ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02637323
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis knee pain corticosteroid intra-articular injection
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2015-11-01; Completion date: 2016-09-01
Enrollment: 81 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study were to characterize the local extent and duration of exposure of TA from FX006 and TCA IR, characterize the systemic PK of FX006 and TCA IR, and assess the safety and general tolerability of a single 5 mL IA injection of 32 mg FX006 relative to 40 mg of TCA IR in patients with OA of the knee.

Detailed description:
This study employed an open-label, single administration design and was conducted in male and female patients ≥40 years of age with OA of the knee.

Patients were enrolled sequentially with at least 10 patients per cohort as follows:

Cohort A: FX006 32 mg, Final Visit at Week 20 Cohort B: FX006 32 mg, Final Visit at Week 16 Cohort C: FX006 32 mg, Final Visit at Week 12 Cohort D: FX006 32 mg, Final Visit at Week 6 Cohort E: FX006 32 mg, Final Visit at Week 1 Cohort F: TCA IR 40 mg, Final Visit Week 6

Each patient was screened to confirm eligibility and assigned to a cohort on Day 1/baseline. Each patient was evaluated for safety during his/her participation in the study at 6, 12, 16, or 20 weeks following a single IA injection depending on the assigned Cohort, and plasma and synovial fluid was collected for drug concentration measurements.

Safety and tolerability was assessed by physical examinations, index knee examinations, vital signs, clinical laboratory evaluations, and adverse events (AEs).

No efficacy assessments were employed in this study.

Arms: arm 1: Single 5 mL intra-articular (IA) injection Extended-release formulation arm 2: Commercially available triamcinolone acetonide, single 1 mL intra-articular (IA) injection Immediate-release formulation
Interventions: intervention 1: FX006 32 mg intervention 2: TCA IR 40
Intervention descriptions: intervention 1: Single 5 mL IA injection intervention 2: Single 1 mL IA injection

Protocol documents:
Clinical trial NCT02665221
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis erythema
Sponsor: NYU Langone Health
Start date: 2015-07-01; Completion date: 2016-09-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this single center, randomized, open label study in relapsing Multiple Sclerosis (MS) patients on PLEGRIDY (peginterferon beta-1a) is to assess the effect of Preparation H (phenylephrine) Maximum Strength Cream compared to no topical treatment of injection site erythema after PLEGRIDY injection.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: No Treatment Arm intervention 2: Topical Preparation H arm
Intervention descriptions: intervention 1: Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy. intervention 2: Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.

Protocol documents:
Clinical trial NCT02722967
Conditions: Schizophrenia Major Depressive Disorder Bipolar I Disorder
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2016-03-01; Completion date: 2016-09-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the helpfulness of the integrated call center in optimizing use of the Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or Bipolar Disorder taking oral aripiprazole.

Detailed description:
The Digital Medicine System includes a drug-device combination of aripiprazole + an ingestible event marker (IEM), a wearable sensor (skin patch), and application software to convey the level of activity and rest, and to mark events through the act of ingestion.

Physician and self-report are the most commonly used to assess medication compliance yet studies have consistently found that healthcare providers' subjective judgments of medication compliance are often inaccurate, with a tendency for practitioners to overestimate subject adherence. The sponsor's intent is to develop a system that will benefit future subjects by providing the ability to measure their medication-taking behavior in an objective manner and being able to monitor several physiologic parameters.

Arms: arm 1: Subjects will receive an intervention consisting of a drug-device combination that consists of an aripiprazole tablet with a tiny sensor embedded within it referred to as an Ingestible Event Marker (IEM) . They will discontinue their normally prescribed oral aripiprazole tablets and will take the aripiprazole(2, 5, 10, 15, 20, or 30 mg) + IEM once daily for the 8-week assessment period for this trial.
Interventions: intervention 1: Aripiprazole + IEM (Ingestible Event Marker)
Intervention descriptions: intervention 1: Oral aripiprazole (2, 5, 10, 15, 20, or 30 mg) with an ingestible event marker in a single daily dose for duration of the trial.

Protocol documents:
Clinical trial NCT02874846
Conditions: Ocular Hypertension Open Angle Glaucoma
Sponsor: Aerie Pharmaceuticals
Start date: 2016-07-01; Completion date: 2016-09-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate effect of Netarsudil Ophthalmic Solution 0.02% on Nocturnal and Diurnal Intraocular Pressure.

Detailed description:

Arms: arm 1: 1 drop in each eye (OU) daily arm 2: 1 drop in each eye (OU) daily
Interventions: intervention 1: Netarsudil ophthalmic solution 0.02% intervention 2: Netarsudil Ophthalmic Solution Vehicle
Intervention descriptions: intervention 1: Once daily in both eyes (OU) in the evening (PM) for 7 days intervention 2: Once daily in both eyes (OU) in the evening (PM) for 7 days

Protocol documents:
Clinical trial NCT02912195
Conditions: Pain
Sponsor: Alameda Health System
Start date: 2016-03-01; Completion date: 2016-09-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Objective: Evaluate the analgesic efficacy of intravenous (IV) lidocaine versus provider chosen dose of IV morphine for the treatment of severe pain in the emergency department.

Study design: Open-label, randomized controlled pilot study.

Detailed description:
Objective: The purpose of this pilot study is to determine the analgesic efficacy of intravenous lidocaine versus morphine for the treatment of severe pain in the emergency department (ED).

Study design: Open-label, randomized, controlled pilot trial. Participants: Investigators and research assistants will recruit patients ≥18 years old with severe pain (NRS ≥7) and an anticipated stay in the emergency department ≥1 hour. A sample size calculation was performed and 32 patients will be enrolled.

Intervention: After a trained research assistant obtains written informed consent, eligible participants will be randomized to the intravenous lidocaine or morphine arms of the study. In the intravenous lidocaine arm, patients will receive IV lidocaine (75 mg if \<50kg, 100 mg if 50 - 100 kg, and 150 mg if \>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \<50kg, 100 mg if 50 - 100 kg, and 150 mg if \>100 kg). In the morphine arm, the ED provider will choose an appropriate dose of morphine for the patient. At 20 and 40 minutes, the participants will be asked "Would you like additional pain medication?". Participants responding in the affirmative will receive morphine 4 mg IV.

Data collection: The trained research assistant will collect data on the patients' pain scores, side effects, and rescue morphine.

Statistical analysis: Investigators will perform descriptive statistics and compare pain scores and pain relief at each time point with unpaired t-tests.

Arms: arm 1: Participants will receive IV lidocaine (75 mg if \<50kg, 100 mg if 50 - 100 kg, and 150 mg if \>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \<50kg, 100 mg if 50 - 100 kg, and 150 mg if \>100 kg) in a 100 mL normal saline minibag.

At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic. arm 2: ED provider will choose an appropriate dose of intravenous morphine for the patient.

At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.
Interventions: intervention 1: Intravenous lidocaine intervention 2: Intravenous morphine
Intervention descriptions: intervention 1: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes intervention 2: Emergency department provider chooses appropriate dose of intravenous morphine

Protocol documents:
Clinical trial NCT02938494
Conditions: Acne Vulgaris
Sponsor: Bausch Health Americas, Inc.
Start date: 2015-11-01; Completion date: 2016-09-01
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Safety and Efficacy of IDP-123 Lotion (0.045% tazarotene) to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris

Detailed description:
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Study to Compare the Safety and Efficacy of IDP-123 Lotion (0.045% tazarotene) to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris

Arms: arm 1: Lotion arm 2: Cream arm 3: Lotion arm 4: Cream
Interventions: intervention 1: IDP-123 Lotion intervention 2: Tazorac Cream intervention 3: Vehicle Lotion intervention 4: Vehicle Cream
Intervention descriptions: intervention 1: Lotion intervention 2: Cream intervention 3: Lotion intervention 4: Cream

Protocol documents:
Clinical trial NCT03050541
Conditions: Healthy
Keywords: MDMA adult
Sponsor: University of Chicago
Start date: 2014-12-01; Completion date: 2016-09-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effects of MDMA on encoding and retrieval of emotional and social memories in healthy young adults. The study will explore the effects on memory retrieval when the drug is administered 1) before encoding, and 2) before retrieval.

Detailed description:
Here, we aim to investigate the effects of MDMA (1 mg/kg) on the encoding and retrieval of positive, negative, social, and neutral memories. The study will use a between subjects design with three groups (N = 20 per group). Two of the groups will be randomly assigned to receive MDMA before one of the two stages of memory: Encoding (ENC) or Retrieval (RET). The third group will receive placebo only (PLC). All three groups will receive capsules before viewing the study materials, and at retrieval two days later, but they will receive MDMA only in the capsule appropriate to their condition, and other capsules will contain placebo.

Participants will participate in two sessions: a viewing session during which they will view emotional and neutral stimuli, followed 48 hours later by a retrieval session, during which there will be a surprise memory test with two components (verbally cued recollection and picture recognition). On all sessions subjects will also complete mood questionnaires.

Arms: arm 1: 20 healthy adult volunteers will be randomly assigned to the encoding group (MDMA at Encoding). This group will receive capsules before viewing the study materials, and at retrieval two days later, but they will receive MDMA only in the capsule appropriate to their condition, and the next session capsule will contain placebo. arm 2: 20 healthy adult volunteers will be randomly assigned to the retrevial group (MDMA at Retrevial). This group will receive placebo before viewing the study materials, and MDMA at retrieval two days later.. arm 3: 20 healthy adult volunteers will be randomly assigned to the placebo group (no drug at either session). This group will receive only placebo during study, session before viewing the study materials, and at retrieval two days later.
Interventions: intervention 1: MDMA intervention 2: Placebo
Intervention descriptions: intervention 1: This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory. intervention 2: None

Protocol documents:
Clinical trial NCT05288673
Conditions: Healthy
Keywords: ALXN1210 Pharmacokinetics Pharmacodynamics
Sponsor: Alexion Pharmaceuticals, Inc.
Start date: 2015-07-28; Completion date: 2016-09-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This study evaluated the safety and tolerability of multiple doses of ALXN1210 (400 and 800 milligrams \[mg\]) following intravenous (IV) administration to healthy participants.

Detailed description:
Participants were divided into 2 cohorts and were randomly assigned in a 3:1 ratio to receive IV ALXN1210 or placebo. Participants in Cohort 1 received 5 IV doses of 400 mg of ALXN1210 or placebo administered every 28 days. To determine if dose continuation and dose escalation to Cohort 2 should occur, the Safety Review Committee conducted a blinded review of the available safety data after Day 15 of the second dose of the last participant in Cohort 1. Participants in Cohort 2 received 5 doses of 400 mg of ALXN1210 or placebo and 5 IV doses of 800 mg of ALXN1210 or placebo administered intravenously every 28 days. Safety, PK, PD, and immunogenicity assessments were performed during the Follow-up Period after the last dose.

Arms: arm 1: Participants received ALXN1210 every 28 days. arm 2: Participants received ALXN1210 every 28 days. arm 3: Participants received placebo every 28 days.
Interventions: intervention 1: ALXN1210 intervention 2: Placebo
Intervention descriptions: intervention 1: ALXN1210 was administered by IV infusion over 5 periods, 1 dose per period: Period 1, induction; Periods 2-5, maintenance. Participants received a total of 5 doses of 400 or 800 mg, each administered every 28 days. intervention 2: Placebo was administered by IV infusion over 5 periods, 1 dose per period. Participants received the same volume and infusion rate as specified for each ALXN1210 dose (400 or 800 mg).

Protocol documents:
Clinical trial NCT01625182
Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Keywords: chronic inflammatory demyelinating polyradiculoneuropathy, CIDP, FTY720, fingolimod.
Sponsor: Novartis Pharmaceuticals
Start date: 2012-12-22; Completion date: 2016-09-03
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.

Detailed description:
This study was a double-blind, randomized, multicenter, placebo-controlled, parallel-group study in patients with a diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy and treated with IVIg, corticosteroids, or both therapies prior to study entry. Patients meeting the eligibility criteria were randomly assigned in a ratio of 1:1 to receive oral fingolimod (0.5 mg/day) or matching placebo.

The study consisted of 3 periods: a Screening Period, a Double-blind Treatment Period and a Follow-up Period after discontinuation of study drug treatment. Patients who complete the study will have an option to enter an extension.

Arms: arm 1: Participants received Fingolimod 0.5 mg orally once daily. arm 2: Participants received matching placebo to Fingolimod orally once daily.
Interventions: intervention 1: Fingolimod intervention 2: Placebo Comparator
Intervention descriptions: intervention 1: Fingolimod 0.5 mg capsules intervention 2: Matching placebo capsules

Protocol documents:
Clinical trial NCT02648217
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2016-01-04; Completion date: 2016-09-05
Enrollment: 263 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa and Asia. The aim of this trial is to compare efficacy and safety of insulin degludec/insulin aspart twice daily and biphasic insulin aspart twice daily in subjects with type 2 diabetes mellitus before, during and after Ramadan.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/insulin aspart intervention 2: biphasic insulin aspart
Intervention descriptions: intervention 1: Injected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued. intervention 2: Injected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.

Protocol documents:
Clinical trial NCT02020889
Conditions: Churg-Strauss Syndrome
Keywords: eosinophils SB 240563 Churg-Strauss Syndrome quality of life mepolizumab safety biomarkers efficacy corticosteroids Eosinophilic granulomatosis with polyangiitis
Sponsor: GlaxoSmithKline
Start date: 2014-02-05; Completion date: 2016-09-05
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram \[mg\] administered subcutaneously \[SC\] every 4 weeks) compared with placebo over a 52-week study treatment period in subjects with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care therapy including background corticosteroid therapy with or without immunosuppressive therapy. During the treatment period, in accordance with standard of care, corticosteroid dose will be tapered. The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of \<=4 mg/day prednisolone/prednisone, reduction in disease relapse and reduction in corticosteroid requirement.

Detailed description:

Arms: arm 1: Each subject will receive mepolizumab 300 mg subcutaneous (SC) injection every 4 weeks (13 administrations) along with standard care. It will be administered as 3 separate injections (100 mg each- total dose 300 mg); individual injection sites will be separated by at least 5 cm. It will be administered into any of the upper arm, thigh or anterior abdominal wall. arm 2: Each subject will receive placebo (0.9% sodium chloride) SC injection every 4 weeks (13 administrations) along with standard care. It will be administered as 3 separate injections; individual injection sites will be separated by at least 5 cm. It will be administered into any of the upper arm, thigh or anterior abdominal wall.
Interventions: intervention 1: Mepolizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Mepolizumab will be provided as a lyophilized cake in sterile vials for individual use to be reconstituted with sterile water for Injection, just prior to use. intervention 2: Placebo will be available as 0.9% sodium chloride

Protocol documents:
Clinical trial NCT01844583
Conditions: Solid Tumors Lymphoma
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2013-06-25; Completion date: 2016-09-06
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the drug-drug interaction (DDI) of either esomeprazole or rifampin on the single-dose PK of alisertib, and to complete an intensive QT study of single and multiple-dose alisertib.

Detailed description:
The drug tested in this study is called alisertib. Alisertib is being tested to assess the effect of a proton pump inhibitor and strong metabolic inducer on the PK of a single 50 mg dose of alisertib administered as enteric-coated tablets (ECTs).

The study enrolled 55 patients. Participants received either:

* Esomeprazole 40 mg and Alisertib 50 mg
* Rifampin 600 mg and Alisertib 50 mg

All participants were asked to take one tablet of alisertib either once or twice daily in all cycles. In Cycle 2, participants were asked to take alisertib plus either esomeprazole or rifampin.

This trial was conducted the United States. The overall time to participate in this study was 10 months. Participants made multiple visits to the clinic plus a final visit, 30 days after receiving their last dose of study drug for a follow-up assessment.

Arms: arm 1: Alisertib 50 mg, tablets, orally, once on Day 1, followed by twice daily on Days 4 to 10, followed by a 14-day rest period in Cycle 1.

Esomeprazole, 40 mg, delayed-release capsules, orally, once daily on Days 1 to 10 plus alisertib, 50 mg, tablets, orally, once on Day 8, followed by twice daily on Days 11 to 17, followed by a 14-day rest period in Cycle 2.

Alisertib 50 mg, tablets, orally, twice daily on Days 1 to 7 beginning with Cycle 3 (21-day cycles) to the end of study (Up to 15 Cycles). arm 2: Alisertib 50 mg, tablets, orally, once on Day 1, followed by twice daily on Days 4 to 10, followed by a 14-day rest period in Cycle 1.

Rifampin 600 mg, capsules, orally, once daily on Days 1 to 10 in Cycle 2 plus alisertib, 50 mg, tablets, orally, once on Day 8, followed by twice daily on Days 11 to 17, followed by a 14-day rest period in Cycle 2.

Alisertib 50 mg, tablets, orally, twice daily on Days 1 to 7 beginning with Cycle 3 (21-day cycles) to the end of study (Up to 15 Cycles).
Interventions: intervention 1: Alisertib intervention 2: Esomeprazole intervention 3: Rifampin
Intervention descriptions: intervention 1: Alisertib tablets intervention 2: Esomeprazole capsules intervention 3: Rifampin capsules

Protocol documents:
Clinical trial NCT02396316
Conditions: Glaucoma, Neovascular
Sponsor: Bayer
Start date: 2015-04-02; Completion date: 2016-09-06
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy and safety of the administration of aflibercept by intravitreal injection in comparison to sham to control intraocular pressure in patients with neovascular glaucoma.

Detailed description:

Arms: arm 1: Aflibercept 2 mg Intravitreal (IVT) injection group arm 2: Sham injection group
Interventions: intervention 1: Aflibercept (Eylea, BAY 86-5321) intervention 2: Sham Injection
Intervention descriptions: intervention 1: After the first aflibercept IVT injection on Day 1, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met. intervention 2: After the first sham injection on Day 1, subjects may receive aflibercept IVT injection at Week 1, Week 5 and/or Week 9 if re-treatment criteria are met.

Protocol documents:
Clinical trial NCT02487498
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Novartis Pharmaceuticals
Start date: 2015-07-27; Completion date: 2016-09-06
Enrollment: 355 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.

Detailed description:

Arms: arm 1: QVA149 capsules for inhalation, delivered via QVA149 SDDPI arm 2: Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
Interventions: intervention 1: QVA149 intervention 2: Umeclidinium/vilanterol intervention 3: Placebo (umeclidinium/vilanterol ) intervention 4: Placebo (QVA149)
Intervention descriptions: intervention 1: QVA149 capsules for inhalation, delivered via QVA149 SDDPI intervention 2: Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler intervention 3: Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler intervention 4: Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI

Protocol documents: