ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01155375
Conditions: Iron Deficiency Anemia
Keywords: Iron deficiency anemia Feraheme ferumoxytol CKD pediatric dialysis-dependent nondialysis-dependent
Sponsor: AMAG Pharmaceuticals, Inc.
Start date: 2011-10-17; Completion date: 2014-06-24
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral iron for the treatment of pediatric participants with chronic kidney disease (CKD).

Detailed description:
Study AMAG-FER-CKD-251 was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with dialysis-dependent CKD. Study AMAG-FER-CKD-252 (NCT01155388) was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with nondialysis-dependent CKD. Due to significant challenges with enrollment for both studies, Study AMAG-FER-CKD-252 was combined with Study AMAG-FER-CKD-251 and enrollment continued under Study AMAG-FER-CKD-251. The enrollment number (n=14) includes the number of participants for both AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies, combined.

Participants were enrolled by age cohorts in a stepwise manner following a safety review by the Data Safety Monitoring Board of 1 age cohort prior to enrollment of a subsequent age cohort, with progression from oldest to youngest: Randomization was stratified by the following age cohorts: 12 to \<18 years, 6 to \<12 years, 2 to \<6 years, and 6 months to \<2 years.

Arms: arm 1: Participants will receive 1 of the following 2 ferumoxytol dose regimens:

* Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3\* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). \*Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.
* Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9. arm 2: Participants will receive oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
Interventions: intervention 1: Ferumoxytol intervention 2: Oral Iron
Intervention descriptions: intervention 1: Experimental: Ferumoxytol intervention 2: Active Comparator: Oral iron

Protocol documents:
Clinical trial NCT01155388
Conditions: Iron Deficiency Anemia Nondialysis-dependent Chronic Kidney Disease
Keywords: Iron deficiency anemia Feraheme ferumoxytol CKD pediatric nondialysis-dependent
Sponsor: AMAG Pharmaceuticals, Inc.
Start date: 2011-10-17; Completion date: 2014-06-24
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral iron for the treatment of pediatric participants with chronic kidney disease (CKD).

Detailed description:
Study AMAG-FER-CKD-252 was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with nondialysis-dependent CKD. Study AMAG-FER-CKD-251 (NCT01155375) was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with dialysis-dependent CKD. Due to significant challenges with enrollment for both studies, Study AMAG-FER-CKD-252 was combined with Study AMAG-FER-CKD-251 and enrollment continued under Study AMAG-FER-CKD-251. The enrollment number (n=14) includes the number of participants for both AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies, combined.

Participants were enrolled by age cohorts in a stepwise manner following a safety review by the Data Safety Monitoring Board of 1 age cohort prior to enrollment of a subsequent age cohort, with progression from oldest to youngest. Randomization was stratified by the following age cohorts: 12 to \<18 years, 6 to \<12 years, 2 to \<6 years, and 6 months to \<2 years.

Arms: arm 1: Participants will receive 1 of the following 2 ferumoxytol dose regimens:

* Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3\* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). \*Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.
* Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9. arm 2: Participants will receive oral iron: 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
Interventions: intervention 1: Ferumoxytol intervention 2: Oral Iron
Intervention descriptions: intervention 1: Experimental: Ferumoxytol intervention 2: Active Comparator: Oral iron

Protocol documents:
Clinical trial NCT01590771
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-07-09; Completion date: 2014-06-24
Enrollment: 498 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to compare safety and efficacy of sitagliptin and placebo therapy when added to stable sulfonylurea alone or in combination with metformin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the addition of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in T2DM participants on sulfonylurea alone or in combination with metformin.

Detailed description:

Arms: arm 1: Sitagliptin 100 mg once daily for 24 weeks. Participants will continue pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during run-in period. arm 2: Matching placebo once daily for 24 weeks. Participants will continue pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
Interventions: intervention 1: Sitagliptin intervention 2: Placebo intervention 3: Gliclazide intervention 4: Glimepiride intervention 5: Metformin
Intervention descriptions: intervention 1: Sitagliptin 100 mg oral tablet once daily for 24 weeks intervention 2: Matching placebo to sitagliptin oral tablet once daily for 24 weeks intervention 3: Participants will continue ongoing open-label therapy with gliclazide (dosed according to the China drug label) throughout the study. intervention 4: Participants will continue ongoing open-label therapy with glimepiride (dosed according to the China drug label) throughout the study. intervention 5: Participants will continue ongoing open-label therapy with metformin (at least 1500 mg daily) throughout the study.

Protocol documents:
Clinical trial NCT02014376
Conditions: Epidermolysis Bullosa
Keywords: Epidermolysis Bullosa Simplex Recessive Dystrophic Junctional non-Herlitz Amicus Therapeutics Scioderm, Inc. SD-101 6% SD-101-6.0 Allantoin 6% SD-101 3% SD-101-3.0 Allantoin 3% Zorblisa
Sponsor: Scioderm, Inc.
Start date: 2014-01-06; Completion date: 2014-06-24
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess whether the topical use of SD-101 cream (3% or 6%) was effective in treating wounds in participants with Simplex, Recessive Dystrophic, or Junctional non-Herlitz Epidermolysis Bullosa (EB).

Detailed description:
This was a Phase 2b, multi-center, randomized, double-blind, vehicle-controlled study to assess the efficacy and safety of SD-101 dermal cream (3% or 6%) on skin lesions in participants with Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB.

SD-101 cream \[containing 3% or 6% or vehicle (0%)\] was applied topically, once a day to the entire body for a period of 90 days. Eligible participants had a target wound assessed at baseline. Selected target wound had to be at least a certain age and within a prespecified size range at study entry. Photographic confirmation of the target wound location was collected at baseline, and the picture saved from the first visit was used to confirm location of the target wound at subsequent visits. The participant returned to the study site at Week 2, Month 1, Month 4, and Month 5 (at 14, 30, 60, and 90 days, respectively) to have the target wound previously identified at baseline re-assessed for the level of healing. In addition, changes in itching, pain, body surface area coverage of blisters and lesions, and scaring of the healed target wound were also assessed at each visit.

Arms: arm 1: SD-101 dermal cream (6%) applied topically once daily over the entire body for 90 days. arm 2: SD-101 dermal cream (3%) applied topically once daily over the entire body for 90 days. arm 3: Vehicle dermal cream (SD-101 0%) applied topically once daily over the entire body for 90 days.
Interventions: intervention 1: SD-101 dermal cream (3%) intervention 2: SD-101 Dermal Cream (6%) intervention 3: Vehicle (SD-101 0%)
Intervention descriptions: intervention 1: SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-3.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 3% and other excipients. intervention 2: SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 6% and other excipients. intervention 3: A white, crystalline powder that is formulated within an odorless, soft, white cream base. It contains no allantoin, only excipients.

Protocol documents:
Clinical trial NCT00858013
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus Nateglinide Pancreatic beta cell function
Sponsor: Ajou University School of Medicine
Start date: 2009-04-24; Completion date: 2014-06-25
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multi-center, randomized controlled study aims to evaluate the durability and efficacy of nateglinide therapy for long term glycemic control compared with glimepiride.

Detailed description:
Selected patients will be randomly assigned to receive nateglinide or glimepiride.

Previous treatment with oral antidiabetic drugs (metformin, a-glucosidase inhibitor, nateglinide or sulfonylurea) will be discontinued. After a 1 month wash-out period (if 6.5 ≤ HbA1c ≤ 8.5), patients will take randomly assigned drugs for 24 months.

Patients will be met by the trial investigator every 3 months following randomization. At each visit, patients whose HbA1c is \> 8.0% will be retested 2 weeks later, and if the retested HbA1c is also above 8.0%, those patients will be withdrawn considering monotherapy failure. We will evaluate the durability of nateglinide in comparison with that of glimepiride based on the withdrawal rate.

Arms: arm 1: Nateglinide 90\~120mg three times a day arm 2: Glimepiride 1\~2mg once a day
Interventions: intervention 1: Nateglinide intervention 2: Glimepiride
Intervention descriptions: intervention 1: Nateglinide 90\~120mg three times a day intervention 2: Glimepiride 1\~2mg once a day

Protocol documents:
Clinical trial NCT01590797
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-07-10; Completion date: 2014-06-25
Enrollment: 467 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to compare safety and efficacy of sitagliptin and placebo therapy when added to stable insulin alone or in combination with metformin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the addition of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in T2DM participants on insulin alone or in combination with metformin.

Detailed description:

Arms: arm 1: Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period. arm 2: Participants treated with placebo matching sitagliptin, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
Interventions: intervention 1: Sitagliptin intervention 2: Placebo intervention 3: Insulin intervention 4: Metformin
Intervention descriptions: intervention 1: Sitagliptin 100 mg once daily for 24 weeks intervention 2: Matching placebo once daily for 24 weeks intervention 3: Participants can be on on pre-mixed (mixture of rapid- and long-acting insulin) or intermediate- or long-acting insulin at a dose of at least 12 U/day. intervention 4: At randomization, participants will be stratified according to their use of metformin (on or not on). All participants receiving metformin will be required to be on a daily dose of metformin at least 1500 mg per day.

Protocol documents:
Clinical trial NCT01765426
Conditions: Healthy Volunteers
Keywords: Prophylactic vaccination
Sponsor: Takeda
Start date: 2013-02-15; Completion date: 2014-06-26
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety, tolerability and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] when administered intradermally in varied dosing schedules and via different methods of administration (conventional needle/syringe versus needle-free PharmaJet® injector).

Detailed description:
This is an exploratory trial to assess the safety, tolerability and immunogenicity of vaccination with a tetravalent dengue vaccine (TDV) in healthy adults delivered intradermally using the conventional needle/syringe or a needle-free PharmaJet® injector.

Two (2) intradermal injections of either vaccine or placebo will be administered to qualified participants (one in each arm) on Day 0 of the study. A subsequent injection will also be given on Day 90 with either vaccine or placebo (in one arm only).

Participants will be evaluated for safety and dengue neutralizing antibody to all four serotypes. All participants will also be evaluated for injection site reactions and have blood drawn for viremia, neutralizing antibodies, cell mediated immunity and innate immunity.

Participants will be required to participate for approximately 10 months from recruitment and collection of data for primary outcomes (through Day 120) including collection of additional samples for measurement of longer term antibody titers (through Day 270).

This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201000034C.

Arms: arm 1: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. arm 2: TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. arm 3: TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. arm 4: TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
Interventions: intervention 1: TDV intervention 2: Placebo
Intervention descriptions: intervention 1: TDV suspension for intradermal administration intervention 2: Phosphate buffered saline (PBS)

Protocol documents:
Clinical trial NCT01400412
Conditions: HIV-1 Infection
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Start date: 2012-01-17; Completion date: 2014-06-30
Enrollment: 262 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study was to compare the effects on bones of the following two drug combinations:

* maraviroc (MVC), emtricitabine (FTC), plus darunavir/ritonavir (DRV/r)
* tenofovir (TDF) plus emtricitabine (FTC) plus darunavir/ritonavir (DRV/r)

Additional study objectives were the following:

* To see how the drug combinations affect the brain and kidneys.
* To see how well the drug combinations lower the HIV viral load.
* To see how safe the drug combinations are, how well people are able to take the study drug combinations, and how well their immune systems respond to the study drugs.

Detailed description:
There are now several HIV treatment options for a person with HIV infection who has not yet been treated. Most people who receive treatment and take their medications as directed have a good result. This is usually determined by measuring the amount of HIV in the blood (viral load). The best response is when HIV cannot be found (less than 50 copies/mL) in the blood. However, it has recently become clear that some people with HIV who are receiving effective HIV drugs continue to have more health problems than people without HIV infection. Sometimes, there is damage to organs in the body, including bone, kidneys, and the brain.

Arms: arm 1: Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD arm 2: Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD
Interventions: intervention 1: Darunavir intervention 2: Ritonavir intervention 3: Tenofovir disoproxil fumarate intervention 4: Emtricitabine intervention 5: Placebo for Tenofovir disoproxil fumarate intervention 6: Placebo for Maraviroc intervention 7: Maraviroc
Intervention descriptions: intervention 1: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. intervention 2: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. intervention 3: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. intervention 4: Emtricitabine was administered orally once a day as one 200 mg capsule. intervention 5: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. intervention 6: Placebo for maraviroc was administered orally once a day as one tablet. intervention 7: Maraviroc was administered orally once a day as one 150 mg tablet.

Protocol documents:
Clinical trial NCT00123474
Conditions: Myeloid Leukemia, Chronic, Chronic-Phase
Keywords: Chronic Phase Chronic Myelogenous Leukemia
Sponsor: Bristol-Myers Squibb
Start date: 2005-07-01; Completion date: 2014-07-01
Enrollment: 724 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: dasatinib intervention 2: dasatinib intervention 3: dasatinib intervention 4: dasatinib
Intervention descriptions: intervention 1: Tablets, Oral, 50 mg BID, indefinitely, survival study intervention 2: Tablets, Oral, 70 mg BID, indefinitely, survival study intervention 3: Tablets, Oral, 100 mg QD, indefinitely, survival study intervention 4: Tablets, Oral, 140 mg QD, indefinitely, survival study

Protocol documents:
Clinical trial NCT00368472
Conditions: Epilepsy
Keywords: Refractory Partial Seizures
Sponsor: Eisai Inc.
Start date: 2006-10-01; Completion date: 2014-07-01
Enrollment: 138 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety of perampanel given as adjunctive, long-term treatment in patients with refractory partial onset seizures.

Detailed description:
This is an Open-Label Extension (OLE) study for patients who completed the E2007-A001-206 (NCT00144690) or the E2007-G000-208 (NCT00416195) double-blind, placebo-controlled, dose-escalation, parallel-group studies.

This study consisted of 3 periods: OLE Titration (12 weeks), OLE Maintenance (424 weeks), and OLE Follow-up (4 weeks). During the OLE Titration Period, participants were titrated to their maximum tolerated dose (MTD) of perampanel, up to a maximum of 12 mg/day. The OLE Maintenance Period began at completion of the OLE Titration Period; participants remained on the dose achieved at the end of the OLE Titration Period unless dose adjustment for tolerability reasons was necessary. Participants who either withdrew from the study prematurely or completed the OLE Maintenance Period returned for a final visit at the end of the 4-week OLE Follow-up Period.

Arms: arm 1: Participants previously receiving placebo/perampanel in the double blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily during the OLE study
Interventions: intervention 1: Perampanel
Intervention descriptions: intervention 1: Perampanel 2 mg to 12 mg, once daily during the OLE study

Protocol documents:
Clinical trial NCT00998296
Conditions: Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2009-10-01; Completion date: 2014-07-01
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this trial is to determine the Maximum Tolerated Dose (MTD) of the combination of BIBW 2992/BIBF 1120 therapy administered concomitantly. The MTD will provide dosing recommendation for subsequent phase II trials in patients with metastatic cancer.

Detailed description:

Arms: arm 1: This is a phase I dose escalation clinical trial and the data obtained shall determine the MTD for the combination of BIBW 2992/BIBF 1120 in 28-day of treatment.
Interventions: intervention 1: BIBW 2992 intervention 2: BIBF 1120
Intervention descriptions: intervention 1: EGFR inhibitor intervention 2: VEGF inhibitor

Protocol documents:
Clinical trial NCT01061177
Conditions: CML in Chronic Phase
Keywords: Leukemia myeloid myelogenous chronic BCR-ABL positive Nilotinib Philadelphia chromosome CML in chronic phase
Sponsor: Novartis Pharmaceuticals
Start date: 2010-05-01; Completion date: 2014-07-01
Enrollment: 1090 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase. The aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.

Detailed description:

Arms: arm 1: This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Interventions: intervention 1: Nilotinib
Intervention descriptions: intervention 1: Nilotinib was supplied by Novartis as 150 mg hard gelatin capsules in bottles. Nilotinib was dosed on a flat scale and not dosed by body weight. This form of supply was continued for all participants entered into the core study.

Protocol documents: