ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01958619
Conditions: Malaria
Keywords: open label healthy volunteers pharmacokinetic parallel group
Sponsor: Medicines for Malaria Venture
Start date: 2013-10-01; Completion date: 2014-01-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A healthy volunteer study to characterise the exposure of the two study medications, following administration of OZ439 + TPGS granules with piperaquine phosphate granules (intended for children) and with piperaquine phosphate tablets (intended for adults). Ideally, to confirm the exposure demonstrated in an earlier bioavailability study.

Detailed description:
A Phase 1 open label parallel group, four arm study conducted in healthy male and female subject aged 18 to 55 years of age. Subjects will receive either treatment A, B, C or D as described below:

* Treatment A: 1440 mg PQP tablets and 800 mg OZ439 + TPGS granules for oral suspension
* Treatment B: 960 mg PQP tablets and 800 mg OZ439 + TPGS granules for oral suspension
* Treatment C: 960 mg PQP granules for oral solution and 800 mg OZ439 + TPGS granules for oral suspension
* Treatment D: 800 mg OZ439 + TPGS granules for oral suspension

Arms: arm 1: Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions. arm 2: Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions. arm 3: Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions. arm 4: OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
Interventions: intervention 1: 1440mg PQP tablets intervention 2: 960mg PQP tablets intervention 3: 800mg OZ439 + TPGS intervention 4: 960mg PQP granules
Intervention descriptions: intervention 1: Piperaquine phosphate tablets (1440mg) intervention 2: Piperaquine phosphate tablets (960mg) intervention 3: OZ439 (800mg) + TPGS granules for oral suspension intervention 4: Piperaquine phosphate granules for oral solution (960mg)

Protocol documents:
Clinical trial NCT01965431
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-10-01; Completion date: 2014-01-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to evaluate the effect of multiple doses of BI 207127 combined with faldaprevir on cardiac safety parameters in healthy subjects

Detailed description:

Arms: arm 1: Tablets/capsules arm 2: Tablets arm 3: Tablets/capsules
Interventions: intervention 1: BI 207127 intervention 2: BI 207127 placebo intervention 3: Faldaprevir placebo intervention 4: Faldaprevir intervention 5: Moxifloxacin (Avalox®)
Intervention descriptions: intervention 1: Medium dose oral administration intervention 2: None intervention 3: None intervention 4: Medium dose oral administration intervention 5: None

Protocol documents:
Clinical trial NCT01968356
Conditions: Skin Flora Bacterial Reduction Post-product Application
Keywords: surgical skin prep CHG IPA
Sponsor: Solventum US LLC
Start date: 2013-10-01; Completion date: 2014-01-01
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

Detailed description:
The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70%. On the abdominal sites, a responder is defined as a subject with a 2-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours. On the inguinal sites, a responder is defined as a subject with a 3-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

Arms: arm 1: Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. arm 2: Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. arm 3: Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. arm 4: Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Interventions: intervention 1: 3M CHG/IPA Prep Colorless intervention 2: 3M CHG/IPA Prep Tint intervention 3: ChloraPrep intervention 4: Saline
Intervention descriptions: intervention 1: Apply topically. intervention 2: Apply topically. intervention 3: Apply topically. intervention 4: Apply topically.

Protocol documents:
Clinical trial NCT01976572
Conditions: Hyperphosphatemia Chronic Kidney Disease
Keywords: CKD Stage V dialysis
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2013-10-01; Completion date: 2014-01-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective is to assess the effects of colestilan on the pharmacokinetic profile of candesartan cilexetil when administered at the same time as, 1 hour before, and 3 hours after the first daily dose of colestilan administered at doses of 5 g three times daily compared to administration of candesartan cilexetil alone, in healthy subjects.

Detailed description:

Arms: arm 1: Single dose of 16 mg candesartan was administered orally on Day 1. arm 2: Colestilan was administered orally 5 g t.i.d (total dose 15 g/day) in the fed state immediately after meals from Day 3 to Day 24 and single dose of 16 mg candesartan was administered orally on Day 7, 13 and 19 at 1 of 3 dosing time-points relative to the first daily dose of 5 g colestilan t.i.d. T-0 of 3 dosing time-points means the single dose of candesartan was administered at the same time relative to the first daily dose of colestilan. arm 3: Colestilan was administered orally 5 g t.i.d (total dose 15 g/day) in the fed state immediately after meals from Day 3 to Day 24 and single dose of 16 mg candesartan was administered orally on Day 7, 13 and 19 at 1 of 3 dosing time-points relative to the first daily dose of 5 g colestilan t.i.d. T-1 of 3 dosing time-points means the single dose of candesartan was administered at 1 hour before relative to the first daily dose of colestilan. arm 4: Colestilan was administered orally 5 g t.i.d (total dose 15 g/day) in the fed state immediately after meals from Day 3 to Day 24 and single dose of 16 mg candesartan was administered orally on Day 7, 13 and 19 at 1 of 3 dosing time-points relative to the first daily dose of 5 g colestilan t.i.d. T+3 of 3 dosing time-points means the single dose of candesartan was administered at 3 hour after relative to the first daily dose of colestilan.
Interventions: intervention 1: colestilan intervention 2: candesartan
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01982253
Conditions: Type 2 Diabetes Mellitus
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2013-10-01; Completion date: 2014-01-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of fasiglifam 25 mg twice daily (BID) and fasiglifam 50 mg once daily (QD) on glycemic control in adults with type 2 diabetes who are inadequately controlled on diet and exercise alone.

Detailed description:
The drug being tested in this study is called fasiglifam. Fasiglifam is being tested to treat people who have diabetes. This study will look at glycemic control in people who take fasiglifam.

The study will enroll approximately 400 patients. Participants will be randomly assigned (by chance) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* Fasiglifam 25 mg twice a day
* Fasiglifam 50 mg once daily
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.

All participants will be asked to take one tablet twice each day throughout the study. All participants will be asked to record any time they have symptoms of hypoglycemia in a diary.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 18 weeks. Participants will make 9 visits to the clinic.

Due to potential concerns about liver safety, on balance, the benefits of treating patients with fasiglifam (TAK-875) do not outweigh the potential risks.

For this reason, Takeda has decided voluntarily to terminate the development activities for fasiglifam.

Arms: arm 1: Fasiglifam placebo-matching tablets, orally, twice daily for up to 12 weeks. arm 2: Fasiglifam 25 mg tablets, orally, twice daily (BID) for up to 12 weeks. arm 3: Fasiglifam 50 mg tablets, orally once daily (QD) and fasiglifam placebo-matching tablets, orally, once daily for up to 12 weeks.
Interventions: intervention 1: Fasiglifam intervention 2: Placebo to fasiglifam
Intervention descriptions: intervention 1: Fasiglifam tablets intervention 2: Fasiglifam placebo-matching tablets

Protocol documents:
Clinical trial NCT01983566
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-11-01; Completion date: 2014-01-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this trial is to investigate the effect of food with different fat content and of gastric pH increase (mediated by multiple dosing of omeprazole) on the relative bioavailability of deleobuvir.

Detailed description:

Arms: arm 1: patient to receive BI 207127 as a single dose in fasted state arm 2: patient to receive BI 207127 as a single dose after a high fat breakfast arm 3: patient to receive BI 207127 as a single dose after a low fat breakfast arm 4: patient to receive BI 207127 as a single dose after 4 days treatment with Omeprazole 40 mg once a day
Interventions: intervention 1: BI 207127 high fat intervention 2: BI 207127 with Omeprazole intervention 3: BI 207127 intervention 4: BI 207127 low fat
Intervention descriptions: intervention 1: BI 207127 as a single dose after a high fat breakfast intervention 2: BI 207127 as a single dose after 4 days treatment of Omeprazole 40 mg once a day intervention 3: BI 207127 as a single dose in fasted state intervention 4: BI 207127 as a single dose after a low fat breakfast

Protocol documents:
Clinical trial NCT01991821
Conditions: PONV
Sponsor: Acacia Pharma Ltd
Start date: 2013-07-01; Completion date: 2014-01-01
Enrollment: 368 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.

Detailed description:

Arms: arm 1: IV APD421 single dose arm 2: IV placebo single dose
Interventions: intervention 1: APD421 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01991860
Conditions: PONV
Sponsor: Acacia Pharma Ltd
Start date: 2013-08-01; Completion date: 2014-01-01
Enrollment: 364 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.

Detailed description:

Arms: arm 1: APD421 (amisulpride), at 5mg given by single intravenous (IV) administration by slow push over one minute at induction of anaesthesia. arm 2: Matching placebo given by single IV administration by slow push over one minute at induction of anaesthesia
Interventions: intervention 1: APD421- Amisulpride for IV injection intervention 2: Placebo
Intervention descriptions: intervention 1: APD421 ( Amisulpride) at 5mg given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia intervention 2: Matching Placebo given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia

Protocol documents:
Clinical trial NCT01993238
Conditions: Body Contouring
Sponsor: Solta Medical
Start date: 2013-11-01; Completion date: 2014-01-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objectives of this study are to evaluate the safety and effectiveness of procedural analgesia for improvements in tolerability of treatment with the Liposonix System.

Detailed description:

Arms: arm 1: Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
Interventions: intervention 1: Liposonix System (Model 2) intervention 2: Pre-treatment analgesia
Intervention descriptions: intervention 1: Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2). intervention 2: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)

Protocol documents:
Clinical trial NCT01993875
Conditions: Chronic Idiopathic Constipation
Sponsor: Mallinckrodt
Start date: 2013-10-01; Completion date: 2014-01-01
Enrollment: 164 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lubiprostone intervention 2: Placebo
Intervention descriptions: intervention 1: Liquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID) intervention 2: Matching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID)

Protocol documents:
Clinical trial NCT01995526
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-12-01; Completion date: 2014-01-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to evaluate how the body processes the study drug known as insulin peglispro and how the study drug affects blood sugar in healthy male Japanese participants. This study will also evaluate safety of the study drug. The study will last up to 46 days for each participant, not including screening.

Detailed description:

Arms: arm 1: Single subcutaneous dose of 1.3 Units per kilogram (U/kg) insulin peglispro on Day 1.
Interventions: intervention 1: Insulin Peglispro
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02033200
Conditions: Vision
Keywords: vision Stendra avanafil PDE5 inhibitor visual acuity intraocular pressure pupillometry color vision discrimination healthy males
Sponsor: VIVUS LLC
Start date: 2014-01-01; Completion date: 2014-01-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if Stendra causes any changes in vision, eye pressure, pupil dilation, and color vision in healthy males.

Detailed description:
The objectives of this study are to assess the effect of Stendra on visual acuity, intraocular pressure, pupillometry, and color vision discrimination in healthy male subjects.

Arms: arm 1: Stendra 200 mg arm 2: placebo
Interventions: intervention 1: Stendra 200 mg intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02088697
Conditions: Healthy Volunteers
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2013-12-01; Completion date: 2014-01-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and sertraline Tablet in Japanese healthy male subjects.

Detailed description:

Arms: arm 1: A single oral dose of ASC-01 Placebo (sertraline 100 mg) arm 2: A single oral dose of sertraline tablets (sertraline 100 mg)
Interventions: intervention 1: Placebo intervention 2: ASC-01
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02201784
Conditions: Lower Limb Surgery
Keywords: Subarachnoid block intrathecal spinal anesthesia isobaric levobupivacaine ropivacaine
Sponsor: Aligarh Muslim University
Start date: 2012-12-01; Completion date: 2014-01-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effects of two intrathecally administered drugs:0.5% levobupivacaine and0.75%Ropivacaine in spinal anesthesia

Detailed description:
Bupivacaine is a highly cardiotoxic drug and also produces prolonged motor blockade.The newer drugs levobupivacaine and ropivacaine being comparatively less cardio and neurotoxic are preferred now a days.So, we conducted this prospective, randomized double blind study with an aim of comparing the efficacy and characteristics of these drugs.

Arms: arm 1: intrathecal administration of 15 mg of Levobupivacaine 0.5% arm 2: intrathecal administration of 22.5 mg of Ropivacaine 0.75%
Interventions: intervention 1: Levobupivacaine intervention 2: Ropivacaine
Intervention descriptions: intervention 1: Comparison of Equipotent doses intervention 2: Comparison of equipotent doses

Protocol documents:
Clinical trial NCT02251613
Conditions: Allergic Conjunctivitis
Sponsor: Alcon Research
Start date: 2013-12-01; Completion date: 2014-01-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness and safety of Olopatadine Hydrochloride (HCl) ophthalmic solution 0.1% versus Epinastine HCl ophthalmic solution, 0.05% in a population of healthy, adult Japanese patients (20 years of age or older) with a history of allergic conjunctivitis to Japanese Cedar Pollen. Patients will be randomly assigned to receive Olopatadine HCl ophthalmic solution, 0.1% in one eye and Epinastine HCl ophthalmic solution, 0.05% in the fellow eye, after which a conjunctival allergy challenge (CAC) with Japanese cedar pollen will be performed.

Detailed description:

Arms: arm 1: Olopatadine HCl ophthalmic solution, 0.1%, 1 drop in the right or left eye as randomized arm 2: Epinastine HCl ophthalmic solution, 0.05%, 1 drop in the in the fellow eye
Interventions: intervention 1: Olopatadine HCl ophthalmic solution, 0.1% intervention 2: Epinastine HCl ophthalmic solution, 0.05%
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02256358
Conditions: Psychomotor Agitation
Keywords: child, ketamine, midazolam
Sponsor: Inje University
Start date: 2013-01-01; Completion date: 2014-01-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Compare the effects of intravenous midazolam and ketamine on emergence agitation after sevoflurane anesthesia

Detailed description:
Emergence agitation is self-limiting aggressive behavior that develops in the early period of awakening from anesthesia. A high level of preoperative anxiety is a risk factor for emergence agitation using Aono's four-point scale. Midazolam and ketamine was administered to the patients to decrease of preoperative anxiety. We aimed to compare the emergence agitation between midazolam group and ketamine group.

Arms: arm 1: Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room. arm 2: Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.
Interventions: intervention 1: Midazolam intervention 2: Ketamine
Intervention descriptions: intervention 1: preoperatively injected intravenous 0.1 mg/kg midazolam intervention 2: Preoperatively injected intravenous 1mg/kg ketamine

Protocol documents:
Clinical trial NCT02314546
Conditions: Sedation, Conscious
Sponsor: Bassett Healthcare
Start date: 2011-12-01; Completion date: 2014-01-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative.

Detailed description:
Midazolam is often given before surgery to sedate a patient before anesthesia is given. Children are often given a small dose either by mouth or squirted into the nose. Children will often spit out the oral midazolam, making it difficult to know how much medicine, if any, they have received. Giving midazolam into the nose is more reliable, but children may complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also occur when midazolam is squirted alone into the nose. The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative.

Arms: arm 1: saline placebo arm 2: Nasal Midazolam only - Patients received 0.2 mg/kg of intranasal midazolam arm 3: Midazolam Plus Xylocaine - Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam
Interventions: intervention 1: Midazolam intervention 2: xylocaine intervention 3: saline placebo
Intervention descriptions: intervention 1: Study participants will be randomly assigned to one of three treatment groups:

* Group 1 - Placebo - Control patients will receive intranasal saline.
* Group 2 - Nasal Midazolam Only - Patients will receive 0.2 mg/kg of intranasal midazolam.
* Group 3 - Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam. intervention 2: Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam. intervention 3: Placebo - Control patients will receive intranasal saline.

Protocol documents: