ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00933543
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris Moderate to severe
Sponsor: Photocure
Start date: 2009-08-01; Completion date: 2010-03-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to study the efficacy and safety of Visonac PDT in patients from 9 to 35 years old with Aktilite® CL512. Patients was randomized to Visonac or vehicle cream without occlusion and red light(dose: 37J/cm2)

Detailed description:
Double blinded, prospective, randomized, stratified, placebo-controlled, multi-center study in patients with moderate to severe acne vulgaris. Patients with facial severity grades 3 to 4 on the Investigator's Global Assessment (IGA) scale will be included. Each patient will be classified according to age in the two age groups 9 to 12 years and 13 to 35 years and randomized to either Visonac or vehicle cream within each age group. All patients will receive 4 treatments 2 weeks apart (at week 0, 2 ,4 and 6 week). Efficacy evaluation will be done after each treatment and at 12 weeks after the first treatment. Safety evaluations will be performed at each treatment visit and at 12 weeks after the first treatment.

Photographs of patients will be taken before and after treatment at first and last treatment visit, and at 12 weeks after first treatment.

Blood samples will be drawn at 3 visits; pre-treatment visit, one week after first treatment and at one week after last treatment visit.

Arms: arm 1: Active treatment, Light dose 37 J/cm2. arm 2: Placebo treatment, Light dose 37 J/cm2.
Interventions: intervention 1: Visonac PDT (MAL PDT) intervention 2: Vehicle cream (placebo) intervention 3: PDT
Intervention descriptions: intervention 1: Cream application followed by illumination with red light. intervention 2: Cream application followed by illumination with red light. intervention 3: Photodynamic Therapy - Light dose 37 J/cm2

Protocol documents:
Clinical trial NCT00942994
Conditions: Hypertension
Keywords: Hypertension Aliskiren Amlodipine HCTZ Systolic blood pressure Diastolic blood pressure Stage II Combination
Sponsor: Novartis
Start date: 2009-06-01; Completion date: 2010-03-01
Enrollment: 412 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the combination of aliskiren, amlodipine and Hydrochlorothiazide (HCTZ) versus the combination of aliskiren and amlodipine as therapy in minority Stage 2 hypertensive patients.

Detailed description:

Arms: arm 1: At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg. arm 2: At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
Interventions: intervention 1: Aliskiren/Amlodipine intervention 2: Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)
Intervention descriptions: intervention 1: Amlodipine capsule (5 mg)

Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg) intervention 2: Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg)

HCTZ capsule (12.5 mg, 25mg)

Protocol documents:
Clinical trial NCT00946985
Conditions: Schizophrenia
Keywords: Schizophrenia Risperidone Risperdal Paliperidone Palmitate Invega Sustenna
Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
Start date: 2009-06-01; Completion date: 2010-03-01
Enrollment: 163 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will assess the use of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse.

Detailed description:
This is a Prospective, Randomized, Active-controlled, Rater-blinded Study to to assess the efficacy of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse. Recently diagnosed is defined as first diagnosis of any psychotic disorder within 5 years prior to screening. High risk of relapse is defined as having documented occurrence of 3 periods of breakthrough symptoms that required a change in patient care per the investigator's judgment (e.g., increase in dose, addition of a new drug, increase in the level of psychiatric care, notable increases in the frequency or intensity of patient contact required to maintain outpatient status, psychiatric hospitalization, etc.) within the previous 24 months, including 1 such period within the previous 6 months. Safety evaluations will include Adverse Event (AE) reporting, hematology and clinical chemistry laboratory tests, vital signs, electrocardiogram (ECG), and evaluations of suicidality and sexual functioning. Patients will receive either paliperidone palmitate 50, 75, 100, or 150 mg eq. monthly by injection for two years or oral risperidone 2, 4, 6, or 8 mg tabs once daily for two years.

Arms: arm 1: paliperidone palmitate 50 75 100 or 150 mg eq. monthly injection for 2 years arm 2: oral risperidone 2 4 6 or 8 mg tabs once daily for two years
Interventions: intervention 1: paliperidone palmitate intervention 2: oral risperidone
Intervention descriptions: intervention 1: 50, 75, 100, or 150 mg eq. monthly injection for 2 years intervention 2: 2, 4, 6, or 8 mg tabs once daily for two years

Protocol documents:
Clinical trial NCT00947011
Conditions: Glucose Homeostasis
Keywords: Healthy volunteers GLP-1 Januvia Sitagliptin
Sponsor: Johns Hopkins University
Start date: 2009-03-01; Completion date: 2010-03-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done to evaluate the effect of glucagon-like peptide-1 (GLP-1, a naturally occurring hormone) on insulin release and to examine whether there is extra insulin release when GLP-1 is not allowed to be rapidly inactivated.

Detailed description:
The purpose of the present proposal is to 1) examine the role of dipeptidyl peptidase (DPP-4) inhibition on insulin release during a hyperglycemic clamp while GLP-1 is being infused and, 2) further elucidate the role of the metabolite of GLP-1, that is GLP-1 9-36 amide (GLP-1m). During stable and very reproducible elevated plasma glucose levels the effect of increased active incretin levels with DPP-4 inhibitors should result in increased plasma insulin levels. Therefore the aim of this protocol is to document whether plasma insulin levels are increased following GLP-1 infusion in the presence or absence of DPP-4 inhibitors. Additionally, the investigators have shown that some improvement in glucose homeostasis during GLP-1 administration is due in part to the metabolite of GLP-1, i.e. GLP-1 (9-36) amide (GLP-1m). Therefore, the investigators will also test the role of the latter by infusing GLP-1m when the volunteers are being treated with DPP-4 inhibitors.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: Januvia
Intervention descriptions: intervention 1: 1 tablet 100 mg once a day intervention 2: 1 tablet 100 mg once a day

Protocol documents:
Clinical trial NCT00961441
Conditions: Epilepsy
Keywords: Levetiracetam Epilepsy Children Adults
Sponsor: UCB BIOSCIENCES, Inc.
Start date: 2009-09-01; Completion date: 2010-03-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To study how the body absorbs, distributes, metabolises and eliminates Keppra XR in both children (12 to 16 years old) and adults (18 to 55 years old) with epilepsy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Keppra XR
Intervention descriptions: intervention 1: Keppra XR 500 mg tablets and Keppra XR 750 mg tablets

Dosage: Keppra XR 1000-3000 mg/day taken once daily. Duration: 4-7 days

Protocol documents:
Clinical trial NCT00963508
Conditions: Pediculosis
Keywords: Head Lice
Sponsor: Sun Pharmaceutical Industries, Inc.
Start date: 2009-08-01; Completion date: 2010-03-01
Enrollment: 403 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.

Detailed description:
This is a Phase III, multi-center, investigator-blinded, two-arm, randomized, parallel group study, evaluating the safety and efficacy of a Malathion Gel, 0.5% formulation, manufactured by Taro. The objective is to show superiority of the novel product to an active control, Nix® Crème Rinse, manufactured by Insight Pharmaceuticals.

Arms: arm 1: Malathion gel 0.5% 30 minute application arm 2: Nix Crème Rinse applied to scalp for 10 minutes
Interventions: intervention 1: Malathion gel 0.5% intervention 2: Permethrin 1% rinse (Nix Crème)
Intervention descriptions: intervention 1: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present. intervention 2: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present.

Protocol documents:
Clinical trial NCT00965497
Conditions: Major Depression Multiple Sclerosis Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis ALS Multiple Sclerosis MS Major Depression Depression Major Depressive Disorder antidepressants Escitalopram Lexapro
Sponsor: University of South Carolina
Start date: 2009-07-01; Completion date: 2010-03-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major depressive disorder in patients who have ALS or MS.

Detailed description:
This eight-week study aims to assess the effectiveness and tolerability of escitalopram in improving symptoms of Major Depression in patients with Amyotrophic Lateral Sclerosis (ALS) or Multiple Sclerosis (MS) as measured by the HAM-D. In addition, the study will assess improvement in the quality of life in patients with Major Depression and ALS or MS.

Arms: arm 1: All patients will receive escitalopram 20 mg daily.
Interventions: intervention 1: escitalopram
Intervention descriptions: intervention 1: After confirmation of diagnoses and safety screening escitalopram will be started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day. The dose will be titrated upward or downward based on clinical response and tolerability. No other psychotropic medications will be permitted during the study. Medications for coexisting medical problems (e.g. hypertension) will be permitted. Study visits will include weekly visits for first 2 weeks and biweekly visits for next 6 weeks. Medications will be dispensed weekly or biweekly and the participants will be followed for 8 weeks.

Protocol documents:
Clinical trial NCT00966940
Conditions: Glaucoma
Keywords: Glaucoma IOP Travoprost
Sponsor: Alcon Research
Start date: 2009-09-01; Completion date: 2010-03-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the safety and efficacy of Travoprost 0.004% and Tafluprost 0.0015% in patients with primary open angle glaucoma or ocular hypertension when both medications are administered in the evening.

Detailed description:

Arms: arm 1: Travoprost first, with tafluprost second. Each product dosed for six weeks. arm 2: Tafluprost first, with travoprost second. Each product dosed for six weeks.
Interventions: intervention 1: Travoprost 0.004% ophthalmic solution (TRAVATAN) intervention 2: Tafluprost 0.0015% ophthalmic solution
Intervention descriptions: intervention 1: One drop in the qualifying eye(s) each evening at 6:00 PM for 6 weeks, topical administration intervention 2: One drop in the qualifying eye(s) each evening at 6:00 PM for 6 weeks, topical administration

Protocol documents:
Clinical trial NCT00988637
Conditions: Plaque Psoriasis
Sponsor: Galderma R&D
Start date: 2009-10-01; Completion date: 2010-03-01
Enrollment: 138 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial will evaluate the efficacy and safety of Clobex® (clobetasol propionate) Spray 0.05% and Vectical™ (calcitriol) Ointment 3 µg/g over a four week period of use in one of two different regimens:

1. Vectical™ Ointment treatment, twice daily on weekdays (Mon - Fri) and Clobex® Spray treatment twice daily on weekends (Sat - Sun) for 28 days
2. Clobex® Spray once each morning and Vectical™ Ointment once each evening for 28 days

Detailed description:

Arms: arm 1: Vectical™ Ointment weekdays \& Clobex® Spray weekends regimen arm 2: Clobex® Spray morning and Vectical™ Ointment evening regimen
Interventions: intervention 1: Vectical™ Ointment weekdays and Clobex® Spray weekends regimen intervention 2: Clobex® Spray morning and Vectical™ Ointment evening regimen
Intervention descriptions: intervention 1: Vectical™ Ointment 3 µg/g, topical, apply twice daily on weekdays (Mon-Fri) and Clobex® Spray 0.05% twice daily on weekends (Sat-Sun) for 28 days intervention 2: Clobex® Spray 0.05%, topical, apply once each morning and Vectical™ Ointment 3 µg/g, topical, apply once each evening for 28 days

Protocol documents:
Clinical trial NCT00999908
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD indacaterol tiotropium
Sponsor: Novartis Pharmaceuticals
Start date: 2009-10-01; Completion date: 2010-03-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.

Detailed description:

Arms: arm 1: Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. arm 2: Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. arm 3: Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
Interventions: intervention 1: Indacaterol 150 μg intervention 2: Tiotropium 18 μg intervention 3: Placebo
Intervention descriptions: intervention 1: Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. intervention 2: Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. intervention 3: Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Protocol documents:
Clinical trial NCT01006655
Conditions: Asthma Bronchial Hyperresponsiveness
Keywords: asthma preschool children bronchial hyperresponsiveness beclometasone dipropionate - HFA Qvar Adenosine Challenge test
Sponsor: Rambam Health Care Campus
Start date: 2009-03-01; Completion date: 2010-03-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Respiratory diseases including Asthma are high prevalent among preschool children. Specific treatment, nowadays, include steroid inhalers and anti leukotrienes. It is known that the amount of the drug reaching small airways and lungs is bigger how much smaller the particles liberated by inhalers. Beclometasone is being used for treating asthma for 30 years. Lately emerged a new presentation of beclometasone, which liberates particles as small as 2.1 µg, that is supposed to reach the small airways at higher concentrations and be more suitable to patients who don't cooperate properly to the procedure of inhalation.

The investigators' group has reported successfully the possibility to perform Pulmonary Challenge tests (adenosine, methacholine and exercise) in tender age. Other studies reported relation between asthma control and reduction in airway hyperreactivity. The purpose of this study is to evaluate the efficacy of Beclometasone dipropionate - Qvar to reduce airways hyperreactivity in preschool children, as demonstrated by adenosine challenge test.

Detailed description:
26 - 30 patients, between 3 -6 years old, mild asthmatics, with positive adenosine challenge test, will received in a randomized, double blind, cross over assignment Beclometasone dipropionate (100µg twice a day) or placebo, through an inhaler (autohaler) device, attached to a spacer device, during four consecutive weeks. Adenosine Challenge test will be performed another time at the end of this four weeks period. After 2 weeks with no medication (wash out period) the patients will receive the second intervention (beclometasone dipropionate or placebo) in a cross over manner and will be submitted to the last adenosine challenge test.

Clinical evaluation, resting spirometry and subjective evaluation through an analogical symptoms scale will be recorded in each visit.

Arms: arm 1: Controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceded and succeeded by AMP challenge test, arm 2: Patients will receive 4 weeks of inhale QVAR (HFA beclomethasone) 100µg through a spacer device, twice a day
Interventions: intervention 1: Beclomethasone dipropionate HFA intervention 2: placebo
Intervention descriptions: intervention 1: 100µg twice a day, through inhaler autohaler, using a spacer device, preceded and followed by adenosine challenge test intervention 2: inhalation twice a day for one month, preceded and followed by adenosine challenge test

Protocol documents:
Clinical trial NCT01019980
Conditions: Fever
Keywords: Antipyretics fever diclofenac acetaminophen children acute upper respiratory tract infections
Sponsor: Novartis Pharmaceuticals
Start date: 2010-03-01; Completion date: 2010-03-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess if a single dose of Diclofenac potassium (0.5 mg/kg) is more or as effective as a single dose of Acetaminophen (10 mg/kg) in the reduction of fever during 2 hours, in the treatment of febrile children with acute upper respiratory infections.

This is a comparative double blind, double dummy, randomized study on the effectiveness of Diclofenac potassium versus Acetaminophen in febrile children with acute upper respiratory tract infections. The patient will be randomized to either group: Group A (Diclofenac potassium (0.5 mg/kg) or Group B (Acetaminophen (10 mg/kg)). A Health Care Professional trained will measure the temperature during 2 hours. During the study period, parents or legal representatives will be invited to fill a survey about the habits and knowledge regarding fever management at home.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Diclofenac potassium intervention 2: Acetaminophen
Intervention descriptions: intervention 1: Diclofenac potassium intervention 2: Acetaminophen

Protocol documents:
Clinical trial NCT01028027
Conditions: Conjunctivitis Keratitis Blepharitis
Keywords: Blepharokeratoconjunctivitis
Sponsor: Bausch & Lomb Incorporated
Start date: 2009-10-01; Completion date: 2010-03-01
Enrollment: 357 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the safety and efficacy of loteprednol etabonate \[LE\] and tobramycin ophthalmic suspension versus tobramycin and dexamethasone ophthalmic suspension in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis (BKC).

Detailed description:

Arms: arm 1: Loteprednol etabonate and tobramycin ophthalmic suspension arm 2: Tobramycin and dexamethasone ophthalmic suspension
Interventions: intervention 1: Loteprednol and tobramycin intervention 2: Tobramycin and dexamethasone
Intervention descriptions: intervention 1: Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days. intervention 2: Tobramycin and dexamethasone ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.

Protocol documents:
Clinical trial NCT01037244
Conditions: Erectile Dysfunction
Sponsor: Warner Chilcott
Start date: 2009-09-01; Completion date: 2010-03-01
Enrollment: 618 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Udenafil intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets via oral administration before an attempt at sexual intercourse. intervention 2: Tablets via oral administration before an attempt at sexual intercourse.

Protocol documents:
Clinical trial NCT01046136
Conditions: Common Cold
Keywords: common cold
Sponsor: Reckitt Benckiser Inc.
Start date: 2009-12-01; Completion date: 2010-03-01
Enrollment: 378 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex in patients with colds. Patients will receive 7 days of treatment with either Mucinex or placebo. The study will assess the effects of Mucinex on sputum and cold symptoms.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: guaifenesin (Mucinex) intervention 2: placebo
Intervention descriptions: intervention 1: bid 7 days intervention 2: bid 7 days

Protocol documents:
Clinical trial NCT01054820
Conditions: Acute Back Strain
Keywords: FLECTORÂ® Patch acute back strain
Sponsor: Pfizer
Start date: 2010-01-01; Completion date: 2010-03-01
Enrollment: 123 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Although approved for minor strains, sprains and contusions, FLECTOR Patch has not been studied extensively in the setting of acute back strain. This study is being conducted as an initial step in demonstrating the benefit of FLECTOR Patch specifically for back strain. In particular, this study is expected to provide information about the amount of improvement in back strain among subjects using the FLECTOR Patch, which may then be used to inform subsequent studies.

Detailed description:

Arms: arm 1: One patch applied every 12 hours
Interventions: intervention 1: FLECTORÂ® Patch (diclofenac epolamine topical patch) 1.3%
Intervention descriptions: intervention 1: One FLECTOR Patch applied to the most painful area on the subject's back every 12 hours for up to 14 days.

Protocol documents: