ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01326910
Conditions: Atopic Dermatitis
Keywords: Eczema
Sponsor: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
Start date: 2011-03-01; Completion date: 2011-06-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This three week study will be conducted to determine the safety and efficacy of an over-the-counter (OTC) cream in children with mild to moderate atopic dermatitis.

Detailed description:
The objective of this trial is to evaluate the efficacy and safety of an OTC colloidal oatmeal skin protectant cream in children with mild to moderate AD in comparison to that of EpiCeram®

Arms: arm 1: Experimental Topical cream applied twice daily (or as needed) arm 2: Marketed Topical cream applied twice daily (or as needed)
Interventions: intervention 1: Colloidal Oatmeal intervention 2: Topical Cream
Intervention descriptions: intervention 1: Topical cream applied twice daily (or as needed) intervention 2: Topical cream applied twice daily (or as needed)

Protocol documents:
Clinical trial NCT01330017
Conditions: Rhinitis Seasonal Rhinitis
Keywords: Seasonal allergies
Sponsor: Bayer
Start date: 2011-03-01; Completion date: 2011-06-01
Enrollment: 539 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The trial will evaluate the nasal congestion symptom relief of the approved 10 mg phenylephrine (PE) dose and the higher 20 mg, 30 mg, and 40 mg PE doses compared with placebo in participants with histories of seasonal allergic rhinitis, using loratadine as background medication.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Phenylephrine HCl intervention 2: Placebo intervention 3: Loratadine
Intervention descriptions: intervention 1: 10-mg immediate-release tablets, orally, up to 4 tablets per dose every 4 hours, for 7 days intervention 2: Placebo tablets, orally, up to five tablets per dose every 4 hours, for 7 days intervention 3: 10-mg tablets, orally, once per day at a dose not to exceed 10 mg in a 24-hour period.

Protocol documents:
Clinical trial NCT01332578
Conditions: Influenza Common Cold
Sponsor: GlaxoSmithKline
Start date: 2011-05-01; Completion date: 2011-06-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study is designed to investigate whether paracetamol from a hot remedy reaches the plasma faster than standard paracetamol tablets. The study will also assess the gastrointestinal transit of two oral cold and influenza ('flu') formulations using gamma scintigraphy. It is postulated that paracetamol in solution, such as from cold and 'flu' hot remedies, provides a greater early exposure compared to standard paracetamol tablets. In addition, the pharmacokinetic (PK) profile of paracetamol in the two formulations will be investigated.

Detailed description:

Arms: arm 1: Paracetamol, phenylephrine and ascorbic acid to be administered in 150 milliliters (mL) of hot water. arm 2: Two paracetamol 500 mg tablets to be administered with 150 mL of hot water.
Interventions: intervention 1: Paracetamol intervention 2: Phenylephrine intervention 3: Ascorbic Acid
Intervention descriptions: intervention 1: Present in both test and active comparator intervention 2: Test product intervention 3: Test product

Protocol documents:
Clinical trial NCT01333722
Conditions: Pain
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2011-04-01; Completion date: 2011-06-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate to severe pain following bunionectomy.

Detailed description:
The bunionectomy was performed under regional anesthesia and propofol sedation. Perioperative anesthesia was standardized for all participants. Upon completion of surgery, designated study personnel ensured continued eligibility per the selection criteria of the protocol.

After an appropriate period of time following bunionectomy, participants who had a pain intensity score of ≥ 40 mm on a 100 mm visual analog scale (VAS) and moderate or severe pain intensity per the categorical pain intensity scale were eligible for randomization, in equal numbers, into 1 of 2 treatment arms: hydrocodone/acetaminophen extended release or placebo.

Arms: arm 1: placebo, 1 oral tablet every 12 hours arm 2: hydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours
Interventions: intervention 1: Hydrocodone/Acetaminophen Extended Release intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Placebo tablet

Protocol documents:
Clinical trial NCT01340196
Conditions: HIV Infections
Sponsor: Boehringer Ingelheim
Start date: 2011-04-01; Completion date: 2011-06-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the drug-drug interaction potential between BI 201335 and concomitantly administered tenofovir which is used in treatment regimens for HIV infection and/or Hepatitis B infection. Results of this study will serve as a basis for guidance of dose adjustments or other precautionary measures when BI201335 and tenofovir are coadministered.

Detailed description:

Arms: arm 1: tenofovir medium dose once daily (qd) for first 15 days; BI 201335 medium dose twice daily (bid) on days 8 through day 22 (morning dose on day 22 only)
Interventions: intervention 1: tenofovir/BI 201335
Intervention descriptions: intervention 1: tenofovir medium dose once daily (qd) for first 15 days; BI 201335 medium dose twice daily (bid) on days 8 through 22 with last dose on morning of day 22

Protocol documents:
Clinical trial NCT01347086
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-05-01; Completion date: 2011-06-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and Caucasian healthy male volunteers administered BI 207127 NA.

Detailed description:

Arms: arm 1: Single dose of BI 207127 NA arm 2: Single dose of matching placebo arm 3: Single dose of BI 207127 NA arm 4: Single dose of matching placebo arm 5: Single dose of BI 207127 NA arm 6: Single dose of matching placebo
Interventions: intervention 1: Matching placebo (low dose) intervention 2: BI 207127 NA (medium dose) intervention 3: BI 207127 NA (low dose) intervention 4: Matching placebo (medium dose) intervention 5: BI 207127 NA (high dose) intervention 6: Matching placebo (high dose)
Intervention descriptions: intervention 1: single dose of matching placebo intervention 2: Single does of BI 207127 NA intervention 3: single dose of BI 207127 NA intervention 4: Single dose of matching placebo intervention 5: Single dose of BI 207127 NA intervention 6: Single dose of matching placebo

Protocol documents:
Clinical trial NCT01347255
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2011-05-01; Completion date: 2011-06-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the anti-psoriatic effect of LEO 90100 cutaneous spray ointment, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

Detailed description:

Arms: arm 1: LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate). arm 2: Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate) arm 3: LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients. arm 4: Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
Interventions: intervention 1: LEO90100 cutaneous spray, ointment intervention 2: LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate intervention 3: LEO 90100 cutaneous spray, ointment, vehicle intervention 4: Daivobet® ointment
Intervention descriptions: intervention 1: once daily application, 4 weeks intervention 2: once daily application, 4 weeks intervention 3: once daily application, 4 weeks intervention 4: once daily application, 4 weeks

Protocol documents:
Clinical trial NCT01355068
Conditions: Healthy
Keywords: phenytoin chewable tablets dilantin epanutin infatabs bioequivalence Partial seizure Tonic-clonic seizure
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2011-05-01; Completion date: 2011-06-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
In this study, the bioequivalence of Epanutin Infatabs® 50 mg (sourced from Germany) and Dilantin Infatabs® 50 mg (sourced from Australia) will be assessed. This is intended to be a pivotal bioequivalence study.

Detailed description:

Arms: arm 1: Epanutin Infatabs 50 mg (sourced from Germany), 1 x 50 mg (REFERENCE) arm 2: Dilantin Infatabs 50 mg (sourced from Australia), 1 x 50 mg (TEST)
Interventions: intervention 1: Epanutin Infatabs (Phenytoin) intervention 2: Dilantin Infatabs (Phenytoin)
Intervention descriptions: intervention 1: Chewable Tablet, 50 mg, Single dose intervention 2: Chewable Tablet, 50 mg, Single dose

Protocol documents:
Clinical trial NCT01366417
Conditions: Antimicrobial Effectiveness
Sponsor: CareFusion
Start date: 2011-05-01; Completion date: 2011-06-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep One-Step Frepp Applicator.

Detailed description:

Interventions: intervention 1: ChloraPrep One-Step intervention 2: 70% isopropyl alcohol
Intervention descriptions: intervention 1: 1.5 ml applicator patient preoperative skin preparation intervention 2: Curity Alcohol Prep Pads

Protocol documents:
Clinical trial NCT01375491
Conditions: Type 2 Diabetes Obesity
Keywords: doxycycline insulin resistance obesity inflammation
Sponsor: University of California, San Diego
Start date: 2009-10-01; Completion date: 2011-06-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Obesity is a heightened state of inflammation in which production of cytokines and matrix metalloproteinases (MMPs) result in loss of function of insulin receptors and insulin resistance. Doxycycline (DOX) is a potent MMP inhibitor. We hypothesize that DOX will enhance insulin sensitivity and decreases inflammation in obese participants with type 2 diabetes (DM2).

Detailed description:
Design and Setting: 84 day (D84), double-blind, randomized, placebo (PL)-controlled clinical trial conducted in an academic tertiary care center.

Patients: Non-DM2 Controls (n=15); participants with DM2 receiving PL (n=13) or DOX (n=11).

Interventions: All participants were evaluated at day 1 (D1); those with DM2 were also evaluated at D84 after DOX 100mg twice daily or PL.

Arms: arm 1: Participants with DM2 receiving doxycycline 100mg BID arm 2: Pills prepared identical to doxycycline.
Interventions: intervention 1: Doxycycline intervention 2: Placebo
Intervention descriptions: intervention 1: generic doxycycline 100mg twice daily intervention 2: Placebo comparator to doxycycline

Protocol documents:
Clinical trial NCT01375946
Conditions: Healthy
Keywords: Pharmacokinetic Profile (PK) and Safety PK analysis of EE and LNG
Sponsor: Agile Therapeutics
Start date: 2011-05-01; Completion date: 2011-06-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A study to evaluate pharmacokinetic profile, wearability and safety of AG200-15, transdermal delivery of levonorgestrel (LNG) and ethinyl estradiol (EE), under normal conditions and external conditions of heat, humidity, cold water and exercise.

Detailed description:
Normal conditions - average daily living activities, Dry Sauna - 10 minutes at 168.8 - 179.6 degrees Fahrenheit, Whirlpool - 10 minutes at 102.2 - 105.8 degrees Fahrenheit, Treadmill - 20 - 30 minutes at 60-80% max heart rate, Cold Water - 5 - 15 minutes at 71.6 degrees Fahrenheit.

There will be three treatment periods. Subjects will be randomly assigned to one of the five conditions for the treatment period. The subject will be exposed daily to the condition assigned while wearing the patch. The study patch will be worn for a 7 day treatment period, followed by a 7 day washout period. The total duration of the study is 6 weeks.

Arms: arm 1: The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna).
Interventions: intervention 1: AG200-15
Intervention descriptions: intervention 1: There will be three treatment periods. Subjects will be randomly assigned to one of the five conditions for the treatment period. The subject will be exposed daily to the condition assigned while wearing the patch. The study patch will be worn for a 7 day treatment period, followed by a 7 day washout period. The total duration of the study is 6 weeks.

Protocol documents:
Clinical trial NCT01395043
Conditions: Postoperative Pain
Keywords: Transversus Abdominis Plane catheter TAP catheter
Sponsor: Aalborg University Hospital
Start date: 2010-09-01; Completion date: 2011-06-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Major abdominal surgery is associated with postoperative pain. Transversus Abdominis Plane(TAP) block has been shown to reduce pain and opioid-requirements after abdominal surgery. However a single block has a short effect of up to 12 hours depending on the type local-anesthetics used.

With this study we wish to investigate the possibilities to place a TAP-catheter in order to prolong the the effect of the TAP-block by giving repeatedly bolus-injections in the TAP catheter and to study the pain and the opioid requirements of patients undergoing elective colon-resection when given a TAP-catheter preoperatively.

Our hypothesis is that it is practical and technical possible to place bilateral TAP-catheters pre-operatively and that pain and opioid-requirements will be low.

Detailed description:
Postoperative pain is a major challenge in the work of anesthesia. Epidural catheter is the golden standard for postoperative pain management after major abdominal surgery. However a number of patient have absolute or relative contraindication to the placement of an epidural catheter. It is therefore necessary to find a good alternative to epidural catheter.

Transversus abdominis plane(TAP) block has been shown to provide analgesia of the abdominal wall and reduce opioid-requirements and pain after abdominal surgery.

However the effect of a TAP block is limited to the time of efficacy of the local analgesic used. Placing a TAP-catheter in order to prolong the effect of the TAP-block by repeatedly bolus-injections in the TAP-catheters has only been sporadically described and so far never investigated in a systematic way.

We will investigate the practical and technical possibility to place bilateral ultrasound-guided TAP-catheters pre-operatively on patients undergoing elective colon-resection. Further more we will evaluate the pain and opioid-requirement postoperatively.

Arms: arm 1: Each patient receives bilateral TAP-catheters preoperatively.
Interventions: intervention 1: Placing bilateral TAP-catheters preoperatively intervention 2: Bupivacain 2.5 mg/ml with epinephrine bolus in TAP-catheters
Intervention descriptions: intervention 1: Place bilateral TAP-catheters preoperatively and give repeated boluses of local analgetics in order to treat postoperative pain after colon-surgery. intervention 2: Intermittent boluses of Bupivacain 2.5 mg/ml with epinephrine, 20 ml in each catheter every 12 hours for the first 2 postoperative days.

Protocol documents:
Clinical trial NCT01398514
Conditions: Fear Conditioning
Sponsor: Massachusetts General Hospital
Start date: 2008-10-01; Completion date: 2011-06-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to learn how differences in learning under mildly-stressful circumstances may be changed by taking an antidepressant medication. This medication is called Lexapro (Escitalopram). The investigators will also examine the impact of any anxiety, depression, and stress related symptoms on learning processes. The investigators will also look at the response of these symptoms to Lexapro.

Detailed description:

Arms: arm 1: Escitalopram 10mg/day arm 2: Matched pill placebo
Interventions: intervention 1: Escitalopram
Intervention descriptions: intervention 1: Escitalopram 10mg/day or matched pill placebo

Protocol documents:
Clinical trial NCT01422369
Conditions: Healthy
Keywords: Healthy Volunteers
Sponsor: Kowa Research Institute, Inc.
Start date: 2011-04-01; Completion date: 2011-06-01
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 4, single center, open label, fixed-sequence, multiple dose, 2-way drug-drug interaction study.

Detailed description:
This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study.

Each subject will qualify for entry into the study not more than 30 days before admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. There will be 1 treatment period, with each subject receiving a once daily dose of pitavastatin 4 mg on Days 1 through 5 and Days 12 through 16 and a once daily dose of darunavir/ritonavir 800 mg/100 mg on Days 6 through 16. On Days 1 through 4, 6 through 10, and 12 through 15, study drug will be administered 30 minutes before a standard breakfast. On Days 5, 11, and 16, subjects will fast at least 8 hours before receiving study drug and remain fasted for 4 hours after dosing.

Arms: arm 1: pitavastatin 4 mg
Interventions: intervention 1: Pitavastatin (NK-104) intervention 2: Darunavir/Ritonavir (Prezista)
Intervention descriptions: intervention 1: Pitavastatin (NK-104) 4mg once daily (QD) intervention 2: Darunavir/Ritonavir (Prezista) 800 mg/100 mg

Protocol documents:
Clinical trial NCT01519284
Conditions: Parkinson Disease
Keywords: Parkinson Disease BIA 9-1067
Sponsor: Bial - Portela C S.A.
Start date: 2009-11-01; Completion date: 2011-06-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics, in comparison to placebo and entacapone.

Detailed description:
Single-centre, double-blind, randomised, parallel-group study in 80 young male and female healthy subjects.

Arms: arm 1: Placebo at all the dosing times arm 2: Day 1 to 7:

BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose

Day 8:

BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose arm 3: Day 1 to 7:

BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose

Day 8:

BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose arm 4: Day 1 to 7:

BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose

Day 8:

BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose arm 5: Day 1 to 7:

Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose

Day 8:

Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose
Interventions: intervention 1: BIA 9-1067 5 mg intervention 2: Entacapone intervention 3: Placebo intervention 4: levodopa/carbidopa intervention 5: BIA 9-1067 15 mg intervention 6: BIA 9-1067 30 mg
Intervention descriptions: intervention 1: BIA 9-1067 OPC, Opicapone 5 mg intervention 2: Entacapone 200 mg intervention 3: placebo (four times a day) intervention 4: standard release levodopa/carbidopa 100/25 mg (single-dose) intervention 5: BIA 9-1067 OPC, Opicapone 15 mg intervention 6: BIA 9-1067 OPC, Opicapone 30 mg

Protocol documents:
Clinical trial NCT01535222
Conditions: Coronary Artery Bypass Graft Cardiopulmonary Bypass
Keywords: cardiac surgery coronary artery bypass graft cardiopulmonary bypass haemostasis modulator blood loss direct inhibitor of plasmin and plasma kallikrein CABG CPB
Sponsor: The Medicines Company
Start date: 2010-11-01; Completion date: 2011-06-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to demonstrate that periprocedural infusion of escalating doses of MDCO-2010 is safe and tolerated in patients undergoing elective CABG surgery, to characterize the single dose pharmacokinetics of MDCO-2010, to investigate the effect of MDCO-2010 on pharmacodynamics (biomarkers of fibrinolysis and coagulation parameters), and to investigate the effect on exploratory clinical endpoints of bleeding, transfusion requirements and reexploration.

Detailed description:
This protocol describes a study of the investigational drug MDCO-2010 as a haemostasis modulator in patients undergoing elective Coronary Artery Bypass Graft (CABG) surgery involving a cardiopulmonary bypass (CPB).

Perioperative bleeding is a serious complication that adversely affects the morbidity and mortality of cardiac surgery. To alleviate this complication, prophylactic antifibrinolytic therapies are now widely accepted as a strategy to inhibit excessive fibrinolysis.

MDCO-2010, a synthetic small molecule, is a direct inhibitor of plasmin and plasma kallikrein. Both of these have been implicated with impaired haemostasis. In addition, potent inhibition of coagulation factors Xa, XIa and activated Protein C has been demonstrated. Thus, MDCO-2010 has the potential to mitigate excessive fibrinolysis and thrombin generation during cardiac surgery involving a cardiopulmonary bypass. In particular the latter is supposed to provide additional benefits beyond reducing transfusion requirements.

Arms: arm 1: 3 patients: loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg arm 2: 3 pts: loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg arm 3: 6 patients: loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg arm 4: 6 patients: loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg arm 5: 6 patients: loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg arm 6: 8 patients: commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
Interventions: intervention 1: MDCO-2010 intervention 2: Placebo
Intervention descriptions: intervention 1: MDCO-2010 solution for infusion. Dosage: Pump priming dose; Loading dose infusion over 6 minutes; Maintenance infusion for duration of surgery intervention 2: Commercially available NaCl

Protocol documents: