ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01907490
Conditions: Head Lice Infestation
Keywords: Topical treatment of Head Lice Infestation
Sponsor: Dr. Reddy's Laboratories Limited
Start date: 2013-03-01; Completion date: 2013-12-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the safety and tolerability of a single application of Ha44 Gel 0.74% w/v for the treatment of head lice under maximal use conditions.

Secondary objective is to evaluate pharmacokinetics of Ha44 and benzyl alcohol (contained in Ha44 vehicle) under maximal use conditions.

Detailed description:
This is an open-label safety and pharmacokinetic (PK) study involving a single application of Ha44 Gel 0.74% administered under maximal use conditions.

All participants must have an active head lice infestation (at least 3 live lice) and be 6 months to 17 years of age. The study will enroll approximately 36 pediatric subjects between the ages of 6 months and 17 years.

Pediatric PK samples will be collected at 0 (predose), 30 and 60 mins and 2 and 8 hrs time points.

More than one household member with an active lice infestation may participate in the study. Eligible subjects will be consented and screened for study eligibility on Day 0 (Visit 1). All subjects will return to the study site for three follow-up clinic visits at Days 1, 7 and 14. The maximum study duration for a subject is 16 days.

Arms: arm 1: Ha44 Gel 0.74%, topical solution, maximum feasible amount applied for 10 minutes
Interventions: intervention 1: Ha44 Gel
Intervention descriptions: intervention 1: Eligible subjects will be treated at the study site on Day 0 with a single application of the maximum feasible amount of Ha44 Gel, to ensure saturation of the scalp and hair.

Protocol documents:
Clinical trial NCT01923389
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: T2DM obesity safety multiple dose intravenous
Sponsor: Pfizer
Start date: 2013-09-01; Completion date: 2013-12-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a trial in obese subjects to study the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-05231023.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: 100 mg PF-05231023
Intervention descriptions: intervention 1: 0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), twice a week for 4 weeks. intervention 2: 100 mg IV infusion twice a week for 4 weeks

Protocol documents:
Clinical trial NCT01924429
Conditions: ADHD
Keywords: Attention Deficit Hyperactivity Disorder ADHD fMRI Imaging Vyvanse Stimulant Medication Treatment Clinical Trial Adult
Sponsor: Jeffrey Newcorn
Start date: 2013-03-01; Completion date: 2013-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the effects of Vyvanse, an FDA approved medication used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD), on brain activity in adults with attention-deficit hyperactivity disorder (ADHD). Participants may qualify for participation in this study because they have ADHD and are willing to participate in two Functional Magnetic Resonance Imaging (fMRI) scans and receive Vyvanse for treatment of their symptoms. Another purpose of this study is to collect and bank samples of blood for research to examine how genes influence brain activation seen during the brain scans. The study also seeks to find out whether certain genes are related to ADHD. Participants' entire genetic makeup will not be determined from this sample.

Detailed description:

Arms: arm 1: Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg arm 2: Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg
Interventions: intervention 1: Lisdexamfetamine
Intervention descriptions: intervention 1: Escalating stepped dose titration: 30, 50 or 70mg

Protocol documents:
Clinical trial NCT01925703
Conditions: Heart Failure Iron Deficiency Anemia
Sponsor: University of North Carolina, Chapel Hill
Start date: 2011-04-01; Completion date: 2013-12-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Intravenous iron replacement has been shown to benefit patients with heart failure and iron deficiency, but the weekly outpatient regimens studied to date are impractical for many patients. Our purpose is to evaluate the short-term effects and safety of an accelerated intravenous iron regimen in hospitalized patients with these two conditions.

Detailed description:
The purpose of this pilot investigation is to evaluate the short-term hematologic effects and safety of an accelerated intravenous iron regimen in patients with heart failure and iron deficiency. Recent investigations have demonstrated improved clinical outcomes with the use of intravenous iron therapy in this patient population, but a weekly regimen administered to ambulatory patients may be inconvenient, impractical, and associated with less than optimal adherence rates for many patients, especially those with reduced functional capacity. The heart failure population is characterized by frequent hospitalizations, which would make an accelerated inpatient regimen a convenient and attractive option for improving heart failure symptoms, exercise tolerance, and quality of life. Accelerated regimens have been demonstrated as being both safe and effective in other patient populations, but no studies to date have evaluated this strategy in hospitalized patients with heart failure.

Arms: arm 1: Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
Interventions: intervention 1: Sodium ferric gluconate
Intervention descriptions: intervention 1: Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.

Protocol documents:
Clinical trial NCT01929707
Conditions: Healthy Participants
Sponsor: Eli Lilly and Company
Start date: 2013-08-01; Completion date: 2013-12-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The main purpose of this study is to evaluate the safety and how well the body will handle a single dose of increasing strength of study drug LY3050258. Each participant will receive LY3050258 or placebo once, in each of 2 dosing periods. At least 7 days will pass between doses. This study will last approximately 45 days for each participant. Screening is required within 28 days before the start of the study.

Detailed description:

Arms: arm 1: Single escalating dose of LY3050258 (2 milligram \[mg\] up to 200 mg) administered in up to two of two periods. arm 2: Single dose of placebo matching LY3050258 administered in up to one of two periods.
Interventions: intervention 1: LY3050258 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01939314
Conditions: Headache Migraine
Keywords: Headache Migraine
Sponsor: Indiana University
Start date: 2012-10-01; Completion date: 2013-12-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the duration of the analgesia.

Detailed description:

Arms: arm 1: Bupivicaine .03ml to each nare arm 2: normal saline .03 ml to each nare
Interventions: intervention 1: Bupivacaine intervention 2: Placebo
Intervention descriptions: intervention 1: Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion intervention 2: Normal Saline Delivered by the Tx 360 Device to the Sphenopalatine Ganglion

Protocol documents:
Clinical trial NCT01944774
Conditions: Pneumonia
Keywords: Moxifloxacin
Sponsor: TaiGen Biotechnology Co., Ltd.
Start date: 2013-03-01; Completion date: 2013-12-01
Enrollment: 207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to Evaluate the Efficacy, safety and pharmacokinetics of Intravenous Nemonoxacin Compared with Intravenous Moxifloxacin in Adult Patients with community-acquired pneumonia (CAP).

Detailed description:
Community-acquired Pneumonia (CAP) remains a leading cause of death in both developing and developed countries. In the choice of antibacterial agents used to treat CAP, fluoroquinolones have received considerable attention because of their wide spectrum of bactericidal activity. TG-873870 (Nemonoxacin), a non-fluorinated quinolone (NFQ), is a selective bacterial topoisomerase inhibitor.

This study will Evaluate the clinical efficacy, microbiological efficacy and safety of Intravenous Nemonoxacin compared with Intravenous Moxifloxacin in adult patients with community-acquired pneumonia.

Besides, the pharmacokinetics (PK) of Nemonoxacin in adult patients with CAP after continuous IV Infusion and the pharmacokinetic (PK)/pharmacodynamic (PD)are to be determined.

Arms: arm 1: Nemonoxacin 500mg/250mL. arm 2: Nemonoxacin 650 mg/325mL arm 3: Moxifloxacin 400mg/250mL
Interventions: intervention 1: Nemonoxacin 500 mg intervention 2: Nemonoxacin 650 mg intervention 3: Moxifloxacin 400 mg
Intervention descriptions: intervention 1: IV Infusion, once daily for 7\~14 days intervention 2: IV Infusion, once daily for 7\~14 days intervention 3: IV Infusion, once daily for 7\~14 days

Protocol documents:
Clinical trial NCT01947855
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2013-09-01; Completion date: 2013-12-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of empagliflozin administered orally once daily in postprandial glucose and 24-hour glycaemic variability compared to placebo given for 4 weeks as mono-therapy in Japanese patients with type 2 diabetes mellitus with insufficient glycaemic control on no antidiabetic treatment.

Detailed description:

Arms: arm 1: Empagliflozin low dose tablet once daily arm 2: Empagliflozin high dose tablet once daily arm 3: Placebo tablet once daily
Interventions: intervention 1: Placebo intervention 2: Empagliflozin intervention 3: Placebo intervention 4: Placebo intervention 5: Empagliflozin intervention 6: Placebo
Intervention descriptions: intervention 1: Placebo tablet matching Empagliflozin low dose intervention 2: Empagliflozin low dose intervention 3: Placebo tablet matching Empagliflozin high dose intervention 4: Placebo tablet matching Empagliflozin low dose intervention 5: Empagliflozin high dose tablet once daily intervention 6: Placebo tablet matching Empagliflozin high dose

Protocol documents:
Clinical trial NCT01957657
Conditions: Renal Insufficiency
Sponsor: Boehringer Ingelheim
Start date: 2013-10-01; Completion date: 2013-12-01
Enrollment: 4 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the trial is to investigate the effect of different degrees of renal impairment on the pharmacokinetics and safety of the combination of BI 207127 and faldaprevir after 3 days of dosing (BI 207127 bid, faldaprevir qd) and a single dose of BI 207127 and faldaprevir on day 4.

Detailed description:

Arms: arm 1: Healthy volunteers with normal renal function arm 2: Patients with mild renal impairment arm 3: Patients with moderate renal impairment arm 4: Patients with severe renal impairment
Interventions: intervention 1: BI 207127 intervention 2: faldaprevir intervention 3: BI 207127 intervention 4: BI 207127 intervention 5: BI 207127 intervention 6: faldaprevir intervention 7: faldaprevir intervention 8: faldaprevir
Intervention descriptions: intervention 1: oral administration intervention 2: oral administration intervention 3: oral administration intervention 4: oral administration intervention 5: oral administration intervention 6: oral administration intervention 7: oral administration intervention 8: oral administration

Protocol documents:
Clinical trial NCT01959334
Conditions: Drug-specific Antibodies Diabetes Mellitus
Keywords: Diabetes Mellitus Hypoglycemia Glucagon Anti-glucagon Antibody Immunogenicity
Sponsor: Eli Lilly and Company
Start date: 2013-09-01; Completion date: 2013-12-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study provides information on immunogenicity of Nasal Glucagon (AMG504-1) with regards to the potential development of treatment-emergent anti-glucagon antibodies.

Detailed description:
This study is a single center, randomized, laboratory-blinded, three periods, parallel design study.

The main objective of this study is to evaluate the immunogenicity of repeated single doses of glucagon following nasal and intramuscular (IM) administration in adults with Type 1 or Type 2 diabetes (T1D or T2D). The secondary objective is to evaluate the safety and tolerability of glucagon following NG and IM administration in adults with T1D or T2D.

A single dose of glucagon was administered in the morning after a 10-hour overnight fast, either by intranasal or intramuscular route, on 3 occasions. Each drug administration was separated by at least seven calendar days. Patients were randomized in a 2:1 ratio (NG:IMG) to receive NG or IMG at each of the 3 periods.

Blood samples were collected for measurement of anti-glucagon antibodies at screening visit, prior to dosing at Period 3, and at the post-study visit (approximately 4 weeks after the last glucagon administration).

Arms: arm 1: Glucagon dose of 1 milligram (mg) administered intramuscularly (IM). arm 2: Nasal Glucagon (NG) doses of 3 mg administered intra-nasally.
Interventions: intervention 1: Nasal Glucagon (NG) intervention 2: Glucagon IM
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01960140
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-10-01; Completion date: 2013-12-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purposes of this study are to determine the effects of baricitinib on the time it takes to remove simvastatin from the body and to look at how well-tolerated and safe baricitinib is when given alone and in combination with simvastatin. Side effects will be documented. The study will last approximately 7 days from the first dose to the end of the study (not including screening or follow-up).

Detailed description:

Arms: arm 1: Single oral dose of 40 milligrams (mg) simvastatin on Day 1. arm 2: Oral doses of 10 mg baricitinib once daily (QD) on Days 3 to 7, with a single oral dose of 40 mg simvastatin coadministered on Day 6.
Interventions: intervention 1: Baricitinib intervention 2: Simvastatin
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT01972659
Conditions: Pre-eclampsia Aggravated
Keywords: sugammadex rocuronium magnesium female
Sponsor: Kocaeli University
Start date: 2012-10-01; Completion date: 2013-12-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Background: The aim of this prospective study was to evaluate the effect of magnesium on the reversal of rocuronium-induced neuromuscular block by sugammadex.

Methods: Eighty patients, aged 18 to 60 years, American Society of Anesthesiologists I-II, undergoing elective gynecological surgery were enrolled. Anaesthesia was induced with propofol and fentanyl and was maintained with 60% nitrous oxide and Oxygen in sevoflurane. The magnesium group received 50 milligram/kilogram (mg/kg) Magnesium intravenous (iv) as a bolus and 15 mg/kg/hour by continuous infusion until the completion of surgery. The placebo group received the equivalent volume of isotonic saline. For intubation, 0.6 mg/kg rocuronium was administered and 0.1 mg/kg was added when Train of four (TOF) counts reached 1 or more during the procedure. At the end of the surgery at a TOF count of 1, 4 mg/kg sugammadex iv was administered. Patients were observed until a TOF ratio of 0.9 was achieved. Patient-controlled analgesia with intravenous morphine was used postoperatively.

Detailed description:
Inclusion criteria:

* American Society of Anesthesiologists physical status I or II
* 18-60 years of age
* undergoing elective gynecological surgery
* requiring endotracheal intubation

Exclusion criteria:

* Patients who had body mass index \> 35
* gastroesophageal reflux
* a history of allergy
* used medication known to interact with the drugs being used in this trial
* who experienced expected or unexpected difficulty during intubation or ventilation
* had neuromuscular disease
* hepatic or renal insufficiency
* pregnant
* were American Society of Anesthesiologists III or IV
* had a family history of malignant hyperthermia
* detection if low or high control plasma magnesium levels

Arms: arm 1: sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery arm 2: sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery
Interventions: intervention 1: placebo intervention 2: Magnesium Sulphate intervention 3: sugammadex
Intervention descriptions: intervention 1: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion intervention 2: Experimental :

50 mg/kg bolus plus 15 mg/kg continuous infusion intervention 3: 4 mg/kg iv bolus at the end of the surgery

Protocol documents:
Clinical trial NCT01975220
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-10-01; Completion date: 2013-12-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing empagliflozin \& metformin and the single tablets of empagliflozin and metformin when administered singularly.

Detailed description:

Arms: arm 1: 1 fixed dose combination (FDC) tablet vs. 3 single tablets under fasted conditions arm 2: 1 fixed dose combination (FDC) tablet vs. 3 single tablets under fed conditions arm 3: 2 fixed low dose combination (FDC) tablets vs. 4 single tablets under fed conditions
Interventions: intervention 1: Empagliflozin/Metformin XR, FDC intervention 2: Empagliflozin/Metformin XR FDC intervention 3: 25 mg Empagliflozin/1000 mg Metformin XR, FDC intervention 4: 1 tablet Empagliflozin/2 tablets Metformin XR intervention 5: 1 tablet Empagliflozin/3 tablets Metformin XR intervention 6: 1 tablet Empagliflozin/2 tablets Metformin XR
Intervention descriptions: intervention 1: Experimental: high dose empagliflozin/metformin XR, FDC tablet intervention 2: Experimental: low dose empagliflozin/metformin XR, FDC tablet intervention 3: Experimental, high dose Empagliflozin/Metformin XR,FDC Tablet intervention 4: Active Comparator: 1x empagliflozin/2x metformin XR tablets intervention 5: Active Comparator: 1x empagliflozin/3x metformin XR tablets intervention 6: Active Comparator: 1x empagliflozin/2x metformin XR tablets

Protocol documents:
Clinical trial NCT02004132
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-12-01; Completion date: 2013-12-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study involves application of Axiron to each underarm. The study will evaluate the transfer of testosterone from underarms to the clothing items that the participant is wearing and other fabric items washed with participant's' clothes. The study is approximately 6 days, not including screening. Screening is required within 28 days prior to the start of the study.

Detailed description:

Arms: arm 1: Axiron administered topically via metered dose pump to each underarm on Day 1
Interventions: intervention 1: Axiron
Intervention descriptions: intervention 1: Solution administered topically using pump and applicator

Protocol documents:
Clinical trial NCT02015546
Conditions: Major Depressive Disorder (MDD)
Keywords: Major Depressive Disorder Vilazodone
Sponsor: Duke University
Start date: 2012-12-01; Completion date: 2013-12-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an 8-week, randomized, double blind, parallel group, 3-arm trial to compare 10 mg/day, 20 mg/day and 40 mg/day as starting doses of vilazodone following a switch from generic SSRIs and SNRIs. Vilazodone HCl under the trade name Viibryd™ is approved by the U.S. FDA for the treatment of major depressive disorder in adults. The purpose of this study is to evaluate the efficacy (how well the drug works), safety (the side effects), and tolerability (how well tolerated) of Vilazodone in preventing relapse or recurrence of depression. As vilazodone is not approved by the United States Food and Drug Administration (FDA) to prevent the recurrence of depression, for the purposes of this study it is considered investigational. The word "investigational" means that the study drug is still being tested in research studies and has not been approved for this use by the FDA.

Detailed description:

Arms: arm 1: Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial) arm 2: vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial) arm 3: vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.
Interventions: intervention 1: Vilazodone
Intervention descriptions: intervention 1: All subjects will receive Vilazodone at 10, 20 or 40mg.

Protocol documents:
Clinical trial NCT02022670
Conditions: Vascular Aging
Keywords: endothelial function arterial stiffness flow-mediated dilation pulse wave velocity sodium nitrite aging vascular diseases
Sponsor: University of Colorado, Boulder
Start date: 2011-10-01; Completion date: 2013-12-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The proposed research will determine the effectiveness of nitrite, a naturally occurring compound in the body, for improving the health and function of arteries in middle-aged and older adults. The study also will provide insight into how sodium nitrite therapy improves artery health by determining the physiological mechanisms (biological reasons) involved. Overall, the proposed research will provide important new scientific evidence on the effectiveness of sodium nitrite for decreasing the risk of developing cardiovascular diseases with aging.

Detailed description:
The improvement in blood vessel function and stiffness will be determined over a 10 week period. Subjects will be randomly assigned to either placebo (0 mg/day), low dose (80 mg/day) or high dose (160 mg/day) sodium nitrite. Main outcome measures will be performed at baseline and week 10.

Arms: arm 1: inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks arm 2: 80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks arm 3: 160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks
Interventions: intervention 1: Placebo intervention 2: Sodium Nitrite
Intervention descriptions: intervention 1: Sugar pill manufactured to mimic sodium nitrite capsules intervention 2: 80 mg/d or 160 mg/d

Protocol documents: