ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00292942
Conditions: Malaria Malaria, Cerebral
Keywords: artesunate artemisinin falciparum
Sponsor: U.S. Army Medical Research and Development Command
Start date: 2006-06-12; Completion date: 2008-01-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to establish the safety, tolerability, and pharmacokinetics of a multiple dose of the antimalarial drug artesunate.

Detailed description:
This study was a Phase 1b, randomized, double-blind, placebo-controlled trial using multiple ascending doses of intravenous artensunate (AS) to determine it's safety, tolerability, and PK in healthy subjects. Subjects were screened within 21 days of dosing. At the screening visit, subject underwent baseline assessments: vital signs were recorded; a physical examination, urinalysis, urine drug screen, and urine pregnancy test were performed; a complete blood cell count (CBC) with differential and indices, reticulocyte count, coagulation markers, and blood chemistry assessments were performed and medical and medication history was collected. Eligible subjects were scheduled for a 6-hour pre-dose electrocardiogram (ECG) and vital sign assessment with measurements taken at approx. the same times as Day 1 (dosing day). On Day 0, subjects were admitted to the clinical pharmacology unit to begin the inpatient phase of the study. Subjects had a brief physical examination and all procedures for the inpatient stay were reviewed. On Day 1, pre-dose vital signs and ECG were performed. Subjects then received study drug or placebo by IV bolus infusion. Subjects were closely monitored by evaluating hemodynamic measurements, periodic ECGs, and assessment of spontaneously reported AEs. Blood was drawn for blood count and chemistry analysis 6h and 24h after each dose. PK blood samples were drawn pre-dose and approx. 5min, 20min, 40min, 1h, 2h, 4h, 6h, and 24h after each dose. On Days 2 and 3 subjects received their second and third doses, respectively, of study drug or placebo with the same monitoring and laboratory measurements as for the first dose. Subjects were discharged 24 hours after the 3rd dose of drug or placebo and were followed as outpatients on Days 7, 10, and 15.

Arms: arm 1: 2 mg/kg of Intravenous artesunate arm 2: 4 mg/kg of Intravenous artesunate arm 3: 8 mg/kg of Intravenous artesunate arm 4: Mannitol (200 mg/vial) diluted in phosphate buffer and delivered in an equivalent volume by subject's weight as artesunate.
Interventions: intervention 1: Intravenous Artesunate intervention 2: Placebo
Intervention descriptions: intervention 1: Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1) intervention 2: Mannitol (200 mg/vial) diluted in Phosphate Buffer and given IV in equivalent volume by subject's weight.

Protocol documents:
Clinical trial NCT00315302
Conditions: Amblyopia
Keywords: Amblyopia Atropine Plano lens
Sponsor: Jaeb Center for Health Research
Start date: 2005-02-01; Completion date: 2008-01-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is:

* To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old.
* To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine treatment with and without a plano lens.

Detailed description:
Atropine is an effective treatment of moderate amblyopia. Reduction of the plus sphere for the sound eye is an accepted method of enhancing and possibly accelerating the treatment effect. Demonstrating additional value of the plano lens in terms of speed of improvement will shorten the treatment period, possibly improving child and parental compliance, leading to improved overall outcomes for patients with amblyopia. If the plano lens leads to greater improvement, then there will be less permanent visual impairment in patients with a history of amblyopia. It also is important to determine if the use of a plano lens in conjunction with atropine has a deleterious effect on the sound eye, and if yes, how often this occurs.

Little is known about the pharmacologic treatment of severe amblyopia. This study will provide important prospectively determined outcome data at little additional expense.

In a study conducted by the Pediatric Eye Disease Investigator Group, A Randomized Trial Comparing Daily Atropine Versus Weekend Atropine for Moderate Amblyopia, the use of weekend atropine for moderate amblyopia was as effective as daily treatment. Intermittent atropine use (such as using it only on the weekends) has the theoretical potential benefit of the sound eye having some time each week during which cycloplegia is only partial. It is possible that allowing some loss of the cycloplegic effect over the course of each week may be safer for the sound eye.

The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. The two treatment regimes for the 18 week primary treatment period are: 1) Atropine 1% once each weekend day in the sound eye and 2) Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye.

Arms: arm 1: Atropine 1% once each weekend day in the sound eye arm 2: Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye
Interventions: intervention 1: Atropine intervention 2: Plano Lens
Intervention descriptions: intervention 1: Atropine 1% once each weekend day intervention 2: Plano lens for the sound eye

Protocol documents:
Clinical trial NCT00316719
Conditions: Chronic Hepatitis B
Keywords: treatment naive CHB adefovir monotherapy
Sponsor: GlaxoSmithKline
Start date: 2006-01-01; Completion date: 2008-01-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: LAM group intervention 2: ADV group
Intervention descriptions: intervention 1: Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily. intervention 2: Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.

Protocol documents:
Clinical trial NCT00318929
Conditions: Elderly Epilepsy Seizures
Keywords: Treatment Efficacy pharmacokinetics
Sponsor: Virginia Commonwealth University
Start date: 2006-04-01; Completion date: 2008-01-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
There is a bimodal distribution to the new onset seizures with one peak occurring in the very young and the second peak occurring in persons over age 65 years. The presentation of seizures in the elderly may vary from that of younger patients and the diagnosis may be confused with other conditions such as transient ischemic attacks. However, the consequences of epilepsy in the elderly can be severe leading to impaired cognition, increased falls, and a decreased quality of life. The treatment of epilepsy may be complicated by pharmacokinetic and pharmacodynamic changes occurring in the elderly.

Detailed description:
There is a bimodal distribution to the new onset seizures with one peak occurring in the very young and the second peak occurring in persons over age 65 years. The presentation of seizures in the elderly may vary from that of younger patients and the diagnosis may be confused with other conditions such as transient ischemic attacks. However, the consequences of epilepsy in the elderly can be severe leading to impaired cognition, increased falls, and a decreased quality of life. The treatment of epilepsy may be complicated by pharmacokinetic and pharmacodynamic changes occurring in the elderly.

Three Veterans Cooperative trials evaluating antiepileptic drug (AED) therapy in the elderly demonstrated that the ability to tolerate the AED is a more determining factor for long term success than the ability to suppress seizure activity. In general, elderly patients appear more intolerable to medications. This may stem from co-morbid conditions, concurrent medications, pharmacokinetic changes, and/or pharmacodynamic changes. Therefore, it is important to study the efficacy and tolerability of AEDs in the elderly.

Valproic acid has been available for the treatment of partial and generalized seizures since 1978. Sodium divalproex is metabolized in the gut to valproic acid. Depakote and Depakote-ER (extended release)are among the dosage forms of sodium divalproex. Depakote is an enteric coated tablet that is designed to dissolve in the more alkaline milieu of the small intestine rather than the more acidic milieu of the stomach. This helps the drug to bypass the stomach and reduces gastrointestinal distress. Once the enteric coating dissolves, the sodium divalproex is metabolized to valproic acid and rapidly absorbed. Depakote is administered twice a day. Depakote-ER is a controlled release drug delivery system designed to release drug over a 22 hour period which allows for once a day dosing. The efficacy and tolerability of Depakote-ER has not been described in elderly patients with epilepsy.

Interventions: intervention 1: Divalproex Sodium Extended-Release Tablets
Intervention descriptions: intervention 1: Once a day dosing

Protocol documents:
Clinical trial NCT00322153
Conditions: Dementia of the Alzheimer's Type
Keywords: memantine Alzheimer's disease moderate to severe Alzheimer's disease
Sponsor: Forest Laboratories
Start date: 2005-06-01; Completion date: 2008-01-01
Enrollment: 677 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety, tolerability, and efficacy of memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of the Alzheimer's type on a concurrent acetylcholinesterase inhibitor (AChEI).

Detailed description:
Memantine is a therapeutic agent that represents a unique class of Alzheimer's disease (AD) treatment options. A once daily (QD) dosing regimen in an AD population would simplify administration for the caregiver. The purpose of this study is to evaluate the safety and efficacy of modified release memantine taken once daily in outpatients with moderate-to-severe AD on a concurrent AChEI.

Arms: arm 1: Oral administration, once daily. arm 2: 28mg, once daily. Oral administration for 24 weeks.
Interventions: intervention 1: memantine ER intervention 2: Placebo
Intervention descriptions: intervention 1: 28mg(7mg capsules) once daily and oral administration for 24 weeks. intervention 2: Matching placebo oral administration once daily.

Protocol documents:
Clinical trial NCT00330460
Conditions: Osteoporosis Osteopenia
Keywords: Osteoporosis Osteopenia AMG 162 Fracture - hip Postmenopausal
Sponsor: Amgen
Start date: 2006-05-01; Completion date: 2008-01-01
Enrollment: 1189 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether in postmenopausal women with low bone mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is not less than that observed in subjects receiving alendronate sodium by more than a pre-specified non-inferiority margin.

Detailed description:

Arms: arm 1: Subjects in this arm will receive active ALN and placebo denosumab arm 2: Subjects in this arm will receive active denosumab and placbo ALN
Interventions: intervention 1: Alendronate intervention 2: Denosumab
Intervention descriptions: intervention 1: ALN; 70 mg; oral; once weekly intervention 2: 60 mg; SC; every 6 months

Protocol documents:
Clinical trial NCT00336583
Conditions: Non-Hodgkin's Lymphoma
Keywords: oxaliplatin ESHAOX refractory relapsed non-hodgkin's lymphoma
Sponsor: Asan Medical Center
Start date: 2006-06-01; Completion date: 2008-01-01
Enrollment: 27 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Oxaliplatin will be used instead of cisplatin in well-known salvage regimen of etoposide, methylprednisolone, cytarabine and cisplatin (ESHAP). Clinical efficacy and toxicity of this ESHAOX salvage regimen will be evaluated in refractory or relapsed non-Hodgkin's lymphoma patients.

Detailed description:
Patients with aggressive non-Hodgkin's lymphoma (NHL) are known to have a malignancy considered curable in many cases. However, diagnosis of refractory or relapsed disease is devastating and the treatment is difficult because regimens of chemotherapy used as salvage therapy are available only in limited numbers. ESHAP, consisting of etoposide, methylprednisolone, high-dose cytarabine and cisplatin, is one of commonly used salvage regimen, and showed its efficacy and feasibility. But it often requires discontinuation of the treatment due to its myelosuppression, neuropathy and renal toxicity, which can also impede further treatment. Oxaliplatin, a platinum coordination complex with an oxalato-ligand as the leaving group and a 1,2-diaminocyclohexane carrier, possesses higher cytotoxic potency on molar basis than cisplatin and carboplatin, and was reported to be active in patients with NHL as a single agent. In addition, the substitution of cisplatin by oxaliplatin in the DHAP regimen, another commonly used one in relapsed or refractory NHL, showed meaningful anti-tumor activity with favorable toxicity profile. Based on preclinical and clinical findings, we will conduct a multi-center phase II study of ESHAOX, which substitutes oxaliplatin with cisplatin in the ESHAP regimen, to evaluate the efficacy and toxicity profile in patients with recurrent or refractory NHL.

Arms: arm 1: relapsed or refractory non-Hodgkin's lymphoma
Interventions: intervention 1: Oxaliplatin
Intervention descriptions: intervention 1: Oxaliplatin, 130 mg per square meter, on day 1

Protocol documents:
Clinical trial NCT00337987
Conditions: Peripheral T-Cell Lymphoma
Sponsor: Yale University
Start date: 2005-11-01; Completion date: 2008-01-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The standard treatment for PTCL is CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy. This study is attempting to determine whether adding other treatments to CHOP therapy will improve the chance of the disease going into remission or staying in remission. Because other drugs for T-cell lymphoma have not yet been given with CHOP, this study is looking at combining CHOP with ONTAK. ONTAK has been FDA approved for treatment of Cutaneous T cell Lymphoma and works by specifically binding to a protein on the surface of the tumor cells and killing the cell without causing damage to other types of cells in the body. Studies have shown that ONTAK has helped patients with PTCL who have failed chemotherapy.

Detailed description:

Interventions: intervention 1: Ontak intervention 2: CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy
Intervention descriptions: intervention 1: ONTAK ( denileukin diftitox) is given at 18 mcg/kg/d (Days 1,2) plus CHOP therapy (Day 3) q 21 days x 6 cycles (cyclophosphamide 750 mg/m²IV, doxorubicin 50 mg/m²IV day, vincristine 1.4 mg/m²IV day, and prednisone 100 mg q day PO days #3-7) plus, G-CSF support beginning on Day 4 to prevent neutropenia intervention 2: ONTAK ( denileukin diftitox) is given at 18 mcg/kg/d (Days 1,2) plus CHOP therapy (Day 3) q 21 days x 6 cycles (cyclophosphamide 750 mg/m²IV, doxorubicin 50 mg/m²IV day, vincristine 1.4 mg/m²IV day, and prednisone 100 mg q day PO days #3-7) plus, G-CSF support beginning on Day 4 to prevent neutropenia

Protocol documents:
Clinical trial NCT00359216
Conditions: Perennial Allergic Rhinitis Obstructive Sleep Apnea Sleep Disorder
Keywords: Hypopnea Syndrome
Sponsor: Organon and Co
Start date: 2006-05-01; Completion date: 2008-01-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 4 randomized, placebo-controlled, parallel-group, single-center, double-blind study to evaluate the effects of mometasone furoate nasal spray (MFNS) in subjects with Sleep-disordered Breathing (SDB) associated with perennial allergic rhinitis (PAR) using Peak Nasal Inspiratory Flow (PNIF), Embletta device home-monitored cardiopulmonary evaluations, and rhinitis evaluations and questionnaires. Approximately 30 subjects 18 to 60 years of age with symptomatic PAR (with or without SAR) will be selected and randomized at one study site. The anticipated duration of subject participation in the study is approximately 39 days. Subjects who qualify at the Screening Visit will complete a 10-14 day run-in/screening period. Following the run-in period, subjects who meet the qualifications at the Baseline Visit will be treated with study medication for 4 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Mometasone furoate nasal spray intervention 2: Placebo
Intervention descriptions: intervention 1: MFNS, 50 mcg/spray. Each subject to take 200 mcg (4 sprays) once daily in the morning. intervention 2: Placebo nasal spray. Each subject to take 4 sprays once daily in the morning.

Protocol documents:
Clinical trial NCT00362232
Conditions: Venous Thromboembolism
Keywords: Prevention of venous thromboembolism
Sponsor: Bayer
Start date: 2006-06-01; Completion date: 2008-01-01
Enrollment: 3148 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.

Detailed description:

Arms: arm 1: Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening. arm 2: Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
Interventions: intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Enoxaparin intervention 3: Placebo: tablet of Rivaroxaban intervention 4: Placebo: syringes of Enoxaparin
Intervention descriptions: intervention 1: Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening. intervention 2: Syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening. intervention 3: Placebo tablet of rivaroxaban administered once daily in the evening. intervention 4: Placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.

Protocol documents:
Clinical trial NCT00368108
Conditions: Parkinson's Disease
Sponsor: Eisai Inc.
Start date: 2006-08-01; Completion date: 2008-01-01
Enrollment: 752 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study of E2007 in levodopa treated Parkinson's disease patients with motor fluctuations.

Detailed description:

Arms: arm 1: The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening. arm 2: The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening. arm 3: The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
Interventions: intervention 1: 2 mg perampanel intervention 2: 4 mg perampanel intervention 3: placebo comparator
Intervention descriptions: intervention 1: 2 mg perampanel intervention 2: 4 mg perampanel intervention 3: placebo comparator

Protocol documents:
Clinical trial NCT00368251
Conditions: Unverricht-Lundborg Disease
Keywords: Unverricht-Lundborg Disease Baltic Myoclonus Progressive Myoclonic Epilepsies Myoclonus Brivaracetam
Sponsor: UCB Pharma
Start date: 2006-11-01; Completion date: 2008-01-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will compare the efficacy and safety of Brivaracetam with placebo in patients with Unverricht- Lundborg Disease (ULD).

Detailed description:

Arms: arm 1: Placebo Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period) arm 2: Brivaracetam (BRV) 5 mg/day 5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period) arm 3: Brivaracetam (BRV) 150 mg/day 150 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
Interventions: intervention 1: Placebo intervention 2: BRV 2.5 mg intervention 3: BRV 25 mg intervention 4: BRV 50 mg
Intervention descriptions: intervention 1: * Pharmaceutical Form: Tablet
* Concentration: 2.5 mg, 25 mg and 50 mg
* Route of Administration: Oral use intervention 2: * Pharmaceutical Form: Tablet
* Concentration: 2.5 mg
* Route of Administration: Oral use intervention 3: * Pharmaceutical Form: Tablet
* Concentration: 25 mg
* Route of Administration: Oral use intervention 4: * Pharmaceutical Form: Tablet
* Concentration: 50 mg
* Route of Administration: Oral use

Protocol documents: