ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02141113
Conditions: Adult Attention-Deficit Hyperactivity Disorder
Sponsor: Rochester Center for Behavioral Medicine
Start date: 2012-11-01; Completion date: 2014-11-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is considered an investigator-initiated clinical research trial, which means that your study doctor is researching a particular medication (in this case a medication that is currently FDA- approved) for the treatment of AD/HD in individuals ages 6-17. The medication is guanfacine hydrochloride.

The hypothesis is that this medication could be used in adults with Attention Deficit/Hyperactivity Disorder who have not received satisfactory results with their current stimulant ADHD medication. The study drug is investigational for use in adults. Investigational means it has not been approved by the U.S. Food and Drug Administration (FDA) for use in adults.

Detailed description:
The purpose of this study is to determine whether guanfacine hydrochloride used as an adjunct therapy (to subjects' current stimulant medication) would bring about a statistically significant improvement in AD/HD symptoms.

Arms: arm 1: 1. mg Guanfacine Hydrochloride (orally, QD)
2. mg Guanfacine Hydrochloride (orally, QD)
3. mg Guanfacine Hydrochloride (orally, QD)
4. mg Guanfacine Hydrochloride (orally, QD)
5. mg Guanfacine Hydrochloride (orally, QD)
6. mg Guanfacine Hydrochloride (orally, QD) arm 2: 1. mg Placebo
2. mg Placebo
3. mg Placebo
4. mg Placebo
5. mg Placebo
6. mg Placebo
Interventions: intervention 1: Guanfacine Hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: 1. mg Guanfacine Hydrochloride (orally)
2. mg Guanfacine Hydrochloride (orally)
3. mg Guanfacine Hydrochloride (orally)
4. mg Guanfacine Hydrochloride (orally)
5. mg Guanfacine Hydrochloride (orally)
6. mg Guanfacine Hydrochloride (orally) intervention 2: Placebo of matching mg

Protocol documents:
Clinical trial NCT02153099
Conditions: Dose Finding Study
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2014-06-01; Completion date: 2014-11-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to characterize the safety and tolerability profile of escalating dose levels of ENV8058 (TAK-058) solution when administered as a single oral dose in healthy adults.

Detailed description:
The drug being tested in this study is called ENV8058 (also known as TAK-058). ENV8058 is being tested to find a safe and well-tolerated dose and to assess how ENV8058 moves throughout the body. This study will look at side effects and lab results in people who took ENV8058. This study was designed as a randomized, sequential-panel, single rising dose study.

The study population will consist of 6 Cohorts with 8 participants in each Cohort; with 6 participants randomized to receive a single dose of ENV8058, and 2 participants to receive placebo. Participants in each Cohort will receive a single dose of study drug after a 10-hour fast. The starting dose is 15 mg followed by administrations of 30, 45, 15, 75 and 150 mg.

* ENV8058 (Tak-058): 5, 15, 30, 45, 75 or 150 mg oral solution
* Placebo (dummy inactive) - this oral solution looks like the study drug but has no active ingredient

This single-centre trial will be conducted in the United States. The overall time to participate in this study is up to 14 days. Participants will make 2 visits to the clinic, including one 5-day period of confinement to the clinic. All participants will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Arms: arm 1: TAK-058 15 mg, 100 mL oral solution, once on Day 1. arm 2: TAK-058 30 mg, 100 mL oral solution, once on Day 1. arm 3: TAK-058 45 mg, 100 mL oral solution, once on Day 1. arm 4: TAK-058 5 mg, 100 mL oral solution, once on Day 1. arm 5: TAK-058 75 mg, 100 mL oral solution, once on Day 1. arm 6: TAK-058 150 mg, 100 mL oral solution, once on Day 1. arm 7: TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
Interventions: intervention 1: TAK-058 (ENV8058) intervention 2: Placebo
Intervention descriptions: intervention 1: TAK-058 (ENV8058) oral solution intervention 2: TAK-058 (ENV8058) placebo-matching oral solution

Protocol documents:
Clinical trial NCT02155881
Conditions: Seasonal Allergic Rhinitis
Keywords: Drug therapy
Sponsor: AstraZeneca
Start date: 2014-08-01; Completion date: 2014-11-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to explore the efficacy and safety of Ciclesonide Nasal Spray 200 microgram (mcg) once daily in the treatment of seasonal allergic rhinitis (SAR) in Russian participants.

Detailed description:
The drug being tested in this study is called ciclesonide. Ciclesonide is being tested to treat allergy symptoms in people who have SAR. This study will look at improvement of allergy symptoms in Russian participants who take ciclesonide nasal spray.

The study will enroll approximately 80 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

* Ciclesonide nasal spray 200 mcg
* Placebo nasal spray (dummy inactive nasal spray) - this is a nasal spray that looks like the study drug but has no active ingredient.

All participants will be asked to take 2 actuations per nostril at the same time each day throughout the study, and will be asked to record the severity of their allergy symptoms twice a day in a diary.

This multi-centre trial will be conducted in Russia. The overall time to participate in this study is up to 5 weeks. Participants will make 3 visits to the clinic, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Arms: arm 1: Ciclesonide 200 mcg nasal spray, 2 actuations (sprays) per nostril (50 mcg ciclesonide/actuation), daily, for 2 weeks. arm 2: Ciclesonide placebo-matching nasal spray, 2 actuations (sprays) per nostril, daily, for 2 weeks.
Interventions: intervention 1: Ciclesonide intervention 2: Ciclesonide Placebo
Intervention descriptions: intervention 1: Ciclesonide nasal spray 50 mcg/actuation intervention 2: Ciclesonide placebo-matching nasal spray

Protocol documents:
Clinical trial NCT02163915
Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2014-06-01; Completion date: 2014-11-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to characterize the safety and tolerability of TAK-137 when administered as multiple oral doses in adults with attention-deficit/hyperactivity disorder (ADHD).

Detailed description:
The drug being tested in this study is called TAK-137. TAK-137 is being tested to find a safe and well-tolerated dose and to assess how TAK-137 is metabolized in people with attention-deficit/ hyperactivity disorder (ADHD). This study will look at side effects and lab results in people who take TAK-137. This study is designed as a randomized, sequential-cohort, multiple rising dose study.

Therefore, the TAK-137 2 mg Cohort will not start until the TAK-137 0.5 mg Cohort has completed, etc.

This trial will be conducted in the United States. The overall time to participate in this study is up to 42 days. Participants will make at least 2 visits to the clinic, including one 9-day period of confinement to the clinic. All participants will be contacted by telephone 7 days after the last dose of study drug for a follow-up assessment.

A decision was made to terminate this study so that emerging data from preclinical studies could be further assessed.

Arms: arm 1: TAK-137 0.5 mg, tablets, orally once on Days 1-7. arm 2: TAK-137 2 mg, tablets, orally once on Days 1-7. arm 3: TAK-137 5 mg, tablets, orally once on Days 1-7. arm 4: TAK-137 10 mg, tablets, orally once on Days 1-7. arm 5: TAK-137, tablets, orally once on Days 1-7. Dose to be determined from data collected in Cohorts 1-3. arm 6: TAK-137 placebo-matching tablets, orally, once on Days 1-7.
Interventions: intervention 1: TAK-137 intervention 2: TAK-137 Placebo
Intervention descriptions: intervention 1: TAK-137 tablets intervention 2: TAK-137 placebo-matching tablets

Protocol documents:
Clinical trial NCT02178059
Conditions: Healthy Volunteers
Keywords: Healthy volunteers, pharmacokinetic, inhalation
Sponsor: AstraZeneca
Start date: 2014-08-01; Completion date: 2014-11-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Relative bioavailability study to compare inhalation of Terbutaline Sulphate 1,5mg via current version of Turbuhaler with inhalation via a new version

Detailed description:
An Open-label, Single-dose, 2-period Cross over Study in Healthy Male and Female Volunteers to Assess Relative Bioavailability of Terbutaline Sulphate 1.5 mg after Inhalation via the M3 Turbuhaler (New Version) Compared with the M2 Turbuhaler (Current Version)

Arms: arm 1: 0.4 mg terbutaline sulphate (delivered dose) per inhalation arm 2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
Interventions: intervention 1: terbutaline sulphate delivered dose intervention 2: terbutaline sulphate metered dose
Intervention descriptions: intervention 1: 0.4 mg terbutaline sulphate (delivered dose) per inhalation intervention 2: 0.5 mg terbutaline sulphate (metered dose) per inhalation

Protocol documents:
Clinical trial NCT02197806
Conditions: Presbyopia
Sponsor: Allergan
Start date: 2014-07-01; Completion date: 2014-11-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to evaluate the safety and efficacy of AGN-199201 alone, AGN-190584 alone and concurrent use of AGN-199201 and AGN-190584 in patients with presbyopia (inability to focus for near vision).

Detailed description:

Arms: arm 1: 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. arm 2: 1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. arm 3: 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. arm 4: 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
Interventions: intervention 1: AGN-199201 intervention 2: AGN-190584 intervention 3: AGN-199201 Vehicle
Intervention descriptions: intervention 1: 1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol. intervention 2: 1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol. intervention 3: 1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.

Protocol documents:
Clinical trial NCT02209766
Conditions: Healthy
Keywords: Safety Tolerability Pharmacokinetics Pharmacodynamics D5884 Japanese Caucasian
Sponsor: AstraZeneca
Start date: 2014-08-01; Completion date: 2014-11-01
Enrollment: 86 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess safety, tolerability and pharmacokinetics of D5884 following administration of single and multiple doses in healthy male Japanese subjects.

Detailed description:
This is a Phase 1, single-centre study that plans to enrol 3 cohorts in 3 study arms (Study Arms A, B and C). Study Arms A and B will be comprised of cohorts of healthy male Japanese subjects in randomised, single-blind, placebo-controlled, single and multiple dose parallel studies and Study Arm C will be comprised of a cohort of healthy male Caucasian subjects in a single and multiple dose open-label study.

Two dose levels, 2 and 4 g D5884, will be investigated in healthy male Japanese subjects. Up to 18 healthy male Japanese subjects aged 20 to 45 years, inclusive, will be enrolled in 2 cohorts (Study Arms A and B) and up to 6 healthy male Caucasian subjects will be enrolled in a 3rd cohort (Study Arm C). Each subject will participate in 1 cohort only.

Following a screening period of a maximum of 42 days, subjects will reside at the study facility for 18 nights starting from the day before dosing (Day -1) to Day 18 (day of discharge). The follow-up period after dosing will be 8 (±2) days after last dose. Dose administration in all 3 study arms will be done in the following sequence: a single dose of D5884 or placebo will be administered; this will be followed by a 2-day washout period; after the washout period, multiple doses of D5884 or placebo will be administered, once daily for 14 consecutive days. The 1st cohort (Study Arm A) will receive 2 g D5884 (n=6) or placebo (n=3), the 2nd cohort (Study Arm B) will receive 4 g D5884 (n=6) or placebo (n=3) and the 3rd cohort (Study Arm C) will receive 4 g D5884 (n=6).

The PK analysis included all evaluable PK data appropriate for the evaluation of interest (eg, with no major protocol deviations or violations thought to significantly affect the PK of the drug) from all subjects who received D5884.

Arms: arm 1: D5884 capsule, Per oral(po) arm 2: Placebo capsule, po
Interventions: intervention 1: D5884 intervention 2: Placebo
Intervention descriptions: intervention 1: 1st cohort: Dose 1(2g) D5884(n=6) in Japanese 2nd cohort: Dose 2(4g) D5884(n=6) in Japanese 3rd cohort: Dose 2(4g) D5884(n=6) in Caucasian intervention 2: 1. st cohort: Dose 1(2g) D5884(n=3) in Japanese
2. nd cohort: Dose 2(4g) D5884(n=3) in Japanese

Protocol documents:
Clinical trial NCT02229214
Conditions: Obesity
Keywords: Renal function Glomerular Filtration Rate Kidney function Qsymia Iohexol Serum Creatinine Creatinine clearance Renal Clearance VI-0521 Healthy volunteers
Sponsor: VIVUS LLC
Start date: 2014-08-01; Completion date: 2014-11-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is measure the effect of VI-0521 on kidney function. Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks of study treatment, and after an additional 4 weeks of off-treatment recovery.

Detailed description:
This is a randomized, double-blind, placebo-controlled, single-site study in healthy overweight or obese male and female volunteers. Oral VI-0521 (combination of phentermine and topiramate \[PHEN/TPM\] extended-release capsule) will be administered daily as follows:

* Days 1-3: PHEN/TPM 3.75 mg /23 mg
* Days 4-6: PHEN/TPM 7.5 mg /46 mg
* Days 7-9: PHEN/TPM 11.25 mg /69 mg
* Days 10-28: PHEN/TPM 15 mg /92 mg

A single dose of Iohexol (a non-radioactive iodine-containing contrast agent) will be administered intravenously on three separate occasions.

The study will include a total of 50 healthy subjects (40 active and 10 placebo), all of whom will have overnight stays on 3 separate occasions.

Total study duration is approximately 10 weeks (2 weeks screening, 4 weeks study treatment, 4 weeks post treatment follow up).

Arms: arm 1: * Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg) arm 2: Days 1-28: Placebo
Interventions: intervention 1: Qsymia intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02238782
Conditions: Healthy Volunteers Bioavailability Study
Keywords: bioavailability pharmacokinetics I phase AZD6244 cancer
Sponsor: AstraZeneca
Start date: 2014-10-01; Completion date: 2014-11-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess the absolute bioavailability of oral selumetinib in healthy male volunteers

Detailed description:

Arms: arm 1: 3 capsules of 25 mg administered orally
Interventions: intervention 1: selumetinib 75mg single dose intervention 2: [14C] selumetinib IV solution
Intervention descriptions: intervention 1: 3 capsules of 25 mg given as a single dose intervention 2: single, radiolabeled, IV (infused), microdose (80 μg) of \[14C\] selumetinib, infused using a syringe pump as a 15-minute infusion, administered 1h 15 min after receiving the oral dose

Protocol documents:
Clinical trial NCT02242981
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2014-09-01; Completion date: 2014-11-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This type of study is called a radiolabeled study. For this study, LY2623091 (study drug) has been specially prepared to contain radiolabeled carbon \[\^14C\]. \[\^14C\] is a naturally occurring radioactive form of the element, carbon. This study will increase understanding about how the drug appears in the blood, urine, and stool after it is administered to healthy participants. Information about any side effects that may occur will also be collected. This study will last up to 22 days for each participant, not including screening. Screening is required within 28 days prior to enrollment

Detailed description:

Arms: arm 1: Single oral dose of LY2623091
Interventions: intervention 1: LY2623091
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT02256267
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2014-10-01; Completion date: 2014-11-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this two-period study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and when it is given as a single oral dose in combination with rifampin (a Food and Drug Administration \[FDA\] approved antibiotic that is used to treat tuberculosis, a bacterial infection that mainly affects the lungs, and other infections). Each participant will complete both study periods.

The study will last about 34 days. Screening is required within 28 days before study drug is given.

Detailed description:

Arms: arm 1: Single oral dose of LY2835219 arm 2: Single oral dose of LY2835219 with rifampin orally, once daily for 14 days
Interventions: intervention 1: LY2835219 intervention 2: Rifampin
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT02263963
Conditions: Postoperative Pain
Sponsor: Spectrum Health Hospitals
Start date: 2013-07-01; Completion date: 2014-11-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus abdominis plane block by assessing the demand of postoperative narcotic, length of hospital stay and incidence of postoperative complications.

Detailed description:

Arms: arm 1: Patient who randomized to this arm, will be blinded, TAP block will be performed under ultrasound guidance, where 20-30 ml of Exparel will be injected in transversus abdominis plane, bilaterally. arm 2: None
Interventions: intervention 1: Exparel intervention 2: TAP Block
Intervention descriptions: intervention 1: In this arm as described above the intervention will be TAP block injection under ultrasound guidance using Exparel. intervention 2: no intervention will be done to this arm.

Protocol documents:
Clinical trial NCT02271425
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2014-10-01; Completion date: 2014-11-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Evacetrapib (study drug) is an investigational drug being developed with the aim to help people at high risk of heart problems in the future.

In this study we will be comparing how much of the study drug gets into the blood stream when it is given as a single dose (in tablet form) compared to an intravenous injection (given directly into a vein via a small needle).

The study is expected to last at least 15 days for each participant, not including screening. Screening will occur up to 28 days before the study drug is given.

Detailed description:

Arms: arm 1: A single oral dose of 130 milligrams (mg) evacetrapib tablet + a single intravenous (IV) dose of 175 micrograms (μg)\[¹³C₈\] evacetrapib administered over a 4 hour infusion.
Interventions: intervention 1: Evacetrapib Tablet intervention 2: Evacetrapib Intravenous
Intervention descriptions: intervention 1: Oral administration intervention 2: Intravenous administration

Protocol documents:
Clinical trial NCT02282605
Conditions: Staphylococcus Aureus Infection
Sponsor: Destiny Pharma Plc
Start date: 2014-09-01; Completion date: 2014-11-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to determine the efficacy, safety and tolerability of two concentrations of XF-73 nasal gel in combination with body and face washing with chlorhexidine gluconate cloths in eradicating nasal carriage of Staphylococcus aureus.

Detailed description:

Arms: arm 1: 0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths. arm 2: 0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths. arm 3: 0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
Interventions: intervention 1: XF-73 nasal gel intervention 2: Placebo nasal gel intervention 3: Chlorhexidine gluconate 2% topical cloths
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02284555
Conditions: Staphylococcal Infection
Sponsor: Destiny Pharma Plc
Start date: 2014-08-01; Completion date: 2014-11-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the nasal eradication of SA in healthy subjects following treatment with mupirocin 2% (Bactroban 2% Nasal Ointment) twice daily for 5 days, by means of a broth enriched culture microbial assay. The sensitivities of broth enrichment and plating assay methods will be compared. The safety and tolerability of Bactroban 2% Nasal Ointment will also be assessed.

Detailed description:

Arms: arm 1: Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).
Interventions: intervention 1: Mupirocin
Intervention descriptions: intervention 1: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC.

Protocol documents: