ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00448279
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2007-04-01; Completion date: 2010-09-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment (2mg/kg iv infusion weekly, or 6mg/kg iv infusion every 3 weeks) while receiving 2nd line chemotherapy of the investigator's choice. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Chemotherapy, schedule and dose at the investigator's discretion. arm 2: Trastuzumab, at the investigator's discretion, either 2 milligrams per kilogram (mg/kg) intravenous (i.v.) every 7 days or 6 mg/kg i.v. every 3 weeks. Chemotherapy, schedule and dose at the investigator's discretion.
Interventions: intervention 1: trastuzumab intervention 2: Chemotherapy
Intervention descriptions: intervention 1: 2mg/kg i.v. weekly, or 6mg/kg i.v. every 3 weeks intervention 2: Schedule and dose at the investigator's discretion

Protocol documents:
Clinical trial NCT00456495
Conditions: Conjunctival Neoplasms
Sponsor: The New York Eye Cancer Center
Start date: 2007-03-01; Completion date: 2010-09-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia using the incidence and severity of adverse events.

Our secondary objective is to assess the efficacy of ranibizumab treatment on malignant conjunctival neoplasia by evaluating tumor destruction or reduction as documented by slit-lamp photography and ultrasonographic imaging and the regression of blood vessels.

Detailed description:
Ranibizumab is a recently approved vascular endothelial growth factor (VEGF) inhibitor shown to be effective in treating exudative macular degeneration. Its analog, Avastin has also been employed to treat macular edema, proliferative diabetic retinopathy and wet age related macular degeneration. Ranibizumab binds to and inhibits vascular endothelial growth factor A (VEGF-A), which has been shown to cause neovascularization and leakage in models of ocular angiogenesis. Binding to VEGF-A prevents ranibizumab's interaction with VEGFR-1 and -2 receptors on the surface of endothelial cells, thereby reducing proliferation, vascular leakage, and angiogenesis.

Given that conjunctival tumors require the formation of new blood vessels to supply the proliferating cells, we propose a study to evaluate the effect of subconjunctival ranibizumab as a primary intervention in patients with conjunctival tumors.

Arms: arm 1: Patients will receive subconjunctival ranibizumab every 2-4 weeks.
Interventions: intervention 1: ranibizumab
Intervention descriptions: intervention 1: Subconjunctival injection of drug every 2 to 4 weeks

Protocol documents:
Clinical trial NCT00456508
Conditions: Hereditary Angioedema (HAE)
Sponsor: Shire
Start date: 2007-04-01; Completion date: 2010-09-01
Enrollment: 147 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and treated for subsequent attacks in this trial.

Detailed description:
This is an open label trial.

The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide in the treatment of acute attacks of hereditary angioedema. This study is designed to provide efficacy and safety data on repeated use of ecallantide. These data are intended to support the marketing authorization of ecallantide in the treatment of acute attacks of hereditary angioedema. Efficacy and safety of ecallantide will be evaluated in this study.

Arms: arm 1: DX-88 (ecallantide) Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
Interventions: intervention 1: ecallantide
Intervention descriptions: intervention 1: solution for SC injection, one 30 mg dose per HAE attack

Protocol documents:
Clinical trial NCT00456885
Conditions: Obesity Impaired Glucose Tolerance
Keywords: obesity double blind placebo controlled weight loss appetite energy expenditure
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2007-04-01; Completion date: 2010-09-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will look at the effect of exenatide, a drug which has been approved for the treatment of type 2 diabetes, on body weight, appetite and energy expenditure among moderately obese women without diabetes.

The study is 35 weeks long and includes 19 outpatient visits. Participants will receive exenatide for 16 weeks and placebo for 16 weeks with a 3 week rest period in between. Neither participants nor investigators will know whether exenatide or placebo is being administered. Participants will be started randomly on either exenatide or placebo.

Our hypothesis is that treatment with exenatide will curb appetite and lead to weight loss and may lead to changes in energy expenditure.

Detailed description:
This study will examine the effect of exenatide on body weight, energy expenditure, satiety, sleep, and metabolic parameters in healthy, moderately obese women (BMI 28-35 kg/m2). We will look at 2 populations of women, one with normal glucose metabolism and one with impaired glucose homeostasis (IGH)--either impaired fasting glucose (IFG, fasting glucose 101-125 mg/dL) or impaired glucose tolerance (IGT, glucose 140-199 mg/dL 2h after a 75g oral glucose load). This is a randomized, double blind, crossover study with two 16-week treatment periods separated by a 3-week washout period. There are 19 study visits over 35 weeks.

The goals of this study are 1) to examine the effect of exenatide on body weight and dysglycemia in populations in which this medication has not been studied, namely obese women with and without IGH and 2) to investigate possible mechanisms of weight loss through measurements of energy expenditure, hunger, satiety, nausea, and sleep.

The primary outcome of this study is weight loss. We will calculate absolute and relative change in body weight from baseline to week 16 (the first treatment period) and from week 19 to week 35 (the second treatment period). Body weight will be measured at every study visit which will also allow us to assess the absolute and relative change from baseline throughout the entire study.

Arms: arm 1: Started on Exenatide, 3 week washout, start placebo arm 2: Started on placebo, 3 week washout, start exenatide
Interventions: intervention 1: exenatide intervention 2: Placebo
Intervention descriptions: intervention 1: 5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks intervention 2: Twice daily injection of placebo

Protocol documents:
Clinical trial NCT00470535
Conditions: Pancreatic Cancer
Keywords: adenocarcinoma of the pancreas recurrent pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer
Sponsor: Roswell Park Cancer Institute
Start date: 2007-01-01; Completion date: 2010-09-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with stage III or stage IV pancreatic cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the progression-free survival (PFS) of patients with stage III or IV adenocarcinoma of the pancreas treated with erlotinib hydrochloride as first- or second-line therapy.

Secondary

* Determine the proportion of patients with a radiological response to this drug.
* Determine the overall survival of these patients.
* Determine the effect of this drug on quality of life in these patients.
* Correlate expression of EGFR, E-cadherin, P-cadherin, vimentin, cytokeratin, fibronectin, and ki67 in baseline tumor blocks and presence of K-ras mutations in baseline tumor biopsy specimens with response to this drug.
* Correlate smoking status with PFS in patients treated with this drug.
* Collect serum samples before, during, and after therapy for future serum proteomic studies and for development of profiles of responders to this drug.

OUTLINE: Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

Patients complete a questionnaire about their smoking status at baseline. Patients also complete questionnaires about their quality of life every three weeks during study therapy and after completion of study therapy.

Blood samples are collected from patients at baseline and periodically during study for future serum proteomic research and for development of profiles of responders to erlotinib hydrochloride therapy. Paraffin-embedded tumor tissue from diagnostic tumor biopsies is assessed at baseline for expression of EGFR, E-cadherin, P-cadherin, vimentin, cytokeratin, fibronectin, and ki67 by immunohistochemical analysis. Tissue from surgical specimens in patients with prior resection is assessed for K-ras mutations by K-ras analysis.

After completion of study therapy, patients are followed for at least 6 months.

PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.

Arms: arm 1: Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity
Interventions: intervention 1: erlotinib hydrochloride intervention 2: immunohistochemistry staining method intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Oral intervention 2: Correlative Study intervention 3: Correlative Study

Protocol documents:
Clinical trial NCT00486434
Conditions: Osteoarthritis
Keywords: Osteoarthritis, oral salmon calcitonin, treatment, efficacy, tolerability
Sponsor: Nordic Bioscience A/S
Start date: 2007-05-01; Completion date: 2010-09-01
Enrollment: 1176 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoarthritis of the knee.

Detailed description:

Arms: arm 1: SMC021 Oral Calcitonin, 0.8 mg twice daily during 24 months arm 2: SMC021 Placebo, orally twice daily during 24 months
Interventions: intervention 1: SMC021 Oral Calcitonin intervention 2: SMC021 Placebo
Intervention descriptions: intervention 1: 0.8mg SMC021 (Oral Calcitoinin) twice daily intervention 2: Placebo orally, twice daily

Protocol documents:
Clinical trial NCT00494780
Conditions: Lymphoma, Follicular
Keywords: CHOP (cyclophosphamide,doxorubicin,vincristine,prednisolone) ofatumumab
Sponsor: GlaxoSmithKline
Start date: 2007-06-01; Completion date: 2010-09-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients with Follicular Lymphoma (FL)

Detailed description:

Arms: arm 1: Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 500mg arm 2: Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 1000mg
Interventions: intervention 1: Ofatumumab intervention 2: Cyclophosphamide intervention 3: Doxorubicin intervention 4: Vincristine intervention 5: Prednisolone, Prednisone or equivalent
Intervention descriptions: intervention 1: ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogen free saline and administered as an IV infusion.Duration of infusion will be approximately 4 hours.Infusions should be given every 3 weeks until a total of 6 infusions has been given intervention 2: Cyclophosphamide 750 mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start intervention 3: Doxorubicin : 50mg/m2 iv for 1 day, 24-48h post-ofatumumumab infusion start intervention 4: Vincristine : 1.4mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start intervention 5: 100mg p.o daily for 5 days, 24-48h post-ofatumumab infusion start

Protocol documents:
Clinical trial NCT00500318
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Bronchitis, Chronic; Emphysema
Sponsor: AstraZeneca
Start date: 2007-07-01; Completion date: 2010-09-01
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the effect of inhaled aclidinium bromide on exercise endurance and in reducing resting and dynamic lung hyperinflation in patients with moderate to severe COPD. It was 9 weeks in duration, consisting of; a 2-week run-in period, 6 weeks of double-blind treatment, and a 1-week follow-up phone call. All patients meeting the eligibility criteria were randomized to one of two treatment groups: aclidinium bromide or placebo.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aclidinium Bromide intervention 2: Placebo
Intervention descriptions: intervention 1: Aclidinium Bromide, 200μg. Once daily oral inhalation. intervention 2: Dose matched placebo, once daily oral inhalation.

Protocol documents:
Clinical trial NCT00506831
Conditions: Scleroderma, Systemic
Sponsor: Stanford University
Start date: 2007-07-01; Completion date: 2010-09-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Systemic sclerosis (SSc) is an autoimmune disease characterized by fibrosis of the skin and internal organs and widespread vasculopathy. Patients with SSc are classified according to the extent of cutaneous sclerosis: patients with limited SSc have skin thickening of the face, neck, and distal extremities, while those with diffuse SSc have involvement of the trunk, abdomen, and proximal extremities as well. The disease course varies depending on the subtype of SSc. However, common features that result in significant morbidity and mortality, in addition to cutaneous fibrosis, include Raynaud's phenomenon and digital ulcerations, interstitial lung disease (ILD), and pulmonary arterial hypertension (PAH). Current therapeutic options for patients with SSc and these clinical manifestations have shown limited efficacy.

Imatinib antagonizes specific tyrosine kinases that mediate fibrotic pathways involved in the pathogenesis of SSc, including c-Abl, a downstream mediator of transforming growth factor (TGF)-beta, and platelet derived growth factor (PDGF) receptors. The efficacy of imatinib has also been reported in the treatment of patients with refractory idiopathic PAH through its effects on vascular remodeling. Based on the mechanism of action and preliminary patient data, we hypothesize that imatinib may be effective in the treatment of the fibrotic and vasculopathic features of patients with SSc. This is an open label pilot study to evaluate the safety and efficacy of imatinib in patients with progressive SSc refractory to other treatment(s). Validated measures of skin thickness and disease activity will be determined over 6-months of therapy and compared with baseline measures.

Detailed description:

Arms: arm 1: 100 mg daily and increase by 100mg daily every 2 weeks to a maximum of 400 mg daily as tolerated
Interventions: intervention 1: Imatinib mesylate
Intervention descriptions: intervention 1: 100 mg orally daily increased by 100 mg/day every 2 weeks to maximum of 400 mg daily as tolerated. Treatment for 6 months total.

Protocol documents:
Clinical trial NCT00524589
Conditions: Prostate Cancer
Keywords: recurrent prostate cancer
Sponsor: Roswell Park Cancer Institute
Start date: 2006-04-01; Completion date: 2010-09-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Calcitriol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Dexamethasone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with dexamethasone may be an effective treatment for prostate cancer that did not respond to hormone therapy .

PURPOSE: This phase II trial is studying how well giving calcitriol together with dexamethasone works in treating patients with prostate cancer that did not respond to hormone therapy.

Detailed description:
OBJECTIVES:

* To investigate the response rate in patients with androgen-independent prostate cancer treated with calcitriol and dexamethasone.
* To evaluate the toxicity of high-dose calcitriol and dexamethasone in these patients.

OUTLINE: Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and on days 2 and 3 to assess VDR and CYP24 expression in peripheral blood mononuclear cells.

Arms: arm 1: Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.
Interventions: intervention 1: calcitriol intervention 2: dexamethasone intervention 3: protein expression analysis intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: IV intervention 2: Oral intervention 3: Correlative Study intervention 4: Correlative Study

Protocol documents:
Clinical trial NCT00525902
Conditions: Uveitis
Sponsor: Oregon Health and Science University
Start date: 2008-01-01; Completion date: 2010-09-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and efficacy of Adalimumab in uveitis.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Adalimumab
Intervention descriptions: intervention 1: 40 mg delivered every 2 weeks by subcutaneous injection

Protocol documents:
Clinical trial NCT00526890
Conditions: Lung Cancer
Keywords: squamous cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer large cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer adenosquamous cell lung cancer
Sponsor: Roswell Park Cancer Institute
Start date: 2006-10-01; Completion date: 2010-09-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Selenomethionine may slow the growth of tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with selenomethionine and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well selenomethionine works when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

Detailed description:
OBJECTIVES:

Primary

* Determine the safety and tolerability of selenomethionine in combination with chemotherapy and radiotherapy in patients with unresectable stage IIIA or IIIB non-small cell lung cancer.
* Determine if the incidence of excessive adverse events, in the form of esophagitis, pneumonitis, and myelosuppression, can be reduced with this regimen.

Secondary

* Estimate response rate, failure-free survival, and overall survival of these patients.
* Correlate selenium levels with degree of observed adverse events.

OUTLINE: This is a multicenter study.

Patients receive oral selenomethionine twice daily for 1 week and then once daily for 6 weeks. Patients also receive paclitaxel IV over 1 hour once weekly and carboplatin IV over 30 minutes once weekly for 6 weeks and undergo radiotherapy 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and weekly during treatment and analyzed by absorption spectrophotometry for selenium measurement of drug concentration

After the completion of study treatment, patients are followed periodically.

Arms: arm 1: Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
Interventions: intervention 1: selenomethionine intervention 2: carboplatin intervention 3: paclitaxel intervention 4: laboratory biomarker analysis intervention 5: radiation therapy
Intervention descriptions: intervention 1: Oral Twice daily intervention 2: Weekly IV intervention 3: Weekly IV intervention 4: Correlative Study intervention 5: Undergoing radiation Therapy

Protocol documents:
Clinical trial NCT00549562
Conditions: Autism
Keywords: Autistic Disorder
Sponsor: Indiana University School of Medicine
Start date: 2007-11-01; Completion date: 2010-09-01
Enrollment: 25 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
This 8-week, prospective open-label study will investigate the effectiveness and tolerability of paliperidone ER in adolescents and young adults with autism. Hypothesis:Paliperidone Er will be well tolerated and efficacious for reducing aggression, self-injury, and irritability in adolescents and young adults.

Detailed description:

Arms: arm 1: 8-Week Open-Label
Interventions: intervention 1: Paliperidone ER
Intervention descriptions: intervention 1: Starting dose is 3 mg per day. Can be titrated up to a maximum dose of 9 mg per day.

Protocol documents: