ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00770757
Conditions: Graft vs Host Disease
Sponsor: Washington University School of Medicine
Start date: 2009-02-01; Completion date: 2011-10-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will test the safety and effectiveness CC-4047 (pomalidomide) in patients with advanced, steroid refractory graft-versus-host disease.

Detailed description:
Chronic Graft vs. Host Disease is a major complication after allogeneic hematopoietic stem cell transplantation developing in 30 - 70% of patients. It is a multisystem alloimmune and autoimmune disorder with a negative impact on quality of life and functional status, increased need for extended immunosuppression and is the leading cause of late transplant related mortality.

CC-4047 is a novel immune modulatory drug that is a thalidomide analog with a 4,000 fold greater inhibition of TNF-α production related to thalidomide. Several features of CC-4047 suggest that this drug may be useful in treating chronic GVHD including in vitro suppression of TNF-α production, increasing Th1 and stimulation of IL-12 and sIL-Rα.

This study is an open-label, single-arm, pilot study of efficacy and safety of CC-4047 in patients with advanced chronic GvHD who failed to achieve a response with high-dose corticosteroids or second line systemic immunosuppressive therapy.

Arms: arm 1: CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
Interventions: intervention 1: CC-4047
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00789997
Conditions: COPD Exacerbation
Keywords: COPD Exacerbation Etanercept TNF alpha Randomized
Sponsor: Ottawa Hospital Research Institute
Start date: 2008-11-01; Completion date: 2011-10-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether treatment with antibiotics plus a TNFalpha antagonist will provide more effective treatment for acute COPD exacerbation compared to the current standard treatment of antibiotics plus prednisone.

Detailed description:
Acute exacerbations of COPD (AECOPD)are usually treated with steroids and antibiotics. Currently this conventional therapy has significant side effects including osteoporosis, cataracts,and suppression of the immune system. Studies have suggested that up to 24% of inpatients and 27% of outpatients fail this treatment by 4 weeks. During an acute exacerbation of COPD, the inflammatory process increases. Studies have shown the TNF-alpha cytokines appears to play a major role. Etanercept is a TNF alpha inhibitor. It inactivates TNF alpha cytokines by blocking their interaction with their cellular receptors. This study will compare the treatment of acute exacerbations of COPD with: 1) Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days, or 2) Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later. Patients randomized to group 1 (the control group) will receive placebo subcutaneous injections, and patients randomized to group 2 (the experimental group) will receive placebo prednisone capsules.

Arms: arm 1: etanercept 50 mg subcutaneous given on the day of randomization and one week later prednisone placebo po daily for 10 days Levofloxacin 750 mg po daily for 10 days. arm 2: prednisone 40 mg daily for 10 days etanercept placebo subcutaneous given on the day of randomization and one week later Levofloxacin 750 mg daily for 10 days.
Interventions: intervention 1: Prednisone intervention 2: Etanercept intervention 3: levofloxacin
Intervention descriptions: intervention 1: prednisone 40 mg daily for 10 days or placebo prednisone intervention 2: etanercept 50 mg subcutaneous given on the day of randomization and one week later or placebo subcutaneous injection intervention 3: Levofloxacin 750 mg daily for 10 days.

Protocol documents:
Clinical trial NCT00806351
Conditions: Fungemia Neutropenia Candidiasis
Keywords: Candidiasis; Invasive Candidiasis; Candida; Candidemia; Fungal Infection; Neutropenia
Sponsor: Pfizer
Start date: 2009-08-01; Completion date: 2011-10-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to gather information on the use of anidulafungin for the treatment of Candida infection in patients with an abnormal immune system. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.

Detailed description:

Arms: arm 1: Subjects were randomized 2:1 (anidulafungin:caspofunin). arm 2: Subjects were randomized 2:1 (anidulafungin:caspofunin).
Interventions: intervention 1: Active Anidulafungin intervention 2: Active Caspofungin
Intervention descriptions: intervention 1: Subjects in this arm will receive active anidulafungin and placebo caspofungin intervention 2: Subjects in this arm will receive active caspofungin and placebo anidulafungin

Protocol documents:
Clinical trial NCT00824421
Conditions: HIV-1
Keywords: HIV-1. Treatment Naive HIV Infections treatment naive
Sponsor: Pfizer
Start date: 2009-02-01; Completion date: 2011-10-01
Enrollment: 195 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 96 week study to determine if UK- 453,061 in combination with Truvada is as efficacious, safe and tolerable as efavirenz in combination with Truvada in HIV-1 infected patients who have not been previously treated with antiretroviral drugs.

Detailed description:

Arms: arm 1: UK 453,061 Dose One plus Truvada arm 2: UK 453,061 Dose Two plus Truvada arm 3: Efavirenz + Truvada
Interventions: intervention 1: UK-453, 061 intervention 2: UK-453, 061 intervention 3: EFV +TVA
Intervention descriptions: intervention 1: UK-453,061 500 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD. intervention 2: UK-453,061 750 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD. intervention 3: Efavirenz 600 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 tablets mg PO QD.

Protocol documents:
Clinical trial NCT00824512
Conditions: Friedreich Ataxia
Sponsor: Ipsen
Start date: 2008-06-01; Completion date: 2011-10-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this protocol is to determine the efficacy of EGb 761 120 mg bid versus placebo in patients suffering from Friedreich Ataxia

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: EGb 761 120 mg intervention 2: Placebo
Intervention descriptions: intervention 1: EGb 761® 120 mg bid, orally for 12 to 14 weeks intervention 2: Placebo 1 tablet BID, orally for 12 to 14 weeks

Protocol documents:
Clinical trial NCT00832819
Conditions: Non-small-cell Lung Cancer
Keywords: Cancer Lung Cancer
Sponsor: Eisai Co., Ltd.
Start date: 2009-02-01; Completion date: 2011-10-01
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determined the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered continually twice daily in combination with carboplatin and paclitaxel to patients with advanced or metastatic non-small cell lung cancer.

Detailed description:

Arms: arm 1: This will be a dose-escalation evaluation of 12-18 participants to determine the maximum tolerated dose of E7080 in combination with paclitaxel and carboplatin. arm 2: Dosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort.
Interventions: intervention 1: E7080 intervention 2: E7080 intervention 3: Paclitaxel intervention 4: Carboplatin
Intervention descriptions: intervention 1: Drug: E7080 will be administered orally starting at a dose of 6 mg twice daily during the 7-day run-in period and for 3 weeks (Cycle 1). intervention 2: Maximum tolerated dose determined in the Dose-Escalation Cohort will be administered to the Expansion Cohort. After E7080 is taken on Day 1, paclitaxel (200 mg/m2) will be administered intravenously (IV), followed by IV carboplatin (AUC 6.0 min/mg/mL). intervention 3: Paclitaxel (200 mg/m2) will be administered intravenously (IV) on Day 1 after administration of E7080. intervention 4: Carboplatin (AUC 6.0 min/mg/mL) will be administered IV on Day 1 after administration of E7080 and Paclitaxel.

Protocol documents:
Clinical trial NCT00843310
Conditions: Multiple Myeloma
Keywords: multiple myeloma frontline treatment first-line treatment
Sponsor: NYU Langone Health
Start date: 2008-11-01; Completion date: 2011-10-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is to determine whether addition of Revlimid to standard therapy will increase overall and complete response rates compared to historical standard frontline therapy and whether this combination treatment has fewer side effects than similar combination induction treatment.

Detailed description:
Current multiple myeloma therapies, typically an induction regimen followed by consolidation therapy with high dose chemotherapy and autologous stem cell rescue (autologous transplantation), can induce remission but relapse and death are inevitable. A growing body of literature suggests that consolidation therapy with autologous transplantation does not confer additional survival benefit and may have increased procedure-related morbidity and mortality in patients over 65 years old. Autologous transplantation is no longer recommended as standard care for this population. In addition, certain patients may not be eligible for autologous transplantation due to co-morbid medical conditions or may elect not to undergo the procedure for personal reasons.

The historic standard of care for multiple myeloma patients who were not eligible for autologous transplantation for consolidation was induction therapy with melphalan/ prednisone (MP), often followed by some form of maintenance therapy after achievement of complete or partial remission. A recent phase 3 study showed that the addition of thalidomide to MP (MPT) demonstrated higher overall and complete response rates. For patients who are eligible for autologous transplantation, thalidomide/ dexamethasone (Thal Dex) induction therapy is considered the standard of care, but a phase 2 study of lenalidomide (Revlimid)/ dexamethasone (Rev Dex) induction therapy demonstrated higher overall and complete response rates compared to Thal Dex. In addition, lenalidomide has a favorable side effect profile compared to thalidomide. Based on these data, we hypothesize that the combination of Revlimid/ melphalan/ dexamethasone (ReMeDex) induction therapy for myeloma patients who are not planned for autologous transplantation due to age restriction or other factors may demonstrate higher overall and/ or complete response rates with fewer side effects.

Arms: arm 1: Treatment phase (28 days/cycle x 6 cycles):

Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.

Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):

lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles.
Interventions: intervention 1: Lenalidomide (Revlimid) intervention 2: Melphalan intervention 3: Dexamethasone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00850070
Conditions: Autistic Disorder
Keywords: autism
Sponsor: The Children's Health Council
Start date: 2009-03-01; Completion date: 2011-10-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is intended to provide a definitive test of the hypothesis that elevating sapropterin (tetrahydrobiopterin, a cofactor for several key brain enzymes)concentrations in the CNS will result in measurable improvements in core symptoms of autism in young individuals, under age 6 years. The study will entail a double-blind, placebo-controlled 16-week intervention.

Detailed description:
Over the past 20 years, several studies have suggested that sapropterin (tetrahydrobiopterin) might ameliorate core symptoms of autism at least in young (under age 6) subjects. However, those studies had somewhat questionable methodologies, a major one being that the doses of sapropterin used were roughly one tenth that thought to be needed to provide physiologically meaningful increases of sapropterin in the central nervous system (CNS). This study will look at the impact of a sustained exposure to this higher dose in well-diagnosed young children with autism.

Arms: arm 1: Sapropterin was supplied as a 100 mg tablet and dosage was based on 20 mg/kg/d, rounding to the nearest 100 mg. Most subjects crushed the tablets and administered it in liquid or a food to mask the taste. Subjects took the same dose daily for 16 weeks. arm 2: The placebo was supplied as a 100 mg tablet, and dosage was based on 20 mg/kg/d, rounding to the nearest 100 mg. Most subjects crushed the tablets and administered it in liquid or a food to mask the taste. Subjects took the same dose daily for 16 weeks.
Interventions: intervention 1: sapropterin intervention 2: Placebo
Intervention descriptions: intervention 1: Patients will receive sapropterin 20 mg per kilogram per day for 16 weeks intervention 2: Patients will receive a placebo identical in form and dosage to the active drug daily for 16 weeks.

Protocol documents:
Clinical trial NCT00850499
Conditions: Follicular Lymphoma
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2009-09-01; Completion date: 2011-10-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, open-label, active-control, multicenter Phase 2 study of VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the 2 treatment arms (55 subjects per arm).

Detailed description:

Arms: arm 1: VELCADE 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 and fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle arm 2: fludarabine 40mg/m2/day orally on Days 1 to 5 and rituximab 375mg/m2 on Day 1 of every 35-day cycle
Interventions: intervention 1: fludarabine intervention 2: rituximab intervention 3: VELCADE
Intervention descriptions: intervention 1: fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle intervention 2: rituximab 375mg/m2 on Day 1 of every 35-day cycle intervention 3: 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle

Protocol documents:
Clinical trial NCT00857220
Conditions: Insomnia Attention Deficit Hyperactivity Disorder
Keywords: Hypnotic Eszopiclone Attention Deficit Hyperactivity Disorder Insomnia Children Adolescent
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2009-05-01; Completion date: 2011-10-01
Enrollment: 304 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A multicenter study to evaluate the safety of eszopiclone in children (6 11 years of age, inclusive) and adolescents (12 17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.

Detailed description:
This is a multi center, open label, long term safety study in pediatric subjects 6 through 17 years of age, inclusive, with a diagnosis of ADHD associated insomnia. Subjects who complete Study 190 246 (Rollover subjects) and meet the study enrollment criteria will be allowed to participate in this long term safety study. Additionally, Treatment naïve subjects will be enrolled in this long term safety study in order to meet the overall subject enrollment objective of obtaining 100 subjects with 12 months of treatment. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Arms: arm 1: None
Interventions: intervention 1: eszopiclone intervention 2: eszopiclone
Intervention descriptions: intervention 1: One 2 mg tablet per day for 12 months intervention 2: one 3mg tablet per day for 12 months

Protocol documents:
Clinical trial NCT00868374
Conditions: Major Depressive Disorder Generalized Anxiety Disorder
Sponsor: Keming Gao
Start date: 2008-06-01; Completion date: 2011-10-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to test the hypothesis that quetiapine XR (Extended Release) monotherapy or adjunctive therapy to antidepressant is superior to placebo monotherapy or placebo adjunctive therapy to antidepressant(s) in the acute treatment of depression symptoms in patients with MDD and comorbid GAD. The secondary objectives are to test the hypotheses that quetiapine XR is superior to placebo in the reduction of anxiety symptoms in patients with major depressive disorder and comorbid generalized anxiety disorder, the improvement of the quality of sleep in patients with major depressive disorder and comorbid generalized anxiety disorder and the improvement of the quality of life in patients with major depressive disorder and comorbid generalized anxiety disorder.

Detailed description:

Arms: arm 1: Quetiapine XR arm 2: None
Interventions: intervention 1: Quetiapine XR intervention 2: Placebo
Intervention descriptions: intervention 1: Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day intervention 2: Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day

Protocol documents:
Clinical trial NCT00879996
Conditions: Opiate Addiction
Keywords: Opiate Addiction Narcotic Addiction Drug Addiction Pain
Sponsor: State University of New York at Buffalo
Start date: 2009-04-01; Completion date: 2011-10-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if buprenorphine or methadone is better for the treatment of chronic pain among patients who have become addicted to prescription narcotics.

Detailed description:
The purpose of this randomized clinical trial is to compare methadone with buprenorphine for the treatment of chronic pain among patients who have developed a physical dependence on prescription opiate analgesics that is associated with psychosocial dysfunction (i.e., addiction).

Arms: arm 1: Methadone 10-60 mg per day in 2-4 divided doses for 6 months arm 2: Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
Interventions: intervention 1: Methadone intervention 2: Buprenorphine/naloxone
Intervention descriptions: intervention 1: Oral, 10-60 mg per day, 2-4 times per day, 6 months intervention 2: Sub-lingual, 4-16 mg per day, divided 2-4 times/day, 6 months

Protocol documents:
Clinical trial NCT00884052
Conditions: Seizures Disorder of Fetus or Newborn
Keywords: Neonatal seizures
Sponsor: Richard H. Haas
Start date: 2007-04-01; Completion date: 2011-10-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The hypothesis is that a loading dose of 20 mg/kg and a maintenance dose of 5 mg/kg of Levetiracetam is going to be safe and effective in the treatment of seizures in neonates.

Detailed description:
In adults, drug clearance is less than half of the glomerular filtration rate and the drug half-life is 6-8 hours. Renal function in infants at birth is characterized by immature glomerular filtration and is only 20% that of older children. The specific esterase responsible for levetiracetam hydrolysis has not been identified and its expression in newborn infants is unknown. Depending on its activity, the expected infant total levetiracetam clearance will likely be between 15-45% of older populations. However, due to immaturity in levetiracetam clearance in infants, accumulation with multiple dosing is possible. Therefore the maintenance dose is reduced compared to older children according to the anticipated impaired clearance.

These anticipated differences in levetiracetam clearance and volume of distribution, will likely result in a prolonged drug half-life of 10-30 hours in infants. This prolonged elimination will require longer sampling to adequately characterize levetiracetam pharmacodynamics in this population.

The primary intent of the data analysis is to determine levetiracetam pharmacokinetics in newborn infants and predict the dosage necessary to maintain concentrations similar to those seen with effective therapy in other populations. Graphs of serum concentration vs. time will be plotted for levetiracetam for each infant. Mean serum drug concentration vs. time curves will also be constructed. Summary statistics (i.e., n, mean, standard deviation, minimum, maximum, and coefficient of variation) will be calculated for serum concentrations for each time point and each dose level.

Arms: arm 1: 6 Babies in Phase 1-Received Dose 1: 20 mg/kg; 5 mg/kg daily 12 Babies in Phase 2-Received Dose 2: 40 mg/kg; 10 mg/kg/day
Interventions: intervention 1: Low dose levetiracetam intervention 2: High dose levetiracetam
Intervention descriptions: intervention 1: 20 mg/kg loading dose; 5 mg/kg daily for 7 days. intervention 2: 40 mg/kg IV load; 10 mg/kg/day maintenance

Protocol documents:
Clinical trial NCT00888329
Conditions: Postoperative Nausea and Vomiting
Keywords: Elective hysterectomy
Sponsor: Mayo Clinic
Start date: 2007-07-01; Completion date: 2011-10-01
Enrollment: 256 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether 40 mg aprepitant administered before surgery is effective for preventing vomiting in the first 24 hours after surgery in women undergoing elective hysterectomy.

Detailed description:
Postoperative nausea and vomiting (PONV) is the most frequent side effect after anesthesia, occurring in approximately 30% of unselected patients, and can be increased up to 70% in certain populations and procedures. Despite screening for patients at high risk for PONV, current prophylactic interventions fail to completely eliminate PONV for a substantial number of patients, leading to dehydration, electrolyte imbalance, prolonged hospitalizations, multiple doses of rescue therapy, and readmissions to the hospital (2). Aprepitant (Emend) is the first neurokin-1-receptor antagonist in a new class of antiemetics, which has already demonstrated powerful additive effects when combined with dexamethasone and a 5-HT3 to prevent both acute and delayed chemotherapy-induced nausea and vomiting (CINV). Early studies have also suggested it may useful in the prevention of postoperative nausea and vomiting (PONV).

Patients undergoing elective inpatient or outpatient hysterectomy will be offered enrollment in this prospective, randomized, double blinded, placebo controlled trial. Subjects will receive Aprepitant vs. placebo prior to induction of standardized anesthesia. Postoperative nausea (assessed with a VRS), vomiting, and use of rescue antiemetic therapy will be documented over a 48h period. Additionally, hospitalization days and readmissions for PONV will be compared. Adverse events will be reported to the IRB and manufacturer. By reducing PONV in a group of high risk patients, we anticipate a demonstrated decrease in rescue antiemetic costs and hospitalization days for PONV related issues.

Arms: arm 1: 40 mg aprepitant arm 2: Placebo
Interventions: intervention 1: Aprepitant intervention 2: Placebo
Intervention descriptions: intervention 1: 40 mg administered orally with a sip of water prior to anesthesia induction. intervention 2: Placebo

Protocol documents: