ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01923467
Conditions: Smoking Cessation
Keywords: smoking nicotine replacement internet
Sponsor: University of Michigan
Start date: 2013-08-01; Completion date: 2014-04-01
Enrollment: 767 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This project is designed to test the effects of affirmation and positive/negative imagery on individuals' thoughts about quitting smoking and willingness to join a stop smoking program. Previous studies have noted that viewing negative images elicits a stronger emotional response, and many stop-smoking campaigns have used such images to push people to quit smoking. However, research also shows that people are generally resistant to health messages. Using affirmation can help to lessen that resistance.

In this study, we use a 2x3 design to study the individual effects of negative imagery and affirmation on smokers' intentions to quit smoking, acceptance of an offer to join a quit smoking program, and program participation and outcomes. We hope to find out whether there is an additive effect of the negative imagery and affirmation on the outcomes listed above. Our specific aims are:

Aim 1: Determine if affirmation increases the uptake of an offer of joining a stop smoking program.

Aim 2: Determine if image type (positive vs. neutral vs. negative) increases the uptake of the stop smoking program offer.

Aim 3: Determine whether there is an interaction between image type and affirmation in people's willingness to join a stop smoking program.

Detailed description:

Arms: arm 1: All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.
Interventions: intervention 1: Project Quit stop smoking program intervention 2: Nicotine patches 21 mg
Intervention descriptions: intervention 1: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success. intervention 2: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt.

Protocol documents:
Clinical trial NCT01933425
Conditions: Neuromuscular Blockade
Keywords: surgical conditions laparoscopy
Sponsor: Herlev Hospital
Start date: 2013-08-01; Completion date: 2014-04-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate if deep neuromuscular blockade improves intraabdominal volume compared to no neuromuscular blockade in patients scheduled for gynecologic laparoscopic surgery with pneumoperitoneum 12 mmHg.

Hypothesis:

Deep neuromuscular blockade improves intraabdominal space (the distance from promontorium to skin surface, cm) compared to no neuromuscular blockade.

Detailed description:

Arms: arm 1: Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal.

Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade arm 2: No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg.

Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.
Interventions: intervention 1: rocuronium intervention 2: sugammadex intervention 3: placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01933464
Conditions: Papulopustular Rosacea
Keywords: Rosacea Cromolyn sodium
Sponsor: University of California, San Diego
Start date: 2013-08-01; Completion date: 2014-04-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to investigate whether topical application of a cromolyn sodium solution is able to decrease the facial redness seen in patients with papulopustular rosacea. Previous work in the lab of Dr. Di Nardo on mice has suggested that cromolyn may be able to have this effect. The study will enroll a total of 10 patients. 5 will randomly be assigned to receive the cromolyn sodium solution, and the other 5 will be randomly assigned to receive the placebo solution. All participants will be instructed to apply their assigned solution twice daily to their face. Patients will return to the clinic 3, 6, and 8 weeks after the distribution of the solutions to measure the efficacy of their assigned solution.

Detailed description:

Arms: arm 1: Subjects in this arm will be asked to apply their assigned medication twice daily to their entire face. The medication they will be receiving is cromolyn sodium ophthalmic solution, 4%. arm 2: Participants in this group will be assigned a solution consisting of only the inactive ingredients in cromolyn sodium ophthalmic solution to apply to their entire face twice daily.
Interventions: intervention 1: Cromolyn Sodium intervention 2: Normal Saline
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01937299
Conditions: Ocular Hypertension Open Angle Glaucoma
Keywords: glaucoma prostaglandin analogue brinzolamide brimonidine
Sponsor: Alcon Research
Start date: 2013-10-01; Completion date: 2014-04-01
Enrollment: 307 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy (TRAVATAN Z®).

Detailed description:
This study was divided into 2 sequential phases. The Screening/Eligibility Phase included one Screening Visit and two Eligibility Visits, during which subjects washed out of all other intraocular pressure (IOP)-lowering medications and dosed with TRAVATAN Z®, 1 drop instilled in each eye once daily for 28 days. Subjects who met all inclusion/exclusion criteria were randomized at the second Eligibility Visit. The Treatment Phase consisted of two on-therapy visits (Week 2 and Week 6).

Arms: arm 1: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks arm 2: Inactive ingredients, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
Interventions: intervention 1: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension intervention 2: Vehicle intervention 3: Travoprost 0.004% ophthalmic solution
Intervention descriptions: intervention 1: None intervention 2: Inactive ingredients used as a placebo comparator intervention 3: None

Protocol documents:
Clinical trial NCT01946243
Conditions: Alzheimers Disease
Sponsor: Avid Radiopharmaceuticals
Start date: 2013-08-01; Completion date: 2014-04-01
Enrollment: 96 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The overall objective of the study is to assess the feasibility of implementing a quantitative process of florbetapir F 18 scan interpretation. The hypothesis is that the use of quantitative analysis will increase the accuracy of florbetapir F 18 scan interpretation.

Detailed description:

Arms: arm 1: Physician readers will interpret Amyvid scans using qualitative analysis followed by the use of quantitation. No subjects will be exposed to Florbetapir F 18 as part of this study.
Interventions: intervention 1: Florbetapir F18
Intervention descriptions: intervention 1: No Florbetapir F 18 will be administered in this study.

Protocol documents:
Clinical trial NCT01957163
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: dry powder inhaler fluticasone furoate/vilanterol umeclidinium bromide safety long acting beta2- receptor agonist long acting muscarininc receptor antagonist efficacy COPD inhaled corticosteroid
Sponsor: GlaxoSmithKline
Start date: 2013-10-01; Completion date: 2014-04-01
Enrollment: 619 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
After screening, subjects will enter a 4 week open-label run-in period with fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide \[UMEC\] \[62.5 mcg\] administered once daily via a DPI; OR UMEC \[125 mcg\] administered once daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last clinic visit. The total duration of subject participation in the study from Screening to Follow-up will be approximately 17 weeks.

Detailed description:

Arms: arm 1: Subjects received one inhalation of FF/VI 100/25 mcg via a DPI followed by one inhalation UMEC (62.5mcg) via DPI once-daily in the morning for 12 weeks. arm 2: Subjects received one inhalation of FF/VI 100/25 mcg via DPI followed by one inhalation of UMEC (125mcg) via a DPI once-daily in the morning for 12 weeks. arm 3: Subjects received one inhalation of FF/VI 100/25 mcg via DPI followed by one inhalation of matching placebo via a DPI once-daily in the morning for 12 weeks.
Interventions: intervention 1: FF intervention 2: VI intervention 3: UMEC intervention 4: Placebo
Intervention descriptions: intervention 1: Dry white powder containing 100mcg of Fluticasone Furoate blended with lactose per blister was administered by DPI. intervention 2: Dry white powder containing 25mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by DPI. intervention 3: Umeclidinium bromide in a powder blend with lactose and magnesium stearate was used at two different doses 62.5mcg and 125mcg. intervention 4: The matching placebo DPI identical in appearance to the inhaler containing active study medication.

Protocol documents:
Clinical trial NCT01958060
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-10-01; Completion date: 2014-04-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Investigation of safety and tolerability of BI 1034020 in healthy male volunteers following intravenous (IV) infusion of subcutaneous (SC) injection of single doses and exploration of the pharmacokinetics and pharmacodynamics of BI 1034020 after single dosing and determination of the bioavailability of subcutaneous injections of BI 1034020

Detailed description:

Arms: arm 1: single rising doses arm 2: single rising doses
Interventions: intervention 1: BI 1034020 intervention 2: Placebo to BI 1034020
Intervention descriptions: intervention 1: intravenous part intervention 2: intravenous part

Protocol documents:
Clinical trial NCT01958164
Conditions: Catheter Obstruction Vascular Access Devices
Sponsor: Boehringer Ingelheim
Start date: 2013-09-01; Completion date: 2014-04-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicentre, open-label, randomised, phase III study designed to evaluate the efficacy and safety of Actilyse 2 mg/2 ml in the restoration of function of CVAD

Detailed description:

Arms: arm 1: First dose of Actilyse 2mg/2ml will be given at time 0. Second dose will be given at 120 if CVAD function has not been restored. arm 2: Saline solution will be given at time 0. First dose of Actilyse 2mg/2ml will be given to patients if CVAD function has not been restored.
Interventions: intervention 1: Actilyse intervention 2: Saline solution intervention 3: Actilyse intervention 4: Actilyse
Intervention descriptions: intervention 1: Actilyse 2mg/2ml will be given if the CVAD has not been restored at time 120min. intervention 2: Instil Saline solution 2 ml into the disfunctional CVAD once at time O only for patients enrolled in Group II intervention 3: Instil Actilyse 2 mg/ 2 ml into the dysfunctional CVAD at time O. intervention 4: Second dose of Actilyse 2mg/2ml will be given if CVAD has not been restored at time 120min.

Protocol documents:
Clinical trial NCT01960114
Conditions: Dental Pain
Keywords: Acetaminophen Paracetamol Analgesics Analgesics Non-Narcotic Pain Postoperative Pain Antipyretics Dental Surgery Third molar extraction
Sponsor: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Start date: 2013-10-01; Completion date: 2014-04-01
Enrollment: 403 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg tablets) in a sub-group of subjects.

Detailed description:

Arms: arm 1: None arm 2: Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo
Interventions: intervention 1: Acetaminophen ER intervention 2: Placebo
Intervention descriptions: intervention 1: Single dose (2 tablets) Acetaminophen ER 750 mg intervention 2: Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo

Protocol documents:
Clinical trial NCT01968070
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-10-01; Completion date: 2014-04-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The main purposes of this study are to evaluate the safety and how well the body handles single and multiple doses of increasing strength of study drug, LY3127760. This study includes three parts. Part 3 may be initiated at sponsor's discretion, based on data from Part 2. Participants will only enroll in 1 of the 3 study parts. This study will last approximately 7 to 13 weeks, depending on part. Screening must be completed within 28 days prior to enrollment.

Detailed description:

Arms: arm 1: Single oral dose of up to 900 milligram (mg) LY3127760 administered in up to 3 of 3 study periods. arm 2: Single oral dose of placebo administered in up to 2 of 3 study periods. Placebo matches LY3127760 in appearance. arm 3: Multiple ascending oral doses of up to 900 mg LY3127760 administered once or twice daily (QD or BID) for 28 days. arm 4: Multiple oral doses of placebo administered QD or BID for 28 days. Placebo matches LY3127760 in appearance. arm 5: Multiple oral doses of 400 mg celecoxib administered QD for 28 days.
Interventions: intervention 1: LY3127760 intervention 2: Celecoxib intervention 3: Placebo
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally

Protocol documents:
Clinical trial NCT01969747
Conditions: Diabetes Mellitus, Type 1
Sponsor: Boehringer Ingelheim
Start date: 2013-11-01; Completion date: 2014-04-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Placebo-controlled, double blind (triple-dummy technique), randomised parallel design comparison of three oral doses (2.5 mg, 10 mg, and 25 mg) of empagliflozin in patients with T1DM as adjunctive therapy to insulin over 28 days. Patients will undergo a 14-day open-label placebo run-in period before randomisation. Background insulin therapy will be kept stable during the first 7 days of the treatment period and will be freely adjusted thereafter.

Detailed description:

Arms: arm 1: Empagliflozin low once daily arm 2: Empagliflozin medium once daily arm 3: Empagliflozin high once daily arm 4: Placebo once daily
Interventions: intervention 1: Empagliflozin medium placebo intervention 2: Empagliflozin low placebo intervention 3: Empagliflozin low placebo intervention 4: Empagliflozin high placebo intervention 5: Empagliflozin medium intervention 6: Empagliflozin medium placebo intervention 7: Empagliflozin high placebo intervention 8: Empagliflozin high placebo intervention 9: Empagliflozin medium placebo intervention 10: Empagliflozin low placebo intervention 11: Empagliflozin low intervention 12: Empagliflozin high
Intervention descriptions: intervention 1: Empagliflozin medium placebo intervention 2: Empagliflozin low placebo intervention 3: Empagliflozin low placebo intervention 4: Empagliflozin high placebo intervention 5: Empagliflozin medium intervention 6: Empagliflozin medium placebo intervention 7: Empagliflozin high placebo intervention 8: Empagliflozin high placebo intervention 9: Empagliflozin medium placebo intervention 10: Empagliflozin low placebo intervention 11: Empagliflozin low intervention 12: Empagliflozin high

Protocol documents:
Clinical trial NCT01977625
Conditions: Menopause Brain Activity Cognition
Keywords: Menopause fMRI Vyvanse
Sponsor: University of Pennsylvania
Start date: 2011-12-01; Completion date: 2014-04-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study seeks to assess the effects of lisdexamfetamine (trademark name: Vyvanse; LDX) on executive function and prefrontal cortex activation in menopausal women ages 45-57, who report subjective cognitive difficulties. This protocol will recruit women from Dr. Epperson's ongoing study, Protocol #812470, to examine the impact of LDX on brain activation during performance of cognitive tasks specifically probing prefrontal cortex function.

Detailed description:

Arms: arm 1: Lisdexamfetamine or Vyvanse arm 2: Placebo pill, capsules
Interventions: intervention 1: Lisdexamfetamine intervention 2: Placebo
Intervention descriptions: intervention 1: The overall objective of this study is to assess the effects of LDX on brain activation patterns during tasks of sustained attention and working memory in menopausal women. intervention 2: To assess the effects of a placebo pill on brain activation patterns during tasks of sustained attention and working memory in menopausal women.

Protocol documents:
Clinical trial NCT01986361
Conditions: Acute Pharyngitis Sore Throat
Keywords: Pharyngitis Sore Throat acute upper respiratory tract infection (URTI)
Sponsor: Reckitt Benckiser LLC
Start date: 2013-09-01; Completion date: 2014-04-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study's purpose is to demonstrate the onset of action, i.e., time to meaningful pain relief in patients with pharyngitis, of flurbiprofen 8.75 mg lozenge using the Double-Stopwatch Method (DSW).

Detailed description:

Arms: arm 1: A single flurbiprofen lozenge is sucked until fully dissolved. arm 2: A single placebo lozenge is sucked until fully dissolved.
Interventions: intervention 1: flurbiprofen intervention 2: placebo
Intervention descriptions: intervention 1: A single flurbiprofen 8.75 mg lozenge which also contains 1 mg of menthol in its vehicle base for flavour and taste purposes (blinding). Lozenge is sucked until dissolved, and not chewed, bit or swallowed. intervention 2: A single placebo lozenge which also contains 1 mg of menthol in its vehicle base for flavour and taste purposes (blinding). Lozenge is sucked until dissolved, and not chewed, bit or swallowed.

Protocol documents:
Clinical trial NCT01992523
Conditions: Acute Coronary Syndrome Adverse Reaction to Antiplatelet Agent
Keywords: Ticagrelor antiplatelet Acute Coronary Syndrome
Sponsor: David Antoniucci
Start date: 2013-11-01; Completion date: 2014-04-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the Mashed Or Just Integral pill of TicagrelOr (MOJITO) study is to evaluate the superiority of Ticagrelor 180 mg LD mashed pill versus Ticagrelor 180 mg LD integral pill both orally administrated in decreasing residual platelet reactivity 1 hour after the administration among 70 patients with STEMI (ST segment elevation myocardial infarction) undergoing PPCI (primary percutaneous coronary intervention) with bivalirudin monotherapy.

Detailed description:

Arms: arm 1: Ticagrelor loading dose (LD) 180 mg as mashed pills arm 2: Ticagrelor loading dose (LD) 180 mg as integral pills
Interventions: intervention 1: Ticagrelor mashed pills intervention 2: Ticagrelor integral pills
Intervention descriptions: intervention 1: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient. intervention 2: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor).

Protocol documents:
Clinical trial NCT02003365
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis knee corticosteroids triamcinolone acetonide synovial fluid
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2013-11-01; Completion date: 2014-04-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to characterize the local duration of exposure of TCA for 2 doses of FX006 relative to 40 mg of TCA IR in patients with OA of the knee.

Detailed description:
This study was an open-label, single administration design, conducted in male and female patients ≥40 years of age with OA of the knee.

Patients were enrolled sequentially with 8 patients per cohort, as follows:

Cohort A: FX006 40 mg, Final Visit at Week 20 Cohort B: FX006 40 mg, Final Visit at Week 16 Cohort C: FX006 10 mg, Final Visit at Week 12 Cohort D: FX006 40 mg, Final Visit at Week 12 Cohort E: Triamcinolone acetonide immediate-release (TCA IR) 40 mg, Final Visit Week 12

Each patient was evaluated for up to 12, 16, or 20 weeks following a single IA injection depending on the assigned cohort. Following the screening visit, safety was evaluated at 3 out-patient visits and synovial fluid was collected at Day 1 for baseline measurements and the Final Visit for drug concentration measurements.

Arms: arm 1: Single 3 mL intra-articular (IA) injection arm 2: Single 3 mL intra-articular (IA) injection arm 3: Single 1 mL intra-articular (IA) injection
Interventions: intervention 1: FX006 10 mg intervention 2: FX006 40 mg intervention 3: TCA IR 40 mg
Intervention descriptions: intervention 1: Extended-release formulation intervention 2: Extended-release formulation intervention 3: Immediate-release formulation

Protocol documents: