ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01408303
Conditions: Hypertriglyceridemia Cardiovascular Disease
Keywords: dyslipidemia hyperlipidemia cardiovascular risk
Sponsor: AstraZeneca
Start date: 2011-08-01; Completion date: 2012-06-01
Enrollment: 646 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in subjects with persistent hypertriglyceridemia and high risk for cardiovascular disease.

Detailed description:
The primary efficacy variable is serum non-HDL cholesterol. The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups. Baseline is defined as the average of Visits 2, 3 and 4 (Weeks -2, -1 and 0) and end-of-treatment is the average of Visits 5 and 6 (Weeks 5 and 6).

Arms: arm 1: olive oil: 4 g/day + prescription statin arm 2: omega-3-carboxylic acids, 2g/day + prescription statin arm 3: omega-3-carboxylic acids, 4g/day + prescription statin
Interventions: intervention 1: Olive oil, 4g intervention 2: omega-3-carboxylic acids, 2g intervention 3: omega-3-carboxylic acids, 4g
Intervention descriptions: intervention 1: Olive oil: 4 x 1 g capsule daily for 6 weeks + prescription statin intervention 2: Epanova: 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks + prescription statin intervention 3: Epanova: 4 x 1 g capsule daily for 6 weeks + prescription statin

Protocol documents:
Clinical trial NCT01449266
Conditions: End-stage Renal Failure
Keywords: Dotarem Dialyses Dialysed Safety Safety and dialysability of Dotarem in dialysed patients
Sponsor: Guerbet
Start date: 2011-11-01; Completion date: 2012-06-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients with chronic renal failure who require hemodialysis treatment.

Detailed description:
Ten adult patients suffering from end stage renal failure and requiring hemodialysis treatment for 3 times were enrolled. Patients received a single dose of Dotarem® at 0.1 mmol/kg before being submitted to hemodialysis to assess the dialysability of Dotarem® . After injection of Dotarem®, 3 sessions of hemodialysis were performed as follows:

The first hemodialysis session started between 1 to 2 h after the injection; The second hemodialysis session occurred 2 days (i.e., 48 ± 2 h) after the Dotarem® injection; The third hemodialysis session occurred 4 days (i.e., 96 ± 4 h) after the Dotarem® injection.

The decrease in serum Dotarem® concentration was assessed after each hemodialysis session. Safety assessments included adverse events (AEs), vital signs, injection-site tolerance, and laboratory assessments.Two safety follow-up visits were performed: one 3 weeks (± 2 days) and one 3 months (± 4 days) after the Dotarem® injection.

Arms: arm 1: Male or female subjects, aged ≥18 years,suffering from end-stage renal failure and requiring hemodialysis treatment 3 times per week, were submitted to a single Dotarem® IV injection at 0.1 mmol/kg before being submitted to 3 hemodialysis sessions to assess the decrease of Dotarem® concentration in the blood.
Interventions: intervention 1: Dotarem® IV injection at 0.1 mmol/kg
Intervention descriptions: intervention 1: Dotarem® was IV administered at a dose of 0.1 mmoL/kg (0.2 mL/kg).

Protocol documents:
Clinical trial NCT01453023
Conditions: Asthma
Keywords: pediatric ages 5 to 11 years
Sponsor: GlaxoSmithKline
Start date: 2011-10-01; Completion date: 2012-06-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will investigate the safety and tolerability, pharmacokinetics, and pharmacodynamics of fluticasone furoate/vilanterol (FF/VI) 100/25mcg administered using the novel dry powder inhaler in children aged 5 to 11 years with persistent asthma.

Detailed description:
This study will investigate the safety and tolerability, pharmacokinetics, and pharmacodynamics of fluticasone furoate/vilanterol (FF/VI) 100/25mcg administered using the novel dry powder inhaler in children aged 5 to 11 years with persistent asthma. Fluticasone furoate (FF, GW685698) is a novel once daily inhaled corticosteroid (ICS) and vilanterol (VI, GW642444) is an inhaled once daily long-acting beta2 agonist (LABA). FF/VI is a novel ICS/LABA combination with once-daily dosing being developed for the treatment of asthma in adults, adolescents, and children of 5 years and above.

This study will be a randomized, double-blind, repeat dose, two period crossover study, with FF as the control. During each of two treatment periods subjects will receive either FF/VI 100/25 micrograms (mcg) or FF 100 mcg daily on 14 consecutive mornings via the novel dry powder inhaler. Approximately 26 subjects will be recruited into this study, with a target of 20 completed subjects. Safety, tolerability, pharmacokinetics and glucose , potassium and cortisol levels will be investigated.

Arms: arm 1: One of two study treatments subjects will receive. Given to allow comparison of FF exposure in combination versus as mono therapy. arm 2: One of two study treatments subjects will receive. FF/VI combined is being tested and compared to fluticasone furoate.
Interventions: intervention 1: Fluticasone Furoate intervention 2: Fluticasone Furoate/Vilanterol
Intervention descriptions: intervention 1: 100mcg delivered via a novel dry powder inhaler on days 1-14 of one study treatment period. intervention 2: 100/25 mcg delivered via a novel dry powder inhaler on days 1-14 of one study treatment period.

Protocol documents:
Clinical trial NCT01455012
Conditions: Restless Legs Syndrome
Keywords: Rotigotine Neupro RLS Cardiovascular Risk Nocturnal Blood Pressure
Sponsor: UCB BIOSCIENCES GmbH
Start date: 2011-09-01; Completion date: 2012-06-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Periodic Limb Movements (PLMs) during sleep in patients with Restless Legs Syndrome (RLS) have been shown to be associated with elevations in Blood Pressure (BP). Rotigotine has been shown to effectively reduce the incidence of PLMs in patients with RLS. The current study aims to demonstrate that treatment with Rotigotine could help reduce the number of nocturnal BP elevations associated with PLMs in patients with RLS.

Detailed description:

Arms: arm 1: Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h) arm 2: Placebo
Interventions: intervention 1: Rotigotine intervention 2: Placebo
Intervention descriptions: intervention 1: Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose. intervention 2: Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Protocol documents:
Clinical trial NCT01462370
Conditions: Dysmenorrhea
Sponsor: Organon and Co
Start date: 2011-11-01; Completion date: 2012-06-01
Enrollment: 139 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a study to determine the overall analgesic effect of a single oral dose of etoricoxib compared to ibuprofen in participants with moderate-to-severe primary dysmenorrhea.

Detailed description:
Participants who meet all the study entry criteria will be randomly allocated to 2 possible sequences of the 2 treatment regimens over the course of 2 menstrual cycles.

In treatment sequence 1, participants will receive etoricoxib 120 mg daily in menstrual cycle 1, and ibuprofen up to 2400 mg/daily in menstrual cycle 2. In treatment sequence 2, participants will receive ibuprofen up to 2400 mg/daily in menstrual cycle 1 and etoricoxib 120 mg daily in menstrual cycle 2.

Arms: arm 1: Participants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2. arm 2: Participants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2.
Interventions: intervention 1: Etoricoxib intervention 2: Ibuprofen intervention 3: Placebo to etoricoxib intervention 4: Placebo to ibuprofen intervention 5: Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg
Intervention descriptions: intervention 1: Etoricoxib 120 mg tablet given orally for one dose. intervention 2: Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day. intervention 3: Placebo to etoricoxib, one tablet. intervention 4: Placebo to ibuprofen, up to four 3-capsule doses. intervention 5: Provided to participants as rescue medication. Participants may take 2 tablets at a time and up to 3 doses within 24 hours for rescue purposes.

Protocol documents:
Clinical trial NCT01462812
Conditions: Migraine Headache
Keywords: Migraine Headache Sumatriptan
Sponsor: Optinose US Inc.
Start date: 2011-01-01; Completion date: 2012-06-01
Enrollment: 223 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through the nose) using the OPTINOSE SUMATRIPTAN Device can reduce the pain and symptoms associated with migraine headaches.

Detailed description:
The primary objective for this study is to compare headache relief (defined as a reduction from moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\] or mild \[Grade 1\] pain) at 120 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute treatment of a single migraine attack.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sumatriptan intervention 2: Placebo
Intervention descriptions: intervention 1: Sumatriptan 20mg intervention 2: Matching placebo

Protocol documents:
Clinical trial NCT01464424
Conditions: Glaucoma Ocular Hypertension Open-Angle Glaucoma
Keywords: Glaucoma Ocular Hypertension Open-Angle Glaucoma Intraocular Pressure
Sponsor: Alcon Research
Start date: 2011-10-01; Completion date: 2012-06-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study was to assess efficacy and tolerability of travoprost 0.004% vs. bimatoprost 0.01% during the after office hour period (4 pm to 8 pm) in subjects with open-angle glaucoma or ocular hypertension after 6 weeks of treatment.

Detailed description:

Arms: arm 1: Travoprost 0.004% ophthalmic solution (TRAVATAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by bimatoprost 0.01% ophthalmic solution (LUMIGAN), same dose, same duration, as randomized, for a total duration of 12 weeks arm 2: Bimatoprost 0.01% ophthalmic solution (LUMIGAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by travoprost 0.004% ophthalmic solution (TRAVATAN), same dose, same duration, as randomized, for a total duration of 12 weeks
Interventions: intervention 1: Travoprost 0.004% ophthalmic solution intervention 2: Bimatoprost 0.01% ophthalmic solution
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01471171
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD Antimuscarinic
Sponsor: AstraZeneca
Start date: 2011-11-01; Completion date: 2012-06-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation and dyspnoea at rest and during exercise after 3 weeks of treatment.

Detailed description:

Arms: arm 1: 3-week treatment periods arm 2: 3-week treatment periods
Interventions: intervention 1: Aclidinium Bromide intervention 2: Placebo
Intervention descriptions: intervention 1: 1 puff of 400 micro grams in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) intervention 2: 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h)

Protocol documents:
Clinical trial NCT01474018
Conditions: Diabetes Mellitus, Type 2
Sponsor: University of Texas Southwestern Medical Center
Start date: 2011-11-01; Completion date: 2012-06-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
QR-Bromocriptine as an add-on treatment to insulin and metformin in the management of type 2 diabetes will result in improved glycemic control, reduced exogenous insulin requirement, increased lean fat mass and improved pancreatic beta-cell function.

Detailed description:
To assess improvement in glycemic control, reliance on exogenous insulin, improvements in lean body mass composition, and improvements in pancreatic beta-cell function.

Arms: arm 1: 5 patients to continue on usual type 2 diabetic treatment consisting of 70/30 insulin, metformin and exercise and nutrition counseling. arm 2: study drug add-on the usual therapy
Interventions: intervention 1: QR-bromocriptine
Intervention descriptions: intervention 1: The study drug is added-on to patients on existing type 2 diabetes treatment with insulin +metformin+exercise/nutritional counseling. The study drug is titrated up starting at one 0.8mg tab daily for 1 week, then 2 (0.8mg) tablets for week 2, then 3 tablets for week 3, then 4 tablets for week 4, then 5 tablets for week 5, then six tablets for week 6 (total 4.8). The limiting factor is nausea at which point the patients will back down the highest tolerated dose and continue on that dose for the remainder of the 6 months of the study.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01486966
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2011-11-01; Completion date: 2012-06-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin detemir plus insulin aspart and NPH insulin plus human soluble insulin both in a basal bolus regimen with or without metformin in Chinese patients with type 2 diabetes.

The trial adopts a group sequential design, where the analysis of the primary efficacy endpoint will be performed at the interim analysis, in addition to the final formal analysis. The decision to continue or stop the trial will be based on the result of the interim analysis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin detemir intervention 2: insulin aspart intervention 3: insulin NPH intervention 4: human soluble insulin intervention 5: metformin
Intervention descriptions: intervention 1: Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4 intervention 2: Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4 intervention 3: Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4 intervention 4: Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4 intervention 5: For subjects previously treated with metformin, the dosage and frequency will be kept unchanged

Protocol documents:
Clinical trial NCT01494350
Conditions: Cutaneous Leishmaniasis
Keywords: cutaneous leishmaniasis topical treatment Tunisia
Sponsor: U.S. Army Medical Research and Development Command
Start date: 2011-12-01; Completion date: 2012-06-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The U.S. Army has recently completed a Phase 3 clinical trial in Tunisia. This is an open-label single site trial designed to expand our safety database and capture additional efficacy (final clinical cure rate of an index lesion) of WR 279,396 Topical Cream in Tunisian subjects with non-complicated, non-severe Cutaneous Leishmaniasis (CL). Subjects will be patients who visit Ministry of Health sponsored clinics in Tunisia who present with at least one CL lesion that is ulcerated and amenable to topical treatment. Potential trial subjects will be consented and screened for eligibility including medical history, physical exam, lesion parasitology, and renal and liver function tests. If eligible for the study, subjects will receive WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream) (target n = 110). The cream will be applied topically to all CL lesions once daily for 20 days by an investigator or study nurse. If a subject develops a new lesion during the study, the new lesion may also be treated with the topical cream.

Detailed description:
Subjects will have an in-clinic follow-up on Days 28 +/- 2 days, 42 +/- 4 days and 98 +/- 8 days to assess safety and cure rates. Safety variables including adverse events (AEs) and serious adverse events (SAEs) will be collected through Day 98. For the primary efficacy evaluation, the index ulcerative lesion will be assessed for clinical response by measurement of the length and width of area of ulceration. All other treated lesions will also be assessed for cure as secondary efficacy endpoints with ulcerated and non-ulcerated lesions being evaluated independently. An ulcerated lesion will be considered to be completely cured if 100% reepithelialization is observed. The length and width of non-ulcerated lesions (nodules, plaques) will also be measured and evaluated for cure (ie, absence of signs of an active lesion). The primary efficacy endpoint is the final clinical cure rate calculated by the number of index lesions that had 100% reepithelialization at Day 98 divided by the total number of index lesions that received at least one topical treatment of WR 279,396.

Arms: arm 1: 120 subjects will be enrolled to this open label study to receive WR 279,396 topical cream
Interventions: intervention 1: WR 279,396 topical cream
Intervention descriptions: intervention 1: WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.

Protocol documents:
Clinical trial NCT01515657
Conditions: Diabetes Mellitus, Type 2
Sponsor: PLx Pharma
Start date: 2012-01-01; Completion date: 2012-06-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as plain aspirin and enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as these other products, when administered to patients with diabetes.

Detailed description:

Arms: arm 1: Investigational drug arm; crossover design arm 2: Active comparator; crossover design arm 3: Active comparator; crossover design
Interventions: intervention 1: PL2200 Aspirin Capsules intervention 2: Immediate-Release Aspirin Tablets intervention 3: Enteric-coated aspirin caplets
Intervention descriptions: intervention 1: 325 mg aspirin; once per day for 3 days intervention 2: 325 mg aspirin; once per day for 3 days intervention 3: 325 mg aspirin; once per day for 3 days

Protocol documents:
Clinical trial NCT01537887
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2012-02-01; Completion date: 2012-06-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the effect on the electrical activity of the heart as measured by an electrocardiogram (ECG) after dosing with 10 days of LY2484595 compared to 10 days of placebo in relation to a single dose of moxifloxacin. Information about any side effects that occur will also be collected.

Detailed description:

Arms: arm 1: Administered orally once daily for 10 days during 1 of the 3 crossover periods, separated by at least a 14-day washout period. arm 2: Administered orally once daily for 10 days during 1 of the 3 crossover periods, separated by at least a 14-day washout period. arm 3: Positive control, unblinded treatment administered orally once during 1 of 3 crossover periods, separated by at least a 14-day washout period.
Interventions: intervention 1: LY2484595 intervention 2: Placebo intervention 3: Moxifloxacin
Intervention descriptions: intervention 1: Administered orally once daily for 10 days. intervention 2: Administered orally once daily for 10 days. intervention 3: Single dose administered orally.

Protocol documents:
Clinical trial NCT01540487
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-02-01; Completion date: 2012-06-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of linagliptin and metformin compared to the administration of two single tablets (linagliptin and metformin ) in Chinese subjects. The availability of a fixed dose combination tablet is expected to significantly enhance patients' compliance with antidiabetic treatment., in particular with concern to the frequent polypharmacy in diabetic patients.

Detailed description:

Arms: arm 1: 24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of linagliptin /metformin (high dose) and single linagliptin and metformin (high dose) tablets single dose in randomized order arm 2: 24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of linagliptin /metformin (low dose) and single linagliptin and metformin (low dose) tablets single dose in randomized order
Interventions: intervention 1: linagliptin/metformin(high dose) intervention 2: Linagliptin/metformin(low dose)
Intervention descriptions: intervention 1: patient would take fixed dose combination tablets of linagliptin /metformin (high dose) and single linagliptin and metformin (High dose) tablets single dose in random order, and each dosage will be separated in 42 days interval. intervention 2: patient would take fixed dose combination tablets of linagliptin /metformin (low dose) and single linagliptin and metformin (Low dose) tablets single dose in random order, and each dosage will be separated in 42 days interval.

Protocol documents: