ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00777764
Conditions: Healthy Asthma
Keywords: Xolair Asthma Skin Tests
Sponsor: Genentech, Inc.
Start date: 2008-08-01; Completion date: 2009-04-01
Enrollment: 60 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study enrolled 30 healthy volunteers and 30 patients with atopic asthma, for a total of 60 subjects. The study examined the tolerability of omalizumab and omalizumab excipients in two successive cohorts of subjects, healthy volunteers and patients with allergic asthma without prior exposure to omalizumab, according to a skin test protocol, consisting of a prick skin test and/or intradermal test.

Detailed description:

Arms: arm 1: Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. arm 2: Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients.
Interventions: intervention 1: Cohort I intervention 2: Cohort 2
Intervention descriptions: intervention 1: In sterile water for injection (SWFI), full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:1000, 1:100 and 1:10 were followed by 20 minutes of observation. For the skin prick test, participants were tested initially with positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration.

For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration.

Dilutions of omalizumab and its excipients were in SWFI. intervention 2: In a saline solution, full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:100,000 and 1:10,000 were followed by 20 minutes of observation.

For the skin prick test, participants were tested initially by positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration.

Dilutions of omalizumab and its excipients were made in saline.

Protocol documents:
Clinical trial NCT00789360
Conditions: Healthy
Keywords: Healthy volunteers
Sponsor: Alexza Pharmaceuticals, Inc.
Start date: 2008-11-01; Completion date: 2009-04-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.

Detailed description:
The planned study is a multiple dose, double-blind, placebo-controlled, randomized, 2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers.

Arms: arm 1: Inhaled Staccato Placebo, 2 inhalations, 8 hours apart; washout of at least 4 days; Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart arm 2: Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart; washout of at least 4 days; Inhaled Staccato Placebo, 2 inhalations, 8 hours apart;
Interventions: intervention 1: Inhaled Placebo intervention 2: Inhaled Loxapine
Intervention descriptions: intervention 1: Inhaled Staccato Placebo, 2 inhalations, 8 hours apart intervention 2: Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart

Protocol documents:
Clinical trial NCT00793520
Conditions: Fibromyalgia
Keywords: fibromyalgia milnacipran Forest Laboratories
Sponsor: Forest Laboratories
Start date: 2008-11-01; Completion date: 2009-04-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the effect of milnacipran on how the brain processes pain in patients with fibromyalgia and to assess the relationship between this effect and brain activation patterns during functional magnetic resonance imaging.

Detailed description:

Arms: arm 1: Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks. arm 2: Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
Interventions: intervention 1: Milnacipran intervention 2: Placebo intervention 3: Placebo intervention 4: Milnacipran
Intervention descriptions: intervention 1: Twice daily oral administration of Milnacipran for 5 weeks. intervention 2: Twice daily oral administration of placebo for 5 weeks. intervention 3: Twice daily oral administration of placebo for 5 weeks. intervention 4: Twice daily oral administration of Milnacipran for 5 weeks.

Protocol documents:
Clinical trial NCT00824720
Conditions: Glaucoma, Open-Angle Ocular Hypertension
Sponsor: Vistakon Pharmaceuticals
Start date: 2008-12-01; Completion date: 2009-04-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension.

Detailed description:

Arms: arm 1: device worn continuously for 14 days arm 2: device worn continuously for 14 days arm 3: device worn continuously for 14 days
Interventions: intervention 1: High Dose Device intervention 2: Low Dose Device intervention 3: Placebo Device
Intervention descriptions: intervention 1: inserted for 14 days intervention 2: inserted for 14 days intervention 3: inserted for 14 days

Protocol documents:
Clinical trial NCT00857948
Conditions: Pediculus Humanus Capitis (Head Lice)
Keywords: head lice Pediculus humanus capitis ivermectin
Sponsor: Topaz Pharmaceuticals Inc
Start date: 2009-03-01; Completion date: 2009-04-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2 single center study designed to compare the safety, local tolerability, and efficacy of 3 strengths of ivermectin treatment conditioner to placebo.

Detailed description:

Arms: arm 1: Participant on 0.15% ivermectin treatment conditioner arm 2: Participants on 0.25% ivermectin treatment conditioner arm 3: Participants on 0.50% ivermectin treatment conditioner arm 4: participants on Placebo (Vehicle control)
Interventions: intervention 1: ivermectin treatment conditioner intervention 2: Placebo, vehicle control
Intervention descriptions: intervention 1: Application followed by thorough rinsing of the hair and scalp with water. intervention 2: Application followed by thorough rinsing of the hair and scalp with water.

Protocol documents:
Clinical trial NCT00862940
Conditions: Alzheimer's Disease
Keywords: Memantine Neuroimaging MRI Brain atrophy
Sponsor: H. Lundbeck A/S
Start date: 2005-09-01; Completion date: 2009-04-01
Enrollment: 277 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Previous studies have shown that memantine helps to treat the symptoms of Alzheimer's Disease (AD). In AD, the rate of brain tissue loss, or atrophy, is faster than in normal aging and this seems to go hand in hand with some of the symptoms of the disease. This suggests that memantine treatment in AD could provide both symptomatic improvement and neuro-protective effects. The purpose of this study was to show whether memantine, in addition to providing symptomatic benefits, can slow the rate of brain atrophy as assessed using magnetic resonance imaging (MRI) technology.

Detailed description:
The primary objective of this study was to evaluate the effects of memantine on the rate of brain atrophy compared to placebo in patients with AD (moderate severity) over a 1-year period. This was a multinational, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study (20 mg memantine). The study also included secondary imaging, cognitive and behavioural measures.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Memantine intervention 2: Placebo
Intervention descriptions: intervention 1: 10 mg tablets twice daily intervention 2: Tablets twice daily

Protocol documents:
Clinical trial NCT00864682
Conditions: Pain
Keywords: propofol lidocaine injection pain
Sponsor: Benaroya Research Institute
Start date: 2008-01-01; Completion date: 2009-04-01
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Injection of propofol is associated with discomfort in subsets of patients. Local anesthetics have been shown to attenuate this response in some patients. This randomized, double-blind, placebo-controlled trial tests the hypothesis that lidocaine mixed with propofol will be superior to lidocaine administered directly into the vein, under tourniquet control, prior to injection of propofol. Both groups are expected to be superior to placebo.

Detailed description:

Arms: arm 1: Saline pretreatment, saline admixture arm 2: Lidocaine pretreatment / saline-propofol admixture arm 3: saline pretreatment / Lidocaine-propofol admixture
Interventions: intervention 1: Saline intervention 2: Lidocaine / propofol admixture intervention 3: lidocaine pretreatment
Intervention descriptions: intervention 1: 3.3 mL normal saline intervention 2: lidocaine 50 mg plus propofol 50 mg intravenous (iv) intervention 3: lidocaine 50 mg iv under tourniquet-control

Protocol documents:
Clinical trial NCT00901628
Conditions: Osteoarthritis, Knee
Keywords: periarticular multimodal drug injection
Sponsor: Seoul National University Hospital
Start date: 2008-04-01; Completion date: 2009-04-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether periarticular multimodal drug injection (PMDI) would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, intra-venous patient controlled analgesia (IV-PCA)and preemptive oral medications. We hypothesized that PMDI would reduce pain level and consumption of PCA and acute pain rescuer and would provide better functional recovery and patient satisfaction. We also hypothesized that the incidence of side effects and complications of the PMDI would be similar to the No-PMDI.

Detailed description:
The preemptive multimodal approaches are regarded as a current standard pain management protocol. Recently, periarticular multimodal drug injection (PMDI) has been considered to be one of the most effective and important component in multimodal approaches. Because the contemporary pain management protocol using the regional anesthesia, continuous femoral nerve block (FNB) and intravenous patient-controlled analgesia (PCA) has been proved significantly improved analgesic effects itself, little information whether the PMDI would provide additional pain relief under this pain management protocol is available. Also, because the safety of the high dose local anesthetics and narcotics has not been clarified, a selective application should be considered to patients who were expected to show better analgesia if there were certain patient related factors to predict the additional pain relief effect of the PMDI. Thus, this prospective double-blind randomized study was conducted to determine whether PMDI would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, IV-PCA and preemptive oral medications in terms of pain relief, consumption of PCA and acute pain rescuer, patients satisfaction, functional recovery, side effects and complications.

Arms: arm 1: Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime arm 2: usual postoperative care without periarticular injection
Interventions: intervention 1: ropivacaine intervention 2: morphine sulfate intervention 3: ketorolac intervention 4: epinephrine intervention 5: cefuroxime
Intervention descriptions: intervention 1: 300mg (0.75%, 40cc) intraoperative periarticular injection intervention 2: 10mg intraoperative periarticular injection intervention 3: 30 mg intraoperative periarticular injection intervention 4: 300 microgram (1:1000) intraoperative periarticular injection intervention 5: 750mg intraoperative periarticular injection

Protocol documents:
Clinical trial NCT00907374
Conditions: Microalbuminuria
Keywords: Microalbuminuria Carotid intima media thickness Endothelial dysfunction Renin angiotensin system Diabetic nephropathy
Sponsor: Charles Drew University of Medicine and Science
Start date: 2005-07-01; Completion date: 2009-04-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to assess the effect of standard versus aggressive inhibition of the renin-angiotensin system (RAS)in type 2 diabetic patients with microalbuminuria (MA) on; a)progression of microalbuminuria, b)estimated glomerular filtration rate (eGFR), c)endothelial dysfunction (measured by post-hyperemia arterial tonometry) and d)the slowing of the progression of atherosclerotic disease (measured by carotid intima media thickness \[CIMT\]).

Detailed description:
Diabetic patients with confirmed MA (50-300 mg albumin per g creatinine) on a morning spot urine sample were entered into a one to three month run-in phase before randomization. (50 mg/g was used as the lower limit to allow room for improvement to reach normal.) Since hypertension and uncontrolled hyperglycemia will cause MA, blood pressure (BP) and hemoglobin A1c (AIC) levels were reduced to \<130/80 mm Hg and \<8.0%, respectively, during this period. All patients had been on various doses of an angiotensin converting enzyme inhibitor (ACE-I) which were reduced to 10 mg benazepril and BP controlled with other classes of anti-hypertensive drugs (except for angiotensin receptor blockers \[ARB's\]). Glycemia was treated with intensification of their current therapy. MA and BP were measured monthly.

When goal levels of BP and AIC were achieved and MA was still present, patients were randomized to either low dose RAS inhibition (10 mg benazepril) (Standard) or aggressive inhibition of the RAS (Aggressive). MA continued to be measured monthly and the progressive increase in doses of an ACE-I and an ARB was as follows. Benazepril (the ACE-I) - 10 mg to 20 mg to 40 mg to adding losartan (the ARB) -25 mg to 50 mg to 100 mg to increasing benazepril to 80 mg with the goal of returning albumin excretion to normal. Other classes of drugs were reduced as necessary to keep systolic BP \> 100 mm Hg. Serum creatinine and potassium\[K+\] were measured monthly, AIC levels every 3 months and CIMT by ultrasound and endothelial function by post hyperemia and nitroglycerine (NTG) - induced peripheral artery tonometry (PAT) via finger plethysmography every six months.

Arms: arm 1: Standard low dose inhibition of the RAS with 10 mg of benazepril orally daily to treat microalbuminuria arm 2: 40-80 mg benazepril plus 25-100 mg losartan both orally once or twice daily
Interventions: intervention 1: benazepril intervention 2: benazepril
Intervention descriptions: intervention 1: benazepril 10 mg orally once daily intervention 2: 40-80 mg benazepril plus 25-100 mg losartan orally once or twice daily

Protocol documents:
Clinical trial NCT01084707
Conditions: Tobacco Dependence
Keywords: Smoking Cessation, Nicotine pharmacokinetics
Sponsor: McNeil AB
Start date: 2009-01-01; Completion date: 2009-04-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.

Detailed description:
This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Arms: arm 1: 2 Self-administrations of Experimental Nicotine once every hour arm 2: 2 administrations of Experimental Nicotine by study personnel once every hour arm 3: 2 administrations of Experimental Nicotine by study personnel once every 30 minutes arm 4: 1 NiQuitin™ lozenge, administered by study personnel once every hour arm 5: 1 piece Nicorette® gum, chewed for 30 minutes once every hour
Interventions: intervention 1: Oral Nicotine intervention 2: Nicotine Lozenge intervention 3: Nicotine gum
Intervention descriptions: intervention 1: Oral Nicotine either self-administered or provided by study personnel within 12 hours intervention 2: Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours intervention 3: Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours

Protocol documents:
Clinical trial NCT01187550
Conditions: Dwarfism, Pituitary
Keywords: Dwarfism, pituitary Growth hormone
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2007-03-01; Completion date: 2009-04-01
Enrollment: 214 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, prospective, multicentric, non-comparative, non-randomized Phase IV interventional study in which subjects pre-diagnosed with Growth Hormone Deficiency (GHD) were treated for 4 weeks with Saizen to compare the response between GHD children born appropriate for gestational age (AGA) and those born small for gestation age (SGA) after 4 weeks of Saizen therapy.

Detailed description:
The response to growth hormone (GH) treatment, short-term as well as long-term, displays considerable inter individual variability. This is particularly evident for the endpoint of paediatric GH administration, that is (i.e.) the growth response, which is pronounced in children who are affected by GHD. This is an open-label, multicentric study in which subjects pre-diagnosed with GHD were treated for 4 weeks with Saizen. Two hundred fourteen GHD evaluable pre-pubertal subjects were planned to be recruited in approximately 9 sites in China. Demographic data, medical history, tanner stage, physical examination, body weight, height, bone age measurement, body mass index, review of baseline medications and procedures and blood sampling were performed at baseline visit, end of treatment visit (week 4) and at 4 week follow-up visit.

OBJECTIVES

Primary objective:

* To compare the response between GHD children born AGA and those born SGA after 4 weeks of Saizen therapy

Secondary Objectives:

* To explore the contribution of selected genes to the phenotype of GHD children
* To explore the impact of gene polymorphisms on the levels of specific serum biomarkers in GHD children after 4 weeks of Saizen therapy
* To explore the relationships between changes in gene expression and changes in serum biomarkers after 4 weeks of Saizen therapy and the spectrum of gene polymorphisms in GHD children

Interventions: intervention 1: Recombinant human growth hormone (r-hGH)
Intervention descriptions: intervention 1: Recombinant human growth hormone (r-hGH) administered at dose of 0.033 milligram/kilogram (mg/kg) body weight (0.1 International Unit \[IU\]/kg body weight) per day by subcutaneous injection.

Protocol documents:
Clinical trial NCT01213329
Conditions: Kidney Transplant
Sponsor: Northwestern University
Start date: 2006-02-01; Completion date: 2009-04-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to check the T and B cells of the immune system in 50 newly transplanted patients whom have received a kidney (50 recipients and 50 donors totaling 100 anticipated participants). This will be done to see how the Standard of Care (SOC) anti-rejection medication, Alemtuzumab (Campath 1-H®) affects these cells- Campath 1-H® reduces the number of T cells produced by one's body.

Detailed description:
The purpose of this study is to check the T and B cells of the immune system in 50 newly transplanted patients whom have received a kidney (50 recipients and 50 donors totaling 100 anticipated participants). This will be done to see how the Standard of Care (SOC) anti-rejection medication, Alemtuzumab (Campath 1-H®) affects these cells- Campath 1-H® reduces the number of T cells produced by one's body. We will look for these cells using a number of laboratory tests; It will require the subjects to each give 65mL of blood at each of the 3 visits that occur during phase 1. Up to 12 subjects will be chosen from phase 1 to participate in phase 2 depending on lab results.

In phase 2, subjects will be randomized to one of the three following groups:

Group one: Continue normal immunosuppression with tacrolimus and Cellcept® (control group)

Group two: Cellcept® will be tapered down to 70% in three months. Tacrolimus will be continued at the same dosage.

Group three: Tacrolimus will be reduced to 70% in three months. Cellcept® will be continued at the same dosage.

There will be an analysis of these cells at different time point, pre and post kidney transplant. The data collection will allow us to study the stability over time of particular phenotypes (cell structures) and T cell function. We will also evaluate how the two different "minimizing protocols" effect the cell structure. Results from laboratory testing may allow us to define certain criteria that can be broadly applied in solid organ transplant recipients. This may allow for safe reduction of the anti-rejection medication that transplant recipients receive.

Arms: arm 1: During Phase I Portion: Each kidney transplant recipient received one 30mg dose (IV push)of Alemtuzmab in the operating room per Standard of Care.
Interventions: intervention 1: Alemtuzumab
Intervention descriptions: intervention 1: All kidney transplant recipients received one 30mg dose (IV push) of Alemtuzumab in operating room per Standard of Care.

Protocol documents: