ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02395055
Conditions: Healthy
Sponsor: Biocad
Start date: 2015-06-01; Completion date: 2015-10-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar candidate manufactured by CJSC BIOCAD, Russia) and Humira when used as a single subcutaneous injection in healthy volunteers.

Detailed description:
This is single center comparative double blind randomized clinical study of pharmacokinetics, tolerance and safety of single subcutaneous injection of BCD-057 (CJSC BIOCAD, Russia) and Humira in healthy volunteers. The purpose of the study is to demonstrate that BCD-057 is equivalent to Humira in terms of pharmacokinetics, tolerability and safety after single subcutaneous injection in healthy volunteers.

The study will enroll 94 healthy volunteers, who will be randomized into 2 groups (1:1 ratio): volunteers from the first group will receive BCD-057; volunteers from the second group will receive Humira. Both study and reference drug will be used at the standard dose of 40 mg.

Arms: arm 1: BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0. arm 2: Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
Interventions: intervention 1: Adalimumab (BCD-057) intervention 2: Adalimumab (Humira)
Intervention descriptions: intervention 1: Adalimumab is a monoclonal antibody against tumor necrosis factor alpha intervention 2: Adalimumab is a monoclonal antibody against tumor necrosis factor alpha

Protocol documents:
Clinical trial NCT02411201
Conditions: Magnetic Resonance Imaging
Sponsor: Guerbet
Start date: 2015-03-01; Completion date: 2015-10-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of the study is to evaluate the pharmacokinetics of DOTAREM® in the body of children aged less than 2 years thanks to several blood samples (3 ml in total) taken following the administration of DOTAREM®.

DOTAREM® is a contrast agent commonly used for enhancement of Magnetic Resonance Imaging (MRI) to potentially improve the quality of the images and help the diagnosis. Children aged less than 2 years scheduled to undergo routine gadolinium-enhanced MRI of any body region may take part in the study. In this case they will receive DOTAREM®, a solution injected at the standard dose of 0.2mL/kg (0.1 mmol/kg) of body weight.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: DOTAREM
Intervention descriptions: intervention 1: Single intravenous injection of 0.1 mmol/kg body weight

Protocol documents:
Clinical trial NCT02419001
Conditions: Healthy Volunteers
Sponsor: Theriva Biologics, Inc.
Start date: 2015-03-01; Completion date: 2015-10-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 1b/2a, Randomized, Multi-Center, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Oral SYN-004 on the Pharmacokinetics of Intravenous Ceftriaxone in Healthy Adult Subjects with a Functioning Ileostomy.

Detailed description:
This is a Phase 1b/2a, randomized, multi-center, open-label study. Twenty otherwise healthy subjects between the ages of 18 and 80 years, inclusive, with functioning ileostomies were planned to be enrolled. In the first treatment period (Period 1) all subjects received an IV infusion of 1 g ceftriaxone. Subjects had a 3 - 7 day washout period between Period 1 and Period 2. In the second treatment period (Period 2) all subjects received an IV infusion of 1 g ceftriaxone and 2 oral doses of either 75 or 150 mg of SYN-004, according to the randomization schedule, which were administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion.

Arms: arm 1: Treatment Sequence AB:

* Period 1: Ceftriaxone 1 g infused IV over 30 minutes
* \[Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion\] arm 2: * Period 1: Ceftriaxone 1 g infused IV over 30 minutes
* \[Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion\] arm 3: Treatment Sequence AB:

* \[Period 1: Ceftriaxone 1 g infused IV over 30 minutes\]
* Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion arm 4: * \[Period 1: Ceftriaxone 1 g infused IV over 30 minutes\]
* Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
Interventions: intervention 1: Period 1 - Treatment Sequence AB intervention 2: Period 1 - Treatment Sequence AC intervention 3: Period 2 - Treatment Sequence AB intervention 4: Period 2 - Treatment Sequence AC
Intervention descriptions: intervention 1: Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004 intervention 2: Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004 intervention 3: Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg intervention 4: Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg

Protocol documents:
Clinical trial NCT02429258
Conditions: Type II Diabetes
Sponsor: AstraZeneca
Start date: 2015-05-01; Completion date: 2015-10-01
Enrollment: 226 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin

Detailed description:
Effect of Dapagliflozin on 24-hour Blood Glucose in 92 Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin

Arms: arm 1: Farxiga with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications arm 2: Placebo with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Interventions: intervention 1: Farxiga intervention 2: Placebo intervention 3: Metformin intervention 4: Insulin
Intervention descriptions: intervention 1: Farxiga 10mg/day intervention 2: Placebo intervention 3: Metformin background therapy \>/= 1500mg/day intervention 4: Insulin \>/= 30 units

Protocol documents:
Clinical trial NCT02431364
Conditions: Healthy
Keywords: KPT-335 Verdinexor Karyopharm First-in-Human Adult Subjects
Sponsor: Karyopharm Therapeutics Inc
Start date: 2015-05-26; Completion date: 2015-10-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This is a randomized, double-blind, sequential, dose-escalation, Phase 1 trial to evaluate the safety and tolerability of verdinexor. Verdinexor or placebo will be given on Days 1 and 3 to healthy adult participants.

Detailed description:
This is a randomized, double-blind, sequential, dose-escalation, Phase 1 trial to evaluate the safety and tolerability of verdinexor. Verdinexor or placebo will be given on Days 1 and 3 to healthy adult participants.

Cohorts of 8 participants each (6 active, 2 placebo) will be sequentially administered verdinexor or placebo (one dose on Day 1 and one dose on Day 3) using a dose-escalation scheme. A conservative, sequential, dose-escalation strategy employing decreasing escalation increments will be used.

Arms: arm 1: Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3. arm 2: Participants received verdinexor 5 milligrams (mg) (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3. arm 3: Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3. arm 4: Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3. arm 5: Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3.
Interventions: intervention 1: Verdinexor intervention 2: Placebo
Intervention descriptions: intervention 1: Participants received verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral intervention 2: Participants received placebo matched to verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral

Protocol documents:
Clinical trial NCT02441114
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Seoul National University Hospital
Start date: 2015-07-01; Completion date: 2015-10-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot study was designed to evaluate the pharmacokinetic characteristics of fluticasone, salmeterol, and tiotropium after co-administration of HCP 0910 (Seretide 250 diskus) and HGP1011 (Spiriva capsule for inhalation) which are prescribed concomitantly for the patients with chronic obstructive pulmonary disease (COPD).

Detailed description:
Within 3 weeks prior to the first administration of study drug, volunteers who agreed the participation of this study by their written consent will undergo screening, including physical examination and clinical laboratory test etc, to evaluate whether they are eligible to participate in this study. Study drugs will be administered at about 8 A.M. in the morning of the drug administration day, followed by blood collection for evaluation of pharmacokinetics. The same schedule with increased dose will be proceeded after 14-day washout period.

Arms: arm 1: Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.

The periods were separated with a washout period of 14 days.
Interventions: intervention 1: HCP0910 and HGP1011
Intervention descriptions: intervention 1: Inhalation of HCP0910 (Seretide 250 diskus (Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 72.5 mcg)) and HGP1011 (Spiriva capsule for inhalation (Micronized Tiotropium Bromide Monohydrate 22.5 mcg))

Protocol documents:
Clinical trial NCT02452866
Conditions: Bacterial Vaginosis
Sponsor: Symbiomix Therapeutics
Start date: 2015-06-01; Completion date: 2015-10-01
Enrollment: 325 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent girls with bacterial vaginosis.

Detailed description:
Approximately 325 patients will be enrolled. Patients determined to be eligible for the study will receive SYM-1219 granules containing 2 grams of secnidazole orally as a single dose.

Patients determined to be eligible at the Baseline visit will receive a single dose of SYM-1219 granules containing 2 grams of secnidazole in 4 ounces of unsweetened applesauce to be self-administered on Day 1. Patients will be contacted by telephone once between Days 8 to 10 to inquire about possible adverse events. A final study visit will occur on Day 21 to 30 to assess the patient for safety.

Arms: arm 1: All pateints recieved single dose SYM-1219 Containing 2 Grams of Secnidazole
Interventions: intervention 1: SYM-1219
Intervention descriptions: intervention 1: Administered with 4 ounces of unsweetened applesauce, and 8 ounces of water

Protocol documents:
Clinical trial NCT02461693
Conditions: Caffeine Affect Cognitive Ability, General Mood
Keywords: Vigilance Mood Randomized Controlled Trial Probability
Sponsor: University of Alabama at Birmingham
Start date: 2015-06-01; Completion date: 2015-10-01
Enrollment: 205 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this project is to examine the effect of expectancy on mood and alertness after consumption of caffeine "treatment" or placebo "control" pill, given that participants know their probability for receiving the caffeine versus placebo pill. Participants will be randomly assigned a probability (ranging from 0-100%) of receiving caffeine vs. placebo, and this probability will be revealed to them before consumption of the assigned pill and subsequent cognitive testing. At the time of consumption, neither study staff administering the intervention nor participants will know for certain which pill is given to each participant. Pill assignment will depend on pre-determined randomization probabilities, which will be provided and assigned by the study statistician. By revealing participants' individual probability of receiving the caffeine pill, we will induce positive or negative expectancies regarding likelihood for receipt of the caffeine pill. These experimental manipulations will: 1) estimate the effect of expectancy on cognitive and affective outcomes, and 2) allow for a more direct estimate of the effect of the caffeine pill under real-world conditions than would a conventional randomized trial.

Detailed description:

Arms: arm 1: One-time treatment with 200mg caffeine pill arm 2: One-time treatment with lactose-based placebo pill
Interventions: intervention 1: Caffeine intervention 2: Placebo
Intervention descriptions: intervention 1: 200mg delivered as pill; one-time dose intervention 2: Lactose-based pill; one-time dose

Protocol documents:
Clinical trial NCT02525744
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2015-08-01; Completion date: 2015-10-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is administered by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will last for about 8 to 9 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.

Detailed description:

Arms: arm 1: Single dose of 7.5 U LY900014 administered subcutaneously (SC) in one to two of five periods. arm 2: Reference formulation. Single dose of Insulin Lispro administered SC in one to two of five periods. arm 3: Single dose of 15 U LY900014 administered subcutaneously (SC) in one to two of five periods. arm 4: Single dose of 30 U LY900014 administered subcutaneously (SC) in one to two of five periods.
Interventions: intervention 1: LY900014 intervention 2: Insulin Lispro (Humalog)
Intervention descriptions: intervention 1: Administered SC intervention 2: Administered SC

Protocol documents:
Clinical trial NCT02544217
Conditions: MELAS LHON Leigh Syndrome Mitochondrial Disease Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation
Sponsor: Khondrion BV
Start date: 2015-05-01; Completion date: 2015-10-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Mitochondrial Diseases are rare progressive, multi-system, often early fatal disorders affecting both children and adults. KH176 is a novel chemical entity currently under development for the treatment of inherited mitochondrial diseases, including MELAS (Mitochondrial Encephalomyopathy, Lactic acidosis, and Stroke-like episodes), Leigh's Disease and Leber's Hereditary Optic Neuropathy (LHON). KH176 is a potent intracellular redox modulating agent targeting the reactive oxygen species which are important in the pathogenesis of disorders of mitochondrial oxidative phosphorylation. After demonstrating a favourable safety profile in the pre-clinical testing, the safety, tolerability and pharmacokinetic and pharmacodynamic characteristics of the compound will now be evaluated in healthy male subjects in this trial

Detailed description:

Arms: arm 1: 2 alternating groups receiving escalating single doses of active/placebo arm 2: 3 multiple escalating groups, receiving active/placebo
Interventions: intervention 1: KH176 intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02577315
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2015-09-01; Completion date: 2015-10-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Bioequivalence of two 12.5 mg empagliflozin/500 mg metformin fixed dose combination tablets compared to the free combination of empagliflozin 25 mg and metformin 1000 mg in healthy male and female volunteers under fed conditions

Detailed description:

Arms: arm 1: fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin, oral with 200 mL of water uder fed conditions arm 2: free combination of 1 tablet of 25 mg Empagliflozin and 1 tablet of 1000 mg of Metformin, oral with 200 mL of water under fed conditions
Interventions: intervention 1: Empagliflozin intervention 2: Metformin intervention 3: Empagliflozin intervention 4: Metformin
Intervention descriptions: intervention 1: Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin intervention 2: Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin intervention 3: Reference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin intervention 4: Reference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin

Protocol documents:
Clinical trial NCT02636049
Conditions: End Stage Renal Disease
Keywords: pharmacokinetics healthy adult volunteer
Sponsor: Rockwell Medical Technologies, Inc.
Start date: 2015-10-01; Completion date: 2015-10-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This is a Phase 1, open-label, three-period sequential dosing study being conducted to determine the pharmacokinetics of Triferic iron administered intravenously (IV) to healthy adults.

Detailed description:
This is a Phase 1, open-label, three-period sequential dosing study being conducted primarily to determine the pharmacokinetics of Triferic iron administered intravenously to healthy adults.. Participation will be up to 5 weeks total duration including Screening, Baseline, Treatment Period, and Follow-up. Following Screening, subjects will be admitted to the clinic on Day -1, prior to Baseline (Day 1). During the Treatment Period, subjects will receive two doses of Triferic. Each subject will receive a single 6-mg dose of Triferic administered IV over 3 hours (hr) on one day (Day 2), and a single 35-µg/kg dose of Triferic administered IV push the following day (Day 3). On Day 4, subjects will be discharged from the clinic and will return approximately one week later for their final Follow-up visit.

Arms: arm 1: Each subject will receive a single 6 mg dose of Triferic administered as a continuous intravenous infusion over 3 hours on Day 2. The Triferic IV dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 0.020 mg/mL. Administration of 300 mL IV at 100 mL/hr for 3 hours results in delivery of 6 mg of Triferic iron. arm 2: Each subject will receive Triferic as 35 µg/kg body weight IV push over 30-60 seconds on Day 3. The Triferic IV push dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 35 µg Triferic iron/kg body weight per subject in 4.5 mL.
Interventions: intervention 1: Triferic
Intervention descriptions: intervention 1: Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron.

Protocol documents:
Clinical trial NCT02717273
Conditions: Liver Transplantation Surgical Site Infection
Sponsor: University of Virginia
Start date: 2009-03-01; Completion date: 2015-10-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will be to prospectively determine differences in Surgical Site Infection (SSI) if a prolonged course of post-operative antibiotics are used following liver transplantation.

Detailed description:
This study will be to prospectively determine differences in SSI if a prolonged course of post-operative antibiotics are used following liver transplantation. All adult patients, admitted to the University of Virginia (UVA) Medical Center for first-time liver transplantation will be randomized to the standard of care of peri-operative antibiotics or extended course of three total days.

Patients will be evaluated primarily for the presence of post-operative surgical site infections but also for fever, elevated white blood counts, secondary infections (urinary tract, pneumonia, and blood stream), length of hospital stay, graft loss, and mortality for 30 days after liver transplant.

Arms: arm 1: The standard of care at the University of Virginia Medical Center for liver transplantation patients is a 3.375 gram dose of piperacillin / tazobactam (Zosyn®) at the time of induction of anesthesia, though this dose may be adjusted for renal insufficiency. This dose is repeated during the operation every six hours. arm 2: For those patients randomized to the study group, antibiotics will be started as per the usual intra-operative dosing regimen, then continued to provide coverage for 72 hours.

This is typically provided as additional doses of 3.375 grams of piperacillin / tazobactam (Zosyn®) every 8 hours for 3 total days (giving a total of 72 hours of antibiotic coverage), though this may be altered based on kidney function.
Interventions: intervention 1: standard intervention 2: extended intervention 3: liver transplant
Intervention descriptions: intervention 1: peri-operative antibiotic regimen only intervention 2: extended three-day course of antibiotics intervention 3: orthotopic liver transplantation

Protocol documents: