ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00213239
Conditions: Hematologic Diseases Neoplasms
Keywords: spinal puncture remifentanil propofol anesthesia dose finding pediatrics
Sponsor: The Hospital for Sick Children
Start date: 2005-09-01; Completion date: 2008-01-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine whether the combination of two anaesthetic medications, propofol and remifentanil, is suitable for short duration surgical procedures, providing a shorter recovery time and fewer side effects than either drug used alone.

Detailed description:
Propofol is the primary medication used by anesthesiologists at HSC to provide sedation for lumbar puncture. Propofol provides amnesia, anxiolysis, and hypnosis, but because propofol has no analgestic properties patients often respond to the pain of LP needle insertion. To ensure patient immobility, the dose of propofol is often increased, resulting in a duration of action that is excessive for lumbar puncture. Remifentanil is an ultra-short acting opioid which can be used to provide analgesia and sedation for short painful procedures with minimal residual pain. However, when used as the sole agent, remifentanil is associated with a high incidence of respiratory depression and/or arterial oxygen desaturation and does not provide amnesia or anxiolysis. The combination of propofol and remifentanil may be particularly suitable for short duration procedures, providing a shorter recovery time and fewer side effects than either drug used alone.

The objective is to determine the minimum effective dose of remifentanil required to prevent movement for insertion of a lumbar puncture needle when co-administered with propofol. The results obtained from this study will be used in a future study of the recovery characteristics of propofol and remifentanil in children undergoing lumbar puncture.

Arms: arm 1: First patient in this arm will receive a bolus of propofol 4 mg/kg followed by remifentanil 0.5 mcg/kg. Subsequent patients randomized to this arm will receive propofol 4 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient) arm 2: First patient in this arm will receive a bolus of propofol 2 mg/kg followed by remifentanil 1 mcg/kg. Subsequent patients randomized to this arm will receive propofol 2 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient)
Interventions: intervention 1: Remifentanil intervention 2: Remifentanil
Intervention descriptions: intervention 1: The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method. intervention 2: The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.

Protocol documents:
Clinical trial NCT00214019
Conditions: Allergic Asthma
Sponsor: University of Wisconsin, Madison
Start date: 2003-11-01; Completion date: 2008-01-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is designed to test the hypothesis that salmeterol use, and not fluticasone use or the combination treatment with fluticasone and salmeterol, is associated with a greater number of sputum eosinophils following antigen challenge and, under these circumstances, the migrating peripheral blood eosinophils are less adherent.

Detailed description:
An antigen challenge is when a participant inhales either cat, ragweed, or dust dander in increasing concentrations until their lung function drops 15 or 20 percent.

Arms: arm 1: Placebo comparator arm 2: Salmeterol Diskus 50 mcg twice per day arm 3: placebo diskus, fluticasone MDI 88 mcg twice per day arm 4: Salmeterol diskus 50 mcg BID, fluticasone MDI 88 mcg twice per day
Interventions: intervention 1: salmeterol intervention 2: Fluticasone intervention 3: Placebo
Intervention descriptions: intervention 1: salmeterol diskus 50 mcg twice per day intervention 2: placebo diskus, fluticasone MDI 88 mcg twice per day intervention 3: placebo diskus

Protocol documents:
Clinical trial NCT00220636
Conditions: Depressive Disorder, Major
Keywords: Major Depression Depression Unipolar Depression Treatment Resistant Depression Adjunctive treatment
Sponsor: St. Luke's-Roosevelt Hospital Center
Start date: 2005-03-01; Completion date: 2008-01-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI) antidepressant treatment for depressed outpatients who are not responding fully to SSRI treatment alone. It is hypothesized that patients' functioning will improve after 12 weeks of treatment with Aripiprazole and SSRI medication.

Detailed description:
This is a pilot study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI) antidepressant treatment for depressed outpatients who are not responding fully to SSRI treatment alone. Fifteen subjects will be given aripiprazole in a flexible dosing schedule and followed for 12 weeks, while continuing their ongoing SSRI medication. Assessments of depressive symptoms, overall functioning, social functioning, and side effects will be completed. It is hypothesized that patients' functioning will improve after 12 weeks of treatment with Aripiprazole and SSRI medication.

Arms: arm 1: Aripiprazole 5 to 30 mg/day
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: Aripiprazole dose ranging from 5 to 30 mg/day, augmenting antidepressant treatment. Aripiprazole is used as an augmenting medication on an open label basis for patients on antidepressant medication who continue to have depressive symptoms. This is an open label case series in which all subjects receive aripiprazole augmentation. There is no comparator group.

Protocol documents:
Clinical trial NCT00222131
Conditions: Indigestion
Keywords: Epigastric Pain Non-Ulcer Dyspepsia (NUD)
Sponsor: University of Kansas Medical Center
Start date: 2003-10-01; Completion date: 2008-01-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Inhibition of gastric acid is the key to satisfactory relief of symptoms with esomeprazole in NUD patients

Detailed description:
Enrolled patients will undergo 24h gastric pH monitoring and subsequently (if gastric pH drops below pH 4 during 24h monitoring) will be randomized to receive placebo (40 mg QD) or esomeprazole (40 mg QD) for 16 weeks of therapy. 24h gastric pH monitoring will be repeated 2nd and 3rd time in all participating patients at the end of 4th and 8th weeks of therapy. Additionally, in all participants NUD symptoms will be re-assessed at the end of 4th, 8th, 12th and 16th weeks of therapy.

Arms: arm 1: Placebo arm 2: Esomeprazole
Interventions: intervention 1: Esomeprazole intervention 2: Placebo
Intervention descriptions: intervention 1: Esomeprazole 40 mg QD intervention 2: Placebo

Protocol documents:
Clinical trial NCT00225732
Conditions: Pain
Sponsor: Cumberland Pharmaceuticals
Start date: 2005-01-01; Completion date: 2008-01-01
Enrollment: 319 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult patients every 6 hours for 48 hours is to determine the efficacy of Caldolor compared to placebo for the treatment of post-operative pain as measured by reduction in the requirement for the narcotic analgesic, morphine, post surgery

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Normal saline as placebo comparator intervention 2: Intravenous ibuprofen
Intervention descriptions: intervention 1: 250 ml normal saline as a placebo comparator was administered every 6 hours for a total of eight doses over the first 48 hours. Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5) intervention 2: 800 mg intravenous ibuprofen diluted in 250 milliliters of normal saline was administered every 6 hours for a total of eight doses over the first 48 hours.

Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5)

Protocol documents:
Clinical trial NCT00232596
Conditions: Seizures
Keywords: Partial Seizures Anticonvulsant Complex Partial Seizures Potassium Channels Epilepsy
Sponsor: GlaxoSmithKline
Start date: 2005-09-01; Completion date: 2008-01-01
Enrollment: 306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).

Detailed description:
This Phase 3 study is being conducted in North America, Argentina, and Brazil to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs). The primary objective is to demonstrate a superior change in total partial seizure frequency for four weeks from baseline to the double-blind period. The proportion of responders (greater than or equal to 50% reduction in total partial seizure frequency for four weeks from baseline to the double-blind period) will also be evaluated.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Retigabine intervention 2: Placebo
Intervention descriptions: intervention 1: Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 7, patients will enter a 12 week maintenance phase intervention 2: Oral tablet.

Protocol documents:
Clinical trial NCT00235989
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Relapsing multiple sclerosis interferon beta 1b Betaferon Betaseron
Sponsor: Bayer
Start date: 2003-06-01; Completion date: 2008-01-01
Enrollment: 63 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if a higher dose of study drug is more effective in preventing relapses in patients with Multiple Sclerosis.

Detailed description:
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Arms: arm 1: Extension Treatment 250 mcg continued arm 2: Extension Treatment 500 mcg reduced to 250 mcg arm 3: Extension Treatment 500 mcg continued arm 4: Extension Treatment 250 mcg increased to 500 mcg
Interventions: intervention 1: Interferon beta 1b (Betaseron, BAY86-5046) intervention 2: Interferon beta 1b (Betaseron, BAY86-5046) intervention 3: Interferon beta 1b (Betaseron, BAY86-5046) intervention 4: Interferon beta 1b (Betaseron, BAY86-5046)
Intervention descriptions: intervention 1: 250 mcg administered s.c.(subcutaneous) every other day intervention 2: 250 mcg administered s.c. every other day (for patients having received 500 mcg before) intervention 3: 500 mcg administered s.c. every other day intervention 4: 500 mcg administered s.c. every other day (for patients having received 250 mcg before)

Protocol documents:
Clinical trial NCT00242580
Conditions: Macular Degeneration Choroidal Neovascularization
Keywords: AMD age-related macular degeneration choroidal neovascularization
Sponsor: Novartis Pharmaceuticals
Start date: 2005-09-01; Completion date: 2008-01-01
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and efficacy of the combination treatments in wet age-related macular degeneration. The combination treatment consists of verteporfin photodynamic therapy and either triamcinolone acetonide or pegaptanib added as an intravitreal injection.

Detailed description:

Arms: arm 1: Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy. arm 2: Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy. arm 3: Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
Interventions: intervention 1: Verteporfin photodynamic therapy intervention 2: Pegaptanib intervention 3: Triamcinolone acetonide
Intervention descriptions: intervention 1: After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, verteporfin was activated by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of infusion. intervention 2: Pegaptanib sodium 0.3 mg administered by intravitreal injection. intervention 3: Triamcinolone acetonide administered by intravitreal injection.

Protocol documents:
Clinical trial NCT00265109
Conditions: Body Dysmorphic Disorder
Keywords: body dysmorphic disorder levetiracetam
Sponsor: Butler Hospital
Start date: 2004-12-01; Completion date: 2008-01-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the usefulness of a medication (Levetiracetam) for people with body dysmorphic disorder.

Detailed description:
Body dysmorphic disorder (BDD), a perceived defect in appearance (e.g., a "large" nose or facial "scarring"), is a relatively common disorder that causes marked distress and impairment in functioning. Recent data suggests that adults with BDD may respond to serotonin reuptake inhibitors (SRIs); however, response to SRIs is often only partial. About one third of patients do not respond to an SRI. Furthermore, patients may stop taking SRIs because of side effects (e.g., sexual side effects). For these reasons, additional monotherapy and SRI augmentation strategies are greatly needed.

Levetiracetam is primarily used as an antiseizure medication and has a wider safety margin than other antiepileptics. Preliminary scientific studies may suggest that it may be helpful for certain psychiatric symptoms and disorders. In the present study we propose to obtain pilot data on 1) levetiracetam monotherapy and 2) levetiracetam augmentation of SRIs in patients with BDD.

Arms: arm 1: Open-label trial; all participants received levetiracetam
Interventions: intervention 1: Levetiracetam
Intervention descriptions: intervention 1: The initial levetiracetam dose will be 250 mg/day, which will be increased to 250 mg BID after 1 week. The dose will then be increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose will be raised more slowly or the maximum dose will not be reached if response occurs at a lower dose or side effects are problematic. Subjects who are unable to tolerate at least 500 mg a day of levetiracetam will be withdrawn from the study.

Protocol documents:
Clinical trial NCT00265343
Conditions: Schizophrenia
Sponsor: Organon and Co
Start date: 2005-12-01; Completion date: 2008-01-01
Enrollment: 306 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an extension study to further test

the efficacy and safety of asenapine compared with a

marketed agent (olanzapine) in the treatment of patients with

persistent negative symptoms of schizophrenia.

Detailed description:

Arms: arm 1: asenapine arm 2: olanzapine
Interventions: intervention 1: asenapine intervention 2: olanzapine
Intervention descriptions: intervention 1: 5-10 mg sublingually twice daily for 26 weeks intervention 2: 5-20 mg by mouth once daily for 26 weeks

Protocol documents:
Clinical trial NCT00267150
Conditions: Pancreas Transplantation Kidney Transplantation
Keywords: Simultaneous Pancreas-Kidney Transplantation mycophenolate GI problems
Sponsor: Novartis Pharmaceuticals
Start date: 2005-11-01; Completion date: 2008-01-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life outcomes and determine the proportion of pancreas-kidney transplant recipients who experience any GI complaints under MMF-based immunosuppressive treatment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Enteric-coated mycophenolate sodium (EC-MPS)
Intervention descriptions: intervention 1: Experimental

Protocol documents:
Clinical trial NCT00275821
Conditions: Age Related Macular Degeneration
Keywords: Age-related macular degeneration, ranibizumab
Sponsor: Novartis
Start date: 2005-12-01; Completion date: 2008-01-01
Enrollment: 353 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will test if the efficacy and safety of an alternative dosing regimen is as effective as monthly injections.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Ranibizumab 0.3 mg - 3 times monthly, then quarterly intervention 2: Ranibizumab 0.5 mg - 3 times monthly, then quarterly intervention 3: Ranibizumab 0.3 mg monthly
Intervention descriptions: intervention 1: Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms. intervention 2: Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms. intervention 3: Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.

Protocol documents:
Clinical trial NCT00276458
Conditions: Hypercholesterolemia
Sponsor: Organon and Co
Start date: 2006-02-01; Completion date: 2008-01-01
Enrollment: 196 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.

Detailed description:

Arms: arm 1: Atorvastatin 40mg tablet + Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). arm 2: Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day).
Interventions: intervention 1: Comparator: atorvastatin intervention 2: Comparator: Placebo intervention 3: Comparator: ezetimibe intervention 4: Comparator: Placebo.
Intervention descriptions: intervention 1: Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks intervention 2: Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks intervention 3: Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks. intervention 4: Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.

Protocol documents:
Clinical trial NCT00278993
Conditions: Prostate Cancer
Keywords: Prostate cancer metastatic disease
Sponsor: Eisai Inc.
Start date: 2006-01-01; Completion date: 2008-01-01
Enrollment: 108 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-centre, phase II, open-label, two-stage design, single-arm study in patients with hormone-refractory prostate cancer (HRPC) with advanced (rising PSA) and/or metastatic disease and who have had prior anti-androgen therapy. The study will further explore the efficacy of E7389 by enrollment of patients into two strata: those who have had no prior systemic chemotherapy for their disease (except for mitoxantrone and estramustine), and those who failed no more than one previous chemotherapeutic regimen with tubulin-binding agents such as docetaxel.

Detailed description:

Arms: arm 1: With stratification
Interventions: intervention 1: E7389
Intervention descriptions: intervention 1: Intravenous 1.4 mg/m2 on a 3-week course.

Protocol documents: