ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00712335
Conditions: Asthmatic Smokers Non-asthmatic Smokers
Keywords: asthmatics smokers inhaled corticosteroids leukotriene receptor antagonists
Sponsor: Inje University
Start date: 2007-02-01; Completion date: 2011-05-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is:

1. To compare neutrophilia, eosinophilic inflammatory markers and asthma symptom indices between smokers and non-smokers.
2. To elucidate the mechanism by which cigarette smokers are resistant to corticosteroids.

Detailed description:
Many smokers have insufficient control of their symptoms due to inefficacy of ICS in this subpopulation of asthmatics. Cigarette smoking has been shown to stimulate production of cysLTs. CysLTs could activate production of IL-8 for neutrophilia as well as cause eosinophilia in the airway of asthmatics.

LTRAs are felt to be less efficacious than ICS in smokers with asthma. However, LTRA's unique mechanism of action could be particularly efficacious in preventing worsening symptoms and lung function for smokers with asthma. Given this, along with the fact that ICS are less effective in smokers, targeting cysLT could lead to significant clinical benefits for asthmatic smokers.

Data from this study may possibly serve as crucial data for the significant clinical benefits for asthmatic smokers and determination of the mechanism of corticosteroid resistance in smokers with asthma.

Arms: arm 1: Asthmatic smokers treated with combination therapy:

Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months arm 2: Asthmatic smoker treated with Montelukast only:

Montelukast dosage: PO 10 mg QHS for 3 months arm 3: Non-smoking asthmatics treated with combination therapy:

Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months arm 4: Non-smoking asthmatic treated with Montelukast only:

Montelukast dosage: PO 10 mg QHS for 3 months arm 5: Normal controls
Interventions: intervention 1: Fluticasone Propionate intervention 2: Montelukast intervention 3: Salmeterol
Intervention descriptions: intervention 1: DPI 250 mcg BID for 3 weeks intervention 2: PO 10 mg QHS for 3 weeks intervention 3: DPI 50mg BID for 3 weeks

Protocol documents:
Clinical trial NCT00716456
Conditions: Lung Adenocarcinoma
Keywords: MAB C225(CETUXIMAB)(ANTI-EGFR) OSI-774, TARCEVA (ERLOTINIB) Lung Adenocarcinoma Lung cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2008-07-01; Completion date: 2011-05-01
Enrollment: 21 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that initially became smaller after taking erlotinib and then started to get bigger despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug administration for treatment of head and neck and colon cancer. The goal of the phase I portion of this trial is to find out the highest dose of cetuximab that can be taken together with erlotinib. This study will also give an idea of how well cetuximab shrinks lung cancer when given with erlotinib.

The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that initially became smaller after taking erlotinib or gefitinib and then started to get bigger despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug administration for treatment of head and neck and colon cancer. The goal of this phase is to determine if cetuximab given with erlotinib causes lung cancers to shrink in size.

Detailed description:

Arms: arm 1: In the phase I portion, patients will be enrolled in cohorts of 3-6 patients;receiving daily erlotinib 100 mg along with cetuximab given every 2 weeks beginning at 250mg/m2 IV. Following the initial dose, for dose levels 1 and 2 (250 mg/m2 and 375 mg/m2) patients will receive treatment every 2 weeks with cetuximab over 60 minutes. For dose level 3 (500 mg/m2) patients will receive treatment every 2 weeks with cetuximab over 120 minutes. The infusion rate of cetuximab should never exceed 10 mg/minute (5 mL/min). The dose may subsequently be reduced for individual patients, depending on a patient's toxicity.
Interventions: intervention 1: erlotinib with cetuximab
Intervention descriptions: intervention 1: The phase I portion will accrue as many as 3 cohorts of 3-6 patients; receiving erlotinib 100 mg daily along with escalating doses of cetuximab administered every 2 weeks beginning at 250mg/m2 IV without a loading dose. Subsequent cetuximab dose levels will be 375 mg/m2, and 500 mg/m2, administered IV every 2 weeks. Patients will have baseline CT, labs and ECG done within 2 weeks of study entry. Three patients will be enrolled per dose level. Patients will be monitored for toxicity weekly for the first 5 weeks, and every 2 weeks thereafter. Patients will be monitored for response by CT in the fourth week of combined therapy and every 8 weeks. All patients in this portion of the trial will receive intravenous cetuximab every two weeks at the MTD (to be determined in phase I portion) and daily erlotinib on an outpatient basis and will obtain clinical re-evaluation and radiographic re-imaging on a schedule similar to that followed in the phase I portion

Protocol documents:
Clinical trial NCT00719706
Conditions: Bipolar Depression
Keywords: Bipolar disorder Bipolar depression Natural substances Depression
Sponsor: Mclean Hospital
Start date: 2008-08-01; Completion date: 2011-05-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this 15-week clinical trial is to test the hypothesis that treatment with two proven mitochondrial enhancers, acetyl-L-carnitine (ALCAR) and α-lipoic acid (ALA), has significantly greater efficacy than placebo as an augmentation treatment in bipolar depressed patients who display an incomplete response to conventional treatments.

Detailed description:
The primary objective of this proposed clinical trial is to test the hypothesis that treatment with two proven mitochondrial enhancers, acetyl-L-carnitine (ALCAR) and α-lipoic acid (ALA), has significantly greater efficacy than placebo as an augmentation treatment in bipolar depressed patients who display an incomplete response to conventional treatments. We propose to test this hypothesis by performing a 15-week placebo-controlled, double-blind, parallel group, flexible-dose study investigating the use of ALCAR and ALA as an augmentation to treatment as usual in depressed bipolar patients. We will compare the efficacy of acetyl-l-carnitine (ALCAR) at doses of 1000-3000mg/day and alpha-lipoic acid (ALA) at doses of 600-1800mg/day with placebo on symptom improvement in individuals diagnosed with bipolar disorder type I, current episode depressed. Improvement will be assessed using the 21-Item Hamilton Depression Rating Scale (HAM-D), the Montgomery Asberg Depression Rating Scale (MADRS), the Young Mania Rating Scale (YMRS), and the Clinical Global Impression-Severity and Improvement Scales (CGI-S and CGI-I).

Furthermore, we hypothesize that improvement in depression symptoms following treatment with ALCAR and ALA will be associated with increases in phosphocreatine (PCr), beta-nucleoside triphosphate (β-NTP), and intracellular pH in the anterior cingulate cortex (ACC) both at week 1 and week 12 of treatment.

Arms: arm 1: 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid arm 2: None
Interventions: intervention 1: acetyl-l-carnitine PLUS alpha-lipoic acide intervention 2: Placebo
Intervention descriptions: intervention 1: 1000-3000 mg/day of acetyl-l-carnitine in addition to 600-1800 mg/day of alpha-lipoic acid. intervention 2: Placebo

Protocol documents:
Clinical trial NCT00728182
Conditions: Stroke
Keywords: Stroke Vascular cognitive impairment Coiling Endovascular repair Brain aneurysm NA-1
Sponsor: NoNO Inc.
Start date: 2008-08-01; Completion date: 2011-05-01
Enrollment: 185 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled, single-dose, design investigating the safety, tolerability and efficacy of NA-1, a peptide designed to reduce ischemic brain damage. Up to 200 male and female patients undergoing endovascular repair of brain aneurysm will be dosed with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after completion of the endovascular procedure on Day 1 of the study period. Subjects will undergo interim procedures Days 2-4 and end-of study procedures on Day 30. Standard safety criteria will be analysed. Efficacy endpoints include the ability of NA-1 to: 1) reduce the volume of ischemic embolic strokes, 2) reduce the number of ischemic embolic strokes, 3) reduce vascular cognitive impairment, and 4) reduce the frequency of large strokes induced by the endovascular procedure. The plasma concentrations of NA-1 will also be analyzed.

Detailed description:

Arms: arm 1: 20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier. arm 2: None
Interventions: intervention 1: NA-1 intervention 2: Placebo
Intervention descriptions: intervention 1: single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion intervention 2: single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Protocol documents:
Clinical trial NCT00741026
Conditions: Insulin Resistance Diabetes Mellitus
Keywords: Insulin Resistance Diabetes mellitus Antipsychotic
Sponsor: Milton S. Hershey Medical Center
Start date: 2008-08-01; Completion date: 2011-05-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this clinical research study is to examine the acute hormonal and metabolic effects of the drug olanzapine, as well as appetite effects, in healthy volunteers. The hypotheses to be tested are that: (1) Olanzapine rapidly attenuates plasma leptin and (2) rapidly alters glucose tolerance in healthy volunteers. These questions will be answered by having volunteers undergo two glucose tolerance tests in a crossover study design.

Detailed description:

Arms: arm 1: Placebo arm 2: Olanzapine 10mg po daily x 3 days
Interventions: intervention 1: Olanzapine 10 mg po qhs for 3 days intervention 2: Placebo
Intervention descriptions: intervention 1: (1) 10 mg tablets administered orally before bed for three consecutive evenings (Total Dose = 30 mg, 3 tablets) intervention 2: (1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)

Protocol documents:
Clinical trial NCT00747006
Conditions: Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1
Sponsor: Mannkind Corporation
Start date: 2008-09-01; Completion date: 2011-05-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if, once a favorable dose of TI Inhalation Powder is established for either a type 1 or 2 patient, based on a average diabetic meal, the patient's favorable dose can be used safely, regardless of change in meal carbohydrate content. Patients were randomly assigned to various carbohydrate loads (0%, 50%, 100%, 150% or 200%). The 100% carbohydrate load was determined based upon their standard insulin dose for their normal meal.

Detailed description:

Arms: arm 1: Under the original protocol, subjects with Type 1 and Type 2 diabetes will have TI Inhalation Powder administered prandially during dose optimization visits and meal challenge visits (with meals of varying carbohydrate contents). Subjects with Type 2 diabetes will also use TI Inhalation Powder daily at each meal between visits. arm 2: Under Amendment 1, TI Inhalation Powder will be administered prandially to a new subset of subjects with Type 2 diabetes during TI dose optimization visits and TI meal challenge visits (with meals of varying carbohydrate contents). Subjects will be crossed over to administration of Humalog 15 minutes before meals during Humalog dose optimization visits and Humalog meal challenge visits (with meals of varying carbohydrate contents). Subjects will also use TI Inhalation Powder daily at each meal between visits.
Interventions: intervention 1: TI Inhalation Powder and Humalog (Amendment 1) intervention 2: TI Inhalation Powder (original protocol)
Intervention descriptions: intervention 1: Subcutaneous (sc) rapid acting analog to be administered at one half of the meal challenge visits 15 minutes before a meal. Only the last 5 - 10 patients (Type 2) will be undergoing this amendment to the protocol. intervention 2: Inhaled insulin technology to be administered immediately before a meal (prandially) for glucose control in Type 1 or Type 2 diabetics

Protocol documents:
Clinical trial NCT00753454
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Joint Disease Arthritis Certolizumab pegol Cimzia
Sponsor: UCB Pharma
Start date: 2008-09-01; Completion date: 2011-05-01
Enrollment: 168 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate (MTX).

Detailed description:
Patients having completed the week 34 assessment in the C87077 (NCT00580840) study or having met the pre-defined criteria for flare (defined as patients that have randomized at Week 18 and experienced at 2 consecutive visits between Week 18 and Week 34 inclusive an equal to Baseline (W0) or worst swollen and tender joints counts), will be given the option to enroll in C87084 and receive certolizumab pegol \[400 mg at Entry, Week 2, and Week 4 followed by 200 mg every two weeks (Q2W)\] in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region or until further notice from UCB.

All patients will continue their MTX treatment at the same stable dose as during the C87077 (NCT00580840) study, unless there is a need to reduce the dose for reasons for toxicity.

Arms: arm 1: Patients having completed the week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of RA in the patient's country or region (or until further notice from UCB).
Interventions: intervention 1: Certolizumab pegol
Intervention descriptions: intervention 1: Liquid certolizumab pegol administered every two weeks as a single injection (400 mg at Entry, Week 2 \& Week 4, followed by 200 mg every 2 weeks).

Protocol documents:
Clinical trial NCT00756886
Conditions: Arrhythmia
Sponsor: University of Alabama at Birmingham
Start date: 2008-09-01; Completion date: 2011-05-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if atorvastatin (Lipitor) reduces the occurence of abnormal heart rhythm (atrial arrhythmia) following non cardiac thoracic surgery.

Detailed description:
The incidence of atrial arrhythmia after thoracic, non-cardiac procedures is exceedingly common and has been reported to occur in between 10-39% of patients. It has been shown to increase majority morbidity and also delay hospital discharge. Recent studies suggest that one week of pre-operative atorvastatin may reduce the incidence of post-operative atrial arrhythmia in patients who undergo cardiac surgery and a multi-institutional study is currently underway to further examine this concept. However, there are no published prospective randomized studies to date that have evaluated the effectiveness of atorvastatin to reduce atrial arrhythmia in patients who undergo thoracic, non-cardiac operations such as esophagectomy or pulmonary resection. The object of this study is to determine if atorvastatin reduces the incidence of atrial arrhythmia (atrial fibrillation or flutter) following non-cardiac thoracic surgery, specifically pulmonary resections.

Arms: arm 1: 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery. arm 2: 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
Interventions: intervention 1: Atorvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: 40 mg QD 7 day continue after procedure for 14 days intervention 2: 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.

Protocol documents:
Clinical trial NCT00780481
Conditions: Obesity
Keywords: Obesity Endothelial Function Fibrinolytic Balance Baseline
Sponsor: Vanderbilt University
Start date: 2007-01-01; Completion date: 2011-05-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
T-PA release is impaired in obese subjects. In order to have a better mechanistic understanding of t-PA release, we will compare t-PA release to Flow Mediated Vasodilation, Radial Artery Tonometry, and other markers of endothelial function and oxidative stress.

Detailed description:

Arms: arm 1: Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.
Interventions: intervention 1: Bradykinin
Intervention descriptions: intervention 1: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose.

Protocol documents:
Clinical trial NCT00796744
Conditions: Foot Ulcer, Diabetic Diabetic Foot
Keywords: Diabetes mellitus Diabetic neuropathy Peripheral vascular disease Infection Topical application plantar foot ulcers
Sponsor: US Biotest, Inc.
Start date: 2008-10-01; Completion date: 2011-05-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess if the experimental drug, DSC127, is safe, how well it can be tolerated, and how different doses effect the healing of the chronic foot ulcers in diabetic subjects.

Detailed description:
This study is designed as a randomized, parallel-group, double-blind, placebo-controlled trial. After a 14-day baseline to evaluate ulcer healing to ensure DU are chronic, a 4-week active treatment followed by 8 weeks of observation and assessment of the treatment will compare the effects of two concentrations of DSC127 and placebo (n = 25 evaluable subjects per group; n=75 total evaluable subjects) to identify the optimal dose of DSC127. Sustained tissue integrity will be evaluated for all subjects during a follow-up period at study weeks 16 and 24.

Subjects will be randomized in a 1:1:1 ratio to one of the three treatment groups.

Group 1: Placebo Vehicle Control Group 2: 0.03% DSC127 in Vehicle Group 3: 0.01% DSC127 in Vehicle

The four week treatment period requires daily application of the treatment to the wound site. First application each week will be at the clinic and for the remainder of the week the patient self-administers the treatment.

If wound healing occurs during the treatment or assessment periods a final assessment visit is conducted and the integrity is assessed four and twelve weeks later (usually weeks 16 and 24 of the study).

Arms: arm 1: control placebo vehicle gel arm 2: 0.03 % DSC127 in Vehicle Control arm 3: 0.01% DSC127 in Vehicle Control
Interventions: intervention 1: NorLeu3-A(1-7) in a gel formulation
Intervention descriptions: intervention 1: Gel will be applied to the wound once daily for four weeks (treatment period). Gel will have either no active ingredient (placebo), 0.03% or 0.01% active ingredient.

Protocol documents:
Clinical trial NCT00806026
Conditions: Idiopathic Restless Legs Syndrome
Keywords: RLS
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-12-01; Completion date: 2011-05-01
Enrollment: 731 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: placebo and pregabalin intervention 2: pramipexol intervention 3: pramipexol intervention 4: Pregabalin intervention 5: pramipexol intervention 6: pramipexol
Intervention descriptions: intervention 1: following 3 months placebo treatment, subjects are to be re-distributed to pregabalin 300 mg per day for 9 months. Both placebo and pregabalin are to be administered orally once a day, 1-3 hours before bedtime. intervention 2: following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.25mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime. intervention 3: following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.5mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime. intervention 4: pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months intervention 5: pramipexol 0.25 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months intervention 6: pramipexol 0.5 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months

Protocol documents:
Clinical trial NCT00806546
Conditions: Migraine Disorders
Sponsor: NuPathe Inc.
Start date: 2009-02-01; Completion date: 2011-05-01
Enrollment: 514 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will use an open-label design to evaluate the safety of NP101. Adult subjects who meet the enrollment criteria will be treated with NP101 (sumatriptan succinate iontophoretic transdermal patch) for acute migraine attacks over a 12 month period.

Detailed description:

Arms: arm 1: sumatriptan iontophoretic transdermal patch
Interventions: intervention 1: NP101
Intervention descriptions: intervention 1: NP101 study patch four hour application

Protocol documents:
Clinical trial NCT00809159
Conditions: Ankylosing Spondylitis
Keywords: ankylosing spondylitis
Sponsor: Novartis Pharmaceuticals
Start date: 2009-03-01; Completion date: 2011-05-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as treatment of moderate to severe ankylosing spondylitis (AS).

Detailed description:

Arms: arm 1: AIN457A 10.0 mg/kg was administered intravenously as a single dose. arm 2: Placebo to AIN457A was administered intravenously as a single dose arm 3: AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. arm 4: AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. arm 5: AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
Interventions: intervention 1: AIN457 intervention 2: Placebo
Intervention descriptions: intervention 1: AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A. intervention 2: Placebo to AIN457

Protocol documents: