ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00496470
Conditions: Chronic Obstructive Pulmonary Disease, COPD
Keywords: Chronic Obstructive Pulmonary Disease, COPD
Sponsor: AstraZeneca
Start date: 2007-05-01; Completion date: 2008-06-01
Enrollment: 660 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD.

Detailed description:

Arms: arm 1: Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily arm 2: Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Interventions: intervention 1: Symbicort (budesonide/formoterol turbuhaler 320/9ug) intervention 2: Spiriva (tiotropium bromide 18ug)
Intervention descriptions: intervention 1: Symbicort (budesonide/formoterol turbuhaler 320/9ug) intervention 2: Spiriva (tiotropium bromide 18ug)

Protocol documents:
Clinical trial NCT00496964
Conditions: Patellofemoral Pain Syndrome
Keywords: Botulinum toxin type A Patellofemoral pain syndrome Knee Injuries Exercise Therapy
Sponsor: Virginia Commonwealth University
Start date: 2005-05-01; Completion date: 2008-06-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the use of botulinum toxin A injected into the lateral thigh muscle improves knee function and reduces knee pain secondary to patellofemoral syndrome. The study hypothesis is that botulinum toxin + specific exercises will be superior to specific exercises alone in improving knee function and reducing knee pain in individuals with patellofemoral syndrome.

Detailed description:
Patellofemoral pain syndrome is a leading cause of knee pain in persons under 45 and is particularly common in women. The prevailing theory for the etiology of patellofemoral pain is an imbalance in force or timing of the pull of the knee extensor muscles on the patella resulting in improper tracking of the patella in the femoral grove. Specifically, the vastus medialis is thought to be ineffective in overcoming the lateral pull of the vastus lateralis. When exercises designed to focus on improving strength and timing of activation of the vastus medialis fail, surgical release of part of the attachment of the vastus lateralis to the patella is considered.

Botulinum toxin temporarily blocks acetylcholine release from motor neurons and is used clinically to produce muscle relaxation.

Subjects with patellofemoral syndrome will be recruited into the study. Half of the subjects will be given a placebo injection while the other half will be given an injection of Botox (Botulinum Toxin A, Allergen) into the vastus lateralis muscle. Group assignment will be randomized and a double blind protocol used. Prior to injection, the subject will record their level of knee pain, fill out several knee function questionnaires, and have the strength and endurance of their knee extensor muscles tested. All subjects will be given an exercise program designed to target strengthening of the medial thigh muscles as well as stretching of lateral structures.

At 4, 6 and 12 weeks knee pain and knee function will again be assessed.

Arms: arm 1: Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program arm 2: Placebo injection + exercise
Interventions: intervention 1: Botulinum toxin A + exercise intervention 2: Placebo
Intervention descriptions: intervention 1: Injection of 100 units Botox (Botulinum toxin type A) into the Vastus Lateralis of the study leg + 12 weeks of exercise for patellofemoral pain intervention 2: Injection of 2 cc placebo containing 0.1cc sodium bicarbonate 8.4% (1meq/cc), 0.9cc normal saline and 1 cc of lidocaine into the vastus lateralis of the study leg followed by 12 weeks of exercise for patellofemoral pain syndrome

Protocol documents:
Clinical trial NCT00509873
Conditions: Bacterial Conjunctivitis
Sponsor: Allergan
Start date: 2007-08-01; Completion date: 2008-06-01
Enrollment: 578 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis

Detailed description:

Arms: arm 1: Gatifloxacin 0.5% Eye Drops arm 2: Placebo Eye Drops
Interventions: intervention 1: Gatifloxacin 0.5% eye drops intervention 2: placebo eye drops
Intervention descriptions: intervention 1: Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily intervention 2: Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily

Protocol documents:
Clinical trial NCT00528021
Conditions: Pediculus Humanus Capitis Head Lice
Keywords: Head Lice Lice Infestation Pediculosis Pediculosis Capitis
Sponsor: Boston Scientific Corporation
Start date: 2007-08-01; Completion date: 2008-06-01
Enrollment: 230 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.

Detailed description:
The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.

Arms: arm 1: Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 2.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair. arm 2: Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 10% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair. arm 3: Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 12.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair. arm 4: None
Interventions: intervention 1: Placebo intervention 2: BGC20-0582
Intervention descriptions: intervention 1: Vehicle Only intervention 2: BGC20-0582 is a topical gel formulation of a naturally derived product. Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or BGC20-0582 at one of the three concentrations. Following application of the BGC20-0582 lice treatment gel of placebo the product is rinsed from the subjects hair.

Protocol documents:
Clinical trial NCT00533351
Conditions: Neuralgia
Sponsor: Allergan
Start date: 2008-03-01; Completion date: 2008-06-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will explore the safety and efficacy of AGN201781 in patients with postherpetic neuralgia or post-traumatic peripheral neuralgia

Detailed description:

Arms: arm 1: AGN201781 50 mg capsules three-time daily for 2 weeks arm 2: placebo 50 mg capsules three-times daily for 2 weeks
Interventions: intervention 1: AGN201781 intervention 2: placebo
Intervention descriptions: intervention 1: AGN201781 50 mg capsules three-times daily for 2 weeks intervention 2: placebo 50 mg capsules three-times daily for 2 weeks

Protocol documents:
Clinical trial NCT00544713
Conditions: Dry Eye Syndrome
Sponsor: Allergan
Start date: 2007-09-01; Completion date: 2008-06-01
Enrollment: 228 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of a new artificial tear for the treatment of dry eye that may occur after LASIK surgery

Detailed description:

Arms: arm 1: Carboxymethylcellulose and Glycerin based artificial tear arm 2: Carboxymethylcellulose based artificial tear
Interventions: intervention 1: Carboxymethylcellulose and Glycerin based artificial tear intervention 2: Carboxymethylcellulose
Intervention descriptions: intervention 1: As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake intervention 2: As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake

Protocol documents:
Clinical trial NCT00563706
Conditions: Schizophrenia
Sponsor: Pfizer
Start date: 2007-12-01; Completion date: 2008-06-01
Enrollment: 199 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this protocol is to establish the efficacy, safety, and tolerability of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of schizophrenia.

Detailed description:

Arms: arm 1: None arm 2: 4mg/day arm 3: matching placebo
Interventions: intervention 1: vabicaserin intervention 2: risperidone intervention 3: placebo
Intervention descriptions: intervention 1: This study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00568061
Conditions: Acute Myocardial Infarction ST Elevation MI STEMI
Keywords: INOT44 NOMI
Sponsor: Mallinckrodt
Start date: 2006-06-01; Completion date: 2008-06-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size at 48-72 hours in patients presenting with an ST segment elevation MI (STEMI) who undergo successful percutaneous coronary intervention.

Detailed description:
The purpose of the trial is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size as a fraction of left ventricular (LV) size at 48-72 hours in patients presenting with an ST segment elevation MI who undergo successful percutaneous coronary intervention (PCI).

The primary endpoint for this study will be myocardial infarction size as a fraction of left ventricular size at 48-72 hours as measured by contrast-enhanced cardiac MRI.

Arms: arm 1: Inhaled Nitric oxide administered at 80 parts per million (ppm) arm 2: Inhaled nitrogen gas (Placebo) administered at 80 ppm
Interventions: intervention 1: Nitric Oxide intervention 2: Placebo
Intervention descriptions: intervention 1: Nitric oxide for inhalation intervention 2: Nitrogen gas (placebo) for inhalation

Protocol documents:
Clinical trial NCT00575380
Conditions: Bacterial Infections Eye Infections Cataract Extraction
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-12-01; Completion date: 2008-06-01
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the drug concentrations in the conjunctiva and aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract surgery

Detailed description:

Arms: arm 1: One drop two times a day for two days and once a day for the next five days arm 2: One drop three times a day for seven days
Interventions: intervention 1: AzaSite Eye Drops intervention 2: Vigamox Eye Drops
Intervention descriptions: intervention 1: One drop two times a day for two days and once a day for the next five days. intervention 2: One drop three times a day for seven days

Protocol documents:
Clinical trial NCT00582660
Conditions: Colorectal Adenoma Colorectal Carcinoma
Sponsor: University of Alabama at Birmingham
Start date: 2001-12-01; Completion date: 2008-06-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess how effective celecoxib is in limiting production of a hormone, prostaglandin, in the subject's body. It is felt that this hormone is involved in the evolution of pre-cancerous growths in the colon to cancerous stage or in the progression of an existing cancer. To answer this question, some subjects are given the new investigational drug, and other subjects a placebo. A placebo is a capsule that contains inactive ingredients. Only by comparing the response of two subject groups, one receiving placebo (inactive), and one receiving celecoxib (active), will we be able to know whether or not celecoxib actually works. The outcome we are assessing is the hormone activity before and after celecoxib is given.

Detailed description:
We propose to test the hypothesis that celecoxib, a specific inhibitor of cyclooxygenase -2 (COX-2), will effectively inhibit the enzymatic activity in all tissues sampled after oral administration of celecoxib for 7 days preoperatively. One hundred twenty patients (120) undergoing standard surgical resection for the treatment of primary colorectal adenomas or carcinomas would be randomized to celecoxib or placebo given for 7 days prior to operation. Peripheral blood will be drawn prior to drug or placebo administration, and then morning of operation. At the time of definitive resection of the specimen, normal intestinal mucosa and primary tumor would be harvested and immediately snap frozen at -80 degrees. Levels of COX-2 activity (prostaglandin production) as well as expression of COX-2 and other markers (matrix metalloproteinases(MMPs), tissue inhibitors of MMPs (TIMPs), cell adhesion and cell cycle control molecules will be evaluated in normal mucosa and primary tumor compared between celecoxib and placebo treated patients.

Arms: arm 1: 400 mg Celecoxib the study drug will be given for 7 days before surgery arm 2: Placebo in a one to one randomization prior to surgery
Interventions: intervention 1: Celecoxib intervention 2: Placebo
Intervention descriptions: intervention 1: 400 mg twice a day for 7 days prior to surgery intervention 2: one tablet of placebo will be given for 7 days prior to surgery

Protocol documents:
Clinical trial NCT00583713
Conditions: Colonoscopy Bowel Preparation
Sponsor: Braintree Laboratories
Start date: 2007-08-01; Completion date: 2008-06-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate and compare the effects on safety measures and clinical chemistry after BLI800 in two groups of patients and one group of healthy controls. The patient groups will be those with mild or moderate hepatic impairment or moderate renal disease.

Detailed description:

Arms: arm 1: Patients with moderate renal impairment arm 2: Healthy volunteers arm 3: Patients with mild/moderate hepatic impairment.
Interventions: intervention 1: BLI-800
Intervention descriptions: intervention 1: BLI-800 oral solution (two doses)

Protocol documents:
Clinical trial NCT00585611
Conditions: Diastolic Heart Failure
Keywords: Heart Failure, Congestive
Sponsor: University of Wisconsin, Madison
Start date: 2005-12-01; Completion date: 2008-06-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to define the underlying vascular abnormalities present in patients with diastolic heart failure and test the effect of a therapy aimed at vascular abnormalities. This study is designed to investigate the effects of therapy with atorvastatin in subjects with diastolic heart failure to improve abnormalities of vascular and myocardial structure and function, with particular emphasis on arterial stiffness and endothelial dysfunction.

Detailed description:
Forty subjects will be given either drug (atorvastatin 40 mg) or placebo in a randomized fashion once daily for six months. Using echocardiography, tonometry, and flow mediated dilation of conduit arteries and arterioles, baseline cardiovascular anatomy and physiology will be defined. Subjects that enroll in the study will be required to come in for 5 study visits. The initial visit is a screening visit; subject consent is obtained and an echocardiogram is performed as well as blood tests. At the randomization visit (4-14 days following screening), the subject will be provided with drug or placebo in a blinded fashion.Also at this visit, subjects will be asked to do a 6 minute walk, QOL questionnaire, and vascular function testing. There will be follow-up study visits at 1 and 3 months following randomization. At each follow-up visit a medical history, pill count and brief physical examination will be performed, a repeat QOL questionnaire administered, and blood tests to assess safety of the statin therapy. At 6 months, the final study visit will occur. At this visit a full history and detailed physical examination will be performed. Repeat echocardiogram, 6 minute walk test, QOL questionnaire, and vascular function examinations will be performed.

Arms: arm 1: Heart failure patients assigned to atorvastatin arm 2: None
Interventions: intervention 1: Atorvastatin intervention 2: placebo
Intervention descriptions: intervention 1: Atorvastatin - 40 mg orally daily for 6 months intervention 2: placebo

Protocol documents:
Clinical trial NCT00586664
Conditions: Allergic Conjunctivitis
Sponsor: Bausch & Lomb Incorporated
Start date: 2007-10-01; Completion date: 2008-06-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy and safety study of bepotastine besilate ophthalmic solution in allergic conjunctivitis

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Bepreve (bepotastine besilate ophthalmic solution) 1.5% intervention 2: placebo comparator intervention 3: Bepotastine Besilate Ophthalmic Solution 1.0%
Intervention descriptions: intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution intervention 3: sterile ophthalmic solution

Protocol documents:
Clinical trial NCT00591019
Conditions: Tinnitus
Keywords: P50, Psychomotor Vigilance Test (PVT), Arousal, Reaction Time
Sponsor: University of Arkansas
Start date: 2006-08-01; Completion date: 2008-06-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
A study on the effects of the FDA approved drug Modafinil upon attention problems associated with tinnitus. This is considered to be a safe drug with few side effects. Each subject will be asked to participate in 3 sessions each lasting approximately 1 hour in which cognitive testing and recordings will be taken. The study involves each subject taking a 2- week supply of Modafinil and a 2- week supply of placebo. We hypothesize inattention related to thalamocortical dysrhythmia found in tinnitus can be reduced by Modafinil thus improving vigilance.

Detailed description:
Modafinil, a drug primarily used in the treatment for narcolepsy, is also being using in treating attention problems found in Attention Deficit Hyperactive Disorder (ADHD). This study will investigate the efficacy of Modafinil upon attention deficits found in tinnitus patients by assessing pre-attentional and attentional processes (e.g., the amplitude of auditory evoked responses and simple reaction time).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Modafinil intervention 2: Placebo
Intervention descriptions: intervention 1: 200 mg/day, morning dose intervention 2: Sugar pill once per day in the morning.

Protocol documents:
Clinical trial NCT00591370
Conditions: Melanoma
Keywords: Memorial Sloan-Kettering Cancer Center patients with measurable, unresectable stage III or IV melanoma
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2005-01-01; Completion date: 2008-06-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Temozolomide (also known as TMZ) is a chemotherapy drug given by mouth. It is similar to DTIC, the only FDA-approved chemotherapy for melanoma, but because temozolomide is given by mouth, it can be given daily over a long period of time. We think that temozolomidemay work best if it is given every day for 6 weeks at a time. Temozolomide given by this extended schedule is experimental, although we have found that it is safe and can shrink melanoma in some patients.

One big advantage of TMZ is that it is given by mouth instead of by vein. This means that it can be given daily over a long period of time rather than off and on like DTIC. We think that TMZ may work better if it is given every day for 6 weeks. TMZ given by this extended schedule is experimental although we have found that TMZ given in this way is safe and can shrink melanoma in some patients. When extended dosing TMZ was given with either thalidomide or long-acting interferon-α, about 30% of patients had their tumors shrink. We think that this shrinkage was due mostly to the TMZ since neither thalidomide nor interferon-α alpha work in melanoma by themselves.

In this study, we will treat patients with TMZ alone using this extended dosing schedule to see how many patients experience tumor shrinkage.

We also want to learn more about which tumors are more likely to shrink from TMZ treatment. We will test samples of your tumor for whether or not a gene called MGMT has been turned on,

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Temozolomide (TMZ)
Intervention descriptions: intervention 1: One group treatment study

Protocol documents:
Clinical trial NCT00591851
Conditions: Breast Cancer
Keywords: breast cancer adenocarcinoma of the breast cardiac safety Breast cancer patients seen at the Memorial Sloan-Kettering Cancer Center
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2004-12-01; Completion date: 2008-06-01
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
HER-2/neu (+) breast cancer is a more aggressive form of breast cancer. HER-2/neu is a protein that is overproduced by your tumor. It makes your cancer more aggressive. Standard treatments for this type of cancer will help some people, but there is a moderate to high chance that your cancer may come back.

The purpose of this study is to see if a new regimen will be effective in preventing cancer from coming back. This is a phase II trial. In this trial, patient get a drug regimen that has been tested in small groups of people to see what dose is safe. Researchers now wish to see how effective the drug is for HER-2/neu (+) breast cancer. The objective includes looking at short-term side effects and risks of the drug. All of the drugs on this regimen can affect the heart which can be a serious side effect. The drugs affect on heart function is a primary focus.

Detailed description:

Arms: arm 1: single arm study
Interventions: intervention 1: AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)
Intervention descriptions: intervention 1: AC \[Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)\] Followed By Paclitaxel (P)

Protocol documents:
Clinical trial NCT00595101
Conditions: Primary Open Angle Glaucoma Ocular Hypertension
Sponsor: Bausch & Lomb Incorporated
Start date: 2007-12-01; Completion date: 2008-06-01
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension

Detailed description:

Arms: arm 1: A single drop of each, once daily in study eye for 28 days arm 2: A single drop of each, once daily in study eye for 28 days arm 3: A single drop of each, once daily in study eye for 28 days arm 4: A single drop of each, once daily in study eye for 28 days
Interventions: intervention 1: PF-03187207 intervention 2: Latanoprost 0.005% intervention 3: PF-03187207 Vehicle intervention 4: Latanoprost Vehicle
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: One drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207. intervention 4: None

Protocol documents: