ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00596362
Conditions: Uveal Melanoma
Keywords: Melanoma Eye Avastin
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2007-04-01; Completion date: 2008-06-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test the safety and effectiveness of Avastin introduced into the inside of the eyeball in causing shrinkage of the uveal melanoma (tumor of the eye). Avastin is an anti-cancer drug specially designed to shrink blood vessels within tumors.

Detailed description:

Arms: arm 1: AVASTIN
Interventions: intervention 1: AVASTIN
Intervention descriptions: intervention 1: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.

Protocol documents:
Clinical trial NCT00608244
Conditions: Liver Failure
Keywords: Tacrolimus Pharmacokinetics Liver Transplantation
Sponsor: Veloxis Pharmaceuticals
Start date: 2007-11-01; Completion date: 2008-06-01
Enrollment: 59 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A three sequence, open-label, multi-center, prospective, study in stable liver transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.

Detailed description:
A three sequence, open-label, multi-center, prospective, study in stable liver transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.

Stable liver transplant patients who fulfill all I/E criteria will be enrolled and kept on Prograf for 7 days. Following a 24-hour PK study on Day 7 to determine pharmacokinetics for Prograf, all patients will be converted to once daily LCP-Tacro for 14 days with one fixed dose change allowed at Day 15.

On Day 14 and Day 21 a 24-hour LCP-Tacro PK study will be performed. On Day 22 patients will be converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days ending with a safety assessment on day 53.

Arms: arm 1: Prograf was administrated BID, doses per product labeling, with an interval of 12±1 hours between the morning and evening doses. Patients continued on the same dose from Day 0 through Day 7. On Day 8, all patients were converted to LCP Tacro QD for 14 Days with one fixed dose change allowed at Day 15. LCP-Tacro was administered orally once daily in the morning, with an interval of 24 ± 1 h between doses. Trough levels were to be maintained within predefined therapeutic ranges of 5 to 15 ng/mL.

LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.
Interventions: intervention 1: LCP Tacro intervention 2: Prograf
Intervention descriptions: intervention 1: In the morning of Day 8 (after completing one week treatment with Prograf), all patients will be converted to LCP Tacro QD with a conversion ratio of 0.66-0.8.

LCP-Tacro will be administered for 14 Days with one fixed dose change allowed at Day 15. LCP-Tacro will be administered orally once daily in the morning, with an interval of 24 ± 1 h between doses.

Trough levels were to be maintained within predefined therapeutic ranges of 5 to 15 ng/mL. intervention 2: Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day 0 through Day 7 to maintain target trough levels of 5-12 ng/mL.

Protocol documents:
Clinical trial NCT00609674
Conditions: Rhinitis, Allergic, Perennial
Keywords: Perennial allergic rhinitis; fluticasone furoate nasal spray
Sponsor: GlaxoSmithKline
Start date: 2008-01-01; Completion date: 2008-06-01
Enrollment: 315 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effects (effectiveness and safety) of an intranasal corticosteroid (fluticasone furoate nasal spray \[FFNS\]), with a placebo nasal spray for the treatment of perennial (year-round) allergic rhinitis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Fluticasone furoate nasal spray intervention 2: Placebo
Intervention descriptions: intervention 1: Fluticasone furoate nasal spray intervention 2: Placebo

Protocol documents:
Clinical trial NCT00612040
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2008-01-01; Completion date: 2008-06-01
Enrollment: 178 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: insulin degludec intervention 2: insulin degludec intervention 3: insulin glargine intervention 4: insulin aspart
Intervention descriptions: intervention 1: Formulation 1: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily intervention 2: Formulation 2: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily intervention 3: Treat-to-target dose titration scheme, injection s.c., once daily intervention 4: Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily

Protocol documents:
Clinical trial NCT00613327
Conditions: Urinary Bladder, Overactive
Keywords: Overactive bladder Oxybutynin chloride OROS
Sponsor: Janssen Korea, Ltd., Korea
Start date: 2007-09-01; Completion date: 2008-06-01
Enrollment: 345 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the efficacy of oxybutynin chloride oral osmotic therapeutic system (OROS) on patient-reported outcomes after 12 weeks of treatment by dose escalation in participants with overactive bladder.

Detailed description:
This is a multicenter (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), prospective (study following participants forward in time) Phase 4 study of oxybutynin chloride OROS in participants with overactive bladder. The total study duration will be 12 weeks and will include following visits: Screening (Week -2), Baseline, Week 2, 4, 6 and 12. Participants will receive oxybutynin chloride OROS tablet at starting dose of 10 milligram (mg) orally once daily. The dose will be adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks will be continued up to Week 12. Maximum allowed dose will be 30 mg per day. Efficacy will primarily be evaluated by assessment of goal achievement (percentage of participants who show a score 4 or 5 in the Likert scale for treatment goal) at Week 12. Participants' safety will also be monitored at each visit.

Arms: arm 1: None
Interventions: intervention 1: Oxybutynin chloride OROS
Intervention descriptions: intervention 1: Participants will receive oxybutynin chloride OROS tablet at starting dose of 10 milligram (mg) orally once daily. The dose will be adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks will be continued up to Week 12. Maximum allowed dose will be 30 mg per day.

Protocol documents:
Clinical trial NCT00613834
Conditions: Pain
Keywords: Essure sterilization pain management intrauterine lidocaine infusion
Sponsor: Oregon Health and Science University
Start date: 2007-05-01; Completion date: 2008-06-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the level of pain women experience with an Essure procedure and the effect that lidocaine might have on that pain. We will also assess the absorption of lidocaine in the uterus by measuring lidocaine levels in the blood.

Detailed description:
We intend to conduct a randomized, blinded, and placebo- controlled clinical trial at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette to determine if intrauterine lidocaine infusion will decrease the amount of pain subjects experience during and after Essure transcervical tubal sterilization.

We plan to enroll women who have selected Essure as their method of tubal sterilization who will be randomized to one of two groups on the days of their procedures. Subjects in Group 1, the treatment group, will receive a standard paracervical block with lidocaine intrauterine infusion and subjects in Group 2, the control group, will receive a standard paracervical block with saline intrauterine infusion. The subjects will be asked to rate their pain on a 100 mm Visual Analog Scale (VAS) at five points during the procedure and once thirty minutes following the procedure. Subjects will also be asked to rate their overall satisfaction with their care prior to leaving the recovery room.

Arms: arm 1: Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization arm 2: Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization
Interventions: intervention 1: Lidocaine intervention 2: Sterile Saline
Intervention descriptions: intervention 1: 5 ml intrauterine infusion of 4% lidocaine using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes intervention 2: 5 ml intrauterine infusion of sterile saline using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes

Protocol documents:
Clinical trial NCT00617903
Conditions: Papulopustular Rosacea
Keywords: rosacea papulopustular azelaic acid foam
Sponsor: LEO Pharma
Start date: 2008-01-01; Completion date: 2008-06-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.

Detailed description:

Arms: arm 1: Participants received azelaic acid foam, 15% topically twice daily for 12 weeks arm 2: Participants received vehicle foam topically twice daily for 12 weeks
Interventions: intervention 1: Azelaic acid intervention 2: Vehicle foam
Intervention descriptions: intervention 1: 15% foam to be applied topically twice daily intervention 2: Active-ingredient-free vehicle to be applied topically twice daily

Protocol documents:
Clinical trial NCT00621959
Conditions: Seasonal Allergic Rhinitis
Keywords: levocetirizine Xyzal Seasonal Allergic Rhinitis total symptom score quality of life
Sponsor: UCB Pharma
Start date: 2008-03-01; Completion date: 2008-06-01
Enrollment: 596 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study objective is to investigate the efficacy of levocetirizine in reducing symptoms associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life

Detailed description:

Arms: arm 1: Matched placebo tablets once daily arm 2: 5 mg levocetirizine dihydrochloride tablet
Interventions: intervention 1: levocetirizine dihydrochloride intervention 2: placebo
Intervention descriptions: intervention 1: 5mg daily (oral tablet) for 14 days intervention 2: 0mg (matching oral tablet)for 14 days

Protocol documents:
Clinical trial NCT00641667
Conditions: Pain Cancer
Keywords: Pain Cancer Fentanyl JNS020QD
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2008-01-01; Completion date: 2008-06-01
Enrollment: 66 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants switched from morphine preparations, oral oxycodone preparations, fentanyl citrate injection or fentanyl patch for cancer pain.

Detailed description:
This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than one center) and non-comparative study of fentanyl one-day transdermal patch. The study consists of 3 periods: Pre-treatment observation period (4-7 days), Treatment period (10 days) and Follow-up period (2 days). Treatment will be initiated at 12.5 microgram per hour (mcg/hr) and the initial dose of fentanyl will be determined based on the daily dose of the opioid analgesic taken by the participant before entering the study and will be maintained for 2 days to ensure safety of participants. Dose escalation or reduction will be as per the Investigator's discretion from Day 3 to Day 7 and thereafter dose will be again maintained from Day 7 to Day 9, ranging from 12.5 mcg/hr-100 mcg/hr and the maximum application dose will be 300 mcg/hr. The patch will be applied on areas including the chest, abdomen, upper arm or thigh and will be replaced daily for 10 days (a total of 9 applications; including the day of final patch removal). Efficacy will primarily be evaluated by visual analog scale (VAS) score. Participants' safety will be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: Fentanyl
Intervention descriptions: intervention 1: Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is as per Investigator's discretion (maximum applied dose is 300 mcg/hr) up to Day 7 and then dose is fixed for next 3 days that is Day 10 (end of treatment period).

Protocol documents:
Clinical trial NCT00661141
Conditions: Aldehyde Dehydrogenase-2 (ALDH2) Deficiency
Keywords: acetaldehyde ethanol ALDH2
Sponsor: Amgen
Start date: 2008-04-01; Completion date: 2008-06-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will evaluate if fomepizole (4-methylpyrazole) can treat symptoms associated with alcohol intolerance due to aldehyde dehydrogenase 2 (ALDH2) deficiency, an inherited metabolic disorder. These symptoms include flushing, nausea, headache, shortness of breath and dizziness, resulting from exposure to acetaldehyde, the primary metabolite of ethanol. Long-term, serious health risks have been associated with repeated exposure to acetaldehyde, a carcinogen, among ALDH2-deficient individuals.

Detailed description:
Approximately 32 subjects will be enrolled in ascending dosing cohorts of 8 subjects each. Each subject will receive an oral dose of study drug (fomepizole or placebo) with concomitant ethanol with group assignment in a randomized 1:1:1:1 ratio (2 subjects each group) on Study Day 1. Each subject is their own intra-subject control with the alternative study drug (fomepizole or placebo) administered on the next day (Study Day 2). Four subjects in each cohort will receive study drug (fomepizole or placebo) administered 30 minutes prior to ethanol, 4 with study drug (fomepizole or placebo) administered 30 minutes after ethanol. The study will assess safety and tolerability of fomepizole and the PK/PD of 4-MP, ethanol and acetaldehyde in the subject population.

Study with completed results acquired from Horizon in 2024.

Arms: arm 1: Participants receive alternating study treatment (oral fomepizole 1.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol. arm 2: Participants receive alternating study treatment (oral fomepizole 3.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol. arm 3: Participants receive alternating study treatment (oral fomepizole 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol. arm 4: Participants receive alternating study treatment (oral fomepizole 7.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.
Interventions: intervention 1: Antizol intervention 2: Placebo intervention 3: Ethanol
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: oral dose of ethanol (0.5 g/kg)

Protocol documents:
Clinical trial NCT00672646
Conditions: Pain
Keywords: Analgesic effect
Sponsor: AstraZeneca
Start date: 2008-04-01; Completion date: 2008-06-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of this study is to investigate if AZD1386 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain. A number of patients will instead receive the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen, will be allowed if a need for additional painkillers would arise. A number of patients will receive naproxen as control.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: Placebo matching AZD1386
Interventions: intervention 1: AZD1386 intervention 2: Naproxen intervention 3: Placebo
Intervention descriptions: intervention 1: 95mg, oral solution, single dose intervention 2: 500mg, capsule, single dose intervention 3: AZD1386 Placebo oral solution

Protocol documents:
Clinical trial NCT00674115
Conditions: Gastric Acid Human Experimentation
Sponsor: Bayer
Start date: 2008-04-01; Completion date: 2008-06-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate.

Detailed description:
Enrolled participants were divided into 2 groups, with 30 participants in each group.

Group 1: This group was randomized into a 2-way crossover design with an added third period. These participants received single administrations (day 1 dosing only) of Zegerid Powder for Oral Suspension, and Prilosec OTC (both at a 20 mg omeprazole dose), in a 2-way randomized order, with a minimum of a 2-week washout period between treatment legs. Following completion of the 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all participants then received a single administration of sodium bicarbonate (at same dose as contained in Zegerid Powder for Oral Suspension) in Period 3. This group underwent a 24-hour intragastric pH study on each of the 3 dosing occasions.

Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid Powder for Oral Suspension and Prilosec OTC tablets, respectively. As with the prior group, there was a minimum of a 2-week washout period between treatment legs. Participants assigned to this treatment group also underwent 24-hour intragastric pH recordings on the days on which they received their 1st and last (7th) dose of the two treatment drugs.

In addition to the above detailed procedures, all participants (both groups) underwent a 24-hour baseline intragastric pH study prior to starting their randomized treatments. This study design enabled all 60 participants to be evaluated for effects of the first dose of Prilosec OTC and Zegerid Powder for Oral Suspension on change in intragastric pH during the subsequent 24-hour period following the first dose.

Arms: arm 1: Omeprazole 20 mg/Sodium Bicarbonate 1680 mg Powder for Oral Suspension arm 2: Omeprazole magnesium 20 mg over-the-counter (OTC) Tablet arm 3: Sodium Bicarbonate 1680 mg Oral Suspension
Interventions: intervention 1: Omeprazole/sodium bicarbonate intervention 2: omeprazole magnesium intervention 3: sodium bicarbonate
Intervention descriptions: intervention 1: Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days. intervention 2: Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days. intervention 3: Sodium bicarbonate. Single dose.

Protocol documents:
Clinical trial NCT00684307
Conditions: Nonvalvular Atrial Fibrillation
Keywords: Anticoagulant Treatment Risk Factors For Stroke
Sponsor: AstraZeneca
Start date: 2007-02-01; Completion date: 2008-06-01
Enrollment: 1084 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to provide dose-guiding information by assessing the safety and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of AZD0837 compared with well-controlled, dose-adjusted Vitamin-K antagonists (VKA) (aiming for an international normalized ratio (INR) 2.0 to 3.0) in patients with non-valvular atrial fibrillation (AF) with one or more additional risk factors for stroke.

Detailed description:

Arms: arm 1: AZD0837 450 mg arm 2: AZD0837 200 mg arm 3: AZD0837 300 mg arm 4: AZD0837 150 mg arm 5: Vitamin-K antagonist at INR 2-3
Interventions: intervention 1: AZD0837 intervention 2: Vitamin-K antagonist at INR 2-3 intervention 3: AZD0837
Intervention descriptions: intervention 1: ER tablet, PO, once daily for a period of 3-9 months. intervention 2: Tablet, PO for a period of 3-9 months. intervention 3: ER tablet, PO, twice daily for a period of 3-9 months

Protocol documents: