ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01004510
Conditions: Malignant Pleural Effusion Non Small Cell Lung Cancer
Keywords: malignant pleural effusion non small cell lung cancer
Sponsor: Peter Bushunow MD
Start date: 2009-11-01; Completion date: 2011-04-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate whether the addition of the bisphosphonate Zometa (zoledronic acid) used along with standard regimens of chemotherapy, will help to control the need for palliative intervention of malignant pleural effusions due to non-small cell lung cancer.

Detailed description:
Malignant pleural effusions are common in late stage non-small cell lung cancer and can lead to significantly increased morbidity in this patient population. The majority of patients are symptomatic due to their malignant effusions. The recurrence rates are thought to be quite high overall and may approach 100% without any further treatment.Currently there is no available non-invasive, medical means for controlling the effusions other than systemic chemotherapy.Zoledronic acid has been shown in a mouse model of malignant pleural effusion to decrease fluid accumulation and tumor dissemination while prolonging survival.

Arms: arm 1: Zometa administered as a 15 minute IV infusion of either 4 mg, 3.5mg, 3.3 mg or 3.0 mg every 4 weeks based on the patient's baseline calculated creatinine clearance(CrCl)using the Cockcroft-Gault formula.
Interventions: intervention 1: zoledronic acid
Intervention descriptions: intervention 1: Zoledronic acid (Zometa) 4mg IV every 4 weeks for 3 treatments with chemotherapy as selected by treating physician

Protocol documents:
Clinical trial NCT01018680
Conditions: Osteoarthritis Knee Pain
Sponsor: Eli Lilly and Company
Start date: 2009-11-01; Completion date: 2011-04-01
Enrollment: 524 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will test the hypothesis that, in patients with knee pain due to osteoarthritis (OA) who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) but still have significant knee pain, duloxetine 60 to 120 milligrams (mg) daily for 10 weeks will provide additional reduction in pain.

Detailed description:
Duloxetine has been studied in pain due to osteoarthritis (OA) in 2 previous placebo controlled clinical trials. In clinical practice, when nonsteroidal anti-inflammatory drugs (NSAIDs) are ineffective in reducing pain due to OA, clinicians often add a second agent without discontinuing NSAIDs. In this study, we will investigate whether adding duloxetine to NSAIDs provides additional pain relief and functional improvement in patients with knee pain due to OA.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Duloxetine intervention 2: Placebo
Intervention descriptions: intervention 1: 30 milligrams (mg) taken by mouth, once daily for 1 week, followed by 60 to 120 mg taken by mouth, once daily for 9 weeks. intervention 2: Taken by mouth, once daily for 10 weeks

Protocol documents:
Clinical trial NCT01018862
Conditions: Perennial Allergic Rhinitis
Sponsor: Meda Pharmaceuticals
Start date: 2009-11-01; Completion date: 2011-04-01
Enrollment: 489 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness of an Investigational use of an allergy medication (MP03-33) used to treat perennial allergic rhinitis (PAR) to placebo (a nasal spray that contains no medicine). In addition, the study will also compare the safety and effectiveness of an investigational use of another allergy medication (MP03-36) used to treat perennial allergic rhinitis to placebo.

Detailed description:
in Children Ages \>6 to \<12 with Perennial Allergic Rhinitis (PAR)

Arms: arm 1: 822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks arm 2: 548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks arm 3: 0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
Interventions: intervention 1: Azelastine hydrochloride nasal spray 0.15% intervention 2: Azelastine hydrochloride nasal spray 0.10% intervention 3: Placebo
Intervention descriptions: intervention 1: 822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks intervention 2: 548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks intervention 3: 0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks

Protocol documents:
Clinical trial NCT01019694
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2009-11-01; Completion date: 2011-04-01
Enrollment: 470 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate long-term safety and patient acceptability of COMBIVENT RESPIMAT Inhalation Spray as compared to the COMBIVENT Inhalation Aerosol Chlorofluorocarbon-Metered Dose Inhaler (CFC-MDI) and the free combination of ATROVENT Hydrofluoroalkane (HFA) and albuterol Hydrofluoroalkane (HFA) inhalation aerosols.

Detailed description:

Arms: arm 1: patient to take 1 inhalation 4 times a day arm 2: patient to take 2 inhalations 4 times a day arm 3: patient to take 2 inhalations of each 4 times a day
Interventions: intervention 1: Combivent CFC-MDI intervention 2: Combivent Respimat 20/100 mcg intervention 3: Atrovent HFA 42 mcg + Albuterol HFA 200 mcg
Intervention descriptions: intervention 1: 36/206 mcg Four times a day (QID) intervention 2: Open label randomized parallel intervention 3: Open label randomized parallel

Protocol documents:
Clinical trial NCT01028014
Conditions: Urethral Sphincter Activity
Sponsor: University of Alabama at Birmingham
Start date: 2010-04-01; Completion date: 2011-04-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Lower urinary tract symptoms such as urinary leakage and overactive bladder affect millions of American women. Women may develop these problems because the innervation of the muscles of the bladder and urethra are injured. Most research on treating these problems has focused on the abnormalities of the bladder muscle, but newer studies have shown abnormalities in the innervation and muscle function of the urethra.

Women with these symptoms may benefit from treatment with medications to improve their urethral function. However, to truly understand what types of medications will help women with these symptoms, the investigators wish to study how these medications affect innervation and muscle function in healthy women who do not have lower urinary tract symptoms.

Detailed description:
Women without urinary incontinence or bladder symptoms (healthy controls)will undergo urethral testing prior to randomization to one of 5 medications or placebo. Participants will take an oral medication for 2 weeks and then return for repeat testing.

Arms: arm 1: Pseudoephedrine 120mg extended release tablets arm 2: Solifenacin 5mg capsule arm 3: Tamsulosin 0.4mg capsule arm 4: Imipramine 25mg tablet arm 5: Cyclobenzaprine 10mg tablet arm 6: Sham
Interventions: intervention 1: Pseudoephedrine intervention 2: Tamsulosin intervention 3: Imipramine intervention 4: Cyclobenzaprine intervention 5: Lactose capsule intervention 6: Solifenacin
Intervention descriptions: intervention 1: Pseudoephedrine ER 120 mg by mouth once daily for 2 weeks intervention 2: Tamsulosin 0.4mg by mouth daily for 2 weeks intervention 3: Imipramine 25mg daily by mouth for 2 weeks intervention 4: Cyclobenzaprine 10mg daily by mouth for 2 weeks intervention 5: Lactose capsule 1 by mouth daily for 2 weeks intervention 6: Solifenacin 5mg by mouth daily for 2 weeks

Protocol documents:
Clinical trial NCT01029886
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes exenatide once weekly Byetta liraglutide Victoza Amylin Lilly
Sponsor: AstraZeneca
Start date: 2010-01-01; Completion date: 2011-04-01
Enrollment: 912 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
No head to head comparisons between exenatide once weekly and liraglutide have been performed. Therefore, the purpose of this study is to compare exenatide once weekly to once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and other clinical benefits. The study includes a 26-week treatment period and a safety follow-up visit 10 weeks after the final study drug dose.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: exenatide once weekly intervention 2: liraglutide
Intervention descriptions: intervention 1: subcutaneous injection, 2mg, once weekly intervention 2: subcutaneous injection, forced titration to 1.8mg, once daily

Protocol documents:
Clinical trial NCT01035138
Conditions: Alzheimer's Disease
Sponsor: Eli Lilly and Company
Start date: 2009-12-01; Completion date: 2011-04-01
Enrollment: 180 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the original study was to assess the safety of semagacestat in Alzheimer's disease (AD) patients during 24 months of open-label treatment. Baseline for the efficacy measures is defined as the baseline for feeder studies LFAN (NCT00594568) and LFBC (NCT00762411). For all safety analyses (adverse events), baseline for patients will be week 0 of this study (LFBF).

Preliminary results from LFAN and LFBC showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. Studies LFAN, LFBC and LFBF have been amended to continue collecting safety data, including cognitive scores, for at least seven months. The CT-Registry will reflect results of analyses from the original protocol in addition to those from the amended protocol. Very few participants from LFBC rolled over into LFBF (N = 9). Due to insufficient sample size, the data for LFBC participants who rolled into LFBF were not analyzed.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: semagacestat
Intervention descriptions: intervention 1: 140mg administered orally, once daily for 24 months; dose reduction to 100mg or 60 mg possible due to intolerability

Protocol documents:
Clinical trial NCT01035333
Conditions: Obesity
Keywords: gastric bypass surgery
Sponsor: Albany College of Pharmacy and Health Sciences
Start date: 2009-11-01; Completion date: 2011-04-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary goal of the study is to determine if orlistat 60mg (Alli) is effective in helping patients achieve a required 10% weight loss goal prior to bariatric surgery. The medication will be added to the usual standard of care which includes education regarding diet and exercise and monthly meetings with a registered dietician.

Detailed description:

Arms: arm 1: Patients assigned to treatment group for up to 6 months of therapy.
Interventions: intervention 1: Orlistat
Intervention descriptions: intervention 1: 60mg capsule three times a day for up to 6 months

Protocol documents:
Clinical trial NCT01040130
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2010-01-01; Completion date: 2011-04-01
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease

Detailed description:

Arms: arm 1: Low dose inhaled orally once daily from the Respimat inhaler arm 2: High dose inhaled orally once daily from the Respimat inhaler arm 3: Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler
Interventions: intervention 1: Olodaterol (BI 1744) intervention 2: Olodaterol (BI 1744) intervention 3: Placebo intervention 4: Olodaterol (BI 1744) intervention 5: Olodaterol (BI 1744) Placebo
Intervention descriptions: intervention 1: Comparison of low and high doses on exercise endurance time in COPD patients intervention 2: Comparison of low and high doses on exercise endurance time in COPD patients intervention 3: Comparison of low and high dose and placebo on exercise endurance time in COPD patients intervention 4: Comparison of low and high dose intervention 5: Placebo that represents olodaterol

Protocol documents:
Clinical trial NCT01040793
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2010-01-01; Completion date: 2011-04-01
Enrollment: 157 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease.

Detailed description:

Arms: arm 1: Low dose inhaled orally once daily from the Respimat inhaler arm 2: High dose inhaled orally once daily from the Respimat inhaler arm 3: Olodaterol (BI 1744) placebo inhaled orally from the Respimat inhaler
Interventions: intervention 1: Olodaterol (BI 1744) intervention 2: Olodaterol (BI 1744) intervention 3: Placebo intervention 4: Olodaterol (BI1744) intervention 5: Olodaterol (BI 1744) placebo
Intervention descriptions: intervention 1: Comparison of low and high dose on exercise endurance time in COPD patients intervention 2: Comparison of low and high dose on exercise endurance time in COPD patients intervention 3: Comparison of low and high dose and placebo on exercise endurance time in COPD patients intervention 4: Comparison of low and high dose on exercise endurance time in COPD patients intervention 5: Placebo that represents olodaterol

Protocol documents:
Clinical trial NCT01042938
Conditions: Breast Cancer
Keywords: Radiation dermatitis in breast cancer patients
Sponsor: University of Rochester
Start date: 2008-01-01; Completion date: 2011-04-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Ionizing radiation is a toxic agent and widely accepted form of treatment for various types of cancer. Despite advances in medical technology, radiation therapy still causes severe early and late skin effects. Radiation-induced dermatitis occurs in approximately 80% of patients. Important consequences of radiation-induced dermatitis include impairment of the quality of a patient's life due to pain and premature interruption of radiation treatment, which in turn, may be impair good local control of disease. The biological pathways responsible for acute radiation-induced dermatitis remain unclear. Currently, there is no standard treatment for the prevention of radiation-induced dermatitis with demonstrated effectiveness. The aim of this randomized, double-blind, placebo-controlled pilot study is to assess the effectiveness of curcumin for the prevention of acute radiation-induced dermatitis during postoperative radiotherapy for breast cancer. We hypothesize that curcumin, a natural phenolic compound found in both turmeric and curry powders, can prevent or alleviate radiation-induced skin reactions in breast cancer patients receiving radiotherapy.

Detailed description:
Specifically, this clinical pilot study will develop data necessary to calculate a sample size for a larger study to be conducted through the National Cancer Institute (NCI) Community Clinical Oncology Program (CCOP) mechanism. Specifically, this pilot project will investigate: 1) if curcumin can prevent or alleviate radiation-induced skin reactions in cancer patients receiving radiotherapy and 2) if skin pigmentation, as well as pain and psychophysiological factors, can predict the severity of radiation-induced dermatitis. Potential future research studies may be conducted to identify the biological mechanisms involved in radiation-induced dermatitis and the radioprotective function of curcumin.

Arms: arm 1: Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks). arm 2: Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks).
Interventions: intervention 1: Curcumin C3 Complex intervention 2: Placebo
Intervention descriptions: intervention 1: Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks) intervention 2: Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks)

Protocol documents:
Clinical trial NCT01058993
Conditions: Neutropenia
Keywords: neutropenia myelokathexis WHIM syndrome AMD 3100 plerixafor Myelokathexis syndrome Neutropenia due to mutations of CXCR-4
Sponsor: University of Washington
Start date: 2010-10-01; Completion date: 2011-04-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an initial study to determine if CXCR4 inhibitor AMD 3100 or plerixafor may be a potential treatment for neutropenia due to CXCR4 mutations, the myelokathexis or WHIM (warts, hypogammaglobulinemia, immunodeficiency and myelokathexis) syndrome. This is the initial study of this concept and will involve up to 6 patients to receive increasing doses of plerixafor administered subcutaneously or on an alternate day basis. It is unknown if these patients will be highly sensitive to a blockade of CXCR4 activity and release more white blood cells than normal volunteers or cancer patients given the same dose of this drug. Therefore doses will begin at a level 12 fold less than currently used to mobilize stem cells and will be increased stepwise to achieve an acceptable circulating level of neutrophils.

Detailed description:
This is an open label, single Center, phase I study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.

Arms: arm 1: SINGLE arm study with increasing doses of Plerixafor
Interventions: intervention 1: AMD3100 or plerixafor
Intervention descriptions: intervention 1: The study will examine the hematological effects/safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4. Plerixafor will be administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating doses of AMD 3100, 20 micrograms per kilogram (mcg/kg), 40 micrograms per kilogram (mcg/kg), 80 micrograms per kilogram (mcg/kg), and 240 micrograms per kilogram (mcg/kg) will be examined in the patients at University of Washington General Clinical Research Center for up to 10 days, requiring subjects be available up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If normal blood neutrophil count is achieved and maintained for at least 24 hours prior to highest dose, we will stop at that level.

Protocol documents:
Clinical trial NCT01077622
Conditions: Leukaemia, Lymphocytic, Chronic
Sponsor: GlaxoSmithKline
Start date: 2009-09-01; Completion date: 2011-04-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Ofatumumab is an IgG1κ fully human monoclonal antibody (mAb) that specifically recognizes an epitope on the human differentiation antigen CD20 molecule. In vitro and in vivo studies demonstrated that ofatumumab depletes CD20 positive (CD20+) B cells through complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC), which results in the antitumour effect.

This is an open-label study to evaluate safety, tolerability, efficacy and PK profile of ofatumumab monotherapy in chronic lymphocytic leukemia (CLL) patients. Ofatumumab will be administered intravenously at the first dose of 300mg followed by 7 weekly infusions of 2000mg, followed by 4 infusions of 2000mg at every 4 weeks.

Primary objective of the study (Part A) is to evaluate tolerability, and the study (Part B) is to assess overall response rate in CLL population.

10 subjects will be enrolled into this study. Subjects will be followed for 48 weeks.

Detailed description:
Ofatumumab is an IgG1κ fully human monoclonal antibody (mAb) that specifically recognizes an epitope on the human differentiation antigen CD20 molecule. In vitro and in vivo studies demonstrated that ofatumumab depletes CD20 positive (CD20+) B cells through complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC), which results in the antitumour effect.

This is an open-label study to evaluate safety, tolerability, efficacy and PK profile of ofatumumab monotherapy in chronic lymphocytic leukemia (CLL) patients. Ofatumumab will be administered intravenously at the first dose of 300mg followed by 7 weekly infusions of 2000mg, followed by 4 infusions of 2000mg at every 4 weeks.

Primary objective of the study (Part A) is to evaluate tolerability, and the study (Part B) is to assess overall response rate in CLL population.

10 subjects will be enrolled into this study. Subjects will be followed for 48 weeks.

Arms: arm 1: ofatumumab , 300mg followed by 7 weekly infusions 2000 mg, followed by 4 monthly infusions 2000mg
Interventions: intervention 1: ofatumumab 100 mg, 1000 mg / vial
Intervention descriptions: intervention 1: ofatumumab , 300mg followed by 7 weekly infusions 2000 mg, followed by 4 monthly infusions 2000mg

Protocol documents:
Clinical trial NCT01092546
Conditions: Normal Pressure Hydrocephalus
Keywords: Amyloid Normal pressure hydrocephalus (NPH) Positron Emission Tomography (PET) Standard uptake value ratios (SUVR)
Sponsor: GE Healthcare
Start date: 2010-03-01; Completion date: 2011-04-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the level of association between the quantitative estimates of brain uptake of \[18F\]flutemetamol and the quantitative immunohistochemical and histochemistry estimates of amyloid levels in frontal lobe biopsy samples obtained from subjects during shunt placement for NPH.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: [18F]Flutemetamol
Intervention descriptions: intervention 1: All subjects will receive an IV dose of \[18F\]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol will be 185 MBq.

Protocol documents: