ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01948908
Conditions: Children Requiring Sedation to Facilitate Laceration Repair
Keywords: Sedation Laceration repair Children Intranasal Midazolam
Sponsor: Columbia University
Start date: 2013-06-01; Completion date: 2015-09-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine exactly how much drug volume should be administered into each nare, so that the drug absorption can be maximized and the amount that runs out of the nose, or is swallowed, is minimized, thereby optimizing the effectiveness of any drug given intranasally. The investigators will determine this ideal "volume of administration" by studying intranasal midazolam in children who require sedation to facilitate laceration repairs. The investigators will evaluate both clinical outcomes as well as pharmacokinetic outcomes associated with each volume of administration. We will block randomize children to receive intranasal midazolam in maximum aliquots of one of the three following VOA: 200 microliters (mcL), 500 mcL, or 1000 mcL.

Detailed description:
The intranasal route is an effective means of administering sedative medications for children. However, sometimes the child has to receive a certain dose that requires a very large volume to be administered into the nose, because of the types of concentrations of drugs that are available. Most drugs are not concentrated enough so that small volumes can be consistently given, so as a result, sometimes a very large amount of medication is administered intranasally. When the amount is too large, most of the medication either runs back out the nose, or down the back of the nose and throat and is swallowed, instead of being absorbed in the nasal cavity, where it can be quickly absorbed and produce optimal effectiveness.

Arms: arm 1: Intranasal midazolam administered in 200 mcL VOA arm 2: Intranasal midazolam administered in 500 mcL VOA. arm 3: Intranasal midazolam administered in 1000 mcL VOA.
Interventions: intervention 1: Intranasal midazolam
Intervention descriptions: intervention 1: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).

Protocol documents:
Clinical trial NCT01949545
Conditions: Solid Tumors Hematologic Malignancies Hepatic Impairment
Sponsor: Amgen
Start date: 2013-10-01; Completion date: 2015-09-01
Enrollment: 46 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and efficacy of carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing. This study is being done in people with varying degrees of liver function to see if they respond differently to the study drug.

Detailed description:

Arms: arm 1: Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death. arm 2: Participants with mild hepatic impairment (bilirubin \> 1-1.5 x ULN or AST \> ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death. arm 3: Participants with moderate hepatic impairment (bilirubin \> 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death. arm 4: (Bilirubin \> 3 × ULN; any AST) Participants with severe hepatic impairment (bilirubin \> 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Interventions: intervention 1: Carfilzomib
Intervention descriptions: intervention 1: Carfilzomib was administered by IV injection over 30 minutes

Protocol documents:
Clinical trial NCT01957410
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder Ketamine Evoked potentials Somatosensory evoked potentials Motor evoked potentials Cortical plasticity
Sponsor: Janssen Research & Development, LLC
Start date: 2014-02-01; Completion date: 2015-09-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate if somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs) obtained with electroencephalography (EEG) and electromyography (EMG) can be used to detect changes in cortical plasticity in responders to a single IV infusion of ketamine as compared to non-responders.

Detailed description:
This study will be conducted in patients with Major Depressive Disorder (MDD) and divided into 2 sequential cohorts. Cohort 1 will be conducted in 12 patients at a single center. For each patient, there will be up to 4 sequential phases: a screening phase of up to 6 weeks, an open-label treatment phase of up to 4 weeks, an optional open-label treatment phase of up to 1 week, and a follow-up phase of up to 1 week (if applicable). Cohort 2 will be conducted in 20 patients and will be a multicenter, double-blind (neither physician nor patient knows the treatment that the patient receives), randomized (the study drug is assigned by chance), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) design. For each patient, there will be up to 4 sequential phases: a screening phase of up to 6 weeks, a double-blind treatment phase of up to 4 weeks, an optional open-label treatment phase of up to 1 week, and a follow-up phase of up to 1 week (if applicable). The total study duration for each patient will be maximally about 12 weeks. Participant safety will be monitored throughout the study.

Arms: arm 1: Patients will receive a single IV dose of ketamine given as a continuous infusion. arm 2: Patients will receive a single IV dose of placebo given as a continuous infusion.
Interventions: intervention 1: Ketamine intervention 2: Placebo
Intervention descriptions: intervention 1: During Cohorts 1 and 2, a single ketamine 0.5 mg/kg dose will be given as a continuous IV infusion over 40 minutes by use of an electronic syringe infusion pump. The predefined dose and infusion rate/duration should not be adjusted. If a patient is unable to tolerate the study medication, the infusion should be stopped. Within 1 week of completion of the open-label treatment phase, participants can receive a single dose of ketamine 0.5 mg/kg administered as an IV infusion over 40 minutes during an optional open-label treatment phase. intervention 2: During Cohort 2, a single placebo dose will be given as a continuous IV infusion over 40 minutes by use of an electronic syringe infusion pump. Within 1 week of completion of the double-blind treatment phase, participants can receive a single dose of ketamine 0.5 mg/kg administered as an IV infusion over 40 minutes during an optional open-label treatment phase.

Protocol documents:
Clinical trial NCT01963403
Conditions: Abnormal Uterine Bleeding, Unspecified Uterine Bleeding Heavy
Keywords: etonogestrel implant birth control irregular bleeding heavy bleeding
Sponsor: University of California, Davis
Start date: 2013-12-01; Completion date: 2015-09-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This double-blinded, placebo-controlled, randomized trial will compare the effects of the use of a combined oral contraceptive pill to a placebo pill for women who are experiencing irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant.

The hypothesis of the study is:

* Use of combined oral contraceptive will significantly improve bleeding patterns for users of ETG implant
* Continuation rate of ETG implant users will be increased by use of combined oral contraceptive in women desiring ETG implant removal because of the undesirable bleeding
* Adverse events will be uncommon and acceptable to women who use a combined oral contraceptive with the ETG implant

Detailed description:
Women who are experiencing irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant will be recruited for this study. Women who have bothersome bleeding will be randomized to use either a combined oral contraceptive pill or a placebo pill.

Participants will take one pill every day and record their bleeding patterns on a daily diary.

Participants will have one screening/enrollment visit, two in-person follow up visits, and one telephone follow up contact. Subjects will be enrolled for a total of 84 days (three months).

Participants will be assigned to a treatment group at her screening/enrollment visit. Her first follow up visit will occur 22-28 days after her enrollment. Participants can choose to:

* Continue use of assigned treatment medication
* Discontinue use of assigned treatment medication, but use an open-label combined oral contraceptive pill
* Discontinue the use of assigned treatment medication, decline use of an open-label combined oral contraceptive pill
* Discontinue use of ETG implant.

Participants who choose to continue use of ETG implant will have a follow up telephone contact 50-56 days after her enrollment visit. A final in-person visit will occur 78-84 days after enrollment. Bleeding patterns will be assessed by daily bleeding diaries completed by the participant.

Arms: arm 1: combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days) arm 2: Placebo
Interventions: intervention 1: EE 30mcg/LNG 150mcg intervention 2: Placebo
Intervention descriptions: intervention 1: 1 pill per day; daily during study participation (up to 84 days) intervention 2: 1 pill per day; daily during study participation (up to 84 days)

Protocol documents:
Clinical trial NCT01971385
Conditions: Herpes Labialis
Sponsor: Massachusetts General Hospital
Start date: 2013-10-01; Completion date: 2015-09-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Subjects with a history of recurrent herpes labialis will be sensitized with either 2% SADBE or placebo. Following this, subjects sensitized with 2% SADBE will received.2% sqauric acid or.5% squaric acid on their cold sore within 72 hours of a recurrence. Subjects sensitized with placebo solution will receive placebo solution on their cold sore within 72 hours of a recurrence. Subjects will be followed for up to 6 mos after application of study medication.

Detailed description:

Arms: arm 1: 2% Squaric Acid solution will be applied for sensitization to the inner arm. arm 2: Patients in placebo group will be given dimethyl sulfoxide.
Interventions: intervention 1: Squaric Acid solution intervention 2: Placebo solution
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01982292
Conditions: Chronic Heart Failure
Keywords: Chronic Heart Failure, CHF, Heart Failure, HF, Immunogenicity, Anti-bodies, Hypersensitivity, Serelaxin, RELAX-REPEAT
Sponsor: Novartis Pharmaceuticals
Start date: 2014-05-01; Completion date: 2015-09-01
Enrollment: 321 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the safety of repeat doses of serelaxin in chronic heart failure.

Detailed description:

Arms: arm 1: Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8 arm 2: Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
Interventions: intervention 1: RLX030 (serelaxin) intervention 2: Placebo
Intervention descriptions: intervention 1: RLX030 (serelaxin) was administered according to a weight-range adjusted dosing regimen at a nominal dose of 30 μg/kg/day as a continuous IV infusion for 48 hours. intervention 2: Matching placebo of serelaxin was administered as a continuous IV infusion for 48 hours.

Protocol documents:
Clinical trial NCT01985425
Conditions: Atrial Fibrillation Thoracic Surgery
Sponsor: Population Health Research Institute
Start date: 2014-04-01; Completion date: 2015-09-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pilot study is to determine the feasibility of comparing colchicine to placebo for the prevention of new onset atrial fibrillation in patients undergoing general thoracic surgery and establish the foundation for a large, multi-centre, clinical trial.

Detailed description:

Arms: arm 1: On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days. arm 2: On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.
Interventions: intervention 1: Colchicine 0.6 mg intervention 2: Placebo Colchicine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01986946
Conditions: Lumbar Spine Fusion Pain Back Pain
Sponsor: Duke University
Start date: 2013-10-01; Completion date: 2015-09-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
1. Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study
2. Purpose of the Study - This prospective randomized study will enroll 200 patients undergoing elective Lumbar Spinal Fusion at Duke University Hospital. The primary objective is to determine the effect of epidural analgesia, as compared with standard care, on post-operative analgesia.

Hypothesis:

The investigators hypothesize that patients undergoing Lumbar Spinal Fusion surgery with epidural catheter placement will have superior post-operative analgesia compared to patients undergoing standard care.

Detailed description:

Arms: arm 1: This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control. arm 2: The intervention to be tested in this study against standard intravenous opioids is infusion of local anesthetic and dilaudid via epidural catheter for post-operative pain control in patients undergoing lumbar spine fusion surgery.
Interventions: intervention 1: Epidural Catheter - Dilaudid intervention 2: Dilaudid
Intervention descriptions: intervention 1: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery. intervention 2: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid).

Protocol documents:
Clinical trial NCT02011113
Conditions: Multiple Myeloma
Keywords: Pomalidomide, CC-4047, Dexamethasone, Relapsed and refractory multiple myeloma, phase 2
Sponsor: Celgene Corporation
Start date: 2013-12-01; Completion date: 2015-09-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of pomalidomide in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Pomalidomide intervention 2: Dexamethasone
Intervention descriptions: intervention 1: 4 mg oral pomalidomide once daily Days 1-21 of each 28-day cycle intervention 2: 40 mg or 20 mg oral dexamethasone once daily on Days 1, 8, 15, 22 of each 28-day cycle

Protocol documents:
Clinical trial NCT02023112
Conditions: Hepatitis C Virus
Keywords: Japanese Hepatitis C Treatment naive Treatment experienced Genotype 2 Ombitasvir Paritaprevir Ritonavir Ribavirin VIEKIRAX Combination Tablets
Sponsor: AbbVie
Start date: 2014-01-01; Completion date: 2015-09-01
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of ABT-450/r/ABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic HCV genotype 2-infected treatment-naïve and interferon (IFN) treatment-experienced subjects with and without compensated cirrhosis.

Detailed description:

Arms: arm 1: ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks arm 2: ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Interventions: intervention 1: ABT-450/r/ABT-267 intervention 2: Ribavirin
Intervention descriptions: intervention 1: Tablet; ABT-450 coformulated with ritonavir and ABT-267 intervention 2: Capsule

Protocol documents:
Clinical trial NCT02025907
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2 Canagliflozin Hemoglobin A1c Metformin Sitagliptin T2DM JNJ-28431754
Sponsor: Janssen Research & Development, LLC
Start date: 2014-02-01; Completion date: 2015-09-01
Enrollment: 218 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin.

Detailed description:
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a study drug, to test whether the study drug has a real effect), multicenter study of efficacy, safety, and tolerability of canagliflozin in participants with T2DM, who have inadequate glycemic (blood sugar) control on maximally or near-maximally effective doses of metformin \>=1500 mg/day and sitagliptin 100 mg/day. Approximately 200 participants will be randomly assigned to 1 of 2 treatment groups in 1:1 ratio for 26 weeks. During the study the participants will be also provided with diet and exercise counseling (standardized non-pharmacological therapy).

Arms: arm 1: Each participant will receive canagliflozin (JNJ-28431754) 100 mg once daily during the first 6 weeks, then the dose may be increased to 300 mg once daily. arm 2: Each participant will receive placebo (inactive medication) once daily for 28 weeks.
Interventions: intervention 1: Canagliflozin, 100 mg intervention 2: Canagliflozin, 300 mg intervention 3: Placebo
Intervention descriptions: intervention 1: One 100 mg capsule taken orally (by mouth) once daily. intervention 2: One 300 mg capsule taken orally (by mouth) once daily. intervention 3: One placebo capsule taken orally (by mouth) once daily.

Protocol documents:
Clinical trial NCT02031471
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2014-01-01; Completion date: 2015-09-01
Enrollment: 57 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single-arm study will evaluate the efficacy, safety and tolerability of subcutaneously administered tocilizumab in monotherapy and/or in combination with methotrexate and other non-biologic disease modifying anti-rheumatic drug (DMARDs) in participants with active rheumatoid arthritis (RA) who are naïve to tocilizumab. Participants will receive tocilizumab 162 milligram (mg) subcutaneously weekly for 24 weeks. Participants who complete the core study achieving at least a moderate European League Against Rheumatism (EULAR) response at Week 24 may enter the extension phase and receive for a further 28 weeks at the most.

Detailed description:

Arms: arm 1: Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the long term extension (LTE) period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
Interventions: intervention 1: tocilizumab
Intervention descriptions: intervention 1: Fixed dose of 162 mg subcutaneously weekly

Protocol documents: