ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01937026
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-09-01; Completion date: 2013-11-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of this study are to assess how the body handles baricitinib when it is given with another drug called probenecid. The study doctor will measure the amount of baricitinib that is absorbed into the blood stream and the time that it takes to remove baricitinib from the body. The safety and tolerability of these drugs will be studied. The study will last about 18 days from the first dose to the end of the study (not including screening).

Detailed description:

Arms: arm 1: Single oral dose of 4 milligrams (mg) baricitinib on Day 1 arm 2: Oral doses of 1000 mg probenecid once daily on Days 3 through 7, with a single oral dose of 4 mg baricitinib co-administered on Day 5
Interventions: intervention 1: Baricitinib intervention 2: Probenecid
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT01959685
Conditions: Pharmacokinetics Tolerability
Sponsor: Repros Therapeutics Inc.
Start date: 2013-10-01; Completion date: 2013-11-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the tolerability and pharmacokinetics (PK) of a single dose of Androxal in healthy adult male subjects as the dose to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study.

Detailed description:
A dose escalating study to determine the tolerability and pharmacokinetics (PK) of a supra-therapeutic dose of Androxal, up to 250 mg, in healthy adult male subjects as the dose to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study.

Arms: arm 1: Placebo, 125 mg Androxal, 250 mg Androxal each given as a single dose
Interventions: intervention 1: Androxal intervention 2: Placebo
Intervention descriptions: intervention 1: 125 mg Androxal, 250 mg Androxal separated by at least 7 days intervention 2: Placebo, single dose

Protocol documents:
Clinical trial NCT01962493
Conditions: Oral Hygiene
Sponsor: GlaxoSmithKline
Start date: 2013-09-01; Completion date: 2013-11-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to compare the stain effect on teeth of twice daily brushing with a 67% sodium bicarbonate containing toothpaste versus standard toothpaste (not containing sodium bicarbonate) for six weeks whilst using a chlorhexidine digluconate 0.2% mouthwash.

Detailed description:

Arms: arm 1: Marketed Sodium bicarbonate toothpaste containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF) arm 2: Non-sodium bicarbonate toothpaste containing 1450ppm fluoride as NaF arm 3: 0.2% w/v Chlorhexidine digluconate mouthwash for rinsing post-brushing with study toothpastes
Interventions: intervention 1: Sodium bicarbonate/ Sodium Fluoride intervention 2: Sodium fluoride intervention 3: Chlorhexidine digluconate
Intervention descriptions: intervention 1: Toothpaste containing sodium bicarbonate and sodium fluoride as cosmetic intervention 2: Toothpaste containing sodium fluoride as cosmetic intervention 3: Mouthwash containing chlorhexidine digluconate

Protocol documents:
Clinical trial NCT01985542
Conditions: Rhinitis, Allergic, Seasonal
Sponsor: Helsinki University Central Hospital
Start date: 2011-05-01; Completion date: 2013-11-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Allergic rhinitis might be caused by decreased resistance of nasal barrier to allergens and other environmental insults. About 20 % of the European population suffers from pollen allergies. Birch pollen allergic rhinitis is the most common allergic disease in the Scandinavia and it exists widely also in the Central Europe. Suffering and high costs of pollen allergies may be reduced by understanding the molecular biology of the nasal barriers during allergic response. Our aim is to observe the effect of season and birch pollen immunotherapy on the molecular biology of nasal epithelium and the microbiome.

Detailed description:
This is a controlled study with an intervention arm, and a control group of healthy volunteers. The population is composed of nonsmoking healthy adults and patients having birch or timothy pollen allergy with rhinoconjuctivitis symptoms and without other diseases. The diagnosis of pollen allergy is verified with positive history, skin prick test, and allergen specific IgE antibodies. Subjects undergo a spirometry with a bronchodilatator test and a histamine challenge. Quality of life and patient history data is collected by questionnaires. Four peripheral blood samples, as well as nasal cell swabs from nasal mucosa without local anesthesia are collected from each patient; in spring and winter before the group of the intervention arm starts with birch pollen subcutaneous immunotherapy; and during the first spring and winter when a subgroups has received the birch pollen immunotherapy. We plan to perform the following analyses for the nasal specimens: transcriptomics and their regulators, sequencing of 16SrRNA and RT-qPCR for assessing mucosal microbiome, mass spectrometry for analyses of proteins and protein-protein complexes, immunohistochemistry for tissue level localization and quantitation of proteins, in silico analyses for the data mining, integration and display. In addition we observe the alterations in inflammatory mediators after in vitro allergen activation of purified peripheral blood leukocytes by ELISA and real time qPCR.

Arms: arm 1: Starts with birch pollen subcutaneous immunotherapy arm 2: not starting with birch pollen subcutaneous immunotherapy
Interventions: intervention 1: birch pollen subcutaneous immunotherapy
Intervention descriptions: intervention 1: birch pollen subcutaneous immunotherapy

Protocol documents:
Clinical trial NCT02007577
Conditions: Pre Diabetes Insulin Resistant
Keywords: insulin resistant
Sponsor: Stanford University
Start date: 2010-07-01; Completion date: 2013-11-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The possibility that obesity-associated inflammatory changes may play a role in the pathogenesis of type 2 diabetes (2DM) has led to increased interest in the possibility that salicylates might represent a useful treatment to improve glucose tolerance. Several studies, performed in patients with 2DM, as well as in nondiabetic, obese individuals, have demonstrated that salicylates have beneficial effects on glucose and insulin metabolism, but have not led to a coherent view as to the mechanism(s) involved.

In this research proposal we will use specific methods to quantify insulin mediated glucose uptake (IMGU), glucose-stimulated insulin secretion rate (GS-ISR), and insulin clearance (I-Cl) in overweight/obese, nondiabetic, insulin resistant individuals. We will use the insulin suppression test (IST) to quantify IMGU in nondiabetic, overweight/obese volunteers to identify those individuals who are sufficiently insulin resistant to be enrolled in this study. We will then use the graded glucose infusion technique in these insulin resistant subjects to generate specific measures of both GS-IS and I-Cl. Following these baseline measurements, salsalate or placebo will be administered for one month to the participants, after which time the IST and the graded glucose infusion will be repeated to quantify and compare the changes in IMGU, GS-ISR, and I-Cl that have resulted from salsalate versus placebo. These results will provide for the first time quantitative data of the effect of salicylates on IMGU, GS-ISR, and I-Cl in overweight/obese, insulin resistant, nondiabetic individuals.

Detailed description:

Arms: arm 1: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner arm 2: Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner
Interventions: intervention 1: salsalate intervention 2: Placebo
Intervention descriptions: intervention 1: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner intervention 2: Participants will take 3 tablets with breakfast and 4 tablets with dinner

Protocol documents:
Clinical trial NCT02038790
Conditions: Opioid Dependence
Keywords: opioid dependence buprenorphine/naloxone Opioid-Related Disorders
Sponsor: Indivior Inc.
Start date: 2013-11-01; Completion date: 2013-11-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to compare overall patient preference for either Suboxone® sublingual film 8/2 or Zubsolv® sublingual tablets 5.7/1.4. Suboxone sublingual film 8/2 contains 8mg buprenorphine and 2mg naloxone. Zubsolv sublingual tablets contain 5.7 mg buprenorphine and 1.4 mg naloxone. Both interventions act as a substitute for opiate drugs like heroin, morphine or oxycodone and help withdrawal from opiate drugs over a period of time.

Detailed description:

Arms: arm 1: Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. arm 2: Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Interventions: intervention 1: Suboxone Sublingual Film intervention 2: Zubsolv sublingual tablets
Intervention descriptions: intervention 1: A single Suboxone sublingual film strip containing 8mg buprenorphine and 2mg naloxone taken sublingually on either Day 0 or Day 1, depending on randomized treatment arm assignment. Study drug will be administered by designated qualified study personnel at the site in the morning prior to 9:00 a.m. under fasting conditions. intervention 2: A single Zubsolv sublingual tablet containing 5.7mg buprenorphine and 1.4mg naloxone taken sublingually on either Day 0 or Day 1, depending on randomized treatment arm assignment. Study drug will be administered by designated qualified study personnel at the site in the morning prior to 9:00 a.m. under fasting conditions.

Protocol documents:
Clinical trial NCT02052414
Conditions: Fibromyalgia
Keywords: side effects safety efficacy Gralise Fibromyalgia gabapentin
Sponsor: The Center for Clinical Research, Winston-Salem, NC
Start date: 2012-07-01; Completion date: 2013-11-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine Gralise in treating fibromyalgia pain:

* efficacy
* safety

Detailed description:
Subject must carry a diagnosis of fibromyalgia based on American College of Rheumatology (ACR) criteria for fibromyalgia

* Patient may be gaba-analogue (Pregabalin, trade name: lyrica, or Gabapentin, trade name: Neurontin) naïve, or had been on other gaba analogue before, and discontinued for lack of efficacy.
* Patient who had allergic reaction or serious adverse reactions will not be included in this study.
* Patient will start with starter pack of Gralise and will reach therapeutic dose of 1800 mg per day by end of 2 weeks.
* Drug is to be taken with meal, once a day in the evening; once patient has reached the therapeutic dose of 1800 mg, patient will come in for visit, at which point the PI will evaluate the patient and may increase or decrease the dosage, but patient may not increase or decrease the dose of medication at his /her discretion.
* During study, patient will have total of 5 visits, 4 of which will be for duration patient will be on Gralise, and the last visit will be for tapering off the medication.
* During study, patient is asked keep a paper diary on which patient will record the numeric pain scale from Fibromyalgia, time the medication was taken, dose of medication, and any side effects.

Arms: arm 1: All patients will be treated with Gralise. Patients who are on pregabalin or gabapentin (lyrica or neurontin) will need to wash off the medication before starting Gralise.

Patients who are ready to take Gralise will start with starter pack, and will gradually titrate the dose up to 1800mg per day. After that, patient will take 1800mg per day out of the bottle.

Patient will be seen in clinic at 4weeks intervals for first 4 visits, and then there will be end of the study visit on week 15. On visit 4, week 12 of treatment, patients will be taught to taper off the study medication.
Interventions: intervention 1: Gabapentin ER
Intervention descriptions: intervention 1: Patient who are on gralise will report efficacy by rating his or her pain rating on a digital pain scale (11 points) from 0 to 10 on each scheduled clinical visits, which will be compared to their pain level at baseline.

In addition, patients will also record the doses and any adverse effects that might arise during the trial in a diary provided by the study. All information will be recorded in a paper diary that will be followed by coordinator during each follow up visits.

Protocol documents:
Clinical trial NCT02080273
Conditions: Dental Plaque Gingivitis
Sponsor: Colgate Palmolive
Start date: 2013-03-01; Completion date: 2013-11-01
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this randomized, single center, parallel clinical research study is to evaluate the comparative efficacy performance of three dentifrices -Colgate Total Toothpaste, Parodontax Toothpaste and Colgate Cavity Protection Toothpaste in controlling gingivitis and dental plaque in adults.

Detailed description:

Arms: arm 1: Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland arm 2: Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland arm 3: Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.
Interventions: intervention 1: Colgate Cavity Protection toothpaste intervention 2: Colgate Total toothpaste intervention 3: Parodontax toothpaste
Intervention descriptions: intervention 1: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment. intervention 2: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste intervention 3: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste

Protocol documents:
Clinical trial NCT02724410
Conditions: Perforated Appendicitis
Keywords: appendectomy
Sponsor: Wake Forest University Health Sciences
Start date: 2011-01-01; Completion date: 2013-11-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the effect of a single-agent home intravenous (IV) versus oral antibiotic therapy on complication rates and resource utilization following appendectomy for perforated appendicitis

Detailed description:
Appendicitis is the most common cause of abdominal pain requiring emergent surgical intervention in children and approximately one third of patients present with perforation. Perforated appendicitis has been demonstrated to have a significant impact on patients and families due to the prolonged hospitalization, high complication rates, and tremendous economic burden from treatment. The most significant complication following operative treatment of perforated appendicitis is intra-abdominal abscess, which develops in approximately 20% of children following appendectomy in recent literature. Due to this frequent and morbid complication, continued research has been driven at determining the most efficacious and cost-effective postoperative antibiotic treatment regimen to reduce post-operative abscess. As postoperative abscess rates following appendectomy for perforated appendicitis remain high, the primary aim of this study was to evaluate a new postoperative antibiotic treatment regimen based on single daily dosing ertapenem while inpatient with randomization into ten day completion course of home antibiotics with IV ertapenem versus oral amoxicillin/clavulanate. The hypothesis is that the ertapenem based regimen will offer reduced rates of postoperative abscess, with no major difference between completion courses of home IV versus oral antibiotics.

Arms: arm 1: Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class:carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages \<13; age 13 or greater, then 1 gm daily) arm 2: Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate(Drug Class:beta lactam antibiotic)(15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours).
Interventions: intervention 1: home intravenous ertapenem intervention 2: home oral amoxicillin-clavulanate intervention 3: peripheral inserted central Catheter
Intervention descriptions: intervention 1: see arm description intervention 2: see arm description intervention 3: All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics.

Protocol documents:
Clinical trial NCT01462292
Conditions: Muscular Dystrophies
Keywords: 968 Duchenne Muscular Dystrophy GSK2402968 DMD Duchenne GSK
Sponsor: GlaxoSmithKline
Start date: 2011-10-26; Completion date: 2013-11-04
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if GSK2402968 is effective in the treatment of ambulant boys with Duchenne muscular dystrophy resulting from a mutation thought to be corrected by exon 51 skipping. Two doses of GSK2402968 and placebo will be used in this study.

Detailed description:
Boys with Duchenne Muscular Dystrophy (DMD) suffer from a relentless, progressive and fatal disease due to lack of dystrophin, a critical muscle protein. There is currently no known cure for the disease. GSK2402968 is thought to correct several genetic mutations through skipping of exon 51 and therefore targets only those boys with these mutations.

A reasonable hypothesis is that increasing dystrophin will result in clinical improvement, and that the amount of dystrophin expressed will correlate with clinical improvement above a threshold level (e.g. around 30% of control). The initial limited efficacy data from completed and ongoing unblinded studies with GSK2402968 are encouraging as they have demonstrated de novo production of dystrophin and improved walking ability (primary efficacy endpoint) after 48 weeks of treatment which has been generally well tolerated.

This study is designed to explore the efficacy, safety and pharmacokinetics of two doses of GSK2402968 given over 24 weeks. The two doses to be assessed are 6mg/kg/week and 3mg/kg/week. Based on pharmacokinetic and pharmacodynamic modeling, it is predicted at steady-state that the 6 mg/kg/week dose will induce dystrophin expression greater than 30% of control. The 3 mg/kg/week dose was chosen as modeling predicts 3 mg/kg/week of GSK2402968 will produce dystrophin expression in the range of 18-22%. Potential variability between subjects could theoretically produce higher expression and lead to a dystrophin level correlated with clinical improvement.

Following the treatment period, the study has a 24 week post-treatment phase. The purpose of the post-treatment phase is to model the half-life of dystrophin, assess maintenance of response, and provide information about resolution of adverse event and laboratory abnormalities following cessation of treatment.

Arms: arm 1: 3 mg/kg/week of investigational product arm 2: 6 mg/kg/week of investigational Product arm 3: Placebo arm 4: Placebo
Interventions: intervention 1: GSK2402968 3mg/kg/week intervention 2: GSK2402968 6 mg/kg/week intervention 3: Placebo to match GSK2402968 3 mg/kg/week intervention 4: Placebo to match GSK2402968 6 mg/kg/week
Intervention descriptions: intervention 1: Comparison of 2 doses of GSK2402968 intervention 2: Comparison of 2 doses of GSK2402968 intervention 3: Matched placebo intervention 4: Matched Placebo

Protocol documents:
Clinical trial NCT01349036
Conditions: Recurrent Glioblastoma
Keywords: Glioblastoma brain cancer
Sponsor: Daiichi Sankyo
Start date: 2011-12-03; Completion date: 2013-11-05
Enrollment: 38 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the response of subjects with recurrent glioblastoma to continuous therapy of PLX3397.

Detailed description:

Arms: arm 1: 10 patients with recurrent glioblastoma who require reoperation will be treated with PLX3397 for 7 days prior to surgery and their tumor tissue will be evaluated for pharmacokinetic levels and pharmacodynamic effects. arm 2: 30 patients will be orally dosed with PLX3397 continuously on 28 day cycles.
Interventions: intervention 1: PLX3397
Intervention descriptions: intervention 1: Capsules administered once or twice daily, continuous dosing

Protocol documents:
Clinical trial NCT01418339
Conditions: Tourette's Disorder
Keywords: Tourette's Disorder Tic disorders
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2011-07-27; Completion date: 2013-11-06
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of the current study is to determine efficacy and safety of once-weekly aripiprazole in reducing Total Tic Severity (TTS) score in children and adolescents with Tourette's Disorder.

Detailed description:

Arms: arm 1: Aripiprazole was administered orally once a week (QW) for 8 weeks in a double-blind manner. Participants randomized to aripiprazole received aripiprazole tablets at a starting dose of 52.5 milligrams (mg) QW on Day 0. At Week 1, according to the investigator's discretion based on efficacy and tolerability, the dose of aripiprazole could remain at 52.5 mg QW or could be increased to 77.5 mg QW. The dose could be increased to 110 mg QW as early as Week 2. For the remainder of the study (up to Week 8), the dose was to be adjusted up and down among these three dose levels, as determined by the investigator. arm 2: Participants randomized to placebo received aripiprazole-matching placebo, tablet, orally, QW for 8 weeks in a double-blind manner.
Interventions: intervention 1: Aripiprazole intervention 2: Placebo
Intervention descriptions: intervention 1: Aripiprazole tablet administered orally once a week. intervention 2: Aripiprazole-matching placebo tablet administered orally once a week.

Protocol documents: