ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00695396
Conditions: Myelodysplastic Syndromes Anemia
Keywords: MDS Myelodysplastic syndromes Anemia Epoetin alfa EPO
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date: 2008-06-01; Completion date: 2010-01-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate that Epoetin alfa treatment reduces red blood cell transfusions in anemic patients with myelodysplastic syndromes (MDS). Myelodysplastic syndromes are a group of disorders characterized by progressive bone marrow failure and an increased risk of development of leukemia.

Detailed description:
This is a randomized (patients are assigned by chance to a treatment group), double-blind (neither the patient or the physician know which treatment is being received by the patient), placebo-controlled, multicenter study of epoetin alfa in anemic patients who are diagnosed with myelodysplastic syndromes (MDS) according to protocol-specified criteria. Patients meeting entry criteria for the study will be randomly assigned to receive epoetin alfa 40,000 IU or 80,000 IU or a matching volume of placebo administered by subcutaneous (under the skin) injection once every week. Doses of study drug will be withheld, decreased, or increased on the basis of weekly hemoglobin concentrations monitored in patients and predefined dose adjustment guidelines. An Independent Data Monitoring Committee (IDMC) will periodically review study data and for the assessment of disease progression, an independent central reviewer will review bone marrow specimens and peripheral blood counts. Safety will be monitored throughout the study at predetermined intervals and as clinically indicated by physical examination, laboratory tests and evaluation of adverse events. Patients in the Treatment Phase will be randomly assigned to receive once weekly epoetin alfa subcutaneously (SC) at a dose of 40,000 IU (1 mL) or 80,000 IU (2ML) or matching volume of placebo (1 mL or 2 mL) once every week for 48 weeks. Patients may continue to receive double-blinded treatment after 48-weeks.

Arms: arm 1: Epoetin alfa 40 000 IU subcutaneously once every week (1 mL dose) for 48 weeks arm 2: Epoetin alfa 80 000 IU subcutaneously once every week (2 mL dose) for 48 weeks arm 3: Placebo Matching volume 1 mL for 48 weeks arm 4: Placebo Matching volume 2 mLfor 48 weeks
Interventions: intervention 1: Placebo intervention 2: Epoetin alfa intervention 3: Placebo intervention 4: Epoetin alfa
Intervention descriptions: intervention 1: Matching volume 2 mLfor 48 weeks intervention 2: 40,000 IU subcutaneously once every week (1 mL dose) for 48 weeks intervention 3: Matching volume 1 mL for 48 weeks intervention 4: 80,000 IU subcutaneously once every week (2 mL dose) for 48 weeks

Protocol documents:
Clinical trial NCT00700310
Conditions: Refractory Partial Seizures
Keywords: Partial onset seizures E2007 perampanel refractory partial seizures adjunctive therapy seizure frequency reduction in seizure frequency safety concomitant AED(s)
Sponsor: Eisai Inc.
Start date: 2008-08-01; Completion date: 2010-01-01
Enrollment: 712 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: perampanel intervention 2: perampanel intervention 3: perampanel intervention 4: Placebo
Intervention descriptions: intervention 1: 2 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose. intervention 2: 4 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose. intervention 3: 8 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose. intervention 4: Placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily.

Protocol documents:
Clinical trial NCT00701714
Conditions: Anemia Chronic Renal Insufficiency
Keywords: Treatment associated with CRI
Sponsor: Sandoz
Start date: 2007-09-01; Completion date: 2010-01-01
Enrollment: 337 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, controlled, double-blind, multicenter multinational safety study involving about 300 predialysis patients aged 18 years or above suffering from anemia.

Symptomatic anemia will be corrected by s.c. application of EPO HEXAL or ERYPO® in order to achieve a hemoglobin target range of 10.0 -12.0 g/dL.

Detailed description:

Arms: arm 1: HX575, EPO HEXAL arm 2: ERYPO
Interventions: intervention 1: HX575 recombinant human erythropoietin alfa intervention 2: ERYPO
Intervention descriptions: intervention 1: Solution for injection (s.c.) intervention 2: Solution for injection (s.c.)

Protocol documents:
Clinical trial NCT00703677
Conditions: Progressive Supranuclear Palsy Corticobasal Degeneration
Keywords: progressive supranuclear palsy corticobasal degeneration PSP CBD lithium tau
Sponsor: Westat
Start date: 2008-09-01; Completion date: 2010-01-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this trial is to evaluate the safety and tolerability of lithium in people with progressive supranuclear palsy or corticobasal degeneration.

Detailed description:
Progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD) are progressive, adult-onset neurodegenerative disorders characterized by the accumulation of hyperphosphorylated tau. Symptomatic treatment is of minimal benefit to individuals with PSP or CBD, and there are no effective disease modifying agents.

Tau phosphorylation is regulated in part by the enzyme GSK-3β (glycogen synthase kinase-3 beta ). Inhibition of this enzyme may benefit individuals with PSP or CBD by decreasing the levels of phosphorylated tau. Lithium is known to inhibit GSK-3β and, thus, may be a rational therapeutic approach.

The primary objective of this study is to determine the safety and tolerability of lithium in people with PSP or CBD. Additionally, this study will evaluate potential biomarkers and clinical outcome measures as well as assess study drug compliance.

In this multicenter, open label study, 45 eligible participants with PSP or CBD will receive the study drug, lithium. The dosage of lithium will be titrated over a 5-week period, and participants will then be followed prospectively for 6 months. Participants will be evaluated at the screening visit, baseline visit, and weeks 2 and 5 during the titration phase. Clinic study visits will then occur on alternate months through week 28. Telephone visits will occur between clinic study visits.

Arms: arm 1: All participants will receive lithium. The dosage will be titrated over a 5-week period. Participants will then be followed prospectively for 6 months. Participants will be evaluated at the screening visit, baseline visit, and weeks 2 and 5 during the titration phase. Clinic study visits will then occur on alternate months through week 28. Telephone visits will occur between clinic study visits.
Interventions: intervention 1: Lithium
Intervention descriptions: intervention 1: All participants will receive lithium. The dosage will be titrated over a 5-week period and then continued for an additional 6 months.

Protocol documents:
Clinical trial NCT00713596
Conditions: Recovery Time Bruising
Keywords: Nasal Surgery Septorhinoplasty fibrin glue fibrinogen Swelling fibrin tisseel
Sponsor: Mayo Clinic
Start date: 2008-07-01; Completion date: 2010-01-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to determine whether the use of fibrin glue during nasal surgery leads to a shorter recovery period with less bruising and/or swelling.

Detailed description:
Septorhinoplasty is a well established technique to correct nasal deformity. Drawbacks of this procedure include a significant recovery following surgery which may often require nasal taping and casting. Swelling and bruising in and around the surgical site may persist for months after the operation. At present, there is no standard regarding the length of time nasal tape and cast should be used following septorhinoplasty. It has never been proven that taping or casting is required - in surgeries that require minimal amounts of tissue handling, we may not use any tape or cast following the procedure. Homologous fibrin glue has been used for various cosmetic facial plastic procedures since the early 1980's. It has been shown to decrease bruising and swelling following surgery. This study is being undertaken to evaluate these benefits of using fibrin glue in nasal surgery.

Arms: arm 1: Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline. arm 2: Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week. arm 3: Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
Interventions: intervention 1: Fibrinogen intervention 2: Septorhinoplasty intervention 3: Taping after septorhinoplasty. intervention 4: Cast applied to the nose after nasal surgery intervention 5: Saline
Intervention descriptions: intervention 1: One time application of 0.5 cc to 2.0 cc of fibrinogen following surgery. intervention 2: Septorhinoplasty to correct nasal deviation. intervention 3: Simple taping over the nose following nasal surgery. intervention 4: A molded cast will be placed on top of the nose following nasal surgery. intervention 5: Approximately 0.5 cc to 2 cc normal saline will be applied after the operation before the nasal taping and casting.

Protocol documents:
Clinical trial NCT00718640
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma Velcade Bortezomib Dexamethasone
Sponsor: Janssen-Ortho Inc., Canada
Start date: 2007-10-01; Completion date: 2010-01-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness and safety of bortezomib in participants previously treated for multiple myeloma (cancer of plasma cells in bone marrow causing numerous tumors and characterized by the presence of abnormal proteins in the blood) with limited kidney function.

Detailed description:
This is an open label (all people know the identity of the intervention), multi-center (study conducted at multiple sites), non-comparative, single arm study of bortezomib. The study consists of 3 phases: Screening phase (21 days before Day 1 of cycle 1); Treatment phase (consist of 8 cycles each cycle of 21 days or until disease progression or unacceptable toxicity); and a Follow-up phase (for participants with positive treatment response or stable disease at the final visit). Follow-up for disease progression will be done in every 3 months up to 2 years. Participants who will experience disease progression after completing at least 2 cycles of bortezomib treatment or have no change from baseline in stable disease after completing at least 4 cycles or as per Investigator's discretion will receive dexamethasone. Efficacy will be primarily evaluated by percentage of participants with renal compromised Multiple Myeloma by International Myeloma Working Group (IMWG) uniform response criteria. Participants' safety will be monitored throughout the study.

Arms: arm 1: Bortezomib 1.3 milligram (mg) per meter\^2 (m\^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
Interventions: intervention 1: Dexamethasone intervention 2: Bortezomib
Intervention descriptions: intervention 1: Dexamethasone 20 mg per day will be administered orally on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-days cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks). intervention 2: Bortezomib 1.3 milligram per meter\^2 (mg/m\^2), bolus intravenous injection will be administered on Days 1, 4, 8 and 11 of each 21-day cycle and up to 8 cycles.

Protocol documents:
Clinical trial NCT00721188
Conditions: Anemia
Sponsor: American Regent, Inc.
Start date: 2006-01-01; Completion date: 2010-01-01
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.

Detailed description:

Arms: arm 1: All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
Interventions: intervention 1: Venofer
Intervention descriptions: intervention 1: Single dose of 7mg intravenous (IV) of iron per kg of body weight for a maximum of 200mg iron IV.

Protocol documents:
Clinical trial NCT00745875
Conditions: Non Small Cell Lung Cancer Lung Cancer
Keywords: NSCLC Phase II ZD4054 Pemetrexed Lung Cancer
Sponsor: AstraZeneca
Start date: 2008-08-01; Completion date: 2010-01-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to collect initial efficacy and safety data on the use of a new treatment ZD4054 (Zibotentan) when used in combination with pemetrexed (a standard chemotherapy agent) for the treatment of non-small cell lung cancer compared to treatment with pemetrexed alone

Detailed description:

Arms: arm 1: ZD4054 + Pemetrexed arm 2: ZD4054 matched placebo + pemetrexed
Interventions: intervention 1: ZD4054 intervention 2: Pemetrexed intervention 3: Placebo
Intervention descriptions: intervention 1: 10mg oral tablet, once daily intervention 2: 500mg2/m IV infusion intervention 3: 10mg oral tablet, once daily

Protocol documents:
Clinical trial NCT00754208
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder Stimulant Treatment Young Children
Sponsor: University of Nebraska
Start date: 2008-09-18; Completion date: 2010-01-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a pilot study evaluating the effectiveness, safety, and tolerability of Ritalin LA in treating Attention Deficit Hyperactivity Disorder (ADHD) in 4 and 5 year old children. Virtually no data has been published on the use of long-acting stimulant preparations in very young children despite early symptomatic development in a significant portion of young children with ADHD. This would be one of the first studies looking at a long-acting preparation of a stimulant medication in the treatment of ADHD in very young children.

Hypotheses

1. Ritalin LA is effective for the treatment of ADHD in 4 and 5 year old children.
2. Ritalin LA is reasonably well-tolerated in the treatment of ADHD in 4 and 5 year old children.

Detailed description:
This protocol involves an 8-week, open-label, pilot study evaluating the effectiveness, safety, and tolerability of Ritalin LA in treating Attention-Deficit/Hyperactivity Disorder (ADHD) in 4 and 5 year old children. The purpose of this study is to ascertain pilot data on the use of long-acting stimulants in preschool-age children since virtually no data exist on these medications in this population. The interventions include utilizing short-acting methylphenidate for the initial dosing and titration and then converting the children to Ritalin LA once an optimal dose has been found. Parents will also be receiving parent education training throughout the study. Evaluations will include obtaining the ADHD-IV at every visit, side effects of the medication, vital signs, EKG, physical exam, the Clinical Global Assessment Scale, and the Clinical Global Impression-Improvement and Severity Scales. This study will also assess parent stress with the Parent Stress Index and the emotional index of the children with the Expressed Emotion Scale for Children. Follow-up will be weekly during the first month and bi-weekly during the second month.

Arms: arm 1: open-label treatment with methylphenidate
Interventions: intervention 1: methylphenidate
Intervention descriptions: intervention 1: Starting dose: methylphenidate (immediate-release pill) or Methylin (immediate-release chewable tablet for those unable to swallow pills) 2.5mg Q AM and Q noon. Target dose of 1mg/kg/day. Titration will occur as follows: 5mg Q AM and Q noon, then 7.5mg Q AM and Q noon, then 10mg Q AM and Q noon, as tolerated, not to exceed 30mg per day. Once each child arrives at a stable dose with a good response and good tolerability, they will be converted to the closest Ritalin LA dose, with a target dose of 1mg/kg/day.

Protocol documents:
Clinical trial NCT00765648
Conditions: Hypertensive Urgency
Keywords: hypertension emergency department Nicardipine Labetalol hypertensive emergency hypertensive urgency
Sponsor: The Cleveland Clinic
Start date: 2008-10-01; Completion date: 2010-01-01
Enrollment: 226 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and efficacy of Cardene I.V. to labetalol administered intravenously for the management of hypertension in the emergency department setting.

Detailed description:
More than 3 million patients yearly receive an intravenous antihypertensive agent in the US. Despite this large number of critically ill patients treated annually, little research exists in the area of acute severe hypertension, specifically hypertensive emergency, a serious condition that contributes to morbidity and mortality.

Two agents that are commonly used to treat acute hypertensive crisis include labetalol and nicardipine. Cardene may provide benefits in titration and has shown to have lower dosage adjustments compared to labetalol. Nicardipine has also shown a decreased need for additional antihypertensives when compared to labetalol in patients with stroke in a neurological ICU.

Arms: arm 1: nicardipine intravenous arm 2: Labetalol
Interventions: intervention 1: nicardipine intravenous intervention 2: Labetalol
Intervention descriptions: intervention 1: nicardipine intravenous 5 mg/hour titrated every 5 minutes by 2.5 mg/hour until target systolic blood pressure range (TSBPR) is reached or maximum dose of 15 mg/hour is achieved.Following achievement of target systolic blood pressure range the infusion rate should be decreased to 3 mg/hour intervention 2: Labetalol: bolus therapy to start at 20 mg intravenous injection over 2 minutes, may repeat 20mg, 40mg or 80mg injections every 10 minutes until target systolic blood pressure range(TSBPR)is reached or a maximum of 300 mg is injected.

Protocol documents:
Clinical trial NCT00768248
Conditions: Amputation Phantom Limb Stump Pain
Keywords: pain phantom limb stump pain catheter nerve block peripheral nerve block NMCSD Post-Amputation Phantom Limb or Stump Pain
Sponsor: University of California, San Diego
Start date: 2008-10-01; Completion date: 2010-01-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this research study is to determine if putting local anesthetic-or numbing medication-through one or two tiny tube(s) placed next to the nerves that go to an amputated limb will decrease phantom limb and/or stump pain.

Detailed description:
Specific Aim 1: To determine if, compared with current standard-of-care treatment, the addition of an ambulatory continuous peripheral nerve block decreases post-amputation phantom limb and stump pain.

Hypothesis 1: Following upper or lower extremity amputation, phantom limb and/or stump pain will be significantly decreased four weeks following a multiple-day ambulatory continuous peripheral nerve block as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).

Specific Aim 2: To investigate the possible relationship between the addition of a multiple-day ambulatory continuous peripheral nerve block to standard-of-care treatment of post-amputation phantom limb and/or stump pain and cortical reorganization.

Hypothesis 2: Following upper or lower extremity amputation with subsequent phantom limb pain/sensation and/or stump pain, the addition of a multiple-day ambulatory continuous peripheral nerve block to standard-of-care treatment will result in cortical reorganization during and four-weeks following the perineural infusion (as measured by MRI).

Arms: arm 1: 3-7 days of perineural local anesthetic infusion arm 2: 3-7 days of perineural normal saline infusion
Interventions: intervention 1: perineural ropivacaine intervention 2: normal saline (placebo)
Intervention descriptions: intervention 1: ropivacaine 0.4%; the basal rate will be set at 7 mL/h intervention 2: the basal rate will be set at 7 mL/h

Protocol documents: