ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00709111
Conditions: HIV Infections
Keywords: CCR5 antagonist CD4 T-cell count immune activation treatment experienced
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Start date: 2009-01-01; Completion date: 2010-04-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Despite viral suppression, antiretroviral therapy (ART) does not restore CD4+ T-cell counts in some subjects. The purpose of this study is to assess whether adding maraviroc (MVC) to a suppressive ART will result in a significant CD4+ T-cell count increase over 24 weeks in subjects with suboptimal CD4+ T-cell recovery despite sustained virologic suppression.

Detailed description:
The majority of HIV-infected subjects with virologic suppression on antiretroviral therapy (ART) have a marked increase in CD4+ T-cell counts over the first year on treatment. However, a portion of these individuals show a suboptimal immune response and remain at an elevated risk for disease progression. The use of the CCR5 inhibitor maraviroc (MVC) is associated with enhanced CD4+ T-cell recovery in subjects who initiate ART. AIDS Clinical Trials Group (ACTG) A5256 studied the effect of ART intensification with MVC on CD4+ T-cell counts in subjects with suboptimal CD4 recovery despite sustained virologic suppression. Eligible subjects added MVC to their ART regimen, and continued MVC for 24 weeks. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC.

Subjects were seen through week 48 for clinical and laboratory evaluations, including plasma HIV-1 RNA, CD4+ T-cell count, and safety laboratories. Subjects had 2 baseline visits prior to starting MVC. Study visits were scheduled at weeks 4, 8, 12, 16, 22, 24, 36, 46, and 48. CD4+ T-cell counts were measured at every study visit and HIV-1 RNA at weeks 12, 24, 36, and 48, regardless of treatment status. Measures of activation, T-cell maturation, and apoptosis were performed at all weeks except 4, 8, and 16. At the end of the study, the pre-entry, entry, week 12, 22, 24, and 36 samples for the HIV-1 RNA by single-copy assay (SCA) were run. The week 46 and 48 samples were not run.

Arms: arm 1: Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Interventions: intervention 1: Maraviroc
Intervention descriptions: intervention 1: The maraviroc doses were 150 mg orally twice daily, 300 mg orally twice daily, or 600 mg orally twice daily, depending on the pharmacokinetic interaction with a subject's pre-study ART and non-ART drug regimen according to the package insert.

Protocol documents:
Clinical trial NCT00726752
Conditions: Neoplasms
Keywords: solid tumor Axitinib Pharmacokinetics Phase 1
Sponsor: Pfizer
Start date: 2008-07-01; Completion date: 2010-04-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses and multiple doses

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Axitinib (AG-013736)
Intervention descriptions: intervention 1: Three single dose level of AG-013736 (5 mg, 7 mg and 10 mg) will be given for all patient. After single dosing at each dose level, multiple doses of 5 mg twice a day (BID) will be started.

Protocol documents:
Clinical trial NCT00728988
Conditions: Acute Coronary Syndrome
Keywords: Asia Lipitor Pre-treatment in Acute Coronary Syndrome
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-09-01; Completion date: 2010-04-01
Enrollment: 499 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This present study is specifically designed to examine the efficacy and safety of a high pre-treatment dose of atorvastatin in Asian patients with NSTE-ACS in China and the Republic of Korea, by using a treatment paradigm similar to that employed in the ARMYDA-ACS study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Atorvastatin intervention 2: Atorvastatin
Intervention descriptions: intervention 1: 80mg 12 hours pre-Percutaneous Coronary Intervention (PCI), 40mg 2 hours pre-PCI and 40mg daily after PCI for 30 days. intervention 2: 40mg daily after PCI for 30 days.

Protocol documents:
Clinical trial NCT00737100
Conditions: Cystic Fibrosis
Sponsor: Boehringer Ingelheim
Start date: 2008-09-01; Completion date: 2010-04-01
Enrollment: 510 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations

Detailed description:

Arms: arm 1: patient to receive low dose tiotropium once daily arm 2: patient to receive high dose tiotropium once daily arm 3: patient to receive placebo once daily
Interventions: intervention 1: Placebo Respimat intervention 2: Tiotropium bromide 5 mcg intervention 3: tiotropium bromide-low dose-2.5mcg
Intervention descriptions: intervention 1: patient to receive placebo matching active drug once daily intervention 2: patient to recieve high dose tiotropium once daily intervention 3: patient to receive low dose tiotropium once daily

Protocol documents:
Clinical trial NCT00739648
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Patients
Sponsor: Amgen
Start date: 2008-10-01; Completion date: 2010-04-01
Enrollment: 322 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent acute exacerbations (AECB) which are associated with enormous healthcare expenditures and significant morbidity, specifically an increased risk of death, a decline in pulmonary function and a significant change in quality of life. Bacteria appear to have an important role in acute exacerbations in chronic bronchitis and COPD. Studies of acute exacerbations in COPD have shown a reduction in bacterial load with prolonged exacerbation-free interval. In addition, recent studies indicate that acquisition of a new strain of H. influenzae, M. catarrhalis, S. pneumoniae or P. aeruginosa are responsible for many of these exacerbations. Chronic inflammation and bacterial infection predispose many patients to frequent and recurrent acute exacerbations.

Mpex believes that intermittent administration of inhaled MP-376 in high risk patients will decrease the incidence of acute exacerbations by both by lowering the organism burden, and resultant inflammation, as well as pre-emptive eradication of any newly acquired bacterial strains.

Detailed description:
This study will be a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of MP-376 inhalation solution given daily for 5 days in a 28 day treatment cycle to COPD patients.

Study with completed results acquired from Horizon in 2024.

Arms: arm 1: Placebo inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles arm 2: MP-376 240 mg BID inhaled via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
Interventions: intervention 1: MP-376 intervention 2: Placebo
Intervention descriptions: intervention 1: MP-376 administered via inhalation for 5 consecutive days within 28-day treatment cycles for up to 12 cycles intervention 2: same frequency as study drug using the same method of delivery

Protocol documents:
Clinical trial NCT00740181
Conditions: Myelodysplasia Leukemia
Keywords: myelodysplasia refractory leukemia acute leukemia
Sponsor: Brown University
Start date: 2008-08-01; Completion date: 2010-04-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will determine the activity of decitabine, low dose cytarabine (ARA-C) and G-CSF for patients with myelodysplasia and leukemia.

Detailed description:
The primary objective of this study is to determine the feasibility and toxicity of decitabine, ARA-C and G-CSF for patients with myelodysplasia, refractory acute leukemia and poor performance status acute leukemia.

Arms: arm 1: Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
Interventions: intervention 1: chemotherapy
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00746551
Conditions: Anemia Pregnancy Complications
Keywords: iron deficiency anemia pregnancy third trimester intravenous iron efficacy a randomized trial Female Ferric Compounds/therapeutic use* Infusions, Intravenous Hematologic/therapy*
Sponsor: Mahidol University
Start date: 2008-09-01; Completion date: 2010-04-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of body iron storage replenishment between low dose intravenous iron and oral iron in late pregnancy.

Detailed description:
Despite routine antenatal oral iron supplementation, the prevalence of iron deficiency anemia (IDA) in the 3rd trimester of pregnancy in developing countries remains high. Apparently, intravenous iron sucrose appears to be safe and efficient in treating within a short period. From literature review, no study of intravenous iron for IDA treatment has been carried out in the third trimester of pregnancy. This research aims to compare the efficacy of body iron storage replenishment at 3 weeks as labor may take place at this point in some women. In this study,500 mg intravenous iron has been given weekly instead of every other day for the sake of patient's convenience in the hope that parenteral iron may become another alternative for treatment of pregnant women with iron deficiency anemia who have difficulties or failures with oral iron.

Arms: arm 1: In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out. arm 2: Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution.
Interventions: intervention 1: Ferli-6® (Continental Pharm co., ltd.) intervention 2: Venofer® (Vifor AG, St. Gallen, Switzerland)
Intervention descriptions: intervention 1: In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out. intervention 2: Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution.

Protocol documents:
Clinical trial NCT00757588
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Start date: 2008-11-01; Completion date: 2010-04-01
Enrollment: 455 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks.

Detailed description:

Arms: arm 1: Saxagliptin, 5 mg, plus insulin, administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin arm 2: Placebo administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin
Interventions: intervention 1: Saxagliptin, 5 mg + insulin intervention 2: Placebo + insulin
Intervention descriptions: intervention 1: Saxagliptin, 5-mg tablets (plus stable insulin dose), given orally once daily (24 weeks short-term, 28 weeks long-term); participants stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue) intervention 2: Placebo tablets given orally once daily for 24 weeks (short-term period)+ insulin with metformin

Protocol documents:
Clinical trial NCT00768053
Conditions: Rheumatoid Arthritis
Keywords: EULAR-RAID active rheumatoid arthritis etanercept
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2008-10-01; Completion date: 2010-04-01
Enrollment: 108 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The Disease Activity Score (DAS) is a system of measurement developed in the 1980s that uses certain criteria, including joint counts and patient perceived disease activity, to measure disease activity in people with Rheumatoid Arthritis . More recently, the European League against Rheumatism (EULAR) has developed a new system of measurement known as the Rheumatoid Arthritis Impact of Disease score, or EULAR-RAID score. The EULAR-RAID score is a composite score based on patient reported outcomes, and includes such criteria as pain, functional disability, fatigue, sleep disturbances, coping, overall assessment of physical well being and overall assessment of psychological well being. The objective of this study is to evaluate the practical modalities and performance of the EULAR- RAID score in patients with rheumatoid arthritis who have been prescribed etanercept as part of usual medical practice.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Etanercept
Intervention descriptions: intervention 1: Etanercept 50 mg once a week

Protocol documents:
Clinical trial NCT00775411
Conditions: Choroidal Neovascularization Age-Related Maculopathy
Sponsor: Allergan
Start date: 2008-11-01; Completion date: 2010-04-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant as adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with choroidal neovascularization secondary to age-related macular degeneration. Subjects will be followed for 26 weeks.

Detailed description:

Arms: arm 1: 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.
Interventions: intervention 1: dexamethasone intervention 2: ranibizumab
Intervention descriptions: intervention 1: 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. intervention 2: Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.

Protocol documents:
Clinical trial NCT00777608
Conditions: Alzheimer's Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-12-01; Completion date: 2010-04-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the performance of the CogState computerized neuropsychological battery, Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) in participants with mild-to-moderate Alzheimer's disease (AD).

Detailed description:

Arms: arm 1: There will be a 14 day period when all participants will receive placebo, followed by 5 mg donepezil, once daily for 14 days then titrated to 10 mg donepezil once daily for 70 days. Participants may then receive open-label donepezil for an additional 24 weeks. arm 2: There will be a 14 day period when all participants will receive placebo. Participants will take placebo capsules orally, once daily for 84 days. Participants may then receive open-label donepezil for an additional 24 weeks.
Interventions: intervention 1: Comparator: Placebo 5mg (run in) intervention 2: Donepezil 5 - 10 mg intervention 3: Comparator: Placebo 5-10 mg intervention 4: Donepezil 10 mg
Intervention descriptions: intervention 1: Matching placebo to donepezil - 5 mg capsules orally for 14 day run in prior to randomization. intervention 2: Donepezil 1 capsule (5 mg) orally, once daily for 14 days.

Donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84). intervention 3: Matching placebo to donepezil, 1 capsule (5 mg) orally, once daily for 14 days.

Matching placebo to donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84). intervention 4: Donepezil 2 capsules (total 10 mg) orally, once daily for 24 weeks, from day 85 (optional).

Protocol documents:
Clinical trial NCT00781859
Conditions: Vitreomacular Adhesion
Sponsor: ThromboGenics
Start date: 2008-12-01; Completion date: 2010-04-01
Enrollment: 326 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to evaluate the safety and efficacy of intravitreal microplasmin 125µg dose in subjects wiht focal vitreomacular adhesion.

Detailed description:

Arms: arm 1: 125µg intravitreal injection of ocriplasmin arm 2: placebo intravitreal injection
Interventions: intervention 1: 125 µg Ocriplasmin intervention 2: Placebo
Intervention descriptions: intervention 1: 125µg ocriplasmin intravitreal injection intervention 2: Placebo intravitreal injection

Protocol documents:
Clinical trial NCT00783094
Conditions: Benign Prostatic Hyperplasia
Sponsor: Eli Lilly and Company
Start date: 2008-11-01; Completion date: 2010-04-01
Enrollment: 422 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a randomized, double-blind, placebo-controlled, parallel-design to compare the efficacy and safety of tadalafil once-a-day dosing versus placebo for 12 weeks followed by an open-label extension to evaluate the long-term safety and efficacy of tadalafil in Japanese men with signs and symptoms of benign prostatic hyperplasia.

Detailed description:

Arms: arm 1: 2.5 mg tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks. arm 2: 5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks. arm 3: Placebo tablet taken by mouth once a day for 12 weeks.

Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Interventions: intervention 1: Tadalafil 2.5 mg intervention 2: Tadalafil 5 mg intervention 3: Placebo
Intervention descriptions: intervention 1: oral, daily intervention 2: oral, daily intervention 3: oral, daily

Protocol documents:
Clinical trial NCT00785772
Conditions: Renal Impairment
Keywords: Gabapentin Pharmacokinetics
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2010-03-01; Completion date: 2010-04-01
Enrollment: 1 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of this study are to evaluate the pharmacokinetics (PK) following administration of gabapentin in Japanese epileptic patients with renal impairment to confirm if there are any clinically relevant differences between the plasma gabapentin concentration simulated by population PK model, which was used for the evidence of the dose adjustment for the patients with renal impairment, and observed plasma gabapentin concentration.

Detailed description:
Only one subject was able to be enrolled. Given enrollment challenges to identify additional appropriate subjects, discussion was held with the Japan Pharmaceuticals and Medical Devices Agency (PMDA) and it was agreed with the PMDA to terminate this study. The study was terminated on December 14, 2010. The study was not terminated due to any safety findings.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Gabapentin intervention 2: Gabapentin intervention 3: Gabapentin
Intervention descriptions: intervention 1: 100-200mg once a day intervention 2: 200-500mg once a day intervention 3: 400-1000mg (200-500 mg twice a day)

Protocol documents:
Clinical trial NCT00798096
Conditions: T Cell Lymphoma
Keywords: T Cell Lymphoma Lymphoma
Sponsor: Rigel Pharmaceuticals
Start date: 2009-03-01; Completion date: 2010-04-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients meeting specific inclusion and exclusion criteria will be enrolled in two stages, 19 patients in Stage 1 and 36 patients in Stage 2. Stage 2 will enroll if 4 or more patients exhibit a response at Week 8 or later in the study. All enrolled patients will be treated with Fostamatinib Disodium until disease progression. Efficacy will be assessed by tumor measurements using CT and PET (when indicated) scans and physical exam at baseline, and scans and physical exam of all disease-involved areas every 8 weeks until progression. Safety will be assessed by periodic physical exams, clinical laboratory studies, and adverse events. All patients will have a follow-up visit 30 days following last study drug treatment. Blood samples for PK assessment will be obtained from all patients enrolled in Stage 1 at protocol defined intervals.

Detailed description:
Up to 61 patients (male and female) meeting the inclusion and exclusion criteria will be enrolled into this trial in two stages. All enrolled patients will be treated with R788 at 200 mg PO bid until disease progression. In the initial stage of the study, a total of 19 patients will be enrolled and treated with Fostamatinib Disodium. Should at least 4 patients exhibit a response at Week 8 or later of the study, the second stage of 36 patients will open to enrollment. Efficacy will be assessed by CT and PET scans (when indicated) and physical exam at baseline, and CT scans and physical exam of all disease-involved areas every 8 weeks until progression. Safety will be assessed by periodic physical exams, clinical laboratory studies, and adverse events. All patients will have a follow-up visit 30 days following last study drug treatment. Blood samples for PK assessment will be obtained from all patients enrolled in Stage 1 at protocol-defined intervals. Patients with accessible tumor tissue will be asked to undergo a biopsy for a fresh tissue sample for assessment of Syk activity in tumor tissue. Archived tissue samples from the initial diagnostic biopsy and the most recent biopsy for lymphoma will be obtained in the event a fresh tumor biopsy cannot be obtained. Patients who have accessible tumor tissue will be asked to consent to a second tumor biopsy at Week 8, to assess the impact of Fostamatinib Disodium treatment on the activity of Syk and its downstream markers. All baseline fresh or archived tumor tissue samples will undergo central pathology review to confirm the diagnosis of TCL.

Arms: arm 1: None
Interventions: intervention 1: Fostamatinib Disodium
Intervention descriptions: intervention 1: 200 mg PO BID

Protocol documents: