ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00366457
Conditions: Pancreatic Cancer Adenocarcinoma of the Pancreas
Sponsor: Massachusetts General Hospital
Start date: 2006-08-01; Completion date: 2011-07-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to learn whether or not the combination of gemcitabine, bevacizumab and erlotinib works in treating patients with advanced or metastatic pancreatic cancer. Bevacizumab is a new anti-cancer drug. It is an antibody that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors. It is approved by the FDA for the treatment of colorectal cancer but is still considered investigational for treating pancreatic cancer.

Detailed description:
* Participants will receive study treatment as an outpatient. The study treatment will be given in time periods called cycles. Each treatment cycle will be 28 days.
* Gemcitabine will be given intravenously on days 1, 8, and 15 (once per week for the first three weeks) of the treatment cycle.
* Bevacizumab will be given intravenously on days 1 and 15 (once every 2 weeks) of the treatment cycle.
* Erlotinib will be taken orally every day of the treatment cycle.
* Participants will see the doctor or nurse practitioner every week for the first 28 days of treatment. During all of the following cycles, they will see the doctor or nurse practitioner on day 1 and day 15 of each cycle.
* Each 4-week cycle can be repeated until the participant or the doctor decided that they should be removed from the study.

Arms: arm 1: single-arm, no masking
Interventions: intervention 1: Bevacizumab intervention 2: Erlotinib intervention 3: Gemcitabine
Intervention descriptions: intervention 1: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. intervention 2: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. intervention 3: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.

Protocol documents:
Clinical trial NCT00383760
Conditions: Adenocarcinoma of the Pancreas Pancreatic Cancer Recurrent Pancreatic Cancer Stage II Pancreatic Cancer Stage III Pancreatic Cancer Stage IV Pancreatic Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2006-08-01; Completion date: 2011-07-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well E7389 works as second-line therapy in treating patients with locally advanced, unresectable, or metastatic pancreatic cancer. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description:
PRIMARY OBJECTIVE:

I. To determine the objective response (complete and partial) to E7389 in patients with locally advanced, unresectable, or metastatic pancreatic adenocarcinoma that progressed after prior gemcitabine hydrochloride-based therapy.

SECONDARY OBJECTIVE:

I. To determine the antitumor activity of E7389, in terms of median survival, 1-year survival rate, response or stable disease duration, toxicity, and time to disease progression, in these patients.

OUTLINE: This is an open-label, multicenter study. Patients receive eribulin mesylate IV on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, all patients are followed at 4 weeks. Patients with complete response, partial response, or stable disease are followed every 3 months.

Arms: arm 1: Patients receive E7389 IV on days 1 and 8.
Interventions: intervention 1: eribulin mesylate
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00404352
Conditions: Multiple Sclerosis
Keywords: Rebif New Formulation Clinical Isolated Syndrome Multiple Sclerosis
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2006-11-01; Completion date: 2011-07-01
Enrollment: 517 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a 24 months randomized, double-blind, Placebo-controlled, multi-center clinical trial with an optional 12 months open label extension.

The primary objective of the study is to evaluate the effect of fetal bovine serum \[FBS\]-free/human serum albumin \[HSA\]-free formulation of Interferon \[IFN\] beta-1a (RNF) 44 microgram (three times weekly and once weekly) versus placebo on the time to conversion to McDonald multiple sclerosis (MS) criteria (2005) in subjects with a first clinical demyelinating event at high risk of converting to MS.

The main secondary objective of study is to evaluate the effect of RNF 44 microgram (three times weekly and once weekly) versus placebo on the "Time to conversion to clinically definite MS (CDMS)" in subjects with a first clinical demyelinating event at high risk of converting to MS.

At the end of 24 month double-blind core REFLEX trial, subjects who will not convert to CDMS and decide to receive open-label (OL) treatment will be enrolled into an open-label, 12 month extension period to evaluate the effect of RNF 44 mcg three times weekly treatment on the time to conversion to McDonald MS and time to conversion to CDMS.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: RNF intervention 2: RNF intervention 3: Placebo
Intervention descriptions: intervention 1: Single dose of RNF administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months, or 36 months for patients enrolled in the OL extension. intervention 2: Single dose of RNF administered subcutaneously once weekly at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months. intervention 3: Placebo was supplied as a transparent, sterile solution for injection in pre-filled syringes matching the RNF pre-filled syringes, each containing 0.5 mL.

Protocol documents:
Clinical trial NCT00424515
Conditions: Mucosal Melanoma Acral/Lentiginous Melanoma Chronically Sun Damaged Melanomas
Keywords: Imatinib Gleevec
Sponsor: Dana-Farber Cancer Institute
Start date: 2006-07-01; Completion date: 2011-07-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate how effective imatinib (Gleevec) is in treating acral/lentiginous and mucosal melanoma which has spread to other parts of the body in patients who's disease carries a c-kit mutation. Imatinib is a protein-kinase inhibitor. It is believed that imatinib may be effective in blocking signals on certain cancer cells which allow the malignant cells to multiply and spread.

Detailed description:
OBJECTIVES:

Primary

* To determine the response rate of patients with metastatic mucosal, acral/lentiginous, or chronically sun damaged melanomas to treatment with of imatinib.
* To determine the time to progression.

Secondary

* To correlate c-kit mutational status with response to therapy.
* To evaluate the use of FDG-PET scanning in determining early biologic response to therapy.
* Tolerability of imatinib.
* To assess amplification of c-kit status through quantitative PCR and/or FISH and other related molecular pathway targets.
* To correlate c-kit amplification status with response to therapy.

Arms: arm 1: Imatinib
Interventions: intervention 1: Imatinib
Intervention descriptions: intervention 1: Imatinib was given at a dose of 400 mg orally daily (4 100mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition.

Protocol documents:
Clinical trial NCT00430781
Conditions: Neoplasms, Uterine Cervix Metastatic Cervical Cancer
Keywords: pazopanib ErB1/ErB2 lapatinib persistent VEGF recurrent metastatic cervical cancer advanced FIGO Stage IVB
Sponsor: GlaxoSmithKline
Start date: 2006-11-01; Completion date: 2011-07-01
Enrollment: 228 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone or pazopanib alone in subjects with metastatic cervical cancer

Detailed description:
A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination with Lapatinib (GW572016) Compared to Pazopanib Monotherapy and Lapatinib Monotherapy in Subjects with International Federation of Gynecology (FIGO) Stage IVB or Recurrent or Persistent Cervical Cancer with Zero or One Prior Chemotherapy Regimen for Advanced/Recurrent Disease

Arms: arm 1: Pazopanib plus lapatinib arm 2: Lapatinib arm 3: Pazopanib
Interventions: intervention 1: pazopanib (GW786034) intervention 2: lapatinib (GW572016)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00457197
Conditions: Bipolar Disorder Alcohol Dependence
Keywords: bipolar disorder alcohol dependence mania manic disorder depression
Sponsor: University of Texas Southwestern Medical Center
Start date: 2007-03-01; Completion date: 2011-07-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out whether an investigational drug called quetiapine can treat bipolar disorder, improve mood and reduce alcohol use and craving.

Detailed description:
The primary aim in the study is to determine if quetiapine treatment is associated with greater reduction in alcohol use than placebo in outpatients with bipolar disorder and alcohol dependence. We will also examine if quetiapine treatment is associated with greater reduction in alcohol craving than placebo in outpatients with bipolar disorder and alcohol dependence and if quetiapine treatment is associated with greater improvement in depressive symptoms than placebo in outpatients with bipolar disorder and alcohol dependence.

Arms: arm 1: This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. arm 2: This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.
Interventions: intervention 1: Placebo intervention 2: Quetiapine
Intervention descriptions: intervention 1: Inactive ingredient matching the active medication in appearance. intervention 2: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.

Protocol documents:
Clinical trial NCT00482391
Conditions: Breast Cancer
Keywords: recurrent breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer male breast cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2007-03-01; Completion date: 2011-07-01
Enrollment: 95 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to study a new treatment for HER-2/neu (+) breast cancer.

Detailed description:

Arms: arm 1: The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
Interventions: intervention 1: trastuzumab intervention 2: cyclophosphamide intervention 3: doxorubicin hydrochloride intervention 4: lapatinib ditosylate intervention 5: paclitaxel intervention 6: laboratory biomarker analysis
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT00495586
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Antibiotics
Sponsor: Catalan Society of Family Medicine
Start date: 2007-10-01; Completion date: 2011-07-01
Enrollment: 318 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness of antibiotic therapy for patients with acute exacerbations of mild-to-moderate chronic obstructive pulmonary disease.

Detailed description:
Antibiotics are usually prescribed for acute exacerbations of chronic obstructive pulmonary disease (COPD) even though their benefit in mild-to-moderate COPD is not demonstrated. The aim of this study is to assess the effectiveness of antibiotic therapy for exacerbations of COPD, what clinical variables are associated with an improved clinical response with antibiotic therapy with respect to placebo and to identify which patients might recover from an acute exacerbation without antibiotic therapy. Methodology: prospective, randomised, double blind, placebo-controlled clinical trial, in which exacerbations (at least one criterion present: increase of dyspnoea, increase of sputum production and/or increase of purulence) of patients older than 40 yr., smokers or ex-smokers of more than 10 pack-years, with COPD and FEV1 greater than 50%, diagnosed by spirometry and a predicted ratio FEV1/FVC\<0.7%. Exclusion criteria: severe COPD (FEV1\<50%), active neoplasm, tracheotomy, pneumonia, hospitalization criteria, patients previously being on antibiotics, immunodepressed, history of hypersensitivity to beta-lactams or intolerance to clavulanate, enrollment in other clinical trials, patients who refuse to take part in this study, and patients who have not had a spirometry test for the past two years. Sample size: 677 patients. Interventions: first visit: the patient will be given details of the clinical trial and will be asked to sign informed consent; other data: sputum color, chest X-ray ordered to rule out pneumonia, C-reactive protein levels, and peak flow measurement. The patient will be randomised to receive amoxicillin plus clavulanate or placebo and will be scheduled to return for a 2nd follow-up visit after 3 or 4 days to assess the clinical response and peak flow measurements and to rule out any worsening of the condition. Third visit: scheduled after 9-11 days to assess the clinical response, drug-compliance and peak flow measurement. Fourth visit after 15-20 days for clinical assessment and to observe whether any relapses have occurred. Date of the following exacerbation will be recorded.

Arms: arm 1: Placebo pills t.i.d. for 8 days arm 2: Amoxycillin and clavulanate t.i.d. for 8 days
Interventions: intervention 1: Placebo intervention 2: Amoxicillin and clavulanic acid
Intervention descriptions: intervention 1: One pill to be taken every eight hours for 8 days intervention 2: 500-125 mg to be taken every eight hours for 8 days

Protocol documents:
Clinical trial NCT00499252
Conditions: Fallopian Tube Carcinoma Primary Peritoneal Carcinoma Recurrent Ovarian Carcinoma
Sponsor: Gynecologic Oncology Group
Start date: 2007-06-01; Completion date: 2011-07-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying the side effects and how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the antitumor activity of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®), in terms of frequency and duration of objective response, in patients with persistent or recurrent platinum-resistant ovarian epithelial, fallopian tube, or primary peritoneal cancer.

II. Determine the toxicity of this drug in these patients.

SECONDARY OBJECTIVES:

I. Determine the duration of progression-free survival and overall survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®) IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Arms: arm 1: Patients receive paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®) 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 descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00503750
Conditions: Breast Cancer
Keywords: Breast Cancer
Sponsor: Emory University
Start date: 2008-04-01; Completion date: 2011-07-01
Enrollment: 27 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II one arm study. Patients with HER2 (Human Epidermal Growth Factor Receptor 2)positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with trastuzumab before having breast surgery.

Detailed description:
This is a phase II one arm study. Patients with HER2(Human Epidermal Growth Factor Receptor 2) positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with trastuzumab before having breast surgery.

Approximately 50 patients will take part at multi-sites with potentially 20 patients participating at the Emory Winship Cancer Institute, Grady Memorial Hospital, and Emory Crawford Long Hospital in Atlanta, Georgia.

Arms: arm 1: Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
Interventions: intervention 1: Pre operativeTrastuzumab intervention 2: ABI-007 (Abraxane) intervention 3: Vinorelbine
Intervention descriptions: intervention 1: Trastuzumab one-time loading dose of 4 mg/kg as 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as 30 minute infusion.

As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52. intervention 2: ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). intervention 3: Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20).

Protocol documents:
Clinical trial NCT00507546
Conditions: Insomnia Spinal Cord Injury Tetraplegia Sleep Disorders
Keywords: sleep melatonin spinal cord injury insomnia tetraplegia
Sponsor: US Department of Veterans Affairs
Start date: 2007-07-01; Completion date: 2011-07-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine if replacing melatonin function with a melatonin agonist (ramelteon) in individuals that lack endogenous melatonin production (tetraplegia) helps to alleviate self-reported sleep disruption.

Detailed description:

Arms: arm 1: 8 mg nightly ramelteon for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of nightly placebo (cross-over) arm 2: placebo nightly for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of 8 mg nightly ramelteon (cross-over)
Interventions: intervention 1: Ramelteon intervention 2: Placebo
Intervention descriptions: intervention 1: 8 mg nightly intervention 2: Nightly 8mg of placebo (same appearance as ramelteon)

Protocol documents:
Clinical trial NCT00522379
Conditions: Parkinson's Disease
Keywords: Parkinson's disease rotigotine patch transdermal dopamine agonist off time Neupro
Sponsor: UCB Pharma
Start date: 2007-07-01; Completion date: 2011-07-01
Enrollment: 514 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to show Rotigotine dose response at four doses of Rotigotine used with L-dopa in treating advanced stage Parkinson's disease.

Detailed description:
To maintain treatment blind, two different active patch sizes were used (10 cm\^2 \& 20 cm\^2). Placebo patches matched according to size and appearance. During the trial subjects applied up to three patches, active and placebo, to achieve their assigned daily dose.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Rotigotine intervention 2: Rotigotine intervention 3: Placebo intervention 4: Rotigotine intervention 5: Rotigotine
Intervention descriptions: intervention 1: 2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks intervention 2: 4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks intervention 3: Placebo transdermal patch applied daily intervention 4: 6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks intervention 5: 8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks

Protocol documents: