ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01857622
Conditions: Non-valvular Atrial Fibrillation
Keywords: anticoagulant DU-176b edoxaban factor Xa oral atrial fibrillation severe renal impairment
Sponsor: Daiichi Sankyo Co., Ltd.
Start date: 2011-11-01; Completion date: 2013-01-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with DU-176b administered to non-valvular atrial fibrillation (NVAF) patients with normal renal function or mild renal impairment (Normal/MiRI).

Detailed description:

Arms: arm 1: DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks. arm 2: DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors. arm 3: DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.
Interventions: intervention 1: DU-176b 15mg intervention 2: DU-176b 30mg intervention 3: DU-176b 60mg
Intervention descriptions: intervention 1: oral DU-176b 15mg once daily intervention 2: oral DU-176b 30mg once daily intervention 3: oral DU-176b 60mg once daily

Protocol documents:
Clinical trial NCT01880723
Conditions: Cystic Fibrosis Healthy
Keywords: exhaled breath condensate diffusion capacity of the lungs for carbon monoxide and nitric oxide albuterol peripheral oxygen saturation ion regulation
Sponsor: University of Arizona
Start date: 2009-05-01; Completion date: 2013-01-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Our aims were to determine if exhaled breath condensate (EBC) could detect differences in ion regulation between cystic fibrosis (CF) and healthy and measure the effect of the albuterol on EBC ions in these populations. We hypothesized EBC chloride and sodium would be lower in CF patients at baseline and that albuterol would decrease EBC sodium and increase EBC chloride.

Detailed description:

Arms: arm 1: 2.5 mg diluted in 3mL normal saline nebulized using a Power Neb2 nebulizer arm 2: nebulized 3 ml normal saline using a Power Neb2 nebulizer
Interventions: intervention 1: Albuterol intervention 2: Placebo saline
Intervention descriptions: intervention 1: 2.5 mg diluted in 3mL normal saline nebulized using a Power Neb2 nebulizer intervention 2: nebulized 3mL normal saline) using a Power Neb2 nebulizer

Protocol documents:
Clinical trial NCT01983020
Conditions: Postoperative Pain
Sponsor: Beth Israel Medical Center
Start date: 2011-04-01; Completion date: 2013-01-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study has been designed as a controlled clinical trial to evaluate the efficacy of brief lidocaine infusion, brief ketamine infusion and a lidocaine/ketamine combined infusion when added to conventional opioid therapy following major spine surgery, as well as to evaluate the effects of the lidocaine/ketamine pain protocol on the feasibility of performing routine intraoperative neurophysiology during spine surgery in adults and determine whether this infusion protocol is compatible with intraoperative neurophysiology on spine surgery patients. If one or more of the approaches is confirmed as efficacious and safe, it could have a significant impact on the routine management of postoperative pain in this context.

Detailed description:

Arms: arm 1: Ketamine infused at 0.25 mg/kg/hour. arm 2: Lidocaine infused at 0.5 mg/kg/hour. arm 3: Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour arm 4: Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
Interventions: intervention 1: Lidocaine intervention 2: Ketamine intervention 3: Saline
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02003638
Conditions: Coronary Artery Disease Carotid Artery Disease Peripheral Artery Disease
Sponsor: University of Pennsylvania
Start date: 2012-03-01; Completion date: 2013-01-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is looking to see if niacin will lessen atherosclerotic plaque inflammation and favorably affect circulating levels of endothelial progenitor cells and microparticles in people with atherosclerotic disease on chronic statin therapy.

Detailed description:

Arms: arm 1: Niacin titrated up to 6 grams taken orally every day for 12 weeks arm 2: Placebo taken orally every day for 12 weeks
Interventions: intervention 1: Niacin intervention 2: Placebo
Intervention descriptions: intervention 1: Niacin titrated to 6000 mg daily intervention 2: Placebo provided in the same pill quantity as niacin arm

Protocol documents:
Clinical trial NCT03065933
Conditions: Bipolar Disorder, Mania
Keywords: mania clonidine bipolar disorder
Sponsor: Mclean Hospital
Start date: 2012-01-01; Completion date: 2013-01-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators plan to to study an extended-release form of clonidine, which the investigators hope will be even better tolerated than the immediate-release form, as an antimanic agent. Subjects will receive an extended-release form of clonidine in addition to their usual medication regimen on the second day of this three-day study. Rating scales, a record of sleep, and a questionnaire of adverse effects will be recorded on each of the 3 days. Any medication changes made by the attending psychiatrist and prns administered will be recorded throughout the study.

Detailed description:
Clonidine has been reported to be effective in a variety of hyperadrenergic states, including mania. It is generally well-tolerated and does not result in the severe adverse effects that are associated with many antipsychotics and mood stabilizers used in the treatment of mania, such as weight gain and akathisia. There is some suggestion that clonidine may be particularly effective in a subset of refractory cases and in patients who cannot tolerate antipsychotic medications or lithium. The investigators plan to to study an extended-release form of clonidine, which the investigators hope will be even better tolerated than the immediate-release form, as an antimanic agent. Subjects will receive an extended-release form of clonidine in addition to their usual medication regimen on the second day of this three-day study. Rating scales, a record of sleep, and a questionnaire of adverse effects will be recorded on each of the 3 days. Any medication changes made by the attending psychiatrist and prns administered will be recorded throughout the study. The investigators believe that studying as few as 10 subjects will give the investigators a sense as to whether the addition of clonidine is helpful in reducing manic symptoms and if the rate of adverse effects is unacceptable.

Arms: arm 1: Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.
Interventions: intervention 1: extended-release clonidine
Intervention descriptions: intervention 1: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.

Protocol documents:
Clinical trial NCT01382940
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2011-07-26; Completion date: 2013-01-06
Enrollment: 351 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study was designed to evaluate the safety of administering rituximab at a more rapid infusion rate in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to biopharmaceuticals that treat diseases by interfering with tumor necrosis factor (anti-TNF therapies), and were receiving methotrexate therapy for more than eight weeks.

Detailed description:

Arms: arm 1: Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
Interventions: intervention 1: rituximab intervention 2: methotrexate intervention 3: methylprednisolone intervention 4: acetaminophen intervention 5: antihistamine
Intervention descriptions: intervention 1: 1000 mg in 250 mL intravenous infusion intervention 2: 10 to 25 mg/week (oral or parenteral) intervention 3: 100 mg methylprednisolone administered by slow intravenous infusion at least 30 minutes prior to the start of each study drug infusion intervention 4: 1 gram acetaminophen administered orally 30 to 60 minutes prior to the start of each study drug infusion intervention 5: 50 mg diphenhydramine hydrochloride or equivalent dose of alternate antihistamine administered orally 30 to 60 minutes prior to the start of each study drug infusion

Protocol documents:
Clinical trial NCT01186419
Conditions: Transfusional Iron Overload Beta-thalassemia
Keywords: Beta-thalassemia Sickle cell anemia Transfusional iron overload Iron overload Iron chelation
Sponsor: Shire
Start date: 2010-08-13; Completion date: 2013-01-08
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to evaluate the safety of two doses of FBS0701, a new oral iron chelator, and its effectiveness in clearing iron from the liver. FBS0701 is a medication taken by mouth that causes the body to get rid of iron. Iron chelators are used in patients with β-thalassemia and other forms of anemia who experience iron overload - iron increases in the body as a result of regularly required blood transfusions. Patients who qualify will be randomized to receive one of two doses of FBS0701 for up to 24 weeks (6 months) with a total study duration of up to 33 weeks. These patients will be eligible to participate in a dosing extension for up to 72 weeks. The maximum duration of dosing will be up to 96 weeks. The safety of patients will be monitored frequently during the study by physical exams, ECGs, and blood tests. To assess the amount of iron in the liver and heart, each patient must undergo 6 MRI scans during the study. Patients will not need to stay in the hospital for this study but will need to visit the outpatient clinic up to 28 times over the 96 week period. Patients currently taking an iron chelator will be required to stop for a total of up to 26 weeks. The results of this study will help to determine if FBS0701 may be effective as an iron chelator.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SPD602 (FBS0701, SSP-004184)
Intervention descriptions: intervention 1: Oral FBS0701 taken one time daily for up to 96 weeks.

Protocol documents:
Clinical trial NCT01270971
Conditions: Onychomycosis of Toenails
Keywords: Onychomycosis nail fungus toenail fungus fungal nail hyperkeratosis nail infection nail treatment toenail infection toenail treatment foot dermatoses fungal culture onycholysis podiatrist podiatry subungual tinea unguium antifungal anti-fungal dermatologist dermatology dermatophyte distal subungual onychomycosis yellow nail thick nail brittle nail crumbling nail discolored nail weak nail
Sponsor: Pfizer
Start date: 2010-12-01; Completion date: 2013-01-08
Enrollment: 594 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.

Detailed description:

Arms: arm 1: AN2690 Topical Solution, 5% arm 2: Solution Vehicle
Interventions: intervention 1: AN2690 Topical Solution, 5% intervention 2: Solution Vehicle
Intervention descriptions: intervention 1: AN2690 Topical Solution, 5%, applied once daily for 48 weeks intervention 2: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks

Protocol documents:
Clinical trial NCT01036022
Conditions: Colitis, Ulcerative
Keywords: mesalazine ulcerative colitis pharmacokinetics/dynamics GSK1399686
Sponsor: GlaxoSmithKline
Start date: 2009-09-15; Completion date: 2013-01-10
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is the first-time-in-patient trial of GSK1399686, a novel locally-acting anti-inflammatory compound, aimed at obtaining initial information on the tolerability, safety, pharmacokinetics (including concentrations in colon mucosa) and anti-inflammatory activity of GSK1399686 upon oral dosing in patients with active ulcerative colitis.

The study is designed as a randomized, double-blind, double-dummy, placebo-controlled, sequential dose escalating trial, with an active control (ASACOL) group as internal control. Up to three cohorts (Cohorts 1-3), each consisting of approximately 20 patients with mild-moderately active ulcerative colitis not limited to the rectum, will be included, one for each dose level of GSK1399686 to be tested. Within a cohort, patients will be randomized in a 3:1:1 ratio to receive GSK1399686 (once daily over 4 weeks, followed by 2 weeks dosing with placebo), placebo, or ASACOL (t.i.d. for 6 weeks), respectively.

An interim analysis of fecal markers and disease activity data will be performed by the end of Cohort 3. Based upon results, the study may be stopped or continued by recruiting either Cohort 4 (if data on an additional dose level would be warranted to establish or clarify a dose-response relationship) or, in the case of a robust efficacy signal at any dose level previously studied, Cohort 5 (to expand the sample size for given dose level in order to evaluate the efficacy of GSK1399686). The number of patients and randomization allocation ratio may be altered in Cohort 5 and it may not include an active control arm. If Cohort 4 is initiated upon interim analysis, then a second interim analysis may be performed at the end of Cohort 4, to assess whether progression into Cohort 5 (as defined above) would be justifiable.

Detailed description:

Arms: arm 1: ASACOL 800mg t.i.d. arm 2: GSK1399686 at 3-4 dose levels arm 3: Placebo
Interventions: intervention 1: GSK1399686
Intervention descriptions: intervention 1: Each dose level of GSK1399686 will be subsequently tested in a cohort of approximately 20 patients, who will be randomized in a 3:1:1 ratio to receive GSK1399686 (once daily over 4 weeks, followed by 2 weeks dosing with placebo), placebo, or ASACOL (t.i.d. for 6 weeks), respectively.

Protocol documents:
Clinical trial NCT01350934
Conditions: Osteoporosis, Postmenopausal
Sponsor: Organon and Co
Start date: 2011-06-19; Completion date: 2013-01-10
Enrollment: 219 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate whether the once weekly administration of the combination tablet alendronate/vitamin D3 (FOSAMAX PLUS) will increase lumbar spine bone mineral density (BMD) more than the daily use of calcitriol.

Detailed description:
This was a 6-month, randomized, open-label, active-comparator controlled, parallel-group study with a 6-month extension to evaluate the safety and efficacy of alendronate sodium 70 mg plus vitamin D3 5600 IU combination tablets versus calcitriol in the treatment of osteoporosis in postmenopausal women in China. Participants were randomly assigned to receive alendronate 70 mg plus vitamin D3 5600 IU combination tablet once weekly orally or calcitriol 0.25 μg daily orally.

Arms: arm 1: Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study). arm 2: Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
Interventions: intervention 1: alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus) intervention 2: Calcitriol intervention 3: Calcium 500 mg
Intervention descriptions: intervention 1: one combination tablet once weekly intervention 2: 0.25 μg once daily orally intervention 3: one 500 mg tablet once daily

Protocol documents:
Clinical trial NCT01421511
Conditions: Skin and Subcutaneous Tissue Bacterial Infections
Keywords: ABSSSI Tedizolid Phosphate TR-701 Acute Bacterial Skin and Skin Structure Infections
Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2011-09-15; Completion date: 2013-01-10
Enrollment: 666 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, double-dummy, multicenter, global Phase 3 study of IV to oral TR-701 FA 200 mg once daily for 6 days versus IV to oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Patients are to start treatment with at least 2 IV doses and may receive IV therapy for the entire treatment duration.

Approximately 100 to 140 sites globally will participate in this study. Patients with an ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment.

Detailed description:
The primary objective is to determine the noninferiority (NI) in the early clinical response rate of intravenous (IV) to oral 6 day TR-701 free acid (FA) compared with that of IV to oral 10-day linezolid treatment at 48-72 hours after the first infusion of study drug in the intent-to-treat (ITT) analysis set in patients with acute bacterial skin and skin structure infections (ABSSSI).

Arms: arm 1: • TR-701 FA IV followed by TR-701 FA tablets arm 2: • Linezolid IV followed by Linezolid Tablets
Interventions: intervention 1: TR-701 FA intervention 2: Linezolid
Intervention descriptions: intervention 1: * TR-701 FA 200 mg once daily in 250 mL sterile saline for injection as a 60 minute IV infusion
* TR-701 FA Tablets, 200 mg, orally once daily intervention 2: * Linezolid 600 mg IV Injection twice daily in 300 mL sterile saline for injection as a 60 minute IV infusion
* Linezolid Tablets, 600 mg, orally every 12 hours

Protocol documents:
Clinical trial NCT00738374
Conditions: Lymphocytic Leukemia, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2008-11-03; Completion date: 2013-01-14
Enrollment: 97 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy and safety of MabThera + chlorambucil as induction therapy, followed in responders by maintenance therapy or observation in elderly patients with previously untreated chronic lymphocytic leukemia. During the induction phase patients will receive 2 x 4 weekly courses of chlorambucil followed by 8 x 4 weekly courses of chlorambucil + MabThera. Subsequently, responders will be randomized to receive 12 doses of MabThera given every 8 weeks, or no further treatment. The anticipated time on study treatment is 2+ years, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: chlorambucil
Intervention descriptions: intervention 1: 375mg/m2 iv on day 1 of course 3; 500mg/m2 iv on day 1 of courses 4-8 (induction phase); 375mg/m2 iv every 8 weeks (maintenance phase). intervention 2: 8mg/m2 po on days 1-7 of courses 1-8

Protocol documents:
Clinical trial NCT01620944
Conditions: HIV
Sponsor: Bristol-Myers Squibb
Start date: 2012-07-31; Completion date: 2013-01-22
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study in antiretroviral (ARV)-naïve Human immunodeficiency virus 1 (HIV-1) ribonucleic acid infected subjects is to compare the response rate at Week 48 of a daily regimen of Atazanavir (ATV)/ Ritonavir (RTV)HS 300/100 mg combined with either one additional drug \[Lamivudine (3TC) 300 mg daily\] or 2 additional drugs \[Tenofovir/Emtricitabine(TDF/FTC) 300/200 mg daily\].

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Atazanavir intervention 2: Ritonavir intervention 3: Lamivudine intervention 4: Tenofovir/Emtricitabine
Intervention descriptions: intervention 1: Capsule, oral, 300 mg, Once daily (QD), 96 weeks intervention 2: Tablets, oral, 100 mg, QD, 96 Weeks intervention 3: Tablet, oral, 300 mg, QD, 96 Weeks intervention 4: Tablets, oral, 300/200 mg, QD, 48 Weeks

Protocol documents:
Clinical trial NCT01614769
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-07-18; Completion date: 2013-01-23
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study aims to assess how glimepiride affects the recovery from hypoglycemia in participants with type 2 diabetes mellitus. The primary objective is to estimate the time taken by participants to recover from hypoglycemia to euglycemia after treatment with either 2 mg or 4 mg of glimepiride when compared to placebo.

Detailed description:

Arms: arm 1: Participants received placebo in the first period, 2 mg glimepiride in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period. arm 2: Participants received 2 mg glimepiride in the first period, 4 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period. arm 3: Participants received 4 mg glimepiride in the first period, placebo in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period. arm 4: Participants received placebo in the first period, 4 mg glimepiride in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period. arm 5: Participants received 2 mg glimepiride in the first period, placebo in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period. arm 6: Participants received 4 mg glimepiride in the first period, 2 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.
Interventions: intervention 1: Placebo intervention 2: Glimepiride 2 mg intervention 3: Glimepiride 4 mg intervention 4: Hypoglycemic Clamp
Intervention descriptions: intervention 1: Two gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods. intervention 2: One placebo tablet and one 2-mg glimepiride tablet taken on Day -1 and Day 1 of the three treatment periods. intervention 3: Two 2-mg glimepiride tablets taken on Day -1 and Day 1 of the three treatment periods. intervention 4: On Day 1 of the three treatment periods, 180 minutes after drug treatment, a fixed-rate insulin infusion is combined with a variable-rate dextrose infusion to maintain plasma glucose concentrations at close to 50 mg/dL for 30 minutes.

Protocol documents: