ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00580398
Conditions: Lung Cancer
Sponsor: Massachusetts General Hospital
Start date: 2008-01-01; Completion date: 2012-04-01
Enrollment: 49 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of the proposed study is to develop and assess the feasibility of delivering a smoking cessation intervention to patients undergoing lung surgery that begins before surgery and continues up to 3 months post-discharge. The secondary aim is to assess smoking cessation rates 3 months following surgery.

Detailed description:
This is a pilot study evaluating the feasibility of a cognitive-behavioral smoking cessation plus Varenicline program, designed specifically for early stage lung cancer patients and patients with a potential lung cancer diagnosis pre and post-surgery. The study population will be approximately 80 smokers who have upcoming lung resection surgery scheduled at Massachusetts General Hospital (MGH) in Boston. A patient will be considered eligible for the intervention or control group if he or she 1) is scheduled for a lung resection surgery with either a lung cancer diagnosis or a potential lung cancer diagnosis, and 2) had a cigarette in the past 2 weeks, 3) is willing to make a pre-surgical quit attempt. Patients will be excluded from the control group if they are 1) non-English speaking, 2) determined medically ineligible by their surgeon/oncologist, 3) suffering from psychosis or dementia 4) is currently on Varenicline has been on Varenicline for more than 3 weeks, or 5) is otherwise unable to participate in the intervention. Patients will be excluded from the intervention group if they are 1) non-English speaking, 2) determined medically ineligible by their surgeon, 3) suffering from psychosis or dementia 4) have been taking Varenicline for longer than three weeks 5) have been taking Bupropion (for smoking cessation purposes) for more than three weeks, 6) is otherwise unable to participate in the intervention.

Arms: arm 1: Usual care included physician advice to quit smoking. arm 2: Intervention participants were provided with a cognitive-behavioral 12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling targeted to the issues of thoracic cancer patients. We offered 7 counseling sessions but were flexible in offering additional counseling when needed. Counseling was delivered by a certified Tobacco Treatment Counselor using Motivational Interviewing (MI) techniques.
Interventions: intervention 1: Smoking cessation counseling intervention 2: varenicline
Intervention descriptions: intervention 1: Median of 9 tobacco treatment counseling sessions conducted in person or by telephone. intervention 2: varenicline (1mg bid, with initial titration up over week 1) for 12 weeks

Protocol documents:
Clinical trial NCT00582712
Conditions: Medullary Thyroid Cancer
Keywords: medullary thyroid cancer lithium
Sponsor: University of Wisconsin, Madison
Start date: 2008-01-01; Completion date: 2012-04-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary objective is to evaluate the tumor response rate of patients with MTC treated with Lithium carbonate

Detailed description:

Arms: arm 1: Lithium carbonate
Interventions: intervention 1: Lithium carbonate
Intervention descriptions: intervention 1: Lithium 300mg by mouth, three times daily, escalating to a lithium level of 0.8-1.2; Continue until progressive disease/unacceptable toxicity; Evaluate every 4 weeks.

Protocol documents:
Clinical trial NCT00591149
Conditions: Head and Neck Cancer Carcinoma, Squamous
Keywords: cancer head and neck cancer squamous cell cancer
Sponsor: University of Kansas Medical Center
Start date: 2007-06-01; Completion date: 2012-04-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A study of Oxaliplatin and Docetaxel followed by Cetuximab for head and neck cancer patients to determine their effect on the control and reduction of tumor size

Detailed description:
This is a non-randomized, open-label, phase II study to assess the effects of oxaliplatin and docetaxel followed by epidermal factor-antibody (EGFR-AB) cetuximab on patients with previously treated recurrent /metastatic squamous cell carcinoma of the head and neck. Head and neck tissue will also be tested to determine if the protein Epidermal Growth Factor Receptor is present in the cancer cells.

Arms: arm 1: Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.

Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.
Interventions: intervention 1: Oxaliplatin intervention 2: Docetaxel intervention 3: Cetuximab
Intervention descriptions: intervention 1: 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles intervention 2: 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles intervention 3: 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks

Protocol documents:
Clinical trial NCT00592007
Conditions: Non Small Cell Lung Carcinoma
Keywords: Non Small Cell Lung Cancer Stage IIIB Stage IV Stable on Erlotinib Exhibit Positivity for Estrogen or Progesterone Receptor
Sponsor: Lyudmila Bazhenova, M.D.
Start date: 2007-09-01; Completion date: 2012-04-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this research study is to see if adding fulvestrant (Faslodex) to erlotinib (Tarceva) is effective in patients with stage IIIb/IV Non-Small Cell Lung Cancer.

Detailed description:
Erlotinib is an oral drug which is able to block endothelial growth factor receptor (EGFR). EGFR stimulates cancer cell growth. Fulvestrant (faslodex) block estrogen hormone from gaining access to tumor and stimulating the tumor cells to grow. Both of these drugs are already approved by FDA but have not been studied in this combination.

We will study if the combination of these drugs will delay treatment failure. Lung cancer tumors in both males and females can be sensitive to estrogen. Only patients whose tumor expresses the estrogen will be eligible for the trial. Estrogen sensitivity will be tested on previously removed tumor specimens.

Arms: arm 1: Single-arm study
Interventions: intervention 1: Fulvestrant and Erlotinib
Intervention descriptions: intervention 1: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress.

Protocol documents:
Clinical trial NCT00607594
Conditions: Adenocarcinoma of the Gastroesophageal Junction Adenocarcinoma of the Stomach Recurrent Gastric Cancer Stage III Gastric Cancer Stage III Esophageal Cancer Stage IV Esophageal Cancer Stage IV Gastric Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2008-01-01; Completion date: 2012-04-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well saracatinib works in treating patients with locally advanced or metastatic stomach or gastroesophageal junction cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the objective disease control rate (i.e., partial or complete response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or stable disease for ≥ 16 weeks) in patients with locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with AZD0530 (saracatinib).

SECONDARY OBJECTIVES:

I. To assess the median time to disease progression, median overall survival, and 1-year survival rate in these patients.

II. To assess the toxicity of AZD0530 in these patients. III. To evaluate potential predictive markers by assessing pretreatment intratumoral levels of src, Y419 phospho-src (P-Src), and c-terminal src kinase (Csk) in archival tumor biopsies.

OUTLINE:

Patients receive saracatinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at least every 2 months.

Arms: arm 1: Patients receive saracatinib PO, at a dose of 175 mg QD in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: saracatinib
Intervention descriptions: intervention 1: Patients receive AZD0530 (saracatinib) PO QD in the absence of disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00610688
Conditions: Vitamin D Deficiency
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2008-01-01; Completion date: 2012-04-01
Enrollment: 192 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to compare the effects of higher dose vitamin D with commonly recommended dose in pregnant women to see which is better in achieving and/or maintaining sufficient vitamin D blood levels during pregnancy and in newborn infants as well as improving growth in the infant.

Detailed description:
Three dosages of Vitamin D will be administered; 400IU, 2000IU and 4000IU per day to pregnant women starting at less than 16 week gestation continued until delivery. The dose will be provided using a randomized control method. Serum levels of 25 hydroxy D will be measured in mothers at 12, 16, 28 and delivery. Cord blood 25 hydroxy D and the infants' birthweight, length and head circumference will be measured at birth.

Arms: arm 1: Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D arm 2: Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3) arm 3: Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3).
Interventions: intervention 1: Prenatal Vitamin intervention 2: Cholecalciferol (Vitamin D3) intervention 3: Cholecalciferol (Vitamin D3)
Intervention descriptions: intervention 1: Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery intervention 2: Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery intervention 3: Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery

Protocol documents:
Clinical trial NCT00624780
Conditions: Generalized Anxiety Disorder
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2009-05-01; Completion date: 2012-04-01
Enrollment: 615 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to characterize the safety and efficacy in patients with generalized anxiety disorder after short- (3 months) and long-term (6 months) use of Pregabalin (Lyrica).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Pregabalin intervention 2: Lorazepam intervention 3: Pregabalin intervention 4: Placebo
Intervention descriptions: intervention 1: Pregabalin 150-300 mg given twice a day intervention 2: Lorazepam 3-4 mg given twice a day intervention 3: Pregabalin 450-600 mg given twice a day intervention 4: Placebo

Protocol documents:
Clinical trial NCT00630994
Conditions: Chronic Myeloproliferative Disorders Secondary Myelofibrosis
Keywords: primary myelofibrosis secondary myelofibrosis essential thrombocythemia polycythemia vera
Sponsor: Mayo Clinic
Start date: 2008-03-01; Completion date: 2012-04-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying the side effects and how well low-dose decitabine works in treating patients with symptomatic myelofibrosis.

Detailed description:
OBJECTIVES:

* Determine the efficacy and safety of low-dose decitabine in patients with symptomatic primary myelofibrosis (PMF) or post essential thrombocythemic (ET) or polycythemic vera (PV) myelofibrosis.
* Analyze the ability of this drug to decrease pathologic angiogenesis and other stromal reactive features intrinsic to PMF or post ET/PV myelofibrosis.

OUTLINE: Patients receive low-dose decitabine IV over 1 hour on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving partial remission, complete remission, or clinical improvement may receive up to 12 courses of decitabine in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for up to 3 years.

Interventions: intervention 1: Dacogen
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00634036
Conditions: Asthma
Keywords: Asthma obesity exacerbation asthmatics fat overweight adipose tissue leptin adiponectin pioglitazone Actos wheezing Pittsburgh Pennsylvania pulmonary lung
Sponsor: Fernando Holguin
Start date: 2009-10-01; Completion date: 2012-04-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Asthmatics who are significantly overweight tend to have more severe symptoms, more flare ups, and are more likely to have poorly-controlled asthma when compared to other asthmatics.

Researchers believe this occurs because excess adipose tissue (fat) in the body can cause higher-than-normal levels of leptin and lower-than-normal levels of adiponectin in the blood.

The researchers of this study are testing a medication called pioglitazone in overweight asthmatics because they believe it can help regulate leptin and adiponectin and that this may improve symptoms of asthma.

Detailed description:
Participants in this study will be randomly assigned (like the flip of a coin) to pioglitazone or a placebo (an inactive pill). They will be given study medication to take everyday for 12 weeks (3 months).

Participants will complete a number of asthma-related questionnaires and a variety of pulmonary function tests. Participants will undergo physical exams, an electrocardiogram, and blood sampling to measure leptin, adiponectin, markers of inflammation, blood cell counts, glucose levels, BNP hormone levels, and liver function.

To monitor participants throughout the study, follow-up visits will be done at 2, 6, and 12 weeks after starting study drug. At these visits many of the pulmonary function tests and questionnaires will be repeated.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: pioglitazone intervention 2: placebo
Intervention descriptions: intervention 1: pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months) intervention 2: matching placebo (inert tablet)

Protocol documents:
Clinical trial NCT00642018
Conditions: Prostate Cancer
Keywords: Hormone Refractory Prostate Cancer
Sponsor: Eli Lilly and Company
Start date: 2008-03-01; Completion date: 2012-04-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine whether LY2181308 in combination with docetaxel is safe and effective treatment for hormone refractory prostate cancer patients.

Detailed description:

Arms: arm 1: Standard of care (SOC) docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel therapy arm 2: LY2181308 administered with docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel
Interventions: intervention 1: docetaxel intervention 2: LY2181308 sodium intervention 3: Prednisone
Intervention descriptions: intervention 1: Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Patients may receive up to 10 cycles of study therapy or until progressive disease. Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy. intervention 2: LY2181308 sodium (referred to as LY2181308 throughout this record) administered weekly plus docetaxel 75 mg/m² intravenously administered every 21 days. Patients may receive up to 10 cycles of study therapy or until progressive disease. Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy. intervention 3: Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy

Protocol documents:
Clinical trial NCT00660179
Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension SERAPHIN
Sponsor: Actelion
Start date: 2008-05-01; Completion date: 2012-04-01
Enrollment: 742 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The AC-055-302/SERAPHIN study will be an event-driven Phase III study, comparing two different doses of macitentan (ACT-064992) (3 and 10 mg) vs placebo in patients with symptomatic PAH. The main study objective is to demonstrate that macitentan (ACT-064992) prolongs time to the first morbidity or mortality event, and to evaluate the benefit/risk profile of macitentan (ACT-064992) in the treatment of patients with symptomatic PAH.

Detailed description:

Arms: arm 1: Macitentan (ACT-064992) tablet, 3 mg, once daily arm 2: Macitentan (ACT-064992) tablet, 10 mg, once daily arm 3: Matching placebo, once daily
Interventions: intervention 1: macitentan (ACT-064992) intervention 2: macitentan (ACT-064992) intervention 3: placebo
Intervention descriptions: intervention 1: Tablet, 3 mg dosage, once daily intervention 2: Tablet, 10 mg dosage, once daily intervention 3: Matching placebo, once daily

Protocol documents:
Clinical trial NCT00670449
Conditions: Multiple Sclerosis
Keywords: FTY720 multiple sclerosis MS
Sponsor: Novartis
Start date: 2008-04-01; Completion date: 2012-04-01
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was an extension study of NCT00537082. This study was designed to evaluate the efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720) to relapsing multiple sclerosis.

Detailed description:
A decision was made to switch all patients on fingolimod 1.25 mg/day to fingolimod 0.5 mg/day in an amendment to the study protocol. The study became open-label with all patients receiving fingolimod 0.5 mg/day on 22 Feb 2010.

The efficacy data for Months 0-6 in this study report is from the core study NCT00537082.

Arms: arm 1: Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study. arm 2: Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study. arm 3: Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
Interventions: intervention 1: Fingolimod
Intervention descriptions: intervention 1: Fingolimod was supplied in capsules.

Protocol documents:
Clinical trial NCT00673049
Conditions: Carcinoma, Large Cell Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Carcinoma, Adenosquamous Cell
Keywords: IGR-1R Non small cell lung cancer CP-751 871 Figitumumab
Sponsor: Pfizer
Start date: 2008-05-01; Completion date: 2012-04-01
Enrollment: 583 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).

Detailed description:
This study was terminated on March 8, 2010 due to an analysis by an independent Data Safety Monitoring Committee (DSMC) indicating that the addition of CP-751,871 \[figitumumab\] to erlotinib \[Tarceva\] would be unlikely to meet the primary endpoint of improving overall survival when compared to erlotinib alone.

This Oncology study continues as terminated, however for ethical reasons some patients, noted with resultant benefit, continue receiving treatment.

Arms: arm 1: The CP 751,871 treatment in combination with erlotinib will be given in three week cycles.

CP 751,871 (20 mg/kg) + erlotinib (150 mg/day) CP 751,871 will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter. arm 2: Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food)
Interventions: intervention 1: CP 751,871 (Figitumumab) intervention 2: Erlotinib intervention 3: Erlotinib
Intervention descriptions: intervention 1: CP 751,871 (20 mg/kg) will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter. intervention 2: Erlotinib (one tablet of 150 mg/day PO). intervention 3: Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food.

Protocol documents:
Clinical trial NCT00718094
Conditions: Mild to Moderately Active Ulcerative Colitis
Keywords: Ulcerative colitis EGCG Green tea polyphenols Inflammatory bowel disease Colitis IBD Green tea
Sponsor: University of Louisville
Start date: 2008-03-01; Completion date: 2012-04-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Green tea consists of several components, with most research focusing on the polyphenol fraction. The polyphenol fraction(-)-epigallocatechin-3-gallate (EGCG)has been studied extensively as an anti-inflammatory agent as well as a preventative agent for cancer. It has been shown to effectively reduce the inflammation associated with animal models of inflammatory bowel disease. This clinical trial will determine the ability of EGCG, in the form of Polyphenon E®, to treat patients with mild to moderately severe ulcerative colitis.

Detailed description:

Arms: arm 1: Polyphenon E® therapy was given for 56 days. arm 2: Oral Placebo
Interventions: intervention 1: Polyphenon E® intervention 2: Placebo Oral Tablet
Intervention descriptions: intervention 1: Oral capsules intervention 2: Oral tablet: placebo

Protocol documents: