ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00732641
Conditions: Multiple Myeloma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2000-12-01; Completion date: 2010-11-01
Enrollment: 244 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to assess the efficacy of peginterferon α-2b, compared to a control arm not receiving any maintenance treatment, in adult subjects with multiple myeloma who have responded to a prior induction therapy. Peginterferon α-2b will be given once weekly as an injection until disease progression or relapse, or for up to a maximum of 5 years (whichever occurs first).

Detailed description:

Arms: arm 1: Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years. arm 2: Participants will be observed and will receive no treatment.
Interventions: intervention 1: Peginterferon
Intervention descriptions: intervention 1: Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.

Protocol documents:
Clinical trial NCT00739661
Conditions: Ovarian Cancer
Keywords: Systemic Hedgehog Hedgehog Pathway Inhibitor
Sponsor: Genentech, Inc.
Start date: 2008-12-01; Completion date: 2010-11-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study was a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of vismodegib (GDC-0449) in patients with ovarian cancer in a second or third complete remission. Patients were randomized in a 1:1 ratio to either vismodegib or placebo. Randomization was stratified based on whether their cancer was in a second or third complete remission.

Detailed description:

Arms: arm 1: Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study. arm 2: Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
Interventions: intervention 1: Vismodegib 150 mg intervention 2: Placebo to vismodegib
Intervention descriptions: intervention 1: Vismodegib 150 mg was provided in hard gelatin capsules. intervention 2: Placebo to vismodegib consisted of the excipients for vismodegib without the active molecule in hard gelatin capsules matching the active drug product in color and size.

Protocol documents:
Clinical trial NCT00744978
Conditions: Alzheimer's Disease
Keywords: Efficacy Safety Pharmacokinetics Alzheimer's disease
Sponsor: Pfizer
Start date: 2009-07-01; Completion date: 2010-11-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
1. Assess the efficacy of varenicline, relative to placebo, on a performance based measure of cognition in patients with mild to moderate Alzheimer's disease
2. Evaluate the effects of varenicline on clinically relevant measures including attention and executive function, behavior, and clinician rated global change.
3. Evaluate the safety and tolerability of varenicline, relative to placebo, in patients with mild to moderate Alzheimer's disease
4. Evaluate the pharmacokinetics of varenicline in patients with mild to moderate Alzheimer's disease.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Varenicline intervention 2: Placebo
Intervention descriptions: intervention 1: 0.5 mg once daily for 1 week followed by 0.5 mg twice daily for 1 week followed by 1 mg twice daily for 4 weeks intervention 2: Placebo once daily for 1 week followed by placebo twice daily for 5 weeks.

Protocol documents:
Clinical trial NCT00746941
Conditions: Progressive Multifocal Leukoencephalopathy
Keywords: PML Human Polyomavirus JC HIV Central Nervous System Disease Mefloquine JC Virus
Sponsor: Biogen
Start date: 2009-01-01; Completion date: 2010-11-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to explore whether mefloquine can delay or stop progression of progressive multifocal leukoencephalopathy (PML) as measured by JC virus (human polyomavirus or JCV) deoxyribonucleic acid (DNA) levels in cerebrospinal fluid (CSF). The secondary objective of the study was to explore whether mefloquine can delay or stop progression of PML based on neurological deterioration, magnetic resonance imaging (MRI) measures of brain lesion evolution or the formation of new lesions, and mortality.

Detailed description:

Arms: arm 1: All participants received local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.

Participants in this treatment arm had the option of adding 250 mg mefloquine by mouth at Week 4 (Day 28) or Week 8 (Day 56) daily for 3 days, and then weekly through Week 24. arm 2: All participants received local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.

Participants received 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
Interventions: intervention 1: mefloquine
Intervention descriptions: intervention 1: 250 mg orally each day for 3 days and then weekly up to 6 months.

Protocol documents:
Clinical trial NCT00748709
Conditions: Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2008-10-01; Completion date: 2010-11-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II open-label exploratory trial of BIBW 2992 administered to patients with tumors of various histologies found to possess EGFR and/or HER2 gene amplification, or EGFR activating mutations.

Detailed description:

Arms: arm 1: BIBW 2992 (Afatinib) for patients FISH positive for/or harboring EGFR or HER2 Mutation
Interventions: intervention 1: BIBW 2992 (Afatinib)
Intervention descriptions: intervention 1: BIBW 2992 (Afatininb) for patients FISH positive for/or harboring EGFR or HER2 Mutation

Protocol documents:
Clinical trial NCT00750282
Conditions: Alzheimer Disease Amyloid Beta-Protein
Keywords: Alzheimer Disease Amyloid beta-Protein
Sponsor: Life Molecular Imaging SA
Start date: 2008-08-01; Completion date: 2010-11-01
Enrollment: 422 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this study is to evaluate the efficacy, safety of a single dose of BAY 94-9172 (ZK 6013443) as an investigational medicinal product (IMP) in detecting cerebral protein-plaque (amyloid beta) with positron emission tomography (PET). IMP binds to amyloidal beta protein accumulating in brain tissue already from early stages of Alzheimer's disease (AD). IMP is therefore a potential tracer to be used for detecting amyloid plaques. For each subject it is required to visit the study centre during the screening phase, on the PET imaging day and for 1 follow-up visit on the next day. A telephone call for safety follow-up will be performed 7 days after IMP administration. During the screening phase the subject's medical, neurological and surgical history, specific laboratory tests related to AD, MRI of the brain and certain neuro-psychiatric tests will be performed. Clinical safety measures (physical examinations, vital signs, electrocardiogram (ECG) and laboratory tests) will be performed on the PET imaging day before IMP injection and monitored during and after two PET imaging sessions. Clinical safety measures will be performed again on the follow-up visit next day. The results of PET imaging with IMP will be compared between probable AD patients and healthy volunteers (HV). The clinical diagnosis is based on international validated and accepted criteria and established after comprehensive clinical and neuro-psychiatric examinations

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Florbetaben (BAY94-9172)
Intervention descriptions: intervention 1: Healthy volunteers and patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions

Protocol documents:
Clinical trial NCT00755261
Conditions: Sarcoma Soft Tissue Sarcoma
Keywords: STS
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2008-09-01; Completion date: 2010-11-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research is being done to find out if adding a drug called Avastin to an already approved regimen used for soft-tissue sarcoma, Doxorubicin, will improve overall survival, and slow disease progression. The study will also evaluate the overall safety of combining these drugs. It is not known if combining these drugs will improve outcome. Avastin has been approved for the treatment of metastatic carcinoma of the colon or rectum. It is not approved for the treatment of soft-tissue sarcoma when added to Doxorubicin.

Detailed description:
The rationale for this trial is to improve the efficacy of prototypical anti-sarcoma chemotherapeutic regimen Doxorubicin when combined with Avastin®. Soft tissue sarcomas are highly vascular tumors and are therefore ideally suited to trials combining angiogenic inhibitors with chemotherapy. Several studies have revealed correlations between prognosis and surrogates for angiogenesis, including microvessel density, and circulating VEGF and basic fibroblast growth factor (bFGF). The aim of this study is to evaluate the safety and efficacy of Avastin® in combination with Doxorubicin for the treatment of advanced soft-tissue sarcomas.

Arms: arm 1: Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.
Interventions: intervention 1: Avastin intervention 2: Doxorubicin
Intervention descriptions: intervention 1: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes. intervention 2: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter.

Protocol documents:
Clinical trial NCT00755807
Conditions: Multiple Sclerosis
Keywords: Central Neuropathic Pain Multiple Sclerosis
Sponsor: Eli Lilly and Company
Start date: 2008-10-01; Completion date: 2010-11-01
Enrollment: 239 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to primarily assess the efficacy and safety of duloxetine 60-120 mg once daily (QD) compared with placebo on the reduction of pain severity in participants with central neuropathic pain due to Multiple Sclerosis.

Detailed description:
Study is a multicenter, randomized, double-blind, parallel, placebo-controlled, 20-week trial with 4 study periods. Participants who screen successfully (Study Period I) will be randomized in a 1:1 fashion to duloxetine 60 mg QD or placebo. Starting with Study Period II, participants will be treated in a double-blind manner for 6 weeks. Participants who complete the 6-week, double-blind period will have the opportunity to participate in a 12-week, open-label, flexible-dose portion of the study (Study Period III). Study Period IV is a taper phase designed to reduce the occurrence of discontinuation adverse events. Participants may enter Study Period IV at any time after Visit 3.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Duloxetine Hydrochloride (HCI) intervention 2: Placebo
Intervention descriptions: intervention 1: Participants received 30 mg duloxetine (po, QD) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks). intervention 2: Participants received placebo oral (po), once daily (QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 milligrams \[mg\] QD for 12 weeks).

Protocol documents:
Clinical trial NCT00757237
Conditions: Cystic Fibrosis
Keywords: aztreonam lysine tobramycin inhalation solution tobramycin nebuliser solution cystic fibrosis pseudomonas aeruginosa lung infection CFQ-R inhaled antibiotic
Sponsor: Gilead Sciences
Start date: 2008-08-01; Completion date: 2010-11-01
Enrollment: 274 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.

Detailed description:
Number of Subjects Planned: Approximately 240 randomized patients

Target Population: CF patients \>= 6 years of age with stable pulmonary disease, who at study entry had a recent positive sputum culture for PA and had been previously treated with aerosolized antibiotics without demonstration of drug intolerance.

The randomized phase of this study, used for hypotheses testing, enrolled participants from both the United States (US) and EU. An open-label, single-arm extension was available for participants in the EU who completed at least one course of AZLI or TIS during the randomized portion of the study. These participants were eligible to receive 3 additional cycles of AZLI in a 28-day, intermittent, repeating treatment regimen. Results of the extension phase will be available the first quarter (Q1) of 2012.

Randomized Phase Study Design (US and EU): This was an open-label, multicenter, randomized, parallel group study. The study design consisted of 2 treatment arms of 28-day, intermittent, repeating treatment regimens: aztreonam for inhalation solution (AZLI) or tobramycin inhalation solution (TIS). The total study period was 26 weeks. The study schedule included 9 visits - Screening, Baseline, Day 14, Day 28, followed by visits every 28 days through the end of the study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aztreonam for Inhalation Solution (AZLI) intervention 2: Tobramycin Inhalation Solution (TIS)
Intervention descriptions: intervention 1: Aztreonam for inhalation solution (75 mg) was administered 3 times a day (TID) for 28 days for each treatment cycle via the PARI eFlow electronic nebulizer. intervention 2: Tobramycin inhalation solution (300 mg) was administered 2 times a day (BID) for 28 days for each treatment cycle via the PARI LC Plus nebulizer with compressor or via another nebulizer compatible with country-specified labeling.

Protocol documents:
Clinical trial NCT00765128
Conditions: Renal Calculus Kidney Stones
Keywords: Percutaneous Nephrolithotomy Kidney stones
Sponsor: Mayo Clinic
Start date: 2008-10-01; Completion date: 2010-11-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having percutaneous nephrolithotomy for kidney stone disease.

Detailed description:

Arms: arm 1: 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. arm 2: 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
Interventions: intervention 1: Ketorolac intervention 2: Placebo
Intervention descriptions: intervention 1: 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. intervention 2: 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.

Protocol documents:
Clinical trial NCT00765232
Conditions: Nephrectomy Laparoscopic Donor Nephrectomy
Keywords: laparoscopic donor nephrectomy
Sponsor: Mayo Clinic
Start date: 2008-10-01; Completion date: 2010-11-01
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having laparoscopic surgery to donate a kidney.

Detailed description:

Arms: arm 1: 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. arm 2: 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
Interventions: intervention 1: Ketorolac intervention 2: Placebo
Intervention descriptions: intervention 1: 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. intervention 2: 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.

Protocol documents:
Clinical trial NCT00772603
Conditions: Epilepsies, Partial
Keywords: Partial onset epilepsy Partial onset seizures
Sponsor: Supernus Pharmaceuticals, Inc.
Start date: 2008-11-01; Completion date: 2010-11-01
Enrollment: 366 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures

Detailed description:
Multicenter, double-blind, randomized, placebo-controlled, three-arm. parallel-group study of the efficacy and safety of extended-release oxcarbazepine in the treatment of adults with refractory partial onset epilepsy.

Arms: arm 1: Placebo - four identical tablets taken orally once daily arm 2: 2400mg OXC XR taken orally once daily as four identical tablets arm 3: 1200mg OXC XR taken orally once daily as four identical tablets
Interventions: intervention 1: Placebo intervention 2: 2400mg SPN-804 intervention 3: 1200mg SPN-804
Intervention descriptions: intervention 1: Non-active tablet identical to study drug tablets intervention 2: tablets containing 600mg OXC XR, identical to non-active tablets intervention 3: two active tablets and two non-active tablets, all identical

Protocol documents:
Clinical trial NCT00773474
Conditions: Metastatic Breast Cancer
Sponsor: George Sledge
Start date: 2008-10-01; Completion date: 2010-11-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A published phase 2 study reported that lonafarnib was administered as a single agent via continuous or intermittent oral dosing to 76 women with advanced breast cancer who were previously treated with chemotherapy and/or with endocrine therapy. Objective response rates of approximately 10% were observed. This study will determine the rate of progression-free survival of patients with metastatic breast cancer who receive lonafarnib.

Detailed description:
OUTLINE: This is a multi-center study

Patients will be treated with lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.

1 Cycle = 21 days of lonafarnib (plus the time required to recover from toxicity if encountered).

ECOG Performance Status 0-1

Life Expectancy: Not Specified

Hematopoietic:

* Platelets \> 100 K/mm3
* Absolute Neutrophil Count (ANC) \> 1.2 K/mm3
* Hemoglobin ≥ 9 g/dl
* Serum potassium ≥ 3.3 mmol/L

Hepatic:

* Aspartate transaminase (AST) ≤ 5.0 x ULN
* Alanine transaminase (ALT) ≤ 5.0 x ULN
* Total bilirubin \< 1.5 x ULN

Renal:

* Calculated creatinine clearance (using Cockcroft-Gault formula) \> 45 cc/min

Cardiovascular:

* No history of Torsades de Pointes, ventricular tachycardia, ventricular fibrillation or ventricular flutter

Arms: arm 1: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
Interventions: intervention 1: Lonafarnib
Intervention descriptions: intervention 1: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.

Protocol documents:
Clinical trial NCT00786994
Conditions: Actinic Keratoses
Keywords: Actinic Keratoses
Sponsor: Birken AG
Start date: 2008-10-01; Completion date: 2010-11-01
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study the impact of Oleogel-S-10 versus placebo on actinic keratoses over a treatment period of 3 months will be tested. Additionally, once and twice daily applications are tested.

Detailed description:
Oleogel-S-10 has shown efficacy and was well tolerated in two previous clinical trials. In the second open label phase II trial the efficacy of Oleogel-S-10 alone was similar compared to a more invasive treatment with cryotherapy. Response rates of 85% with a clear-ance of more than 75 % of the lesions of the patients treated with Oleogel-S-10 over three months were reported. These encouraging results led to the present randomized, multicenter, double blind phase II trial. The efficacy of the treatment shall be tested in a double blind placebo controlled (petroleum jelly) fashion in order to obtain more reliable results for the planning of a phase III study.

Arms: arm 1: Oleogel-S10 100 mg/g ointment for three months once a day (54 patients) arm 2: Oleogel-S10 100 mg/g ointment for three months twice a day (54 patients) arm 3: Placebo (petroleum jelly) for three months once a day (27 patients) arm 4: Placebo (petroleum jelly) for three months twice a day (27 patients)
Interventions: intervention 1: Oleogel-S10 100 mg/g intervention 2: Placebo (petroleum jelly)
Intervention descriptions: intervention 1: topical use once or twice daily intervention 2: topical use once or twice daily

Protocol documents: