ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00854308
Conditions: Non-Small Cell Lung Cancer
Keywords: Tarceva Lung Cancer NSCLC
Sponsor: Genentech, Inc.
Start date: 2009-04-01; Completion date: 2012-01-01
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase II, double-blind, randomized, multicenter trial designed to preliminarily evaluate the activity and safety of treatment with MetMAb + erlotinib versus erlotinib + placebo in second- and third-line Non-Small Cell Lung Cancer (NSCLC). Up to 180 patients will be randomized in a 1:1 ratio to one of the two treatment arms.

Detailed description:

Arms: arm 1: MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity. arm 2: Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
Interventions: intervention 1: Erlotinib HCl intervention 2: MetMAb intervention 3: placebo (0.9 % saline)
Intervention descriptions: intervention 1: Erlotinib 150 mg oral dose once daily. intervention 2: MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg in 250 CC 0.9% saline intravenous infusion every 3 weeks. intervention 3: Placebo Intravenous infusion every 3 weeks.

Protocol documents:
Clinical trial NCT00865514
Conditions: Healthy
Keywords: dichloroacetate tyrosine maleylacetoacetate trichloroethylene leucine haplotype
Sponsor: University of Florida
Start date: 2011-08-01; Completion date: 2012-01-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This project focuses on the kinetics, metabolism and human toxicology of dichloroacetate (DCA)and tyrosine catabolism. The hypothesis is that tyrosine metabolism will be greatest in subject who harbor the KRT variant for GSTz1/MAAI for which DCA exhibits a high Km.

Detailed description:
Specific Aim 4. Quantify the effects of DCA on human tyrosine metabolism and on its own biotransformation in relation to dose and genotype.

Arms: arm 1: Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
Interventions: intervention 1: Dichloroacetate intervention 2: Genotyping intervention 3: Leucine intervention 4: tyrosine
Intervention descriptions: intervention 1: Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine. intervention 2: Subjects will have 5 mls of blood drawn for genotyping intervention 3: Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine. intervention 4: Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.

Protocol documents:
Clinical trial NCT00868452
Conditions: Bipolar Depression
Keywords: Bipolar I Latuda Lurasidone
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2009-04-01; Completion date: 2012-01-01
Enrollment: 348 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I depression.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: lurasidone + (lithium or divalproex) intervention 2: Placebo + (lithium or divalproex)
Intervention descriptions: intervention 1: lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7. intervention 2: 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7

Protocol documents:
Clinical trial NCT00872599
Conditions: Hypertension
Keywords: Hypertension Phenotyping High Salt intake frequently sampled IV glucose tolerance test(FSIVGTT) fenofibrate epoxyeicosatrienoic acids hydroxyeicosatetraenoic acids dihydroxyeicosatrienoic acid PPAR Alpha Agonist CYP Monooxygenase Activity
Sponsor: Vanderbilt University
Start date: 2009-09-01; Completion date: 2012-01-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The hypothesis is to test to see if the drug fenofibrate will increase important chemicals in the body and specifically in the kidney, help to rid the body of salt by the kidneys, decrease blood pressure and improve insulin sensitivity during high-salt intake in individuals with hypertension.

Detailed description:
Hypertension affects 73 million people in the United States and a billion people worldwide and contributes to death due to stroke, myocardial infarction, end-stage kidney disease and congestive heart failure. Fifty to 60% of individuals with hypertension have "salt-sensitive" hypertension, characterized by an exaggerated blood pressure response to increased salt intake. Salt-sensitive hypertension is associated with increased mortality due to cardiovascular disease.

This study will test the hypothesis that administration of a PPARa agonist, an intervention increases renal tubular Cyp2c and 4a expression in rodents, will increase urinary excretion of 20-hydroxyeicosatetraenoic acid(HETE) and epoxyeicosatrienoic acids(EET)s, induce natriuresis, decrease blood pressure, and improve insulin sensitivity during high-salt intake in individuals with hypertension.

Metabolites of the P450 arachidonic acid monooxygenases play an important role in the regulation of blood pressure in rodent models.

Targeted disruption of murine Cyp4a genes provides insight into the roles of renal monooxygenases and epoxygenases in the regulation of salt excretion and blood pressure.

PPARa agonists induce the expression of renal tubular monoxygenases and epoxygenases and decrease blood pressure in both Ang II- dependent and salt-sensitive rodent models of hypertension.

PPARa agonists have been reported to reduce blood pressure in clinical trials in humans. The effect of PPARa agonist on renal vasodilation, sodium excretion and excretion of urinary epoxygenase or monooxygenase products in response to salt loading is not known.

The regulation of urinary 20-HETE excretion may be impaired in human hypertension.

Arms: arm 1: Randomized study of fenofibrate versus placebo during high salt diet arm 2: Randomized study of fenofibrate versus placebo during high salt intake.
Interventions: intervention 1: fenofibrate intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will be randomized to receive either fenofibrate 160 mg/day or matching placebo for five days by mouth. intervention 2: Subjects will be randomized to receive placebo or fenofibrate for five days by mouth

Protocol documents:
Clinical trial NCT00884897
Conditions: Social Cognition Social Anxiety Emotional Intelligence
Keywords: Social Cognition Schizophrenia Oxytocin
Sponsor: University of Maryland, Baltimore
Start date: 2010-01-01; Completion date: 2012-01-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Objective: Social Cognition and Emotional Intelligence have been shown to be deficient in patients with schizophrenia and these are not remediated by antipsychotic medications or psychosocial interventions. Social cognition is associated with functional outcome, an important step in striving for recovery in this population. The hormone and neurotransmitter, oxytocin, which has been associated with social bonding and trust has been shown to improve measures of some aspects of social cognition in humans. The study will assess the effect of acute administration of intranasal oxytocin on measures of social cognition and functioning as well as on emotional intelligence and symptoms.

Study population: The study population will include patients with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who have been on a stable medication regimen for 6 weeks. We will enroll a total of 30 subjects (N=15 placebo and N=15 oxytocin groups).

Experimental design and methods: After a one week lead in phase, participants will undergo 3 weeks of oxytocin (20 IU BID) or placebo administration (double blind) in addition to their existing medication regimen. Outcome measures will be administered during the lead in phase, and at the end of the study drug administration phase (under the acute effect of OT). The primary outcome measure will be the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) and the Maryland Assessment of Social Competence (MASC). Secondary measures include rating from the domains of social cognition (emotion perception, attributional style, theory of mind and social perception), symptom rating and measures of social anxiety and quality of life. Side effects and symptoms will be measured weekly.

Detailed description:

Arms: arm 1: We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis. arm 2: We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.
Interventions: intervention 1: Oxytocin intervention 2: Placebo
Intervention descriptions: intervention 1: Oxytocin given as 20 IU BID intervention 2: Placebo given as 20 IU BID

Protocol documents:
Clinical trial NCT00904839
Conditions: Colorectal Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2009-05-01; Completion date: 2012-01-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate PFS rate at 9 months of BIBF 1120 in combination with mFolfox6 compared with mFolfox6 combined to bevacizumab in first line patients with metastatic colorectal cancer.

Detailed description:

Arms: arm 1: BIBF1120 medium dose twice daily arm 2: Bevacizumab 5mg/kg once daily every other week
Interventions: intervention 1: BIBF 1120 intervention 2: BIBF 1120 intervention 3: mFolfox intervention 4: Bevacizumab intervention 5: mFolfox 6 intervention 6: bevacizumab
Intervention descriptions: intervention 1: BIBF 1120 100 and 150 mg capsules intervention 2: BIBF 1120 100 and 150 mg capsules intervention 3: standard i.v chemotherapy intervention 4: 100 mg/Kg solution , IV infusion intervention 5: IV standard chemotherapy intervention 6: 100 mg/4 ml solution

Protocol documents:
Clinical trial NCT00913497
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 diabetes mellitus in children insulin glulisine insulin aspart post prandial
Sponsor: Spectrum Health Hospitals
Start date: 2009-06-01; Completion date: 2012-01-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To determine whether insulin glulisine decreases the breakfast post prandial glycemic excursion in comparison to insulin aspart.

Detailed description:
This is a treatment, open label, crossover study comparing two and four hour breakfast post prandial blood glucose levels after receiving a dose of insulin glulisine or insulin aspart administered subcutaneously and consuming the breakfast meal from a prescribed menu containing 45, 60 or 75 grams of carbohydrate. Each subject will receive insulin glulisine for ten days and insulin aspart for ten days.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin glulisine intervention 2: insulin aspart
Intervention descriptions: intervention 1: Insulin glulisine (Apidra®) Sanofi-Aventis; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days intervention 2: Insulin aspart (NovoLog®) Novo Nordisk; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days.

Protocol documents:
Clinical trial NCT00919126
Conditions: Anaesthesia
Keywords: Xenon in Anaesthesia
Sponsor: Air Liquide SA
Start date: 2009-06-01; Completion date: 2012-01-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the quantity of propofol administered with Xenon in two inspiratory concentrations, to maintain comparable depth of anaesthesia during the maintenance period of general anaesthesia.

Detailed description:
The inert or "noble" gas Xenon has anaesthetic properties that have been recognized 50 years ago. Several preclinical studies and investigations using xenon as an inhalational anaesthetic in humans were performed and reported that this gas has many properties of the ideal anaesthetic agent. Moreover, it is known that when xenon is combined with volatile anaesthetics or opioids, the required doses of those substances are reduced, resulting in a lower incidence of side effects. Patients could benefit from the administration of xenon if this inspired concentration would result in reduced doses of co-administered drugs.

This trial should allow evaluating the propofol consumption required in combination with xenon administered in inspiratory concentrations of 50% and 70% to maintain comparable depth of general anaesthesia as total i.v. anaesthesia, in ASA III patients presenting increased risk of perioperative cardiac complications and undergoing laparotomy or orthopaedic surgery.

Arms: arm 1: Xenon 50% (45%-55%) in Oxygen (45%-55%), arm 2: Xenon 70% (65%-75%) in Oxygen (25%-35%) arm 3: Medical Air in Oxygen (45%-55%)
Interventions: intervention 1: Xenon intervention 2: Xenon intervention 3: Medical Air in Oxygen
Intervention descriptions: intervention 1: Maintenance of anaesthesia obtained with Xenon 50% and propofol infusion adjusted to depth of anaesthesia. intervention 2: Maintenance of anaesthesia obtained with Xenon 70% and propofol infusion adjusted to depth of anaesthesia. intervention 3: Maintenance of anaesthesia obtained with propofol infusion adjusted to depth of anaesthesia.

Protocol documents:
Clinical trial NCT00934024
Conditions: Nicotine Dependence
Keywords: nicotine dependence tobacco smoking
Sponsor: Medical University of South Carolina
Start date: 2009-04-01; Completion date: 2012-01-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the impact of varenicline treatment on cue induced craving to smoking using brain imaging. The investigators hypothesize that participants will report reduced urges to smoke and will have less activation in parts of the brain associated with craving.

Detailed description:
Treatment with varenicline reduces overall subjective cigarette craving and smoking reward in nicotine-dependent smokers. This preliminary study will explore the impact of varenicline treatment on smoking cue-induced craving and associated regional brain activation using BOLD fMRI. Twenty healthy smokers (10 males, 10 females) will undergo two BOLD fMRI scans with the presentation of smoking-related and neutral cues at baseline and after five weeks of treatment with open-label varenicline. The investigators hypothesize that participants will report reduced urges to smoke on the Questionnaire of Smoking Urges-Brief and have less activation of the brain areas associated with craving during the fMRI after 5 weeks of varenicline and smoking cessation counseling compared to the baseline scan.

Arms: arm 1: All participants received varenicline. A priori determined analysis was between participants who quit smoking and those who continued to smoke.

This arm was abstinent after 5 weeks of varenicline treatment.. arm 2: All participants received varenicline. A priori determined analysis was between participants who quit smoking and those who continued to smoke.

This arm was participants who continued to smoke after 5 weeks of varenicline treatment.
Interventions: intervention 1: varenicline
Intervention descriptions: intervention 1: Participants will be treated with a standard course of varenicline, 0.5 mg 1 tablet every day for 3 days, then 0.5 mg 1 tab twice a day for four days, and 1 mg 1 tablet twice a day for three months.

Protocol documents:
Clinical trial NCT00936897
Conditions: Postmenopausal Osteoporosis
Sponsor: Amgen
Start date: 2009-07-01; Completion date: 2012-01-01
Enrollment: 833 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, randomized, open-label, parallel group, study being conducted in the United States and in Europe in postmenopausal women. Approximately 800 subjects will be randomized across about 65 sites in a 1:1 ratio to either denosumab 60mg SC Q6M, or ibandronate 150mg PO QM.

Detailed description:

Arms: arm 1: Ibandronate 150mg PO QM (tablet) arm 2: denosumab 60mg Subcutaneous Q6M (pre-filled syringe)
Interventions: intervention 1: Ibandronate intervention 2: Denosumab
Intervention descriptions: intervention 1: Ibandronate 150mg PO QM (tablet) intervention 2: denosumab 60mg SC Q6M (pre-filled syringe)

Protocol documents:
Clinical trial NCT00942305
Conditions: Cytomegalovirus Infection
Keywords: Allogeneic stem cell transplant CMV seropositive (R+) transplant
Sponsor: Chimerix
Start date: 2009-10-01; Completion date: 2012-01-01
Enrollment: 239 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This was a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study of brincidofovir (BCV) administered orally once or twice weekly for up to 11 weeks. Dosing was initiated immediately following engraftment (between Days 14-30 post-transplant) to prevent/control cytomegalovirus (CMV) infection or prevent disease in R+ hematopoietic stem cell transplant (HCT) recipients.

Detailed description:
This was to be a 2-part study. Part 1 was a randomized, double-blind, placebo-controlled, dose-escalation study of multiple doses of oral brincidofovir (BCV) in R+ hematopoietic stem cell transplant (HCT) recipients. In Part 2, one of the dose levels administered in Part 1 was to be tested against placebo to evaluate the statistical significance of BCV as a therapy for preventing progression of cytomegalovirus (CMV) infection or preventing CMV disease. The first 3 dose-escalating cohorts in Part 1 were to include 32 subjects within each cohort (24 randomized to receive oral BCV and 8 randomized to receive placebo in a 3:1 ratio) for a total of 96 planned subjects. Following completion of the first 3 cohorts and subsequent safety review of the data, up to an additional 3 cohorts of 32 subjects each could have been enrolled. Two additional cohorts (labeled Cohort 4 and Cohort 4A) beyond the initial 3 cohorts were actually enrolled in Part 1 of the study. Following the safety and antiviral activity analyses of the 5 cohorts in Part 1 and the number of subjects enrolled in each of those cohorts, Part 2 of the study was not conducted.

Arms: arm 1: * Cohort 1 = 40 mg of matching placebo administered once weekly (QW)
* Cohort 2 = 100 mg of matching placebo administered QW
* Cohort 3 = 200 mg of matching placebo administered QW
* Cohort 4 = 200 mg of matching placebo administered twice weekly (BIW)
* Cohort 4A = 100 mg of matching placebo administered BIW arm 2: * Cohort 1 = 40 mg brincidofovir (BCV) administered once weekly (QW)
* Cohort 2 = 100 mg BCV administered QW
* Cohort 3 = 200 mg BCV administered QW
* Cohort 4 = 200 mg BCV administered twice weekly (BIW)
* Cohort 4A = 100 mg BCV administered BIW
Interventions: intervention 1: Brincidofovir intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects received their first dose of study drug of brincidofovir (BCV) within 30 (+5) days post-transplant and were treated through Week 13 post-transplant. intervention 2: Subjects received their first dose of study drug within 30 (+5) days post-transplant and were treated through Week 13 post-transplant.

Matching placebo administered for each cohort.

Protocol documents:
Clinical trial NCT00969618
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Sponsor: Eli Lilly and Company
Start date: 2009-11-01; Completion date: 2012-01-01
Enrollment: 211 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess long-term safety and tolerability in adult patients who have completed a previous atomoxetine study.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Atomoxetine
Intervention descriptions: intervention 1: 40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks

Protocol documents: