ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01775904
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-02-01; Completion date: 2013-05-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate two different formulations of LY2886721. In addition, this study will determine how much of study drug (LY2886721) gets into the blood steam and how long the body takes to get rid of it after taking each formulation with or without a meal. Information about any side effects that may occur will also be collected. Each participant may be involved in the study for approximately 7 weeks.

This study requires 4 periods. In each period, participants will receive LY2886721 as a tablet or capsule, with or without food and water. There is a 7 day washout between each period.

Detailed description:

Arms: arm 1: Reference formulation. A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods. arm 2: A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods. arm 3: A single oral dose of a 70 mg LY2886721 in an orally disintegrating tablet (ODT) given with water and after a high-fat breakfast in one of four periods. arm 4: A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given with water and without a meal in one of four periods.
Interventions: intervention 1: LY2886721 in a Capsule intervention 2: LY2886721 in an orally disintegrating tablet (ODT)
Intervention descriptions: intervention 1: Administered orally. intervention 2: Administered orally.

Protocol documents:
Clinical trial NCT01785615
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome atorvastatin women
Sponsor: University of Rochester
Start date: 2004-11-01; Completion date: 2013-05-01
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Little is known regarding the association of individual components of the metabolic syndrome (MBS) and prothrombotic, inflammatory and preclinical cardiac structural and functional markers in women with this syndrome. Less is known about adequate treatment as the pathological mechanism of this syndrome is not well understood.

The purpose of this study is two fold;

1. To determine basic differences in biochemical and cardiovascular structural markers in women with and those without MBS and their association with the individual components of MBS.
2. To determine the impact of atorvastatin to lower the risk factors of Metabolic Syndrome. Atorvastatin is one of the most effective drugs approved by the United States Food and Drug Administration (FDA) for the treatment of high cholesterol. It belongs to a class of drugs called statins and its role in primary prevention is still unclear. Thus this population seems to be an ideal group that may benefit from this intervention.

Detailed description:
The first phase of the study is an observational phase as previously described. The second phase was a prospective evaluation of the effect of a well known "statin" drug (Lipitor) on different biochemical factors measured in the blood. The eligible study participants had blood work done upon enrollment and if criteria was met(according to the Adult Treatment Panel III), they were given dietary counseling (NYHA - New York Heart Association Step 1 diet) as a lead in phase. Lab work was repeated at 3 weeks to evaluate the impact of the diet and if participant's profile still met criteria for MBS,randomization for either atorvastatin (Lipitor) 80mg or placebo (sugar pill) for 12 weeks took place.

Arms: arm 1: 44 women randomized to 80 mg atorvastatin for 6weeks arm 2: 44 women randomized to placebo for 6 weeks
Interventions: intervention 1: Atorvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: 80mg intervention 2: 80mg

Protocol documents:
Clinical trial NCT01786629
Conditions: Colonoscopy Bowel Preparation Endoscopy
Sponsor: Braintree Laboratories
Start date: 2012-12-01; Completion date: 2013-05-01
Enrollment: 338 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the safety, tolerance and efficacy of SUPREP Bowel Prep Kit to an FDA approved control as bowel preparations prior to colonoscopy in adult patients.

Detailed description:

Arms: arm 1: SUPREP Bowel Prep Kit arm 2: FDA approved bowel preparation containing electrolytes
Interventions: intervention 1: SUPREP Bowel Prep Kit intervention 2: FDA approved bowel preparation containing electrolytes
Intervention descriptions: intervention 1: solution for oral administration prior to colonoscopy intervention 2: solution for oral administration prior to colonoscopy

Protocol documents:
Clinical trial NCT01807026
Conditions: Alzheimer Disease Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-03-01; Completion date: 2013-05-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done for the following reasons:

To determine the safety of LY2886721 and any side effects that may be associated with it and to see how much of the study drug is in the blood and the cerebrospinal fluid (CSF) when one dose is given to healthy participants and participants diagnosed with Alzheimer's disease. It will also look at how safe and tolerable the study drug is when given to healthy participants in higher doses.

This research study is being conducted in three groups, referred to as Groups (Cohorts) A, B, or C.

Group A will enroll participants with Alzheimer's disease while Groups B and C will enroll healthy participants.

For Group A or B, participation in this research study could last up to 34 days. For Group C, participation could last up to 60 days.

Detailed description:

Arms: arm 1: Participants with Alzheimer's disease received a single, 70-milligrams (mg) (1 capsule), oral dose of LY2886721. arm 2: Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule). arm 3: Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721. arm 4: Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule). arm 5: Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721. arm 6: Healthy participants received a single, oral dose of LY2886721-matching placebo (4 capsules).
Interventions: intervention 1: LY2886721 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01811953
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-03-01; Completion date: 2013-05-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets empagliflozin and metformin under fed conditions (Part II).

Detailed description:

Arms: arm 1: fixed-dose-combination tablet, oral with 240 ml water under fasted conditions arm 2: fixed-dose-combination tablet, oral with 240 ml water under fed conditions arm 3: tablets, oral with 240 ml water under fasted conditions arm 4: tablets, oral with 240 ml water under fed conditions arm 5: fixed-dose-combination tablet, oral with 240 ml water under fed conditions arm 6: tablets, oral with 240 ml water under fed conditions
Interventions: intervention 1: Empagliflozin intervention 2: Metformin intervention 3: Empagliflozin intervention 4: Empagliflozin/Metformin intervention 5: Metformin intervention 6: Empagliflozin/Metformin intervention 7: Empagliflozin intervention 8: Metformin intervention 9: Empagliflozin/Metformin
Intervention descriptions: intervention 1: medium dose oral administration intervention 2: oral administration intervention 3: low dose of Empagliflozin oral administration intervention 4: low dose of Empagliflozin intervention 5: oral administration intervention 6: medium dose of Empagliflozin oral administration intervention 7: medium dose oral administration intervention 8: oral administration intervention 9: medium dose of Empagliflozin oral administration

Protocol documents:
Clinical trial NCT01821937
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-03-01; Completion date: 2013-05-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the trial is to assess the bioavailability of Faldaprevir soft capsule with single oral dose and multiple oral doses in Chinese subjects

Detailed description:

Arms: arm 1: 10 subjects (approximate sex ration: 1:1) will be assigned to trial by single and multiple dose. arm 2: 10 subjects (approximate sex ration: 1:1) will be assigned to trial by single and multiple dose.
Interventions: intervention 1: faldaprevir(high dose) intervention 2: Faldaprevir(low dose)
Intervention descriptions: intervention 1: faldaprevir(high dose) will be taken by 1 day single use and 10 days multiple use. the subjects will be assigned to high dose treatment in random order intervention 2: faldaprevir(low dose) will be taken by 1 day single use and 10 days multiple use. the subjects will be assigned to low dose treatment in random order

Protocol documents:
Clinical trial NCT01827670
Conditions: Dentine Hypersensitivity
Sponsor: GlaxoSmithKline
Start date: 2013-02-01; Completion date: 2013-05-01
Enrollment: 119 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice daily brushing of a toothpaste containing stannous fluoride in comparison to marketed (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.

Detailed description:

Arms: arm 1: Participants to brush whole mouth with 1-inch strip of the test dentifrice (0.454% SnF) for one timed minute, followed by rinsing with 5 milliliter (mL) of water. arm 2: Participants to brush whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
Interventions: intervention 1: Stannous fluoride intervention 2: Sodium monofluorophosphate
Intervention descriptions: intervention 1: Test dentifrice containing 0.454% SnF intervention 2: Control dentifrice containing 0.76% w/w Sodium Monofluorophosphate \[1000 parts per million (ppm) fluoride\]

Protocol documents:
Clinical trial NCT01829243
Conditions: Fibromyalgia Neurocognition
Keywords: Milnacipran Fibromyalgia Neurocognition
Sponsor: Duke University
Start date: 2011-07-01; Completion date: 2013-05-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study was designed to investigate whether milnacipran is safe and effective in improving cognitive function in fibromyalgia. In addition, this study was aimed to investigate whether improvement in neurocognitive status due to milnacipran correlates with improvements in pain, to investigate whether improvement in neurocognitive status due to milnacipran correlates with improvements in fatigue, and to determine whether treatment with improvement in neurocognitive status, pain and fatigue correlates with functional improvement.

Detailed description:
Cognitive dysfunction is observed in fibromyalgia, especially for episodic memory, learning, and working memory.There is evidence for dysregulation of the attention system from low-level sensory processes up to emotional processes, and increased sensitivity to distraction.Milnacipran's balance of norepinephrine (NE) to serotonin (5-HT) of 3:1, similar to amitriptyline, a tricyclic that has demonstrated efficacy in fibromyalgia, as compared to venlafaxine which is 1:30, or duloxetine which is 1:10.7 In addition, because of milnacipran's effect on 5-HT, it should also be effective in treating other symptoms such as sleep disturbances and mood changes, which are associated to fibromyalgia, as well as other functional somatic syndromes. It is worth noting that several medications to treat fibromyalgia are sedating (e.g pregabalin, opioids, muscle relaxants) and impair neurocognition.

Arms: arm 1: Eligible subjects will receive milnacipran (12.5 mg-200 mg/day) in the forces titration schedule in flexible doses to the maximum tolerated dose starting with 12.5 mg qd for 1 day, 12.5 mg bid for 2 days, 25 mg bid for 4 days, 50 mg bid for 7 days and 100 mg bid thereafter. Patients who cannot tolerate higher doses will have a step-wise reduction in doses (e.g. 200 mg/day dose will be reduced to 100 mg/day; 100 mg/day will be reduced to 50 mg/day). Drug will be discontinued at the end of the study. arm 2: Eligible subjects will receive placebo (12.5 mg-200 mg/day) in the forces titration schedule in flexible doses to the maximum tolerated dose starting with 12.5 mg qd for 1 day, 12.5 mg bid for 2 days, 25 mg bid for 4 days, 50 mg bid for 7 days and 100 mg bid thereafter. Patients who cannot tolerate higher doses will have a step-wise reduction in doses (e.g. 200 mg/day dose will be reduced to 100 mg/day; 100 mg/day will be reduced to 50 mg/day). Drug will be discontinued at the end of the study.
Interventions: intervention 1: Milnacipran intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01831817
Conditions: Dentinal Hypersensitivity
Sponsor: GlaxoSmithKline
Start date: 2013-01-01; Completion date: 2013-05-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.

Detailed description:
This will be a single center, eight week, randomized, controlled, examiner blind, four treatment arms, parallel design study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at baseline, four and eight weeks to monitor clinical efficacy and safety.

Arms: arm 1: Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate arm 2: Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate arm 3: Dentifrice containing 1000 ppmF as sodium monofluorophosphate arm 4: Dentifrice containing 1100 ppmF as sodium fluoride
Interventions: intervention 1: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice intervention 2: 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice intervention 3: Sodium monofluorophosphate dentifrice intervention 4: Sodium Fluoride dentifrice
Intervention descriptions: intervention 1: Calcium sodium phosphosilicate dentifrice (5% w/w) and 1500 ppm F as sodium monofluorophosphate intervention 2: No calcium sodium phosphosilicate and 1500 ppm F as sodium monofluorophosphate intervention 3: Sodium monofluorophospate dentifrice (1000 ppm F) intervention 4: Dentifrice containing 1100ppm F as sodium fluoride

Protocol documents:
Clinical trial NCT01960296
Conditions: Clopidogrel
Keywords: clopidogrel general surgery
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2012-01-01; Completion date: 2013-05-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients who on taking clopidogrel are randomized to either continue clopidogrel into general surgery or discontinue clopidogrel 7 days before surgery. All patients resume clopidogrel after surgery. The investigators track the development of bleeding complications that may develop within 90 days of the surgery. Patients are medically cleared to be in either arm of the study by their cardiologist and surgeon. There is currently no evidence to support for or against the use continuation or discontinuation of clopidogrel prior to general surgery.

Detailed description:
A medical record review was performed of 104 consecutive patients undergoing general surgical procedures while receiving antiplatelet therapy. Patients were identified from an administrative database by crossreferencing clopidogrel with abdominal operative procedures. The records of only patients who were actively receiving antiplatelet therapy, with the last clopidogrel dose within 45 days of their operation, were considered in the study.

Arms: arm 1: Continue home dose of clopidogrel into surgery arm 2: Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Interventions: intervention 1: Clopidogrel intervention 2: Discontinue Clopidogrel
Intervention descriptions: intervention 1: Continue home dose of clopidogrel into surgery intervention 2: Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.

Protocol documents:
Clinical trial NCT02028754
Conditions: Dry Eye Syndromes Cataract
Sponsor: Allergan
Start date: 2011-07-01; Completion date: 2013-05-01
Enrollment: 180 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effect of sodium carboxymethylcellulose eye drops in the treatment of dry eye after cataract surgery.

Detailed description:

Arms: arm 1: Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day. arm 2: Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
Interventions: intervention 1: Sodium Carboxymethylcellulose intervention 2: Levofloxacin intervention 3: Prednisolone
Intervention descriptions: intervention 1: Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days post-cataract surgery. intervention 2: Levofloxacin 1 drop in the study eye 3 times a day for 7 days post-cataract surgery. intervention 3: Prednisolone 1 drop in the study eye 4 times a day for the 1st week post surgery, 3 times a day for the 2nd week post surgery, 2 times a day for the 3rd week post surgery, and 1 time a day for the 4th week post surgery.

Protocol documents:
Clinical trial NCT02101359
Conditions: Cataract
Sponsor: Laboratoires Thea
Start date: 2011-06-01; Completion date: 2013-05-01
Enrollment: 609 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and safety assessment of T2380 for mydriasis and anaesthesia in phacoemulsification cataract surgery versus reference group (topical mydriatics and anaesthetic) 2X246 patients.

Detailed description:
In order to perform pupil size measurements and ocular discomfort assessments at specific times, the surgical procedure was divided into 5 time periods according to the following time points: T1 (just before first incision), T2 (just before viscoelastic injection), T3 (just before capsulorhexis), T4 (just before intraocular lens injection), and T5 (just before cefuroxime injection).

Arms: arm 1: Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery.

At the beginning of surgery, 200 μL of T2380 were administrated intracamerally. arm 2: Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery.

Topical Mydriatic treatments were instilled three times before surgery.
Interventions: intervention 1: T2380 intervention 2: Mydriatics intervention 3: Tetracaine
Intervention descriptions: intervention 1: 200 microlitres of T2380 will be administrated intracamerally intervention 2: 3 drops of tropicamide and phenylephrine were instilled 30 minutes before surgery. The second and the third instillation of both phenylephrine and tropicamide will be realised respectively within 20 and 10 minutes before surgery. intervention 3: Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery

Protocol documents:
Clinical trial NCT02687217
Conditions: Perioperative Hyperoxygenation Wound Infection
Keywords: PerioperativeHyperoxygenation Wound Site Infection Appendicitis
Sponsor: Lady Hardinge Medical College
Start date: 2011-11-01; Completion date: 2013-05-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study evaluates the role of supplemental hyper-oxygenation given perioperatively on wound site infection after appendectomy. Half of the patients received ≥50% oxygen and half of them received no oxygen during the surgical procedure.

Detailed description:
Patient with the diagnosis of acute appendicitis of \>15 years of age group, with no comorbidities who presented to surgical emergency in Dr. Ram Manohar Lohia Hospital were considered for the present study.

30 patients who fulfilled the inclusion criteria and who voluntarily consented for the study were randomly allocated to the two groups- Group A (control group) and Group B (study group).

These patients were operated through Mc-Burney incision given in the right lower quadrant.

Both the groups were comparable in their demographic and preoperative profile. The study group was given ≥50% of oxygen intraoperatively and the control group was given no oxygen.

In postoperative period, oxygen was given to group A at the rate of 4 litre/minute (L/min) and group B at the rate of 6 litre/minute (L/min).

The assessment of the wound was done by using ASEPSIS (Additional treatment; Serous discharge; Erythema; Purulent exudate; Separation of deep tissues; Isolation of bacteria; and Stay) score. A score of more than 20 is considered to be infected.

Fever, raised total leucocyte count, positive pus culture, Ultrasound evidence of fluid collections, removal of sutures and duration of hospital stay were also measured for the evaluation of economic implications due to SSI.

Arms: arm 1: Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively arm 2: Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.
Interventions: intervention 1: oxygen
Intervention descriptions: intervention 1: Hyperoxygenation ≥50% of oxygen by mask(non-rebreathing) was given through out the surgery.

Received 6L/min of oxygen through venturimask upto 2 hours in post operative period.

Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery.

Protocol documents: