ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01521845
Conditions: Coronary Arteriosclerosis
Keywords: elective percutaneous coronary intervention hs-CRP CKMB and troponin I
Sponsor: Shahid Beheshti University of Medical Sciences
Start date: 2012-01-01; Completion date: 2012-05-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the effect of omega 3 on biomarkers of cardiac necrosis(CKMB and troponin I) and inflammation marker CRP.

Detailed description:
Percutaneous coronary intervention (PCI) has become the most common form of coronary revascularization worldwide. Although PCI is a safe procedure, it may have multiple risks including bleeding, coronary dissection, abrupt vessel closure, and myocardial necrosis. It is estimated that approximately 25% of patients undergoing PCI have significant postprocedural creatinine kinase (CK)/creatinine kinase myocardial band (CK-MB) elevations and approximately 50% of patients have significant post-procedural troponin elevations. Initially, it was felt these elevations were simple enzyme leaks with no long-term implications.

Now, several studies have demonstrated that periprocedural infarction is associated with short-, intermediate-, and long-term adverse outcomes, most notably mortality. Pretreatment with antiplatelets such as aspirin and clopidogrel play an important role in reducing cardiovascular events (CV events) following PCI.

Omega -3 polyunsaturated fatty acids (PUFAs) have antiplatelet effect. It may also improve response to aspirin and clopidogrel in low-response patients.

This study is a randomized clinical trial (RCT) evaluating the effect of omega 3 supplement \[with 400mg Eicosapentaenoic acid (EPA) and 200mg docosahexanoic acid (DHA)\] on biomarkers of cardiac necrosis (CKMB and troponin I) in patients undergoing elective PCI. Eighty patients planed to do elective PCI will be categorized into two groups. The first group will be received standard regimen for PCI (aspirin, clopidogrel, and heparin) and the second group will be treated with standard regimen in addition to 3 gram omega 3 (12 hours before PCI). Blood samples will be drawn in all patients before and 8 and 24 h after intervention for cardiac biomarkers assessment (CK-MB, troponin I)and inflammation marker C-reactive protein (CRP). Major adverse cardiac events (MACE) will be evaluated as a second endpoint.

Arms: arm 1: receive omega 3 in addition to standard treatment arm 2: This group is without omega 3 : just receives standard treatment
Interventions: intervention 1: omega 3
Intervention descriptions: intervention 1: 3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI

Protocol documents:
Clinical trial NCT01522456
Conditions: Acne Vulgaris
Sponsor: Galderma R&D
Start date: 2012-04-01; Completion date: 2012-05-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the tolerability of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to Retin-A Micro® (tretinoin gel) microsphere when used by subjects with acne vulgaris for 3 weeks in terms of local tolerability parameters (erythema, dryness, scaling, stinging/burning) and preference.

Detailed description:
Adult subjects with acne vulgaris will receive tretinoin gel 0.1% on one side of the face and adapalene 0.1% / benzoyl peroxide 2.5% gel on the other side of the face once daily for a period 3 weeks (22 days). Tolerability assessments (erythema, dryness, scaling, stinging/burning)on both sides of the face will be taken on each visit, on each weekday from from baseline to day 22. The investigator and subjects will respond to user preference questions on days 5, 12, 19, and 22.

Arms: arm 1: Adapalene 0.1% and benzoyl peroxide 2.5% gel arm 2: Tretinoin gel, 0.1%
Interventions: intervention 1: Epiduo Gel intervention 2: Retin-A Micro Microsphere 0.1%
Intervention descriptions: intervention 1: Once-daily application of fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel. intervention 2: Once-daily application of tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.

Protocol documents:
Clinical trial NCT01528124
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2012-02-01; Completion date: 2012-05-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Singapore. The aim of this trial is to evaluate the safety and tolerability of the study drug in healthy people and investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.

Detailed description:

Arms: arm 1: 0.9% sodium chloride given as a single subcutaneous injection arm 2: Single escalating doses of LY3025876 given as subcutaneous injections
Interventions: intervention 1: LY3025876 intervention 2: Placebo
Intervention descriptions: intervention 1: Given as a subcutaneous injection intervention 2: Given as a subcutaneous injection

Protocol documents:
Clinical trial NCT01532362
Conditions: Non Small Cell Lung Cancer
Sponsor: Jonsson Comprehensive Cancer Center
Start date: 2011-11-01; Completion date: 2012-05-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective for this trial is to determine the biological ability of apricoxib to decrease T reg cells in the peripheral blood and tumor infiltrating lymphocytes in subjects compared to those who have not in subjects with early stage Non-small Cell Lung Cancer (NSCLC). The secondary objectives are to determine the efficacy of apricoxib to inhibit CD4+CD25+ T reg and FOXP3 function and exploration of COX-2 dependent biomarkers of apoptosis resistance, angiogenesis, invasion, and immunity.

Detailed description:

Arms: arm 1: As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries. arm 2: None
Interventions: intervention 1: Apricoxib
Intervention descriptions: intervention 1: As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.

Protocol documents:
Clinical trial NCT01540825
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-02-01; Completion date: 2012-05-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the current study is to investigate the safety and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses.

A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing.

Detailed description:

Arms: arm 1: Powder for oral solution arm 2: Powder for oral solution arm 3: Powder for oral solution arm 4: Powder for oral solution arm 5: Powder for oral solution arm 6: Powder for oral solution arm 7: Powder for oral solution arm 8: Powder for oral solution arm 9: Powder for oral solution arm 10: Powder for oral solution arm 11: Powder for oral solution
Interventions: intervention 1: BI 113608 intervention 2: BI 113608 intervention 3: BI 113608 intervention 4: BI 113608 intervention 5: Placebo intervention 6: BI 113608 intervention 7: BI 113608 intervention 8: BI 113608 intervention 9: BI 113608 intervention 10: BI 113608 intervention 11: BI 113608
Intervention descriptions: intervention 1: Low dose powder for oral solution intervention 2: High dose powder for oral solution intervention 3: Medium dose powder for oral solution intervention 4: Low dose powder for oral solution intervention 5: Powder for oral solution intervention 6: Low dose powder for oral solution intervention 7: High dose powder for oral solution intervention 8: High dose powder for oral solution intervention 9: Medium dose powder for oral solution intervention 10: Medium dose powder for oral solution intervention 11: Low dose powder for oral solution

Protocol documents:
Clinical trial NCT01541891
Conditions: Dry Eye Syndrome
Keywords: PRO-148 Dry eye syndrome
Sponsor: Laboratorios Sophia S.A de C.V.
Start date: 2011-10-01; Completion date: 2012-05-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.

Detailed description:
A phase 2, randomized, double masked clinical, parallel-group clinical trial to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.

Arms: arm 1: Drug: PRO-148 Intervention name: PRO-148 applied in ocular surface of patients with mild to moderate dry eye syndrome q.i.d. for 60 days arm 2: Drug: SYSTANE® Intervention name: SYSTANE® applied in ocular surface of patients with mild to moderate dry eye syndrome q.i.d. for 60 days
Interventions: intervention 1: PRO-148 Ophthalmic Solution intervention 2: Active Comparator: SYSTANE ® Ophthalmic Solution
Intervention descriptions: intervention 1: PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days. intervention 2: Sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium chloride, zinc chloride and polyquad (polidronium chloride) 0,001%. four times per day (c/6 hours) during 60 days.

Protocol documents:
Clinical trial NCT01545765
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Sponsor: Galderma R&D
Start date: 2012-05-01; Completion date: 2012-05-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the duration of anesthetic effect produced , Lidocaine7% + Tetracaine 7% cream when applied with 2 different application times on the face and thigh.

Detailed description:
Subjects will have 4 target zones defined; 2 on the face and 2 on the anterior thighs. Upon inclusion into the study, subjects will have the study drug applied with a different application time to one side of the face and anterior thigh according to the randomization. After the completion of the application process, study drug on both sides of the face and on both anterior thighs will be removed by peeling.

After drug removal, the duration of anesthetic effect of the study drug will be tested using a pinprick test. Five (5) pinpricks using a 21-gauge needle will be performed at the 4 target zones (each side of the face and both anterior thighs). The pinprick test will be repeated up to 8 hours after drug removal. There will be a total of 20 post drug removal pinprick test completed.

Arms: arm 1: None
Interventions: intervention 1: Lidocaine 7% + Tetracaine 7% cream
Intervention descriptions: intervention 1: Study drug will be applied with a different application time to one side of the face and anterior thigh according to the randomization list.

Protocol documents:
Clinical trial NCT01553708
Conditions: Deep Partial Thickness Burn
Keywords: Wound healing Epithelialization Safety
Sponsor: Chulalongkorn University
Start date: 2011-12-01; Completion date: 2012-05-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Partial thickness burn wounds are most likely to heal within 2-3 weeks mainly by mechanism of epithelialization. However, it depends on the depth of the wounds and patient condition. Infection is one of the most common complications causing delay in wound healing which might affect to quality of patient's life. Generally, the standard treatment of partial thickness burn wound is topical 1% silver sulfadiazine cream. Previous studies had been reported the broad spectrum antimicrobial activity of silver sulfadiazine cream but it did not demonstrate the accelerating effect of wound healing. Therefore, the combination of substance which can promote wound healing to topical silver sulfadiazine cream might benefit for partial thickness burn wound treatment.

The objective of this study was to compare the results of partial thickness burn wound treatment at burn unit, Siriraj hospital with topical cream containing 1% silver sulfadiazine plus 6% epidermal growth factor (EGF) and 1% silver zinc sulfadiazine. The demographic data (age, sex, %body surface area burn), time of wound closure, pain and itching, dose and type of pain and itching medication, adverse effect of topical medication, some laboratory results and cost of expenses.

This is the prospective, double blinded, randomize-controlled study. The sample sizes were partial thickness burn wound patients who were treated at burn unit, Siriraj hospital. Patients were allocated into 2 groups receiving treatment with either topical silver sulfadiazine plus EGF or silver zinc sulfadiazine. All parameter data were analyzed with repeated measure ANOVA and independent t-test.

Detailed description:

Arms: arm 1: Epidermal growth factor with silver sulfadiazine cream was applied to the experimental wounds completely and then covered with sterile gauze. The wound was cleaned every 24 h and the cream was then applied again after cleaning process. arm 2: Silver sulfadiazine cream was applied to cover the controlled-wound completely and then covered with sterile gauze. The wound was cleaned every 24 h and the cream was then applied again after cleaning process.
Interventions: intervention 1: Epidermal growth factor with silver sulfadiazine cream intervention 2: Silver zinc sulfadiazine cream
Intervention descriptions: intervention 1: Compare the duration for complete partial thickness burn wound healing between sample (epidermal growth factor with silver sulfadiazine cream) and control (silver zinc sulfadiazine cream) intervention 2: Compare the duration for complete partial thickness burn wound healing between sample (epidermal growth factor with silver sulfadiazine cream) and control (silver zinc sulfadiazine cream)

Protocol documents:
Clinical trial NCT01560143
Conditions: Obesity
Sponsor: Manjunath Prakash Pai
Start date: 2012-03-01; Completion date: 2012-05-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
If tigecycline clearance increases with body size then serum exposure values will be lower in obese class III compared to normal weight subjects because exposure changes inversely with clearance when the dose is fixed without regard to weight.

Detailed description:
Not required

Arms: arm 1: All subjects receive a single dose of tigecycline
Interventions: intervention 1: Tigecycline
Intervention descriptions: intervention 1: 100 mg IV as a single infusion over 30 minutes

Protocol documents:
Clinical trial NCT01576809
Conditions: Upper Respiratory Infections
Keywords: Paracetamol acetaminophen phenylephrine guaifenesin syrup URTI productive cough
Sponsor: Novartis
Start date: 2012-03-01; Completion date: 2012-05-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label, in-use study to assess the warming sensation, acceptability and local tolerability of paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg syrup, given as a single dose in subjects suffering from symptoms of an upper respiratory tract infection. The purpose is to evaluate the acceptability concerning a warming sensation effect and its potential benefit in the target population.

The primary objective is to assess the warming sensation caused by the excipient IFF flavor 316 282, in a syrup containing paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup. The syrup contains (0.15% w/v) warming flavor.

The Secondary Objectives are to assess subject acceptability of the syrup and the safety and tolerability of the syrup. The study will be run in fifty-six (56) subjects suffering from symptoms of an upper respiratory tract infection (URTI) for 7 days or less, e.g. nasal congestion associated with colds and flu symptoms such as pain, headache and/or fever. Subjects must have one or more symptoms per category:

1. mild to moderate body pain, headache, fever or sore throat
2. nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing
3. productive cough Adolescents will be included in the study population

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin
Intervention descriptions: intervention 1: Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup

Protocol documents:
Clinical trial NCT01586962
Conditions: Upper Respiratory Infections
Keywords: paracetamol pseudoephedrine syrup upper respiratory tract infection
Sponsor: Novartis
Start date: 2012-05-01; Completion date: 2012-05-01
Enrollment: 56 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label, in-use study to assess the warming sensation, acceptability and local tolerability of paracetamol 500 mg + pseudoephedrine 30 mg syrup, given as a single dose in subjects suffering from symptoms of an upper respiratory tract infection. The purpose is to evaluate the acceptability concerning a warming sensation effect and its potential benefit in the target population.

The primary objective is to assess the warming sensation caused by the excipient IFF flavor 316 282, in a syrup containing paracetamol 500 mg + pseudoephedrine 30 mg per 30 ml syrup. The syrup contains (0.15% w/v) warming flavor.

The Secondary Objectives are to assess subject acceptability of the syrup and the safety and tolerability of the syrup. The study will be run in fifty-six (56) subjects suffering from symptoms of an upper respiratory tract infection (URTI) for 7 days or less, e.g. nasal congestion associated with colds and flu symptoms such as pain, headache and/or fever. Subjects must have one or more symptoms per category:

1. mild to moderate body pain, headache, fever or sore throat
2. nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing Adolescents will be included in the study population

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: IFF flavor 316 282, Paracetamol, Pseudoephedrine
Intervention descriptions: intervention 1: Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine

Protocol documents:
Clinical trial NCT01587885
Conditions: Heartburn
Keywords: Frequent Heartburn Omeprazole Omeprazole, sodium bicarbonate drug combination Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Proton Pump Inhibitors
Sponsor: Bayer
Start date: 2012-01-01; Completion date: 2012-05-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate a single ingredient product (omeprazole 20 mg) with a combination product capsule (omeprazole 20 mg + sodium bicarbonate 1100 mg) in participants with frequent heartburn.

Detailed description:

Arms: arm 1: Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg once a day for 4 days. arm 2: Participants will receive omeprazole 20 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
Interventions: intervention 1: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg intervention 2: Omeprazole 20 mg
Intervention descriptions: intervention 1: Capsules, orally intervention 2: Tablets, orally

Protocol documents:
Clinical trial NCT01592851
Conditions: Dentine Hypersensitivity
Sponsor: GlaxoSmithKline
Start date: 2012-04-01; Completion date: 2012-05-01
Enrollment: 113 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over a two week treatment period.

Detailed description:

Arms: arm 1: Dentifrice containing stannous fluoride arm 2: Marketed dentifrice containing Sodium Monofluorophosphate
Interventions: intervention 1: Stannous Fluoride intervention 2: Sodium Monofluorophosphate
Intervention descriptions: intervention 1: dentifrice containing stannous fluoride intervention 2: dentifrice containing Sodium Monofluorophosphate

Protocol documents:
Clinical trial NCT01592864
Conditions: Dentine Hypersensitivity
Sponsor: GlaxoSmithKline
Start date: 2012-03-01; Completion date: 2012-05-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over an eight week treatment period.

Detailed description:

Arms: arm 1: Dentifrice containing stannous fluoride arm 2: Marketed dentifrice containing Sodium Monofluorophosphate
Interventions: intervention 1: Stannous Fluoride intervention 2: Sodium Monofluorophosphate
Intervention descriptions: intervention 1: dentifice intervention 2: dentifrice

Protocol documents:
Clinical trial NCT01602822
Conditions: HIV
Keywords: HIV Prevention Non-occupational Post-Exposure Prophylaxis (NPEP) Post-Exposure Prophylaxis (PEP)
Sponsor: Kenneth H. Mayer, MD
Start date: 2012-02-01; Completion date: 2012-05-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in HIV uninfected adults.

Detailed description:
Participants are given a regimen containing tenofovir disoproxil fumarate (TDF) 300mg and emtricitabine (FTC) 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily,for 28 days.

Arms: arm 1: Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
Interventions: intervention 1: Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
Intervention descriptions: intervention 1: TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily

Protocol documents:
Clinical trial NCT01607411
Conditions: Dental Caries
Sponsor: GlaxoSmithKline
Start date: 2012-02-01; Completion date: 2012-05-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes.

Detailed description:

Arms: arm 1: toothpaste with no fluoride arm 2: Experimental toothpaste containing 1426 ppm Fluoride arm 3: Experimental toothpaste containing 1000 ppm Fluoride arm 4: Experimental toothpaste containing 500 ppm Fluoride
Interventions: intervention 1: Fluoride intervention 2: Placebo
Intervention descriptions: intervention 1: Fluoride Toothpaste intervention 2: Fluoride free toothpaste

Protocol documents: