ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00968981
Conditions: Solid Cancers
Keywords: Hedgehog BCC basal cell carcinoma
Sponsor: Genentech, Inc.
Start date: 2009-09-01; Completion date: 2010-10-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a two stage, Phase Ib study designed to describe the pharmacokinetics of GDC-0449 in patients with advanced solid tumors that are refractory to treatment or for whom no standard therapy exists.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: GDC-0449 intervention 2: GDC-0449 intervention 3: GDC-0449
Intervention descriptions: intervention 1: Daily oral repeating dose intervention 2: Three times weekly oral repeating dose intervention 3: Once weekly oral repeating dose

Protocol documents:
Clinical trial NCT00970814
Conditions: Alcoholism
Keywords: Alcoholism Alcohol Drinking Alcoholic Intoxication Alcohol Abuse
Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Start date: 2009-10-01; Completion date: 2010-10-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to assess the efficacy of levetiracetam XR in increasing the percentage of subjects with no heavy drinking days and in reducing the weekly percentage of heavy drinking days in subjects with alcohol dependence confirmed by DSM-IV criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks per drinking day for women (designated as "very heavy" drinkers).

Detailed description:

Arms: arm 1: Group received Levetiracetam arm 2: Placebo
Interventions: intervention 1: BBCET intervention 2: BBCET intervention 3: Levetiracetam XR intervention 4: Sugar Pill
Intervention descriptions: intervention 1: 11 BBCET sessions intervention 2: 11 BBCET Sessions intervention 3: 500mg - 2000mg Once per day 16 weeks intervention 4: 500mg - 2000mg Once per day 16 weeks

Protocol documents:
Clinical trial NCT00991510
Conditions: Stable Renal Transplant Recipients
Keywords: renal transplantation mycophenolate mofetil pharmacokinetics immunosuppression
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2009-08-01; Completion date: 2010-10-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to further investigate how much of the drug substance "mycophenolate mofetil" can be found in the blood of patients with kidney or renal transplants when treated with Myfenax® or CellCept®. Additionally, the safety and side effects of the two products will be compared. All information already available on these products indicates that the safety profiles of the two products will be the same.

Detailed description:

Arms: arm 1: The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).

Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening. arm 2: The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).

Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
Interventions: intervention 1: mycophenolate mofetil (Myfenax) intervention 2: mycophenolate mofetil (Cellcept)
Intervention descriptions: intervention 1: Each participant received at least 500 mg orally, twice daily (morning and evening) during those study periods labeled as 'T' (test drug). Participants receive the dose equivalent to the pre-study dose (within the recommended therapeutic range) of mycophenolate mofetil. intervention 2: Each participant received at least 500 mg orally, twice daily (morning and evening) during those study periods labeled as 'R' (reference drug). Participants receive the dose equivalent to the pre-study dose (within the recommended therapeutic range) of mycophenolate mofetil.

Protocol documents:
Clinical trial NCT00992108
Conditions: Face Pain
Keywords: Bruxism Myofascial pain EMG Ultrasound Masticatory myofascial face pain from bruxism and clenching
Sponsor: University of California, Los Angeles
Start date: 2009-10-01; Completion date: 2010-10-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Botulinum toxin-A (BTX-A) prevents the release of acetylcholine in presynaptic terminals of the neuromuscular junction. It has been proposed to be effective in spastic conditions of the head and neck including oromandibular dystonias, bruxism, and muscular hypertrophy (1,2,3,4). However, only one randomized, double-blinded, placebo controlled trial has been completed involving 20 patients demonstrating both objective and subjective improvement in the BTX-A treated group over those treated with saline at one week, one month, and six months (5).

Currently, in most orofacial pain practices, when the diagnosis of masticatory myofascial pain in the head region is made, patients are treated with a standard myofascial protocol. This protocol involves stretching, application of moist heat, spray and stretch, and lidocaine trigger point injections into the masticatory muscles. This is considered the standard of care among most orofacial pain practioners.

There have been no randomized, double-blinded, head-to-head trials comparing BTX-A injections to lidocaine injections in the treatment of masticatory myofacial pain. Moreover, in all studies, muscles were targeted using surface landmarks with no confirmatory tests to guarantee the medication was administered to the intended muscle. In previous studies, the medial and lateral pterygoid muscles, important masticatory muscles that is often hyperactive in masticatory myofacial pain was not injected due to lack of palpable surface landmarks. Ultrasound and electromyography (EMG) guidance will help us locate these muscles.

The purpose of this study is to objectively measure functional improvement in patients with masticatory myofascial pain injected with lidocaine versus BTX-A. A pilot study enrolling 20 patients is proposed. 20 patients will be randomized to receive either BTX-A or lidocaine injections into the bilateral temporalis, masseter, and medial and lateral pterygoid. Objective and subjective clinical parameters will be measured. These include pain at rest and with chewing, maximum non-assisted and assisted mouth opening, protrusive and laterotrusive jaw movements, subjective efficacy of treatment, and side-effects of treatment. Patients will be assessed at baseline, one week, one month, and three months after the procedure.

Detailed description:

Arms: arm 1: lidocaine injection group arm 2: None
Interventions: intervention 1: lidocaine intervention 2: chemodenervation
Intervention descriptions: intervention 1: 1cc 1% intervention 2: botulinum toxin

Protocol documents:
Clinical trial NCT00995085
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD ADD TOVA METADOXINE
Sponsor: Alcobra Ltd.
Start date: 2009-10-01; Completion date: 2010-10-01
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical study is designed to evaluate the safety and tolerability of a single oral administration of a Metadoxine slow release formulation to subjects diagnosed as having ADHD. Study also assess cognitive effects of such drug administration.

Detailed description:
Primary outcome measure is the safety and tolerability of study drug after a single dosing.

Additional outcomes include commission error rate from the TOVA test. The result is measured as standard score in % compared to the values of the normal population.

Exploratory outcome measures include:

1. TOVA measures like response time , variability, omissions etc.
2. Subtests from Wechsler: digit memory, digit-number signs etc

Arms: arm 1: Metadoxine is a pyrolate salt of Pyridoxine
Interventions: intervention 1: Extended Release Metadoxine
Intervention descriptions: intervention 1: one oral 1400mg dose (2 tablets)

Protocol documents:
Clinical trial NCT00997620
Conditions: Seasonal Allergic Rhinitis
Keywords: Hay Fever Daytime somnolence Cognition
Sponsor: Western Sky Medical Research
Start date: 2010-03-01; Completion date: 2010-10-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hypothesis is that treating hay fever patients who had daytime sleepiness and slowed thinking because of the hay fever will improve when treated with an effective anti-hay fever medication, an intranasal steroid, that is will have less daytime sleepiness and demonstrate better thinking.

Detailed description:
In this study of patients with seasonal allergic rhinitis we will monitor daytime sleepiness as measured by validated daytime sleep score (Eppworth Daytime Sleepiness Scale) and cognitive performance weekly as measured by a validated test of cognitive performance (TOVA). The treatment group with intervention of fluticasone furoate nasal spray 110 mcg two sprays in each nostril once daily will be compared to a placebo treated group of similar subjects with seasonal allergic rhinitis.

Arms: arm 1: Placebo treatment given as a once daily dose intranasally.in subjects with active seasonal allergic rhinitis. arm 2: IFluticasone Furoate 110 mcg given intranasly once daily in am as an active treatment of seasonal allergic rhinitis
Interventions: intervention 1: Fluticasone furoate Nasal Spray 110 mcg intervention 2: Placebo
Intervention descriptions: intervention 1: Fluticasone fuorate nasal spray 110 mcg 2 sprays each nostril am will be compared to similar appearing placebo given 2 sprays each nostril am. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of fluticasone furoate 110 mcg once daily and continue the evaluations. intervention 2: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of Placebo once daily and continue the evaluations.

Protocol documents:
Clinical trial NCT01000805
Conditions: Major Depressive Disorder
Sponsor: Eli Lilly and Company
Start date: 2009-11-01; Completion date: 2010-10-01
Enrollment: 528 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Duloxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks. intervention 2: Participants received placebo QD, po for 8 weeks.

Protocol documents:
Clinical trial NCT01005290
Conditions: Hypertension
Keywords: cardiovascular fixed dose combination pill hypertension
Sponsor: Ferrer Internacional S.A.
Start date: 2009-10-01; Completion date: 2010-10-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the effect on systolic pressure of the 3 drugs given together in the cardiovascular combination pill (acetylsalicylic acid, simvastatin, and ramipril) to the effect on systolic pressure of ramipril given alone.

Detailed description:

Arms: arm 1: A once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks. arm 2: A once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks.
Interventions: intervention 1: Combination pill intervention 2: Ramipril
Intervention descriptions: intervention 1: A once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks. intervention 2: A once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks.

Protocol documents:
Clinical trial NCT01007123
Conditions: Constipation Chronic Constipation
Keywords: Chronic idiopathic constipation A3309
Sponsor: Albireo
Start date: 2009-11-01; Completion date: 2010-10-01
Enrollment: 190 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation.

Detailed description:

Arms: arm 1: Administered once daily for the duration of the study arm 2: Administered once daily for the duration of the study. arm 3: Administered once daily for the duration of the study arm 4: Administered once daily for the duration of the study
Interventions: intervention 1: A3309
Intervention descriptions: intervention 1: A3309 in three different dosage levels or placebo once daily for the duration of the study

Protocol documents:
Clinical trial NCT01045447
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2010-01-01; Completion date: 2010-10-01
Enrollment: 465 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the trial.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/insulin aspart intervention 2: insulin glargine
Intervention descriptions: intervention 1: Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily with main meal. Dose was individually adjusted. intervention 2: Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily. Dose was individually adjusted.

Protocol documents:
Clinical trial NCT01045707
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2010-01-01; Completion date: 2010-10-01
Enrollment: 530 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diabetic drug).

The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension period is registered as NN5401-3726.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/insulin aspart intervention 2: insulin glargine
Intervention descriptions: intervention 1: Injected s.c. (under the skin) once daily with the breakfast meal. Dose was individually adjusted. intervention 2: Injected s.c. (under the skin) once daily. Dose was individually adjusted.

Protocol documents:
Clinical trial NCT01060072
Conditions: Inflammation Pain
Sponsor: Bausch & Lomb Incorporated
Start date: 2010-02-01; Completion date: 2010-10-01
Enrollment: 407 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to compare the safety and efficacy of loteprednol etabonate to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Detailed description:

Arms: arm 1: Loteprednol etabonate 0.5% ophthalmic suspension arm 2: Vehicle of loteprednol etabonate ophthalmic suspension
Interventions: intervention 1: Loteprednol etabonate intervention 2: Vehicle of Loteprednol Etabonate
Intervention descriptions: intervention 1: Topical administration of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye four times a day (QID), postoperative day 1-14. intervention 2: Topical administration of vehicle of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye QID, postoperative day 1-14.

Protocol documents:
Clinical trial NCT01073930
Conditions: Bowel Preparation
Keywords: Bowel Preparation Colonoscopy
Sponsor: Ferring Pharmaceuticals
Start date: 2010-05-01; Completion date: 2010-10-01
Enrollment: 608 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep: 2-sachets for oral solution in two divided doses given a night before (first dose - sachet) and approximately 5 hours prior to procedure (second dose - sachet) or HalfLytely: for oral solution and two 5 mg Bisacodyl tablets, given the day before the procedure to evaluate its effectiveness, tolerability and safety.

Detailed description:

Arms: arm 1: "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy. arm 2: HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
Interventions: intervention 1: PicoPrep intervention 2: HalfLytely intervention 3: bisacodyl
Intervention descriptions: intervention 1: PICOPREP (sodium picosulfate, magnesium oxide and citric acid) powder for oral solution consisted of 2 pouches of powder administered in a divided dose. Each PICOPREP pouch was reconstituted by mixing the contents in a cup with 5 ounces of cold water. The first pouch was taken between 5:00 PM and 9:00 PM the evening prior to the colonoscopy procedure. Subjects were to consume five (5) 8-ounce glasses of clear liquids over the next few hours. The second pouch was taken approximately 5 hours before but no more than 9 hours prior to the colonoscopy procedure. Subjects were to consume three (3) 8-ounce glasses of clear liquids. intervention 2: HalfLytely contains polyethylene glycol electrolyte solution (PEG-EL), sodium chloride, sodium bicarbonate and potassium chloride. The day prior to the colonoscopy procedure and after the first bowel movement or after 6 hours following administration of the bisacodyl tablets, whichever occurred first, subjects were to drink the 2 liter HalfLytely at a rate of one 8-ounce glass every 10 minutes. The entire solution was to be consumed. intervention 3: Two 5 mg bisacodyl tablets were taken in the afternoon on the day prior to the colonoscopy procedure.

Protocol documents:
Clinical trial NCT01073943
Conditions: Bowel Preparation
Keywords: Bowel Preparation Colonoscopy
Sponsor: Ferring Pharmaceuticals
Start date: 2010-05-01; Completion date: 2010-10-01
Enrollment: 603 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep: 2-sachets for oral solution in two divided doses given in the afternoon (first dose - sachet) and 6 hours later in the evening (second dose - sachet), given the day before the procedure or HalfLytely: for oral solution and two 5 mg Bisacodyl tablets, given the day before the procedure to evaluate its effectiveness, tolerability and safety.

Detailed description:

Arms: arm 1: "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy. arm 2: HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
Interventions: intervention 1: PicoPrep intervention 2: HalfLytely intervention 3: bisacodyl
Intervention descriptions: intervention 1: PicoPrep (sodium picosulfate, magnesium oxide and citric acid) powder for oral solution consisted of 2 pouches of powder administered in a divided dose. Each PicoPrep pouch was reconstituted by mixing the contents in a cup with 5 ounces of cold water. Subjects randomized to the PicoPrep group will begin treatment (1st sachet) one day before colonoscopy between 4:00 and 6:00 PM, and will complete the treatment (2nd sachet) at least 6 hours later, between 10:00 PM and 12:00 AM. Subjects will consume approximately (5) 8 oz. glasses of clear liquids following the first sachet administration in the afternoon and (3) 8 oz. glasses of clear liquids following the second sachet administration in the evening, one day before colonoscopy. intervention 2: HalfLytely contains polyethylene glycol electrolyte solution (PEG-EL), sodium chloride, sodium bicarbonate and potassium chloride. The day prior to the colonoscopy procedure and after the first bowel movement or after 6 hours following administration of the bisacodyl tablets, whichever occurred first, subjects were to drink the 2 liter HalfLytely at a rate of one 8-ounce glass every 10 minutes. The entire solution was to be consumed. intervention 3: Two 5 mg bisacodyl tablets were taken in the afternoon on the day prior to the colonoscopy procedure.

Protocol documents: