ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00118755
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2005-07-01; Completion date: 2009-04-01
Enrollment: 435 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xeloda 850 mg/m\^2 orally twice a day (po bid) on Days 1-14, oxaliplatin 130 mg/m\^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each 3-week cycle; or 2) Xeloda 1500 mg/m\^2 po bid on Days 1-7, oxaliplatin 85 mg/m\^2 IV on Day 1 and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: capecitabine intervention 2: Oxaliplatin intervention 3: bevacizumab intervention 4: capecitabine intervention 5: Oxaliplatin intervention 6: bevacizumab
Intervention descriptions: intervention 1: 850 mg/m\^2 po bid on Days 1-14 of each 3-week cycle intervention 2: 130 mg/m\^2 IV on Day 1 of each 3-week cycle intervention 3: 7.5 mg/kg IV on Day 1 of each 3-week cycle intervention 4: 1500 mg/m\^2 po bid on Days 1-7 of each 2-week cycle intervention 5: 85 mg/m\^2 IV on Day 1 of each 2-week cycle intervention 6: 5 mg/kg IV on Day 1 of each 2-week cycle

Protocol documents:
Clinical trial NCT00131508
Conditions: Anemia, Sickle Cell
Keywords: Hemoglobin S Disease Sickle Cell Anemia
Sponsor: St. Jude Children's Research Hospital
Start date: 2004-05-01; Completion date: 2009-04-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Children with sickle cell anemia (SCA) seem to have higher energy needs than children who do not have the disease. This may be the reason why children and teenagers with sickle cell anemia tend to be smaller, weigh less, and have less fat and muscle than children and teens that do not have the disease.

This study is being done to find out if giving a supplement called glutamine will help children with sickle cell anemia by lowering their energy needs and improving their growth and strength. Children will be randomly assigned (like a flip of a coin) to one of two groups. One group will take glutamine and one group will take a placebo (a protein mixture that looks like glutamine but may not have the same effect in the body). No one will know which group is taking which supplement until the study has been completed. Children will be in the study for 12 months.

Detailed description:
1. The study will compare the effect of glutamine and placebo on resting energy expenditure (REE) in children with sickle cell anemia (SCA) by comparing the change in REE ratio between baseline and 12 months.
2. The study investigates the effect of oral glutamine and placebo on body composition in children with SCA by comparing the difference in body mass indexes (BMIs) and percent of body fat (DEXA Scan) between baseline and 12 months of treatment in the two groups.
3. This Study will investigate the effect of oral glutamine and placebo on growth in children with SCA by comparing the Z scores for one year before baseline to 1 year while on study.
4. This study will investigate the effect of oral glutamine and placebo in children with SCA by comparing the difference in the levels of plasma and red blood cell glutamine between baseline and 12 months of treatment in the two groups.
5. This study will investigate the clinical effects (strength and exercise endurance) of oral glutamine and placebo in children with SCA by comparing the difference between baseline and 12 months of treatment in the two groups.
6. This study will evaluate quality of life in children with SCA who have glutamine or placebo for 12 months.
7. This study will evaluate the changes in REE over time in a small group of patients that will have REE measurement at months 3, 6, and 9. This objective will be offered to all patients, but will be "additional studies" that are not required to participate in the protocol.

Arms: arm 1: Glutamine arm 2: None
Interventions: intervention 1: Glutamine intervention 2: Placebo
Intervention descriptions: intervention 1: 0.6 gm/kg of oral glutamine per day, in two doses for one year. intervention 2: Placebo

Protocol documents:
Clinical trial NCT00150345
Conditions: Possible Fungal Infection
Keywords: Neutropenia Fever of unknown origin Empirical treatment Voriconazole
Sponsor: Pfizer
Start date: 2005-01-01; Completion date: 2009-04-01
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A well-known side-effect of cytostatics (drugs against malignancies) is a decrease in the number of white blood cells, especially of the so-called neutrophil granulocytes, which are very important for the defense against infections. Hence their decrease (called "neutropenia") leads to a predisposition to infections.

Since infections during neutropenia can be very dangerous, the patients are treated with antibiotics from the very first signs of such an infection (usually fever). If the antibiotics (drugs against bacteria) do not lead to a normalization of the body temperature within four days, a drug against fungi is added.

In the IDEA study, one half of the patients receive the antifungal drug voriconazole (as usual) only in case the antibiotics alone do not lead to a normalization of the body temperature (current standard of care). The other half of the patients receive voriconazole immediately after onset of fever (concomitantly with the antibiotics).

The research question is, whether in the "early-treatment" group fewer manifest fungal infections will be observed than in the "late-treatment" group.

Detailed description:

Arms: arm 1: Voriconazole starts within 18 hours of onset of fever intravenously with a loading dose of 6 mg/kg q12h for the first two doses followed by 4 mg/kg q12h (maintenance dose). Switched to oral treatment (200 mg BID) is possible after at least four days. Treatment will be ended if the patient is afebrile (\< 38.0 °C) for 7 days with neutrophil counts \< 500/µL, or if the patient is afebrile (\< 38.0 °C) for 2 days with neutrophil counts \> 500/µL. arm 2: Treatment with voriconazole (for dosage see "early treatment arm") is initiated only if a patient is persistently febrile on day 5 after the onset of fever despite antibiotic treatment.
Interventions: intervention 1: voriconazole (Vfend) intervention 2: voriconazole (Vfend)
Intervention descriptions: intervention 1: voriconazole, early treatment intervention 2: voriconazole, deferred treatment

Protocol documents:
Clinical trial NCT00174252
Conditions: Fetal Growth Retardation
Sponsor: Pfizer
Start date: 2005-02-01; Completion date: 2009-04-01
Enrollment: 57 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To estimate the percentage of children with serum IGF-1 \> 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Genotonorm (Somatropin)
Intervention descriptions: intervention 1: 0.40 mg/kg/week dived in 7 daily subcutaneous injections during 2 years

Protocol documents:
Clinical trial NCT00181883
Conditions: Bipolar Disorder Mania
Keywords: children bipolar disorder quetiapine preschoolers
Sponsor: Massachusetts General Hospital
Start date: 2005-02-01; Completion date: 2009-04-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of Quetiapine, in the treatment of preschool children aged 4 to 6 years with bipolar and bipolar spectrum disorder. This is an exploratory, pilot study, seeking to determine whether Quetiapine is efficacious and well tolerated in the treatment of preschoolers with pediatric bipolar and bipolar spectrum disorder in this age group. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.

Detailed description:
Seroquel is a psychotropic agent that affects multiple neurotransmitter receptors in the brain: serotonin 5HT1A and 5HT2, dopamine D1 and D2, histamine H1 (IC50=30nM), and adrenergic receptors.

This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of Quetiapine, in the treatment of preschool children aged 4 to 6 years with bipolar and bipolar spectrum disorder. This is an exploratory, pilot study, seeking to determine whether Quetiapine is efficacious and well tolerated in the treatment of preschoolers with pediatric bipolar and bipolar spectrum disorder in this age group. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.

Arms: arm 1: 2.5 - 5.0mg/kg PO BID quetiapine

Other Names:

Seroquel
Interventions: intervention 1: quetiapine
Intervention descriptions: intervention 1: 2.5 - 5.0mg/kg PO BID quetiapine

Protocol documents:
Clinical trial NCT00224289
Conditions: Glaucoma
Keywords: Latanoprost Glaucoma Intraocular pressure
Sponsor: Yale University
Start date: 2005-03-01; Completion date: 2009-04-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Latanoprost is a commonly used treatment for glaucoma. Because of its mechanism of action, it is plausible that the age of a patient using the medication may affect its efficacy and time of onset.

We are going to study the effectiveness of Latanoprost in people of different ages, to see if it changes based on the age of the patient.

Detailed description:
Latanoprost is a topical ocular hypotensive medication with a well established safety and efficacy profile. Its effect is mediated by an increase in uveoscleral outflow, due to enzymatic degradation of the extracellular matrix within the ciliary muscle. Since the amount of extracellular matrix within the human eye increases with age, and uveoscleral outflow decreases with age, it would be expected that there should be a difference in the efficacy of latanoprost in patients of different ages. This has not been demonstrated in studies assessing the overall effect of latanoprost across adult age groups using multivariate analysis. (Camras CB et al, 1996).

However, a difference in timing of onset of drug effect may get overlooked in clinical studies and in clinical practice as well, as patients tend to be seen from two to eight weeks after initiation of treatment, by which time any differences in response time may have already occurred and leveled off.

To our knowledge, there are no studies specifically looking at the timing of onset of drug effect of latanoprost in different age groups. Because of the theoretical plausibility of this effect based on the mechanism of action of latanoprost, this represents an opportunity to further elucidate the characteristics of this medication in a manner which has clinical and scientific relevance.

Our aim is thus to determine if there is a difference in timing of onset of the ocular hypotensive effect of latanoprost in glaucoma patients of different age groups.

Arms: arm 1: All participants will be taking Latanoprost; This study compares efficacy within age groups.
Interventions: intervention 1: Latanoprost 0.005%
Intervention descriptions: intervention 1: Latanoprost 0.005% ophthalmic solution QHS 8 weeks

Protocol documents:
Clinical trial NCT00226655
Conditions: Brain Edema Brain Tumor
Keywords: peritumoral brain edema edema malignant brain tumor astrocytoma brain tumor dexamethasone Decadron
Sponsor: Celtic Pharma Development Services
Start date: 2005-07-01; Completion date: 2009-04-01
Enrollment: 112 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone (Decadron) to treat peritumoral brain edema. This open-label, extended-use study is open to all patients who participate in either of the blinded studies, NTI 0302, NTI 0303, or other designated studies, including patients who may have discontinued blinded study medication early but completed the protocol-stipulated follow-up periods.

Detailed description:
XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.

Arms: arm 1: All patients will receive hCRF (XERECEPT) 2mg/day
Interventions: intervention 1: hCRF [XERECEPT (corticorelin acetate injection)]
Intervention descriptions: intervention 1: 2mg/day

Protocol documents:
Clinical trial NCT00257556
Conditions: Infertility
Sponsor: Ferring Pharmaceuticals
Start date: 2005-10-01; Completion date: 2009-04-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Prospective open label, randomised, parallel group, comparative pilot.

Detailed description:
Ongoing pregnancy rate, defined as positive fetal heart action 9 weeks after the first positive pregnancy test. Number/diameter of follicles, number of oocytes retrieved, number of pronuclear oocytes (referred to as zygotes or pre-embryos in the UK), quality of pronuclear stage oocytes, number of embryos transferred, quality of embryos, number of frozen embryos, endometrial thickness and morphology on day of HCG administration, estradiol levels at day of HCG administration, implantation rate, number of days stimulated with gonadotrophins and number of ampoules used, clinical pregnancy rate at 6 weeks after the first positive pregnancy test, pregnancy outcome.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Menotrophin intervention 2: Follitropin alfa
Intervention descriptions: intervention 1: 150 IU Menotrophin daily subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily. intervention 2: 150 IU follitropin alfa daily by subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.

Protocol documents:
Clinical trial NCT00269113
Conditions: Non-Hodgkin's Lymphoma
Sponsor: Hoffmann-La Roche
Start date: 1998-09-01; Completion date: 2009-04-01
Enrollment: 360 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the efficacy and safety of the standard chemotherapy of the East German Study Group for Hematology and Oncology versus standard chemotherapy plus MabThera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-Hodgkin's and mantle cell lymphoma. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: Standard chemotherapy
Intervention descriptions: intervention 1: 375mg/m2 iv monthly for 8 cycles intervention 2: As prescribed

Protocol documents:
Clinical trial NCT00280748
Conditions: Lung Cancer Metastatic Cancer
Keywords: recurrent non-small cell lung cancer stage IV non-small cell lung cancer tumors metastatic to brain
Sponsor: UNC Lineberger Comprehensive Cancer Center
Start date: 2005-05-01; Completion date: 2009-04-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with pemetrexed may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving whole-brain radiation therapy together with pemetrexed works in treating patients with brain metastases from non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Estimate the response in patients with intracranial brain metastases from non-small cell lung cancer treated with whole-brain radiotherapy and pemetrexed disodium.

Secondary

* Determine the toxicity of this regimen in these patients.
* Estimate the overall survival of patients treated with this regimen.
* Evaluate the functional status of patients treated with this regimen.
* Assess neurological function and progression in patients treated with this regimen.
* Determine the response of patients with extracranial disease treated with pemetrexed disodium.

OUTLINE: Patients undergo whole-brain radiotherapy 5 days a week for 3 weeks beginning on day 1. Patients also receive pemetrexed disodium IV on day 1, 2, or 3 and day 28 of course 1, and on day 1 of each subsequent course. Treatment with pemetrexed disodium repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 30 days and then every 2 months for 2 years.

Arms: arm 1: Single Arm Study
Interventions: intervention 1: pemetrexed disodium intervention 2: radiation therapy
Intervention descriptions: intervention 1: 500 mg/m2 once every 21 days up to 126 days intervention 2: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy

Protocol documents:
Clinical trial NCT00285012
Conditions: Smoking Cessation
Keywords: smoking cessation smoking cessation in COPD
Sponsor: Pfizer
Start date: 2006-05-01; Completion date: 2009-04-01
Enrollment: 504 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to be conducted in subjects with mild-to-moderate COPD who are cigarette smokers with the intent of demonstrating differences in smoking cessation between varenicline and placebo.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: placebo intervention 2: Varenicline Tartarate
Intervention descriptions: intervention 1: 1mg (placebo) by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days) intervention 2: 1 mg by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days)

Protocol documents:
Clinical trial NCT00299000
Conditions: Mucopolysaccharidosis VI Maroteaux-Lamy Syndrome
Sponsor: BioMarin Pharmaceutical
Start date: 2006-05-01; Completion date: 2009-04-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the safety and efficacy of two dose levels of Naglazyme in infants under the age of one year who have MPS VI by monitoring physical appearance, x-ray of the skeletal system and growth.

Detailed description:
The primary objective of the study was to evaluate the efficacy of two dose levels of Naglazyme in preventing the progression of skeletal dysplasia in infants under the age of one year who have MPS VI by monitoring physical appearance, x-ray of the skeletal system and growth.

The secondary objective of the study was to evaluate the efficacy of the two dose levels of Naglazyme in preventing several measures of disease progression in infants under the age of one year who have MPS VI by monitoring urinary GAGs, gross and fine motor function, cardiac function, vision, hearing, and use of health resources.

The safety objective of the study was to evaluate the safety of two dose levels of Naglazyme in infants under the age of one year who have MPS VI.

Arms: arm 1: Dose comparison arm 2: Dose Comparison
Interventions: intervention 1: Naglazyme
Intervention descriptions: intervention 1: Weekly infusion for minimum of 52 weeks. Naglazyme is diluted in sterile 0.9% sodium chloride solution

Protocol documents:
Clinical trial NCT00304746
Conditions: Depressive Disorder, Major
Sponsor: Mclean Hospital
Start date: 2006-04-01; Completion date: 2009-04-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We hypothesize that AndroGel may offer some relief to subjects with low or borderline testosterone levels who suffer from depression and have failed to respond to a trial of a standard antidepressant.

During this nine week, outpatient, double-blind study, male subjects between the ages of 30 and 65 years with treatment-refractory depression and low or borderline low testosterone levels will be treated with either AndroGel or placebo. Following this nine week, double-blind phase, eligible subjects will have the option to continue into a six month, open-label phase during which time all subjects will receive the AndroGel patch.

Detailed description:
We will recruit 100 men between the ages of 30 and 65 years who have treatment-refractory depression and low or borderline low testosterone levels for participation in this study. For a period of nine weeks subjects will receive double-blind treatment with either AndroGel (testosterone gel) or placebo. During this double-blind treatment phase subjects will come to McLean Hospital for a total of seven visits. Both clinical assessments (including ratings of your levels of depression and anxiety, quality of life, and visuospatial memory)and laboratory tests will be performed at these visits. Following the nine week, double-blind phase, eligible subjects may enter into a six month, open-label treatment phase in which all subject receive AndroGel. If you participate in the open-label phase, you will be asked to return to the site for 8 visits during the six month period.

Arms: arm 1: AndroGel (1% testosterone transdermal gel), 2.5 g to 10 g daily arm 2: Placebo gel
Interventions: intervention 1: Testosterone gel intervention 2: Placebo
Intervention descriptions: intervention 1: AndroGel 2.5g and 5g sachets at doses ranging from 10g/day for duration of trial. intervention 2: Placebo

Protocol documents:
Clinical trial NCT00319111
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension bosentan BENEFIT CTEPH inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
Sponsor: Actelion
Start date: 2006-01-01; Completion date: 2009-04-01
Enrollment: 151 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.

Detailed description:

Arms: arm 1: Open label bosentan treatment
Interventions: intervention 1: bosentan
Intervention descriptions: intervention 1: Oral bosentan

* Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients
* Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight \< 40 kg)

Protocol documents:
Clinical trial NCT00320411
Conditions: Neoplasms, Breast
Keywords: Stage IV breast cancer Herceptin metastatic breast cancer ErbB1 ErbB2 trastuzumab lapatinib
Sponsor: GlaxoSmithKline
Start date: 2005-11-28; Completion date: 2009-04-01
Enrollment: 62 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study (EGF104911) is designed to evaluate the efficacy and safety of lapatinib in patients with advanced or metastatic breast cancer. Eligible subjects must have ErbB2 overexpressing tumors and are refractory to treatment with anthracycline, taxanes and trastuzumab containing regimens. The study data obtained from EGF104911 will be combined with the data from EGF100642 and integrated analysis will be carried out in order to enhance the credibility of the study results.

Detailed description:

Arms: arm 1: Lapatinib 1500mg QD
Interventions: intervention 1: lapatinib
Intervention descriptions: intervention 1: Lapatinib 1500mg QD

Protocol documents: