ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01231620
Conditions: Influenza, Human
Keywords: Seasonal Influenza Pandemic Orthomyxoviridae Infections Influenza Influenza A Virus, H1N1 Subtype Enzyme Inhibitors Influenza, seasonal Respiratory Tract Diseases Zanamivir Pharmacologic Actions Antiviral Agents Anti-Infective Agents H1N1 Neuraminidase inhibitor Influenza B virus
Sponsor: GlaxoSmithKline
Start date: 2011-01-15; Completion date: 2015-03-18
Enrollment: 626 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the safety and efficacy of zanamivir given intravenously and how well it works at two different doses in hospitalized adolescents and adults with flu. Zanamivir will be compared with oseltamivir, which is used for treating flu.

Detailed description:
The recent influenza pandemic has highlighted the need for alternative formulations for anti-influenza therapies. This will be an international Phase III, double-blind, double-dummy, 3-arm study to evaluate the efficacy, antiviral activity and safety of IV zanamivir 600 mg twice daily compared to oral oseltamivir 75 mg twice daily, and 600 mg IV zanamivir twice daily compared to 300 mg IV zanamivir for 5 days in hospitalized subjects with laboratory confirmed or suspected influenza infection. For a given subject, the initial 5-day treatment course may be extended for up to 5 additional days if clinical symptoms or patient characteristics as assessed by the investigator warrant further treatment. Alternatively, if the investigator considers that a subject is failing to improve clinically on their randomized treatment, the investigator can choose to initiate the switch/rescue option (600 mg IV zanamivir twice daily) on any day from Day 6 through Day 10 for up to an additional 5 days of treatment. On switching treatments, subjects complete a maximum of 14 days of treatment and are followed-up to Post-Treatment +28 Days.

Arms: arm 1: 300mg of IV zanamivir infusion twice daily plus oral oseltamivir placebo twice daily arm 2: 600mg of IV zanamivir infusion twice daily plus oral oseltamivir placebo twice daily arm 3: 75mg oral oseltamivir twice daily plus intravenous placebo zanamivir twice daily
Interventions: intervention 1: Zanamivir intervention 2: Placebo to match zanamivir intervention 3: Oseltamivir intervention 4: Placebo to match oseltamivir
Intervention descriptions: intervention 1: Zanamivir aqueous solution, 10 mg/mL, will be provided as a single use, sterile clear, colorless preparation in 20 mL clear glass vials. intervention 2: Placebo to match IV zanamivir will be provided as a normal saline solution of a matched volume. intervention 3: Oseltamivir will be provided as over-encapsulated 75 mg capsules. intervention 4: Placebo to match oral oseltamivir will be provided as capsules with a common excipient of appropriate quality.

Protocol documents:
Clinical trial NCT02151643
Conditions: Hyperphosphataemia
Keywords: Dialysis Dependent Chronic Kidney Disease
Sponsor: Phosphate Therapeutics
Start date: 2014-05-07; Completion date: 2015-03-18
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to see whether PT20 can help people with a high level of phosphate in their blood (called Hyperphosphatemia) that are being treated with dialysis for kidney disease.

Detailed description:
PT20 represents a mechanism to address many of the limitations associated with current phosphate binding agents. The available clinical and non clinical evidence suggests that PT20 binds phosphate and prevents its uptake more efficiently than other phosphate binding drugs and may therefore either reduce the pill burden associated with controlling phosphate levels, or result in lower phosphate levels with the same pill burden.

The this study is the first to investigate the efficacy and safety of PT20 in subjects with dialysis-dependent chronic kidney disease (CKD).

Arms: arm 1: PT20 400 mg tid (1.2 g/day) administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study arm 2: PT20 800 mg tid (2.4 g/day) administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study arm 3: PT20 1600 mg tid (4.8 g/day) administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study arm 4: PT20 3200 mg tid (9.6 g/day) administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study arm 5: Matched Placebo (for PT20) tid administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study
Interventions: intervention 1: PT20 intervention 2: Placebo
Intervention descriptions: intervention 1: Modified ferric oxide adipate tablets intervention 2: Placebo tablets matched to each PT20 dose arm

Protocol documents:
Clinical trial NCT02310581
Conditions: Post-operative Pain
Keywords: Bunionectomy
Sponsor: INSYS Therapeutics Inc
Start date: 2015-02-24; Completion date: 2015-03-19
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group, placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of Buprenorphine Sublingual (under the tongue) Spray and/or matching placebo in participants with moderate to severe postoperative pain after bunionectomy. The study will comprise 4 periods: the Screening Period, the Surgical Period, the Treatment Period, and the Follow-up Period.

Participants will be admitted to the study site on the morning of the scheduled surgery, will remain at the study site until postoperative Day 3 (a total of 3 nights at the study site), and will return for the Follow-up Visit 5 to 9 days after surgery.

Detailed description:

Arms: arm 1: Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days. arm 2: Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days. arm 3: Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days. arm 4: Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
Interventions: intervention 1: Buprenorphine Sublingual Spray intervention 2: Placebo
Intervention descriptions: intervention 1: Buprenorphine sublingual spray delivered via single 100 μL spray intervention 2: Placebo-matching buprenorphine sublingual spray delivered via single 100 μL spray

Protocol documents:
Clinical trial NCT01372150
Conditions: Major Depressive Disorder
Keywords: major depressive disorder MDD depression
Sponsor: Pfizer
Start date: 2011-11-17; Completion date: 2015-03-20
Enrollment: 340 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release vs Placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).

Detailed description:

Arms: arm 1: None arm 2: Active control for assay sensitivity arm 3: None
Interventions: intervention 1: desvenlafaxine succinate sustained release intervention 2: fluoxetine intervention 3: placebo
Intervention descriptions: intervention 1: Subjects randomized to DVS SR group receive 25, 35 or 50 mg/day based on subject weight at the Baseline visit. DVS SR provided as oral tablets. intervention 2: Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules intervention 3: Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules

Protocol documents:
Clinical trial NCT01597505
Conditions: Clostridium Difficile Infection
Keywords: CDAD Clostridium difficile Associated Diarrhea CDI Clostridium difficile Infection Diarrhea
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2012-05-16; Completion date: 2015-03-20
Enrollment: 606 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
606 participants with Clostridium Difficile Associated Diarrhea (CDAD) participated in this study and received either oral vancomycin or CB-183,315 (surotomycin) in a blinded fashion. Treatment lasted for 10 days and participants were followed up for at least 40 days and a maximum of 100 days. The purpose of this study was to evaluate how well surotomycin treats CDAD as compared to vancomycin.

Detailed description:

Arms: arm 1: 250 mg Surotomycin over- encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days arm 2: 125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
Interventions: intervention 1: Surotomycin intervention 2: Vancomycin intervention 3: Placebo
Intervention descriptions: intervention 1: 250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg, for 10 days intervention 2: 125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days intervention 3: Placebo for Surotomycin over-encapsulated tablet administered orally, twice daily for 10 days

Protocol documents:
Clinical trial NCT02100670
Conditions: Pain
Sponsor: GlaxoSmithKline
Start date: 2013-11-01; Completion date: 2015-03-22
Enrollment: 385 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase III pivotal efficacy study will assess efficacy and onset of pain relief of MFC51123 gel vs. placebo and MFC51123 gel vs. 1% diclofenac gel and 3% menthol gel in participants with an ankle sprain to support topical MFC51123 gel registration.

Detailed description:
This is a multi-center, randomized, double-blind, repeat-dose, placebo-controlled, parallel-group trial in participants with ankle sprain. Eligible participants will be randomly assigned to one of four treatment groups (1% diclofenac plus 3% menthol gel, 1% diclofenac plus 0.09% menthol gel, 3% menthol gel or placebo gel with 0.09% menthol). Treatment will be self-administered by participants four times daily on an out-patient basis. Participants will rate pain intensity score (NRS) at rest and on movement, pain relief score (PRS) and cooling and soothing sensations. After leaving the clinic, participants will continue to complete scheduled pain intensity and pain relief assessments and answer questions about cooling sensation by answering questions in a paper diary card. The investigator (or designee) will measure the ankle swelling via the 'figure-of-eight' method on treatment Days 1 (at Baseline), 3, 7 and 10.

Participants will continue treatment until they are pain free or for up to 10 days, whichever occurs first. At the end of the treatment, participants will be assessed for function of the injured joint by the investigator. In addition, the participants will evaluate treatment satisfaction, sensory features of the gel and provide a global assessment of the treatment by using a questionnaire.

Arms: arm 1: 1% diclofenac sodium plus 3% menthol gel supplied in 30 gram (g) tubes sufficient for each subject to apply 4g of gel to the injured ankle region four times daily for up to 10 days. arm 2: 1% diclofenac sodium plus 0.09% menthol gel supplied in 30g tubes sufficient for each subject to apply 4g of gel to the injured ankle region four times daily for up to 10 days. arm 3: 3% menthol gel supplied in 30g tubes sufficient for each subject to apply 4g of gel to the injured ankle region four times daily for up to 10 days. arm 4: Placebo with 0.09% menthol gel supplied in 30g tubes sufficient for each subject to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
Interventions: intervention 1: 1% diclofenac sodium plus 3% menthol intervention 2: 1% diclofenac sodium plus 0.09% menthol intervention 3: 3% menthol intervention 4: Placebo with 0.09% menthol gel
Intervention descriptions: intervention 1: To be applied four times daily for 10 days. intervention 2: To be applied four times daily for 10 days. intervention 3: To be applied four times daily for 10 days. intervention 4: To be applied four times daily for 10 days.

Protocol documents:
Clinical trial NCT01734785
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2013-02-08; Completion date: 2015-03-23
Enrollment: 607 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.

Detailed description:

Arms: arm 1: 5 mg once daily arm 2: 1 tablet once daily arm 3: 1 tablet once daily
Interventions: intervention 1: Linagliptin intervention 2: Empagliflozin + Linagliptin intervention 3: Empagliflozin + Linagliptin intervention 4: Empagliflozin + Linagliptin intervention 5: Empagliflozin placebo + Linagliptin placebo intervention 6: Empagliflozin + Linagliptin
Intervention descriptions: intervention 1: tablet intervention 2: Fixed dose combination. intervention 3: Fixed dose combination intervention 4: Fixed dose combination intervention 5: Matching Empagliflozin + Linagliptin low dose intervention 6: Fixed dose combination.

Protocol documents:
Clinical trial NCT00886691
Conditions: Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma
Sponsor: GOG Foundation
Start date: 2010-12-27; Completion date: 2015-03-23
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how well bevacizumab with or without everolimus works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and everolimus may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether bevacizumab is more effective when given together with or without everolimus in treating ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the progression-free survival hazard ratio of the combination of oral everolimus (RAD001) and bevacizumab compared to oral placebo and bevacizumab in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer.

SECONDARY OBJECTIVES:

I. To determine the nature and degree of toxicity of oral everolimus (or placebo) plus bevacizumab.

II. To characterize and compare progression-free survival and overall survival in patients with measurable disease (Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria) and patients with detectable (non-measurable) disease.

III. To estimate the proportion of patients with measurable disease who have objective tumor responses by treatment.

IV. To provide descriptive information about cancer antigen (CA)-125 responses by regimen and where possible by objective tumor responses.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15 and everolimus orally (PO) once daily (QD) on days 1-28.

ARM II: Patients receive bevacizumab as in Arm I and placebo PO QD on days 1-28.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Arms: arm 1: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and everolimus PO QD on days 1-28. arm 2: Patients receive bevacizumab as in Arm I and placebo PO QD on days 1-28.
Interventions: intervention 1: Bevacizumab intervention 2: Everolimus intervention 3: Laboratory Biomarker Analysis intervention 4: Placebo
Intervention descriptions: intervention 1: Given IV intervention 2: Given PO intervention 3: Correlative studies intervention 4: Given PO

Protocol documents:
Clinical trial NCT02232178
Conditions: Hernioplasty
Keywords: unilateral inguinal hernioplasty
Sponsor: Innocoll
Start date: 2014-10-20; Completion date: 2015-03-23
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy hernioplasty and assess the relative bioavailability of Xaracoll compared to a local bupivacaine infiltration.

Detailed description:
Inguinal hernioplasty is a common surgery. Common surgical methods used include laparoscopic and open placement of synthetic mesh. Managing postoperative pain and preventing morbidity after open mesh hernioplasty remain considerable medical challenges.

Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The Xaracoll implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the surgical site to provide postoperative pain control.

This study will assess the pharmacokinetic profile of 2 doses of the XaraColl implant after open laparotomy hernioplasty and assess the relative bioavailability of the Xaracoll implant compared to a local bupivacaine infiltration.

Arms: arm 1: Bupivacaine HCl implant arm 2: Bupivacaine HCl implant arm 3: Bupivacaine HCl
Interventions: intervention 1: 2 100mg Xaracoll implants intervention 2: 3 100mg Xaracoll implants intervention 3: 150mg Bupivacaine HCl injection
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01327547
Conditions: HIV Coinfection
Keywords: HIV coinfection maraviroc CCR5 blocker entry inhibitor liver disease viral hepatitis
Sponsor: ViiV Healthcare
Start date: 2011-05-18; Completion date: 2015-03-24
Enrollment: 138 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To describe liver enzyme elevations in patients who are coinfected with HIV and either Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with their current suppressive anti-HIV drug therapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Maraviroc intervention 2: Placebo
Intervention descriptions: intervention 1: 150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy intervention 2: 150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy

Protocol documents:
Clinical trial NCT01600716
Conditions: Urinary Incontinence Multiple Sclerosis Neurogenic Bladder
Sponsor: Allergan
Start date: 2012-06-13; Completion date: 2015-03-27
Enrollment: 144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.

Detailed description:

Arms: arm 1: OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA 100 U injection. arm 2: Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
Interventions: intervention 1: OnabotulinumtoxinA intervention 2: Placebo (Normal Saline)
Intervention descriptions: intervention 1: OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1 in the onabotulinumtoxinA 100 U arm. After a minimum of 12 weeks, patients in both the onabotulinumtoxinA 100 U arm and the placebo arm could request/qualify for an onabotulinumtoxinA injection. intervention 2: Placebo (normal saline) is administered into the detrusor at Day 1.

Protocol documents:
Clinical trial NCT01392859
Conditions: Asthma Allergic Asthma Non-allergic Asthma
Sponsor: Children's Mercy Hospital Kansas City
Start date: 2011-06-01; Completion date: 2015-03-29
Enrollment: 211 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Asthma, a chronic disease which produces significant morbidity and mortality in children, is a significant health problem to a large segment of society. Despite considerable advances in the diagnosis and treatment of asthma over the past several years, a sizeable portion of patients do not respond to the "core" treatments. The investigators are now learning that the underlying pathophysiology of disease is different among patients with asthma therefore; treatments which are beneficial in some patient groups may be not achieve affect in other groups.

Antihistamines have been studied in the past for the treatment of asthma. These studies have shown that there may be a beneficial effect of antihistamines in patients with allergic asthma where histamine likely plays a large role in disease and treatment response. However, there is not enough evidence to include these drugs in the standard treatment of asthma.

The investigators hypothesize that histamine plays a definable, significant role in disease pathogenesis and treatment response in children with allergic asthma. The investigators plan to test this overall hypothesis through two specific aims. The first aim will characterize the relative contribution of histamine in allergic vs. non-allergic asthma. This aim will be accomplished by comparison of the microvasculature response to histamine in children with allergic asthma and children with non-allergic asthma, measured by histamine iontophoresis with laser Doppler (HILD) monitoring, to determine potential phenotype-associated differences in the pharmacodynamic response to histamine.

Detailed description:

Arms: arm 1: Group 1 will begin with active Levocetirizine(LCT) 0.5 mg/ml oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and placebo will be provided for 5-8 days. arm 2: Group 2 will begin with placebo oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and active Levocetirizine(LCT) 0.5 mg/ml will be provided for 5-8 days.
Interventions: intervention 1: Levocetirizine 0.5 Mg/mL Oral Solution
Intervention descriptions: intervention 1: Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD.

Protocol documents: