ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02194621
Conditions: Oral Bacteria Levels in the Mouth
Sponsor: Colgate Palmolive
Start date: 2014-01-01; Completion date: 2014-03-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to evaluate the antibacterial effects of two toothpastes containing 0.3% triclosan, 2% copolymer and 0.234% sodium fluoride in a silica base as compared to a control regular fluoride toothpaste on anaerobic and malodor bacteria 12 hours after 13 days of product use. A secondary objective was to demonstrate that a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234% sodium fluoride and a flavor with odor-masking ingredients in silica base (Colgate Total Toothpaste-Flavor Option 1) provides a level of antibacterial efficacy that is "equivalent" to a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234% sodium fluoride and a regular flavor in silica base (Colgate Total Toothpaste-Flavor Option 2) after 13 days of product use.

Detailed description:

Arms: arm 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 1 ingredient - Total Flavor Option 1 arm 2: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 2 ingredient. Total Flavor Option 2 arm 3: Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)
Interventions: intervention 1: Total Flavor option 1 intervention 2: Total Flavor option 2 intervention 3: Placebo toothpaste: Crest Cavity Protection toothpaste
Intervention descriptions: intervention 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1 intervention 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2 intervention 3: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)

Protocol documents:
Clinical trial NCT02299349
Conditions: Total Knee Arthroplasty
Sponsor: TriHealth Inc.
Start date: 2013-08-01; Completion date: 2014-03-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Despite a robust multimodal pain management regimen, patients undergoing total knee arthroplasty (TKA) continue to report low satisfaction with postoperative pain management. Patient satisfaction further declines with any adverse event such as a drug reaction to neuroleptic medications or a patient fall due to a femoral nerve block. A new method of pain management throughout the hospital experience is warranted to improve patient satisfaction and the possibility of related adverse events. The purpose of this study is to examine if there is a difference in post operative pain and morphine (MSO4) total consumption for hospitalized TKA patients without femoral nerve block receiving an intra-operative periarticular injection of bupivacaine liposome suspension versus a concentrated multi drug.

Detailed description:
The void in the literature is that while multimodal pain management reduces postoperative pain in the majority of TKA patients6-14, too many are still dissatisfied with overall pain control13 and adverse drug reactions (dizziness and somnolence) to neuroleptic medications15. Additionally, postoperative falls are greater with femoral nerve blocks16, and new neurological symptoms are associated with the block17. Bupivacaine liposome suspension periarticular injection has large scale national anecdotal support for TKA pain control with avoidance of regional block adversity. There is one recent randomized control trial in TKA patients favorably comparing periarticular injection with bupivacaine liposome suspension versus bupivacaine hydrochloride (HCL)5. To date the clinical use and published evidence most robustly supports bupivacaine liposome suspension in patients undergoing bunionectomy or hemorrhoidectomy. Additionally, in preparation for shorter hospital stays for total joint arthroplasty, a more effective and better tolerated pain management solution is needed.

Hypothesis Statement:

Hospitalized TKA patients without a pre-operative femoral nerve block will experience improved postoperative pain control and less MSO4 equivalence consumption when receiving an injection of bupivacaine liposome suspension versus concentrated multi drug.

Arms: arm 1: bupivacaine liposome suspension periarticular injection arm 2: concentrated multi drug periarticular injection
Interventions: intervention 1: bupivacaine liposome suspension intervention 2: concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL
Intervention descriptions: intervention 1: bupivacaine liposome suspension periarticular injection intervention 2: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl

Protocol documents:
Clinical trial NCT02305316
Conditions: Parkinson Disease
Sponsor: Bial - Portela C S.A.
Start date: 2014-02-01; Completion date: 2014-03-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more.

Detailed description:
Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more. A total of twenty-eight (28) healthy volunteers received a single dose of 50 mg OPC, orally.

Arms: arm 1: Each subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized arm 2: Each subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized
Interventions: intervention 1: BIA 9-1067 non-micronized intervention 2: BIA 9-1067 micronized
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02370602
Conditions: Healthy Volunteers
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2013-10-01; Completion date: 2014-03-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to estimate phosphodiesterase 10A (PDE10A) occupancy in brain following a single dose of TAK-063.

Detailed description:
The drug being tested in this study is called TAK-063. TAK-063 is was tested to estimate phosphodiesterase10A (PDE10A) occupancy in the brain following a single dose of TAK-063. This study used positron emission tomography (PET) scans to look at changes in the volume of tissue distribution before and after TAK-063 administration to calculate PDE10A occupancy in the brain.

The study enrolled 13 participants. Participants were assigned to a treatment group based on an enrollment schedule. The first 4 participants were assigned to the Pilot Cohort and received one dose of TAK-063 30 mg or 1000 mg tablets. The remaining participants were enrolled into the Main Cohort and received one dose of TAK-063 at 3, 10, 30 or 100 mg. Participants in both cohorts also received 3 separate intravenous infusions of \[\^11C\]T-773 \<8 μg; 400MBq ± 10% followed by a PET scan.

This single-centre trial was conducted in Sweden. The overall time to participate in this study was 46 days. Participants made 3 visits to the clinic, including one 3-day period of confinement to the clinic. Participants were contacted by phone on Day 16 for follow-up safety assessments.

Arms: arm 1: \[\^11C\]T-773 \<8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 prior to PET scans and TAK-063 30 mg or 1000 mg, tablets, orally, once on Day 2 and after PET scan #2 and prior to PET scan #3 and \[\^11C\]T-773 IV after TAK-063 and prior to PET scan #3 on Day 2. arm 2: TAK-063 3 to 100 mg, tablets, orally, once, on Day 1, and \[\^11C\]T-773 \<8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2 .
Interventions: intervention 1: TAK-063 intervention 2: [^11C]T-773
Intervention descriptions: intervention 1: TAK-063 tablets intervention 2: \[\^11C\]T-773 IV solution

Protocol documents:
Clinical trial NCT02401529
Conditions: Postoperative Pain Postoperative Nausea and Vomiting
Keywords: Dexamethasone Prednisolone Tonsillectomy Nausea Pain, Postoperative Postoperative Nausea and Vomiting Randomized controlled trial Post-tonsillectomy pain delayed feeding
Sponsor: King Fahd General Hospital
Start date: 2013-01-01; Completion date: 2014-03-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to evaluate the effect of postoperative systemic rapid onset and short acting dexamethasone followed by a tapering dose of oral prednisolone on post-tonsillectomy morbidities. Half of the patients who comply with the inclusion criteria were selected to receive a single postoperative dose of intravenous dexamethasone followed by oral steroids; the second group received placebo.

Detailed description:
The effect of preoperative systemic steroids on post-tonsillectomy morbidities such as pain, nausea, vomiting and delayed feeding was proven. However, this study aims to evaluate the effect of postoperative systemic rapid onset and short acting dexamethasone followed by a tapering dose of oral prednisolone on the aforementioned morbidities and on decreasing the duration and costs of hospital stays. patients who were in the waiting list for tonsillectomy procedure were screened for medical history and those who comply with the inclusion criteria were randomly assigned into two equal groups of 50 patients each. One group was selected to receive a single postoperative dose of intravenous dexamethasone followed by oral steroids; the second group received placebo. Questionnaires investigating postoperative pain, nausea, vomiting, and oral intake were answered by patients, parents or guardians where applicable.

Arms: arm 1: Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). arm 2: Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
Interventions: intervention 1: IV dexamethasone intervention 2: Oral prednisolone intervention 3: Paracetamol intervention 4: IV saline
Intervention descriptions: intervention 1: 0.15 mg/kg intervention 2: 0.25mg/kg/day for 7 days then tapering for next 7 days intervention 3: acetaminophen 15 mg/kg/dose every 6 hours intervention 4: IV saline

Protocol documents:
Clinical trial NCT02587117
Conditions: Oral Lichen Planus
Keywords: Antioxidant Lycopene Prednisolone
Sponsor: B.P. Koirala Institute of Health Sciences
Start date: 2013-02-01; Completion date: 2014-03-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Oral lichen planus (OLP) is a common sub-acute, chronic inflammatory mucocutaneous disease.This study was evaluated the comparative efficacy of lycopene and prednisolone for the treatment of oral lichen planus. Half of participants (total number of participants was twenty eight) were received lycopene and the other half were received prednisolone.

Detailed description:
Prednisolone and lycopene were produced remission of lesions in oral lichen planus patients, but they do so by different mechanisms.

The main cause of oral lichen planus is still unknown. Some authors advocate the disease appears to be a result of T-cell-mediated autoimmune responses in oral epithelial tissues. But, recent study suggests that increased reactive oxygen species (ROS) and lipid peroxidation together with an imbalance in the antioxidant defense system may play a part in the generation of disease.

Lycopene exerts its antioxidant activity by physical and chemical quenching of free radicals and decreases free radicals-initiated oxidative reactions, particularly lipid peroxidation and DNA oxidative damage, thereby preventing tissue damage.

Prednisone have both anti-inflammatory and immunosuppressant effects.It suppresses the inflammatory response by limiting the recruitment of inflammatory cells and inhibiting synthesis of pro-inflammatory products such as prostaglandins (PGs), leukotrienes (LTs) and platelet activating factors (PAF) by indirectly inhibiting phospholipase A2 and negative regulating cyclooxygenase (COX-2).

Arms: arm 1: Lycopene- 4 mg capsule by mouth single dose per day for 2 months arm 2: Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
Interventions: intervention 1: lycopene intervention 2: Prednisolone
Intervention descriptions: intervention 1: Each capsule contain 2 mg lycopene. Each patient was received two capsules of lycopene (total dose was 4 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy. intervention 2: Each capsule contain 20 mg prednisolone. Each patient was received two capsules of prednisolone (total dose was 40 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy.

Protocol documents:
Clinical trial NCT02661594
Conditions: Healthy
Keywords: TQT amisulpride volunteer ECG
Sponsor: Acacia Pharma Ltd
Start date: 2013-11-01; Completion date: 2014-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Randomised, single-dose, crossover, placebo-controlled study to see if intravenous amisulpride has any effect on the heart rhythm, in particular the QT interval, in healthy adult volunteers.

Detailed description:
Phase 1, randomised, single-dose, period-balanced, crossover, placebo- controlled study to assess the effects of iv doses of amisulpride on the QT interval, corrected for heart rate by Fridericia's formula (QTcF), in healthy male and female subjects of Caucasian and Japanese ethnicity aged 20-45 years.

Arms: arm 1: A: APD421 5 mg followed by B: APD421 40 mg; C: Moxifloxacin 400 mg; D: Placebo. arm 2: B: APD421 40 mg; D: Placebo. A: APD421 5 mg C: Moxifloxacin 400 mg; arm 3: C: Moxifloxacin 400 mg A: APD421 5 mg D: Placebo B: APD421 40 mg arm 4: D: Placebo C: Moxifloxacin 400 mg B: APD421 40 mg A: APD421 5 mg
Interventions: intervention 1: APD421 5 mg intervention 2: APD421 40 mg intervention 3: Moxifloxacin intervention 4: Placebo
Intervention descriptions: intervention 1: Therapeutic dose of amisulpride intervention 2: Supra-therapeutic dose of amisulpride intervention 3: Positive control for assay sensitivity intervention 4: Placebo comparator to establish baseline for calculating change in QTcF

Protocol documents:
Clinical trial NCT02847260
Conditions: Pulmonary Arterial Hypertension
Sponsor: United Therapeutics
Start date: 2012-04-01; Completion date: 2014-03-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the safety and tolerability of a rapid dose titration regimen of subcutaneous Remodulin® therapy in patients with PAH.

Detailed description:
This is an open label, single territory, multi-centre study in subjects with pulmonary arterial.

hypertension (PAH). Subjects were treatment naïve or receiving an approved endothelin receptor antagonist (ERA) and / or phosphodiesterase (PDE)-5 inhibitor for at least 60 days prior to screening and maintained on a stable dose for at least 30 days.

Arms: arm 1: Remodulin will be initiated, whilst subjects are hospitalized (minimum of 72 hours) and under medical supervision, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments are permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min is achieved, the dose increments can be increased up to 4 ng/kg/min with dose increments separated by at least 24 hours. The aim is to achieve a target dose of 10, 20, and 30 ng/kg/min by the end of weeks 1, 4 and 12, respectively.
Interventions: intervention 1: Remodulin
Intervention descriptions: intervention 1: Treatment will be initiated whilst hospitalized at approximately 2.0 ng/kg/min with dose increments of 1- 2 ng/kg/min approximately every 12 hours according to clinical response and tolerability. Following subject discharge, the dose rate is increased by 1-2 ng/kg/min with dose increments separated by at least 24 hours. When a dose rate of 20 ng/kg/min is achieved dose increments can be increased at a rate of up to 4 ng/kg/min with dose increments separated by at least 24 hours depending on tolerability. The aim is to achieve a dose rate of at least 10, 20 and 30 ng/kg/min by the end of weeks 1, 4 and 12, respectively and a dose rate by the end of week 16 that achieves pre-defined treatment goals subject to clinical response and tolerability.

Protocol documents:
Clinical trial NCT00436748
Conditions: Anemia Chronic Kidney Disease Kidney Disease
Keywords: Chronic Kidney Disease Dialysis Anemia Nephrology Pediatric Hemodialysis Peritoneal Dialysis Chronic Renal Insufficiency
Sponsor: Amgen
Start date: 2008-09-16; Completion date: 2014-03-03
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are the following:

1. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa once a week (QW) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis, and
2. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa every 2 weeks (Q2W) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis.

Detailed description:

Arms: arm 1: Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously. arm 2: Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
Interventions: intervention 1: Darbepoetin Alfa intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous or intravenous injection intervention 2: Matching placebo solution for subcutaneous or intravenous injection to maintain the blind in the Q2W arm.

Protocol documents:
Clinical trial NCT01636206
Conditions: Dry Eye Disease
Sponsor: Shire
Start date: 2012-10-16; Completion date: 2014-03-03
Enrollment: 332 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the safety of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse events when administered BID for approximately 1 year.

Detailed description:

Arms: arm 1: Placebo arm 2: Active
Interventions: intervention 1: Lifitegrast intervention 2: Placebo
Intervention descriptions: intervention 1: Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: \~1 year intervention 2: Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: \~1 year

Protocol documents:
Clinical trial NCT01875991
Conditions: Rheumatoid Arthritis Plaque Psoriasis
Sponsor: Amgen
Start date: 2013-06-05; Completion date: 2014-03-04
Enrollment: 217 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study will estimate the preference of rheumatoid arthritis (RA) and Plaque Psoriasis (PsO) patients who self inject etanercept for one of two experimental autoinjectors.

Detailed description:
Candidates for treatment are those who in the determination of the investigator's standard of care and the caring physician's intent are to initiate treatment with etanercept. Participants must be naïve to etanercept and naïve to other autoinjector pens or prefilled syringes and be able to self-inject. The study will consist of a 30 day screening period, and 2 treatment periods of 4 weeks duration each (one treatment period using Autoinjector A and the other using Autoinjector B). At the end of the study, participants may continue treatment with commercially available etanercept at the physician's discretion.

Arms: arm 1: Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks. arm 2: Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
Interventions: intervention 1: Etanercept via Autoinjector A intervention 2: Etanercept via Autoinjector B
Intervention descriptions: intervention 1: Autoinjector A is a hand-held, reusable, electromechanical device used with a single-use disposable cassette preassembled with an etanercept 50-mg prefilled syringe. intervention 2: Autoinjector B is a single-use, spring-loaded, self-contained autoinjector preassembled with an etanercept 50-mg prefilled syringe.

Protocol documents:
Clinical trial NCT01591863
Conditions: Clostridium Difficile-associated Diarrhea
Keywords: Clostridium difficile-associated diarrhea CDAD Pediatric
Sponsor: Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2012-06-15; Completion date: 2014-03-07
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: fidaxomicin
Intervention descriptions: intervention 1: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.

6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days.

Protocol documents: