appropriate dose of metronidazole in premature infants has not been established and it is likely to be different from older children and adults.

The investigators will investigate the appropriate metronidazole dose in very premature infants by: 1) determining how premature infants eliminate metronidazole from the body and 2) determining the safest and most effective dose of metronidazole in premature infants.

The investigators hypothesis are: 1) The rate of removal of metronidazole will increase with infant maturity and 2) an appropriate metronidazole dosing regimen will result in necessary drug levels to treat bacteria involved in necrotizing enterocolitis.

Detailed description:

Arms: arm 1: Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
Interventions: intervention 1: Metronidazole
Intervention descriptions: intervention 1: Metronidazole will be administered intravenously to premature infants as a 15 mg/kg loading dose followed by maintenance doses of 7.5 mg/kg every 12 hours for infants with \>=14 postnatal days and every 24 hours for infants \<14 postnatal days.

Protocol documents: