ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02094352
Conditions: Complex Regional Pain Syndrome
Keywords: Complex Regional Pain Syndrome Pain management Ketamine infusion
Sponsor: Hospital for Special Surgery, New York
Start date: 2014-03-24; Completion date: 2015-04-20
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether epidural and ketamine infusions are effective in the treatment of Complex Regional Pain Syndrome (CRPS).

Detailed description:
Potential patients must clear all study requirements to be enrolled. Study requirements include labwork, psychiatric evaluation, and cardiology evaluation.

Once enrolled, patients will be in one of two groups:

1. Receives epidural infusion
2. Receives epidural and ketamine infusions

The patient and study staff are blinded.

This study requires multiple visits to Hospital for Special Surgery in New York City over the course of three months and concludes with a final visit after six months. The study will only cover costs associated with the scheduled in-patient and out-patient visits. The study patient will be responsible for all other costs (including travel and hotel accommodations) that he/she may incur for participating in this study.

Arms: arm 1: Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.

Outpatient: Patients will receive three ketamine booster infusions over the course of three months. arm 2: Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.

Outpatient: Patients will receive three saline booster infusions over the course of three months.
Interventions: intervention 1: Ketamine Infusion + Epidural Infusion intervention 2: Control Group + Epidural infusion intervention 3: Ketamine Booster Infusion intervention 4: Control Group Booster Infusion
Intervention descriptions: intervention 1: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration. intervention 2: The saline and epidural infusions will be administered over 96 hours with appropriate titration. intervention 3: Patients will receive three ketamine booster infusions over the course of three months. intervention 4: Patients will receive three saline booster infusions over the course of three months.

Protocol documents:
Clinical trial NCT02255760
Conditions: MEDI3902 for Prevention of P. Aeruginosa Pneumonia
Keywords: MEDI3902 Safety, Pharmacokinetics, Healthy Volunteers
Sponsor: MedImmune LLC
Start date: 2014-09-04; Completion date: 2015-04-20
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy adult subjects 18 to 60 years of age.

Detailed description:
This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy adult subjects 18 to 60 years of age. Approximately 40 subjects will be enrolled across 4 fixed dose cohorts at 1 study site. This study will last approximately 90 days, constituting a screening period of up to 28 days, 1 day of investigational product administration, and a 60 day safety follow up period.

Arms: arm 1: Participants will receive a single intravenous (IV) dose of MEDI3902 infused for a minimum of 13 minutes on Day 1. arm 2: Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1. arm 3: Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1. arm 4: Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. arm 5: Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours.
Interventions: intervention 1: MEDI3902 - Dose 1 intervention 2: MEDI3902 - Dose 2 intervention 3: MEDI3902 - Dose 3 intervention 4: MEDI3902 - Dose 4 intervention 5: Placebo
Intervention descriptions: intervention 1: Participants will receive a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1. intervention 2: Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1. intervention 3: Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1. intervention 4: Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. intervention 5: Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours.

Protocol documents:
Clinical trial NCT02341599
Conditions: Healthy Volunteers Renal Impairment
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2014-12-11; Completion date: 2015-04-20
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to characterize the effect of renal function on the plasma, urine, and dialysate pharmacokinetic profile of MK-6183 (CB-238,618) in humans. The study will also assess the safety profile and tolerability of MK-6183 in healthy participants, participants with varying degrees of renal impairment (RI), or participants with end-stage renal disease (ESRD) requiring hemodialysis (HD), based on estimated glomerular filtration rate (eGFR).

Detailed description:

Arms: arm 1: Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m\^2). arm 2: Participants with mild RI (Stage 2: eGFR ≥60 to \<90 mL/min/1.73m\^2). arm 3: Participants with moderate RI (Stage 3: eGFR ≥30 to \<60 mL/min/1.73m\^2). arm 4: Participants with severe RI (Stage 4: eGFR \<30 mL/min/1.73m\^2) not receiving HD. arm 5: Participants with ESRD who are receiving HD for at least 3 months preceding the initial dose in this study (Stage 5).
Interventions: intervention 1: MK-6183
Intervention descriptions: intervention 1: MK-6183 (CB-238,614) is supplied as lyophilized powder 500 mg vial and mixed into solution for 100 mL intravenous (IV) administration over 1 hour.

Protocol documents:
Clinical trial NCT02350309
Conditions: Insomnia Disorder
Keywords: Insomnia Disorder E2006 Multiple Sleep Latency Test Lemborexant
Sponsor: Eisai Inc.
Start date: 2014-12-13; Completion date: 2015-04-21
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage strengths of lemborexant (5 mg and 10 mg) in participants with insomnia disorder.

Detailed description:
The study will have 2 phases: Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods that taken together, will last up to a maximum of 21 days: a Screening Period and a Baseline Period. The Randomization Phase will comprise 4 treatment periods (Treatment 1, Treatment 2, Treatment 3, Treatment 4) with intervening washout periods between treatment periods (Washout 1, Washout 2, Washout 3). A single dose of study drug will be administered in a randomized, 3-way double-blind crossover manner at Treatment Periods 1-3; flurazepam 30 mg will be administered in an open-label manner at Treatment Period 4.

Arms: arm 1: Participants will receive a single, oral tablet formulation dose of lemborexant 5 mg within 5 minutes before bedtime. arm 2: Participants will receive a single, oral tablet formulation dose of lemborexant 10 mg within 5 minutes before bedtime. arm 3: Participants will receive a single, oral tablet formulation dose of lemborexant-matched placebo within 5 minutes before bedtime. arm 4: Participants will receive a single, oral capsule formulation dose of flurazepam 30 mg within 5 minutes before bedtime.
Interventions: intervention 1: Lemborexant 5 mg intervention 2: Lemborexant 10 mg intervention 3: Lemborexant-matched placebo. intervention 4: Flurazepam 30 mg
Intervention descriptions: intervention 1: Lemborexant 5 mg tablet. intervention 2: Lemborexant 10 mg tablet. intervention 3: Lemborexant-matched placebo tablet. intervention 4: Flurazepam 30 mg capsule.

Protocol documents:
Clinical trial NCT00406419
Conditions: Rheumatoid Arthritis
Keywords: anti-CD20 stage CD20 RA
Sponsor: Genentech, Inc.
Start date: 2006-12-27; Completion date: 2015-04-22
Enrollment: 1015 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab or 500mg of i.v. ocrelizumab on Days 1 and 15. A repeat course of i.v. treatment will be administered at Weeks 24 and 26. All patients will receive 7.5mg - 25mg/week concomitant methotrexate at a stable dose. The anticipated time on study treatment is 1-2 years. Target sample size is 1000.

Detailed description:

Arms: arm 1: Participants received two intravenous (IV) infusion matching placebo to ocrelizumab on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 milligram (mg) was administered weekly. arm 2: Participants received two IV infusion of ocrelizumab 200 mg on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 mg was administered weekly. arm 3: Participants received two IV infusion of ocrelizumab 500 mg on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 mg was administered weekly.
Interventions: intervention 1: Methotrexate intervention 2: ocrelizumab intervention 3: Placebo
Intervention descriptions: intervention 1: Methotrexate tablet was administered orally at a dose 7.5-25 mg intervention 2: Ocrelizumab was administered via IV infusion at a dose specified in arm description intervention 3: Matching placebo to ocrelizumab was administered via IV infusion

Protocol documents:
Clinical trial NCT00418262
Conditions: Fetal Alcohol Syndrome Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: fetal alcohol syndrome attention deficit disorder attention deficit disorder with hyperactivity ADD FAS FASD ADHD
Sponsor: University of Oklahoma
Start date: 2005-08-01; Completion date: 2015-04-22
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.

Detailed description:
Abnormalities of attention, function, and activity level in children exposed to alcohol in utero share similarities and differences to children who do not have alcohol exposure. Previous psychological studies have examined either core attention deficit hyperactivity (ADHD) symptoms of hyperactivity, inattention, and impulsivity or hypothesized neuropsychological differences in children with fetal alcohol syndrome (FAS) and ADHD. Atomoxetine Hydrochloride is a non-stimulant medication used to treat ADHD. This study will determine if atomoxetine HCL significantly reduces symptoms of ADD/ADHD in children with fetal alcohol exposure.

Arms: arm 1: Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
Interventions: intervention 1: Atomoxetine
Intervention descriptions: intervention 1: Titrating with oral administration of 0.25 mg/kg, 0.50 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with food.

Protocol documents:
Clinical trial NCT01142596
Conditions: Schizophrenia
Sponsor: Organon and Co
Start date: 2010-05-25; Completion date: 2015-04-22
Enrollment: 201 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-site, randomized fixed-flexible dose long-term study of asenapine in participants with schizophrenia. The first six weeks of the study will be double-blind and the remainder of the study will be open label. Participants in this study consist of participants who have completed the preceding short-term study (P06124 \[NCT01098110\]), who meet the inclusion criteria and wish to continue receiving study drug, and whom the investigators have deemed eligible for study participation. Participants who were on placebo twice daily (BID) in core trial P06124 will get placebo for the first 2 weeks then 5 mg asenapine BID for the next 4 weeks of double blind treatment, and will be re-randomized after week 6 to asenapine 5 mg BID or asenapine 10 mg BID. Participants who were on asenapine 5 mg BID in core trial P06124 will be re-randomized after Week 6 to asenapine 5 mg BID or asenapine 10 mg BID. Participants who were on asenapine 10 mg BID in core trial P06124 will be re-randomized after Week 6 to asenapine 5 mg BID or asenapine 10 mg BID. After re-randomization, drug will be administered open-label for 46 weeks. During this period dose is flexible can be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability.

Detailed description:

Arms: arm 1: Participants continue in the same arm they were on in core trial P06124 (except placebo arm starts 5 mg BID at Week 2) and will be re-randomized after Week 6 to asenapine 5 mg BID or asenapine 10 mg BID, administered open-label for 46 weeks. Open label dose can be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability arm 2: Participants continue in the same arm they were on in core trial P06124 (except placebo arm starts 5 mg bid at Week 2) and will be re-randomized after Week 6 to asenapine 5 mg BID or asenapine 10 mg BID, administered open-label for 46 weeks. Open label dose can be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
Interventions: intervention 1: Asenapine intervention 2: Placebo
Intervention descriptions: intervention 1: Asenapine 5 mg sublingual tablet BID, Asenapine 10 mg sublingual tablet BID intervention 2: Placebo sublingual tablet BID (first 2 weeks, participants who were in placebo arm of P06124 study only)

Protocol documents:
Clinical trial NCT02181803
Conditions: Schizophrenia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-08-05; Completion date: 2015-04-23
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 3-part dose titration study will assess MK-8189 safety, tolerability, pharmacokinetics (PK), and central nervous system activity. Part 1 (Panels A and B) will assess MK-8189 administered as monotherapy in participants with schizophrenia. Part 2 (Panel C) will assess MK-8189 administered as add-on to atypical antipsychotic treatment in participants with schizophrenia. Part 3 (Panel D) will assess monotherapy with MK-8189 in healthy participants, including those of Japanese descent. The primary hypothesis is that there is at least one dose of MK-8189 that is generally safe and well-tolerated which will have the desired PK parameters in participants with schizophrenia.

Detailed description:
As specified by Phase 1 protocol-flexible language in the protocol, modifications to the dose or dosing regimen can be made to achieve the scientific goals of the trial objectives and/or ensure appropriate safety of the trial participants. The proposed doses for each Part may be adjusted downward based on evaluation of safety, tolerability, and pharmacokinetic data observed in previous panels.

Arms: arm 1: Participants with schizophrenia will receive monotherapy of MK-8189 in escalating doses starting at 2 mg once daily (QD) up to 40 mg QD, depending on safety and tolerability arm 2: Participants with schizophrenia will receive add-on therapy of MK-8189 in escalating doses starting at 2 mg QD up to 20 mg QD, depending on safety and tolerability arm 3: Participants with schizophrenia will receive add-on therapy of MK-8189 in escalating doses starting at 4 mg QD up to 20 mg QD, depending on safety and tolerability arm 4: Healthy participants will receive monotherapy of MK-8189 in escalating doses starting at 2 mg QD up to 16 mg QD, depending on safety and tolerability arm 5: Participants with schizophrenia will receive dose-matched placebo to MK-8189 monotherapy arm 6: Participants with schizophrenia will receive dose-matched placebo to MK-8189 add-on therapy arm 7: Healthy participants will receive dose-matched placebo to MK-8189 monotherapy
Interventions: intervention 1: MK-8189 intervention 2: Placebo intervention 3: Base Monotherapy
Intervention descriptions: intervention 1: MK-8189, oral, 2 mg and/or 10 mg tablets, taken QD for a total daily dose of 2 mg, 4 mg, 8 mg, 10 mg, 12 mg, 14 mg, 16 mg, 20 mg, or 40 mg intervention 2: Placebo matching oral 2 mg and/or 10 mg MK-8189 tablets, taken QD intervention 3: For Part 2 only: participants need to be on monotherapy with an atypical antipsychotic medication (eg, Olanzapine, Quetiapine, Paliperidone, Asenapine, Iloperidone, Aripirprazole, Lurasidone, Risperidone \[not to exceed daily dose of 6 mg\], or Ziprasidone.) The participant should be on a stable and well tolerated treatment regimen for at least 2 months prior to screening. NOTE: Clozapine is not allowed.

Protocol documents:
Clinical trial NCT00752557
Conditions: Osteoporosis
Keywords: Bone mineral density bone morphogenetic protein osteoporosis
Sponsor: Pfizer
Start date: 2008-12-03; Completion date: 2015-04-24
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to assess whether a locally-administered rhBMP-2/CPM injection can rapidly increase bone mass in subjects at high risk for osteoporotic fractures of the hip. All subjects will receive standard treatment for low bone mass, consisting of bisphosphonates, calcium, and vitamin D (all taken by mouth). Subjects that are randomly selected to receive treatment with rhBMP-2 will receive an injection directly into the hip. The injection is given in a surgery room using a light anesthesia.

Detailed description:

Arms: arm 1: rhBMP-2/CPM , 1.0 mg/mL arm 2: rhBMP-2/CPM , 2.0 mg/mL arm 3: Oral bisphosphonate therapy (standard of care)
Interventions: intervention 1: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy) intervention 2: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy) intervention 3: bisphosphonates, calcium, and vitamin D
Intervention descriptions: intervention 1: Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 1.0 mg/mL. intervention 2: Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 2.0 mg/mL. intervention 3: Oral bisphosphonate therapy

Protocol documents:
Clinical trial NCT01264679
Conditions: Iron Deficiency Anemia
Keywords: Iron deficiency anemia Feraheme ferumoxytol chronic kidney disease CKD pediatric dialysis-dependent nondialysis-dependent
Sponsor: AMAG Pharmaceuticals, Inc.
Start date: 2011-12-27; Completion date: 2015-04-24
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study AMAG-FER-CKD-253 is an extension study of the combined AMAG-FER-CKD-251 (NCT01155375) and AMAG-FER-CKD-252 (NCT01155388) studies to evaluate the efficacy and safety of episodic treatment of iron deficiency anemia (IDA) with ferumoxytol.

Detailed description:
Study AMAG-FER-CKD-251 was a study evaluating the efficacy and safety of intravenous (IV) ferumoxytol in pediatric participants with dialysis-dependent chronic kidney disease (CKD). Study AMAG-FER-CKD-252 was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with nondialysis-dependent chronic kidney disease.

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.

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.

Participants who completed the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies had the option of participating in this extension study.

Arms: arm 1: When a participant has persistent or recurrent IDA (defined as hemoglobin \<12.0 grams \[g\]/deciliter \[dL\] and with either transferrin saturation \<40% or ferritin \<100 nanograms/milliliter), the participant will begin a 7-week treatment period. Participants will receive 2 IV injections of ferumoxytol 7.0 milligrams (mg) iron/kilogram (maximum of 510 mg/dose), the first dose administered on Day 1 and the second on Days 3 through 9 of the Treatment Period.
Interventions: intervention 1: Ferumoxytol
Intervention descriptions: intervention 1: IV Ferumoxytol

Protocol documents:
Clinical trial NCT01963260
Conditions: Immune Thrombocytopenia Purpura
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-10-31; Completion date: 2015-04-26
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to assess the safety and tolerability of single rising doses of MK-8723 in healthy adult participants and adult participants with chronic immune thrombocytopenia purpura (ITP) and to assess pharmacodynamics of MK-8723 in participants with ITP. The primary hypothesis is that the true placebo-adjusted platelet response rate to MK-8723 in adult patients with chronic ITP is \>50%.

Detailed description:
In Part 1 of the trial, safety and pharmacokinetics of MK-8723 will be evaluated in healthy participants. In Part 2 of the trial, safety, pharmacokinetics, and pharmacodynamics will be evaluated among participants with ITP. In Part 1, dose escalation will occur in up to 5 serial panels of participants; each participant will receive a single intravenous (IV) dose of MK-8723 (or placebo). In Part 2, dose escalation will occur in up to 3 serial panels of participants with ITP; each participant will receive a single IV dose of MK-8723 (or placebo), once safety and tolerability of the corresponding dose is shown in Part 1. Amendment 3 specified a re-enrollment procedure for eligible participants in Part 2 to participate in more than one dosing panel.

Arms: arm 1: MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1. arm 2: MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1. arm 3: MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1. arm 4: MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1. arm 5: MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1. arm 6: Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1. arm 7: MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. arm 8: MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2. arm 9: MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. arm 10: Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
Interventions: intervention 1: MK-8723 intervention 2: Matching Placebo
Intervention descriptions: intervention 1: MK-8723 administered as a single IV infusion over approximately 4 hours on Day 1. intervention 2: Matching placebo to MK-8723 administered as a single IV infusion over approximately 4 hours on Day 1.

Protocol documents: