ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02337738
Conditions: Parkinson's Disease
Sponsor: Takeda
Start date: 2015-01-27; Completion date: 2016-09-17
Enrollment: 404 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (0.5 mg or 1 mg/day) as an add-on to levodopa in Japanese participants with Parkinson's disease with wearing-off phenomenon.

Detailed description:
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, phase 2/3 study to evaluate the efficacy and safety of TVP-1012 as an add-on to levodopa in Japanese participants with Parkinson's disease with wearing-off phenomenon.

The study period consisted of a 28-week trial period. The participants who fulfilled the inclusion criteria and did not meeting any of the exclusion criteria were enrolled, and randomized in a 1:1:1 ratio to the 0.5 mg of TVP-1012, the 1 mg of TVP-1012, or the placebo group. In each treatment group, participants received 0.5 mg of TVP-1012, 1 mg of TVP-1012, or placebo once daily in a double-blinded manner.

Arms: arm 1: TVP-1012 1 mg once daily orally, before or after breakfast, concomitantly with levodopa tablet for 26 weeks as treatment period after 2 weeks of run-in period. arm 2: TVP-1012 0.5 mg once daily orally, before or after breakfast, concomitantly with levodopa tablet for 26 weeks as treatment period after 2 weeks of run-in period. arm 3: One placebo tablet once daily orally, before or after breakfast, concomitantly with levodopa tablet for 26 weeks as treatment period after 2 weeks of run-in period.
Interventions: intervention 1: TVP-1012 1mg intervention 2: TVP-1012 0.5mg intervention 3: Placebo
Intervention descriptions: intervention 1: TVP-1012 1mg Tablets intervention 2: TVP-1012 0.5mg Tablets intervention 3: Placebo Tablets

Protocol documents:
Clinical trial NCT02098109
Conditions: Multiple Myeloma Lymphoma, Non-Hodgkin
Sponsor: Washington University School of Medicine
Start date: 2014-08-20; Completion date: 2016-09-18
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the results of stem cell mobilization using drugs called filgrastim (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02 filgrastim (Granix) and plerixafor.

Detailed description:
This study will compare the results of stem cell mobilization using drugs called filgrastim (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02 filgrastim (Granix) and plerixafor. The FDA has determined that Granix is biosimilar to Neupogen, which means that they are similar in terms of quality, safety, and efficacy; however, Granix has not been tested in the context of stem cell mobilization to see how its effectiveness compares to that of Neupogen

Arms: arm 1: * XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
* Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
* Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
* Patients who undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be followed through Day +100 post-infusion (+/- 30 days) to assess for transplant outcomes (neutrophil and platelet engraftment, and readmission rate). Patients who successfully mobilize \> 2.0 x 10\^6 CD34+ cells/kg but do not undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be discontinued from follow-up. arm 2: * Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met)
* Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met)
* Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
* Patients who undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be followed through Day +100 post-infusion (+/- 30 days) to assess for transplant outcomes (neutrophil and platelet engraftment, and readmission rate). Patients who successfully mobilize \> 2.0 x 10\^6 CD34+ cells/kg but do not undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be discontinued from follow-up.
Interventions: intervention 1: XM02 Filgrastim intervention 2: Filgrastim intervention 3: Apheresis intervention 4: Plerixafor intervention 5: Stem Cell Transplant
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT02388295
Conditions: Multiple System Atrophy, MSA
Keywords: Multiple System Atrophy (MSA), PET imaging, myeloperoxidase (MPO) inhibitor
Sponsor: AstraZeneca
Start date: 2015-04-27; Completion date: 2016-09-19
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
AZD3241 myeloperoxidase (MPO) inhibitor trial is assessing safety and tolerability, randomized trial, in patients with Multiple System Atrophy.

Detailed description:

Arms: arm 1: Subjects will be randomized to one of the two doses of AZD3241 or placebo in a 1:1:1 ratio. arm 2: Subjects will be randomized to one of the two doses of AZD3241 or placebo in a 1:1:1 ratio.
Interventions: intervention 1: AZD3241 intervention 2: Placebo
Intervention descriptions: intervention 1: Drug: AZD3241 administered for 12 weeks orally as a tablet. intervention 2: Placebo to match AZD3241 administered for 12 weeks orally as a tablet.

Protocol documents:
Clinical trial NCT02284893
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Start date: 2014-09-09; Completion date: 2016-09-20
Enrollment: 461 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks.

Detailed description:

Arms: arm 1: Saxagliptin 5 mg and matching placebo 0 mg (once daily) plus Dapagliflozin 10 mg and matching placebo 0 mg (once daily) arm 2: Sitagliptin 100 mg and matching placebo 0 mg (once daily)
Interventions: intervention 1: Saxagliptin intervention 2: Dapagliflozin intervention 3: Sitagliptin intervention 4: Placebo matching with Saxagliptin intervention 5: Placebo matching with Dapagliflozin intervention 6: Placebo matching with Sitagliptin
Intervention descriptions: intervention 1: administered orally once daily intervention 2: administered orally once daily intervention 3: administered orally once daily intervention 4: administered orally once daily intervention 5: administered orally once daily intervention 6: administered orally once daily

Protocol documents:
Clinical trial NCT02453685
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2015-08-31; Completion date: 2016-09-20
Enrollment: 335 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted globally. The aim of this trial is to compare stepwise insulin intensification of biphasic insulin aspart (BIAsp) 30 and basal-bolus therapy with insulin glargine and insulin aspart in insulin naïve type 2 diabetic patients inadequately controlled on oral anti-diabetic therapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: biphasic insulin aspart 30 intervention 2: insulin glargine intervention 3: insulin aspart
Intervention descriptions: intervention 1: Injected s.c./subcutaneously once daily with the largest meal Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued. intervention 2: Injected s.c./subcutaneously once daily at the same time every day, with the possibility of treatment intensification with insulin aspart (Basal-bolus arm) Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued. intervention 3: Injected s.c./subcutaneously once daily.

Protocol documents:
Clinical trial NCT02743780
Conditions: Ocular Hypertension Open-Angle Glaucoma
Keywords: Ocular Hypertension Open-Angle Glaucoma POAG Glaucoma
Sponsor: Alcon Research
Start date: 2016-03-02; Completion date: 2016-09-20
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the clinical profile of topical-ocular MGV354 merits further development for the indication of lowering intraocular pressure (IOP).

Detailed description:
Part 1 will evaluate the safety and tolerability of single ascending doses of MGV354 compared to placebo in healthy male and female subjects. Part 2 will evaluate the safety and tolerability of MGV354 in a multiple ascending dose design (two highest tolerated doses from Part 1) compared to placebo when administered for 7 days to patients with ocular hypertension or glaucoma. Part 3 will explore the safety, tolerability and efficacy of a single dose level of MGV354 (maximum tolerated dose) compared to placebo when administered for 7 days in patients with ocular hypertension or glaucoma.

Arms: arm 1: Part 3: MGV354 ophthalmic suspension, 1 drop in both eyes once per day for 7 days arm 2: Part 3: MGV354 placebo, 1 drop in both eyes once per day for 7 days
Interventions: intervention 1: MGV354 ophthalmic suspension intervention 2: MGV354 placebo
Intervention descriptions: intervention 1: None intervention 2: Inactive ingredients used as placebo comparator

Protocol documents:
Clinical trial NCT02780713
Conditions: Breast Cancer
Keywords: Breast cancer Healthy volunteers Pharmacokinetics AZD9496 Safety Tolerability
Sponsor: AstraZeneca
Start date: 2016-06-02; Completion date: 2016-09-20
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase 1 open label single centre study of AZD9496 administered orally in healthy volunteers. The study design involves single administration of different forms, formulations and doses of AZD9496. The study is designed to investigate these different AZD9496 variants. The study will evaluate the pharmacokinetic profiles and the safety and tolerability of the different forms, formulations and doses of AZD9496

This is a fixed sequence study with 5-sequential treatment periods in healthy volunteers. Each volunteer will receive 5 single doses of AZD9496 in different forms, formulations and doses.

Detailed description:
A phase 1, open-label, single centre study to assess the pharmacokinetics, Safety and tolerability of different forms, formulations and doses of AZD9496 in healthy volunteers. This is a fixed sequence study with 5-sequential treatment periods. Each subject will receive 5 single doses of AZD9496 in different forms, formulations and doses.

* Treatment period one will assess AZD9496 Variant A: 100mg.
* Treatment period two will assess AZD9496 Reference form: 100mg.
* Treatment period 3 will assess one of AZD9496 Variants, B, C or D: 100mg.
* Treatment period 4 will assess one of AZD9496 Variants, B, C or D: 100mg.
* Treatment period 5 will assess one of AZD9496 Variants A, B, C or D: \*300mg. \*Based on a review of pharmacokinetic and safety results from Treatment Periods 1, 3 and 4, a lower dose of 200 mg may be administered in Treatment Period 5.

Arms: arm 1: This is a fixed sequence study with 5-sequential treatment periods in healthy volunteers. Each volunteer will receive 5 single doses of AZD9496 in different forms, formulations and doses.

1. Treatment period 1 will assess AZD9496 Variant A: 100mg.
2. Treatment period 2 will assess AZD9496 Reference: 100mg.
3. Treatment period 3 will assess one of AZD9496 Variants, B, C or D: 100mg.
4. Treatment period 4 will assess one of AZD9496 Variants, B, C or D: 100mg.
5. Treatment period 5 will assess one of AZD9496 Variants A, B, C or D: \*300mg. \*Based on a review of PK and safety results from Treatment Periods 1, 3 and 4, a lower dose of 200 mg may be administered in Treatment Period 5
Interventions: intervention 1: AZD9496 (Reference) intervention 2: AZD9496 Variant A intervention 3: AZD9496 Variant B intervention 4: AZD9496 Variant C intervention 5: AZD9496 Variant D
Intervention descriptions: intervention 1: AZD9496 (Reference) intervention 2: AZD9496 Variant A. intervention 3: AZD9496 Variant B intervention 4: AZD9496 Variant C intervention 5: AZD9496 Variant D

Protocol documents:
Clinical trial NCT02486627
Conditions: Complicated Urinary Tract Infection Acute Pyelonephritis
Keywords: cUTI AP ACHN-490 anti-infective anti-bacterial antibiotic anti-microbial UTI bacterial infection Gram-negative
Sponsor: Achaogen, Inc.
Start date: 2016-01-11; Completion date: 2016-09-22
Enrollment: 609 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a randomized, multicenter, multinational, double-blind study comparing the efficacy and safety of plazomicin compared with meropenem followed by optional oral (PO) therapy in the treatment of cUTI, including AP, in adults.

Detailed description:

Arms: arm 1: Patients received 15 milligrams per kilogram (mg/kg) plazomicin as an intravenous (IV) infusion once daily followed by matching placebo infusions 8 and 16 hours later. After a minimum of 4 days of IV plazomicin, patients could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral). arm 2: Patients received 1.0 g meropenem as an IV infusion every 8 hours (q8h). After a minimum of 4 days of IV meropenem, patients could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral).
Interventions: intervention 1: plazomicin intervention 2: meropenem intervention 3: levofloxacin (oral)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02767947
Conditions: Tinea Corporis
Sponsor: Bausch Health Americas, Inc.
Start date: 2016-02-08; Completion date: 2016-09-22
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study was to evaluate the safety, efficacy, and pharmacokinetics of luliconazole cream 1% when applied topically for 7 days in pediatric participants 2 years to 17 years of age (inclusive) with tinea corporis.

Detailed description:

Arms: arm 1: Luliconazole cream 1% will be applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area. arm 2: Vehicle cream (containing no active ingredient) will be applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
Interventions: intervention 1: Luliconazole Cream 1% intervention 2: Vehicle Cream
Intervention descriptions: intervention 1: Luliconazole cream will be applied per schedule specified in the arm. intervention 2: Vehicle cream will be applied per schedule specified in the arm.

Protocol documents:
Clinical trial NCT01936909
Conditions: Heart Failure
Sponsor: Virginia Commonwealth University
Start date: 2014-02-01; Completion date: 2016-09-23
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The RED-HART is a randomized double-blinded placebo-controlled study of Anakinra (IL-1 blocker) in patients with recently decompensated heart failure to determine the safety and efficacy in terms of aerobic exercise capacity and ventilatory efficiency measured with a cardiopulmonary exercise test.

Detailed description:

Arms: arm 1: Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks arm 2: Anakinra 100 mg daily for 12 weeks arm 3: Placebo injections daily for 12 weeks
Interventions: intervention 1: Anakinra (weeks 1-2) intervention 2: Anakinra (weeks 3-12) intervention 3: Placebo
Intervention descriptions: intervention 1: Anakinra 100 mg daily for weeks 1 and 2 intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02410200
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Pediatrics
Sponsor: Biogen
Start date: 2015-09-30; Completion date: 2016-09-23
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the effect of BG00012 (dimethyl fumarate) on brain magnetic resonance imaging (MRI) lesions in pediatric participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to characterize the pharmacokinetics of BG00012 in pediatric participants with RRMS and to evaluate the safety and tolerability of BG00012 in pediatric participants with RRMS.

Detailed description:

Arms: arm 1: Oral BG00012 120 mg twice daily (BID) for the first 7 days followed by 240 mg BID for 24 weeks.
Interventions: intervention 1: dimethyl fumarate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01170065
Conditions: Pulmonary Fibrosis
Sponsor: Boehringer Ingelheim
Start date: 2010-06-25; Completion date: 2016-09-26
Enrollment: 198 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug.

The primary objective will be to establish the long term tolerability and safety profile of BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF).

As a secondary objective the effects of long term treatment with BIBF 1120 on survival as well as safety and efficacy parameters will be investigated in an open-label, not randomized, un-controlled design.

Detailed description:

Arms: arm 1: Low dose BIBF 1120 once daily arm 2: Low dose BIBF 1120 twice daily arm 3: Intermediate dose BIBF 1120 twice daily arm 4: High dose BIBF 1120 twice daily
Interventions: intervention 1: BIBF 1120 intervention 2: BIBF 1120 intervention 3: BIBF 1120 intervention 4: BIBF 1120
Intervention descriptions: intervention 1: Intermediate dose BIBF 1120 twice daily intervention 2: High dose BIBF 1120 twice daily intervention 3: Low dose BIBF 1120 twice daily intervention 4: Low dose BIBF 1120 once daily

Protocol documents:
Clinical trial NCT01732458
Conditions: Post-operative Nausea Post-operative Vomiting
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-02-12; Completion date: 2016-09-26
Enrollment: 229 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of aprepitant for the prevention of post-operative nausea and vomiting (PONV) in pediatric participants.

Post-operative aprepitant plasma concentrations will be evaluated with a non-compartmental analysis (NCA) at each dose and for each age cohort. Full PK profiles analyzed using population PK modeling and simulation will be described in a separate report.

Detailed description:
Because the opportunity to collect specimens for PK analyses in children will be limited, a flexible sparse sampling scheme using ranges of collection times will be utilized which will limit the burden to participants.

Arms: arm 1: Pediatric participants receive a single dose of apprepitant that is equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered intravenously (IV) immediately prior to anesthesia. arm 2: Pediatric participants receive a single dose of apprepitant that is equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia. arm 3: Pediatric participants receive a single dose of apprepitant that is equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia. arm 4: Pediatric participants in the control regimen are administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.
Interventions: intervention 1: Aprepitant intervention 2: Placebo to Aprepitant intervention 3: Ondansetron intervention 4: Placebo to match ondansetron
Intervention descriptions: intervention 1: Administered as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia. Aprepitant was supplied in a sachet containing a powder for suspension (PFS) that was reconstituted up to total volume of 5 mL using potable water. intervention 2: None intervention 3: Administered IV at a dose of 4 mg for participants \>40 kg in weight and 0.1 mg/kg for participants ≤40 kg in weight. In participants \<1 month of age, the dose of ondansetron was administered per the product label or based on local standard of care. Ondansetron was supplied by the Sponsor as vials or ampules, depending on the country. intervention 4: Participants in the aprepitant regimen received normal saline IV (provided by the site) as the placebo for ondansetron on Day 1, immediately prior to induction of anesthesia.

Protocol documents:
Clinical trial NCT01732822
Conditions: Peripheral Artery Disease
Keywords: Peripheral artery disease Atherothrombotic events Atherosclerosis
Sponsor: AstraZeneca
Start date: 2012-12-04; Completion date: 2016-09-26
Enrollment: 13885 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.

Detailed description:
A randomized, double-blind, parallel group, multicentre phase IIIb study to compare ticagrelor with clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischemic stroke in patients with established Peripheral Artery Disease (EUCLID Examining Use of tiCagreLor In paD)

Arms: arm 1: Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets arm 2: Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets
Interventions: intervention 1: Ticagrelor intervention 2: Clopidogrel
Intervention descriptions: intervention 1: Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets intervention 2: Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets

Protocol documents:
Clinical trial NCT01833169
Conditions: PI3K Pathway Activated Tumors
Keywords: Solid tumor malignancy hematologic malignancy PI3K pathway activation P13K activated tumors BKM120 signature AML acute myelogenous leukemia cervical ovarian hepatobiliary buparlisib
Sponsor: Novartis Pharmaceuticals
Start date: 2013-03-29; Completion date: 2016-09-26
Enrollment: 146 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this signal seeking study was is to determine whether treatment with BKM120 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.

Detailed description:

Arms: arm 1: BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
Interventions: intervention 1: BKM120
Intervention descriptions: intervention 1: BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28-day cycle

Protocol documents: