ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00304707
Conditions: Smoking Cessation Alcohol-Related Disorders
Sponsor: National Institute on Drug Abuse (NIDA)
Start date: 2005-04-01; Completion date: 2011-02-01
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Smoking is often a problem for alcohol dependent individuals. Many people who seek treatment for alcohol dependence are unable to quit smoking. The purpose of this study is to evaluate the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving treatment for alcohol dependence.

Detailed description:
Past research suggests that over 75% of alcohol dependent individuals in early alcohol recovery smoke cigarettes; smoking-related mortality exceeds alcohol-related mortality in this population. Many alcohol dependent individuals in early recovery are interested in smoking cessation treatment; however, studies indicate that these smokers find it very difficult to quit smoking. More effective treatment methods are needed for smokers in early alcohol recovery. Bupropion is a dopaminergic antidepressant that may be effective in treating nicotine dependent individuals. The purpose of this study is to evaluate the effectiveness of bupropion in nicotine dependent individuals receiving treatment for alcohol dependence. In addition, this study will investigate the psychological mechanisms that may mediate the efficacy of bupropion in smoking cessation. We will also collect DNA from subjects in order to explore whether response to bupropion is mediated by particular genetic variants in the dopaminergic, metabolic and nicotinic receptor systems of smokers.

Participants will be randomly assigned to receive either 300 mg of bupropion or placebo, daily for 8 weeks. In addition, all participants will receive a nicotine patch for 7 weeks. This will consist of a 21-mg nicotine patch for 4 weeks, a 14-mg nicotine patch for 2 weeks, and a 7-mg nicotine patch for 1 week. All participants will undergo seven counseling sessions. Follow-up visits will occur at Weeks 7, 12, and 24. Pre-quit variables (e.g., smoking satisfaction) and three post-quit variables (craving, nicotine withdrawal, and negative effects) will be evaluated at all study visits.

Arms: arm 1: participants in this arm receive bupropion arm 2: placebo
Interventions: intervention 1: Bupropion intervention 2: placebo
Intervention descriptions: intervention 1: 300 mg QD intervention 2: placebo

Protocol documents:
Clinical trial NCT00309959
Conditions: Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Small Cell Carcinoma Cervical Squamous Cell Carcinoma Recurrent Cervical Carcinoma
Sponsor: Gynecologic Oncology Group
Start date: 2006-11-01; Completion date: 2011-02-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well ABI-007 works in treating patients with persistent or recurrent cervical cancer. Drugs used in chemotherapy, such as ABI-007, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description:
OBJECTIVES:

I. Estimate the antitumor activity of ABI-007 in patients with persistent or recurrent squamous or nonsquamous cell carcinoma of the cervix who have failed on higher-priority treatment protocols.

II. Determine the nature and degree of toxicity of ABI-007 in this cohort of patients.

III. To determine the expression of the SPARC (secreted protein, acidic and rich in cysteine) protein in the tumor tissue and plasma (exploratory study) of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive ABI-007 IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and periodically during study for SPARC protein expression analysis by ELISA. Archived tumor tissue samples are also analyzed.

After completion of study treatment, patients are followed periodically for up to 5 years.

Arms: arm 1: Patients receive ABI-007 IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Paclitaxel Albumin-Stabilized Nanoparticle Formulation intervention 2: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00335829
Conditions: Liver Cancer
Keywords: localized unresectable adult primary liver cancer adult primary hepatocellular carcinoma advanced adult primary liver cancer recurrent adult primary liver cancer
Sponsor: Yale University
Start date: 2006-05-01; Completion date: 2011-02-01
Enrollment: 26 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 tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoembolization kills tumor cells by carrying chemotherapy drugs directly into the tumor and blocking the blood flow to the tumor. Giving bevacizumab together with chemoembolization may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with chemoembolization works in treating patients with liver cancer that cannot be removed by surgery.

Detailed description:
OBJECTIVES:

Primary

* Improve median progression-free survival of patients with unresectable hepatocellular cancer treated with bevacizumab and transarterial chemoembolization therapy.

Secondary

* Characterize the safety and toxicity of this regimen in these patients.
* Determine the response rate in patients treated with this regimen.

OUTLINE: Patients receive bevacizumab once in weeks 1, 3, and 5. Beginning in week 3, patients also receive transarterial chemoembolization (TACE) therapy. Treatment repeats approximately every 8 weeks for up to 3 courses. Patients achieving \< 100% necrosis by MRI after the first course receive 2 additional courses of bevacizumab and TACE.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: bevacizumab intervention 2: chemotherapy intervention 3: embolization therapy intervention 4: hepatic artery infusion
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00389207
Conditions: HIV Infections
Sponsor: Boehringer Ingelheim
Start date: 2006-10-01; Completion date: 2011-02-01
Enrollment: 576 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary purpose of this study is to compare the efficacy and safety of two different nevirapine (Viramune) dosing regimens (once daily (QD) and twice daily (BID) application) and of atazanavir/ritonavir (Reyataz/Norvir), all on an emtricitabine/tenofovir disoproxil fumarate (DF) (Truvada) background. Patients will receive either nevirapine (NVP) 200 mg twice daily, or NVP 400 mg once daily , or ritonavir-boosted atazanavir (ATZ/r), all in combination with emtricitabine (FTC) and tenofovir DF (TDF).

All patients receiving NVP will start at 200 mg once daily for 2 weeks, because it has been demonstrated that this lead-in dosing regimen reduces the frequency of NVP-induced rash. At Visit 3 (Week 2), patients increase the NVP dose to either 200 mg twice daily or to 400 mg once daily. Patients receiving ATZ/r will be treated with ATZ 300 mg once daily, boosted by 100 mg ritonavir (RTV) once daily. Background antiretroviral therapy for all patients consists of one tablet of Truvada. Treatment duration is 48 weeks (primary endpoint) with an extension to 144 weeks. Patients may also participate in the metabolic sub-study, comparing NVP and ATZ/r for signs and symptoms of lipodystrophy and serum lipid/glycaemic abnormalities.

Detailed description:

Arms: arm 1: nevirapine (NVP) 200 mg BID in combination with emtricitabine (FTC) and tenofovir DF (TDF) arm 2: nevirapine (NVP) 400 mg QD in combination with emtricitabine (FTC) and tenofovir DF (TDF) arm 3: ritonavir-boosted atazanavir in combination with emtricitabine (FTC) and tenofovir DF (TDF)
Interventions: intervention 1: nevirapine bid intervention 2: nevirapine qd intervention 3: atazanavir
Intervention descriptions: intervention 1: nevirapine twice daily intervention 2: nevirapine once daily intervention 3: atazanavir once daily

Protocol documents:
Clinical trial NCT00394082
Conditions: Metastatic Breast Cancer
Keywords: Metastatic breast cancer, Abraxane, Bevacizumab
Sponsor: Celgene
Start date: 2006-06-01; Completion date: 2011-02-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of weekly ABI-007 in combination with bevacizumab.

The evaluation of progression-free survival of weekly ABI-007 in combination with bevacizumab for patients with previously untreated advanced/metastatic breast cancer.

Detailed description:

Arms: arm 1: ABI-007 is administered on days 1, 8 and 15 at 125 mg/m\^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
Interventions: intervention 1: ABI-007 intervention 2: Bevacizumab
Intervention descriptions: intervention 1: 125 mg/m\^2 of ABI-007 administered by intravenously (IV) over 30 minutes on days 1, 8 and 15 of each 28 day cycle. intervention 2: Bevacizumab administered once every 2 weeks (10 mg/kg) by IV infusion after ABI-007 has been given. The first dose is one Day 1, cycle 1.

Protocol documents:
Clinical trial NCT00407563
Conditions: Epithelial Ovarian Cancer Primary Peritoneal Carcinoma
Sponsor: Accelerated Community Oncology Research Network
Start date: 2007-01-01; Completion date: 2011-02-01
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness and tolerability of the combination of bevacizumab and Abraxane in the treatment of women with epithelial ovarian cancer or peritoneal cancer. The study will also evaluate how the patient's quality of life is during their treatment.

Detailed description:

Interventions: intervention 1: Bevacizumab intervention 2: Abraxane
Intervention descriptions: intervention 1: Bevacizumab will be given via IV infusion at 10mg/kg given on days 1 and 15 of a 28-day cycle. intervention 2: Abraxane will be given via IV infusion at 100mg/m²over 30 minutes on days 1, 8, and 15 of a 28-day cycle.

Protocol documents:
Clinical trial NCT00407745
Conditions: Neuralgia Spinal Cord Injuries
Keywords: Pain central neuropathic pain
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-01-01; Completion date: 2011-02-01
Enrollment: 220 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population.

Detailed description:

Arms: arm 1: None arm 2: flexible dosing over 4 weeks followed by 12 weeks maintenance and one week taper period
Interventions: intervention 1: placebo intervention 2: pregabalin
Intervention descriptions: intervention 1: Placebo intervention 2: Pregabalin capsules taken twice daily up to 17 weeks (150-600 mg/day)

Protocol documents:
Clinical trial NCT00414648
Conditions: Lymphangioleiomyomatosis
Keywords: Lymphangiomyomatosis mTOR
Sponsor: University of Cincinnati
Start date: 2006-12-01; Completion date: 2011-02-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Lymphangioleiomyomatosis (LAM) is a rare lung disease of women that is caused by genetic mutations. It results in the uncontrolled growth of an unusual type of smooth muscle cell in the lung. These cells invade lung tissue, including the airways, blood vessels, and lymph vessels, and restrict the flow of air, blood, and lymph, respectively. Respiratory failure, lung collapse (pneumothorax), and pleural effusions (chylothorax) are hallmarks of the disease. This study will evaluate the safety and effectiveness of sirolimus, an inhibitor of the mTOR pathway, in stabilizing or improving lung function in people with LAM.

Detailed description:
LAM is an uncommon, progressive, cystic lung disease that predominantly affects young women. The disease is caused by mutations in tuberous sclerosis complex (TSC) genes, which regulate cellular pathways that control nutrient sensing, cell size, cell migration, and cell proliferation. Individuals with LAM often experience pneumothorax and chylothorax, as well progressive loss of lung function. Sirolimus is drug that was approved for the prevention of kidney transplant rejection. It directly affects the cellular pathway that causes LAM. This study will evaluate the safety and effectiveness of sirolimus in stabilizing or improving lung function in people with LAM.

Individuals interested in participating in this 2-year, double-blind study will first report to the study sites for pulmonary function testing to determine their eligibility for participation. Participants deemed eligible will be randomly assigned to receive either sirolimus or placebo for 1 year. Sirolimus or placebo will be administered in 2 tablet doses (2 mg for sirolimus) for the duration of the study. Study visits will occur at baseline, Week 3, every 3 months for 12 months, and months 18 and 24. Study visits will include a physical exam, questionnaires, a pregnancy test, blood and urine collection, and functional lung tests. A 6-minute walk test will occur at most study visits; a chest x-ray will be taken at baseline and month 24; and a volumetric computed tomography scan will occur at baseline, month 12, and month 24. Adverse events, medication side effects, and lung function will be assessed at each visit.

Arms: arm 1: Participants receive sirolimus daily for 1 year and are followed with serial pulmonary function tests, 6-minute walk tests, and symptom and QOL questionnaires over a 2-year period. arm 2: Participants receive placebo daily for 1 year and followed with serial pulmonary function tests, 6-minute walk tests, and symptom and QOL questionnaires over a 2-year period.
Interventions: intervention 1: Sirolimus intervention 2: Placebo
Intervention descriptions: intervention 1: A sirolimus dose of 2 tablets (1 mg/tablet) per day for 1 year. intervention 2: A placebo dose of 2 tablets per day for 1 year.

Protocol documents:
Clinical trial NCT00417976
Conditions: Pancreatic Cancer
Keywords: Advanced Pancreatic Cancer
Sponsor: Tony Bekaii-Saab
Start date: 2006-12-01; Completion date: 2011-02-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II study of biweekly (every other week) bevacizumab followed by gemcitabine then infusional 5-fluorouracil in patients with stage III or IV pancreatic cancer. Patients' response will be evaluated every 8 weeks using usual CT scanning techniques. RECIST (Response Evaluation Criteria in Solid tumors) criteria will be applied to evaluate response. Tumor marker levels (Ca 19-9) will be assessed every 4 weeks, but will not be used to measure response.

Detailed description:
Rationale: Research indicates that the vascular endothelial growth factor (VEGF), or a substance made by cells that stimulates new blood vessel formation, plays an important role in the growth and metastasis of many cancers, including pancreatic carcinoma. Both VEGF and its receptors are overexpressed in pancreatic cancer. Bevacizumab works by blocking VEGF and the growth of cancer cells in the process. The current study combines bevacizumab with two commonly used pancreatic cancer drugs, gemcitabine and infusional 5-FU. Previous studies indicate that bevacizumab combined with other anti-cancer drugs such as 5-FU improves patient survival. In addition, other research suggests that the drug administration schedule of the current study may improve patient outcomes compared to other types of administration and sequencing.

Purpose: The primary objective of this study is to assess the rate of progression free survival at 6 months in patients with advanced pancreatic cancer given gemcitabine, infusional 5-FU, and bevacizumab. Secondary objectives of this study include measuring response rates, 6 month and 1-year survival rates, and median overall survival.

Treatment: Study participants will be given bevacizumab, gemcitabine, and 5-FU. These drugs will be administered through intravenous infusions in that order every other week on days 1 and 15. Treatments will be given in 28-day cycles. Participants will therefore receive study drugs during weeks 1 and 3, and then receive no study drugs during weeks 2 and 4. Imaging exams will be performed every 8 weeks to assess disease size. Several other tests will be given throughout the study to closely monitor patients. Tumor level markers will be assessed every 4 weeks, but will not be used to measure response. Study treatments will be discontinued due to disease growth or severe adverse effects.

Arms: arm 1: None
Interventions: intervention 1: Gemcitabine intervention 2: Bevacizumab intervention 3: Infusional 5-Fluorouracil
Intervention descriptions: intervention 1: 1000 mg/m2 over 100 minutes every 2 weeks. intervention 2: 10 mg/kg every 2 weeks. intervention 3: 2400 mg/m2 over 48 hours every 2 weeks.

Protocol documents:
Clinical trial NCT00420212
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: relapsing oral remitting multiple sclerosis
Sponsor: Biogen
Start date: 2007-01-01; Completion date: 2011-02-01
Enrollment: 1234 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. To determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for the disease to get worse.

The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS.

Detailed description:

Arms: arm 1: Participants received two placebo capsules orally three times daily (TID) arm 2: Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD) arm 3: Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Interventions: intervention 1: BG00012 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00420407
Conditions: Injuries Shock, Traumatic
Sponsor: The University of Texas Health Science Center at San Antonio
Start date: 2007-02-01; Completion date: 2011-02-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hypothesis: We hypothesize that resuscitation regimens which minimize the total volume of resuscitation fluid, while restoring organ perfusion, will lead to lower morbidity and mortality in critically ill patients following trauma.

Detailed description:

Arms: arm 1: Vasopressin arm 2: bolus of NS (normal saline) followed by continuous infusion of NS, no vasopressin added
Interventions: intervention 1: normal saline control intervention 2: vasopressin
Intervention descriptions: intervention 1: no vasopressin added to bolus or 5 hour continuous infusion intervention 2: vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours

Protocol documents:
Clinical trial NCT00463788
Conditions: Breast Neoplasm
Keywords: cancer breast metastatic triple negative
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2007-06-01; Completion date: 2011-02-01
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine whether overall response to cetuximab combined with cisplatin is better than overall response to cisplatin alone together with showing that the overall response for cetuximab and cisplatin was above a pre-specified threshold of 0.2 in the treatment of "triple negative" metastatic breast cancer.

The secondary objective of this study is to compare the differences between the two treatment groups using the following criteria : Progression-Free Survival (PFS) Time, Overall Survival (OS), Time to Response (TTR) and Safety.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: cetuximab, cisplatin intervention 2: cisplatin
Intervention descriptions: intervention 1: Subjects will receive an initial dose of cetuximab 400 milligram per square meter (mg/m\^2) followed by weekly doses of 250 mg/m\^2. All doses will be given by intravenous (IV) infusion.

Subjects will receive cisplatin (75 mg/m\^2 IV on Day 1) every 3 weeks, with a maximum of 6 cycles.

Administration of the Investigational Medicinal Product (IMP) will be stopped upon the first occurrence of disease progression, unacceptable toxicity or withdrawal of consent. intervention 2: Subjects will receive cisplatin (75 mg/m\^2 IV on Day 1) every 3 weeks, with a maximum of 6 cycles.

Subjects have the option of receiving cetuximab plus cisplatin at progression within the first 6 cycles, or cetuximab alone at progression after the 6 cycles.

Administration of the IMP will be stopped upon the first occurrence of disease progression (except in cisplatin arm where switch to cetuximab plus cisplatin, or cetuximab alone is possible), unacceptable toxicity or withdrawal of consent.

Protocol documents: