ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01558362
Conditions: Coronary Artery Disease
Keywords: myocardial perfusion imaging single photon emission tomography Coronary artery disease gamma camera imaging Phase 1 clinical trial cyclotron
Sponsor: Ottawa Heart Institute Research Corporation
Start date: 2012-04-01; Completion date: 2012-09-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The need exists for alternatives to 99mTc based perfusion radiotracers for cardiac patient management. An alternative radiotracer, I123-CMICE-013, has been developed at the Canadian Molecular Imaging Center of Excellence (C-MICE) at the University of Ottawa Heart Institute. Initial testing results in rats and pigs suggest that in addition to being a cyclotron-produced alternative to 99mTc tracers, I-123-CMICE-013 may be a superior tracer for measuring myocardial perfusion.This Phase 1 study will study the safety and tolerability, biodistribution, pharmacokinetics and radiation dosimetry, and distribution and localization of I123-CMICE-013in healthy adult volunteers.

Detailed description:
Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) is an established, cost effective tool for the risk stratification and management of patients suspected or known to have coronary artery disease (CAD)Myocardial perfusion imaging is significantly affected by interruptions in the supply of 99mMo, the parent isotope of 99mTc used for the majority of MPI. An alternative radiotracer, I123-CMICE-013,developed at the Canadian Molecular Imaging Center of Excellence (C-MICE) at the University of Ottawa Heart Institute, has completed pre-clinical trial testing and is ready for Phase 1 human trials.

This Phase I study will be a single centre, open label study. Subjects will receive 2 doses of study drug. One rest dose and one stress dose will be administered on separate days, one week apart. Subjects will undergo a standard clinical exercise stress protocol for the stress dose. Gamma camera imaging following each administration will be done over 2 days.

Biodistribution, pharmacokinetics, dosimetry and safety variables will be analyzed.

Arms: arm 1: Administration and analysis of alternative MPI radiotracer
Interventions: intervention 1: 123I-CMICE-013
Intervention descriptions: intervention 1: 2 intravenous doses of drug will be given one week apart. Doses will be equivalent to 1 rest dose and 1 stress dose. Serial nuclear imaging will follow dose injections. All volunteers had a rest dose first followed by a stress dose.

Protocol documents:
Clinical trial NCT01569126
Conditions: Healthy Volunteer
Sponsor: Eli Lilly and Company
Start date: 2012-04-01; Completion date: 2012-09-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of this study are to look at safety, how well the study drug (LY110140) is tolerated, and how much of the study drug gets into the blood stream when given as single dose (SD) and multiple doses (MD) to healthy Japanese male participants. Participants will participate in SD portion for approximately 6 weeks and in MD portion for approximately 10 weeks.

Detailed description:

Arms: arm 1: 5 mg administered once in the fasted state on Day 1 arm 2: 20 mg administered once in the fasted state on Day 1 arm 3: 40 mg administered once in the fasted state on Day 1 arm 4: Placebo once daily oral dosing for 28 consecutive days arm 5: 20 mg once daily oral dosing for 28 consecutive days arm 6: 40 mg once daily oral dosing for 28 consecutive days
Interventions: intervention 1: LY110140 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered orally as capsules intervention 2: Administered orally as capsules in the placebo arm and to maintain the blind in the 20 mg LY110140 (MD) arm

Protocol documents:
Clinical trial NCT01570634
Conditions: Diarrhoea, Clostridium Difficile
Keywords: Clostridium difficile infection diarrhea cramping
Sponsor: Salient Pharmaceuticals Incorporated
Start date: 2012-03-01; Completion date: 2012-09-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Clostridium difficile (C. difficile) can cause symptoms ranging from mild diarrhea to life-threatening colitis. Illness from C. difficile most commonly affects patients in hospitals and long-term care facilities and typically occurs after a patient has received antibiotics.

In vitro data indicate Calcium Aluminosilicate Anti-Diarrheal (CASAD) has the potential to bind TNFα, IL-1, IL-6, and IL-10 in the intestines and, therefore, may act to reduce severity of fever, leukocytosis, and bowel injury in patients with C. difficile infection. This would likely occur in conjunction with neutralization of C. difficile toxins A\&B by CASAD. Computer modeling of CASAD performed by Phillips et al. at Texas A\&M University supports this hypothesis.

The investigators hypothesize that adding CASAD 1.5 grams po tid to any standard-of-care therapy will reduce the duration and severity of diarrhea and other symptoms in patients with C. difficile infection.

Detailed description:

Arms: arm 1: Treatment with CASAD for 14 days
Interventions: intervention 1: Calcium Aluminosilicate Anti-Diarrheal (CASAD)
Intervention descriptions: intervention 1: CASAD 3 500mg capsules po tid for 14 days with 4 weeks of follow up

Protocol documents:
Clinical trial NCT01594515
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-05-01; Completion date: 2012-09-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.

Detailed description:

Arms: arm 1: Powder for oral solution arm 2: Powder for oral solution arm 3: Powder for oral solution arm 4: Powder for oral solution arm 5: Powder for oral solution arm 6: Powder for oral solution arm 7: Powder for oral solution arm 8: Powder for oral solution arm 9: Powder for oral solution arm 10: Solution for oral administration
Interventions: intervention 1: BI 1015550 intervention 2: BI 1015550 intervention 3: BI 1015550 intervention 4: BI 1015550 intervention 5: BI 1015550 intervention 6: Placebo intervention 7: BI 101550 intervention 8: BI 1015550 intervention 9: BI 1015550 intervention 10: BI 1015550
Intervention descriptions: intervention 1: High dose powder for oral solution intervention 2: Medium dose powder for oral solution intervention 3: Low dose powder for oral solution intervention 4: Low dose powder for oral solution intervention 5: Low dose powder for oral solution intervention 6: Solution for oral administration intervention 7: High dose powder for oral solution intervention 8: Low dose powder for oral solution intervention 9: Medium dose powder for oral solution intervention 10: Medium dose powder for oral solution

Protocol documents:
Clinical trial NCT01598740
Conditions: Heart Failure
Sponsor: Sorbent Therapeutics
Start date: 2012-06-01; Completion date: 2012-09-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the effects of CLP, with and without spironolactone, on serum, urine, and fecal contents in heart failure patients with chronic kidney disease.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CLP intervention 2: Spironolactone
Intervention descriptions: intervention 1: Oral administration intervention 2: oral administration

Protocol documents:
Clinical trial NCT01605942
Conditions: Cataract
Sponsor: Allergan
Start date: 2012-06-01; Completion date: 2012-09-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a safety and efficacy study of a Dexamethasone Drug Delivery System for anterior segment inflammation and pain following cataract extraction with lens implantation.

Detailed description:

Arms: arm 1: Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. arm 2: Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Interventions: intervention 1: Dexamethasone Drug Delivery System intervention 2: Placebo Drug Delivery System
Intervention descriptions: intervention 1: Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. intervention 2: Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.

Protocol documents:
Clinical trial NCT01606436
Conditions: Schizophrenic Disorders
Sponsor: Denovo Biopharma LLC
Start date: 2012-06-01; Completion date: 2012-09-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study determined if a single dose of LY2140023 (pomaglumetad methionil) affects the electrical activity in the heart in participants with schizophrenia. This study also helped determine how a single high dose of LY2140023 is tolerated by participants.

Detailed description:
The primary objective of this study was to determine that a single supratherapeutic dose of LY2140023 does not differ from placebo in the mean change from baseline in 12-lead electrocardiogram (ECG) QT interval measurements, such that the upper bound of the 2-sided 90% confidence interval (CI) for the greatest time-matched mean effect is \<10 ms in subjects with schizophrenia. The secondary objective was to further evaluate the tolerability of a supratherapeutic single dose of LY2140023 monohydrate.

Male or female subjects diagnosed with schizophrenia and aged between 18 and 65 years, inclusive, who had not been hospitalized for psychiatric illness for at least 12 weeks prior to Day 1 of the lead-in period, and who had a Clinical Global Impression - Severity scale score of \<4 were included in the study.

Arms: arm 1: 400 milligrams (mg) LY2140023 (5 x 80 mg tablets) administered orally as a single dose during 1 of 3 treatment periods separated by 2-day washout periods. arm 2: Placebo tablets (5) matching LY2140023 administered orally as a single dose during 1 of 3 treatment periods separated by 2-day washout periods. arm 3: Positive control, unblinded 400 milligrams (mg) moxifloxacin (1 x 400 mg tablet) administered orally as a single dose during 1 of 3 treatment periods separated by 2-day washout periods.
Interventions: intervention 1: LY2140023 intervention 2: Placebo intervention 3: Moxifloxacin
Intervention descriptions: intervention 1: Administered orally. intervention 2: Administered orally. intervention 3: Administered orally.

Protocol documents:
Clinical trial NCT01609218
Conditions: Healthy Volunteer Study
Sponsor: Denovo Biopharma LLC
Start date: 2012-06-01; Completion date: 2012-09-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study will evaluate the effect of activated charcoal on absorption of LY2140023. The study involves a single dose of 80 milligrams (mg) LY2140023 taken as 1 tablet by mouth 2 times during study (once with activated charcoal, once without activated charcoal). This study will last approximately 16 days, not including screening. Screening is required within 28 days prior to study entry.

Detailed description:

Arms: arm 1: Single oral dose of 80 milligrams (mg) LY2140023 administered alone arm 2: Single oral dose of 80 mg LY2140023 followed 1 hour later by single oral dose of 75 grams (g) aqueous activated charcoal.
Interventions: intervention 1: LY2140023 intervention 2: Aqueous activated charcoal
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01623466
Conditions: Healthy
Keywords: PK and Safety
Sponsor: Agile Therapeutics
Start date: 2012-07-01; Completion date: 2012-09-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pharmacokinetics, safety and wearability in two size patches of AG890 over eight weeks will be evaluated.

Detailed description:
To evaluate pharmacokinetic (PK) profile, patch wearability (adhesion and skin irritation), and safety of AG890-6.5 and AG890-12.5 TCDS.

Arms: arm 1: Evaluate levonorgestrel delivery in AG890-6.5 arm 2: Evaluate levonorgestrel delivery in AG890-12.5
Interventions: intervention 1: levonorgestrel
Intervention descriptions: intervention 1: transdermal contraceptive delivery system

Protocol documents:
Clinical trial NCT01632579
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2012-06-01; Completion date: 2012-09-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a phase I study of LY3023703 in healthy participants. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Participants will remain in the study for approximately 3 months. This study is for research purposes only and is not intended to treat any medical condition.

Detailed description:

Arms: arm 1: Single dose of placebo administered orally on up to one occasion separated by at least a 3 week wash out period. arm 2: Up to 6 single escalating doses of LY3023703 \[0.1 milligram (mg) up to 60 mg\] administered orally on up to two occasions per participant separated by at least a 3 week wash out period. arm 3: Positive control. Single 400 mg dose of celecoxib administered orally, open label, on one occasion separated by at least a 3 week washout period.
Interventions: intervention 1: LY3023703 intervention 2: Placebo intervention 3: Celecoxib
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally

Protocol documents:
Clinical trial NCT01634165
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2012-07-01; Completion date: 2012-09-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study involves 2 single injections of LY2963016 and 2 single injections of Lantus. There will be at least 6 days between each injection.

The study will compare LY2963016 to Lantus at two different doses.

This study is approximately 10 weeks long, not including screening. Screening is required within 4 weeks of the start of the study.

Detailed description:

Arms: arm 1: Single 0.3 units/kilogram (U/kg) subcutaneous dose of LY2963016 arm 2: Single 0.3 U/kg subcutaneous dose of Lantus arm 3: Single 0.6 U/kg subcutaneous dose of LY2963016 arm 4: Single 0.6 U/kg subcutaneous dose of Lantus
Interventions: intervention 1: LY2963016 intervention 2: Lantus
Intervention descriptions: intervention 1: Administered subcutaneously intervention 2: Administered subcutaneously

Protocol documents:
Clinical trial NCT01640834
Conditions: Diabetes Mellitus, Type 1
Sponsor: Eli Lilly and Company
Start date: 2012-07-01; Completion date: 2012-09-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study involves taking a single dose of 100 milligrams (mg) or 300 mg LY2409021 or placebo (an inactive medicine) taken as up to 3 capsules by mouth. The study will evaluate if this drug will reduce the amount of insulin a type 1 diabetic needs over 24 hours. This study includes a 7-day hospitalization period at the clinical research unit (CRU) and will involve screening within 30 days of the start of the study as well as telephone consultations within 5 days after discharge from the CRU.

Detailed description:

Arms: arm 1: LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.

Placebo: 2 capsules, administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3. arm 2: LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.

Glucagon: 1 mg administered via intramuscular injection on Day 3. arm 3: Placebo: 3 capsules administered as a single oral dose on Day 2.

Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.
Interventions: intervention 1: LY2409021 intervention 2: Placebo intervention 3: Glucagon
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered via intramuscular injection

Protocol documents:
Clinical trial NCT01643616
Conditions: Other Surgical Procedures
Keywords: Sciatic Nerve Ultrasound Anesthesia, Regional Orthopedic Surgery
Sponsor: Helios Research Center
Start date: 2010-11-01; Completion date: 2012-09-01
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
For distal sciatic nerve block this prospective, randomised comparison with ultrasound guided distal subepineural block tested the hypothesis, that intraepineural injection of local anesthetic using nerve stimulation technique is common and associated with high success rate.

Detailed description:
Classical methods for nerve localization (loss of resistance, cause of paresthesias, nerve stimulation technique)assumed that the target is a close approximation to the nerve, without epineural perforation. Intraneural injections were considered as evitable, with high risk for nerve damages.

Ultrasound guidance provided for the first time a real-time visualization of the spread of local anesthetic. Some recent studies proved, that an intraneural injection using nerve stimulator technique is common and not necessarily accompanied with nerve damages.

In the ultrasound group (group US) the investigators tested the hypothesis, that an intraneural injection of local anesthetic generate a high success rate and a short onset time without clinical apparent nerve damages.

In the nerve-stimulation group (group NS) the investigators tested the hypothesis, that an intraneural injection of local anesthetic is common, and in case of intraneural injection accompanied likewise with high success rate and shorter onset time.

For the sciatic division the investigators tested the hypothesis, that classical methods of nerve localization (nerve-stimulation technique, cause of paresthesias) are not able to avoid epineural perforation.

Arms: arm 1: Ultrasound guided block :

20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients) arm 2: Nerve stimulation technique:

20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)
Interventions: intervention 1: midazolam intervention 2: Prilocaine 1% intervention 3: Ropivacaine 0.75% intervention 4: Prilocaine 1% intervention 5: ultrasound guidance intervention 6: nerve stimulation technique
Intervention descriptions: intervention 1: Prior to performing the regional anesthesia the investigators administered midazolam as a premedication by mouth (3,75-7,5mg) or intravenously (2-3mg). intervention 2: 20ml Prilocaine 1% for distal sciatic nerve block (30ml Prilocaine 1% in outpatients) intervention 3: 10ml Ropivacaine 0.75% for distal sciatic nerve block (not in outpatients) intervention 4: 10ml Prilocaine 1% for saphenous nerve block intervention 5: In group US the sciatic nerve localization and needle guidance is realized using ultrasound. intervention 6: In the group NS sciatic nerve localization and needle guidance is realized using nerve stimulation technique. However, ultrasound is used observing (Observer) the procedure, but blinded for the physician (Anesthetist) performing the block.

Protocol documents:
Clinical trial NCT01654549
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: Steatohepatitis, Helicobacter pylori, Insulin resistance, Alanine aminotransferase, Aspartate aminotransferase,
Sponsor: Tehran University of Medical Sciences
Start date: 2012-04-01; Completion date: 2012-09-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR) index, and anthropometric measurements (body mass index and waist circumference)in non-diabetic subjects with non-alcoholic fatty liver disease.

Detailed description:
Helicobacter pylori (HP) antigens have been found in the liver of individuals with benign and malignant liver diseases. The role of HP in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) is controversial.

This randomized double blind clinical trial was performed in non-diabetic dyspeptic patients with positive antibody to HP and the evidence of fatty liver in ultrasonography. After excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) and positive urea breath test (UBT) were enrolled. They were randomly assigned to lifestyle modification alone or lifestyle modification plus HP eradication groups. Quadruple therapy (omeprazole, amoxicillin, bismuth subcitrate, and clarithromycin) for HP eradication was performed in two weeks. HP eradication was documented by UBT. Liver fat content, fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein, HOMA-IR, and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six weeks post-treatment.

Arms: arm 1: Obtaining ideal body weight by calorie restriction diet and programmed physical activity arm 2: H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
Interventions: intervention 1: H.pylori eradication
Intervention descriptions: intervention 1: Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)

Protocol documents:
Clinical trial NCT01660893
Conditions: Anesthesia
Keywords: operative dental procedure
Sponsor: St. Renatus, LLC
Start date: 2012-08-01; Completion date: 2012-09-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.

Detailed description:
The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure.

A total of 140 subjects, randomized 2:2:1 (Kovacaine Mist:Tetracaine alone:Placebo) will be enrolled to achieve 125 completed subjects; a total of 50 Kovacaine Mist subjects, 50 tetracaine alone subjects and 25 placebo subjects. Recruitment will be from diverse dental patient populations. At the two study sites, a balanced enrollment of 70 subjects each is planned to allow for a potential 10% drop-out rate.

Arms: arm 1: Tetracaine HCl 3% and oxymetazoline HCl 0.05% arm 2: Tetracaine HCl 3% arm 3: Placebo
Interventions: intervention 1: Tetracaine HCl 3% and oxymetazoline HCl 0.05% intervention 2: Tetracaine HCl 3% intervention 3: Placebo
Intervention descriptions: intervention 1: 3 unilateral intranasal sprays per dose intervention 2: 3 unilateral intranasal sprays per dose intervention 3: 3 unilateral intranasal sprays per dose

Protocol documents: