ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02056392
Conditions: Solid Tumours
Keywords: Phase I, healthy, pharmacokinetics
Sponsor: AstraZeneca
Start date: 2014-03-01; Completion date: 2014-08-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Study to assess the effect of Selumetinib \[AZD6244; ARRY-142886\] \[Hyd-Sulfate\]), on QTc interval in healthy male volunteers.

Detailed description:
A double-blind (Selumetinib \[AZD6244; ARRY-142886\] \[Hyd-Sulfate\]), Placebo-controlled, Open-Label (Moxifloxacin) Positive-controlled, Randomized, Three-period Crossover Study to Assess the Effects of Single Oral Dose of Selumetinib (75 mg) on QTc Interval Compared to Placebo, using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers

Arms: arm 1: Volunteers will receive selumetinib 75mg administered by mouth, as a capsule arm 2: Volunteers will receive moxifloxacin 400mg administered by mouth, as a capsule arm 3: Volunteers will receive selumetinib 75mg placebo, administered by mouth, as a capsule.
Interventions: intervention 1: Selumetinib intervention 2: Moxifloxacin intervention 3: selumetinib placebo
Intervention descriptions: intervention 1: Volunteers will receive 75 mg selumetinib oral dose (Treatment A) intervention 2: Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B) intervention 3: Volunteers will receive selumetinib placebo oral dose (Treatment C)

Protocol documents:
Clinical trial NCT02059148
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2014-02-01; Completion date: 2014-08-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days apart. One dose will be given with a standard meal, one dose with a high-fat meal and one dose without food. The study will evaluate the effects of the standard and high-fat meals on how much drug gets into the bloodstream. Side effects will be documented. This study is approximately 43 days, not including screening. Screening is required within 28 days prior to the start of the study.

Detailed description:

Arms: arm 1: Single oral dose of LY2835219 given with a standard meal in one of three study periods. arm 2: Single oral dose of LY2835219 given with no food in one of three periods. arm 3: Single oral dose of LY2835219 given with a high fat meal in one of three periods.
Interventions: intervention 1: LY2835219
Intervention descriptions: intervention 1: Administered orally.

Protocol documents:
Clinical trial NCT02060903
Conditions: Head Lice Infestation
Keywords: Head Lice Hatchtech
Sponsor: Dr. Reddy's Laboratories Limited
Start date: 2014-02-01; Completion date: 2014-08-01
Enrollment: 379 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study was to assess the efficacy, safety and tolerability of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to the scalp and hair for 10 minutes at home.

Detailed description:
This was a randomized, double-blind, multicenter, vehicle-controlled, parallel-group study in subjects with active head lice infestation. The study was designed to assess the efficacy, safety and tolerability of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to scalp and hair for 10 minutes at home.

Approximately 106 index subjects with their household members were enrolled into the study. A total of approximately 318 subjects were enrolled, assuming an average of 3 members per household participating in the study.

Arms: arm 1: Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver. arm 2: Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.
Interventions: intervention 1: Abametapir Lotion 0.74% w/w intervention 2: Vehicle Lotion
Intervention descriptions: intervention 1: Abametapir Lotion 0.74% was dispensed to subjects on Day 0 for self-administration at home on the same day. intervention 2: Vehicle Lotion was dispensed to subjects on Day 0 for self-administration at home on the same day.

Protocol documents:
Clinical trial NCT02070640
Conditions: Cholecystitis
Keywords: cholecystectomy cholecystitis
Sponsor: Ohio State University
Start date: 2013-01-01; Completion date: 2014-08-01
Enrollment: 99 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to assist in real-time identification of anatomy during cholecystectomy (gallbladder removal). We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.

Detailed description:
This study is designed to determine the clinical utility of intravenous indocyanine green (ICG) injection pre-operatively for cholecystectomy, followed by visualizuation of the biliary tree with a near-infrared light source and camera. Testing will be done during an abdominal surgery which requires gallbladder removal. Subjects will be recruited during consult for their surgical procedure. The study itself will take an estimated 5 minutes during the procedure. 2.5mg of ICG will be injected intravenously 60-30 minutes before surgery, and following perfusion of the biliary tree, images will be recorded and visibility of the appropriate anatomy will be assessed using a near-infrared light source and camera. If fluorescence has faded prior to adequate visualization, a repeat dose of 2.5mg IV ICG may be given. Following the completion of imaging, the standard procedure for cholecystectomy will be performed including intraoperative cholangiography (IOC), which is standard of care. Subject post-operative recovery will be monitored for the duration of their hospital stay. Adverse events will be monitored at the patient's routine follow up visit.

Arms: arm 1: Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography. 2.5 mg of indocyanine green is injected 30-60 minutes prior to surgery. Visualization of the biliary tree during surgery is achieved with a near-infrared light source and camera.
Interventions: intervention 1: Injection of indocyanine green (ICG) intervention 2: Near Infrared Cholangiography Fluorescence (NIRF-C)
Intervention descriptions: intervention 1: 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery in order to visualize the biliary tree using a near-infrared light source and camera. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization. intervention 2: These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.

Protocol documents:
Clinical trial NCT02093689
Conditions: Intraocular Lens Replacement Intraoperative Floppy Iris Syndrome
Sponsor: Omeros Corporation
Start date: 2014-02-01; Completion date: 2014-08-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of OMS302 on the signs of Intraoperative Floppy Iris Syndrome in patients at risk.

Detailed description:
OMS302 is a mydriatic/anti-inflammatory combination investigational drug product being developed for use during intraoperative lens replacement (ILR). This study evaluates the effect of OMS302 on the signs of Floppy Iris Syndrome in subjects with a history of tamsulosin exposure who are undergoing ILR.

Arms: arm 1: OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution arm 2: OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution arm 3: Placebo contains 20mM sodium citrate diluted in BSS and administered as irrigation solution.
Interventions: intervention 1: Part 1 OMS302 intervention 2: Part 2 OMS302 intervention 3: Part 2 Placebo
Intervention descriptions: intervention 1: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5-mL solution containing 60.75 mM phenylephrine HCl (12.37 mg/mL) and 11.25 mM ketorolac trometamol (4.24 mg/mL) formulated in a 20 mM sodium citrate buffer (pH 6.3 ± 0.5). For administration to patients, 4.0 mL of the drug product is added to a 500-mL bottle of commercially available irrigation solution. intervention 2: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5-mL solution containing 60.75 mM phenylephrine HCl (12.37 mg/mL) and 11.25 mM ketorolac trometamol (4.24 mg/mL) formulated in a 20 mM sodium citrate buffer (pH 6.3 ± 0.5). For administration to patients, 4.0 mL of the drug product is added to a 500-mL bottle of commercially available irrigation solution. intervention 3: Placebo drug product is a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 ± 0.5). For administration to patients, 4.0 mL of the drug product is added to a 500-mL bottle of commercially available irrigation solution.

Protocol documents:
Clinical trial NCT02096679
Conditions: Healthy Volunteers
Keywords: Phase I, healthy, pharmacokinetics, Mass balance
Sponsor: AstraZeneca
Start date: 2014-05-01; Completion date: 2014-08-01
Enrollment: 8 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Study to evaluate the pharmacokinetic and Mass Balance of single dose \[14C\] AZD9291 in healthy male volunteers

Detailed description:
A Single-centre, Non-Randomised, Open-label, Pharmacokinetic and Mass Balance Study of Orally Administered \[14C\]-AZD9291 in Healthy Male Volunteers

Arms: arm 1: Volunteers will receive 20 mg \[14C\]-AZD9291 containing a nominal 1 μCi activity, administered by mouth, as a solution.
Interventions: intervention 1: AZD9291
Intervention descriptions: intervention 1: Volunteer will receive a single oral dose of 20 mg \[14C\]-AZD9291 as a solution on Day 1

Protocol documents:
Clinical trial NCT02102932
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-05-01; Completion date: 2014-08-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of Empagliflozin and metformin compared to the administration of single tablets (Empagliflozin and metformin ) in Chinese subjects. The availability of a fixed dose combination tablet is expected to significantly enhance patient's compliance with antidiabetic treatment, in particular with concern to the frequent polypharmacy in diabetic patients.

Detailed description:

Arms: arm 1: 24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 12.5 mg empagliflozin/850 mg metformin and single 10 mg empagliflozin, 2.5 mg empagliflozin, 850 mg metformin tablets single dose in randomized order arm 2: 24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 5 mg empagliflozin/850 mg metformin and single Empagliflozin(5mg) and metformin (850mg) tablets single dose in randomized order arm 3: 24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 12.5 mg empagliflozin/500 mg metformin and single 10 mg empagliflozin, 2.5 mg empagliflozin, 500 mg metformin tablets single dose in randomized order arm 4: 24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 5 mg empagliflozin/500 mg metformin and single Empagliflozin(5mg) and metformin (500mg) tablets single dose in randomized order
Interventions: intervention 1: 5 mg empagliflozin/850 mg metformin FDC intervention 2: 12.5 mg empagliflozin intervention 3: 12.5 mg empagliflozin intervention 4: 850 mg metformin intervention 5: 5 mg empagliflozin intervention 6: 5 mg empagliflozin intervention 7: 850 mg metformin intervention 8: 12.5 mg empagliflozin/850 mg metformin FDC intervention 9: 12.5 mg empagliflozin/500 mg metformin FDC intervention 10: 5 mg empagliflozin/500 mg metformin FDC intervention 11: 500 mg metformin intervention 12: 500 mg metformin
Intervention descriptions: intervention 1: 5 mg empagliflozin/850 mg metformin FDC intervention 2: 10 mg empagliflozin tablet and 2.5 mg empagliflozin tablet intervention 3: 10mg empagliflozin tablet and 2.5 mg empagliflozin tablet intervention 4: 850mg metformin tablet intervention 5: 5 mg empagliflozin intervention 6: 5 mg empagliflozin intervention 7: 850 mg metformin intervention 8: 12.5 mg empagliflozin/850 mg metformin FDC intervention 9: 12.5 mg empagliflozin/500 mg metformin FDC intervention 10: 5 mg empagliflozin/500 mg metformin FDC intervention 11: 500 mg metformin intervention 12: 500 mg metformin

Protocol documents:
Clinical trial NCT02106962
Conditions: Arteriovenous Fistula
Keywords: hemodialysis fistula clotting tranexamic acid bacitracin
Sponsor: California Institute of Renal Research
Start date: 2014-04-01; Completion date: 2014-08-01
Enrollment: 17 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate how the use of Tranexamic acid and Bacitracin applied to the bleeding site after the hemodialysis fistula needle is removed will affect Time to Clot and Infection Rate

Detailed description:
Visit 1 - Initial Application:

* A patient candidate identified by the PI who meets all of the inclusion criteria and none of the exclusion criteria will be consented for the study.
* The medical history will be collected from the subject.
* The subject will receive routine hemodialysis
* Directly after the completion of hemodialysis, the following study drug application steps will occur:

  1. Site 1 Initial Compression: Apply fixed amount of Tranexamic acid and bacitracin 5% or 25% to gauze and compress for 3 minutes to needle site 1.
  2. Site 2 Initial Compression: Apply fixed amount of Tranexamic acid and bacitracin 5% or 25% to gauze and compress for 3 minutes to needle site 2.
  3. Second Compression per site: If bleeding has not stopped, repeat application with new gauze and same amount of ointment to each respective site and compress for 5 minutes more at each site.
  4. Third Compression per site: If after the second application and compression the bleeding persists repeat both application and compression for another 5 minutes (total time would be 13 minutes at this step).
  5. Test Failure: If after the third application to each needle site there is still bleeding, the testing would be considered a failure and routine procedures should be utilized to stop the bleeding.
* Any adverse events will be collected.

Visit 2 - Follow-Up:

• The 1 week follow up visit will be performed to review study drug application site and to collect any adverse events reported by subject

The clotting time will be compared to the clotting time at a different dialysis session in which no treatment will be used

Arms: arm 1: Measure Native AV Fistula clotting time after dialysis using 5% Tranexamic Acid compared to normal Clotting time of Native AV Fistula after dialysis arm 2: Measure Native AV Fistula clotting time after dialysis using 25% Tranxemic Acid compared to normal clotting time of native AV Fistula after dialysis
Interventions: intervention 1: Topical Tranexamic Acid 5% with bacitracin intervention 2: Topical Tranexamic Acid 25% with bacitracin
Intervention descriptions: intervention 1: Selected participants received a fixed amount of tranexamic acid 5 %and bacitracin applied with compression up to 3 times (13 minutes total) per hemodialysis fistula needle site. intervention 2: Selected participants received a fixed amount of tranexamic acid 25%and bacitracin applied with compression up to 3 times (13 minutes total) per hemodialysis fistula needle site.

Protocol documents:
Clinical trial NCT02108288
Conditions: Glaucoma Ocular Hypertension
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2014-04-01; Completion date: 2014-08-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating the combination drug will be determined.

Detailed description:

Arms: arm 1: Once daily arm 2: Once daily arm 3: Once daily
Interventions: intervention 1: OPC-1085EL ophthalmic solution intervention 2: Carteolol long-acting ophthalmic solution intervention 3: Latanoprost ophthalmic solution
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02121535
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-04-01; Completion date: 2014-08-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study will be performed as an open-label, randomised, single-dose, two-sequence, four-period replicated crossover design. A total of 72 Japanese healthy male subjects will be randomised to 2 groups. The subjects are administrated either T80/A5/H12.5 mg FDC tablet once or T80/A5 mg FDC tablet and hydrochlorothiazide (HCTZ) 12.5 mg tablet once in each period. The length of admission will be 7 days in each period.

Detailed description:

Arms: arm 1: A Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination (FDC) tablet arm 2: A Telmisartan 80 mg/ Amlodipine 5 mg fixed dose combination (FDC) tablet and a Hydrochlorothiazide 12.5 mg tablet
Interventions: intervention 1: T80/A5 mg FDC tablet intervention 2: T80/A5 mg FDC tablet intervention 3: H12.5 mg tablet intervention 4: T80/A5/H12.5 ng FDC tablet intervention 5: H12.5 mf tablet intervention 6: T80/A5/H12.5 mg FDC tablet
Intervention descriptions: intervention 1: None intervention 2: A Telmisartan 80 mg/ Amlodipine 5 mg FDC tablet intervention 3: None intervention 4: A Telmisartan 80 mg/Amlodipine 5 mg/HCTZ 12.5 mg FDC tablet intervention 5: A HCTZ 12.5 mg tablet intervention 6: None

Protocol documents:
Clinical trial NCT02123017
Conditions: Colonoscopy Preparation
Keywords: Bowel Evacuation Colonoscopy Preparation
Sponsor: Cumberland Pharmaceuticals
Start date: 2014-04-01; Completion date: 2014-08-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the efficacy and safety of bisacodyl combined with escalating doses of lactulose to be used as a preparation for colonoscopy.

Detailed description:

Arms: arm 1: 15 mg of bisacodyl, plus 30 grams of crystalline lactulose x three doses arm 2: 15 mg of bisacodyl, plus 45 grams of crystalline lactulose x three doses arm 3: 15 mg of bisacodyl, plus 60 grams of crystalline lactulose x three doses
Interventions: intervention 1: 90 grams of Crystalline Lactulose intervention 2: 135 grams of Crystalline Lactulose intervention 3: 180 grams of Crystalline Lactulose
Intervention descriptions: intervention 1: 15 mg of bisacodyl, plus 30 grams crystalline lactulose x 3 doses intervention 2: 15 mg of bisacodyl, plus 45 grams crystalline lactulose x 3 doses intervention 3: 15 mg of bisacodyl, plus 60 grams crystalline lactulose x 3 doses

Protocol documents:
Clinical trial NCT02137382
Conditions: Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Keywords: maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis
Sponsor: Abbott
Start date: 2014-01-01; Completion date: 2014-08-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis

Detailed description:

Arms: arm 1: Subjects first received Creon N for 5 days. After a washout period of 3 to 14 days, they received Creon® for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to \<10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units. arm 2: Subjects first received Creon® for 5 days. After a washout period of 3 to 14 days, they received Creon N for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to \<10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units.
Interventions: intervention 1: Creon® intervention 2: Creon N
Intervention descriptions: intervention 1: active comparator intervention 2: experimental drug

Protocol documents:
Clinical trial NCT02143141
Conditions: Scheduled Cesarean Sections Postoperative Pain Management Side Effects
Keywords: postoperative pain narcotic side effects
Sponsor: Wake Forest University Health Sciences
Start date: 2011-11-01; Completion date: 2014-08-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators are attempting to see if eliminating the amount of long acting spinal narcotic during cesarean section delivery will demonstrate pain scores with movement when evaluated 24 hours postoperatively as those that receive the standard dosage of spinal narcotic when combined with oral acetaminophen or placebo. The investigators also are evaluating if there are decreased side effects related to decreased narcotic usage.

Detailed description:
Subjects are randomized on the morning of surgery to receive a standard dose of spinal narcotic or to receive no long acting spinal narcotic. The subjects may or may not also receive acetaminophen orally postoperatively. Pain scores are done on postoperative day one as well as evaluation of potential narcotic side effects such as nausea/vomiting, itching, and sedation.

Arms: arm 1: duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours arm 2: no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively
Interventions: intervention 1: duramorph intervention 2: placebo
Intervention descriptions: intervention 1: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching. intervention 2: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.

Protocol documents: