ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01746901
Conditions: Healthy
Keywords: Relative abuse potential study; oxycodone; nalteone; Opioid-related disorders; drug abusers Chronic pain
Sponsor: Pfizer
Start date: 2013-02-01; Completion date: 2013-08-09
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused.

Detailed description:
Abuse Liability Study

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: Placebo intervention 2: intact ALO-02 60 mg/7.2 mg intervention 3: crushed ALO-02 60 mg/7.2 mg intervention 4: crushed oxycodone IR 60 mg intervention 5: crushed ALO-02 40 mg/4.8 mg intervention 6: crushed oxycodone IR 40 mg
Intervention descriptions: intervention 1: Placebo solution + Placebo ALO-02 (intact) intervention 2: Placebo solution + ALO-02 60 mg/7.2 mg (intact) intervention 3: crushed ALO-02 60 mg/7.2 mg in solution + placebo ALO-02 (intact) intervention 4: crushed oxycodone immediate-release (IR) 60 mg in solution + placebo ALO-02 (intact) intervention 5: crushed ALO-02 40 mg/4.8 mg in solution + placebo ALO-02 (intact) intervention 6: crushed oxycodone immediate-release (IR) 40 mg in solution + placebo ALO-02 (intact)

Protocol documents:
Clinical trial NCT03642262
Conditions: Healthy Subjects
Sponsor: Reckitt Benckiser Inc.
Start date: 2013-06-02; Completion date: 2013-08-09
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Demonstrate bioequivalence of guaifenesin in Mucinex® extended release (ER) 600 mg tablet in normal healthy volunteers compared to the immediate release guaifenesin 200 mg tablet reference product marketed

Detailed description:

Arms: arm 1: Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition. arm 2: Guaifenesin 200 mg immediate release (IR) tablet thrice (at 0, 4, and 8 hours) by mouth under fasting condition.
Interventions: intervention 1: Mucinex®
Intervention descriptions: intervention 1: Mucinex® 600 mg single dose ER bi-layer tablet

Protocol documents:
Clinical trial NCT00742027
Conditions: Classical Hodgkin's Lymphoma
Keywords: Classical Hodgkin Lymphoma Classical Hodgkin's Lymphoma Hodgkin Lymphoma Hodgkin's Lymphoma Nodular sclerosing Mixed-cellularity Lymphocyte-rich Lymphocyte depleted HL Classical HL Refractory Hodgkin's Lymphoma Refractory Hodgkin Lymphoma Refractory HL
Sponsor: Novartis Pharmaceuticals
Start date: 2008-09-16; Completion date: 2013-08-12
Enrollment: 129 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluated the efficacy of oral panobinostat in participants with refractory/relapsed classical Hodgkins lymphoma (HL) who have received prior treatment with high dose chemotherapy and autologous stem cell transplant. Safety of panobinostat also was assessed. Other markers that may correlate with efficacy or safety were explored.

Detailed description:

Arms: arm 1: Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months).
Interventions: intervention 1: Panobinostat
Intervention descriptions: intervention 1: Panobinostat hard gelatin capsules.

Protocol documents:
Clinical trial NCT01469767
Conditions: Atopic Dermatitis
Keywords: eczema itch scratching actigraphy adherence
Sponsor: Wake Forest University
Start date: 2012-02-01; Completion date: 2013-08-17
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the efficacy of short-term treatment with fluocinonide cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD).

Detailed description:
The purpose of this study is to assess the efficacy of short-term treatment with fluocinonide cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD). Our hypothesis is that subjects will have a reduction in Investigator's Global Assessment scores at Day 7 and Day 14 compared to Baseline.

Secondary objectives include the use of actigraphy monitoring to determine the ability of Vanos® cream to reduce itch, and thus nocturnal scratching, in AD. Our hypothesis is that subjects will have a reduction in nocturnal scratching activity, as measured by actigraphy movement count per hour, at Day 7 and Day 14 compared to Baseline. Other secondary outcome measures include Eczema Area and Severity Index (EASI) score, body surface area involvement and Visual Analog Scale for itch. The investigators hypothesize that each of these measures will be improved at Day 7 and Day 14 compared to Baseline.

Arms: arm 1: Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.
Interventions: intervention 1: Fluocinonide cream
Intervention descriptions: intervention 1: Fluocinonide cream 0.1% applied twice daily for 5 days.

Protocol documents:
Clinical trial NCT01223352
Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension children pediatric bosentan
Sponsor: Actelion
Start date: 2011-03-08; Completion date: 2013-08-19
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (PAH) \<12 years of age.

Detailed description:

Arms: arm 1: 2 mg/kg bosentan administered three times a day (morning, afternoon, evening) for a planned duration of 24 weeks arm 2: 2 mg/kg bosentan administered twice daily (morning and evening) for a planned duration of 24 weeks
Interventions: intervention 1: bosentan
Intervention descriptions: intervention 1: 32 mg quadrisected dispersible tablet. The dosage of bosentan (2 mg/Kg) was adjusted according to the patient's body weight at initiation of the study treatment. Dosage readjustment was permitted after 12 weeks of treatment.

Protocol documents:
Clinical trial NCT01620489
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2012-06-14; Completion date: 2013-08-20
Enrollment: 279 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of liraglutide in subjects with type 2 diabetes and moderate renal impairment.

The trial medication will be add-on to the subject's stable pre-trial OAD and/or insulin regimen.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: liraglutide intervention 2: placebo
Intervention descriptions: intervention 1: 1.8 mg administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen. intervention 2: Administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.

Protocol documents:
Clinical trial NCT00896454
Conditions: Breast Cancer Hypercalcemia of Malignancy Colon Cancer Endocrine Cancer Head and Neck Cancer Kidney Cancer Lung Cancer Lymphoma Metastatic Cancer Multiple Myeloma Parathyroid Neoplasms Renal Cancer Thyroid Cancer Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Non-Small Cell Lung Cancer
Keywords: hypercalcemia calcium bisphosphonates denosumab amgen malignancy 20070315 HMC oncology hematology
Sponsor: Amgen
Start date: 2009-11-16; Completion date: 2013-08-21
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia of Malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates by lowering corrected serum calcium \</= 11.5 mg/dL (2.9 millimoles /L) by day 10.

Detailed description:

Arms: arm 1: Eligible subjects will receive denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study days 8 and 15.
Interventions: intervention 1: denosumab
Intervention descriptions: intervention 1: 120 mg subcutaneously (SC) every 4 weeks with a loading dose of 120 mg SC on study days 8 and 15.

Protocol documents:
Clinical trial NCT01680341
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2012-08-31; Completion date: 2013-08-22
Enrollment: 272 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/insulin aspart intervention 2: insulin degludec/insulin aspart
Intervention descriptions: intervention 1: Twice weekly self-titration at intervals of 3-4 days, based upon a single pre-breakfast and pre-dinner SMPG (self-measured plasma glucose) value. For subcutaneous (s.c., under the skin) administration. intervention 2: Once weekly self-titration based upon the lowest of 3 pre-breakfast and 3 pre-dinner SMPG (self-measured plasma glucose) values. For subcutaneous (s.c., under the skin) administration.

Protocol documents:
Clinical trial NCT01890785
Conditions: Healthy Volunteers
Sponsor: Shire
Start date: 2013-07-15; Completion date: 2013-08-22
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Compare the pharmacokinetic profiles when the contents are emptied into a soft food and orange juice compared to the SPD489 when swallowed as an intact capsule.

Detailed description:

Arms: arm 1: lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions arm 2: Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt arm 3: Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice
Interventions: intervention 1: Lisdexamfetamine Dimesylate
Intervention descriptions: intervention 1: Single dose of a 70 mg capsule on Day 1

Protocol documents:
Clinical trial NCT01915771
Conditions: Intra-subject Variability of Pharmacokinetics
Sponsor: Aegerion Pharmaceuticals, Inc.
Start date: 2013-07-29; Completion date: 2013-08-23
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Objectives:

To evaluate the intra-subject variability of the pharmacokinetics (PK) of single oral capsule doses of 20 mg lomitapide.

Detailed description:
This study will be a single centre, open-label study. It will comprise of 2 single oral doses with at least a 14-day washout between doses. Following the first dose subjects will be discharged from the unit for the remainder of the washout period. Subjects will be re-admitted to the unit on Day -1 (Period 2) and following an overnight fast they will be administered the second dose on Day 1 (Period 2). Subjects will be discharged from the unit following the 168 h PK blood draw.

Arms: arm 1: It will comprise of 2 single oral doses with at least a 14-day washout between doses.
Interventions: intervention 1: lomitapide
Intervention descriptions: intervention 1: 20 mg dose

Protocol documents:
Clinical trial NCT01725282
Conditions: Major Depressive Disorder
Keywords: patients FK949E
Sponsor: Astellas Pharma Inc
Start date: 2011-12-14; Completion date: 2013-08-24
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study, quetiapine XR or placebo will be administered orally for 6 weeks to major depressive disorder patients with lack of response to existing antidepressants, with the aim of evaluating the efficacy of quetiapine XR and dose-response in three quetiapine XR dose groups based on changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores.

Detailed description:

Arms: arm 1: Participants received matching placebo tablets once daily before bedtime for 7 weeks. arm 2: Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks. arm 3: After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week. arm 4: After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
Interventions: intervention 1: quetiapine extended release (XR) intervention 2: Placebo
Intervention descriptions: intervention 1: Extended release tablets intervention 2: matching tablets

Protocol documents:
Clinical trial NCT01482221
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder MDD Inadequate Response to Antidepressant Therapy Channel blocker of the NMDA class of glutamate receptors
Sponsor: AstraZeneca
Start date: 2011-12-16; Completion date: 2013-08-26
Enrollment: 542 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effect and safety of AZD6765 in patients with major depressive disorder who exhibit inadequate response to antidepressants. AZD6765 is a channel blocker of the N-methyl-D-aspartate (NMDA) class of glutamate receptors.

Detailed description:
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase IIb Efficacy and Safety Study of Adjunctive AZD6765 in Patients with Major Depressive Disorder (MDD) and a History of Inadequate Response to Antidepressants

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: AZD6765 iv intervention 2: AZD6765 iv intervention 3: Placebo
Intervention descriptions: intervention 1: 50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by iv infusion. intervention 2: 100 mg (AZD6765 Solution for Infusion, 1.0 mg/mL) by iv infusion. intervention 3: 0.9 sodium chloride \[normal saline\] solution for injection by iv infusion

Protocol documents:
Clinical trial NCT00485589
Conditions: Rheumatoid Arthritis
Keywords: FILM RA anti-CD20 CD20
Sponsor: Genentech, Inc.
Start date: 2007-06-11; Completion date: 2013-08-29
Enrollment: 613 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who are naive to methotrexate. Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or ocrelizumab 500mg i.v. on Days 1 and 15. Repeat courses of i.v. treatment will be administered at weeks 24, 52 and 76. All patients will receive concomitant methotrexate (7.5 mg escalating to 20mg p.o. weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone. arm 2: Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone. arm 3: Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Interventions: intervention 1: Methotrexate intervention 2: Ocrelizumab intervention 3: Placebo
Intervention descriptions: intervention 1: Oral repeating dose intervention 2: Intravenous repeating dose intervention 3: Intravenous repeating dose

Protocol documents:
Clinical trial NCT01334086
Conditions: Acute Myeloid Leukemia
Keywords: AML
Sponsor: University Health Network, Toronto
Start date: 2011-09-01; Completion date: 2013-08-30
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Chemotherapy induced nausea and vomiting (CINV) is a major adverse effect of chemotherapy. This study is determining the incidence of vomiting/retching of the standard induction chemotherapy regimen for patients with acute myeloid leukemia (AML) who are also receiving an antiemetic known as aprepitant.

The standard frontline chemotherapy for patients with AML consists of cytarabine given as a 7 day continuous infusion plus 3 days of an anthracycline, most commonly daunorubicin, on days 1-3. This is known as the 3+7 regimen. Antiemetic treatments are usually given to patients for nausea and vomiting. Granisetron (a 5-HT3 receptor antagonist) is used on the 3 daunorubicin days and other antiemetics can be used for breakthrough nausea/vomiting.

This study will test that the prophylactic use of aprepitant, in addition to the standard antiemetic regimen used at Princess Margaret Hospital (PMH), will reduce the incidence of delayed onset vomiting/retching by Day 5 in AML patients receiving the standard 3+7 regimen, compared to retrospective data using this regimen.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Aprepitant
Intervention descriptions: intervention 1: Oral aprepitant will be given to the participant on Days 1-5 of standard induction treatment. A dose of 125 mg will be given on Day 1 and 80 mg will be given on Days 2-5.

Protocol documents:
Clinical trial NCT01091103
Conditions: Metastatic Progressive Castration-resistant Prostate Cancer
Sponsor: Pfizer
Start date: 2010-02-18; Completion date: 2013-08-31
Enrollment: 60 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
This study is being conducted to determine the effect of enzalutamide on the androgen signaling pathway in correlation with the anti-tumor effects of enzalutamide to identify potential predictors of response or resistance to therapy.

Detailed description:

Arms: arm 1: Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. Study drug treatment continued until disease progression, unacceptable toxicity, or withdrawal.
Interventions: intervention 1: Enzalutamide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01093521
Conditions: Cystic Fibrosis
Keywords: IV Gallium Gallium Ganite Cystic Fibrosis Gallium Infusion
Sponsor: University of Washington
Start date: 2010-04-01; Completion date: 2013-08-31
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to test the pharmacokinetics, safety, and tolerability of an intravenous infusion of a drug called Ganite (gallium nitrate) in patients with cystic fibrosis. We want to see this drug is safe and tolerable and to see if high levels of the drug are found in the sputum.

Funding Source - Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD)

Detailed description:
This is a two center pharmacokinetic and safety dosing study of IV gallium nitrate (Ganite®) in cystic fibrosis (CF) patients. Eighteen subjects are planned. Each subject will be administered a single 5-day infusion of study medication (one of 2 doses). No placebo is used. Each subject will receive 5 days of continuous infusion of the experimental treatment. There will be two dosing cohorts (cohort 1: 100 mg/m2/day and cohort 2: 200 mg/m2/day). Cohort 2 will begin enrollment only after Data Safety Monitoring Committee (DSMC) safety review and approval of cohort 1 data. Study visits occur at baseline (day 1), day 3 (visit 2), day 6 (visit 3), day 8 (visit 4), day 14 (visit 5), day 28 (visit 6), and day 56 (visit 7).

Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.

The following treatment regimens will be used:

• Experimental treatment continuous infusion of gallium nitrate at the following doses cohort 1: 100 mg/m2/day and cohort 2: 200 mg/m2/day All subjects who receive at least one dose of study medication will be considered evaluable for safety and efficacy analyses. Incidence of adverse events will be monitored during the trial.

Primary endpoints will be assessment of pharmacokinetic and safety/tolerability data.

Secondary efficacy assessments will be based on changes in lung function and sputum P. aeruginosa density in sputum.

Total duration of subject participation will be five weeks. Total duration of the study is expected to be 20 months.

Arms: arm 1: Five day continuous IV Gallium Nitrate (Ganite®) infusion at 100 mg/m2 arm 2: Five day continuous IV Gallium Nitrate (Ganite®) infusion at 200 mg/m2
Interventions: intervention 1: 100 mg/m2 dose intervention 2: 200 mg/m2 dose
Intervention descriptions: intervention 1: 5 day infusion of gallium nitrate (IV Ganite®) at a dose of 100 mg/m2/day intervention 2: 5 day infusion of gallium nitrate (IV Ganite®) at 200 mg/m2/day

Protocol documents:
Clinical trial NCT00390806
Conditions: Lung Cancer, Non-Small Cell
Keywords: Brain metastases from Non-Small Cell Lung Cancer Brain metastases brain tumor lung cancer oral chemotherapy HYCAMTIN topotecan NSCLC WBRT whole brain radiation
Sponsor: GlaxoSmithKline
Start date: 2006-12-01; Completion date: 2013-09-01
Enrollment: 472 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The current prognosis for patients with metastatic brain cancer from NSCLC is very poor. The current standard treatment for this disease is radiation therapy to the brain. The goal of the current study is to test whether the combination of orally administered HYCAMTIN capsules and whole brain radiation therapy will prolong the survival time of patients with this potentially serious condition.

Detailed description:

Arms: arm 1: topotecan 1.1 mg/m2 followed by whole brain radiation 3 Gy/day for 10 days, followed by optional continuation therapy with topotecan 2.3 mg/m2 for 5 days Q21 days as monotherapy. arm 2: Whole brain radiation 3 Gy/day for 10 days
Interventions: intervention 1: HYCAMTIN, oral capsules intervention 2: Radiation
Intervention descriptions: intervention 1: topotecan oral capsules 1.1 mg/m2 intervention 2: Whole brain radiation

Protocol documents: