ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00538291
Conditions: Colorectal Cancer
Keywords: recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer
Sponsor: City of Hope Medical Center
Start date: 2005-08-01; Completion date: 2009-02-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies such as cetuximab, 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. Cetuximab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with capecitabine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with capecitabine work in treating patients with metastatic colorectal cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the response rate in patients with metastatic colorectal cancer treated with cetuximab and capecitabine that progressed on prior fluoropyrimidine-containing therapy comprising irinotecan with or without oxaliplatin.

Secondary

* To determine the progression-free survival and overall survival of patients treated with this regimen.
* To determine the tolerance to therapy in these patients.
* To assess biological correlates of response in available tissue biopsies and blood samples.

OUTLINE: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood collection periodically for correlative studies. Samples are analyzed for expression of genes correlated with fluoropyrimidine responsiveness via quantitation RT-PCR; degree of expression of EGFR via immunohistochemistry; and expression pattern analysis via gene expression profiling and polymorphism.

After completion of study treatment, patients are followed periodically.

Arms: arm 1: Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
Interventions: intervention 1: cetuximab intervention 2: capecitabine intervention 3: gene expression analysis intervention 4: microarray analysis intervention 5: polymorphism analysis intervention 6: reverse transcriptase-polymerase chain reaction intervention 7: immunohistochemistry staining method
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None

Protocol documents:
Clinical trial NCT00539734
Conditions: Age-related Macular Degeneration
Keywords: age-related macular degeneration (AMD) choroidal neovascularization membrane(CNVM) ranibizumab anti-vascular endothelial growth factor electrophysiology electroretinography
Sponsor: Prince of Songkla University
Start date: 2007-08-01; Completion date: 2009-02-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Age-related macular degeneration, a leading cause of blindness, is caused by an abnormal growth of the vessels beneath the retina. Ranibizumab (Lucentis) is a new drug that inhibits the growth of new vessels and has recently been approved by FDA for treating this condition. This study is carried out to evaluate the changes in retinal function after an injection of ranibizumab.

Detailed description:
The functional changes of the retina can be recorded by an electroretinography (ERG).

Interventions: intervention 1: ranibizumab
Intervention descriptions: intervention 1: A single dose of 0.5 mg ranibizumab injected intravitreally.

Protocol documents:
Clinical trial NCT00542789
Conditions: Gastric Ulcer Duodenal Ulcer Rheumatoid Arthritis Osteoarthritis Lumbago
Keywords: gastrointestinal GI NSAID Japan Japanese Gastric ulcer duodenal ulcer
Sponsor: AstraZeneca
Start date: 2007-08-01; Completion date: 2009-02-01
Enrollment: 343 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers

Detailed description:

Arms: arm 1: Placebo arm 2: Esomeprazole 20 mg
Interventions: intervention 1: Esomeprazole intervention 2: Placebo
Intervention descriptions: intervention 1: 20mg once daily oral intervention 2: once daily oral

Protocol documents:
Clinical trial NCT00544869
Conditions: Cardiac Edema
Keywords: Vasopressin antagonist , Cardiac Edema ,Diuretics
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2007-10-01; Completion date: 2009-02-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To investigate the plasma drug level, efficacy, and safety of 7-day repeated oral administration of OPC-41061 at 15 mg/day (treatment period 1) and subsequent 7-day repeated administration of OPC-41061 at 15 mg/day or 30 mg/day if diuretic effect is insufficient (treatment period 2) in congestive heart failure (CHF) patients with extracellular volume expansion despite conventional diuretic therapy.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: OPC-41061 （Tolvaptan)
Intervention descriptions: intervention 1: 15-30mg/day,daily for 14days

Protocol documents:
Clinical trial NCT00546637
Conditions: Overactive Bladder Syndrome
Sponsor: Pfizer
Start date: 2007-11-01; Completion date: 2009-02-01
Enrollment: 947 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement when added to ongoing alpha blocker treatment.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Fesoterodine intervention 2: Placebo
Intervention descriptions: intervention 1: Fesoterodine 4mg or 8mg intervention 2: Placebo

Protocol documents:
Clinical trial NCT00562588
Conditions: Cerebrovascular Accident
Sponsor: Boehringer Ingelheim
Start date: 2007-07-01; Completion date: 2009-02-01
Enrollment: 551 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
German stroke units are hesitating to use Aggrenox for secondary ischaemic stroke / transient ischaemic attack (TIA) prevention in a sub-acute treatment setting. They argue that clinical experience with sub-acute Aggrenox treatment is limited and poorly documented when compared with sub-acute acetylsalicylic acid (ASA) treatment. However, long term treatment (started after 3-6 months after stroke/TIA) with Aggrenox was safe and superior to ASA treatment in preventing recurrent strokes. There is no evidence for ASA to prevent from neurological progression after stroke during the first 3 months. Results from a cohort study suggest that starting Aggrenox within 72 hours after stroke predicts clinical improvement in the National Institute of Health Stroke Scale (NIHSS) at discharge from the hospital. Dipyridamole suppresses acute inflammatory responses to stroke.

This study is designed to investigate the tolerability and efficacy of a secondary stroke prevention treatment with Aggrenox when initiated within 24 hours of stroke onset on a stroke unit compared to later initiation after a 7 day ASA treatment and outside off a stroke unit setting.

Detailed description:

Interventions: intervention 1: Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg) intervention 2: ASA 100 mg qd
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00577395
Conditions: Osteoporosis
Sponsor: Warner Chilcott
Start date: 2008-07-01; Completion date: 2009-02-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to compare the difference in bone microarchitecture of the distal radius at month 12 in postmenopausal osteopenic women treated with risedronate 150mg taken once a month compared to placebo.

Detailed description:

Arms: arm 1: one 150 mg risedronate once a month, orally arm 2: Placebo tablet once a month, orally
Interventions: intervention 1: placebo intervention 2: risedronate
Intervention descriptions: intervention 1: oral tablet once a month for 12 months intervention 2: tablet, 150 mg once a month for 12 months

Protocol documents:
Clinical trial NCT00582491
Conditions: Cocaine Dependence Substance-induced Sleep Disorder Substance-induced Cognitive Disorder
Keywords: Modafinil Sleep Cognition Cocaine Dependence
Sponsor: Yale University
Start date: 2006-08-01; Completion date: 2009-02-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Subjects participating in this protocol will participate in three phases: 1) pre-admission, 2) inpatient admission, and 3) follow-up. Pre-admission involves screening (detailed in inclusion/exclusion criteria section) and one week of outpatient sleep and activity monitoring. Inpatient admission is 16 consecutive nights on the Clinical Neuroscience Research Unit and involves subjective and objective tests of sleep, sleepiness, attention, and learning. During inpatient admission subjects will take modafinil or placebo. For follow-up, subjects will return to the CNRU for one night and again participate in objective tests of sleep, sleepiness, attention, and learning. We hypothesize that modafinil will decrease subject and objective measures of sleepiness and will promote attention and learning in cocaine dependent persons.

Detailed description:
A relatively new treatment for the excessive daytime sleepiness (EDS) associated with inadequate sleep is the drug modafinil. Modafinil decreases subjective reports and objective measures of daytime sleepiness under conditions of sleep restriction, while enhancing cognitive performance. At the same time, sleep quality does not appear to be affected significantly. Interestingly, recent clinical trials in cocaine-dependent populations suggest that modafinil reduces the relapse to cocaine use, by unknown mechanisms.

We propose to employ both subjective and objective measures of nocturnal sleep and daytime sleepiness, as well as measures of general cognitive performance and sleep-dependent memory consolidation, to explore potential mechanistic relationships between cocaine abstinence, EDS, and modafinil's efficacy in preventing cocaine relapse.

The following specific aims are proposed:

Specific Aim 1: To establish whether objective measures of poor nocturnal sleep (e.g., reduced total sleep time and sleep efficiency) that progressively characterize periods of sustained cocaine abstinence are also associated with objective evidence of excessive daytime sleepiness (EDS).

Specific Aim 2: To establish the ability of modafinil to reverse the excessive daytime sleepiness (EDS) and deficits in cognitive performance that characterize cocaine abstinence.

Specific Aim 3: To conduct a pilot study to determine whether the observed abnormalities in objective sleep, EDS, and/or cognitive function predict relapse to cocaine use and/or whether successful abstinence from cocaine is associated with normalization of the same.

Arms: arm 1: Modafinil 400mg orally everyday for 16 days arm 2: Placebo orally everyday for 16 days
Interventions: intervention 1: Modafinil intervention 2: Placebo
Intervention descriptions: intervention 1: Modafinil 400mg orally every day for 16 days intervention 2: Placebo orally everyday for 16 days

Protocol documents:
Clinical trial NCT00586846
Conditions: Osteosarcoma
Keywords: Cisplatin Doxorubicin Methotrexate Osteosarcoma 03-074
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2003-07-01; Completion date: 2009-02-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to test the safety and feasibility of the simultaneous administration of a biphosphonate with chemotherapy for the treatment of osteosarcoma in newly diagnosed patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Cisplatin intervention 2: Doxorubicin intervention 3: Methotrexate
Intervention descriptions: intervention 1: Cisplatin 120 mg/m\^2 intervention 2: 75mg/m\^2 intervention 3: Methotrexate 12g/m\^2

Protocol documents:
Clinical trial NCT00588354
Conditions: Lumbar and Other Intervertebral Disc Disorders With Radiculopathy
Keywords: herniated disk radiculopathy clonidine epidural steroid corticosteroid nucleus pulposus transforaminal
Sponsor: Mayo Clinic
Start date: 2006-10-01; Completion date: 2009-02-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a randomized, blinded study of transforaminal epidural injection of clonidine versus a similar injection of corticosteroid for acute lumbosacral radiculopathy. The hypothesis was that clonidine will be as effective as steroid for this condition.

Detailed description:
Patients with approximately 3 months of low back pain and leg pain due to intervertebral disc herniation were randomized to transforaminal epidural injections of 2% lidocaine and either clonidine (200 or 400 micrograms) or triamcinolone (40 mg) (corticosteroid). Patients received one to three injections administered at about 2 weeks apart. Patients, investigators, and study coordinators were blinded to the treatment. The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. The hypothesis was that clonidine will be as effective as steroid for this condition.

Arms: arm 1: Transforaminal epidural clonidine injection arm 2: Transforaminal epidural steroid injection
Interventions: intervention 1: Clonidine intervention 2: Triamcinolone hexacetonide intervention 3: Lidocaine HCl
Intervention descriptions: intervention 1: 200 or 400 micrograms clonidine intervention 2: 40 or 80 milligrams triamcinolone intervention 3: 1 ml 2% lidocaine (20 mg/mL)

Protocol documents:
Clinical trial NCT00592839
Conditions: Nocturnal Vasomotor Symptoms
Keywords: Nocturnal vasomotor symptoms in postmenopausal women
Sponsor: Duramed Research
Start date: 2007-12-01; Completion date: 2009-02-01
Enrollment: 157 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening period and approximately 5 scheduled clinic visits. Participants will receive one of two strengths of SCE-B tablets plus matching placebo or placebo only, and will have a physical and gynecological exams that may include transvaginal ultrasound, endometrial biopsy and a pap smear. Participants will be asked to wear a monitoring device for a portion of the study and be asked to complete a daily dairy.

Detailed description:

Arms: arm 1: 0.3 mg SCE-B Daily arm 2: 0.625 mg SCE-B Daily arm 3: Placebo
Interventions: intervention 1: SCE-B intervention 2: Placebo
Intervention descriptions: intervention 1: 0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo intervention 2: Matching placebo for 0.3 mg and 0.625 mg tablets

Protocol documents:
Clinical trial NCT00600015
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer Advanced Sorafenib Erlotinib Double-blind Placebo-controlled
Sponsor: SCRI Development Innovations, LLC
Start date: 2008-02-01; Completion date: 2009-02-01
Enrollment: 166 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will investigate the use of the newer targeted agents erlotinib and sorafenib in patients with stage IIIB or stage IV NSCLC who have received 1-2 prior chemotherapy regimens. Patients will be randomized to receive erlotinib (150 mg/day) and sorafenib (400 mg twice daily), or erlotinib (150 mg/day) and a placebo.

Detailed description:
The rationale of this study is to combine two distinct kinase inhibitors to evaluate synergistic inhibition of angiogenesis and epidermal growth factor receptor (EGFR) signaling. Erlotinib is a oral tyrosine kinase inhibitor that targets EGFR. Sorafenib is a oral tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor (VEGFR), platelet derived growth factor receptor beta, Raf-1, Flt-3, and C-kit. These agents also do not exhibit overlapping adverse event profiles which provided additional support for studying this combination therapy.

Arms: arm 1: Erlotinib + Sorafenib arm 2: Erlotinib + Placebo
Interventions: intervention 1: Erlotinib + Sorafenib intervention 2: Erlotinib + Placebo
Intervention descriptions: intervention 1: Patients who are randomized to Cohort A will take sorafenib 400 mg (2 x 200-mg tablets) orally twice a day, and erlotinib 150 mg orally once a day. intervention 2: Patients who are randomized to Cohort B will take erlotinib 150 mg orally once a day and placebo orally twice a day.

Protocol documents:
Clinical trial NCT00600743
Conditions: Bulimia
Keywords: Eating Food Intake Appetite
Sponsor: St. Luke's-Roosevelt Hospital Center
Start date: 2008-01-01; Completion date: 2009-02-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The ultimate aim of this study is to test the hypothesis that the oral cholecystokinin (CCK) agonist GSKI181771X will reduce the size of a binge meal among individuals with Bulimia Nervosa. The study will be conducted in phases. First, an effective dose for reducing food intake, when normal subjects eat normally will be attained. Next, it will be determined whether intake at this dose is reduced in control subjects instructed to eat to capacity. If the dose is still effective compared to placebo, the same dose will be tested in patients with bulimia nervosa.

Detailed description:
This study tests the hypothesis that an oral CCK antagonist GSKI181771X will reduce the size of a binge meal. It was intended to study the effects of increasing doses on antagonist on normal individuals to find an effective dose in a non-binge meal before moving to a binge meal. Once the effects of the antagonist on a binge meal were found, the compound would be used on patients with bulimia nervosa. However, the product expired and more was not available before the patients were tested. Data are presented for the normal participants who were instructed to eat normally, followed by a group that was instructed to binge eat. Comparisons were made between groups with different instructions and between binge and normal meals.

Arms: arm 1: 'Instructions to eat normally' Placebo 1 mg dose arm 2: 'Instructions to eat normally' drug 1 mg dose 'GSKI181771X (CCK-1R agonist)' arm 3: 'Instructions to eat normally' 2 mg placebo arm 4: 'Instructions to eat normally' 2 mg drug 'GSKI181771X (CCK-1R agonist)' arm 5: 'Instructions to eat normally' 4 mg placebo arm 6: 'Instructions to eat normally' 4 mg drug 'GSKI181771X (CCK-1R agonist)' arm 7: Instructions to binge eat 4 mg placebo arm 8: Instructions to binge eat 4 mg drug 'GSKI181771X (CCK-1R agonist)'
Interventions: intervention 1: GSKI181771X (CCK-1R agonist) intervention 2: Instructions to binge eat intervention 3: Instructions to eat normally intervention 4: Placebo
Intervention descriptions: intervention 1: Drug one trial vs placebo intervention 2: Subjects will be instructed to binge eat and will also be given either drug or placebo intervention 3: Subjects will be instructed to eat normally and will also be given either drug or placebo intervention 4: Drug one trial vs placebo

Protocol documents:
Clinical trial NCT00605384
Conditions: Chronic Hepatitis B
Sponsor: Bristol-Myers Squibb
Start date: 2008-08-01; Completion date: 2009-02-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to find out whether a combination of entecavir (ETV) plus tenofovir (TNF) works better against Hepatitis B virus than adefovir (ADV) added to continuing lamivudine (LVD) therapy in patients whose Hepatitis B virus (HBV) is resistant against lamivudine. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Entecavir + Tenofovir intervention 2: Adefovir + continuing Lamivudine
Intervention descriptions: intervention 1: Tablets, Oral Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks intervention 2: Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks

Protocol documents:
Clinical trial NCT00606801
Conditions: Cocaine Abuse
Keywords: cognitive enhancers Nootropic Agents
Sponsor: Yale University
Start date: 2007-06-01; Completion date: 2009-02-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate galantamine's effects on cognitive performance in abstinent cocaine users. Galantamine, a medication approved for treatment of Alzheimer's disease, is an acetylcholine esterase inhibitor. Galantamine also directly potentiates nicotine receptors. Both of these effects may result in improved cognitive performance in a group of subjects known to have impaired performance in various cognitive tasks.

Detailed description:
Galantamine, compared to placebo, will improve cognitive performance in abstinent cocaine users. The cognitive performance will be measured with the Stroop test and 3 Cambridge Neuropsychological Test Automated Battery (CANTAB) tests: Paired Associate Learning (PAL), Delayed Pattern Recognition Memory (PRM),and Rapid Visual Information Processing (RVIP). Performance on these tests has been shown to be impaired in abstinent cocaine users, compared to healthy controls.

Galantamine, compared to placebo, will not be associated with any significant changes in mood. Monitoring of mood will be achieved with 3 mood scales: 1) Center for Epidemiologic Studies Depression (CES-D) scale, Positive and Negative Affect Schedule (PANAS) and the Profile of Mood States (POMS).

Currently this study is completed, Patients are no longer being enrolled. There were 28 completers. This study has been published.

Arms: arm 1: Galantamine 8 mg/day arm 2: placebo
Interventions: intervention 1: Galantamine intervention 2: placebo
Intervention descriptions: intervention 1: Galantamine 8 mg/day intervention 2: sugar pill

Protocol documents: