ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01509807
Conditions: Retraction of Colostomy
Keywords: Ileostomy reversal
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2012-01-01; Completion date: 2012-10-01
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospitalization costs.

Detailed description:
This is a phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with EXPAREL (bupivacaine liposome injectable suspension) compared with postsurgical administration of standardized intravenous (IV) morphine sulfate for postsurgical analgesia in adult patients undergoing ileostomy reversal with general anesthesia.

Arms: arm 1: IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC) arm 2: EXPAREL (bupivacaine liposome injectable suspension)
Interventions: intervention 1: IV morphine sulfate or Sponsor-approved equivalent intervention 2: EXPAREL
Intervention descriptions: intervention 1: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. intervention 2: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.

Protocol documents:
Clinical trial NCT01515410
Conditions: Parkinson's Disease Motor Fluctuations
Keywords: Parkinson's disease PD stage2/3Parkinson's Advanced Parkinson's Disease with Motor Fluctuations
Sponsor: Depomed
Start date: 2012-01-01; Completion date: 2012-10-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to explore the efficacy and tolerability of DM-1992 compared to a standard carbidopa/Levodopa Immediate-Release (CD/LD IR) tablet (Sinemet IR) as measured by:

* "ON" time with no dyskinesia or non-troublesome dyskinesia
* "OFF" time

Detailed description:

Arms: arm 1: DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD) arm 2: An Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
Interventions: intervention 1: DM-1992 intervention 2: Sinemet IR
Intervention descriptions: intervention 1: 72.5mg carbidopa/230mg levodopa intervention 2: Immediate-release tablet containing 25mg carbidopa and 100mg levodopa

Protocol documents:
Clinical trial NCT01523782
Conditions: Acute Lymphoblastic Leukemia
Keywords: Acute Lymphoblastic leukemia Elderly patient Asparaginase
Sponsor: ERYtech Pharma
Start date: 2009-04-01; Completion date: 2012-10-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to determine the maximum tolerated and efficient dose of GRASPA® in combination with polychemotherapy treatment of elderly patients with ALL, 55 years and over, Philadelphia chromosome-negative (ALL Ph-).

Detailed description:
This open label, non randomised, multicentric and national phase IIa study was designed to evaluate the safety and efficacy of GRASPA®, a suspension of red blood cells encapsulating E. Coli L-asparaginase, at different doses and in combination with the polychemotherapy regimen recommended by the European Working Group on Adult ALL (EWALL) for frontline therapy of patients with ALL Ph-, aged 55 years old and over. Patients with a good performance status (WHO score ≤2) and a newly diagnosed ALL Ph- were treated with the backbone polychemotherapy consisting of a first 4-week induction phase comprising dexamethasone, vincristine and idarubicin, a second 4-week induction phase including cyclophosphamide, cytarabine, a 6-month consolidation phase consisting of 6 alternating cycles with methotrexate, asparaginase and folinic acid (cycles 1, 3 and 5) and high-dose cytarabine (cycles 2, 4 and 6) with Granulocyte colony stimulating factor (G-CSF) support followed by a 16-month maintenance period with mercaptopurine, methotrexate and vincristine/dexamethasone pulses. GRASPA® was administered on day 3 of induction 1 and on day 6 of induction 2 of the chemotherapy regimen.

Arms: arm 1: Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase. arm 2: Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase arm 3: Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Interventions: intervention 1: GRASPA
Intervention descriptions: intervention 1: Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase

Protocol documents:
Clinical trial NCT01525173
Conditions: Glaucoma Ocular Hypertension
Sponsor: Allergan
Start date: 2012-01-01; Completion date: 2012-10-01
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of either bimatoprost 0.01% ophthalmic solution (Lumigan®) alone or bimatoprost 0.01% ophthalmic solution (Lumigan®) and brimonidine tartrate 0.1% ophthalmic solution (Alphagan® P) in combination in patients previously treated with latanoprost 0.005% ophthalmic solution monotherapy who require additional intraocular pressure (IOP) lowering medication.

Detailed description:

Arms: arm 1: 1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks. arm 2: 1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
Interventions: intervention 1: 0.1% brimonidine tartrate ophthalmic solution intervention 2: 0.01% bimatoprost ophthalmic solution intervention 3: 0.2% hypromellose lubricant eye drops intervention 4: latanoprost 0.005% ophthalmic solution
Intervention descriptions: intervention 1: 1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks. intervention 2: 1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks. intervention 3: 1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks. intervention 4: 1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.

Protocol documents:
Clinical trial NCT01535560
Conditions: Acute Otitis Externa
Keywords: Acute otitis externa
Sponsor: Alcon Research
Start date: 2012-04-01; Completion date: 2012-10-01
Enrollment: 589 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to demonstrate superiority of AL-60371 relative to Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).

Detailed description:
Participants or legal guardians completed a telephone diary twice daily to record assessments of ear pain, ear medication use, and impact of ear pain on sleep and other daily activities.

Arms: arm 1: AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days arm 2: AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
Interventions: intervention 1: AL-60371, 0.3% otic suspension intervention 2: AL-60371 Vehicle
Intervention descriptions: intervention 1: Investigational otic suspension intended for the treatment of acute otitis externa intervention 2: Inactive ingredients used as placebo

Protocol documents:
Clinical trial NCT01537120
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-12-01; Completion date: 2012-10-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial will attempt to develop the use of Continuous Glucose Monitoring (CGM) as a tool for the evaluation of both new and existing pharmacological treatments for type 2 diabetes, using the twice daily administered dipeptidyl peptidase-4 (DPP4) inhibitor, vildagliptin as a probe. The primary hypothesis is that two weeks of treatment with 50 mg of oral Vildagliptin, twice daily will lead to a statistically significant decrease in 24 hour weighted-mean glucose (WMG) relative to placebo.

Detailed description:

Arms: arm 1: Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily
Interventions: intervention 1: Vildagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01542541
Conditions: Intestinal FDG Uptake
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2011-07-01; Completion date: 2012-10-01
Enrollment: 68 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients who undergo PET-CT scans to look for cancer are given an intravenous contrast (FDG) that is taken-up by active cells such as cancer cells. This contrast can then be seen in the body using the PET-CT scanner. However, cells in the colon also take up the FDG, and can produce "false positive" signals from the colon. Our hypothesis is that much of this signal comes from bacteria that are present in high concentrations in the colon. If this is the case, using an antibiotic to suppress the activity of bacteria may improve the ability of PET-CT to distinguish abnormal cells from normal cells in the colon.

Detailed description:

Arms: arm 1: None arm 2: Randomly-selected matched PET-CT scans performed on same day as intervention group.
Interventions: intervention 1: Rifaximin
Intervention descriptions: intervention 1: 550mg BID for 2 days

Protocol documents:
Clinical trial NCT01568112
Conditions: Healthy
Keywords: BG00012 gastrointestinal events flushing events dose titration pre-medication aspirin
Sponsor: Biogen
Start date: 2012-04-01; Completion date: 2012-10-01
Enrollment: 173 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate whether premedication with 325 mg microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the incidence and severity of flushing and GI events following oral administration of BG00012 dosed at 240 mg twice a day (BID) in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BG00012 when administered orally as a 240 mg BID dose regimen with and without 325 mg ASA premedication or following a slow-titration dosing schedule in healthy volunteers.

Detailed description:

Arms: arm 1: Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks. arm 2: Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks. arm 3: Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks. arm 4: Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
Interventions: intervention 1: BG00012 (dimethyl fumarate) intervention 2: BG00012 placebo intervention 3: ASA intervention 4: ASA placebo
Intervention descriptions: intervention 1: Each capsule contains 120 mg dimethyl fumarate (DMF). Fast titration involves taking one 120 mg capsule in the morning and one in the evening (240 mg daily) for one week, and then escalating to a dose of 480 mg daily (two capsules morning and evening) for the remainder of the study.Slow titration expands the dose escalation time to 4 weeks. intervention 2: Placebo matching BG00012 intervention 3: 325 mg microcoated aspirin (ASA) intervention 4: Placebo matching aspirin

Protocol documents:
Clinical trial NCT01587079
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Sponsor: Pearl Therapeutics, Inc.
Start date: 2012-04-01; Completion date: 2012-10-01
Enrollment: 159 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD

Detailed description:

Arms: arm 1: PT003 MDI Dose 1 arm 2: PT003 MDI Dose 2 arm 3: PT003 MDI Dose 3 arm 4: PT003 MDI Dose 4 arm 5: PT003 MDI Dose 5 arm 6: PT001 MDI arm 7: PT005 MDI arm 8: Tiotropium Bromide
Interventions: intervention 1: PT003 intervention 2: PT001 intervention 3: PT005 intervention 4: Tiotropium inhalation powder
Intervention descriptions: intervention 1: PT003 MDI administered as two puffs BID for 7 days intervention 2: PT001 MDI administered as two puffs BID for 7 days intervention 3: PT005 MDI administered as two puffs BID for 7 days intervention 4: Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days

Protocol documents:
Clinical trial NCT01593761
Conditions: Skin Infection
Keywords: cABSSSI MRSA
Sponsor: CrystalGenomics, Inc.
Start date: 2012-06-01; Completion date: 2012-10-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective:

To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with cABSSSI (major cutaneous abscesses) due to MRSA.

Secondary Objective(s):

* To assess the pharmacokinetics of CG400549 (960 mg daily) in subjects with cABSSSI due to MRSA
* To explore the in vitro susceptibility of cABSSSI-related bacteria to CG400549.
* To assess the safety of multiple doses of CG400459

Detailed description:
This will be an open-label, exploratory study to evaluate the safety, pharmacokinetics, and efficacy of CG400549, daily for 10 to 14 days, in subjects with cABSSSI (major cutaneous abscesses) due to MRSA. All subjects will receive active treatment.

Subjects will begin study treatment upon confirmation of clinical eligibility (ie, confirmation of MRSA infection is not required pretreatment). Subjects who begin treatment with CG400549 and are subsequently not found to have S. aureus infection will be discontinued from study treatment, treated as appropriate for the identified pathogen(s), and followed for safety. These subjects will be included in the safety analyses but not in the primary efficacy analysis.

Arms: arm 1: All the patients will be administered with CG400549.
Interventions: intervention 1: CG400549
Intervention descriptions: intervention 1: 960mg QD at fed state approx 1 hour after meal

Protocol documents:
Clinical trial NCT01602068
Conditions: Cataract
Keywords: Iontophoresis Cataract Surgery Ophthalmology Posterior Chamber Intraocular Lens Implant
Sponsor: Eyegate Pharmaceuticals, Inc.
Start date: 2012-05-01; Completion date: 2012-10-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to placebo in patients undergoing cataract surgery with implantation of a posterior chamber intraocular lens.

Detailed description:
Phase 2, proof-of-concept (POC) clinical trial designed to evaluate the safety and efficacy of ocular iontophoretic delivery of dexamethasone phosphate ophthalmic solution compared to ocular iontophoresis with a placebo (100 mM citrate buffer of pH 5.7) in patients planning to have cataract surgery with implantation of a posterior chamber intraocular lens (IOL). The population studied was comprised of males and females scheduled for unilateral cataract surgery with implantation of a posterior chamber IOL. Eligible patients were enrolled into the study and were randomized on Day 1 in a 1:1 ratio into one of the following two treatment arms. Treatments were administered on the day prior (Day -1) to cataract surgery (Day 0). Subjects were scheduled to return to the clinic on Days 1, 7, 14, and 28. All subjects were scheduled to exit the study on Day 28. Subjects were asked to complete a daily pain score assessment questionnaire for the first 14 days post-surgery (Days 0 - 14).

Arms: arm 1: Dexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery) arm 2: Placebo (100 mM sodium citrate buffer solution) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)
Interventions: intervention 1: Dexamethasone Phosphate Ophthalmic intervention 2: 100 mM Sodium Citrate Buffer
Intervention descriptions: intervention 1: Transcleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) intervention 2: Transcleral iontophoresis delivery of 100 mM sodium citrate buffer solution

Protocol documents:
Clinical trial NCT01607853
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2012-06-01; Completion date: 2012-10-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the anti-psoriatic effect of Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes), Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) compared with Daivobet® gel and Daivobet® gel vehicle applied for 24 hours (+/- 2 hours), using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) intervention 2: Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) intervention 3: Daivobet® gel applied for 24 hours (+/- 2 hours) intervention 4: Daivobet® gel vehicle applied for 24 hours (+/- 2 hours)
Intervention descriptions: intervention 1: Once daily application, 3 weeks intervention 2: Once daily application, 3 weeks intervention 3: Once daily application, 3 weeks intervention 4: Once daily application, 3 weeks

Protocol documents:
Clinical trial NCT01654250
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD methylphenidate extended-release
Sponsor: Pfizer
Start date: 2012-07-01; Completion date: 2012-10-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD

Detailed description:

Arms: arm 1: NWP09 arm 2: Placebo
Interventions: intervention 1: NWP09 intervention 2: Placebo
Intervention descriptions: intervention 1: Methylphenidate, variable dose, daily dosing, 1 week duration intervention 2: Placebo

Protocol documents:
Clinical trial NCT01661790
Conditions: Malignant Pleural Effusion
Keywords: Bevacizumab; non-small cell lung cancer; malignant pleural effusion; intrapleural administration
Sponsor: Chinese PLA General Hospital
Start date: 2009-08-01; Completion date: 2012-10-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the efficacy and Safety of intrapleural Bevacizumab and cisplatin as a treatment for malignant pleural effusions (MPE) in patients with non-small cell lung cancer (NSCLC).

Detailed description:

Arms: arm 1: Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks arm 2: Cisplatin 30mg by intrapleural given every two weeks
Interventions: intervention 1: Bevacizumab intervention 2: Cisplatin
Intervention descriptions: intervention 1: Bevacizumab300mg\&Cispltin30mg by intrapleural administration of each 2 week intervention 2: Cisplatin 30mg,intrapleural administration,each 2 week

Protocol documents:
Clinical trial NCT01680328
Conditions: Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Delivery Systems
Sponsor: Novo Nordisk A/S
Start date: 2012-08-01; Completion date: 2012-10-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This trial is conducted in Europe. The aim of this trial is to assess and describe the pain in relation to subcutaneous (under the skin) injection of different combinations of injection speed and volume with respect to acceptance of the injection pain and backflow.

Detailed description:

Arms: arm 1: The study consists of 80 treatment arms in a cross-over design with 19 treatments and 19 periods. The 80 treatment arms will represent different orders of the 19 treatments and each treatment arm will be used for one subject. A subject not completing all treatments will be replaced by another subject using the same treatment arm.
Interventions: intervention 1: 19 injections intervention 2: sodium chloride 0.9% solution
Intervention descriptions: intervention 1: Subjects will receive 19 injections in randomised order of which 13 will be in the abdomen and 6 in the thighs. Out of the 19 injections, 2 are needle insertions only. The remaining 17 injections represent different combinations of injection speed and volume of sodium chloride 0.9% solution for injection. The order of the injection speed and volume combinations will be blinded for the subject and the pain will be evaluated by the subject on a VAS (Visual Analogue Scale). intervention 2: Solution for injection.

Protocol documents: