ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02199028
Conditions: Type 1 Diabetes Mellitus
Keywords: hyaluronidase infusion sets insulin pump Continuous glucose monitor
Sponsor: Stanford University
Start date: 2014-07-01; Completion date: 2015-03-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This research study examines the effect of hyaluronidase on the length of time of insulin infusion set wear. The aim of the study is to improve the length of time that an infusion set can be worn by infusing hyaluronidase directly into the insulin infusion site.

Detailed description:
The investigators would like to see if the use of hyaluronidase will improve insulin infusion set survival and improve the onset of insulin action. The investigators will also assess the accuracy of the Dexcom G4P sensors with extended site use beyond the 7 day FDA approved time frame.

The use of sensor information combined with the knowledge of infused insulin from pump therapy could potentially help us detect when an infusion set is beginning to fail. Information from the sensor function to the point of failure, and sensor function in response to Tylenol may allow us to develop special formulas to determine when a sensor is not working well. This will be very important for creating an artificial pancreas.

Thirty subjects will be enrolled. Fifteen patients from each of the two sites: Stanford University and University of Colorado.

Arms: arm 1: Participants assigned to active treatment arm (Hylenex) for weeks 1 and 3.

On weeks 1 and 3 (Hyaluronidase weeks) subjects injected 1 milliliter (ml) Hyaluronidase (150 units/ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear.

On weeks 2 and 4 (control weeks) no Hyaluronidase was administered. arm 2: Participants were first assigned to the control arm. They received active treatment (Hyaluronidase) on weeks 2 and 4.

On weeks 1 and 3 (control weeks) no Hyaluronidase was administered.

On weeks 2 and 4 (Hyaluronidase weeks) subjects injected 1 milliliter (ml) Hyluronidase (150 units/ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear.
Interventions: intervention 1: Hyaluronidase intervention 2: Control
Intervention descriptions: intervention 1: 150 units/ml - subjects injected 1 milliliter (ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear. intervention 2: No hyaluronidase administered into insulin infusion set.

Protocol documents:
Clinical trial NCT02203591
Conditions: Bacterial Reduction Post-product Application
Keywords: surgical skin prep CHG IPA
Sponsor: 3M
Start date: 2014-07-01; Completion date: 2015-03-01
Enrollment: 738 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to demonstrate 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 site, a responder is defined as a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

On the inguinal site, a responder is defined as a subject with a 3-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

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

Protocol documents:
Clinical trial NCT02207491
Conditions: Ocular Hypertension Open-angle Glaucoma
Keywords: Glaucoma
Sponsor: Aerie Pharmaceuticals
Start date: 2014-07-01; Completion date: 2015-03-01
Enrollment: 411 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the ocular hypotensive efficacy and ocular and systemic safety of AR-13324 Ophthalmic Solution, 0.02% compared to the active comparator Timolol maleate Ophthalmic Solution, 0.5%

Detailed description:

Arms: arm 1: 1 drop AR-13324 in the evening (PM) \& 1 drop placebo in the morning (AM) in both eyes (OU) arm 2: 1 drop Timolol maleate twice daily (BID) in the morning (AM) \& evening (PM) in both eyes (OU)
Interventions: intervention 1: Timolol maleate Ophthalmic Solution 0.5% BID intervention 2: AR-13324 Ophthalmic Solution 0.02% intervention 3: Placebo
Intervention descriptions: intervention 1: 1 drop BID, AM/PM, OU intervention 2: 1 drop once daily (QD), PM, OU intervention 3: 1 drop QD, AM, OU

Protocol documents:
Clinical trial NCT02207907
Conditions: Oral Hygiene
Sponsor: GlaxoSmithKline
Start date: 2014-08-01; Completion date: 2015-03-01
Enrollment: 247 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study will be to compare the Gingival Bleeding and Gingival Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be conducted at Silverstone Research Group. Participants will be recruited from their database and by use of an external recruitment agency.

Detailed description:

Arms: arm 1: Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride arm 2: Toothpaste containing 1100 ppm fluoride as sodium fluoride
Interventions: intervention 1: Sodium bicarbonate plus sodium fluoride intervention 2: Sodium fluoride
Intervention descriptions: intervention 1: Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride intervention 2: Toothpaste containing 1100 ppm fluoride as sodium fluoride

Protocol documents:
Clinical trial NCT02208297
Conditions: Inflammation Pain Cataract
Sponsor: Bausch & Lomb Incorporated
Start date: 2014-09-01; Completion date: 2015-03-01
Enrollment: 326 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID)

Detailed description:
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID) for the treatment of inflammation and pain following cataract surgery.

Arms: arm 1: Loteprednol Etabonate Gel 0.38% administered two times daily (BID) arm 2: Vehicle gel administered two times daily (BID)
Interventions: intervention 1: Loteprednol Etabonate Gel (BID) intervention 2: Vehicle Gel (BID)
Intervention descriptions: intervention 1: One drop of LE gel instilled into the study eye two times per day (BID) for 14 days intervention 2: One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days

Protocol documents:
Clinical trial NCT02233296
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2015-01-01; Completion date: 2015-03-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the effect of food on the pharmacokinetics (PK) of a single dose of lasmiditan in healthy participants.

Detailed description:
An open-label, cross-over, two-period, randomized, sequential study in order to investigate the effect of food on the pharmacokinetics of lasmiditan 200 mg. Two single doses of lasmiditan will be administered with the participants in fed and fasted states.

Arms: arm 1: Dosing Sequence: Administration of lasmiditan 200 mg in fed state in Dosing Period 1 followed by administration of lasmiditan 200 mg in fasted state in Dosing Period 2 arm 2: Dosing Sequence: Administration of lasmiditan 200 mg in fasted state in Dosing Period 1 followed by administration in lasmiditan 200 mg fed state in Dosing Period 2.
Interventions: intervention 1: Lasmiditan
Intervention descriptions: intervention 1: 2 discrete doses separated by 6 days.

Protocol documents:
Clinical trial NCT02241486
Conditions: Burn Pain
Keywords: Burn pain Procedural pain Sublingual fentanyl Morphine
Sponsor: Loyola University
Start date: 2013-09-01; Completion date: 2015-03-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.

Detailed description:
The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury. It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.

Arms: arm 1: Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.
Interventions: intervention 1: Sublingual Fentanyl Spray
Intervention descriptions: intervention 1: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).

Protocol documents:
Clinical trial NCT02245360
Conditions: Seasonal Allergic Rhinitis
Keywords: GRAZAX
Sponsor: Abbott
Start date: 2014-10-01; Completion date: 2015-03-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the immunologic effects and safety of 60-day treatment of the Standardized Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.

Detailed description:

Arms: arm 1: Grass tablet 75,000 Standardized Quality units Tablet (SQ-T) arm 2: Placebo
Interventions: intervention 1: Phleum pratense grass pollen allergen extract intervention 2: placebo
Intervention descriptions: intervention 1: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days intervention 2: placebo tablet given once daily over 60 days

Protocol documents:
Clinical trial NCT02255500
Conditions: Pain
Keywords: Total knee arthroplasty
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2014-09-01; Completion date: 2015-03-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and pharmacokinetics of EXPAREL in subjects who undergo femoral nerve block with bupivacaine HCl for unilateral total knee arthroplasty (TKA).

Detailed description:
On Day 1, eligible subjects will receive a single 20 mL dose of bupivacaine hydrochloride (HCl) 0.5% with epinephrine 1:200,000 within 2 hours prior to the surgical procedure as an ultrasound-guided femoral nerve block (FNB). EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site prior to wound closure. There will be no local coadministration of the two drugs.

Blood samples for bupivacaine pharmacokinetic (PK) analysis will be obtained from subjects at baseline (prior to bupivacaine HCl administration for nerve block), 15 minutes, 30 minutes, and 1, 2, 4, 8, 12, 24, 48, 72, and 96 hours after the beginning of EXPAREL administration, and on Day 14.

Arms: arm 1: Femoral nerve block with bupivacaine HCl 0.5% with epinephrine 1:200,000 within 2 hours of the surgical procedure. Infiltration of EXPAREL 266 mg just prior to wound closure.
Interventions: intervention 1: Bupivacaine FNB intervention 2: EXPAREL Infiltration
Intervention descriptions: intervention 1: A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB. intervention 2: A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site just prior to wound closure.

Protocol documents:
Clinical trial NCT02284386
Conditions: Pain
Keywords: Total knee arthroplasty
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2014-12-01; Completion date: 2015-03-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 4, multicenter, open-label study designed to characterize the pharmacokinetic (PK) profile of total bupivacaine in approximately 15 adult subjects undergoing primary unilateral total knee arthroplasty (TKA) with bupivacaine hydrochloride (HCl) spinal nerve block (SNB) and EXPAREL local infiltration into the surgical site.

Detailed description:
On Day 1, following an epinephrine "wash" of the spinal block syringe, eligible subjects will receive a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure as a spinal block. EXPAREL 266 mg in 20 mL (expanded with 70 mL of preservative-free sterile normal saline to a total volume of 90 mL) will be infiltrated into the surgical site at the end of the surgery prior to wound closure. There will be no local co-administration of the two drugs.

Blood samples for bupivacaine PK analysis will be obtained from subjects at baseline (prior to bupivacaine HCl administration for nerve block), 15 minutes, 30 minutes, and 1, 2, 4, 8, 12, 24, 48, and 72 hours after the beginning of EXPAREL administration, and on Day 14.

Arms: arm 1: Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.
Interventions: intervention 1: Bupivacaine SNB intervention 2: EXPAREL Infiltration
Intervention descriptions: intervention 1: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure. intervention 2: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure.

Protocol documents:
Clinical trial NCT02292433
Conditions: Type 2 Diabetes Mellitus
Keywords: Phase 1 type 2 diabetes monotherapy PF-04937319
Sponsor: Pfizer
Start date: 2015-01-01; Completion date: 2015-03-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Study B1621018 will assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Dose Levels of Pf-04937319 in Japanese Subjects with Type 2 Diabetes Mellitus As Monotherapy

Detailed description:

Arms: arm 1: PF-04937319 Split dose arm 2: Placebo split dose
Interventions: intervention 1: PF-04937319 high dose intervention 2: PF-04937319 low dose intervention 3: Placebo
Intervention descriptions: intervention 1: tablets, 150 mg with breakfast plus 100 mg with lunch, 7 days intervention 2: tablets, 50 mg with breakfast plus 50 mg with lunch, 7 days intervention 3: tablets, breakfast plus lunch, 7 days

Protocol documents:
Clinical trial NCT02320695
Conditions: Sting
Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Start date: 2015-03-01; Completion date: 2015-03-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to have subjects report whether or not several antibiotic products sting when they are applied to minor wounds created on the inner arms.

Detailed description:
The primary objective of this study is to assess the sting potential of single applications of over-the-counter (OTC) topical antibiotic ointments and cream compared to saline (negative control) and isopropyl alcohol (positive control) when applied to a tape-stripped wound site.

Arms: arm 1: 0.9% Sodium Chloride Saline Solution (0.3 cc) arm 2: 70% Isopropyl Alcohol (0.3 cc) arm 3: Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc) arm 4: Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc) arm 5: Neosporin® Original Ointment (0.3 cc) arm 6: Neosporin® Plus Pain relief Ointment (0.3 cc)
Interventions: intervention 1: Saline intervention 2: Isopropyl Alcohol intervention 3: Pain Relieving Cream intervention 4: Antibiotic/Pain Relieving Ointment intervention 5: Original Ointment intervention 6: Pain Relief Ointment
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT02325713
Conditions: Healthy
Keywords: ODT-PZQ Bio-availability Praziquantel Cysticide Pharmacokinetics
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2015-01-01; Completion date: 2015-03-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a phase I, open-label, randomized, 4 period, crossover, single-center trial. The purpose of this trial is to assess the relative bio-availability of racemate Oral Dispersible Tablet praziquantel (ODT-PQZ) (MSC1028703A) 150 milligram (mg) versus the current marketed praziquantel (PZQ) (Cysticide® 500 mg) formulation in healthy male volunteers.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None arm 9: None arm 10: None arm 11: None arm 12: None arm 13: None arm 14: None arm 15: None arm 16: None
Interventions: intervention 1: Oral dispersible tablet of praziquantel (ODT-PZQ) intervention 2: Cysticide intervention 3: ODT-PZQ intervention 4: ODT-PZQ intervention 5: ODT-PZQ intervention 6: Cysticide
Intervention descriptions: intervention 1: Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal. intervention 2: Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal. intervention 3: Treatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal. intervention 4: Treatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal. intervention 5: Treatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal. intervention 6: Treatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal.

Protocol documents:
Clinical trial NCT02336594
Conditions: Gout
Sponsor: Ardea Biosciences, Inc.
Start date: 2014-11-01; Completion date: 2015-03-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a Phase 1, randomized, open-label, 4-way crossover pharmacokinetic (PK) and pharmacodynamic (PD) study in healthy adult male subjects designed to assess the relative bioavailability of RDEA3170 2.5 mg tablets administered as a 10 mg dose (2.5 mg × 4 tablets) and of a single RDEA3170 10 mg tablet. This study will also assess the effect of a low-fat and high-fat meal on the PK and PD of RDEA3170 10 mg tablets.

Detailed description:

Arms: arm 1: 2.5 mg x 4 tablets qd (once daily) fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat. arm 2: 10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat arm 3: 2.5 x 4 mg tablets qd fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat arm 4: 10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat
Interventions: intervention 1: RDEA3170 10 mg intervention 2: RDEA3170 2.5 mg
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02339246
Conditions: Renal Failure
Sponsor: Veloxis Pharmaceuticals
Start date: 2015-01-01; Completion date: 2015-03-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to compare the pharmacokinetic parameters of three different formulations of tacrolimus.

Eligible patients will be treated with all three formulations in a pre-defined sequence.

Detailed description:
The pharmacokinetic parameters T(max), C(max) and AUC(0-24) will be compared between the three formulations Envarsus XR once daily, Astagraf XL once daily and Prograf Twice daily.

Arms: arm 1: Prograft capsules Twice daily for 7 days, followed by Envarsus XR tablets once daily for 7 days followed by Astagraf XL capsules once daily for 7 days. arm 2: Prograf capsules twice daily for 7 days followed by Astagraf XL capsules once daily for 7 days followed by Envarsus XR tablets once daily.
Interventions: intervention 1: Prograf vs Envarsus XR vs Astagraf XL intervention 2: Prograf vs Astagraf XL vs Envarsus XR
Intervention descriptions: intervention 1: prograf vs Envarsus XR vs Astagraf XL intervention 2: Prograf vs Astagraf XL vs Envarsus XR

Protocol documents:
Clinical trial NCT02348658
Conditions: Hypertension
Keywords: Pharmacological therapy
Sponsor: Takeda
Start date: 2015-01-01; Completion date: 2015-03-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a phase 1, randomized, open-label, crossover study to evaluate the food-effect of single oral dose of TAK-536TCH final formulation tablet in healthy adult male participants.

Detailed description:
The purpose of this study is to evaluate the food effect on the pharmacokinetics and safety of a single oral dose of TAK-536TCH under fasted and fed conditions in the morning in healthy adult male participants.

Arms: arm 1: Dosing in the fasted state followed by fed dosing arm 2: Dosing in the fed state followed by fasted dosing
Interventions: intervention 1: TAK-536TCH
Intervention descriptions: intervention 1: TAK-536TCH tablets

Protocol documents:
Clinical trial NCT02350998
Conditions: Bilateral Middle Ear Effusion
Sponsor: Otonomy, Inc.
Start date: 2015-01-01; Completion date: 2015-03-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The study is designed to characterize safety and any procedural issues associated with TTT drug administration of OTO-201.

Detailed description:

Arms: arm 1: 6 mg OTO-201 administered trans-tympanostomy tube
Interventions: intervention 1: OTO-201
Intervention descriptions: intervention 1: None

Protocol documents: