ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00283504
Conditions: ALLERGIC ASTHMA
Sponsor: Children's Hospital of The King's Daughters
Start date: 2006-01-01; Completion date: 2009-01-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The researcher proposes to assess levels of sputum inflammatory markers (eosinophils, eosinophil cationic protein (ECP), neutrophils IL-8) before and while on anti-IgE therapy in a pediatric population of moderate to severe asthmatics who have ongoing persistent asthma symptoms despite on moderate to high doses of inhaled corticosteroids (ICS).

Associations will be assessed between the types of sputum inflammatory markers and the patient's atopic status and level of asthma control as indicated by the following measures:

1. pulmonary function test (PFT)
2. asthma symptoms based on the Asthma Control Test (ACT)

Detailed description:
Objectives:

Primary: Describe inflammatory cell types in study patients and compare changes in inflammatory cell patterns before and during anti-IgE therapy.

Secondary:Describe patterns of sputum eosinophilia and neutrophilia in relation to asthma symptom improvement based on ACT and PFT

Hypotheses:

Differences in inflammatory response after the addition of anti-IgE therapy can be described in neutrophilic, eosinophilic and neutrophilic/eosinophilic asthmatics.

Neutrophilic asthmatics patients will fail to respond when placed on anti-IgE while eosinophilic asthmatics will respond well.

Sputum inflammatory markers are sensitive markers of inflammation and can predict response to new asthma treatment modalities such as anti-IgE therapy.

Arms: arm 1: One arm:active drug
Interventions: intervention 1: ANTI-IGE THERAPY (XOLAIR)
Intervention descriptions: intervention 1: Xolair dosing is based on body weight and baseline serum total IgE concentration(0.016 x kg body weight x IgE levels), with a maximum dose per 4 weeks of 750mg.Depending on their weight and IgE levels, patients get their Xolair shots every 2 or every 4 weeks.

Protocol documents:
Clinical trial NCT00288587
Conditions: Heart Failure CHF
Keywords: Heart Failure Congestive Heart Failure CHF
Sponsor: NxStage Medical
Start date: 2003-10-01; Completion date: 2009-01-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the ability of Ultrafiltration to influence the rate of hemodynamic improvement, as measured by the decline in the pulmonary artery occlusion pressure, in patients with NYHA class III/IV Heart Failure.

Detailed description:
This study will be preformed in a specialized heart failure unit at the Cleveland Clinic Foundation (CCF) and will include both the UF-treated group and a control group receiving usual and customary care. Patients will be stratified according to renal function at the time of admission. Therapies will be guided by specific hemodynamic criteria routinely used at the study institution.

Arms: arm 1: Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure. arm 2: Patients treated with conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.
Interventions: intervention 1: IV loop diuretic intervention 2: NxStage System One
Intervention descriptions: intervention 1: Use of conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure. intervention 2: Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.

Protocol documents:
Clinical trial NCT00320255
Conditions: Thrombosis Cancer Pulmonary Embolism
Keywords: anticoagulant
Sponsor: Bristol-Myers Squibb
Start date: 2006-06-01; Completion date: 2009-01-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.

Detailed description:

Arms: arm 1: Participants received placebo tablets once daily arm 2: Participants received apixaban as tablet, 5 mg, once daily arm 3: Participants received apixaban as tablet, 10 mg, once daily arm 4: Participants received apixaban as tablet, 20 mg, once daily arm 5: Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. arm 6: Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
Interventions: intervention 1: Apixaban intervention 2: Placebo
Intervention descriptions: intervention 1: Oral tablets administered once daily in 5-, 10-, or 20-mg dose intervention 2: Oral tablets administered once daily

Protocol documents:
Clinical trial NCT00322023
Conditions: Schizophrenia
Keywords: Negative symptoms NMDA Glutamate Glycine
Sponsor: Nathan Kline Institute for Psychiatric Research
Start date: 2006-03-01; Completion date: 2009-01-01
Enrollment: 55 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will determine whether increasing D-serine within the body will improve negative symptoms and cognitive impairments in people with schizophrenia.

Detailed description:
Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans each year. Schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or hallucinations, believe that others are controlling their thoughts, and even fail at maintaining a job or caring for themselves. Current medications help to relieve most of these symptoms, but not all. Some people with schizophrenia still suffer from negative symptoms, such as difficulty with talking, expressing emotions, and motivation; they may also suffer from cognitive impairments, such as decreased concentration and memory loss. D-serine, an amino acid found within the body, activates brain cell receptors that appear to play a role in learning and memory. This study will determine whether adding a D-serine solution to a stable antipsychotic medication regimen will decrease negative symptoms in people with schizophrenia.

Participants in this open-label study will remain on their regular medication regimen for at least 2 weeks. During this time and before starting treatment, participants will be interviewed about their emotional problems, marital status, education, family background, employment history, and any drug or alcohol problems. Participants will also undergo a physical exam, an electrocardiogram (EKG), vital sign measurements, psychological tests, cognitive tasks, and an electroencephalogram (EEG). Participants will then begin 4 weeks of treatment with D-serine. In addition to participants' regular medication regimen, they will drink a D-serine powder mixed with water twice daily. Every 2 weeks, participants will undergo a physical exam and an interview about any changes in symptoms or emotional problems that they may be experiencing. Blood and urine samples will be taken throughout the study. After 4 weeks, participants will undergo an EKG, EEG, and the same psychological tests and cognitive tasks completed prior to treatment. A follow-up visit will occur 2 weeks post-treatment to monitor any changes in negative symptoms.

Arms: arm 1: D-serine 30 mg/kg arm 2: D-serine 60 mg/kg arm 3: D-serine 120 mg/kg
Interventions: intervention 1: D-serine intervention 2: D-serine intervention 3: D-serine intervention 4: D-serine
Intervention descriptions: intervention 1: D-serine at following dose levels: 30 mg/kg, 60 mg/kg, and 120 mg/kg. PK/PD studies done at day 1. Medication will be administered as powder dissolved in liquid given in two divided doses daily for 4 weeks. intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00323479
Conditions: Early Breast Cancer
Keywords: breast cancer treatment joint disorders
Sponsor: AstraZeneca
Start date: 2006-06-01; Completion date: 2009-01-01
Enrollment: 114 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to describe the joint symptoms and structural joint changes under anastrozole as adjuvant treatment in postmenopausal women with early breast cancer.

Detailed description:

Interventions: intervention 1: Anastrozole
Intervention descriptions: intervention 1: 1mg/Day oral

Protocol documents:
Clinical trial NCT00332462
Conditions: Liver Transplantation
Keywords: Liver transplantation, Cyclosporine
Sponsor: Novartis Pharmaceuticals
Start date: 2006-05-01; Completion date: 2009-01-01
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this exploratory study is to evaluate the rejection rate in patients treated with cyclosporine (CsA) preceding oral administration of cyclosporine micro emulsion in de novo liver recipients. The blood levels of CsA and CsA micro emulsion will be monitored by C-2h monitoring. In addition, this study will assess the safety of this treatment regimen.

Detailed description:

Arms: arm 1: Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
Interventions: intervention 1: Cyclosporine (Sandimmun® i.v.) intervention 2: Cyclosporine (Sandimmun® Optoral)
Intervention descriptions: intervention 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels. intervention 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.

Protocol documents:
Clinical trial NCT00333437
Conditions: Scleroderma, Systemic
Keywords: Scleroderma, Systemic
Sponsor: University of California, San Francisco
Start date: 2006-05-01; Completion date: 2009-01-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Researchers from the Division of Pulmonary and Critical Care Medicine at University of California, San Francisco (UCSF) are conducting a study to evaluate whether mycophenolate mofetil (an immunosuppressive medication, trade named CellCept) is safe and effective for preventing the lung damage from scleroderma from getting worse.

Detailed description:
The proposed study is designed to evaluate the safety and efficacy of mycophenolate mofetil (CellCept) for the treatment of symptomatic pulmonary alveolitis due to systemic sclerosis (SSc). This study utilizes a prospective, open-label, experimental design.

Primary Hypothesis: The alveolitis in patients with SSc, as defined by decreased forced vital capacity (FVC), bronchoalveolar lavage (BAL), and High Resolution Chest Tomography (HRCT) is responsive to 1 year of daily mycophenolate mofetil therapy.

Secondary Hypothesis: Quality of life, six-minute walk and single-breath diffusing capacity for carbon monoxide (DLCO) improve in patients with SSc mediated alveolitis after therapy with mycophenolate mofetil. This response to therapy is associated with a change in the inflammatory cytokine profile present in BAL fluid.

Arms: arm 1: Mycophenolate Mofetil
Interventions: intervention 1: Mycophenolate mofetil
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00337272
Conditions: Chronic Insomnia
Keywords: chronic insomnia
Sponsor: Accelerated Community Oncology Research Network
Start date: 2006-08-01; Completion date: 2009-01-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the treatment of insomnia in patients that have completed their first chemotherapy treatment for breast cancer.

Detailed description:
Phase IV, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of ramelteon 8mgs in the treatment of insomnia in patients with breast cancer.

Arms: arm 1: Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period. arm 2: Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
Interventions: intervention 1: Placebo intervention 2: Ramelteon
Intervention descriptions: intervention 1: Placebo taken 30 minutes before bedtime days 1-28 of treatment period intervention 2: 8 mgs daily for days 1-28 of treatment period

Protocol documents:
Clinical trial NCT00359073
Conditions: Asthma
Keywords: asthma leukotrienes rhinovirus
Sponsor: University of Wisconsin, Madison
Start date: 2006-10-01; Completion date: 2009-01-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
People with asthma may have asthma worsening when they have an upper respiratory infection due to a virus or a common cold. Leukotrienes are increased in nasal secretions from children with Respiratory Syncytial Virus (RSV) and lung washings during times of acute lung inflammation. Experimental virus exposure in adults is also associated with increases in nasal leukotrienes.

The degree to which leukotrienes play a role in asthma worsening is unknown.There is information linking leukotrienes to viral infections, allergic inflammation, and asthma exacerbation.This information supports the hypothesis that virus-induced leukotrienes contribute to the severity of respiratory infections and in susceptible individuals, lead to lower airway obstruction and exacerbations of asthma. We propose to use montelukast in an experimental viral challenge model to explore this hypothesis.

Detailed description:
Viral infections are important causes of wheezing illnesses throughout childhood and in adults with asthma. There has been progress in identifying mechanisms and risk factors for severe respiratory symptoms, and in particular, wheezing. Given this close relationship, it would be attractive to apply antiviral strategies to the prevention and treatment of asthma, and both RV and RSV are obvious targets. Unfortunately, attempts at developing an RSV vaccine have so far been unsuccessful, and vaccination to prevent RV infection does not seem to be feasible due to the large number of serotypes. Antiviral medications have been tested in clinical trials, however one problem with this approach is that once the clinical signs and symptoms appear, viral replication is well underway.

The other potential therapeutic approach for respiratory viral infections would be to selectively inhibit pro-inflammatory immune responses induced by the virus. The beneficial effects of systemic glucocorticoids indicate that this approach is valid; the challenge will be to develop treatments with greater efficacy and a reduced potential for adverse effects. The large body of information linking cysteinyl leukotrienes to viral infections, allergic inflammation, and asthma exacerbations, strongly supports the hypothesis that virus-induced leukotrienes contribute to the severity of respiratory infections and in susceptible individuals, lead to lower airway obstruction and exacerbations of asthma. We propose to use montelukast in an experimental viral challenge model to explore this hypothesis.

Arms: arm 1: montelukast (10 mg everyday) arm 2: Placebo comparator
Interventions: intervention 1: montelukast intervention 2: placebo
Intervention descriptions: intervention 1: 10 mg everyday intervention 2: like placebo

Protocol documents:
Clinical trial NCT00361283
Conditions: Inflammation
Sponsor: University of Florida
Start date: 2004-06-01; Completion date: 2009-01-01
Enrollment: 108 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to test whether atorvastatin (also known as Lipitor) has anti-inflammatory effects in people with no known heart disease or high cholesterol. We also are investigating whether or not genetic differences between people plays a role in the drug response.

Detailed description:
All subjects received 16 weeks of Atorvastatin after a two week run in. Key dependent variables were the 16 week value minus the baseline value (post run-in). Last observation carried forward was used for missing values. The key comparisons are for two groups OATP1B1 reduced carriers and on-carriers and their association with Cytokines and Lipids. Secondarily, we were interested in changes over the 16 weeks for the pooled sample, irrespective of genetics.

Arms: arm 1: 80mg of atorvastatin given once daily for 16 weeks
Interventions: intervention 1: Atorvastatin
Intervention descriptions: intervention 1: atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks

Protocol documents:
Clinical trial NCT00381888
Conditions: Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Sarcoma Thromboembolism Vaginal Cancer Vulvar Cancer
Keywords: thromboembolism cervical cancer endometrial cancer ovarian epithelial cancer ovarian germ cell tumor borderline ovarian surface epithelial-stromal tumor ovarian sarcoma ovarian stromal cancer uterine sarcoma vaginal cancer vulvar cancer fallopian tube cancer
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2007-01-01; Completion date: 2009-01-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Fondaparinux may help prevent blood clots from forming in patients who are undergoing surgery for gynecologic cancer.

PURPOSE: This phase II trial is studying how well fondaparinux works in preventing blood clots in patients undergoing surgery for gynecologic cancer.

Detailed description:
OBJECTIVES:

Primary

* Evaluate the efficacy of prolonged (4 weeks) fondaparinux sodium administration in venous thromboembolism prophylaxis in patients undergoing gynecologic oncology surgery.

Secondary

* Evaluate the safety of this regimen in these patients (4 weeks).
* Determine the feasibility of this regimen in these patients (4 weeks).

OUTLINE: This is an open-label study.

Beginning after surgery, patients receive fondaparinux sodium subcutaneously once daily on days 1-28 in the absence of disease progression or unacceptable toxicity. Patients undergo duplex ultrasonography of the lower extremities between day 28-35.

Arms: arm 1: Patients treated with at least one dose of Fondaparinux (2.5 mg subcutaneous, Days 1-28 by mouth).
Interventions: intervention 1: fondaparinux sodium
Intervention descriptions: intervention 1: Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.

Protocol documents:
Clinical trial NCT00387088
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2006-09-01; Completion date: 2009-01-01
Enrollment: 3991 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.

Detailed description:

Arms: arm 1: Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded) arm 2: Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Interventions: intervention 1: Respimat intervention 2: Tiotropium
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00387660
Conditions: Lung Cancer
Keywords: extensive stage small cell lung cancer limited stage small cell lung cancer recurrent small cell lung cancer
Sponsor: University of California, Davis
Start date: 2001-10-01; Completion date: 2009-01-01
Enrollment: 80 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, 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 how well giving irinotecan together with carboplatin works in treating patients with metastatic or recurrent small cell lung cancer.

Detailed description:
OBJECTIVES:

* Determine the response rates in patients with metastatic or recurrent small cell lung cancer treated with irinotecan hydrochloride and carboplatin.
* Determine the median survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no) and disease stage (metastatic vs relapsed).

Patients receive irinotecan hydrochloride IV over 90 minutes and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Irinotecan 200 mg/m2, every 21 days (intravenous) + Carboplatin AUC = 5 mg/ml x min (intravenous), every 21 days for 6 cycles arm 2: Irinotecan 150 mg/m2 (intravenous), every 21 days + Carboplatin AUC = 5 mg/ml x min (intravenous, every 21 days for 6 cycles
Interventions: intervention 1: carboplatin intervention 2: irinotecan
Intervention descriptions: intervention 1: Patients receive carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. intervention 2: Patients receive irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Protocol documents: