ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01675453
Conditions: Coronary Artery Disease Edema
Keywords: Organ dysfunction Hypertonic solution Extravascular water Cardiopulmonary Bypass
Sponsor: Meshalkin Research Institute of Pathology of Circulation
Start date: 2012-01-01; Completion date: 2012-09-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The organ dysfunction following cardiopulmonary bypass (CPB) occurs frequently in cardiac surgery patients. Systemic inflammatory response initiated by CPB through releasing of several mediators lead to altered endothelial integrity and in consequence the leakage of proteins and fluids from the intravascular to the interstitial compartment is occurred. Increased capillary permeability and decreased colloid osmotic pressure were shown to play a key role for fluid shift and increasing of extravascular water. Further tissue edema can result in injury to many organs, including the heart, lungs, brain, kidneys and can lead to adverse outcomes.

Hypertonic solution creates an osmotic gradient across the cellular membrane, causing a fluid shift from the intracellular and the interstitial spaces of tissue into the intravascular compartment.

The purpose of this study is to investigate the efficacy and safety of 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 in patients scheduled for first-time coronary artery bypass grafting with cardiopulmonary bypass.

Detailed description:

Arms: arm 1: On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) arm 2: On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)
Interventions: intervention 1: 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 intervention 2: 0.9% NaCl
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01677299
Conditions: Type 2 Diabetes Mellitus
Sponsor: Elcelyx Therapeutics, Inc.
Start date: 2012-05-01; Completion date: 2012-09-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate how EFB0027 and EFB0026 behave in subjects with type 2 diabetes mellitus.

In addition, this study will compare the effects of EFB0027 and EFB0026 on circulating concentrations of glucose and gastrointestinal hormones in subjects with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: BID arm 2: BID arm 3: BID arm 4: BID
Interventions: intervention 1: EFB0027 (metformin delayed release) intervention 2: EFB0026 (metformin immediate-release)
Intervention descriptions: intervention 1: Comparison of enteric-coating to assess effect on PK intervention 2: Active comparator

Protocol documents:
Clinical trial NCT01710800
Conditions: GERD
Keywords: impedance reflux GERD
Sponsor: Walter Reed National Military Medical Center
Start date: 2008-09-01; Completion date: 2012-09-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the effects of proton pump inhibitors (PPIs) on the total number of reflux episodes in the distal esophagus measured by impedance in patients with and without gastroesophageal reflux disease (GERD) based on 24-hour pH testing. In addition to changing the acidity of the refluxate, the investigators hypothesize that PPIs also reduce the total number of reflux episodes due to its anti-secretory effects.

Detailed description:

Arms: arm 1: Patients will be randomized to receive either PPI or placebo and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes arm 2: Patients were randomly assigned to receive 40 mg esomeprazole twice daily prior to undergoing a 24 hour pH study with impedance to measure the number of reflux episodes
Interventions: intervention 1: Esomeprazole intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01722604
Conditions: Glaucoma Open Angle or Ocular Hypertension
Sponsor: Bausch & Lomb Incorporated
Start date: 2012-01-01; Completion date: 2012-09-01
Enrollment: 258 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.

Detailed description:

Arms: arm 1: Ophthalmic suspension arm 2: ophthalmic suspension
Interventions: intervention 1: brinzolamide 1% ophthalmic suspension intervention 2: Azopt 1%
Intervention descriptions: intervention 1: brinzolamide 1% ophthalmic suspension intervention 2: Azopt 1%, RLD

Protocol documents:
Clinical trial NCT01734694
Conditions: Health Care Associated Pneumonia Osteomyelitis/Septic Arthritis Endocarditis Bacteremia Acute Bacterial Skin and Skin Structure Infections
Sponsor: Henry Ford Health System
Start date: 2011-10-01; Completion date: 2012-09-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical concern. This may be due to various reasons, including new dosing recommendations as well as an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity. This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin use.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Vancomycin intervention 2: Ceftaroline intervention 3: Daptomycin intervention 4: Linezolid
Intervention descriptions: intervention 1: Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;

Target trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections; intervention 2: Dose based on package insert labeling

CrCL \> 50 mL/min: 600 mg IV q12h

CrCL 31-50 mL/min: 400 mg q12h

CrCL 15-30 mL/min: 300 mg q12h

CrCL \< 15mL/min: 200 mg q12h; intervention 3: Dose based on renal function and literature dosing recommendations

CrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h

CrCL \< 30 mL/min: 6 - 10 mg/kg IV q48h intervention 4: 600 mg IV/PO q12h

Protocol documents:
Clinical trial NCT02012582
Conditions: Traumatic Brain Injury
Sponsor: veriNOS operations GmbH
Start date: 2009-11-01; Completion date: 2012-09-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In the exploratory multi-center Phase 2 a study safety, tolerability, pharmacodynamics and pharmacokinetics of the Nitric Oxide Synthase inhibitor VAS203 is assessed in patients with moderate and severe traumatic brain injury. Traumatic brain injury patients (32 males) receive 15, 20 and 30 mg/kg VAS203, respectively, by continuous infusion in three cohorts (Cohort 1 open; Cohorts 2 and 3 double blind, randomised placebo-controlled). End of Study for all patients will be Day 14; adverse events and concomitant medications will be documented throughout the study.

Objectives are to assess safety and tolerability of VAS203, to evaluate concentrations of metabolites of VAS203 in plasma and microdialysate and to assess pharmacodynamic effects of VAS203 on surrogate parameters. Safety parameter will include vital signs (blood pressure heart rate, respiration rate, oxygen saturation and blood gases), fluid balance, ECG, laboratory examinations (clinical chemistry, liver function, haematology/coagulation, urinalysis, renal parameters) and adverse events. Concentration of VAS203 will be determined in plasma and microdialysate. Pharmacodynamic parameters will include intracranial pressure (ICP), biochemical parameters in microdialysate (nitrite/nitrate, arginine, citrulline, pyruvate, lactate, glucose), Partial Oxygen Pressure in brain parenchyma and Therapy Intensity Level (TIL).

Detailed description:
Intravenous administration of study medication for each patient will start as soon as possible but not later than 12 hours after trauma. Patients in Group 1 will receive open label study drug (VAS203). Patients in Group 2 and 3 will be randomised to treatment with VAS203 or placebo.

In addition to study treatment, each patient will receive the best "standard of care" for the study centre; no treatment will be withheld.

Arms: arm 1: Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg arm 2: 10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg arm 3: 10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg arm 4: 0.9 % Sodium chloride infusion
Interventions: intervention 1: VAS203 intervention 2: Saline
Intervention descriptions: intervention 1: i.v. infusion intervention 2: i.v. infusion

Protocol documents:
Clinical trial NCT02368093
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Sponsor: Taichung Veterans General Hospital
Start date: 2010-01-01; Completion date: 2012-09-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Rheumatoid arthritis were randomized to a 6-month treatment of oral dextromethorphan hydrobromide or placebo as an add-on therapy to traditional disease-modifying anti-rheumatic drugs (DMARDs). Disease activity were assessed.

Detailed description:
Biologic-naïve rheumatoid arthritis (RA) patients who fulfilled the 2010 criteria of the American College of Rheumatology (ACR) for RA were enrolled. All patient were randomized to a 6-month treatment with either oral DXM \[dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan) with T1/2 = 7.75h, Tmax = 4.83h, Cmax = 14.6 ng mL-1 and mean residual time = 5.86 h, 120mg per day with once daily dose taken after breakfast\] or placebo pills with the same appearance as DXM tablets. The randomization was performed by the pharmacy of the Taichung Veterans General Hospital. Non-study medications were not changed during the course of study.

Twenty-four patients received add-one DXM therapy and the other 24 patients received traditional DMARDs alone in stable dose. Disease activity was assessed by the 28-joint disease activity score (DAS28) before starting add-on DXM therapy (as a baseline) and at the end of 6 months of therapy with or without add-on DXM. Patients were categorized as good, moderate or poor responders based on the amount of change in the DAS28 and the level of DAS28 reached. Good responders were defined as patients who had a decrease in DAS28 from baseline (∆DAS28)\>1.2 and a DAS28≦3.2 at evaluation time; moderate responders had either ∆DAS28\>1.2 and a DAS28\>3.2 or ∆DAS28 of 0.6-1.2 and a DAS28≦5.1 at evaluation time; and poor responders were those who had either ∆DAS28\<0.6 or a DAS28\>5.1 at evaluation time.

Arms: arm 1: Dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast\] arm 2: placebo pills with the same appearance as Detosiv tablets.
Interventions: intervention 1: Dextromethorphan hydrobromide
Intervention descriptions: intervention 1: 120mg per day with once daily dose taken after breakfast for 6 months

Protocol documents:
Clinical trial NCT01353664
Conditions: Lymphoma Cancer
Keywords: rollover protocol romidepsin Gloucester Pharmaceuticals Celgene Corporation continuing treatment
Sponsor: Celgene
Start date: 2011-05-01; Completion date: 2012-09-05
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is intended to provide access to Romidepsin for participants who received Romidepsin in other trials sponsored by Gloucester Pharmaceuticals or Celgene Corporation and for participants whom the investigator feels may benefit from continuing treatment with Romidepsin.

Detailed description:
Participants must have previously participated in a Romidepsin study sponsored by Gloucester Pharmaceuticals or Celgene Corporation.

Arms: arm 1: This study is an open-label, single-arm study. The study is divided into the Screening Period, Treatment Period, and Follow-up Period.
Interventions: intervention 1: Romidepsin
Intervention descriptions: intervention 1: The participants will generally continue at the same dose, infusion time and frequency used for the last dose of romidepsin given in the preceding romidepsin study. If the participant entered this rollover study in the middle of a cycle, then the cycle number and cycle day will be carried over from the preceding romidepsin study.

Protocol documents:
Clinical trial NCT01496365
Conditions: Diabetic Peripheral Neuropathy
Keywords: Keywords: pain, diabetes, neuropathy
Sponsor: Daiichi Sankyo
Start date: 2011-11-28; Completion date: 2012-09-07
Enrollment: 452 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability and effectiveness of DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with DPN.

Detailed description:
Diabetic peripheral neuropathy (DPN) affects up to 50% of patients who have diabetes for at least 25 years. Up to 26% of all patients with DPN experience neuropathic pain. DPN pain contributes to sleep disorders, depression, and anxiety, which together may have an impact on a patient's well-being and quality of life.

There are currently several drugs used to treat painful DPN. For example, Lyrica® (pregabalin) is approved by the United States Food and Drug Administration (FDA) to treat neuropathic pain associated with DPN and is commonly prescribed. The dosage of the FDA-approved drugs is limited by side-effects such as dizziness, sleepiness, weight gain and swelling of the hands, legs, and feet. As a result, many patients suffering from DPN pain do not get satisfactory pain relief.

Arms: arm 1: DS-5565 5 mg/day (one 5 mg tablet at bedtime) arm 2: DS-5565 10 mg/day (one 10 mg tablet at bedtime) arm 3: DS-5565 15 mg/day (one 5 mg tablet plus one 10 mg tablet at bedtime) arm 4: DS-5565 20 mg/day (one 10 mg tablet in the morning and one 10 mg tablet at bedtime) arm 5: DS-5565 30 mg/day (one 5 mg tablet plus one 10 mg tablet in the morning and one 5 mg tablet plus one 10 mg tablet at bedtime) arm 6: Pregabalin 300 mg/day (two 150 mg capsules, in the morning and at bedtime)
Interventions: intervention 1: DS-5565 tablet intervention 2: pregabalin capsule intervention 3: Placebo tablet intervention 4: placebo capsule
Intervention descriptions: intervention 1: 5mg and 10mg tablets intervention 2: 75mg and 150mg over-encapsulated intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00526071
Conditions: Fabry Disease
Keywords: Amicus Therapeutics AT1001 Galafold Migalastat Substrate
Sponsor: Amicus Therapeutics
Start date: 2007-09-17; Completion date: 2012-09-08
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study to evaluate the long-term safety, tolerability, and pharmacodynamics (PD) of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease

Detailed description:
This was a long-term open-label study of migalastat in participants with Fabry disease who were previously enrolled in a Phase 2 study of migalastat (FAB-CL-201 \[NCT00214500\], FAB-CL-202 \[NCT00283959\], FAB-CL-203 \[NCT00283933\], or FAB-CL-204 \[NCT00304512\]). Participants could enter this extension study immediately upon completion of participation in their previous study of migalastat, or at a later time point. Thus, some participants did not necessarily have continuous treatment with migalastat from the end of the original study to the time of enrollment into this extension study. Participants who enrolled before Protocol Amendment 2 received migalastat 150 milligrams (mg) orally once every other day (QOD). After the amendment, these participants entered a dose escalation period (DEP) at their next scheduled visit. During the DEP, participants received migalastat 250 mg (once daily \[QD\] for 3 days and 4 days off per week) for the first 2 months. If there were no safety concerns, the dose was then increased to 500 mg QD for 3 days and 4 days off per week). Participants received 500 mg (QD for 3 days and 4 days off per week) for up to 10 months, depending on the approval date of the protocol amendments at each site. An interim review of safety and PD data was performed after all enrolled participants had completed at least 4 months of treatment in the DEP. After the review, the dose and regimen of migalastat was returned to 150 mg QOD for all participants, except those who were on another dose as previously agreed by the investigator and medical monitor.

The sponsor (Amicus Therapeutics) discontinued Study FAB-CL-205 for logistical reasons and not due to either safety concerns or lack of efficacy. Participants who were ongoing in Study FAB-CL-205 at the time of discontinuation were offered participation in another open-label, long-term treatment study of migalastat (AT1001-041 \[NCT01458119\]). Participants who did not enroll in Study AT1001-041 were contacted by telephone or another suitable method approximately 1 month after the End of Study (EOS) visit to inquire about adverse events and concomitant medications.

Arms: arm 1: Migalastat was administered orally, 150 mg QOD, 250 mg QD for 3 days, 4 days off per week for 2 months, or 500 mg QD for 3 days, 4 days off per week for up to 10 months, depending on the approval date of the protocol amendments at each site. Participants received migalastat for up to 56 months.
Interventions: intervention 1: migalastat HCl
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00704405
Conditions: Hepatitis C, Chronic
Keywords: hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-03-27; Completion date: 2012-09-10
Enrollment: 285 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC) participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of study therapy (SVR24).

Detailed description:

Arms: arm 1: Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 weeks. arm 2: Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks. arm 3: Vaniprevir 300 mg (total daily dose, taken once daily \[q.d.\]) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks. arm 4: Vaniprevir 600 mg and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks. arm 5: PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
Interventions: intervention 1: Vaniprevir intervention 2: Pegylated Interferon (Peg-IFN) intervention 3: Ribavirin (RBV) intervention 4: Placebo (PBO)
Intervention descriptions: intervention 1: Participants took capsules containing 100 mg Vaniprevir twice daily (b.i.d.), three in the morning (300 mg and 600 mg regimens) and three in the evening (600 mg regimen only), orally, for 24 or 48 weeks. intervention 2: Participants used prefilled syringe containing 180 µg/0.5 mL Peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks intervention 3: Participants took tablets containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks. The dose was 1000 mg for participants weighing \<=75 kg and 1200 mg for participants weighing \>75 kg. intervention 4: Participants took PBO capsules matching Vaniprevir capsules, three in the morning and three in the evening, for 24 or 48 weeks.

Protocol documents:
Clinical trial NCT01285310
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid, Arthritis
Sponsor: Amgen
Start date: 2010-12-09; Completion date: 2012-09-10
Enrollment: 237 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Apremilast is safe and effective in the treatment of patients with rheumatoid arthritis, specifically in improving signs and symptoms of rheumatoid arthritis (tender and swollen joints, pain, physical function and structure) in treated patients who have had an inadequate response to Methotrexate.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Apremilast 30 mg intervention 2: Apremilast 20 mg intervention 3: Placebo
Intervention descriptions: intervention 1: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase. intervention 2: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase. intervention 3: Oral Placebo tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in active treatment / active treatment extension phase. Participants who are nonresponders will advance early to 20 mg Apremilast BID at Week 16.

Protocol documents: