ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01006252
Conditions: Melanoma
Keywords: metastatic second-line
Sponsor: Eli Lilly and Company
Start date: 2009-12-01; Completion date: 2011-03-01
Enrollment: 336 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study was to see how tasisulam-sodium affected metastatic melanoma when compared against paclitaxel as measured by overall survival.

Detailed description:

Arms: arm 1: Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression. arm 2: Paclitaxel 80 milligrams per square meter (mg/m\^2) administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression
Interventions: intervention 1: Tasisulam-sodium intervention 2: Paclitaxel
Intervention descriptions: intervention 1: Administered intravenously on Day 1 of a 28-day cycle, until disease progression. intervention 2: 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression

Protocol documents:
Clinical trial NCT01009346
Conditions: Head and Neck Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2009-10-01; Completion date: 2011-03-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
1.Phase I: To estimate the Maximum Tolerated Dose (MTD) of RAD001 in combination with cetuximab and cisplatin for treatment of metastatic squamous cell cancer of the head and neck (SCCHN).

Secondary Objectives

1.To assess the toxicity of RAD001 in combination with weekly cetuximab and cisplatin on days 1 and 8 of each 28 day cycle in patients with recurrent or metastatic SCCHN,

Detailed description:
This was a dose escalation study with RAD001 in combination with cetuximab and cisplatin in recurrent/metastatic SCCHN. Patients with ECOG performance status 0-2, with no prior systemic therapy for recurrent/metastatic SCCHN were enrolled. The dose levels for RAD001 were 2.5mg, 5mg or 10 mg administered oral daily, cetuximab 250mg/m2 weekly infusion, and cisplatin 40mg/m2 days 1 and 8. Each cycle was 28 days. Safety monitoring plan was outlined in the protocol and study calendar at specific time points. Response was evaluated with CT/MRI and PET scans every 2 cycles. DLT criteria and MTD was defined.

Dose escalation followed the conventional 3+3 design.

Arms: arm 1: Daily RAD001 in combination with weekly cetuximab and cisplatin/ carboplatin on Day 1, 8 of each 28 day cycle.
Interventions: intervention 1: RAD001 intervention 2: Cetuximab intervention 3: Cisplatin intervention 4: Carboplatin
Intervention descriptions: intervention 1: Dose Level -1 2.5mg/day

Dose Level 1 5mg/day\*

Dose Level 2 10mg/day

MTD RAD001 intervention 2: 250mg/m2/week intervention 3: 40mg/m2 Day 1, 8 every 28 days intervention 4: Carboplatin will be administered on Day1 and Day 8 of each 28 day cycle to a target AUC of 3 over 30 minutes. Carboplatin will be dosed using the Calvert formula:

Total dose (mg) = (target AUC) x (glomerular filtration rate + 25) Creatinine clearance will be used to estimate the GFR. The Cockgroft-Gault formula will be used to estimate the creatinine clearance.

Protocol documents:
Clinical trial NCT01012999
Conditions: Pain Opiate
Keywords: acute pain, intranasal, sufentanil, Acute pain control with an intranasal opiate
Sponsor: University of Utah
Start date: 2009-11-01; Completion date: 2011-03-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the appropriate dose and effectiveness of intra-nasal administration of a potent narcotic, sufentanil, for the treatment of moderate to severe pain due to broken bone(s) in the arm or leg.

Detailed description:

Arms: arm 1: Intranasal sufentanil administered at a dose of 0.5 mcg/kg times one dose at beginning of thirty minute period
Interventions: intervention 1: sufentanil
Intervention descriptions: intervention 1: Intra-nasal delivery, dosing range 0.5 mcg/kg, administered once at the beginning of the 30 minute study period

Protocol documents:
Clinical trial NCT01018511
Conditions: Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms
Keywords: EC905 Solifenacin succinate Tamsulosin hydrochloride OCAS Treatment Benign Prostatic Hyperplasia Vesomni Lower Urinary Tract Symptoms
Sponsor: Astellas Pharma Europe B.V.
Start date: 2010-01-11; Completion date: 2011-03-01
Enrollment: 1334 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with LUTS associated with BPH with a substantial storage component.

Detailed description:

Arms: arm 1: Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet arm 2: Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet arm 3: Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet arm 4: Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Interventions: intervention 1: Placebo tamsulosin hydrochloride OCAS 0.4 mg intervention 2: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg intervention 3: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg intervention 4: tamsulosin hydrochloride OCAS 0.4 mg intervention 5: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg) intervention 6: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
Intervention descriptions: intervention 1: tablet intervention 2: tablet intervention 3: tablet intervention 4: tablet intervention 5: tablet intervention 6: tablet

Protocol documents:
Clinical trial NCT01020747
Conditions: Recurrent Respiratory Papillomatosis
Sponsor: Massachusetts General Hospital
Start date: 2009-11-01; Completion date: 2011-03-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I single center open labeled study is planned to assess the safety and tolerability of bevacizumab for treating patients with bilateral Recurrent Respiratory Papillomatosis (RRP). Approximately 20 patients will receive bevacizumab directly injected into the vocal folds. Patients who enroll in the protocol will be injected with bevacizumab in one vocal fold that represents the more diseased of the two folds. A sham injection with saline will be administered to the other vocal fold as the control. This therapy will be administered once every 6 ± 1 week for 6 months, with the same vocal fold selected for the initial treatment always getting the drug injection. The investigator will also treat lesions by laser photoangiolysis of both vocal folds using the 532 nm potassium-titanyl-phosphate (KTP) laser.

Detailed description:

Interventions: intervention 1: Avastin® (bevacizumab) intervention 2: Saline
Intervention descriptions: intervention 1: Bevacizumab injections (\~7.5-12.5mg in 0.3 - 0.5 c.c.) into diseased vocal folds in conjunction with 532 nm pulsed-KTP laser photoangiolysis, administered every 6 ±1 weeks, for a total of 5 treatments. No patient will have an injection volume exceed 0.5 cc. for any single treatment. If initial results indicate a benefit, as described below, an extension of the active treatment period will be permitted up to a total treatment duration of 18 months. intervention 2: A sham injection with saline (0.3-0.5 cc) has been administered to the other vocal fold as the control. This therapy will be administered once every 6 ± 1 week for 6 months, with the same vocal fold selected for the initial treatment always getting the drug injection.

Protocol documents:
Clinical trial NCT01021423
Conditions: Mantle Cell Lymphoma Non-Hodgkin's Lymphoma
Keywords: Mantle Cell Lymphoma Non-Hodgkin's Lymphoma CC-5013 Revlimid Lenalidomide
Sponsor: Celgene
Start date: 2010-04-01; Completion date: 2011-03-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR).

This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant. A study design with the control arm of no active treatment was no longer appropriate. The termination of the trial was not based on any safety concerns in the study.

Detailed description:

Arms: arm 1: Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal. arm 2: Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Interventions: intervention 1: Lenalidomide intervention 2: Placebo
Intervention descriptions: intervention 1: 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal. intervention 2: Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.

Protocol documents:
Clinical trial NCT01047540
Conditions: HSV-2
Sponsor: AiCuris Anti-infective Cures AG
Start date: 2010-03-01; Completion date: 2011-03-01
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: AIC316 intervention 2: AIC316 intervention 3: AIC316 intervention 4: AIC316 intervention 5: Placebo
Intervention descriptions: intervention 1: Oral administration intervention 2: Oral administration intervention 3: Oral administration intervention 4: Oral administration intervention 5: Oral administration

Protocol documents:
Clinical trial NCT01049334
Conditions: Pharyngitis
Sponsor: Reckitt Benckiser LLC
Start date: 2009-11-01; Completion date: 2011-03-01
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen lozenge throughout the course of treating sore throat due to acute pharyngitis.

Detailed description:

Arms: arm 1: Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days. arm 2: Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Interventions: intervention 1: Placebo intervention 2: Flurbiprofen
Intervention descriptions: intervention 1: Participants were instructed to suck one placebo lozenge during the initial two-hour clinic visit. Upon discharge, participants were instructed to use study medication lozenge every 3-6 hours as needed for pain, up to a total of 5 study lozenges in 24 hours. intervention 2: Participants were instructed to suck one flurbiprofen 8.75 mg lozenge during the initial two-hour clinic visit. Upon discharge, participants were instructed to use study medication lozenge every 3-6 hours as needed for pain, up to a total of 5 study lozenges in 24 hours.

Protocol documents:
Clinical trial NCT01061333
Conditions: Asthma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-06-01; Completion date: 2011-03-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will assess the Early Airway Response (EAR) associated change in forced expiratory volume in one second (FEV1) and plasma 9α-11ß-PGF2 ('9P') after single dose pretreatment of nedocromil, montelukast, and mometasone.

Detailed description:

Arms: arm 1: Placebo arm 2: Montelukast arm 3: Nedocromil arm 4: Mometasone
Interventions: intervention 1: Nedocromil intervention 2: Comparator: Montelukast intervention 3: Comparator: Mometasone intervention 4: Placebo
Intervention descriptions: intervention 1: Nedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge intervention 2: Montelukast single 10 mg tablet administered 2 hours prior to allergen challenge intervention 3: Mometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge intervention 4: Mometasone placebo twisthaler, Nedocromil placebo metered dose inhaler, Montelukast placebo tablet

Protocol documents:
Clinical trial NCT01069289
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Symbicort Oxis Chronic Obstructive Pulmonary Disease COPD Efficacy
Sponsor: AstraZeneca
Start date: 2010-01-01; Completion date: 2011-03-01
Enrollment: 1293 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.

Detailed description:

Arms: arm 1: Symbicort Turbuhaler 160/4.5 microgram, 2 inhalations twice daily arm 2: Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily
Interventions: intervention 1: Budesonide/formoterol (Symbicort Turbuhaler) intervention 2: Formoterol (Oxis Turbuhaler)
Intervention descriptions: intervention 1: 2x160/4.5 microgram, inhalation, twice daily, 12 weeks intervention 2: 2 X 4.5 microgram, inhalation, twice daily, 12 weeks

Protocol documents:
Clinical trial NCT01070329
Conditions: Major Depressive Disorder
Sponsor: Eli Lilly and Company
Start date: 2010-03-01; Completion date: 2011-03-01
Enrollment: 527 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Duloxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Participants received 30 milligrams (mg) duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase. intervention 2: Participants received placebo QD, po for 8 weeks, followed by placebo QD, po during the 2-week taper phase.

Protocol documents:
Clinical trial NCT01091116
Conditions: Osteoarthritis, Knee
Keywords: Injections, Intra-Articular
Sponsor: Menarini Group
Start date: 2010-03-01; Completion date: 2011-03-01
Enrollment: 423 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether intra-articular (knee joint) administration of MEN16132 is effective reducing the pain from knee osteoarthritis.

Detailed description:
MEN16132 is a non-peptide bradykinin B2-receptor antagonist showing analgesic and anti-inflammatory activity in nonclinical osteoarthritis models. This study is being conducted as a dose finding study to determine the safety and efficacy of MEN16132, given as three doses/four treatment regimens in comparison to placebo, as well the time to onset and duration of effect.

Arms: arm 1: Intra-articular administration of two 0.125 mg doses of MEN16132 at 2-week interval. arm 2: Intra-articular administration of two 0.25 mg doses of MEN16132 at 2-week interval. arm 3: Intra-articular administration of two 0.5 mg doses of MEN16132 at 2-week interval. arm 4: Intra-articular administration of one 0.5 mg dose of MEN16132 followed by one intra-articular injection of placebo at 2-week interval. arm 5: Intra-articular administration of two doses of Placebo at 2-week interval.
Interventions: intervention 1: MEN16132 - 0.125 mg intervention 2: MEN16132 - 0.25 mg intervention 3: MEN16132 - 0.5 mg intervention 4: MEN16132 - 0.5 mg intervention 5: Placebo
Intervention descriptions: intervention 1: Intra-articular administration of two low doses of MEN16132 at 2-week interval. intervention 2: Intra-articular injection of two intermediate doses of MEN16132 at 2-week interval intervention 3: Intra-articular injection of two high doses of MEN16132 at 2-week interval intervention 4: Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval intervention 5: Intra-articular injection of 2 doses of Placebo control at 2-week interval

Protocol documents:
Clinical trial NCT01100437
Conditions: Chronic Pain
Keywords: opioid morphine naltrexone withdrawal signs withdrawal symptoms
Sponsor: Pfizer
Start date: 2010-04-01; Completion date: 2011-03-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are stabilized on EMBEDA.

Detailed description:
The decision to terminate the trial was due to a lack of study drug supply. Decision was not based on any safety concerns. The date of the notification of termination letter was March 11, 2011.

Arms: arm 1: EMBEDA (morphine sulfate plus naltrexone hydrochloride ER) capsules crushed and mixed in solution and administered orally at each patient's stable dose, given either once daily or twice daily. arm 2: EMBEDA (morphine sulfate plus naltrexone hydrochloride ER) capsules, administered orally and intact at each patient's stable dose, given either once daily or twice daily
Interventions: intervention 1: EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush intervention 2: EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole
Intervention descriptions: intervention 1: Placebo capsules plus EMBEDA capsules crushed and mixed in solution administered orally at each patient's stable dose, given either once daily or twice daily intervention 2: EMBEDA capsules, administered orally and intact at each patient's stable dose, given either once daily or twice daily with 150mL placebo solution

Protocol documents:
Clinical trial NCT01108458
Conditions: Pancreatic Cancer
Sponsor: George Albert Fisher
Start date: 2010-07-01; Completion date: 2011-03-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A phase 2 study combining pertuzumab with erlotinib for patients with gemcitabine refractory pancreatic adenocarcinoma

Detailed description:
A single-institution, single-arm phase 2 study investigating pertuzumab and erlotinib as a palliative regimen in the treatment of locally-advanced or metastatic pancreatic adenocarcinoma.

Arms: arm 1: Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks

Erlotinib hydrochloride 150 mg/day by mouth
Interventions: intervention 1: Pertuzumab intervention 2: Erlotinib
Intervention descriptions: intervention 1: iv, 840 mg, 420 mg intervention 2: PO, 150 mg

Protocol documents:
Clinical trial NCT01118325
Conditions: Stable Coronary Artery Disease
Keywords: Stable Coronary Artery Disease Platelet Aggregation
Sponsor: AstraZeneca
Start date: 2010-04-01; Completion date: 2011-03-01
Enrollment: 146 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the drug characteristics of Ticagrelor, and to determine if 4 weeks treatment will reduce the blood clotting.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: ticagrelor intervention 2: clopidogrel
Intervention descriptions: intervention 1: Drug oral treatment intervention 2: Drug oral treatment

Protocol documents:
Clinical trial NCT01128114
Conditions: Acute Bipolar Mania
Keywords: Acute bipolar mania Seroquel XR Quetiapine fumarate Add-on therapy
Sponsor: AstraZeneca
Start date: 2010-06-01; Completion date: 2011-03-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the broad clinical benefit of dosing Seroquel XR with flexible in the treatment of acute bipolar mania patients with partial response to existing therapy. Clinical benefit will be assessed with the Clinical Global Impression-Clinical Benefit (CGI-CB) score, according to a classification based on the principles outlined in the CGI efficacy index. Improvement in clinical benefit will be defined as a decrease from baseline in CGI-CB.

Detailed description:
A 4-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Broad Clinical Benefit for Seroquel XR (Quetiapine Fumarate Extended Release) With Flexible Dose as an add-on Therapy in the Treatment of Acute Bipolar Mania Patients With Partial Response to Current Therapy

Arms: arm 1: Quetiapine fumarate (Seroquel XR)
Interventions: intervention 1: Quetiapine fumarate (Seroquel XR)
Intervention descriptions: intervention 1: Extended Release(XR) 50 mg, 200 mg, 300 mg and/or 400 mg tablet, oral, once daily in the evening, from assignment to the end of the study.

Protocol documents:
Clinical trial NCT01128842
Conditions: Advanced Malignant Solid Tumors
Keywords: Neratinib Capecitabine Combination Solid Tumor
Sponsor: Puma Biotechnology, Inc.
Start date: 2010-04-01; Completion date: 2011-03-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, phase 1 study of a single cohort of neratinib (HKI-272) in combination with capecitabine.

Detailed description:

Arms: arm 1: Neratinib + Capecitabine
Interventions: intervention 1: Neratinib intervention 2: Capecitabine
Intervention descriptions: intervention 1: 240 mg once daily by mouth. intervention 2: 1500 mg/m\^2 twice daily by mouth.

Protocol documents: