ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00763009
Conditions: Coronary Artery Disease
Sponsor: UConn Health
Start date: 2002-09-01; Completion date: 2009-07-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to understand why different people respond differently to the medication Persantine. The effects of Persantine will be evaluated by performing echocardiograms, blood tests and by measuring the flow of blood in the arteries of the heart in patients undergoing a clinically indicated percutaneous coronary intervention.

Detailed description:
Participants will receive three doses of Persantine intravenously for the research study. Before and after receiving the Persantine doses, patients will have an echocardiogram and coronary artery blood flow will be measured. Blood tests,measure the function of the adenosine transporter. In addition variations in the gene for the adenosine transporter will be evaluated.

Arms: arm 1: Compare to baseline
Interventions: intervention 1: dipyridamole
Intervention descriptions: intervention 1: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously

Protocol documents:
Clinical trial NCT00767806
Conditions: Chronic Low Back Pain
Sponsor: Eli Lilly and Company
Start date: 2008-09-01; Completion date: 2009-07-01
Enrollment: 401 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if duloxetine reduces the severity of chronic low back pain.

Detailed description:

Arms: arm 1: Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment arm 2: Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
Interventions: intervention 1: Duloxetine intervention 2: Placebo
Intervention descriptions: intervention 1: 60 mg orally once daily for 12 weeks intervention 2: Placebo once daily orally for 12 weeks

Protocol documents:
Clinical trial NCT00779246
Conditions: Staphylococcal Infections
Keywords: Methicillin resistance Infection control Staphylococcus aureus Cross infection Epidemiology Chlorhexidine
Sponsor: Christiana Care Health Services
Start date: 2008-06-01; Completion date: 2009-07-01
Enrollment: 1518 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This pilot study in our medical intensive care unit will evaluate the clinical and cost-effectiveness of an active surveillance program for methicillin-resistant Staphylococcus aureus (MRSA), compared to routine daily bathing with chlorhexidine gluconate (CHG)-impregnated cloths. Outcomes include rate of MRSA acquisition, and of other hospital-acquired infections (e.g., catheter-associated bloodstream infections).

Detailed description:

Arms: arm 1: Active surveillance cultures (ASC) (via nasal swabs) will be performed for all patients admitted to the medical intensive care unit (ICU) during the designated study period. All patients will be placed in contact isolation until nasal swabs return negative; otherwise will remain in isolation. arm 2: Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures (ASC) will also be used in this arm, but results will be blinded and not used to determine whether patients should be in contact isolation.
Interventions: intervention 1: Nasal swabs for MRSA culture intervention 2: Chlorhexidine gluconate intervention 3: Contact isolation
Intervention descriptions: intervention 1: Patients will have nasal swabs performed upon ICU admission, upon discharge, and every 2 weeks while they remain in the ICU. intervention 2: CHG-impregnated cloths (2%) will be used to bathe patients at least daily during the duration of their medical ICU stay. Surveillance cultures will be obtained on admission, discharge and every 2 weeks while in the ICU, but results will be blinded until conclusion of the study. intervention 3: All patients will be placed in contact isolation until the results of their active surveillance cultures are negative; if positive, they will remain in isolation.

Protocol documents:
Clinical trial NCT00779506
Conditions: Schizophrenia
Keywords: Acute schizophrenia PANSS
Sponsor: AstraZeneca
Start date: 2008-11-01; Completion date: 2009-07-01
Enrollment: 96 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an 8-week, multi-centre, Open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients. The eligible patient will be assigned to study treatment with Quetiapine XR on Day 1.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Detailed description:

Arms: arm 1: Seroquel XR 400-800mg
Interventions: intervention 1: Quetiapine Fumarate XR
Intervention descriptions: intervention 1: oral, once daily, flexible dose

Protocol documents:
Clinical trial NCT00787618
Conditions: Renal Impairment
Keywords: Renal impairment
Sponsor: Repros Therapeutics Inc.
Start date: 2008-10-01; Completion date: 2009-07-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
PK and safety profile of Proellex® in females with various stages of impaired renal function

Detailed description:
The study will evaluate the pharmacokinetics and safety profile of Proellex® in females with various stages of impaired renal function and in volunteers with normal renal function

Arms: arm 1: 50 mg Proellex single dose Female subjects with mild renal impairment function. arm 2: 50 mg Proellex, Female subjects with moderate renal impairment function. arm 3: 50 mg Proellex, Female subjects with normal renal function.
Interventions: intervention 1: 50 mg Proellex
Intervention descriptions: intervention 1: Single dose

Protocol documents:
Clinical trial NCT00793910
Conditions: Postoperative Pain
Keywords: Gabapentin PRK pain
Sponsor: Walter Reed Army Medical Center
Start date: 2008-07-01; Completion date: 2009-07-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness of an oral medication called gabapentin in reducing pain after Photorefractive Keratectomy (PRK) eye surgery and to assess the frequency of use of rescue medication interventions, defined as non-steroidal anti-inflammatory (NSAID) eye drops and oral narcotic medication.

Detailed description:

Arms: arm 1: oral medication arm 2: None
Interventions: intervention 1: Gabapentin intervention 2: placebo
Intervention descriptions: intervention 1: Gabapentin 300 mg taken by mouth thrice daily for 7 days intervention 2: placebo (sugar pill) taken by mouth thrice daily for 7 days

Protocol documents:
Clinical trial NCT00796328
Conditions: Spinal Induced Hypotension in Cesarean Delivery
Sponsor: IWK Health Centre
Start date: 2008-11-01; Completion date: 2009-07-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to determine the ED90 for an infusion of phenylephrine to prevent spinal induced low blood pressure in parturients presenting for an elective cesarean delivery. The up-down methodology (UDM) is commonly used study method to determine the dose of a drug that causes the desired effect in over 90% of the subjects to whom it given. For example: the investigators want to know what is the best dose of phenylephrine (from a range of commonly used doses) to prevent a drop in blood pressure during cesarean delivery ninety times out of one hundred when it is given at that dose. The ED90 is the effective dose at which 90% of subjects will have a "positive" response to a phenylephrine infusion, i.e. no drop in blood pressure. The investigators hypothesize that the ED90 will be between 40 - 60 mcg/min.

The primary outcome measure is the ED90 for phenylephrine infusions that prevents a drop in blood pressure in women undergoing cesarean delivery.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Phenylephrine infusion
Intervention descriptions: intervention 1: Up-down, biased coin design

Protocol documents:
Clinical trial NCT00801684
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD pulmonary inhalation
Sponsor: Alkermes, Inc.
Start date: 2009-02-01; Completion date: 2009-07-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study was to evaluate the efficacy, safety, and tolerability of single doses of trospium inhalation powder (TrIP) administered to subjects with chronic obstructive pulmonary disease (COPD).

Detailed description:
This was a single-center, randomized, double-blind, cross-over, placebo-controlled study. Following screening, each eligible subject was randomized to a dosing sequence. Study subjects received a total of 5 single doses, each separated by a 3- to 14-day washout period. Doses A, B, C, and D were administered in a double-blind fashion, in sequences generated by a 4-period Latin square design. The 4 dosing sequences were: ABCD, BDAC, CADB, and DCBA. Dose E was administered in an open-label fashion as the final dose in each dosing sequence for all subjects.

Subjects reported to the clinic the evening prior to each dose. Protocol assessments were carried out until 24 hours postdose. Pulmonary function testing (via spirometry) was captured at specified timepoints at baseline as well as before and after dosing. Other efficacy and safety outcomes were assessed according to protocol. Blood sampling was performed for assessment of trospium concentrations at specified timepoints.

Arms: arm 1: Represents Dose A in the Dosing Sequence assignments. arm 2: Represents Dose B arm 3: Represents Dose C arm 4: Represents Dose D arm 5: Represents Dose E. All subjects received Dose E as their final (5th) dose, after completing their initial 4 single doses according to their sequence assignment.
Interventions: intervention 1: Placebo intervention 2: TrIP-2D intervention 3: TrIP-2SS intervention 4: TrIP-2D intervention 5: TrIP-2SS + Foradil
Intervention descriptions: intervention 1: Supplied as an empty size-2 capsule and administered as a single dose via C2S inhaler. intervention 2: Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler. intervention 3: Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler. intervention 4: Trospium inhalation powder containing 400 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler. intervention 5: Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), plus foradil (12 mcg formoterol fumarate) supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.

Protocol documents:
Clinical trial NCT00805441
Conditions: Alcohol Dependence
Keywords: Alcoholic
Sponsor: Eli Lilly and Company
Start date: 2008-12-01; Completion date: 2009-07-01
Enrollment: 190 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
H8R-MC-HJAQ is a Phase 2, parallel, double-blind, randomized study comparing LY686017 with placebo in a 12-week trial that includes Medical Management. This study is an outpatient study in which approximately 180 alcohol dependent subjects will be enrolled. Subjects will be randomized in a 1:1 fashion to LY686017 or placebo, and will receive once daily dosing for twelve weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: LY686017 intervention 2: Placebo
Intervention descriptions: intervention 1: 50 milligrams (mg) daily by oral route for 12 weeks intervention 2: Daily by oral route for 12 weeks

Protocol documents:
Clinical trial NCT00807001
Conditions: Chronic Hepatitis C (HCV)
Keywords: Hepatitis C, HCV, treatment-naive
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-12-01; Completion date: 2009-07-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a proof-of-concept study which will provide data about the safety and antiviral activity of several doses of the investigational drug IDX184 given for 3 days in treatment-naive HCV genotype 1-infected subjects so that optimal doses can be chosen for testing in later studies.

Detailed description:

Arms: arm 1: Subjects randomized 8:2 (active:placebo) to receive one 25 milligrams (mg) capsule of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. arm 2: Subjects randomized 8:2 (active:placebo) to receive two 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. arm 3: Subjects randomized 8:2 (active:placebo) to receive three 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. arm 4: Subjects randomized 8:2 (active:placebo) to receive four 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care.
Interventions: intervention 1: IDX184
Intervention descriptions: intervention 1: oral dose, active or placebo

Protocol documents:
Clinical trial NCT00809926
Conditions: Stage 2 Hypertension
Keywords: Hypertension, aliskiren and valsartan
Sponsor: Novartis
Start date: 2009-01-01; Completion date: 2009-07-01
Enrollment: 451 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of the valsartan/aliskiren combination compared to valsartan alone in patients with Stage 2 hypertension.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Valsartan/aliskiren intervention 2: Valsartan
Intervention descriptions: intervention 1: Valsartan/aliskiren (160/150mg) for 2 weeks followed by forced titration to valsartan/aliskiren (320/300mg) for the remaining 6 weeks intervention 2: Valsartan (160mg) for 2 weeks followed by forced titration to Valsartan (320mg) for the remaining 6 weeks

Protocol documents:
Clinical trial NCT00810303
Conditions: Pharmacokinetics Drug Interactions Pharmacodynamics Intestinal Transporter Expression
Sponsor: University Medicine Greifswald
Start date: 2009-03-01; Completion date: 2009-07-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effects of a chronic co-medication of efavirenz on pharmacokinetics and sterol-lowering effects of ezetimibe at steady-state in healthy subjects genotyped for ABCB1, ABCC2, CYP2B6 and UGT1A1.

Detailed description:

Arms: arm 1: A study with a duration of 34 days with 4 periods (= 4 pharmakokinetics) on 12 healthy subjects.
Interventions: intervention 1: Ezetrol (ezetimibe) multiple dose intervention 2: Ezetrol (ezetimibe) multiple dose and Sustiva (efavirenz) single dose intervention 3: Ezetrol (ezetimibe) and Sustiva (efavirenz) multiple dose intervention 4: Sustiva (efavirenz) single dose
Intervention descriptions: intervention 1: administration of 1 tablet/day Ezetrol (10 mg ezetimibe) on study day 6-15 and a pharmakokinetic on study day 15 (0-24 h blood sampling, 0-24 h urine sampling and 5 d feces sampling (study day 11-15)) intervention 2: administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe) on study day 16-20 and 2 capsules Sustiva(R) (2x200 mg efavirenz) on study day 16 with a pharmakokinetic (0-120 h blood sampling, urine sampling (24 h intervals) and feces sampling on study days 16-20) intervention 3: administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe) and 2 capsules/day Sustiva(R) (2x200 mg efavirenz) on study day 21-30 and with a pharmakokinetic (0-120 h blood sampling, urine sampling (24 h intervals) on study day 30 and feces sampling on study day 26-30) intervention 4: administration of 2 capsules Sustiva(R) (2x200 mg efavirenz) on study day 1 with a pharmakokinetic (0-120 h blood sampling, urine sampling (24 h intervals) and feces sampling on study days 1-5)

Protocol documents:
Clinical trial NCT00817778
Conditions: Type 2 Diabetes
Keywords: Type II Diabetes
Sponsor: AstraZeneca
Start date: 2009-01-01; Completion date: 2009-07-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Metformin

Detailed description:

Arms: arm 1: Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days arm 2: Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
Interventions: intervention 1: AZD1656 intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will be treated with tolerable dose twice daily for another 24 days. intervention 2: Subjects will be treated with tolerable dose twice daily for another 24 days.

Protocol documents:
Clinical trial NCT00822185
Conditions: Congenital Bleeding Disorder Healthy
Sponsor: Novo Nordisk A/S
Start date: 2009-01-01; Completion date: 2009-07-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of activated recombinant human coagulation factor VII analogue (NN1731, vatreptacog alfa (activated)) in healthy Japanese male subjects. In addition, the pharmacokinetics of NN1731 will be examined

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: vatreptacog alfa (activated) intervention 2: vatreptacog alfa (activated) intervention 3: vatreptacog alfa (activated) intervention 4: vatreptacog alfa (activated) intervention 5: placebo intervention 6: placebo intervention 7: placebo intervention 8: placebo
Intervention descriptions: intervention 1: One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg intervention 2: One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg intervention 3: One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg intervention 4: One single dose is injected i.v. over 2 minutes to 6 subjects, 30 mcg/kg intervention 5: Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg intervention 6: Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg intervention 7: Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg intervention 8: Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg

Protocol documents:
Clinical trial NCT00837967
Conditions: Asthma
Keywords: Asthma Symbicort Turbuhaler
Sponsor: AstraZeneca
Start date: 2009-01-01; Completion date: 2009-07-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of the study is to compare the tolerability of Symbicort® Turbuhaler® 160/4.5 μg 10 inhalations with terbutaline Turbuhaler® 0.4 mg 10 inhalations for 3 days on top of Symbicort® Turbuhaler® 160/4.5 μg 1 inhalation twice a day (bid) in adult asthma patients.

Detailed description:

Arms: arm 1: Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days arm 2: Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,
Interventions: intervention 1: Symbicort Turbuhaler intervention 2: Terbutaline Turbuhaler
Intervention descriptions: intervention 1: 160/4.5μg for 3 days intervention 2: 0.4 mg for 3 days

Protocol documents:
Clinical trial NCT00846768
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2009-02-01; Completion date: 2009-07-01
Enrollment: 47 participants; Allocation: ; Intervention model: CROSSOVER

Brief summary:
The primary objective of the trial is to determine the effect of BI 17444Cl on the lung function over a 24-hour period, when it is inhaled using the Respimat inhaler in patients with chronic obstructive pulmonary disease. In the trial four treatments of each 3 weeks of duration are included: 2 dosages in a once daily administration and 2 dosages for administration twice daily.

Detailed description:

Interventions: intervention 1: BI 1744 CL
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00851890
Conditions: Chronic Hepatitis C Virus Infection
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2009-03-01; Completion date: 2009-07-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the safety, tolerability, pharmacokinetics and antiviral activity of ABT-333 (also known as dasabuvir) in treatment-naïve, hepatitis C virus (HCV)-infected participants.

Detailed description:
This was a Phase 2a, blinded, randomized, placebo-controlled clinical trial in hepatitis C virus (HCV)-infected adults with 2 planned sequential evaluations, Part 1 and Part 2. The study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of ABT-333 or placebo monotherapy, followed by 26 days of ABT-333 or placebo with pegylated interferon a-2a (pegIFN) and ribavirin (RBV) combination therapy. Review of safety and efficacy in Part 1 of the study showed similar response rates across ABT-333 doses so Part 2 of the study was not performed. The study also assessed emergence of resistant HCV in conjunction with kinetics of viral load decay and rebound in treatment-naïve, HCV-infected participants.

Arms: arm 1: Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. arm 2: Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. arm 3: Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. arm 4: Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
Interventions: intervention 1: ABT-333 intervention 2: Placebo for ABT-333 intervention 3: Pegylated interferon intervention 4: Ribavirin
Intervention descriptions: intervention 1: 50 mg capsules intervention 2: Capsule intervention 3: Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly intervention 4: 200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day

Protocol documents: