ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02431598
Conditions: Transient Severe Arterial Phase Motion
Sponsor: Duke University
Start date: 2015-06-01; Completion date: 2015-09-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate changes in volunteer breath-holding capacity in response to gadoxetate disodium (Eovist) administration, compared with saline, and gadoterate dimeglumine (Dotarem). Healthy volunteers will be recruited from three study sites. These subjects will be given three, blinded, randomized injections while undergoing an MRI of their liver and holding their breath. During the scan, the subjects' oxygen saturation and heart rate will be closely monitored. Following the scan, the subjects will complete a questionnaire regarding the breath hold.

Detailed description:

Arms: arm 1: While in the MRI scanner, the subject will receive a clinical dose of Eovist, Dotarem, or normal saline. Each subject will receive all three, in random order, blinded to which agent is received in a given instance. arm 2: While in the MRI scanner, the subject will receive a clinical dose of Eovist, Dotarem, or normal saline. Each subject will receive all three, in random order, blinded to which agent is received in a given instance. arm 3: While in the MRI scanner, the subject will receive a clinical dose of Eovist, Dotarem, or normal saline. Each subject will receive all three, in random order, blinded to which agent is received in a given instance.
Interventions: intervention 1: gadoxetate disodium intervention 2: gadoterate dimeglumine intervention 3: Saline
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02445326
Conditions: Chronic Allergic Conjunctivitis
Sponsor: Ocular Therapeutix, Inc.
Start date: 2015-04-01; Completion date: 2015-09-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis

Detailed description:

Arms: arm 1: OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use arm 2: PV (placebo drug delivery vehicle)
Interventions: intervention 1: Dexamethasone intervention 2: Placebo Vehicle
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02451150
Conditions: Pediatric Hypertension
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2015-08-01; Completion date: 2015-09-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of TAK-536 (azilsartan) in pediatric patients aged 6 to less than 16 years with hypertension.

Detailed description:
The drug being tested in this study is called azilsartan. Azilsartan was being tested to evaluate how it is processed by the body (pharmacokinetics). This study looked at lab results in pediatric participants who took azilsartan.

The study enrolled 6 patients. Participants were assigned to study medication dose by body weight as follows:

* Body Weight \<50 kg: azilsartan 5 mg
* Body Weight ≥50 kg: azilsartan 10 mg

All participants took a single oral dose of azilsartan on Day 1 of the study.

This multi-center trial was conducted in Japan. The overall time to participate in this study was 17 days. Participants made multiple visits to the clinic, and were contacted by telephone on Day 6 and Day 15 after last dose of study drug for a follow-up assessment.

Arms: arm 1: Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1. arm 2: Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
Interventions: intervention 1: Azilsartan
Intervention descriptions: intervention 1: Azilsartan tablets

Protocol documents:
Clinical trial NCT02467075
Conditions: Acute Kidney Injury
Keywords: CT, iodinated contrast, contrast-induced AKI, kidney injury
Sponsor: University of Michigan
Start date: 2015-07-01; Completion date: 2015-09-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This double-blinded placebo-controlled study will examine the incidence and significance of contrast-induced acute kidney injury following IV iodine-based contrast material administration in subjects with stage IIIB or stage IV chronic kidney disease.

Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive either weight-based low-osmolality iodinated contrast material or saline. The primary outcome measure will be the incidence of stage II AKI by AKIN (Acute Kidney Injury Network) criteria.

Detailed description:
This double-blinded placebo-controlled non-inferiority study will examine the incidence and significance of contrast-induced acute kidney injury following intravenous iodine-based contrast material administration in subjects with stage IIIB or stage IV chronic kidney disease.

Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive either weight-based low-osmolality iodinated contrast material or saline. The primary outcome measure will be the incidence of stage II AKI by AKIN criteria.

Secondary outcome measures will include AKI by other definitions (stage I AKI, traditional CI-AKI definition), hospital length of stay, 30-day readmission rate, number of additional percutaneous interventions within 30 days, number of additional CT examinations within 30 days, and 30-day mortality rate. All subjects will receive a minimum of 1 mL/kg/hr (max: 125 mL/hr) of volume expansion for at least three hours before and after the CT..

Arms: arm 1: Subjects scheduled for a clinical CT will be randomized to receive weight-based low-osmolality iodinated contrast with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT. arm 2: Subjects scheduled for a standard of care CT will be randomized to receive weight-based normal saline instead of contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.
Interventions: intervention 1: Iopamidol 300 (Contrast) intervention 2: Placebo (Normal Saline)
Intervention descriptions: intervention 1: Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan intervention 2: Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan

Protocol documents:
Clinical trial NCT02480439
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2015-06-01; Completion date: 2015-09-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the relative bioavailability of a TAK-648 tablet compared with a TAK-648 oral solution, and to assess the effect of food on the bioavailability of a TAK-648 tablet in healthy participants.

Detailed description:
This study will assess the relative Bioavailability (BA) of TAK-648 tablet compared with that of TAK-648 solution and the effect of food on the BA of the TAK-648 tablet.

The study will enroll approximately 24 healthy participants. Participants will be randomly assigned to one of the three treatment sequences:

* TAK-648 tablet in fed state, followed by TAK-648 tablet in fasted state, followed by TAK-648 oral solution in fasted state
* TAK-648 tablet in fasted state, followed by TAK-648 oral solution in fasted state, followed by TAK-648 tablet in fed state
* TAK-648 oral solution in fasted state, TAK-648 tablet in fed state, TAK-648 tablet in fasted state The dosing in a period and the subsequent period will be separated by a minimum 7-day washout interval. Participants will be asked to take single dose of TAK-648 tablet or oral solution on Day 1 of each period.

This single-center trial will be conducted in the United States. Participants will make 4 visits to the clinic including three 4-day periods of confinement to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.

Arms: arm 1: Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 3. arm 2: Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 3. arm 3: Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, after a high fat meal, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
Interventions: intervention 1: TAK-648 Tablet intervention 2: TAK-648 Oral Solution
Intervention descriptions: intervention 1: Tak-648 tablet intervention 2: TAK-648 oral solution

Protocol documents:
Clinical trial NCT02482935
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2015-06-01; Completion date: 2015-09-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the amount of abemaciclib that reaches the blood stream and how long the body takes to get rid of it when given with and without food. In addition, the safety and tolerability of the study drug will be evaluated. Information about any side effects that may occur will also be collected. The study will last about 43 days for each participant, not including screening.

Detailed description:

Arms: arm 1: Abemaciclib capsules administered once orally in the fed state. arm 2: Abemaciclib capsules administered once orally in the fasted state.
Interventions: intervention 1: Abemaciclib
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT02489734
Conditions: Delirium on Emergence
Keywords: sevoflurane emergence delirium preschool
Sponsor: Children's Hospital of Fudan University
Start date: 2015-07-01; Completion date: 2015-09-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the incidence of emergence delirium will be reduced when end-tidal concentration of sevoflurane decreases.

Detailed description:
Sevoflurane induction and maintenance were selected. Intubation was performed after lidocaine spray on vocal cord. After that, an effective caudal or brachial plexus block was performed. End-tidal concentration of sevoflurane was maintained at 2.5%. Spontaneous respiratory was maintained. Sevoflurane was stopped after the end of surgery. Patients were randomly assigned to 2 groups: high concentration group (Group HC, end-tidal concentration of sevoflurane when extubating \>=0.5%) and low concentration group (Group LC, end-tidal concentration of sevoflurane when extubating \<0.5%). Patients in Group LC were extubated when they coughed or purposeful movement appeared. The patients whose end-tidal concentration of sevoflurane \>= 0.5% were excluded. Patients in Group HC were extubated when any of the criteria was met: 1.the patient coughed or purposeful movement appeared 2.end-tidal concentration of sevoflurane decreased to 0.5%. A trained nurse (blind to groups) recorded PAEDs scores in PACU.

Arms: arm 1: low concentration group arm 2: high concentration group
Interventions: intervention 1: sevoflurane intervention 2: Sevoflurane
Intervention descriptions: intervention 1: extubation when end-tidal concentration of sevoflurane \< 0.5% intervention 2: extubation when end-tidal concentration of sevoflurane \>= 0.5%

Protocol documents:
Clinical trial NCT02513212
Conditions: Dentin Sensitivity
Keywords: Sensitivity
Sponsor: Procter and Gamble
Start date: 2015-07-01; Completion date: 2015-09-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the effects toothbrush type (power or manual) has on the safety and effectiveness of professional dentinal hypersensitivity treatment with a marketed oxalate-containing solution.

Detailed description:

Arms: arm 1: Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush arm 2: Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush
Interventions: intervention 1: Potassium Oxalate intervention 2: Stannous fluoride paste intervention 3: Manual toothbrush intervention 4: Power toothbrush
Intervention descriptions: intervention 1: Professionally applied liquid intervention 2: SnF2 Paste intervention 3: Marketed manual toothbrush intervention 4: Marketed power toothbrush

Protocol documents:
Clinical trial NCT02542280
Conditions: Infertility
Sponsor: Ain Shams Maternity Hospital
Start date: 2013-07-01; Completion date: 2015-09-01
Enrollment: 360 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigator suggests that local endometrial injury using pipelle catheter performed in the follicular phase (cycle day 5, 6 or 7) of the stimulation cycle may improve the pregnancy rates among patients undergoing intrauterine insemination.

Detailed description:
In a selected group of patients with repeated implantation failure, endometrial injury in the preceding cycle may improve ICSI outcome.

Little is known about the efficacy of this procedure in improving intrauterine insemination outcome.

Also little is known about the effect of this procedure if done in the stimulation cycle weather in ICSI or intrauterine insemination cycles.

Arms: arm 1: Endometrial injury during ovarian stimulation combined with intrauterine insemination. arm 2: Ovarian stimulation combined with intrauterine insemination.
Interventions: intervention 1: endometrial injury. intervention 2: intrauterine insemination intervention 3: ovarian stimulation
Intervention descriptions: intervention 1: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination. intervention 2: Placement of washed sperm in the uterus using a catheter, around the time of ovulation. intervention 3: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm.

Protocol documents:
Clinical trial NCT02654769
Conditions: Actinic Keratosis
Sponsor: Actavis Inc.
Start date: 2015-02-01; Completion date: 2015-09-01
Enrollment: 441 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.05% to Picato gel, 0.05% and to establish the superiority of the efficacy of these two products over the vehicle gel in the treatment of Actinic Keratosis (AK) on the trunk or extremities.

Detailed description:
Picato® (ingenol mebutate) gel is the first and only ingenol mebutate product approved by the FDA in 2012 for the topical treatment of AK(s) on the face and scalp (0.015% formulation) and on the trunk and extremities (0.05% formulation). A generic ingenol mebutate gel, 0.05% has been developed for the topical treatment of clinically typical, visible, and discrete non-hyperkeratotic, non-hypertrophic AK lesions of the trunk or extremities.

Arms: arm 1: Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) \[Reference Listed Drug (RLD)\] arm 2: Generic ingenol mebutate gel, 0.05% \[Test\] arm 3: Vehicle gel of the test product
Interventions: intervention 1: Ingenol Mebutate (Picato®) intervention 2: Generic Ingenol Mebutate intervention 3: Vehicle Foam
Intervention descriptions: intervention 1: Brand product intervention 2: Generic formulated to have the same therapeutic effect of the brand intervention 3: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.

Protocol documents:
Clinical trial NCT02712554
Conditions: Pain Nausea Vomiting
Keywords: Pain Nausea Vomiting
Sponsor: Charleston Laboratories, Inc
Start date: 2015-06-01; Completion date: 2015-09-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the abuse potential of CL-108 tablets, including the abuse deterrent effects of promethazine, following oral administration, relative to hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid users.

Detailed description:
The purpose of this study is to assess the abuse potential of CL-108 tablets, including the abuse deterrent effects of promethazine, following oral administration, relative to hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid users; to assess the cognitive and behavioral effects of CL-108 tablets following oral administration relative to hydrocodone/APAP tablets and placebo in non-dependent, recreational opioid users; and to assess the safety of orally administered CL-108 tablets relative to hydrocodone/APAP tablets and placebo in non-dependent, recreational opioid users.

Arms: arm 1: CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth arm 2: CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth arm 3: M366 22.5 mg/975 mg tablet by mouth arm 4: M366 37.5 mg/1625 mg tablet by mouth arm 5: Placebo 0 mg tablet by mouth
Interventions: intervention 1: CL-108 intervention 2: M366 intervention 3: Placebo
Intervention descriptions: intervention 1: 7.5 mg/325 mg/12.5 mg tablet intervention 2: 7.5 mg/325 mg tablet intervention 3: None

Protocol documents:
Clinical trial NCT02772978
Conditions: Pathological Gambling
Keywords: decision making impulsivity
Sponsor: University of California, San Francisco
Start date: 2014-08-01; Completion date: 2015-09-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study deals with how people decide between rewards of different value. The investigators want to understand how the brain's dopamine system impacts this kind of decision making. The investigators will use a medication, tolcapone, which can temporarily affect the dopamine system.

Detailed description:
Tolcapone increases the effects of dopamine in the brain. Dopamine is a substance that is normally present in the brain. It may increase body movement and may also change a person's ability to process information. Tolcapone stops one's own naturally-released dopamine from being broken down as quickly. The investigators are interested in learning if tolcapone has positive effects on a person's decisions about rewards.

Arms: arm 1: This cognitive science study consists of a single "arm" in which all subjects receive both tolcapone and placebo in randomized, double-blind, counterbalanced, crossover fashion arm 2: This cognitive science study consists of a single "arm" in which all subjects receive both tolcapone and placebo in randomized, double-blind, counterbalanced, crossover fashion
Interventions: intervention 1: Tolcapone intervention 2: Placebo
Intervention descriptions: intervention 1: Tolcapone is in the medication class of catechol-O-methyltransferase (COMT) inhibitors intervention 2: A placebo is a tablet or capsule that looks like the study medication (in this case, tolcapone) but does not contain any active ingredients

Protocol documents:
Clinical trial NCT03551730
Conditions: Healthy Volunteers
Sponsor: Portola Pharmaceuticals
Start date: 2012-12-01; Completion date: 2015-09-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.

Detailed description:
A randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenously administered PRT064445 after dosing to steady state with one of four direct/indirect factor Xa (fXa) inhibitors in healthy volunteers.

Arms: arm 1: 210 mg PRT064445 given as a single IV bolus arm 2: 420 mg PRT064445 given as a single IV bolus arm 3: 210 mg PRT064445 (lyophilized formulation) given as a single IV bolus arm 4: Placebo administered intravenously (IV) as a bolus.
Interventions: intervention 1: PRT064445/Enoxaparin intervention 2: Placebo/Enoxaparin intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT03551743
Conditions: Healthy Volunteers
Sponsor: Portola Pharmaceuticals
Start date: 2012-12-01; Completion date: 2015-09-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.

Detailed description:
A randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenously administered PRT064445 after dosing to steady state with one of four direct/indirect factor Xa (fXa) inhibitors in healthy volunteers.

Arms: arm 1: 600 mg PRT064445 given as a single IV bolus arm 2: 1280 mg PRT064445: 800 mg IV at \~30 mg/min, followed by a continuous infusion of 480 mg (4 mg /min over 60 minutes) arm 3: 800 mg PRT064445 as a single IV bolus arm 4: Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion.
Interventions: intervention 1: PRT064445/Edoxaban intervention 2: Placebo/Edoxaban intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents: