ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01108055
Conditions: Bladder Cancer Bladder (Urothelial, Transitional Cell) Cancer Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive) Bladder (Urothelial, Transitional Cell) Cancer Resectable (Pre-Cystectomy) Bladder (Urothelial, Transitional Cell) Cancer Metastatic or Unresectable
Sponsor: Sandy Srinivas
Start date: 2010-04-01; Completion date: 2015-07-01
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We will combine an oral investigational vascular endothelial growth factor (VEGF inhibitor) called pazopanib which is being studied in kidney cancer will be combined with standard chemotherapy called taxol in patients with relapsed recurrent urothelial cancer.

Detailed description:
Based on the results from the Phase 1 study of pazopanib combined with paclitaxel and the activity of paclitaxel in urothelial cancer, testing this regimen in a disease where there is an unmet need appears appropriate.

Arms: arm 1: Cycle of 28 days. Pazopanib: 800mg daily

Cycle of 28 days Paclitaxel: 80mg/m2 on days 1,8 and 15
Interventions: intervention 1: Pazopanib (GW786034) intervention 2: Paclitaxel
Intervention descriptions: intervention 1: Cycle of 28 days. Pazopanib: 800mg/day intervention 2: Cycle of 28 days Paclitaxel: 80mg/m2 days 1,8 and 15

Protocol documents:
Clinical trial NCT01115517
Conditions: Pterygium
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2010-10-01; Completion date: 2015-07-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of the use of bevacizumab (Avastin) as an adjunctive medication during pterygium surgery in preventing pterygium recurrence. A pterygium is a white fleshy growth on the surface of the eye, which can be removed surgically. However, after surgical removal, pterygia can recur. One way of minimizing recurrence is by applying a medication called mitomycin C to the surface of the eye during pterygium surgery. However, mitomycin is associated with certain side effects, such as thinning of the eye wall and poor wound healing. Bevacizumab has a different mechanism of action and there is some evidence that it may be useful in preventing pterygium recurrence. In this study, the safety and efficacy of adjunctive intraoperative use of bevacizumab and mitomycin C for preventing pterygium recurrence will be directly compared.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Bevacizumab intervention 2: Mitomycin C
Intervention descriptions: intervention 1: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution. intervention 2: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.

Protocol documents:
Clinical trial NCT01119794
Conditions: Lymphoma, Non-Hodgkins
Keywords: B-cell small lymphocytic lymphoma marginal zone lymphoma follicular lymphoma mantle cell lymphoma Waldenström macroglobulinemia. Low Grade B cell Non-Hodgkins Lymphoma
Sponsor: Brown University
Start date: 2010-07-01; Completion date: 2015-07-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to: Investigate the Overall Response Rate (ORR) of the combination of ofatumumab and bortezomib in patients with low-grade B-cell non-Hodgkin lymphoma (LG-NHL) that relapse beyond 6 months of a previous rituximab-containing regimen.

Detailed description:
41 patients will be enrolled in this trial with low grade lymphomas and will be given Ofatumumab 1000 mg and Bortezomib IV 1.6 mg/m2 weekly times 4 treatments and will then receive maintenance treatment with the 2 agents every 2 months for 1 year unless disease progression.

Arms: arm 1: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22 Bortezomib 1.6 mg/m2 IV Ofatumumab 1000 mg IV on day 1 maintenance phase Patients will remain until progression
Interventions: intervention 1: Ofatumumab and Bortezomib
Intervention descriptions: intervention 1: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22 Bortezomib 1.6 mg/m2 IV Ofatumumab 1000 mg IV on day 1 maintenance phase Patients will remain until progression

Protocol documents:
Clinical trial NCT01153984
Conditions: Carcinoma，Non-Small-Cell Lung
Sponsor: Hoffmann-La Roche
Start date: 2011-06-01; Completion date: 2015-07-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single-arm, multi-center study will evaluate the progression-free survival in participants with histologically documented, advanced and/or metastatic chemotherapy naive, non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) positive mutations and receiving erlotinib treatment. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal due to any reason or death.

Detailed description:

Arms: arm 1: Participants will receive 150 milligrams (mg) erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
Interventions: intervention 1: Erlotinib
Intervention descriptions: intervention 1: Erlotinib 150 mg oral doses will be administered daily.

Protocol documents:
Clinical trial NCT01162421
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Anti-Inflammatory Biological Therapy adalimumab Disease-Modifying Antirheumatic Drugs Antirheumatic Agents Agents
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2010-09-01; Completion date: 2015-07-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Canadian study to evaluate early use of adalimumab after methotrexate failure in early rheumatoid arthritis. The study hypothesis will verify if adalimumab effectively reduces joint damage in more participants when introduced earlier than in current practice.

Detailed description:

Arms: arm 1: Participants in the Early Adalimumab arm will receive adalimumab and methotrexate at Baseline and every other week for study duration. arm 2: Participants in the Standard of Care arm will receive methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may be initiated after a minimum of 6 months.
Interventions: intervention 1: adalimumab intervention 2: Methotrexate
Intervention descriptions: intervention 1: Study drug will be provided to participants in Early Adalimumab arm as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). 40 mg of adalimumab will be administered subcutaneously at Baseline and then every other week for 24 months. Adalimumab may be initiated in participants in standard of care (SOC) arm after a minimum of 6 months of treatment recommended by their study doctor. intervention 2: Participants in both arms will receive a methotrexate regimen based on local guidelines and their study doctor's judgment.

Protocol documents:
Clinical trial NCT01188109
Conditions: Pancreatic Neoplasms Pancreatic Cancer
Keywords: Pancreatic Neoplasms Pancreatic cancer
Sponsor: Emory University
Start date: 2010-07-01; Completion date: 2015-07-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate if the investigators can use a specific marker in the pancreatic tumor itself to determine which patients will benefit from receiving combination chemotherapy of gemcitabine and cisplatin after undergoing resection of a pancreatic cancer.

The investigators will also investigate if there is any benefit to receiving both chemotherapy drugs as opposed to only gemcitabine after undergoing complete resection of the tumor.

Detailed description:
The study will specifically be looking at ERCC1 expression in pancreas cancer with regards to its prognostic and predictive value as a biomarker for patients receiving Gem / Cis as adjuvant therapy after resection.

Arms: arm 1: Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.
Interventions: intervention 1: Gemcitabine intervention 2: Cisplatin
Intervention descriptions: intervention 1: Standard of care chemotherapy and dosage

Dose - 1000 mg/m²

Schedule - Days 1 and 15; Q 28 days intervention 2: Dose - 50 mg/m²

Schedule - Days 1 and 15; Q 28 days

Protocol documents:
Clinical trial NCT01260701
Conditions: Adenocarcinoma of the Gastroesophageal Junction Diffuse Gastric Adenocarcinoma Gastric Intestinal Type Adenocarcinoma Gastric Mixed Adenocarcinoma Recurrent Gastric Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2011-01-01; Completion date: 2015-07-01
Enrollment: 75 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II clinical trial studies how well Akt inhibitor MK2206 works in treating patients with advanced gastric or gastroesophageal junction cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the overall survival (OS) for patients with advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma treated with MK-2206 (Akt inhibitor MK2206).

SECONDARY OBJECTIVES:

I. To estimate the progression free survival (PFS) in this patient population. II. To estimate the response rate (confirmed and unconfirmed complete response \[CR\] and partial response \[PR\] by Response Evaluation Criteria In Solid Tumors \[RECIST\] 1.1) in this patient population.

III. To assess the frequency and severity of toxicity associated with this regimen.

OUTLINE (CLOSED TO ACCRUAL 05/01/13):

Patients receive Akt inhibitor MK2206 orally (PO) every other day on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months for 2 years.

Arms: arm 1: Patients receive Akt inhibitor MK2206 PO every other day on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Akt Inhibitor MK2206
Intervention descriptions: intervention 1: Given PO

Protocol documents:
Clinical trial NCT01277601
Conditions: Chronic Hepatitis B
Keywords: Chronic Hepatitis B Hep B Non cirrhotic Tenofovir disoproxil fumarate (TDF) Peginterferon α-2a (Peg-IFN)
Sponsor: Gilead Sciences
Start date: 2011-04-01; Completion date: 2015-07-01
Enrollment: 751 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon α-2a (Peg-IFN) combination therapy for 48 weeks versus standard of care TDF monotherapy or Peg-IFN monotherapy for 48 weeks in non-cirrhotic adults with chronic hepatitis B virus (HBV) as determined by loss of hepatitis B surface antigen (HBsAg).

The study will consist of 2 phases for participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups. Following an initial 48 weeks of treatment, participants in these groups will be monitored for 24 weeks for signs of worsening HBV, and those meeting TDF retreatment and flare management criteria will be eligible to receive TDF monotherapy during a retreatment phase, up to Week 120.

Detailed description:

Arms: arm 1: TDF plus Peg-IFN for 48 weeks arm 2: TDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks arm 3: TDF monotherapy for 120 weeks arm 4: Peg-IFN monotherapy for 48 weeks
Interventions: intervention 1: TDF intervention 2: Peg-IFN
Intervention descriptions: intervention 1: TDF 300 mg tablets administered orally once daily intervention 2: Peg-IFN 180 µg administered via subcutaneous injection once weekly

Protocol documents:
Clinical trial NCT01281475
Conditions: Angelman Syndrome
Keywords: Angelman syndrome Levodopa Carbidopa L-dopa
Sponsor: Wen-Hann Tan
Start date: 2011-01-01; Completion date: 2015-07-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to determine whether levodopa will lead to an improvement in the development and tremor in children with Angelman syndrome (AS).

It has been suggested that levodopa, a medication that is usually used to treat Parkinson disease in adults, may help children with AS in their overall development and reduce the tremor that some of them have.

If levodopa is found to be beneficial for children with AS, this could lead to a new treatment for AS.

Funding Source - FDA-OOPD

Detailed description:
Levodopa is a prodrug that "delivers" dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa. Animal studies have suggested that levodopa can reverse the excess phosphorylation of some enzymes involved in synaptic and neuronal function, including calcium/calmodulin-dependent kinase type 2 (CaMKII).

Recently, it was shown that excess phosphorylation of CaMKII may be responsible for some of the neurological deficits seen in Angelman syndrome. Therefore, it is hypothesized that levodopa may lead to an improvement in the neurodevelopment and abnormal movements (e.g. tremors) in children with Angelman syndrome.

Although many children have used levodopa for a variety of medical conditions over the last 30 years, it has not been approved by the Food and Drug Administration (FDA) for use in children, and it has not been formally studied in children with Angelman syndrome.

Therefore, the purpose of this study is to find out whether levodopa will lead to an improvement in the development and in the tremor in children with AS.

Arms: arm 1: Levodopa is prescribed as a combination of levodopa/carbidopa (4:1) to reduce the peripheral side effects. The dosage used was 15 mg/kg/day in 3 divided doses. arm 2: The placebo contains excipients similar to those in the active drug, but it does not contain levodopa or carbidopa, so it is not expected to have any effect.
Interventions: intervention 1: Levodopa intervention 2: Placebo Oral Capsule
Intervention descriptions: intervention 1: Levodopa/Carbidopa (4:1)

Dosages are based on levodopa.

Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.

Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day. intervention 2: The placebo contains excipients similar to those in the active drug, but it does not contain levodopa or carbidopa.

Protocol documents:
Clinical trial NCT01331824
Conditions: Bladder Cancer
Keywords: Bladder Cancer Urothelial Cancer Chemotherapy Second-line Metastatic
Sponsor: Matthew Galsky
Start date: 2011-02-01; Completion date: 2015-07-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to determine in subjects with metastatic measurable bladder cancer (or urothelial cancers originating elsewhere in the genitourinary tract) who have progressed on 1 prior chemotherapeutic regimen the objective response rate to treatment with amrubicin. The secondary objectives will be to evaluate progression-free survival, survival at 1 year, and the safety of amrubicin as second-line therapy in patients with metastatic urothelial carcinoma.

Detailed description:
Multiple small phase II trials exploring a variety of agents as second-line therapy for metastatic urothelial carcinoma have been performed. Overall, the most active of these agents have shown response rates of approximately 10-20% . Currently, there are no FDA approved agents for the second-line treatment of metastatic urothelial carcinoma.

The current study will explore the safety and activity of the novel anthracycline, amrubicin, as second-line chemotherapy in patients with advanced urothelial carcinoma.

The primary objective will be to evaluate the activity (as determined by objective response rate) of amrubicin as second-line chemotherapy in patients with metastatic urothelial carcinoma. The secondary objectives will be to evaluate progression-free survival, survival at 1 year, and the safety of amrubicin as second-line therapy in patients with metastatic urothelial carcinoma.

Subjects will receive amrubicin IV daily x 3 days, every 21-days, with prophylactic granulocyte colony stimulating factor. This 21-day time period is referred to as a cycle. Subjects will undergo repeat computed tomography (CT) scans after every 2 cycles. In the absence of progressive cancer, or prohibitive side effects, subjects will receive up to 6 cycles of treatment with amrubicin.

Arms: arm 1: 35 mg/m2/day intravenously
Interventions: intervention 1: Amrubicin
Intervention descriptions: intervention 1: Patients will receive 35 mg/m2/day of amrubicin intravenously for 3 consecutive days as the initial dose starting on Day 1 of a 21-day cycle for up to 6 cycles

Protocol documents:
Clinical trial NCT01374425
Conditions: Colorectal Cancer
Sponsor: Genentech, Inc.
Start date: 2011-08-01; Completion date: 2015-07-01
Enrollment: 376 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a randomized, open-label, multicenter, Phase II study with primary objectives to assess whether expression of select chemotherapy markers is associated with progression-free survival (PFS) in participants treated with bevacizumab plus leucovorin, 5-fluorouracil, and oxaliplatin (mFOLFOX6) or bevacizumab plus leucovorin, 5-fluorouracil, and irinotecan (FOLFIRI). The study population will consist of participants with first-line mCRC.

Detailed description:

Arms: arm 1: Participants will receive bevacizumab plus mFOLFOX6 by intravenous (IV) infusion on Day 1 of each 2-week cycle until disease progression or unacceptable toxicity. Participants may be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin, with bevacizumab continued in 3-week cycles. arm 2: Participants will receive bevacizumab plus FOLFIRI by IV infusion on Day 1 of each 2-week cycle until disease progression or unacceptable toxicity. Participants may be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan, with bevacizumab continued in 3-week cycles.
Interventions: intervention 1: 5-Fluorouracil intervention 2: Bevacizumab intervention 3: Irinotecan intervention 4: Leucovorin intervention 5: Oxaliplatin intervention 6: Capecitabine
Intervention descriptions: intervention 1: 5-Fluorouracil 400 milligrams per meter-squared (mg/m\^2) by IV bolus and subsequent 2400 mg/m\^2 by IV infusion over 46 hours will be administered every 2 weeks until disease progression or unacceptable toxicity. intervention 2: Bevacizumab 5 milligrams per kilogram (mg/kg) of body weight via IV infusion will be administered every 2 weeks until disease progression or unacceptable toxicity. If participants are discontinued from oxaliplatin or irinotecan due to unacceptable toxicity, bevacizumab may be given in 3-week cycles with capecitabine. intervention 3: Irinotecan 180 mg/m\^2 via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity. intervention 4: Leucovorin 400 mg/m\^2 or dose deemed appropriate by Investigator via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity. intervention 5: Oxaliplatin 85 mg/m\^2 via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity. intervention 6: Capecitabine 850 or 1000 mg/m\^2 may be offered in the event of unacceptable toxicity to oxaliplatin or irinotecan, to be given orally twice a day on Days 1 to 14 in 3-week cycles.

Protocol documents:
Clinical trial NCT01378858
Conditions: Tobacco Use Disorder Medication Adherence
Keywords: Smoking Substance-Related Disorders medication adherence Methadone
Sponsor: Albert Einstein College of Medicine
Start date: 2011-07-01; Completion date: 2015-07-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.

Detailed description:
There is a marked prevalence of tobacco use and tobacco-related disease among methadone maintenance patients. Varenicline's demonstrated efficacy may not be generalizable to methadone maintained smokers because of poor adherence, which is highly prevalent among drug users. Adherence to smoking cessation medication is strongly associated with cessation, and is one of the few factors shown to increase cessation among methadone maintained smokers, but strategies to promote smoking cessation medication adherence have not been evaluated in methadone patients. Based on the Information, Motivation, and Behavior model, the investigators plan a directly observed therapy (DOT)-based intervention targeting behavioral skills necessary for optimal adherence. Because methadone clinic-based DOT interventions have been shown to improve medication adherence and clinical outcomes in HIV and TB, the investigators plan to determine in a randomized trial whether DOT varenicline provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence. The investigators will also evaluate moderating effects of drug and alcohol use and psychiatric symptoms on DOT effects. The investigators hypothesize subjects in the mDOT arm will have greater 7 day point prevalence abstinence at 12 weeks, reduction in cigarettes/day, time to first daily cigarette, ≥ 24 hour quit attempts, and 7 day point prevalence abstinence at 24 weeks compared to subjects receiving self administered varenicline. The investigators also hypothesize that adherence in the mDOT arm will be higher than in the TAU arm. Lastly the investigators hypothesize that ongoing illicit drug use and psychiatric symptoms will moderate the effect of mDOT on adherence.

Arms: arm 1: Subjects in the TAU arm will self administer varenicline for 12 weeks. arm 2: Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.
Interventions: intervention 1: Varenicline
Intervention descriptions: intervention 1: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.

Protocol documents: