ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01038869
Conditions: Acne Vulgaris Post Inflammatory Hyperpigmentation
Sponsor: Derm Research, PLLC
Start date: 2009-12-01; Completion date: 2010-05-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Residual post-inflammatory hyperpigmentation (PIH)from acne is disturbing to individuals with skin of color. Finacea has been anecdotally known to be beneficial in resolving PIH related to acne vulgaris. However, it has not been clinically tested for this purpose. The current study will investigate the efficacy and safety of Finacea in the treatment of acne vulgaris and PIH.

Detailed description:

Arms: arm 1: Open label pilot study, Topical gel to be appiled twice daily for 16 weeks
Interventions: intervention 1: Azelaic acid
Intervention descriptions: intervention 1: Apply sparingly to the face twice a day (morning and night). Massage gently into the skin until vanishing. Approximately 0.5g (2.5cm strip) is sufficient for the entire facial area.

Protocol documents:
Clinical trial NCT01043185
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD lesogaberan impedance pH pharmacokinetics safety tolerability
Sponsor: AstraZeneca
Start date: 2009-12-01; Completion date: 2010-05-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment.

Detailed description:

Arms: arm 1: AZD3355 30 mg arm 2: AZD3355 90 mg arm 3: AZD3355 120 mg arm 4: AZD3355 240 mg arm 5: Placebo
Interventions: intervention 1: AZD3355 intervention 2: AZD3355 intervention 3: AZD3355 intervention 4: AZD3355 intervention 5: placebo
Intervention descriptions: intervention 1: 30 mg orally in the morning and 30 mg in the evening for 1 day intervention 2: 90 mg orally in the morning and 90 mg in the evening for 1 day intervention 3: 120 mg orally in the morning and 120 mg in the evening for 1 day intervention 4: 240 mg orally in the morning and 240 mg in the evening for 1 day intervention 5: Placebo capsules orally in the morning and placebo capsules in the evening for 1 day

Protocol documents:
Clinical trial NCT01044537
Conditions: Type 2 Diabetes Mellitus
Keywords: phase 1 safety and tolerability PK PD type 2 diabetes mellitus T2DM
Sponsor: Pfizer
Start date: 2010-02-01; Completion date: 2010-05-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04937319 following single escalating oral doses in adult subjects with Type 2 Diabetes Mellitus (T2DM).

Detailed description:
The purpose of this phase 1 study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF04937319 following single escalating oral doses in adult subjects with T2DM.

Arms: arm 1: In each ascending-dose cohort, approximately 6 subjects will receive active treatment and 3 will receive placebo. arm 2: In each ascending-dose cohort, approximately 6 subjects will receive active treatment and 3 will receive placebo. There will be approximately 6 dosing levels of PF-04937319
Interventions: intervention 1: Placebo intervention 2: PF-04937319
Intervention descriptions: intervention 1: Placebo to match PF-04937319 will be provided. intervention 2: The initial planned dosing schedule is: 10, 30, 100, 200, and 400 mg, with one cohort to be determined. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses. All doses will be administered as a single oral dose as a powder-in-capsule (PIC) formulation. PF-04937319 will be supplied as 10 mg and 80 mg (and potentially 1 mg) PIC.

Protocol documents:
Clinical trial NCT01048333
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease Onset of effect COPD Oxis Turbuhaler
Sponsor: AstraZeneca
Start date: 2010-01-01; Completion date: 2010-05-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
* Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single dose,compared with salmeterol, 50 μg single dose, in patients with moderate COPD.Forced Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes postdose.
* Secondary efficacy variables: Average FEV1 during the first 15 minutes (area under the FEV1 curve from 0 to 15 minutes), Average FEV1 during 120 minutes (area under the FEV1 curve from 0 to 120 minutes)

Detailed description:

Arms: arm 1: Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler arm 2: Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus arm 3: Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler arm 4: Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler arm 5: Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler arm 6: Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
Interventions: intervention 1: Formoterol intervention 2: Salmeterol intervention 3: Placebo
Intervention descriptions: intervention 1: Formoterol Turbuhaler 9 μg and Placebo Diskus intervention 2: Salmeterol Diskus 50 μg and Placebo Turbuhaler intervention 3: Placebo Diskus and Placebo Turbuhaler

Protocol documents:
Clinical trial NCT01076283
Conditions: Alcoholism
Keywords: baclofen alcoholism urge craving alcohol drinking biobehavioral mechanisms of baclofen in alcoholism
Sponsor: Brown University
Start date: 2009-12-01; Completion date: 2010-05-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This pilot trial has the goal to demonstrate the feasibility of a study to test the effects of baclofen in a laboratory experiment using cue-reactivity and alcohol-self administration paradigms in non-treatment seeking alcohol-dependent subjects.

Detailed description:

Arms: arm 1: Baclofen 10 mg three times a day (t.i.d.) for 8-10 days arm 2: Cyproheptadine 2 mg t.i.d. for 8-10 days
Interventions: intervention 1: Baclofen intervention 2: Cyproheptadine
Intervention descriptions: intervention 1: Baclofen 10mg t.i.d. intervention 2: 'active' placebo

Protocol documents:
Clinical trial NCT01102270
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea Arousal threshold Sedative medication upper airway
Sponsor: Brigham and Women's Hospital
Start date: 2009-01-01; Completion date: 2010-05-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to find out whether taking eszopiclone (Lunesta) changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (respiratory arousal threshold). We would like to see if taking eszopiclone can reduce the severity of obstructive sleep apnea in some people (those that have a low respiratory arousal threshold; i.e. wake up easily to respiratory stimuli).

Detailed description:
Obstructive sleep apnea is an exceedingly common disease with major neurocognitive and cardiovascular consequences. The current primary treatment e.g. Continuous positive airway pressure (CPAP) is effective but poorly tolerated by many patients particularly those with mild-moderate disease. Secondary treatments such as oral appliances to advance the mandible or surgical procedures to enlarge the airway are commonly appealing to the patient. However, these approaches have only modest success in reducing apnea frequency to an acceptable level. Thus, finding tolerable and effective therapy for sleep apnea remains an important objective.

The causes of sleep apnea vary between patients. Targeted therapy according to the underlying causes of sleep apnea in individual patients is likely to be most effective. However, current therapeutic options for sleep apnea are quite limited. The purpose of this physiological research study is to determine if taking eszopiclone (Lunesta)changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (the arousal threshold) and if administration of the sedative medication eszopiclone (Lunesta) to certain sleep apnea patients (those with a low arousal threshold ie wake up easily) would be beneficial.

Arms: arm 1: Eszopiclone 3mg prior to sleep (1 night) arm 2: Sugar Pill (placebo) prior to sleep (1 night)
Interventions: intervention 1: Eszopiclone intervention 2: Placebo
Intervention descriptions: intervention 1: 3mg tablet once prior to sleep intervention 2: 1 placebo capsule prior to sleep

Protocol documents:
Clinical trial NCT01112241
Conditions: Obliterative Bronchiolitis
Keywords: Obliterative bronchiolitis Bronchodilator responsiveness Partial forced expiratory flow Lung volumes
Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Start date: 2010-04-01; Completion date: 2010-05-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study has been designed to provide a substantial evidence of acute bronchodilator responsiveness to two sequentially inhaled drugs, a beta2-agonist (i.e., albuterol) and an anticholinergic (i.e., tiotropium bromide), in a group of patients who developed obliterative bronchiolitis after hematopoietic stem cell transplantation.

Detailed description:
Obliterative bronchiolitis is a life-threatening non-infectious pulmonary complication of allogeneic hematopoietic stem cell transplantation (HSCT). It is characterized by the development of an obstructive abnormality which has been considered to be insensitive to bronchodilator treatments. However, this knowledge stems from measurements of forced expiratory volume in 1 s (FEV1) which is relatively insensitive to changes in small airway caliber. Moreover, it is known from studies in chronic obstructive pulmonary disease that symptoms improve after bronchodilator treatment even when FEV1 is minimally increased and correlate with the reduction of lung hyperinflation, which is the major consequence of severe expiratory airflow limitation. Therefore, measurements of airway caliber by parameters not affected by volume history and absolute lung volumes are preferable for assessing the effect of bronchodilator interventions.

In the current study, the bronchodilators responsiveness will be assessed by using not only spirometry but also measurements of absolute lung volumes and the forced expiratory flow of a partial maneuver (V'part) started from submaximal lung inflation, thus free of volume history effects.

Arms: arm 1: At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide \[Spiriva®\] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
Interventions: intervention 1: albuterol plus tiotropium
Intervention descriptions: intervention 1: Four separate doses of 100 μg of albuterol and 18 μg of tiotropium bromide. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber and tiotropium by a dry-powder device.

Protocol documents:
Clinical trial NCT01114893
Conditions: Open-angle Glaucoma (OAG) Ocular Hypertension
Sponsor: Alcon Research
Start date: 2010-04-01; Completion date: 2010-05-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of three concentrations of travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.

Detailed description:

Arms: arm 1: TRAVATAN 0.004% once daily arm 2: Travoprost Vehicle arm 3: Travoprost Group A arm 4: Travoprost Group B arm 5: Travoprost Group C
Interventions: intervention 1: Travoprost 0.004% intervention 2: Travoprost Vehicle intervention 3: Travoprost (Groups A, B and C)
Intervention descriptions: intervention 1: 1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days intervention 2: 1 drop in each eye 8 times daily for 5 days intervention 3: 1 drop in each eye 8 times daily for 5 days

Protocol documents:
Clinical trial NCT01122862
Conditions: Healthy Subjects
Keywords: tooth plaque
Sponsor: GlaxoSmithKline
Start date: 2010-04-01; Completion date: 2010-05-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A clinical study to evaluate the effect of a commercial mouth rinse on plaque re-growth

Detailed description:

Arms: arm 1: Commercially available 0.12% Chlorhexidine mouthrinse arm 2: Commercially available cosmetic mouthrinse arm 3: Sterile Water
Interventions: intervention 1: 0.12% chlorhexidine mouthrinse intervention 2: Cosmetic mouthrinse intervention 3: Sterile water
Intervention descriptions: intervention 1: commercially available 0.12% chlorhexidine mouthrinse intervention 2: Commerically available cosmetic mouthrinse intervention 3: Sterile water

Protocol documents:
Clinical trial NCT01129583
Conditions: Post Traumatic Stiffness
Keywords: Botulinum Toxin Elbow Stiffness
Sponsor: Columbia University
Start date: 2003-11-01; Completion date: 2010-05-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized double blind placebo controlled study to investigate the hypothesis that injection of botulinum toxin A into the muscles surrounding the elbow following the surgical treatment of an elbow fracture will reduce postoperative stiffness and improve function.

Detailed description:
This is a randomized double blind placebo controlled prospective study in which botulinum toxin A (Botox®) or normal saline will be intraoperatively injected into the muscles surrounding the elbow following the surgical treatment of an elbow fracture or elbow fracture dislocation.

Eligible patients will be identified by the Principal Investigator in his practice or by fellows and residents from the clinic population and emergency department admissions. After providing informed consent, all subjects will undergo a baseline examination that will include a medical and orthopaedic history, physical examination, and radiographs. The surgical procedure itself will not differ from the standard care for elbow fractures. The only difference is injection of Botox® or normal saline into the muscles of the injured arm. Subjects will undergo post-operative evaluation at various intervals for up to two years. The study and control group will be compared to each other and to contralateral arms in regards to elbow range of motion, patient questionnaire scores (DASH) and an observer-based elbow scoring system (Broberg and Morrey).

Traumatic injury to the elbow resulting in a fracture or fracture/dislocation of the elbow often leads to a stiff elbow with limited function. Posttraumatic elbow stiffness is a common problem that is difficult to manage. The best way to decrease the morbidity is through prevention. An intraoperative injection of Botox® has been effective in treating upper limb spasticity disorders and may prevent the development of elbow stiffness, and decrease the need for future surgery to regain motion.

Arms: arm 1: 100 U injected into biceps, 100 U into brachialis arm 2: 100 U injected into biceps, 100 U into brachialis
Interventions: intervention 1: Botulinum Toxin Type A intervention 2: Saline
Intervention descriptions: intervention 1: Injection into the biceps brachii and brachialis immediately following the initial fracture surgery intervention 2: Injection into the biceps brachii and brachialis immediately following the initial fracture surgery

Protocol documents:
Clinical trial NCT01148745
Conditions: Iron Deficiency Anemia
Sponsor: Dialysis Clinic, Inc.
Start date: 2010-03-01; Completion date: 2010-05-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the time point of transferrin saturation (TSAT) and ferritin stabilization after a thirteen-treatment period following a ferumoxytol load, as well as to determine the point at which serum ferritin and TSAT concentrations can be checked in iron deficiency anemia (IDA) hemodialysis patients.

Detailed description:

Arms: arm 1: FDA approved drug
Interventions: intervention 1: ferumoxytol
Intervention descriptions: intervention 1: 510 milligram (mg) intravenous (IV) injection (30 mg/second (sec) over 17 seconds) after at least one hour of hemodialysis (HD), second 510 mg IV injection administered at next consecutive dialysis treatment (3-5 days after first injection)

Protocol documents:
Clinical trial NCT01181609
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2005-06-01; Completion date: 2010-05-01
Enrollment: 54 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the efficacy and safety of intravenous Avastin in combination with chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum. The anticipated time of study treatment is until disease progression.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: bevacizumab [Avastin]
Intervention descriptions: intervention 1: 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks according to the chemotherapy regimen

Protocol documents:
Clinical trial NCT01210079
Conditions: Opioid-Induced Hyperalgesia
Keywords: opioid-induced hyperalgesia methadone gabapentin opioid addiction
Sponsor: University of California, Los Angeles
Start date: 2002-09-01; Completion date: 2010-05-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Utilizing a double-blind, placebo-controlled design, the proposed work will evaluate the ability of an adjuvant anticonvulsant analgesic to diminish or reverse the opioid-induced hyperalgesia complicating the pain states suffered by Methadone-Maintained (MM) patients. Specifically, in a sample of MM patients, gabapentin, which has proven efficacy in treating neuropathic pain will be evaluated for its ability to ameliorate or diminish the opioid-induced hyperalgesia in these patients as reflected by changes on pain threshold and tolerance to both cold-pressor and electrical pain, at peak and through methadone blood levels. The results of this work will not only provide pharmacologic insight into the mechanisms underlying poor pain tolerance in this at-risk population, but also direction for the medical management of pain complicated by opioid-induced hyperalgesia.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Gabapentin; intervention 2: Placebo
Intervention descriptions: intervention 1: Gabapentin titrated to daily dose of 2400mg PO over 1 week with established dose taken daily for 5 weeks. intervention 2: Placebo titrated over 1 week with established dose taken daily for 5 weeks.

Protocol documents:
Clinical trial NCT01565356
Conditions: Alzheimer's Disease
Keywords: Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging
Sponsor: Avid Radiopharmaceuticals
Start date: 2010-03-01; Completion date: 2010-05-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will re-read 10-minute positron emission tomography (PET) scans acquired in previous clinical studies of AV-45 at 30 and 50 minutes after injection and compare the results.

Detailed description:

Interventions: intervention 1: florbetapir F 18
Intervention descriptions: intervention 1: IV injection, 111 or 370MBq (3 or 10mCi), single dose

Protocol documents:
Clinical trial NCT02101190
Conditions: Parkinson's Disease
Keywords: BIA 9-1067 Opicapone catechol-O-methyltransferase (COMT)
Sponsor: Bial - Portela C S.A.
Start date: 2010-03-01; Completion date: 2010-05-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the pharmacokinetics (PK) of BIA 9-1067 in patients with moderate chronic hepatic impairment and in matched healthy subjects.

Detailed description:
This was an open-label, single-dose, parallel-group, in-patient, nonrandomized study conducted in 8 patients with moderate chronic hepatic impairment and in 8 healthy matched subjects matched by origin, age, sex, weight, and smoking habits.

Each hepatic impaired patient and matched healthy subject participated in the study for approximately one month, including a 21-day screening period and a 4-day/4-night inpatient period. The inpatient period covered the period from Day -1 to Day 4 morning (through 72 hours after administration). The final study evaluation was performed for all subjects in the morning of the day of discharge, Day 4.

Arms: arm 1: Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067 arm 2: Group 2 - healthy subjects treated with BIA 9-1067
Interventions: intervention 1: BIA 9-1067
Intervention descriptions: intervention 1: Opicapone, OPC

Protocol documents:
Clinical trial NCT02149875
Conditions: Acute Cerebral Stroke Within 12 Hours for the First Time
Keywords: Acute ischemic stroke Dl-3-n-butylphthalide Cerebrolysin
Sponsor: Shanghai 6th People's Hospital
Start date: 2010-01-01; Completion date: 2010-05-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12 hours of acute ischemic stroke (AIS) in China. Patients were randomly assigned to receive a 10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo. National Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) were used to evaluate the efficacy in the patients with AIS at 11-day and 21-day after therapy. Adverse events were also analyzed among the three groups.

Detailed description:

Arms: arm 1: Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days arm 2: Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days arm 3: Intravenous infusion of 100 ml saline intravenous q.d. for 10 days
Interventions: intervention 1: Dl-3-n-butylphthalide intervention 2: Cerebrolysin intervention 3: Placebo
Intervention descriptions: intervention 1: Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily. intervention 2: Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days. intervention 3: 100 ml saline intravenous infusion once daily for 10 days.

Protocol documents: