ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00170573
Conditions: Ovarian Cancer
Keywords: Pegylated liposomal doxorubicin PPE Ovarian Cancer
Sponsor: North Eastern German Society of Gynaecological Oncology
Start date: 2001-09-01; Completion date: 2010-08-01
Enrollment: 77 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Effect of biweekly schedule of PLD on dose-limiting toxicity of PPE and patient's quality of life

Detailed description:
Pegylated liposomal doxorubicin (PLD) formulation has been approved for the treatment of recurrent ovarian cancer (ROC). Toxic skin reactions e.g. palmar-plantar erythrodysesthesia (PPE) were reported as being the dose-limiting toxicity and have an impact on patients' quality of life (QoL). The primary aim of this study was to optimise the toxicity profile by choosing a biweekly schedule of PLD Furthermore, QoL was investigated. Secondary objective of this study was to evaluate the response rates of this new regimen.

Arms: arm 1: 40 mg/m² biweekly
Interventions: intervention 1: Caelyx
Intervention descriptions: intervention 1: 40 mg/m² biweekly

Protocol documents:
Clinical trial NCT00218439
Conditions: Tobacco Use Disorder
Keywords: Smoking
Sponsor: University of Minnesota
Start date: 2005-10-01; Completion date: 2010-08-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Smokers report that they often smoke cigarettes during stressful times. The combined effect of smoking and exposure to stress leads to exaggerated increases in blood pressure, heart rate and other measures of stress response. This combination may result in greater cardiovascular harm than either smoking or stress alone. The purpose of this study is to determine the effects of paroxetine on the response to stress after smoking.

Detailed description:
Smokers report that they often smoke cigarettes during stressful times. Smoking and stress produce similar physiological responses such as increases in heart rate, blood pressure, and adrenaline levels. The combination of smoking and stress results in greater increases in these physiological responses compared to smoking or stress alone. Such increases are thought to be harmful to cardiovascular health. Additionally, smokers with exaggerated responses to stress may be more likely to relapse following a smoking cessation attempt. The purpose of this study is to assess the effects of paroxetine, a selective serotonin reuptake inhibitor (SSRI), on the cardiovascular response to stress after smoking.

Participants in this double-blind, placebo-controlled study will receive 1 month of paroxetine and 1 month of placebo with the order of which is taken during the first month randomly assigned. Paroxetine will be administered at a daily dose of 10 mg for the first week and increased to a daily dose of 20 mg for the remainder of the study. After one month of medication, participants will abstain from smoking for one night and then undergo mental stress testing the following day. Immediately prior to the mental stress testing, participants will smoke a cigarette. Mental stressors will include speaking and math tasks. Physiological measures of stress (e.g., blood pressure, heart rate, and plasma catecholamine concentrations) and subjective measures of stress will be evaluated. Following the second month of medication, participants will again undergo the procedure for mental stress testing and evaluation.

Arms: arm 1: Active medication for 4 weeks followed by placebo for 4 weeks arm 2: Placebo for 4 weeks followed by active for 4 weeks
Interventions: intervention 1: Paroxetine intervention 2: Placebo
Intervention descriptions: intervention 1: 10 mg for 1 week followed by 20 mg for 3 weeks intervention 2: None

Protocol documents:
Clinical trial NCT00236899
Conditions: Metastatic Breast Cancer (MBC)
Sponsor: Eli Lilly and Company
Start date: 2005-09-01; Completion date: 2010-08-01
Enrollment: 241 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate time to progression disease (PD).

Detailed description:

Arms: arm 1: Docetaxel and Gemcitabine (Tri-weekly) arm 2: Paclitaxel and Gemcitabine (Tri-weekly) arm 3: Docetaxel and Gemcitabine (Weekly) arm 4: Paclitaxel and Gemcitabine (Weekly)
Interventions: intervention 1: Gemcitabine intervention 2: Docetaxel intervention 3: Paclitaxel
Intervention descriptions: intervention 1: Arm A: 1000 mg/m², 30 minute (min) intravenous (IV) infusion on Days 1 and 8, repeated every 21 days for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).

Arm B: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Arm C: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Arm D: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. intervention 2: Arm A: 75 milligram per square meter (mg/m²), 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Arm C: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15, to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. intervention 3: Arm B: 175 mg/m², IV infusion over approximately 3 hours, followed by Gemcitabine, on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Arm D: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Protocol documents:
Clinical trial NCT00238108
Conditions: Sleep Disorders Hypertension
Keywords: Sleep disorders High blood pressure
Sponsor: Brigham and Women's Hospital
Start date: 2005-10-01; Completion date: 2010-08-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effectiveness of treatment with melatonin supplements in improving sleep in individuals with high blood pressure who are taking beta-blockers.

Detailed description:
Hypertension, or high blood pressure, is a condition in which an individual's blood pressure is higher than the normal level. It is estimated that one in three individuals in the United States has high blood pressure, though many do not know it because there are usually no symptoms. Uncontrolled hypertension may lead to stroke, heart attack, heart failure, or kidney failure. Beta-blockers are one class of drugs that have been developed to help lower blood pressure, and thereby decrease the risk for these serious problems. Beta-blockers also lower the levels of melatonin, a hormone that has a sleep-promoting effect. Many individuals who take beta-blockers for hypertension complain that they have trouble sleeping, which may be related to the beta-blockers' effect on melatonin levels. This study will evaluate the effectiveness of treatment with melatonin supplements in improving sleep in individuals with high blood pressure who are taking beta-blockers. In addition, the study will examine whether the melatonin supplements aid in lowering blood pressure.

Participants in this double-blind study will be randomly assigned to receive either melatonin supplements or placebo for the duration of the study. Participants will take part in two inpatient phases. Each inpatient stay will last 4 days and will be separated by 3 to 4 weeks. While in the clinic, participants' sleep patterns and core temperature will be recorded and plasma, saliva, and urine samples will be collected. Blood pressure will be measured before and after each inpatient stay, as well as at points during the stay. Throughout the study, participants' activity will be monitored by an accelerometer worn around the wrist.

Arms: arm 1: Melatonin (2,5 mg, by mouth, 1 per day, for 3-4 weeks) arm 2: Placebo
Interventions: intervention 1: Melatonin intervention 2: Placebo
Intervention descriptions: intervention 1: 2,5 mg melatonin, by mouth, 1 per day, for 3-4 weeks intervention 2: Placebo

Protocol documents:
Clinical trial NCT00268762
Conditions: Ischemic Stroke
Keywords: stroke thrombin inhibition thrombolysis bleeding outcome
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2003-02-01; Completion date: 2010-08-01
Enrollment: 65 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Is the combination of low doses of argatroban in combination with rt-PA safe, and does it increase recanalization in patients with acute ischemic stroke.

Detailed description:
All patients with acute ischemic stroke who qualify for IV rt-PA under accepted guidelines, and who have an occluded middle cerebral artery documented on TCD, receive standard dose IV rt-PA and a bolus and 48 hour infusion of argatroban aimed at prolonging the aPTT 1.75 X baseline. Follow up CT scanning and TCD every 30 minutes for 2 hours and then daily will determine the incidence of hemorrhage, recanalization and reocclusion, and serial neurological exam will determine the clinical outcome. For patients without temporal windows, a baseline CT-Angiogram (CTA) demonstrating arterial occlusion can also be enrolled. In those patients, a follow-up CTA (24-36 hours) will be performed.

Arms: arm 1: Argatroban IV Infusion 1 mcg/kg/min for 48 hours
Interventions: intervention 1: argatroban
Intervention descriptions: intervention 1: Argatroban IV Infusion at 1mcg/kg/min for 48 hours.

Protocol documents:
Clinical trial NCT00291499
Conditions: Osteoarthrosis
Keywords: symptomatic OA of the hand
Sponsor: IBSA Institut Biochimique SA
Start date: 2005-06-01; Completion date: 2010-08-01
Enrollment: 163 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of the present study is to investigate the effectiveness of Condrosulf® 800 mg tablets vs. placebo once a day for 6 months in the symptomatic treatment of finger joint osteoarthritis.

Primary endpoints of the study are the evaluation of global spontaneous pain (Huskisson's Visual Analogue Scale: VAS) and the score of Dreiser's algo-functional index (FIHOA) during the treatment with the tested product, Condrosulf®, versus placebo.

Detailed description:
The goal of the present study is to investigate the effectiveness of Condrosulf® 800 mg tablets vs. placebo once a day for 6 months in the symptomatic treatment of finger joint osteoarthritis in 160 randomised patients.

Primary endpoints:

Primary endpoints of the study are the evaluation of global spontaneous pain (Huskisson's Visual Analogue Scale: VAS) and the score of Dreiser's algo-functional index (FIHOA) during the treatment with the tested product, Condrosulf®, versus placebo.

Secondary endpoints are:

Efficacy evaluation: Global impression of efficacy expressed by the patient and the physician (VAS), Grip strength (measured manometrically); Morning stiffness duration; Consumption of Paracetamol; Tolerability (4-point verbal scale); Adverse Events occurring during the treatment period; Other parameters:Treatment compliance; Biological markers of arthritis

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Chondroitin 4&6 sulfate (Condrosulf) intervention 2: Placebo
Intervention descriptions: intervention 1: 800 mg/day for 6 months intervention 2: 800 mg placebo/day for 6 months

Protocol documents:
Clinical trial NCT00295503
Conditions: Mesothelioma
Keywords: mesothelioma bevacizumab chemotherapy
Sponsor: University of Texas Southwestern Medical Center
Start date: 2006-02-01; Completion date: 2010-08-01
Enrollment: 53 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To estimate the time to progression of cancer in patients with previously untreated mesothelioma receiving cisplatin, pemetrexed and bevacizumab

Detailed description:
Secondary endpoints will include:

objective response rate

overall survival

In addition, the objective of the analysis of the correlative science data is to determine any association between tumor expression of VEGF/KDR complex and/or the presence of sv40 (as detected by PCR amplification) and objective response.

Arms: arm 1: cisplatin, pemetrexed, and bevacizumab
Interventions: intervention 1: bevacizumab intervention 2: cisplatin intervention 3: pemetrexed
Intervention descriptions: intervention 1: 15 mg/kg IV every 3 weeks intervention 2: 75 mg/m2 IV every 3 weeks intervention 3: 500 mg/m2 every 3 weeks

Protocol documents:
Clinical trial NCT00300365
Conditions: Metabolic Syndrome
Keywords: HDL cholesterol Metabolic syndrome
Sponsor: University of Pennsylvania
Start date: 2005-11-01; Completion date: 2010-08-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We will test our primary hypothesis that combining niacin extended release (niacin-ER), at a daily dosage of up to 2.0 g with pioglitazone, at a daily dosage of 45 mg will result in a 12% greater increase in HDL-C when compared to niacin-ER monotherapy over 12 weeks in non-diabetic patients with the metabolic syndrome (see Table 1).

Detailed description:
This is a two-arm, parallel, double-blind randomized prospective clinical trial. The subjects will be asked to provide informed consent, and then undergo screening for enrollment criteria at the first visit (-5 weeks). The subjects who are eligible, and provide informed consent will return for Visit 2 baseline data (-4 weeks), and then begin the unblinded niacin-ER titration. Specifically, subjects will receive a starting dose of niacin-ER of 500 mg per day, which will be increased in 500 mg increments every week up to a dose of 2000 mg per day. Subjects will need to tolerate at least 1500 mg per day of niacin-ER in order to remain in the study and be randomized. Thus subjects who are unable to tolerate the 2000 mg daily dose of niacin-ER will be taken back to 1500 mg per day for one week and then randomized. Subjects who develop prohibitive side effects at doses less than 1500 mg per day will be discontinued from the study. All subjects who are able to take the target dose of niacin-ER will continue that dose of niacin-ER and come to the General Clinical Research Center (GCRC) to be randomized in a 1:1 fashion to either niacin-ER plus pioglitazone or niacin-ER plus matching placebo for 12 weeks. Pioglitazone will be started at 30 mg and then increased to 45 mg at week 6. This entry design is designed to minimize the differences in mean dose of niacin-ER and dropout rate between study groups.

Arms: arm 1: Intervention: Pioglitazone, initially 30mg, then titrated to 45mg + niacin ER 2.0 g/day + aspirin 325 mg/day arm 2: Intervention: Pioglitazone Placebo + 2.0 g/day Open-Label Niacin + 325 mg/day Aspirin
Interventions: intervention 1: Pioglitazone intervention 2: Placebo intervention 3: Niacin ER intervention 4: Aspirin
Intervention descriptions: intervention 1: Pioglitazone, initially 30 mg, then titrated to 45 mg/day intervention 2: Pioglitazone placebo intervention 3: Niacin ER 2.0 g/day intervention 4: asprin 325 mg/day

Protocol documents:
Clinical trial NCT00303953
Conditions: Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma
Sponsor: National Cancer Institute (NCI)
Start date: 2006-01-01; Completion date: 2010-08-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well PXD101 works in treating patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. Evaluate response rate in patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma treated with PXD101.

SECONDARY OBJECTIVES:

I. Determine the toxicity of this drug in these patients. II. Estimate the 6-month progression-free survival rate in patients treated with this drug.

TERTIARY OBJECTIVES:

I. Determine the major histocompatability complex of class II proteins (HLA-DR, -DP, -DQ), TUNEL, and CD8 infiltration status, by immunochemistry on paired pre- and post-treatment tumor samples, in the first 20 patients enrolled.

II. Measure CIITA and HLA-DR mRNA expression using quantitative reverse transcriptase-polymerase chain reaction and determine, preliminarily, the associations of these markers with progression-free survival.

III. Evaluate paired pre- and post-treatment peripheral blood mononuclear cells from patients for histone acetylation status and determine correlation with findings from duplicate experiments on pre- and post-needle core biopsies.

OUTLINE: This is a multicenter study.

Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Needle core biopsies and peripheral blood mononuclear cells are obtained from the first 20 patients pre- and post-treatment for biomarker correlative studies.

After completion of study treatment, patients are followed every 3-6 months for up to 3 years.

Arms: arm 1: Patients will receive an infusion of PXD101 once a day for 5 days. Treatment may repeat every 3 weeks for up to 2 years. Some patients will also undergo core biopsy and blood collection for laboratory studies before and after treatment.

After finishing treatment, patients will be evaluated every 3-6 months for up to 3 years.
Interventions: intervention 1: belinostat
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00325234
Conditions: Breast Cancer
Sponsor: Eli Lilly and Company
Start date: 2006-06-01; Completion date: 2010-08-01
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to help answer the following research questions:

* whether the chemotherapy combination therapy Pemetrexed-Carboplatin or Gemcitabine-Vinorelbine can help participants with advanced breast cancer to make the tumor smaller or disappear and for how long
* to learn more about the side effects in each chemotherapy combination treatment arm
* to assess how participants with advanced breast cancer report health changes while receiving any of the chemotherapy combination arm

Detailed description:

Arms: arm 1: Pemetrexed 600 mg/m\^2 was administered intravenously over approximately 10 minutes on Day 1.

Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC (Area under the plasma drug concentration versus time curve) 5.0 mg\*min/mL. The cycle of treatment was 21 days. arm 2: Vinorelbine 30 mg/m\^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m\^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
Interventions: intervention 1: Pemetrexed intervention 2: Carboplatin intervention 3: Gemcitabine intervention 4: Vinorelbine
Intervention descriptions: intervention 1: 600 mg/m\^2, administered intravenously (IV) every 21 days until disease progression or unacceptable toxicity. intervention 2: AUC 5 mg\*min/mL, administered IV every 21 days until disease progression or unacceptable toxicity. intervention 3: 1200 mg/m\^2 gemcitabine, administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity. intervention 4: 30 mg/m\^2 vinorelbine administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00326885
Conditions: Malignant Ascites
Keywords: Ascites Epithelial Cancer Epithelial Carcinoma Epithelial Ovarian Cancer Epithelial Ovarian Carcinoma Fallopian Tube Cancer Fallopian Tube Carcinoma Malignant Ascites Ovarian Cancer Ovarian Carcinoma Ovarian Epithelial Cancer Ovarian Epithelial Carcinoma Peritoneal Cancer Peritoneal Carcinoma Recurrent Ascites Recurrent Malignant Ascites Recurrent Symptomatic Malignant Ascites Symptomatic Malignant Ascites Symptomatic Ascites Neoplasms, Glandular and Epithelial Ovarian Neoplasms Fallopian Tube Neoplasms Peritoneal Neoplasms
Sponsor: Neovii Biotech
Start date: 2006-06-01; Completion date: 2010-08-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether the investigational drug catumaxomab is a safe and effective treatment for recurrent symptomatic malignant ascites.

Detailed description:
A multi-center, phase II study of catumaxomab in ovarian cancer patients with recurrent symptomatic malignant ascites requiring therapeutic paracentesis. Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 3-4 days. Each patient will participate in this study for up to 7 months (includes the baseline therapeutic paracentesis and screening period, 11 to 21 days treatment period, and up to 180 days/6 months follow-up), with monthly post-study follow-up for the lifetime of the patient.

Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells (DCs) and natural killer (NK) cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.

Arms: arm 1: None
Interventions: intervention 1: catumaxomab
Intervention descriptions: intervention 1: Catumaxomab is administered intraperitoneally via an indwelling catheter (or port) as a 3-hour infusion 4 times (Days 0, 3, 7, and 10) in ascending doses (10 mcg, 20 mcg, 50 mcg, and 150 mcg, respectively).

Protocol documents: