ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00136318
Conditions: Depression
Keywords: Pegasys-Induced depression
Sponsor: Charite University, Berlin, Germany
Start date: 2004-01-01; Completion date: 2008-09-01
Enrollment: 208 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary end points

* incidence of depression defined as a Montgomery Asberg Depression Scale Score (MADRS) of 13 or higher during antiviral therapy (up to 48 weeks, depending on genotype)
* effect of an antidepressive pre-treatment over two weeks and a continuously concomitant treatment with Escitalopram (S-citalopram) on frequency and severity of depression in patients with chronic hepatitis C (HCV) treated with Peg-interferon alfa-2a (PEGASYS) and ribavirin, measured by the Montgomery Asberg Depression Scale

Secondary end points

* time to depression defined as a MADRS score of 13 or higher
* incidence of major depression defined by Diagnostic and Statistical Manual IV (DSM-IV) criteria
* severe depression according to MADRS scale (score 25 or higher)
* Health related quality of life (HRQOL) measured by the Short Form 36 (SF-36)
* sustained virologic response
* tolerability
* safety
* changes/group differences in other psychiatric depression scales (Hamilton Depression Rating Scale, Beck Depression Inventory)

Other investigations:

* cognitive function, anxiety (word fluency test, trail making test part A and B, othe scales)
* Predictive parameters for patients especially gaining from an antidepressive therapy (e.g. age, gender, weight, height, alanine aminotransferase (ALAT) quotient defined as median ALAT values before treatment divided by the upper standard value, HCV-RNA serum concentration level of fibrosis in liver histology, baseline values of the different psychometric scales)
* alanine aminotransferase (ALAT), aspartate transaminase (ASAT), thyrotrophin (TSH)
* biomarkers (genetic parameters, cytokines,...)

Detailed description:

Arms: arm 1: After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram. arm 2: After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.
Interventions: intervention 1: Escitalopram intervention 2: Placebo intervention 3: Peginterferon alfa-2a intervention 4: Ribavirin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Patients with HCV genotype 1 or 4 received treatment for 48 weeks with PEGinterferon-alfa2a, 180 mcg weekly. Patients with genotype 2 or 3 received PEGinterferon-alfa2a, 180 mcg weekly. intervention 4: Patients with HCV genotype 1 or 4 received treatment for 48 weeks with ribavirin, 1000 mg per day (body weight 75 kg) or 1200 mg per day (body weight, 75 kg). Patients with HCV genotype 2 or 3 received ribavirin, 800 mg per day for 24 weeks.

Protocol documents:
Clinical trial NCT00153920
Conditions: Multiple Myeloma
Keywords: multiple myeloma Velcade bortezomib
Sponsor: Dana-Farber Cancer Institute
Start date: 2003-12-01; Completion date: 2008-09-01
Enrollment: 66 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Bortezomib (Velcade) has just recently been approved by the FDA for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. This study will determine if Velcade is effective in treating patients with multiple myeloma that have had no prior treatment for the disease. We will also use whole-genome scanning to identify drug response biomarkers in bone marrow samples as well as nerve fiber studies to compare nerves prior to the use of Velcade and after treatment with Velcade.

Detailed description:
Primary Objective

• To evaluate the objective response rate (CR + PR) to bortezomib alone in patients with newly diagnosed multiple myeloma.

Secondary Objectives

* To evaluate the tolerability and toxicity.
* To evaluate time to progression.
* To assess the frequency and severity of peripheral neuropathy.
* To evaluate the impact of early intervention with dose modification and explore symptomatic treatment of peripheral neuropathy.

Exploratory Objectives

• To perform pharmacogenomic analysis of molecular markers associated with response or non-response.

Statistical Design A one stage design is used to evaluate ORR. With 60 evaluable participants, if at least 27 objective responses are observed then bortezomib will be considered promising. The probability of concluding the treatment promising is \>0.95 with a true ORR of 55% and \<0.07 with a true ORR of 35%.

Arms: arm 1: Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
Interventions: intervention 1: bortezomib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00154310
Conditions: Renal Transplantation
Keywords: Renal transplantation, everolimus, immunosuppressants, CNI-free
Sponsor: Novartis
Start date: 2005-06-01; Completion date: 2008-09-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and well-tolerated as the standard regimen containing enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion, but results in better renal function.

Detailed description:

Arms: arm 1: Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant. arm 2: Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
Interventions: intervention 1: Everolimus intervention 2: Cyclosporine intervention 3: Enteric-coated mycophenolate sodium intervention 4: Corticosteroids
Intervention descriptions: intervention 1: Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL. intervention 2: Tablets orally twice a day to maintain protocol specific target blood levels intervention 3: Enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. intervention 4: Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.

Protocol documents:
Clinical trial NCT00171834
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: EPO EPO906 Brain metastasis Lung cancer Lung metastasis NSCLC
Sponsor: Novartis Pharmaceuticals
Start date: 2003-08-01; Completion date: 2008-09-01
Enrollment: 89 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study objective is to evaluate the maximum tolerated dose, safety and efficacy of patupilone in patients with NSCLC who have progressed after prior chemotherapy.

Detailed description:

Interventions: intervention 1: Patupilone
Intervention descriptions: intervention 1: Patupilone (2.5 mg/mL) was supplied as a clear, colorless concentrate for solution for infusion in glass vials containing 5 mg/2 mL in Phase I and 10 mg/4 mL in Phase II part of the study. Patupilone was administered as a single intravenous (i.v.) infusion over 5 to 10 minutes (Amendment 1) till Amendment 2 and over 10 to 20 minutes (Amendment 2) till the completion of Phase I part of the study. Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks in Phase II part of the study.

Protocol documents:
Clinical trial NCT00184548
Conditions: Acquired Bleeding Disorder Trauma
Sponsor: Novo Nordisk A/S
Start date: 2005-10-01; Completion date: 2008-09-01
Enrollment: 554 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely injured trauma patients by assessing mortality and morbidity.

Please note that this trial and trial F7TRAUMA-1648 (NCT00323570) have been merged.

Detailed description:
The decision to discontinue the F7TRAUMA-1711 trial is not due to any safety concerns. The result of the pre-planned futility analysis performed in June 2008 predicted a very low likelihood of reaching a successful outcome on the primary efficacy endpoint at the end of the trial and as a consequence, the company has decided to close the trial as this juncture.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: eptacog alfa (activated) intervention 2: placebo
Intervention descriptions: intervention 1: Sterile, freeze-dried powder in single-use vials to be reconstituted with sterile water for injection.

Three doses of 200, 100 and 100 mcg/kg to be administered bolus i.v. (intravenous) over approx. three hours. intervention 2: placebo

Protocol documents:
Clinical trial NCT00211536
Conditions: Type 1 Diabetes
Keywords: Diabetes Implantable Insulin Pump Intraperitoneal Insulin Delivery
Sponsor: Medtronic Diabetes
Start date: 2002-06-01; Completion date: 2008-09-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effectiveness of insulin delivered in the peritoneum (abdomen)by an implantable pump in Type 1 diabetics.

Detailed description:
Implantable insulin delivery pumps have been shown to reduce the occurrence of severe hypoglycemia in Type 1 DM subjects, as demonstrated in numerous European studies. Glycemic control is difficult to attain in subjects using exogenous insulin due to the risk of severe hypoglycemia. This study is aimed at comparing the efficacy of intraperitoneal (IP) insulin therapy to intensive subcutaneous insulin therapy over a period of 12 months.

Arms: arm 1: The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin. arm 2: The control group will remain on their current pre-study subcutaneous insulin therapy of either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used, or be required to change or modify their current diabetes therapy for the purpose of the study.
Interventions: intervention 1: Medtronic MiniMed Implantable Pump Human Recombinant Insulin intervention 2: Medtronic MiniMed Implantable Pump System intervention 3: Aventis HOE21PH U400
Intervention descriptions: intervention 1: 400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements. intervention 2: The implantable pump system is intended to provide continuous intraperitoneal delivery of insulin in subjects with diabetes. intervention 3: 400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.

Protocol documents:
Clinical trial NCT00224016
Conditions: Detrusor Hyperreflexia
Sponsor: Watson Pharmaceuticals
Start date: 2004-12-01; Completion date: 2008-09-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition (e.g. spina bifida) that contributes to their overactive bladder.

Detailed description:
This study will use a multicenter, randomized, open-label, active-controlled, dose-titration, parallel group design, in approximately pediatric patients with detrusor overactivity associated with a neurological condition.

Arms: arm 1: Oxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day arm 2: 5 to 15 mg/day immediate release or extended release tablets, or syrup
Interventions: intervention 1: Oxybutynin intervention 2: Oxybutynin
Intervention descriptions: intervention 1: 1.3, 2.6, 3.9 mg/day transdermal intervention 2: 5 to 15 mg/day immediate release or extended release tablets, or syrup

Protocol documents:
Clinical trial NCT00230971
Conditions: Appendicitis Cholecystitis Diverticulitis Intra-Abdominal Abscess Intra-Abdominal Infection Peritonitis
Keywords: Intra-Abdominal Infections Abscess
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2005-10-01; Completion date: 2008-09-01
Enrollment: 473 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: tigecycline intervention 2: ceftriaxone plus metronidazole
Intervention descriptions: intervention 1: every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours) intervention 2: Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.

Protocol documents:
Clinical trial NCT00233103
Conditions: Depression
Keywords: Sertraline TBI depression SSRI brain injury
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2003-06-01; Completion date: 2008-09-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized clinical trial of sertraline vs. placebo for post-TBI depression

Detailed description:
Purpose: The purpose of this study is to document the efficacy of sertraline (Zoloft) in the treatment of depression (major depressive disorder) after TBI, including the impact on quality of life. Researchers will also explore the effects of sertraline on anxiety disorders, which often accompany post-TBI depression.

Background: Major depression is experienced by many more people after TBI than prior to injury and more often than in people without a brain injury. Many studies have also shown that this higher than 'normal' incidence looms for many years post TBI. Major depression is associated with a variety of negative outcomes, including poorer functioning in basic activities, reduced employment, elevated divorce rate, reduced social and recreational activity and increased sexual dysfunction.

Need for Research: Of the current drug treatments for major depression, sertraline and similar drugs (known as selective serotonin reuptake inhibitors, or selective serotonin reuptake inhibitor (SSRIs)) have few side effects in people who have experienced a brain injury and have been shown to be effective in people with no known brain injury. However, information on the impact of SSRIs on post-TBI depression, based on randomized, double-blind studies, is unavailable.

Current Research Activity: Approximately 50 men and women volunteers who are post TBI and currently diagnosed with major depressive disorder are being randomly assigned to a 12-week period of taking Zoloft or a placebo. Over the period of study, participants will have the severity of their depressive symptoms assessed (as well as their symptoms of anxiety); a simple measure of the volunteer's perceived quality of life will be implemented prior to the study and at its termination. It is hypothesized that sertraline will reduce the symptoms of depression and anxiety and will increase the person's perceived quality of life to a significantly greater extent than will the placebo.

Arms: arm 1: Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg). arm 2: Placebo for 10 weeks.
Interventions: intervention 1: Sertraline intervention 2: Placebo
Intervention descriptions: intervention 1: Sertraline arm intervention 2: Placebo

Protocol documents:
Clinical trial NCT00245518
Conditions: Hot Flashes
Keywords: prostate cancer soy androgen deprivation quality of life isoflavones
Sponsor: Johns Hopkins University
Start date: 2005-06-01; Completion date: 2008-09-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are being treated with testosterone suppression therapy. Hypothesis: Treating men who have prostate CA with daily Revival will result in at least a 50% reduction in hot flashes compared to placebo.

Detailed description:
This research study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are undergoing (ADT) androgen deprivation therapy. Participants will be given either placebo or Revival. Participants will be asked to take their supplement once/day for 14 weeks.Blood will be drawn to check on liver, kidney, thyroid, cholesterol,and prostate health. Urine will be collected to check on bone markers. Patients will be asked to complete questionnaires to test memory, attention span, and vocabulary.Possible benefits may include increase in memory, decrease in hot flashes, and a general increase in quality of life.

Arms: arm 1: Isoflavone arm 2: None
Interventions: intervention 1: Isoflavone intervention 2: Placebos
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00254462
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD Atomoxetine
Sponsor: University of Nebraska
Start date: 2005-10-01; Completion date: 2008-09-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of attention deficit hyperactivity disorder (ADHD) in young children.

Detailed description:
Attention deficit hyperactivity disorder (ADHD) is one of the most common mental disorders in children. Children with ADHD often have impaired functioning in home and school and usually experience difficulty relating to peers. If left untreated, the disorder can have long-term adverse effects into adolescence and adulthood. Atomoxetine is a selective noradrenergic reuptake inhibitor that is FDA-approved for the treatment of ADHD in children, adolescents, and adults. Unlike most other medications for ADHD, atomoxetine is not a stimulant. Studies have shown that atomoxetine is effective in treating ADHD, but more information is needed on its effectiveness in young children. This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of ADHD in young children.

Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. In addition, all children will receive parent training for the duration of the study. For the first 5 weeks, participants will report to the study site weekly for assessments of ADHD symptoms. Study visits will occur every other week for the remainder of the study.

Arms: arm 1: atomoxetine capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks arm 2: matching placebo capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks
Interventions: intervention 1: Atomoxetine intervention 2: Placebo intervention 3: Parent Training
Intervention descriptions: intervention 1: Participants will receive atomoxetine for 8 weeks up to a maximum of 1.8 mg/kg/day. Dosed once daily in capsule formulation. intervention 2: Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation. intervention 3: All children will receive parent training for the duration of the study.

Protocol documents:
Clinical trial NCT00264849
Conditions: Asthma
Keywords: Asthma omalizumab Severe persistent allergic asthma
Sponsor: Novartis
Start date: 2005-11-01; Completion date: 2008-09-01
Enrollment: 406 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.

Detailed description:

Arms: arm 1: During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level. arm 2: During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for 32 weeks.
Interventions: intervention 1: Omalizumab intervention 2: Optimized asthma therapy
Intervention descriptions: intervention 1: Omalizumab administered by subcutaneous injection. The dosage received was individualized based on body weight and serum IgE level. intervention 2: Optimized asthma therapy (OAT) according to Global Initiative for Asthma (GINA) 2004 guidelines during the first 4 weeks of the run-in period of the study.

Protocol documents: