ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00411619
Conditions: Tuberous Sclerosis Subependymal Giant Cell Astrocytoma
Keywords: Tuberous Sclerosis Complex (TSC) Subendymal Giant Cell Astrocytomas (SEGA'S) Mammalian Target of Rapamycin (mTOR) Everolimus (RAD001) Tuberous Sclerosis with Subependymal Giant Cell Astrocytomas
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2007-01-01; Completion date: 2014-01-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the safety and potential side effects of everolimus (an experimental drug) on a person with Tuberous Sclerosis Complex who also has been diagnosed with a brain tumor (astrocytoma)

The hypothesis is that the drug will cause the tumor size to decrease, and may have beneficial activity separate from effects on tumors in patients.

Detailed description:
Tuberous Sclerosis Complex (TSC)is a genetic disorder with a birth incidence of approximately one in six thousand. Five to twenty percent of patients with TSC will develop astrocytoma, a slowly progressive tumor. They grow and cause damage to surrounding brain tissue, blockage of spinal fluid (hydrocephalus), blindness, trouble walking, seizures, and brain damage. If untreated, they can be fatal. Standard treatment involves surgery to remove the tumor; however surgery may itself cause brain damage, bleeding, or infection, as well as other complications. Studies have shown that everolimus suppresses the chemicals that cause tumors to grow in tuberous sclerosis, and may cause them to shrink.

The primary objective of this study is to find out the effects of everolimus on astrocytomas in a six month trial in patients with Tuberous Sclerosis who have been diagnosed with an astrocytoma

Arms: arm 1: As this was a non-randomized, open-label, single arm study, all patients in the study received treatment with everolilmus
Interventions: intervention 1: Everolimus
Intervention descriptions: intervention 1: Initial everolimus dosage will be 3 mg/m2/d taken daily or every other day, with titration to achieve a trough serum level of 5-15 ng/ml. Patients unable to tolerate levels in this range will have doses held or reduced 25% to achieve trough serum levels of 5-10 ng/ml. If trough serum level of 5-15 ng/ml is not achieved at a dosage of 3 mg/m2/d, then dosage escalation by 25% will be undertaken as tolerated. Everolimus will be similarly adjusted during the extension phase. If a subject misses more than 10 consecutive everolimus doses, additional days of everolimus treatment will be added so total duration of treatment is 6 months. If this occurs, dates of subsequent study events will be adjusted according to number of missed doses. This process will also be followed in the extension phase.

Protocol documents:
Clinical trial NCT00445848
Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung
Sponsor: SWOG Cancer Research Network
Start date: 2007-07-01; Completion date: 2014-01-01
Enrollment: 89 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. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving erlotinib together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage IIIB or stage IV primary non-small cell lung cancer who have never smoked.

Detailed description:
OBJECTIVES:

Primary

* Assess overall survival of patients with stage IIIB or IV primary non-small cell lung adenocarcinoma who have never smoked and are treated with erlotinib hydrochloride and bevacizumab.

Secondary

* Assess progression-free survival of patients treated with this regimen.
* Assess the response rate (confirmed and unconfirmed, complete and partial) in a subset of patients with measurable disease treated with this regimen.
* Evaluate the frequency and severity of toxicities associated with this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: bevacizumab intervention 2: erlotinib hydrochloride
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00454779
Conditions: Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
Keywords: SCCHNC Metastatic Recurrent
Sponsor: Amgen
Start date: 2007-01-01; Completion date: 2014-01-01
Enrollment: 113 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail the chemotherapy only arm. This study will be conducted in the United States. Approximately 150 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN.

Detailed description:

Arms: arm 1: Panitumumab + Docetaxel + Cisplatin arm 2: control
Interventions: intervention 1: Cisplatin intervention 2: Panitumumab intervention 3: Docetaxel intervention 4: Cisplatin intervention 5: Docetaxel
Intervention descriptions: intervention 1: chemotherapy arm intervention 2: experimental arm intervention 3: chemotherapy arm intervention 4: experimental arm intervention 5: experimental arm

Protocol documents:
Clinical trial NCT00477269
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension, tyrosine kinase inhibitor, STI571
Sponsor: Novartis Pharmaceuticals
Start date: 2006-04-01; Completion date: 2014-01-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, tolerability, and efficacy of imatinib mesylate in patients with pulmonary arterial hypertension

Detailed description:

Arms: arm 1: STI571 arm 2: Placebo arm 3: Open label extension
Interventions: intervention 1: Imatinib mesylate intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00478036
Conditions: Open Angle Glaucoma
Keywords: glaucoma selective laser trabeculoplasty anterior chamber flare
Sponsor: University of Colorado, Denver
Start date: 2007-05-01; Completion date: 2014-01-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Investigators will compare, in a randomized, prospective, masked and controlled fashion the effect of a non-steroidal anti-inflammatory agent (Acular LS), a corticosteroid (Pred Forte) and a placebo (Refresh Tears) on patient discomfort, degree of intraocular pressure (IOP) lowering and degree of ocular inflammation following selective laser trabeculoplasty treatment for open angle glaucoma.

Detailed description:
Currently, many ophthalmologists use anti-inflammatory agents like corticosteroids and nonsteroidal anti-inflammatory agents (NSAIDs) as a preventative measure to control the post-selective laser trabeculoplasty (SLT) anterior chamber inflammation. Both classes of compounds reduce inflammation through the inhibition of the cyclooxygenase pathway, whereas the corticosteroid class also inhibits the lipoxygenase pathway of the arachidonic acid cascade. Although effective, topical corticosteroids are associated with increase in intraocular pressure (IOP), posterior subcapsular cataract formation, and reduced response to infection. These adverse side effects have not been reported to occur with topical NSAIDs, which are effective in controlling the pain after SLT along with the prevention and suppression of the ocular inflammation. There are ophthalmologists who forgo using the anti-inflammatory agents post SLT and prescribe Refresh Tears to their patients to comfort the treated eye.

The significance of the study lies in assessing the efficacy of Acular LS, compared to Pred Forte and to Refresh Tears in reducing discomfort, inflammation and maximizing IOP lowering following SLT procedure for open angle glaucoma with the hope of resolving the dispute over the effective post-operative care in SLT patients.

Arms: arm 1: Acular LS - 1 drop in treated eye, 4 times a day, for 4 days arm 2: Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days arm 3: Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days
Interventions: intervention 1: Acular LS intervention 2: Pred Forte intervention 3: Refresh Tears
Intervention descriptions: intervention 1: Details covered in arm description intervention 2: Details covered in arm description intervention 3: Placebo

Protocol documents:
Clinical trial NCT00617539
Conditions: Breast Cancer Metastatic Cancer
Keywords: recurrent breast cancer stage IV breast cancer male breast cancer tumors metastatic to brain
Sponsor: University of California, San Francisco
Start date: 2005-02-01; Completion date: 2014-01-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving irinotecan together with temozolomide and to see how well it works in treating patients with breast cancer who have received previous treatment for brain metastases.

Detailed description:
OBJECTIVES:

Primary

* To evaluate the objective response rate systemically and in the CNS to the combination of irinotecan hydrochloride and temozolomide among patients with breast cancer and progressive brain metastases that have progressed after previous treatment for brain metastases.
* To determine the toxicities associated with the combination of irinotecan hydrochloride and temozolomide in breast cancer patients with progressive brain metastases.

Secondary

* To evaluate the time to first progression at any site (CNS or extra-CNS) in patients treated with the combination of irinotecan hydrochloride and temozolomide.
* To evaluate the overall survival of patients treated with the combination of irinotecan hydrochloride and temozolomide for brain metastases.

OUTLINE: Patients receive irinotecan IV on days 1 and 15 and oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 4 weeks.

Arms: arm 1: None
Interventions: intervention 1: irinotecan hydrochloride intervention 2: temozolomide
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00637780
Conditions: Arthritis, Juvenile Rheumatoid
Keywords: Sulfasalazine delayed release tablets azulfidine entabs Pharmacokinetics Juvenile Idiopathic Arthritis (JIA)
Sponsor: Pfizer
Start date: 2010-06-01; Completion date: 2014-01-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will characterize the steady state pharmacokinetics of sulfasalazine delayed release tablets in pediatric Juvenile Idiopathic Arthritis patients. Data from this study will fulfill the post approval commitment to the FDA.

Detailed description:

Arms: arm 1: Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 6 days
Interventions: intervention 1: Sulfasalazine
Intervention descriptions: intervention 1: Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 7 days. Blood sampling for Pharmacokinetic assessment to be performed on Day 7

Protocol documents:
Clinical trial NCT00650091
Conditions: Pulmonary Fibrosis
Keywords: Idiopathic Pulmonary Fibrosis Prednisone Azathioprine NAC N-acetylcysteine
Sponsor: Duke University
Start date: 2009-10-01; Completion date: 2014-01-01
Enrollment: 264 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Idiopathic pulmonary fibrosis (IPF) is a long-term lung disease that affects an individual's ability to breathe. In this randomized, double-blind, placebo-controlled trial, we assigned patients with idiopathic pulmonary fibrosis who had mild-to-moderate lung-function impairment to one of three groups - receiving a combination of prednisone, azathioprine, and NAC (combination therapy), NAC alone, or placebo - in a 1:1:1 ratio.

Detailed description:
IPF is a disease with widespread and permanent scarring of lung tissue which eventually results in death. Individuals with IPF may experience breathing difficulties, cough, chest pain, and a decreased exercise capacity. Although the cause of IPF is unknown, it may be a result of an inflammatory response to an unknown substance. NAC, an antioxidant that is effective at loosening up mucus that forms in the lungs, may improve lung function. The purpose of this study is to evaluate the effectiveness of NAC at preventing the loss of lung function in people with IPF.

In the initial double-blind, placebo-controlled trial, subjects who have idiopathic pulmonary fibrosis with mild-to-moderate impairment in pulmonary function are randomly assigned to receive a three-drug regimen of prednisone, azathioprine, and acetylcysteine; acetylcysteine alone; or placebo.

After safety concerns were identified by the data and safety monitoring board, the three-drug regimen was stopped by the National Heart, Lung, and Blood Institute (NHLBI) on October 14, 2011, and a clinical alert was issued. After a brief period of interruption for modification of the protocol and approval by the institutional review boards, patients continued to be recruited for the acetylcysteine group and the placebo group and were followed for the pre-specified duration of 60 weeks.

Study visits will occur at baseline and Weeks 4, 15, 30, 45, and 60. At all study visits, a physical exam and blood collection will occur. At selected visits, the following study procedures will occur: lung function testing; urine collection; a 6-minute walk test, and questionnaires to assess health status, breathing, and quality of life. Participants will record medication usage and symptoms in a daily diary.

Arms: arm 1: Participants will receive N-acetylcysteine (NAC) for 60 weeks. arm 2: Participants will receive placebo for 60 weeks.
Interventions: intervention 1: N-acetylcysteine (NAC) intervention 2: Placebo
Intervention descriptions: intervention 1: Participants will receive 600 mg of NAC three times a day. intervention 2: Participants will receive placebo each day.

Protocol documents:
Clinical trial NCT00669331
Conditions: Bronchiectasis
Keywords: randomized clinical trial mannitol mucoactive
Sponsor: Syntara
Start date: 2009-11-01; Completion date: 2014-01-01
Enrollment: 485 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
No gold standard therapy exists for clearing mucus from the airways of patients with bronchiectasis. While rhDNase has a proven place in the treatment of cystic fibrosis (CF), it failed to improve Forced expiratory volume in one second (FEV1) in a short-term non-CF bronchiectasis study and has been shown to be detrimental after 6 months therapy in non CF bronchiectasis, moreover it has no proven effect on mucociliary clearance. Hypertonic saline has been shown to have a comparable mode of action to inhaled mannitol, but has yet to be examined as a long term treatment option in bronchiectasis.

The purpose of this study is to examine the efficacy and safety of 52 weeks treatment with inhaled mannitol in subjects with non-cystic fibrosis bronchiectasis. Previous studies with inhaled mannitol have demonstrated improvement in mucociliary clearance; mucus rehydration; improvement in quality of life and respiratory symptoms in patients with bronchiectasis and pulmonary function in cystic fibrosis. The results of this current study in combination with a recently completed 3 month study seek to confirm these early findings and to extend the evidence to support its use as a mucoactive therapy in subjects with bronchiectasis.

We hypothesize that mannitol will improve the overall health and hygiene of the lung through regular and effective clearing of the mucus load. As a consequence of the reduction in mucus load and inflammatory process, the frequency of bronchiectasis related pulmonary exacerbations and the need for exacerbation related antibiotic treatment should fall. Days in hospital and community health care costs are expected to change in line with improvements in respiratory health.

Finally, we plan to demonstrate that inhaled mannitol is safe and well tolerated over a 52 week period. We will test these hypotheses using 400 mg mannitol twice daily (BD) against control.

Detailed description:

Arms: arm 1: Inhaled mannitol 400mg arm 2: Matched control - inhaled mannitol 50mg
Interventions: intervention 1: Inhaled mannitol intervention 2: Matched control
Intervention descriptions: intervention 1: 400mg dose of Mannitol BD (twice a day) for 52 weeks intervention 2: 50mg dose of Mannitol BD (twice a day) for 52 weeks

Protocol documents:
Clinical trial NCT00674765
Conditions: Alcoholism
Sponsor: University of Pennsylvania
Start date: 2008-01-01; Completion date: 2014-01-01
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effects of quetiapine in reducing percent heavy drinking days and increasing percent abstinent days in alcohol dependent patients who are frequent heavy drinkers.

Detailed description:
This trial is a phase 2, randomized, double-blind, placebo-controlled, parallel group trial intended to assess the efficacy of quetiapine compared to placebo in alcoholics who are frequent heavy drinkers.

Arms: arm 1: Seroquel arm 2: Placebo
Interventions: intervention 1: Seroquel intervention 2: Placebo
Intervention descriptions: intervention 1: 400 mg/day intervention 2: 400 mg/day

Protocol documents:
Clinical trial NCT00717756
Conditions: Liver Cancer
Keywords: liver cancer, second line
Sponsor: Brown University
Start date: 2009-01-01; Completion date: 2014-01-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will determine whether lenalidomide has activity in patients with advanced liver cancer that have had growth of their cancer after sorafenib.

Detailed description:
This study will determine the response rate and toxicities of lenalidomide as second line treatment for patients with liver cancer who have progressed after sorafenib.

Arms: arm 1: None
Interventions: intervention 1: lenalidomide
Intervention descriptions: intervention 1: 25 mg po qd x 21 days then 1 week off equals one cycle

Protocol documents:
Clinical trial NCT00754325
Conditions: Advanced Breast Cancer
Sponsor: Bristol-Myers Squibb
Start date: 2008-09-01; Completion date: 2014-01-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out what effect the combination of fulvestrant (Faslodex) and dasatinib (Sprycel) has on advanced breast cancer compared to fulvestrant alone.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dasatinib intervention 2: Fulvestrant
Intervention descriptions: intervention 1: Tablets, Oral, 100 mg, once daily (QD), upto 2 years intervention 2: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1. In subsequent cycles, 500 mg IM administered on Day 1. IM day 1 and 15 first cycle then IM Day 1 for all other cycles for 2 years

Protocol documents:
Clinical trial NCT00783965
Conditions: Skin Carcinoma
Keywords: nevoid basal cell carcinoma syndrome basal cell carcinoma of the skin
Sponsor: UCSF Benioff Children's Hospital Oakland
Start date: 2004-07-01; Completion date: 2014-01-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

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

PURPOSE: This randomized phase II trial is comparing two different schedules of topical tazarotene and topical placebo to see how well they work in treating patients with basal cell skin cancer and basal cell nevus syndrome on the chest.

Detailed description:
OBJECTIVES:

Primary

* To expand and refine chemopreventive strategies in individuals with basal cell nevus syndrome (BCNS) on the chest and back, who are at high risk for the development of basal cell carcinomas (BCCs).
* To determine whether tazarotene 0.1% cream applied to the chest for two years will reduce the numbers of basal cell carcinomas (BCCs) observed, as compared to the number expected, based on changes in BCC numbers observed during months 0-12.

Secondary

* To compare the difference in total BCC burden (measured as the total lesion surface area) between chest and back over various time points and aggregated intervals of interest.
* To determine whether there are any detectable wash-in or wash-out periods for the tazarotene effects.
* Explore the use of a random effects model for longitudinal analysis of total lesions over time.

OUTLINE: This is a multicenter study. Patients are randomized into 1 of 2 arms.

* Arm I: Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients apply vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest in the absence of disease progression or unacceptable toxicity.

Treated chest and untreated back is evaluated at 3 month intervals for 36 months.

Arms: arm 1: Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest. arm 2: Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.
Interventions: intervention 1: tazarotene intervention 2: placebo
Intervention descriptions: intervention 1: Applied to the skin intervention 2: Applied to the skin

Protocol documents: