ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00107315
Conditions: Colorectal Cancer
Keywords: recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer
Sponsor: Roswell Park Cancer Institute
Start date: 2004-07-01; Completion date: 2008-06-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab 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 bevacizumab together with capecitabine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with capecitabine works as first-line therapy in treating older patients with metastatic colorectal cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the time to disease progression in older patients with metastatic colorectal cancer treated with bevacizumab and capecitabine as first-line therapy.

Secondary

* Determine the response rate in patients treated with this regimen.
* Determine the median survival of patients treated with this regimen.
* Determine the toxic effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13-16 months.

Arms: arm 1: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7
Interventions: intervention 1: bevacizumab intervention 2: capecitabine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00120250
Conditions: Post-Traumatic Stress Disorders
Keywords: PTSD Sleep disturbance Eszopiclone Double-blind Crossover
Sponsor: Massachusetts General Hospital
Start date: 2005-06-01; Completion date: 2008-06-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to obtain data investigating the safety and efficacy of eszopiclone for the treatment of post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with eszopiclone treatment on neuroendocrine correlates of PTSD. The investigators hypothesize that eszopiclone will be significantly more effective than placebo and well tolerated for PTSD-related sleep disturbance, improvement in sleep will be associated with improvement in overall PTSD symptoms, and patients with PTSD-related sleep disturbances will have abnormal levels of stress hormones.

Detailed description:
Post-traumatic stress disorder (PTSD) is characterized by three symptom groupings: re-experiencing symptoms including flashbacks, nightmares, and intrusive memories; physiological hyperarousal; and avoidance symptoms. Of the three major categories of symptoms in PTSD listed by the Diagnostic and Statistical Manual of Mental Disorders, sleep-related problems are listed in two of them: difficulty falling asleep is considered an aspect of hyperarousal symptoms, and nightmares are a type of re-experiencing symptom. Both are found commonly in PTSD. Little is known about the relationship of neuroendocrine dysregulation in PTSD and sleep disturbance. It is possible that successful treatment of sleep disturbance in PTSD may alter an abnormal stress hormone pattern. The novel cyclopyrrolone hypnotic eszopiclone thus presents an intriguing opportunity to examine the treatment of sleep disturbances and nightmares in PTSD. This study will determine the safety, efficacy and impact on neuroendocrine parameters of eszopiclone compared to placebo for sleep disturbance and overall PTSD symptoms in individuals with PTSD and reported sleep disturbance.

Arms: arm 1: Subjects received 3mg eszopiclone nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of placebo, followed by another 1 week washout. arm 2: Subjects received placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of 3mg eszopiclone, followed by another 1 week washout.
Interventions: intervention 1: Eszopiclone
Intervention descriptions: intervention 1: The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.

Protocol documents:
Clinical trial NCT00135356
Conditions: HIV-Associated Lipodystrophy Syndrome
Keywords: HIV infections
Sponsor: Bristol-Myers Squibb
Start date: 2005-07-01; Completion date: 2008-06-01
Enrollment: 219 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn if human immunodeficiency virus (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral treatment (HAART) regimen have better changes in fat distribution after switching to atazanavir-ritonavir than those remaining on their current protease inhibitor boosted HAART regimen.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs) intervention 2: continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)
Intervention descriptions: intervention 1: Capsules, Oral, ATV 300 mg + RTV 100 mg once daily up to 96 weeks intervention 2: Protease inhibitor \[PI\] combination + 2 NRTIs

Protocol documents:
Clinical trial NCT00152516
Conditions: Epilepsy, Partial
Keywords: Partial Onset Seizures levetiracetam Epilepsy Keppra
Sponsor: UCB Pharma
Start date: 2004-10-01; Completion date: 2008-06-01
Enrollment: 255 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: levetiracetam (LEV)
Intervention descriptions: intervention 1: Per protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.

Protocol documents:
Clinical trial NCT00158379
Conditions: Ovarian Cancer
Sponsor: North Eastern German Society of Gynaecological Oncology
Start date: 2003-07-01; Completion date: 2008-06-01
Enrollment: 105 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Time to progression (physical examination and radiologic imaging

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Paclitaxel
Intervention descriptions: intervention 1: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®

Protocol documents:
Clinical trial NCT00179660
Conditions: Non-Hodgkins Lymphoma
Keywords: celgene cc-5013 CC5013 NHL Non-Hodgkins Lymphoma Revlimid
Sponsor: Celgene Corporation
Start date: 2005-08-01; Completion date: 2008-06-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the activity of lenalidomide in relapsed or refractory aggressive NHL.

Detailed description:

Arms: arm 1: Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
Interventions: intervention 1: Lenalidomide
Intervention descriptions: intervention 1: Capsules for oral administration.

Protocol documents:
Clinical trial NCT00183963
Conditions: Breast Carcinoma
Sponsor: University of Southern California
Start date: 2006-08-01; Completion date: 2008-06-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The subjects in this trial have been diagnosed as having a pre-cancerous disease of the breast called ductal carcinoma in situ (DCIS). This condition is associated with the development of breast cancer in up to 50% of cases.

The subjects are being asked to participate in this research study. They are being offered voluntary admission to this study to test the effects of a new investigational drug called Fulvestrant (Faslodex). This drug is approved by the United States Food and Drug Administration (FDA) for the treatment of advanced breast cancer but has not been approved for the treatment of DCIS. However, the FDA has given permission for the drug to be tested in this study. The purpose of this study is to find out if Fulvestrant has any effect on the subject's precancerous changes by comparing samples taken before and after receiving Fulvestrant.

Detailed description:

Arms: arm 1: None arm 2: Tamoxifen 20 mg arm 3: Fulvestrant 250mg arm 4: Fulvestrant 500mg IM
Interventions: intervention 1: Tamoxifen intervention 2: Fulvestrant intervention 3: Fulvestrant
Intervention descriptions: intervention 1: 20mg intervention 2: 250mg intervention 3: 500 mg IM

Protocol documents:
Clinical trial NCT00189228
Conditions: Asthma
Sponsor: University of New Mexico
Start date: 2005-09-01; Completion date: 2008-06-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We are using anti-IgE to investigate the role of pulmonary mast cells in asthma.

Detailed description:
Subjects with mild allergic asthma are examined before, immediately after and 2 months after a course of treatment with anti-IgE. The following are examined: Allergen skin tests, allergen induced asthma, peripheral blood basophils, pulmonary bronchial mucosal mast cells.

Arms: arm 1: This is a single arm, parallel study examining differences of therapeutic outcomes of Xolair. Xolair is being examined as an intervention that might change the outcome of immunization.
Interventions: intervention 1: Xolair
Intervention descriptions: intervention 1: Patients are administered Xolair

Protocol documents:
Clinical trial NCT00190749
Conditions: Schizophrenia Schizoaffective Disorder
Sponsor: Eli Lilly and Company
Start date: 2003-10-01; Completion date: 2008-06-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: olanzapine intervention 2: risperidone
Intervention descriptions: intervention 1: 5-20 mg, oral, capsules, daily, 12 weeks. intervention 2: 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.

Protocol documents:
Clinical trial NCT00191477
Conditions: Bladder Neoplasms
Sponsor: Eli Lilly and Company
Start date: 2004-01-01; Completion date: 2008-06-01
Enrollment: 355 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized, double-blind, placebo-controlled Phase 3 multicenter study to assess the efficacy and safety of intravesical instillation of gemcitabine versus placebo immediately after transurethral resection of the bladder tumor.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Gemcitabine intervention 2: Placebo
Intervention descriptions: intervention 1: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT) intervention 2: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)

Protocol documents:
Clinical trial NCT00225017
Conditions: HIV Infection Hyperlipidemia
Keywords: Atazanavir Endothelial function Treatment Experienced
Sponsor: Northwestern University
Start date: 2005-06-01; Completion date: 2008-06-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the change in brachial artery reactivity in HIV-infected subjects with elevated lipid levels who are switched to an atazanavir containing antiretroviral regimen

Detailed description:
HIV-infected subjects on a stable protease inhibitor (PI) containing antiretroviral regimen with plasma HIV RNA \<500 copies/mL, who have LDL cholesterol levels \>130 mg/dL or fasting triglycerides levels \>200 mg/dL, will be randomized (1:1) to continue their current antiretroviral regimen or to switch the PI to atazanavir (ATV). Brachial artery reactivity will be measured before (at entry) and 12 and 24 weeks after subjects are randomized.

ARM A: Switch current PI to atazanavir 400 mg once daily plus current \> 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.

Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (\<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily.

ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus \> 2 NRTIs) for 24 weeks

Brachial artery reactivity in response to two vasoactive stimuli (increased forearm blood flow and nitroglycerin) will be assessed by measuring brachial artery diameter.

Arms: arm 1: ARM A: Switch current PI to atazanavir 400 mg once daily plus current \> 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.

Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (\<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily. arm 2: ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus \> 2 NRTIs) for 24 weeks
Interventions: intervention 1: Atazanavir intervention 2: current antiretroviral regimen
Intervention descriptions: intervention 1: atazanavir 400 mg once daily intervention 2: Continue current antiretroviral regimen for 24 weeks, single or RTV-boosted PI plus \> 2 NRTIs

Protocol documents:
Clinical trial NCT00225251
Conditions: Dysthymic Disorder
Keywords: Dysthymic Disorder Dysthymia Depression Chronic Depression Wellbutrin XL
Sponsor: St. Luke's-Roosevelt Hospital Center
Start date: 2004-11-01; Completion date: 2008-06-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a ten-week, double-blind study of Wellbutrin XL in outpatients with dysthymic disorder, a form of low-grade chronic depression. We hypothesize that patients taking Wellbutrin XL will show greater improvement in depression symptoms and psychosocial functioning than patients taking placebo.

Detailed description:
This is a ten-week, double-blind, placebo-controlled study designed to evaluate the tolerability, dosing and efficacy of Wellbutrin XL in outpatients who meet Diagnostic and Statistical Manual-IV criteria for early onset, primary type dysthymic disorder (low-grade chronic depression). It is hypothesized that patients taking Wellbutrin XL will show greater improvement in depression symptoms and psychosocial functioning than patients taking placebo.

Arms: arm 1: Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day arm 2: Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
Interventions: intervention 1: bupropion XL intervention 2: Placebo
Intervention descriptions: intervention 1: Antidepressant medication intervention 2: Placebo

Protocol documents:
Clinical trial NCT00232479
Conditions: Breast Cancer
Sponsor: University of Miami
Start date: 2005-09-01; Completion date: 2008-06-01
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.

Detailed description:
Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations

Arms: arm 1: single arm study evaluating the efficacy of neoadjuvant taxotere, herceptin and carboplatin given in a dose dense fashion
Interventions: intervention 1: trastuzumab, docetaxel and carboplatin in dose dense regimen
Intervention descriptions: intervention 1: trastuzumab 4 mg/kg day 1 and then 2 mg/kg/week x 11, carboplatin 6 mg AUC Day 1, 15, 29, 43, docetaxel 75 mg/meter squared Days 1, 15, 29, 43, neulasta 6 mg Day 2, 16, 30, 44

Protocol documents:
Clinical trial NCT00236184
Conditions: Heartburn
Sponsor: Eisai Inc.
Start date: 2005-10-01; Completion date: 2008-06-01
Enrollment: 629 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10 mg in treating frequent heartburn.

Detailed description:
This is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. The study will last for up to five weeks and consists of the following three phases: a one to two week screening period that includes a one-week, single-blind, placebo run-in phase, a two week double-blind, randomized treatment phase, and a one week single-blind, placebo follow-up phase.

Arms: arm 1: Oral placebo tablet arm 2: oral rabeprazole 10 mg enteric-coated tablet
Interventions: intervention 1: rabeprazole sodium intervention 2: Placebo
Intervention descriptions: intervention 1: Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase. intervention 2: Following a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.

Protocol documents:
Clinical trial NCT00236197
Conditions: Heartburn
Keywords: Heartburn Rabeprazole
Sponsor: Eisai Inc.
Start date: 2005-10-01; Completion date: 2008-06-01
Enrollment: 619 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn.

Detailed description:
This is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. The study will last for up to five weeks and consists of the following three phases: a one to two week screening period that includes a one week, single-blind, placebo run-in phase, a two week double-blind, randomized treatment phase, and a one week single-blind, placebo follow-up phase.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: rabeprazole sodium intervention 2: placebo
Intervention descriptions: intervention 1: Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally,placebo once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase. intervention 2: Following a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.

Protocol documents:
Clinical trial NCT00238355
Conditions: Infection Unspecified Adult Solid Tumor, Protocol Specific
Keywords: infection unspecified adult solid tumor, protocol specific
Sponsor: OHSU Knight Cancer Institute
Start date: 2003-08-01; Completion date: 2008-06-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Voriconazole and caspofungin acetate may control invasive fungal infections in patients who have weakened immune systems.

PURPOSE: This phase II trial is studying how well giving voriconazole together with caspofungin acetate works in treating invasive fungal infections in patients with weakened immune systems.

Detailed description:
OBJECTIVES:

Primary

* Determine the 12-week complete and partial response rate in immunocompromised patients with invasive fungal infections treated with voriconazole and caspofungin acetate.

Secondary

* Determine the 12-week survival rate in patients treated with this regimen.
* Determine the safety of this regimen in these patients.

OUTLINE: Patients receive voriconazole orally or IV over 1 hour twice daily and caspofungin acetate IV over 1 hour once daily on days 1-84. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: caspofungin acetate intervention 2: voriconazole
Intervention descriptions: intervention 1: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84. intervention 2: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses. Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours (at least one hour before or after meals).

Protocol documents: