ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00626275
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis arthritis
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2007-10-01; Completion date: 2008-09-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the effectiveness of ADL5859 in relieving pain associated with rheumatoid arthritis (RA) compared with placebo and naproxen (similar to Aleve®). A second objective is to see whether the effect of ADL5859 differs after a single dose compared with multiple doses.

Detailed description:
This Phase 2a study was conducted in 2 parts. Part A was a randomized, single-dose, double-blind, placebo- and active-controlled, 3-way crossover phase during which participants were administered study medication in the clinical facility. Part B was a 14-day, randomized, double-blind, placebo-controlled, parallel-group, multiple-dose phase in which participants self-administered study medication at home.

Arms: arm 1: ADL5859: 200 milligrams (mg), capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study arm 2: Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study arm 3: Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study arm 4: ADL5859: 100 mg, capsules, administered orally, twice daily (BID) for 2 weeks during Part B of the study arm 5: Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
Interventions: intervention 1: ADL5859 intervention 2: Naproxen intervention 3: Placebo intervention 4: ADL5859 intervention 5: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT00628108
Conditions: Allergic Rhinitis Chronic Urticaria
Keywords: Xyzal Levocetirizine Allergy Children Seasonal Allergies
Sponsor: UCB Pharma
Start date: 2008-03-01; Completion date: 2008-09-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the safety of levocetirizine in children ages 6-11 months with symptoms of allergic rhinitis or chronic idiopathic urticaria.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Levocetirizine 1.25 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks intervention 2: Placebo oral liquid once a day for two weeks

Protocol documents:
Clinical trial NCT00628758
Conditions: Asthma
Keywords: Symbicort Turbuhaler Persistent Asthma
Sponsor: AstraZeneca
Start date: 2005-12-01; Completion date: 2008-09-01
Enrollment: 430 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adult patients with persistent asthma.

Detailed description:
A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.

Arms: arm 1: Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed) arm 2: Conventional Best Practice for Treatment of Asthma
Interventions: intervention 1: Symbicort TBH - Turbuhaler intervention 2: beta-II-agonist, inhale steroid
Intervention descriptions: intervention 1: Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed) intervention 2: Salbulin inh. 200-400 dosage 100 microgram (mcg)/dosage Salbutamol Sustained Release(SR)capsule 4 mg/8 mg Salbutol tablet (tb) 2 mg Salbutol forte syrup 2 mg/5 ml Ventolin tb, syrup, intravenous(IV),5mgx10 ampule(amp) Ventolin inhaler (inh) 200 dosage, 100 mcg/dosage Ventolin nebul 2.5 mg Volmax tb 4 mg/8 mg Vent-o-sal inh 100 mcg/200 dosage Combivent inh 100 mcg/dosage Combivent neb 2.5 mg/dosage Bricanyl tb 2.5 mg Bricanyl durules ret tb 5 mg Bricanyl syrup 30mg Bricanyl inhaler 0.25 mg/dosage, 400 dosage Bricanyl turbuhaler 0.5 mg/dosage, 200dosage

Protocol documents:
Clinical trial NCT00635609
Conditions: Acne Vulgaris
Sponsor: Warner Chilcott
Start date: 2008-03-01; Completion date: 2008-09-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized, multi-center, open label, active-comparator study to compare the efficacy and tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with moderate to severe acne vulgaris.

Detailed description:
Efficacy of Doryx Delayed Release Tablets to doxycycline hyclate will be assessed using an Investigator's Global Assessment (IGA) score and the absolute change from baseline to 12 weeks in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline to 12 weeks in non-inflammatory lesions count of Doryx Delayed Release Tablets compared to doxycycline hyclate will be evaluated.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Doxycycline hyclate (Doryx) intervention 2: Doxycycline hyclate
Intervention descriptions: intervention 1: 150mg/day, oral, delayed release tablets intervention 2: 100 mg/day, oral, tablets, immediate release

Protocol documents:
Clinical trial NCT00639678
Conditions: Healthy
Keywords: healthy volunteers
Sponsor: Human Genome Sciences Inc.
Start date: 2008-03-01; Completion date: 2008-09-01
Enrollment: 322 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and tolerability of raxibacumab in healthy subjects.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: placebo intervention 2: raxibacumab intervention 3: placebo intervention 4: raxibacumab
Intervention descriptions: intervention 1: 40 mg/kg intravenously, double dose (day 0 and 14), Group 3 intervention 2: 40 mg/kg intravenously, double dose (day 0 and 14), Group 1 intervention 3: 40 mg/kg placebo, single dose (day 0), Group 4 intervention 4: 40 mg/kg intravenously, single dose, day 0, Group 2

Protocol documents:
Clinical trial NCT00644657
Conditions: Coronary Artery Disease Chest Pain
Keywords: Platelets, platelet aggregation inhibitors
Sponsor: University of Oklahoma
Start date: 2007-03-01; Completion date: 2008-09-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will explore the effect of clopidogrel on coated-platelets in patients who are given a loading dose before diagnostic catheterization or percutaneous coronary intervention. We hypothesis that clopidogrel will reduce the percentage of platelets that are coated and therefore more hypercoagulable.

Detailed description:
Platelet activity will be determined by light transmission aggregometry at baseline, after a 300 mg dose of clopidogrel and after the catheterization and/or angioplasty procedure. The change in the percentage of platelets that are coated platelets will be determined.

Interventions: intervention 1: Clopidogrel
Intervention descriptions: intervention 1: All subjects will receive a 300 mg loading dose

Protocol documents:
Clinical trial NCT00675792
Conditions: Anesthesia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-05-01; Completion date: 2008-09-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to compare the incidence of

residual neuromuscular blockade at the time of tracheal extubation after reversal of rocuronium bromide-induced neuromuscular blockade by 4 mg/kg sugammadex with that of 50 µg/kg neostigmine. Residual neuromuscular blockade is defined as the fourth twitch to first twitch (T4/T1) ratio of

\< 0.90.

Detailed description:
Undetected residual neuromuscular blockade is common in the post-anesthesia care

unit (PACU). In fact, 16%-42% of patients receiving intermediate-acting muscle

relaxants in the operating room have T4/T1 ratios \<0.7-0.8 in the PACU. Respiratory and pharyngeal muscle function can be adversely affected during minimal neuromuscular blockade. Studies in awake volunteers and surgical patients have demonstrated that T4/T1 ratios of 0.7 - 0.9 are associated with impaired airway protective reflexes, upper airway obstruction, a decreased hypoxic ventilatory response, and post-operative hypoxemia. The incidence and severity of residual neuromuscular blockade at the time of tracheal extubation will be evaluated to determine how these influence the length of stay in the operating room and PACU.

Arms: arm 1: 4 mg/kg sugammadex arm 2: 50 µg/kg neostigmine
Interventions: intervention 1: Sugammadex intervention 2: Neostigmine intervention 3: Rocuronium
Intervention descriptions: intervention 1: Participants received 4 mg/kg sugammadex at 1-2 Post Tetanic Counts (PTCs) or better after the last dose of rocuronium bromide. intervention 2: Participants received 50 µg/kg neostigmine combined with 10 µg/kg glycopyrrolate after the last dose of rocuronium bromide as per standard of care. intervention 3: Participants received a single intubation bolus dose of 0.6 mg/kg rocuronium bromide, followed if necessary to maintain neuromuscular blockade by one or more single bolus dose(s) of 0.15 mg/kg rocuronium bromide.

Protocol documents:
Clinical trial NCT00682630
Conditions: Malaria
Keywords: Malaria anti-malarial pyronaridine pyronaridine artesunate (Pyramax) artemisinin based combination therapy (ACT)
Sponsor: Medicines for Malaria Venture
Start date: 2007-09-01; Completion date: 2008-09-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to determine the bioequivalence of the combination of pyronaridine and artesunate (180:60mg) to-be-marketed tablet to the clinical trial reference tablet administered as a single total dose of 720:240 mg in healthy adults. The secondary objective is to assess the safety of the two formulations.

Detailed description:
This is a phase I, randomized, single dose, two-way cross-over study of two tablet formulations of the combination of pyronaridine and artesunate (180:60 mg). The study will include 42 healthy participants, comprising male and female adults.

Participants will be randomized to receive either reference tablet formulation or to-be-marketed formulation first and then will be crossed over to receive the opposite Intervention. The study will consist of two single dose treatments of 720:240 mg tablets, separated by a washout period of 43 days.

Participants will go to the clinic the evening before dosing (dosing days were Day 0 for period 1 and Day 43 for period 2) under fasting condition and remain in the hospital for 24 hours after receiving dosing.

Participants will stay in the hospital for 24 hours after their arrival at the clinic. They will return to the clinic at Day 2, 3, 5, 7, 14, 21, 28, 35 and 42 on an ambulatory basis. At Day 43, the dosing for the second sequence will start and a similar schedule of visits will be followed. Each participant will be followed-up for an additional 42 days after the start of the second study period, until the final visit (Day 85). The total duration of participation is 85 days plus a maximum of 2 weeks screening period.

Arms: arm 1: Participants first received clinical trial reference 720:240 mg tablets on Day 0. After a washout period of 43 days, they then received to-be-marketed 720:240 mg tablets on Day 43, with a follow-up period of 42 days. arm 2: Participants first received to-be-marketed 720:240 mg tablets on Day 0. After a washout period of 43 days, they then received clinical trial reference 720:240 mg tablets on Day 43, with a follow-up period of 42 days.
Interventions: intervention 1: pyronaridine artesunate clinical trial reference tablets intervention 2: pyronaridine artesunate to-be-marketed tablets
Intervention descriptions: intervention 1: Single total oral dose of 720:240 mg (4 tablets of 180:60 mg) intervention 2: Single total oral dose of 720:240 mg (4 tablets of 180:60 mg)

Protocol documents:
Clinical trial NCT00687544
Conditions: Hepatitis C, Chronic Hepacivirus HIV Infections
Keywords: HIV
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-12-01; Completion date: 2008-09-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this study, adult Indonesian subjects with human immunodeficiency virus (HIV) coinfected with chronic hepatitis C (CHC) will be given peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) combination therapy. The efficacy rate (sustained virologic response, end of treatment virologic response, and sustained biochemical response), the subject morbidity rate as caused by other opportunistic infection (eg, bacterial pneumonia, tuberculosis, and other bacterial infection), and the safety and tolerability of this combination therapy will be examined.

Detailed description:

Arms: arm 1: PEG-IFN + RBV therapy in previously untreated chronic HCV subjects coinfected with HIV
Interventions: intervention 1: Peginterferon alfa-2b (SCH 054031) intervention 2: Ribavirin (SCH 018908)
Intervention descriptions: intervention 1: Subjects will be given peginterferon alfa-2b (PEG-IFN) subcutaneously, at a dose of 1.5 ug/kg weekly. Treatment duration will be 48 weeks for subjects with Hepatitis C Virus (HCV) genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline Hepatitis C Virus-ribonucleic acid (HCV-RNA) below 800,000 IU/mL. intervention 2: Subjects will be given ribavirin 800 mg/day orally(PO) when body weight is \<65 kg, 1000 mg/day when body weight is between 65 kg and 85 kg, and 1200 mg/day when body weight is \>85 kg. Treatment duration will be 48 weeks for subjects with HCV genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline HCV-RNA below 800,000 IU/mL.

Protocol documents:
Clinical trial NCT00690443
Conditions: Hypercholesterolemia
Keywords: Hyperlipidemia
Sponsor: Aegerion Pharmaceuticals, Inc.
Start date: 2008-05-01; Completion date: 2008-09-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the efficacy of combination therapy AEGR-733 plus atorvastatin 20 mg versus monotherapy on serum lipoproteins over 4 and 8 weeks of therapy. The primary efficacy parameter is percent change in LDL-C after 8 weeks of therapy.

Detailed description:
Following a 35-day washout of current lipid-lowering medication (if any) and adherence to a low-fat diet, subjects will receive either atorvastatin 20 mg for 8 weeks, OR AEGR-733 2.5 mg + atorvastatin 20 mg for 4 weeks followed by AEGR-733 5 mg + atorvastatin 20 mg for 4 additional weeks. During the entire study, subjects will be instructed to follow a low-fat/low cholesterol diet and limit alcohol consumption to -/\< 1 drink per day.

Arms: arm 1: 2.5 mg AEGR 733 plus atorvastatin 20 mg weeks 1-4 followed by 5 mg AEGR 733 plus atorvastatin 20 mg weeks 5-8 arm 2: Following 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks.
Interventions: intervention 1: Atorvastatin intervention 2: AEGR-733
Intervention descriptions: intervention 1: atorvastatin 20 mg tablets, daily dosing, for 8 weeks. intervention 2: 2.5 mg AEGR-733 capsules, daily dosing, 4 weeks followed by 5 mg AEGR-733 capsules, daily dosing, 4 weeks

Protocol documents:
Clinical trial NCT00690495
Conditions: Anesthesia
Keywords: Anesthesia Induction Pain
Sponsor: B. Braun Melsungen AG
Start date: 2008-05-01; Completion date: 2008-09-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether a modified propofol preparation shows any effect on the incidence of injection pain in adults undergoing elective surgery under general anesthesia.

Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.

Detailed description:
Pain on injection is a most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.

Arms: arm 1: Modified propofol (Propofol 0.5%) arm 2: Propofol 1%
Interventions: intervention 1: Propofol intervention 2: Propofol 1%
Intervention descriptions: intervention 1: Propofol (drug), intravenous, induction of anesthesia intervention 2: Propofol (drug), intravenous, induction of anesthesia

Protocol documents:
Clinical trial NCT00693693
Conditions: Atopic Dermatitis
Sponsor: Wake Forest University
Start date: 2006-11-01; Completion date: 2008-09-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to better understand adherence to Locoid when people use it to treat atopic dermatitis.

Detailed description:
An investigator-blinded prospective study of subjects with mild to moderate atopic dermatitis (\>5% Body Surface area and 2 or 3 on the Investigator Global Assessment (IGA) scale). The drug will be used within FDA-approved labeling. Subjects will be randomized to each of the following topical hydrocortisone 17-butyrate 0.1% preparations- ointment, cream or lipocream- in the manufacturer's original tube fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened and this data can be downloaded and tabulated with the associated software.

The study will consist of a 2-week Treatment Phase (visits at Baseline and Week 2). Subjects will be instructed to apply the medication twice daily (morning and evening) for 2 weeks to all of their AD lesions.

Adherence will be measured by MEMs cap.

Arms: arm 1: topical hydrocortisone 17-butyrate 0.1% Cream preparation applied twice daily to all lesions of atopic dermatitis arm 2: topical hydrocortisone 17-butyrate 0.1% Ointment preparation applied twice daily to all lesions of atopic dermatitis arm 3: topical hydrocortisone 17-butyrate 0.1% Lipocream preparation applied twice daily to all lesions of atopic dermatitis
Interventions: intervention 1: hydrocortisone 17-butyrate 0.1% Cream preparation intervention 2: hydrocortisone 17-butyrate 0.1% Ointment preparation intervention 3: hydrocortisone 17-butyrate 0.1% Lipocream preparation
Intervention descriptions: intervention 1: Apply medication twice a day to affected areas of atopic dermatitis intervention 2: Apply medication twice a day to affected areas of atopic dermatitis intervention 3: Apply medication twice a day to affected areas of atopic dermatitis

Protocol documents:
Clinical trial NCT00713349
Conditions: Wounds
Keywords: White Petrolatum Xenaderm Vehicle Partial thickness wounds Healing Cryo-surgery
Sponsor: Healthpoint
Start date: 2008-06-01; Completion date: 2008-09-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of the study is to compare the healing of wounds induced by cryo-injury when treated with white petrolatum versus an ointment vehicle.

Detailed description:

Arms: arm 1: Xenaderm Vehicle arm 2: Placebo Comparator
Interventions: intervention 1: Xenaderm Vehicle intervention 2: Placebo comparator
Intervention descriptions: intervention 1: Ointment to be applied three times a day on cryo-surgery wound for 21 days. intervention 2: Ointment to be applied three times a day on cryo-surgery wound for 21 days.

Protocol documents:
Clinical trial NCT00716443
Conditions: Nasolabial Folds
Keywords: Nasolabial folds wrinkles topical anesthetic
Sponsor: Galderma R&D
Start date: 2008-07-01; Completion date: 2008-09-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Pliaglis® Cream versus compounded topical anesthetic for pain management during Restylane® injections for the correction of nasolabial folds.

Detailed description:
Open-label, randomized study designed to assess the effectiveness of a topical anesthetic (Pliaglis® Cream) versus a compounded topical anesthetic at needle stick, immediately after, one and three hours after Restylane® injections in the nasolabial folds.

Arms: arm 1: tetracaine 4% / lidocaine 7% cream; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and a compounded topical anesthetic ointment was used on the other side of the face. Restylane® was injected into both sides of the face. arm 2: apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and a compounded topical anesthetic ointment was used on the other side of the face. Restylane® was injected into both sides of the face.
Interventions: intervention 1: tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream) intervention 2: benzocaine 20% / lidocaine 6% / tetracaine 4% ointment
Intervention descriptions: intervention 1: Apply tetracaine/lidocaine cream once on one side of the face prior to Restylane® injections intervention 2: apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections

Protocol documents:
Clinical trial NCT00746395
Conditions: Inflammatory Bowel Disease
Keywords: capsule endoscopy prokinetic lubiprostone Normal volunteers
Sponsor: University of South Alabama
Start date: 2008-04-01; Completion date: 2008-09-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This investigation is designed to compare lubiprostone and placebo for cleansing and propulsion in preparation for capsule endoscopy.

Detailed description:
Introduction of small bowel capsule endoscopy made available an unique technique for diagnostic evaluation of the gastrointestinal tract. After esophagogastroduodenoscopy and colonoscopy about 5% of bleeding cases remain unexplained and capsule endoscopy provides small bowel yield. Capsule endoscopy has special application for evaluation of inflammation bowel disease and other small bowel conditions. Several adjuncts are used to enhance the examination by improving cleansing preparation or propulsion. Metoclopramide, tegaserod, simethicone, erythromycin, phosphates and polyethylene glycol (PEG) colon cleansing agents have been tried and some show improved visualization or increased propulsion where more capsules reach to colonic cecum while still recording within the limits of its 8 hour battery. Recently, our group had an observational report of our experience showing that either full bowel cleansing preparation or prokinetics such as metoclopramide or tegaserod enhanced visualization and functioning capsule transit to the colon. Lubiprostone is a novel chloride channel activator that increases intestinal fluid secretion and motility. It is FDA approved and indicated for treatment of chronic idiopathic constipation.

This investigation is designed to compare lubiprostone and placebo for cleansing and propulsion in preparation for capsule endoscopy. The FDA approved 24 mcg constipation dose was chosen because other medications used in similar single dose in our pilot studies appear effective.

Arms: arm 1: lubiprostone 24mcg single dose po prior to capsule endoscopy arm 2: Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
Interventions: intervention 1: Lubiprostone intervention 2: Placebo
Intervention descriptions: intervention 1: 24 mcg oral administration intervention 2: Oral administration

Protocol documents: