ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00420849
Conditions: Multiple Myeloma
Sponsor: Celgene Corporation
Start date: 2006-11-01; Completion date: 2009-11-01
Enrollment: 587 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-centre, single-arm treatment study combining lenalidomide plus high dose dexamethasone.

Subjects who qualify for participation will receive lenalidomide plus high dose dexamethasone in 4 week cycles. Subjects will be seen every 2 weeks for the first 3 cycles of therapy and then every 4 weeks after the third cycle until disease progression is documented, study drug is discontinued for any reason or lenalidomide becomes commercially available for this indication. Assessments of safety and quality of life are performed during the study.

Detailed description:

Arms: arm 1: Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
Interventions: intervention 1: Lenalidomide intervention 2: Dexamethasone
Intervention descriptions: intervention 1: Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression, drug became commercially available or limited to 6 treatment cycles. intervention 2: Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycle for cycles 1 through 4. Beginning cycle 5, a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.

Protocol documents:
Clinical trial NCT00581555
Conditions: Psoriasis
Keywords: Psoriasis
Sponsor: Pfizer
Start date: 2007-10-01; Completion date: 2009-11-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the use of etanercept as a replacement therapy for ciclosporin in patients with plaque psoriasis.

Detailed description:
The purpose of this study is to evaluate the efficacy and safety of etanercept as a replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who have achieved an adequate response with ciclosporin.

Arms: arm 1: Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin. arm 2: Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
Interventions: intervention 1: Etanercept intervention 2: Placebo
Intervention descriptions: intervention 1: Etanercept 50 mg QW initiated during taper of ciclosporin intervention 2: Randomized to placebo during taper of ciclosporin

Protocol documents:
Clinical trial NCT00619619
Conditions: Depression Major Depressive Disorder
Keywords: MDD Child Adolescent Pharmacokinetic Outpatient Pediatrics Depressive Disorder Major
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2008-02-01; Completion date: 2009-11-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to test the safety and tolerability of single ascending doses of Desvenlafaxine Succinate Sustained-Release (DVS SR) in both child and adolescent outpatients with major depressive disorder. This study will also characterize the pharmacokinetic profile of DVS SR in children and adolescents with major depressive disorder.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
Intervention descriptions: intervention 1: DVS SR Tablets of 10mg, 25mg, 50mg, and 100mg. Assigned DVS SR daily doses of 10mg, 25mg, 50mg, 100mg, or 200mg for up to 8 weeks.

Protocol documents:
Clinical trial NCT00754559
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2008-08-01; Completion date: 2009-11-01
Enrollment: 286 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the effectiveness of tocilizumab in combination with traditional DMARDs with regard to the clinical improvement in disease activity (achievement of LDAS) after 24 weeks' treatment in patients with active rheumatoid arthritis (RA) who have had an inadequate response to current traditional DMARD and/or anti-TNF therapy. Patients will receive tocilizumab 8mg/kg iv every 4 weeks, in addition to ongoing DMARDs at the stable pre-entry dose prescribed by the physician, for a total of 6 infusions during the regular treatment period and a further 6 infusions during an optional extension phase. The anticipated time on study treatment is 6 to 12 months, and the target sample size is \<500 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Tocilizumab
Intervention descriptions: intervention 1: 8mg/kg iv every 4 weeks

Protocol documents:
Clinical trial NCT00824291
Conditions: Depressive Disorder, Major
Keywords: Major Depressive Disorder
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2009-02-01; Completion date: 2009-11-01
Enrollment: 437 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: desvenlafaxine succinate sustained release intervention 2: Genotyping
Intervention descriptions: intervention 1: 50 mg/day oral tablet for 12 weeks intervention 2: CYP2D6 genotyping at randomization

Protocol documents:
Clinical trial NCT00891462
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease
Sponsor: AstraZeneca
Start date: 2009-04-01; Completion date: 2009-11-01
Enrollment: 561 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period, 12-week double-blind treatment, and 2-week follow-up phone visit.

Detailed description:

Arms: arm 1: Aclidinium bromide dose, inhaled, for 12 weeks of treatment arm 2: Aclidinium bromide dose, inhaled, for 12 weeks of treatment arm 3: Inhaled placebo for 12 weeks
Interventions: intervention 1: Aclidinium bromide intervention 2: Aclidinium bromide intervention 3: Placebo
Intervention descriptions: intervention 1: Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment intervention 2: Aclidinium bromide 400 μg, oral inhalation twice per day for 12 weeks of treatment intervention 3: Dose-matched placebo, oral inhalation twice per day for 12 weeks of treatment

Protocol documents:
Clinical trial NCT00086190
Conditions: Parkinson Disease Depression
Keywords: Parkinson disease depression Parkinson's disease paroxetine venlafaxine antidepressant
Sponsor: University of Rochester
Start date: 2005-06-01; Completion date: 2009-11-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out if two antidepressant medications, paroxetine and venlafaxine, can help control depression in Parkinson's disease, and if these medications affect the motor symptoms of Parkinson's disease such as tremor, stiffness, slowness, and balance.

Detailed description:
Nearly 50 percent of individuals with Parkinson's disease (PD) suffer from depression-a condition that causes disability and can reduce quality of life. The University of Rochester Medical Center is conducting a research study of antidepressant medications to find out more about how to treat depression in PD. Antidepressant medications have not been adequately studied in persons with PD.

The purpose of this study is to find out if the antidepressant medications paroxetine and venlafaxine can help control depression in PD and whether or not these medications affect the motor symptoms of PD such as tremor, stiffness, slowness, and balance.

This is a randomized, double blind, placebo-controlled, 12-week study of paroxetine immediate release (Paxil) and venlafaxine extended release (Effexor XR). Paroxetine and venlafaxine XR are drugs that have been approved by the Food and Drug Administration (FDA) and are available by prescription. Paroxetine and venlafaxine XR have been shown to be effective in treating depression in the general population. Two hundred, twenty-eight persons will be enrolled among 15 medical centers throughout the United States and Canada. Each person will participate in the trial for 12 weeks. Each participant will be randomly assigned to take either paroxetine or venlafaxine, or a placebo.

Arms: arm 1: Paroxetine and venlafaxine will be compared to placebo over 12 weeks. arm 2: Paroxetine and venlafaxine will be compared to placebo over 12 weeks. arm 3: Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
Interventions: intervention 1: paroxetine intervention 2: venlafaxine intervention 3: placebo
Intervention descriptions: intervention 1: Paroxetine 10 mg tablets or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the paroxetine or matching placebo will be increased to 20 mg, followed by a 10 mg increase every two weeks (if tolerated). Dosage for this study will not exceed 40 mg. intervention 2: Venlafaxine XR 37.5 mg capsules or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the venlafaxine XR capsules or matching placebo will be increased to 75 mg followed by 75 mg increments every 2 weeks (if tolerated). Dosage for this study will not exceed 225 mg. intervention 3: an inactive substance

Protocol documents:
Clinical trial NCT00116857
Conditions: Cardiovascular Diseases Depression Heart Diseases Myocardial Infarction Angina, Unstable
Sponsor: Washington University School of Medicine
Start date: 2005-02-01; Completion date: 2009-11-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the effects of omega-3 fatty acid (FA) augmentation of sertraline on depression and cardiac endpoints after myocardial infarction (MI).

Detailed description:
BACKGROUND:

Depression is a risk factor for morbidity and mortality following an acute MI and unstable angina. Two recent studies (sertraline versus placebo and sertraline plus cognitive therapy versus usual care) reported only modest reductions in depression following an acute MI or unstable angina, and many treated patients remained depressed. Neither study reported better medical outcomes in the treated patients. Earlier studies found that even subclinical depression increases the risk of mortality in cardiac patients. Thus, more effective treatments are needed to eliminate depression and improve medical outcomes in patients following an acute MI or unstable angina. Omega-3 FAs have been shown to augment the efficacy of antidepressants for major depression and to improve several cardiac risk factors. However, these findings have been shown in separate lines of research. No previous study has investigated whether omega-3 FAs can simultaneously improve depression and reduce cardiovascular risk factors in post-MI patients.

DESIGN NARRATIVE:

One hundred fifty patients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for a current major depressive episode and who score 15 or higher on the Beck Depression Inventory II with a history of acute MI, unstable angina, or other cardiac event will be enrolled in a randomized, double-blind, placebo-controlled trial of omega-3 augmentation of sertraline. The participants will be randomly assigned to receive either sertraline plus omega-3 or sertraline plus placebo for 10 weeks. At baseline and again after ten weeks, the subjects will complete the following: 1) assessments of depression and psychosocial functioning; 2) 24-hour electrocardiogram monitoring for heart rate variability analysis; and 3) blood draws to measure procoagulant and proinflammatory markers, and plasma levels of sertraline and omega-3. If this study shows that omega-3 reduces depression and improves cardiovascular disease markers, there will be a basis for proposing a larger clinical trial to determine whether it can also improve survival after hospitalization for acute MI or unstable angina.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sertraline/omega-3 intervention 2: Sertraline/Corn Oil
Intervention descriptions: intervention 1: Sertraline (50 mgs) plus omega-3 (2 grams) intervention 2: Sertraline (50 mgs) plus corn oil (2 grams) (placebo)

Protocol documents:
Clinical trial NCT00117286
Conditions: Prostate Cancer
Keywords: Prostate Cancer Androgen ablation therapy
Sponsor: Ferring Pharmaceuticals
Start date: 2005-03-01; Completion date: 2009-11-01
Enrollment: 57 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was an extension study for the study FE200486 CS14 (NCT00116779). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.

The study was terminated when all ongoing participants had been treated for at least 5 years.

Detailed description:
Participants who completed the main FE200486 CS14 study initially continued with the same dose in the FE200486 CS14A extension study. A protocol amendment changed the dosage to 160 mg (40 mg/mL) for all study participants.

The data include data from the participants who participated in both the main study (FE200486 CS14; NCT00116779) and the extension study FE200486 CS14A.

Arms: arm 1: Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants. arm 2: Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Interventions: intervention 1: Degarelix
Intervention descriptions: intervention 1: Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.

Protocol documents:
Clinical trial NCT00178464
Conditions: Sickle Cell Disease
Keywords: sickle cell disease hemoglobin SS disease hemoglobin S Beta-0 Thalassemia silent infarction in sickle cell disease overt stroke in sickle cell disease aspirin transcranial Doppler ultrasound neurocognitive testing
Sponsor: University of Rochester
Start date: 2005-03-01; Completion date: 2009-11-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Neurologic complications secondary to cerebrovascular damage are prevalent in children with sickle cell disease. These patients experience both clinically overt cerebrovascular accidents and "silent infarctions" demonstrated by magnetic resonance imaging (MRI). They are also at risk for neurocognitive abnormalities.We hypothesize that daily, low-dose aspirin therapy will safely diminish the incidence and progression of cognitive deficits as well as the predisposition to overt and silent stroke in children with homozygous sickle cell disease (Hgb SS) or hemoglobin S Beta Zero Thalassemia (Hgb SB-0 Thal). In order to optimize the design of a future trial to test this hypothesis, we propose a pilot study to test the safety and tolerability of aspirin in young children with sickle cell disease.

Detailed description:
The trial's primary objective is to evaluate the safety and tolerability of daily low-dose aspirin in children with sickle cell disease. The secondary objectives are to assess (1) The feasibility of recruiting children with Hgb SS and Hgb S Beta-0 Thalassemia to an aspirin trial, (2) The level of compliance with aspirin administration in the proposed patient population, (3) The most useful assessments in a battery of age-appropriate neurocognitive tests, (4) The feasibility of magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) studies and the utility of classification systems for use in group comparisons, (5) Preliminary data regarding trends in transcranial Doppler (TCD) ultrasound velocities over time and the validity of using trends for group comparisons, (6) Preliminary data regarding the effect of aspirin therapy on the incidence of cognitive deficit, imaging changes, overt stroke, painful crises, and acute chest syndrome. Subjects will include children between the ages of 2 and 7.99 years with documented Hgb SS or Hgb S Beta-0 Thalassemia who are followed at Golisano Children's Hospital at Strong and the University of Miami. All subjects will receive daily aspirin (about 2.5 - 5.1 mg/kg daily). Subjects will receive therapy for 12 months. There will be careful laboratory and clinical monitoring every 3-6 months and more frequently if needed. Pre and post treatment clinical complications, neurocognitive testing, MRI, MRA, and TCD studies will be assessed.

Arms: arm 1: One-arm study
Interventions: intervention 1: aspirin
Intervention descriptions: intervention 1: 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.

Protocol documents:
Clinical trial NCT00191854
Conditions: Breast Cancer
Sponsor: Eli Lilly and Company
Start date: 2005-03-01; Completion date: 2009-11-01
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The gemcitabine-paclitaxel and gemcitabine-platinum combinations have shown promise in the treatments of MBC; however, the optimal dosing schedules for these combinations have not yet been determined. The primary objective of this study is to compare the response rates of the gemcitabine-paclitaxel, gemcitabine-carboplatin, and gemcitabine-cisplatin combinations when administered on a biweekly schedule in metastatic breast cancer.

Detailed description:

Arms: arm 1: gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.

paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles. arm 2: gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.

carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles. arm 3: gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.

cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles
Interventions: intervention 1: gemcitabine intervention 2: paclitaxel intervention 3: carboplatin intervention 4: cisplatin
Intervention descriptions: intervention 1: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles intervention 2: 150 mg/m2, IV, every 14 days x 8 cycles intervention 3: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles intervention 4: 50 mg/m2, IV, every 14 days x 8 cycles

Protocol documents:
Clinical trial NCT00192036
Conditions: Non Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2004-08-01; Completion date: 2009-11-01
Enrollment: 49 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the response rate of patients with non small lung cancer to gemcitabine in combination with radiotherapy. The tolerability and safety of this combination will also be evaluated.

Detailed description:

Arms: arm 1: Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).

Cisplatin: 80 mg/m2, IV, every 21 days x 5 cycles.

Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5.
Interventions: intervention 1: gemcitabine intervention 2: cisplatin intervention 3: radiation
Intervention descriptions: intervention 1: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5) intervention 2: 80 mg/m2, IV, every 21 days x 5 cycles intervention 3: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5

Protocol documents:
Clinical trial NCT00193037
Conditions: Breast Cancer
Keywords: Breast Cancer
Sponsor: SCRI Development Innovations, LLC
Start date: 2001-02-01; Completion date: 2009-11-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients, with subsequent crossover to the opposite arm at disease progression or patient intolerance. We will explore this as well as any possible cross resistance between these two agents.

Detailed description:
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:

* Liposomal Doxorubicin
* Docetaxel

For ever 2 patients treated, 1 will receive treatment A (Liposomal Doxorubicin) and 1 will receive treatment B (Docetaxel). Patients demonstrating progression on either ARM will be eligible for cross over to treatment in the other ARM, provided patient still meets the eligibility laboratory and performance status criteria. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Arms: arm 1: Liposomal doxorubicin 40 mg/m2 by 1 hour IV infusion repeated every 28 days. arm 2: Weekly docetaxel 36 mg/m2 by 30 minute IV infusion on days 1, 8, and 15 of the 28 day cycle
Interventions: intervention 1: Liposomal Doxorubicin intervention 2: Docetaxel
Intervention descriptions: intervention 1: Liposomal Doxorubicin intervention 2: Docetaxel

Protocol documents: