ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00855595
Conditions: Papulopustular Rosacea
Keywords: Rosacea
Sponsor: LEO Pharma
Start date: 2009-02-01; Completion date: 2009-07-01
Enrollment: 207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus an anti-inflammatory dose of doxycyline (40mg) daily or with metronidazole 1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at total of twelve weeks to determine the rapidity of improvement, and the length of time to reach 25%, 50% and 75% clearing compared to baseline.

Detailed description:
The change in inflammatory lesion count will be assessed at each post-baseline visit by an analysis of variance model (ANOVA) with factors treatment and center, but not including treatment-by-center interaction.

Investigator's Global Assessment (IGA) of papulopustular rosacea (static score): 0 - Clear (Virtually no rosacea ie, no papules and/or pustules; no or residual erythema; no or mild to moderate degree of telangiectasia may be present); 1 - Minimal (Rare papules and/or pustules; residual to mild erythema; mild to moderate degree of telangiectasia may be present); 2 - Mild (Few papules and/or pustules; mild erythema; mild to moderate degree of telangiectasia may be present); 3 - Mild to moderate (Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate degree of telangiectasia may be present); 4 - Moderate (Pronounced number of papules and/or pustules; moderate erythema; mild to moderate degree of telangiectasia may be present); 5 - Moderate to severe (Many papules and/or pustules, occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia may be present); 6 - Severe (Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe degree of telangiectasia may be present).

Arms: arm 1: Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks arm 2: Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
Interventions: intervention 1: Azelaic acid (Finacea, BAY39-6251) intervention 2: Metronidazole (Metrogel) intervention 3: Doxycycline (Oracea)
Intervention descriptions: intervention 1: Participants received topical azelaic acid gel 15% twice daily for 12 weeks intervention 2: Participants received topical metronidazole 1% gel once daily for 12 weeks intervention 3: Participants received systemic doxycycline 40 mg once daily for 12 week

Protocol documents:
Clinical trial NCT00863928
Conditions: Pain
Sponsor: Benaroya Research Institute
Start date: 2008-10-01; Completion date: 2009-07-01
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is evaluating the effect of a Belladonna and Opium suppository administered intraoperatively on post operative pain after laparoscopic radical prostatectomy for prostate cancer. This is a blinded randomized study. 50% of patients will receive the suppository, 50% of patients will not. Neither you or your surgeon will know which group you are in.

Detailed description:
All patients undergoing LRP at Virginia Mason Medical Center between November 1, 2008 and July 30, 2009 were offered the opportunity to participate in a randomized double blind clinical trial. Operating surgeons were blinded to suppository placement which was administered after induction of anesthesia. All patients underwent a standardized anesthesia regimen. Post-operative pain was assessed by a visual analog scale (VAS) and post-operative narcotic use was calculated in intravenous morphine equivalents.

Arms: arm 1: No suppository given arm 2: B \& O suppository, belladonna 16.2 mg and opium 60 mg suppository (Paddock Laboratories, Minneapolis, MN)
Interventions: intervention 1: belladonna 16.2 mg and opium 60 mg suppository
Intervention descriptions: intervention 1: belladonna 16.2 mg and opium 60 mg suppository

Protocol documents:
Clinical trial NCT00864513
Conditions: Pancreas Cancer
Keywords: pancreas metastatic recurrent
Sponsor: Georgetown University
Start date: 2007-10-01; Completion date: 2009-07-01
Enrollment: 17 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is for patients with pancreatic cancer that has grown and/or spread after having previously received the standard chemotherapy drug called gemcitabine.

In this study a drug called pemetrexed is being tested. This drug is approved by the FDA for use in lung cancer and mesothelioma. The purpose of this study is to see if pemetrexed keeps pancreas cancer that has grown and/or spread after gemcitabine from growing. Subjects will receive pemetrexed IV once every 21 days until disease progression or unacceptable side effects occur.

Detailed description:
This is an open label Phase II trial using pemetrexed as second-line treatment in patients with advanced pancreatic cancer progressing within six months of prior gemcitabine-based therapy. Subjects will receive pemetrexed 500 mg/m2 IV every 21 days until disease progression or unacceptable toxicity.

Arms: arm 1: pemetrexed
Interventions: intervention 1: pemetrexed
Intervention descriptions: intervention 1: pemetrexed 500 mg/m2 IV day 1 of each 21 day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles

Protocol documents:
Clinical trial NCT00868231
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD Antimuscarinic
Sponsor: AstraZeneca
Start date: 2009-03-01; Completion date: 2009-07-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The main purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients.

Detailed description:

Arms: arm 1: Aclidinium bromide 400 μg twice-daily by inhalation arm 2: Tiotropium 18 μg once-daily by inhalation arm 3: Placebo
Interventions: intervention 1: Aclidinium bromide 400 μg bid intervention 2: Tiotropium 18 μg once-daily intervention 3: Placebo
Intervention descriptions: intervention 1: Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 15 days. intervention 2: Tiotropium 18 μg once-daily via inhalation by Handihaler® dry powder inhaler: 1 puff in the morning for 15 days. intervention 3: Inhaled placebo: 1 puff in the morning (placebo to tiotropium) or in the morning and evening (placebo to aclidnium) for 15 days.

Protocol documents:
Clinical trial NCT00872534
Conditions: Upper Gastrointestinal Mucosal Damage
Keywords: To evaluate the acute gastrointestinal safety of PL-2100.
Sponsor: PLx Pharma
Start date: 2009-01-01; Completion date: 2009-07-01
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the gastrointestinal safety of PL-2200 versus immediate-release aspirin by assessing endoscopic gastroduodenal mucosal injury at approved daily cardiac-protective doses of aspirin (325 mg) in normal healthy volunteers.

Detailed description:

Arms: arm 1: PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix. arm 2: Immediate release 325mg aspirin
Interventions: intervention 1: acetylsalicylic acid
Intervention descriptions: intervention 1: 325mg once a day for 7 days

Protocol documents:
Clinical trial NCT00875277
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2009-04-01; Completion date: 2009-07-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its combination with calcipotriol and betamethasone using a psoriasis plaque test method.

Detailed description:

Arms: arm 1: LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks arm 2: LEO 29102 cream vehicle applied topically twice daily for 4 weeks. arm 3: Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks. arm 4: LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks. arm 5: LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks. arm 6: Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
Interventions: intervention 1: LEO 29102 cream intervention 2: LEO 29102 Cream Vehicle intervention 3: Betamethasone Dipropionate Cream intervention 4: LEO 29102 Plus Calcipotriol Cream intervention 5: LEO 29102 Plus Betamethasone Dipropionate intervention 6: Daivobet® Ointment
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT00878501
Conditions: Pain
Keywords: Phase II Pain
Sponsor: AstraZeneca
Start date: 2009-03-01; Completion date: 2009-07-01
Enrollment: 241 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with osteoarthritis of the knee and at what dose. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: AZD1386 intervention 2: AZD1386 intervention 3: Placebo
Intervention descriptions: intervention 1: oral, during 4 weeks intervention 2: oral, during 4 weeks intervention 3: Oral, during 4 weeks

Protocol documents:
Clinical trial NCT00883168
Conditions: Seasonal Allergic Rhinitis
Sponsor: Meda Pharmaceuticals
Start date: 2009-04-01; Completion date: 2009-07-01
Enrollment: 1791 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the combination of two allergy medications (formulated azelastine/fluticasone product)is more effective than placebo or either component medication alone (azelastine or fluticasone).

Detailed description:
This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, single-blind, placebo lead-in period (Day -7 to Day 1). Subjects will be instructed to take placebo lead-in medication twice daily (1 spray per nostril), approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity requirements and continue to meet all of the study inclusion/exclusion criteria will be randomized in a 1:1:1:1 ratio to receive 1 spray per nostril twice daily of MP29-02, azelastine hydrochloride, fluticasone propionate, or placebo nasal spray.

Efficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS). On Days 1 through 14, subjects will rate the instantaneous and reflective TNSS symptoms of sneezing, nasal congestion, runny nose, and nasal itching; the instantaneous and reflective total ocular symptom score (TOSS) symptoms of itchy eyes, watery eyes and eye redness; the symptom of postnasal drip will be reflectively, twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. Additional secondary efficacy variables will include reflective individual nasal and ocular symptom scores, as well as change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).

Subjects ≥ 18 years of age will complete the RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject-reported adverse events (AEs), nasal examinations, and vital signs assessments

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo intervention 2: azelastineHcl intervention 3: fluticasone propionate intervention 4: azelastine Hcl/fluticasone propionate
Intervention descriptions: intervention 1: Placebo intervention 2: azelastine hydrochloride 548 mg intervention 3: fluticasone propionate 200 mcg intervention 4: azelastine hydrochloride 548 mcg/fluticasone propionate 200 mcg

Protocol documents:
Clinical trial NCT00893971
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Sponsor: Pearl Therapeutics, Inc.
Start date: 2009-05-01; Completion date: 2009-07-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the safety of a single dose of PT003 compared with single doses of PT001 and PT005, and compared with PT001 plus PT005 delivered together as two separate single doses in healthy subjects.

Detailed description:

Arms: arm 1: Inhaled PT001 18 μg arm 2: Inhaled PT005 2.4 μg arm 3: Inhaled PT003 (PT001 18 μg / 2.4 μg PT005) arm 4: PT001 18 μg + PT005 2.4 μg
Interventions: intervention 1: PT001 intervention 2: PT005 intervention 3: PT003 intervention 4: PT001 + PT005
Intervention descriptions: intervention 1: Inhaled PT001, single dose intervention 2: Inhaled PT005, single dose intervention 3: Inhaled PT003, single dose intervention 4: Inhaled PT001 + PT005, single dose

Protocol documents:
Clinical trial NCT00907101
Conditions: P Acnes Colonization
Sponsor: Galderma R&D
Start date: 2009-06-01; Completion date: 2009-07-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness of Epiduo® Gel in reducing antibiotic sensitive and resistant strains of P acnes in vivo.

Detailed description:

Arms: arm 1: Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)

Other Names:

Epiduo® Gel Apply once daily
Interventions: intervention 1: Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)
Intervention descriptions: intervention 1: Apply once daily

Protocol documents:
Clinical trial NCT00926367
Conditions: Acne Vulgaris
Keywords: Acne
Sponsor: Stiefel, a GSK Company
Start date: 2009-05-01; Completion date: 2009-07-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a single-blind (blinded expert grader), randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene gel and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product

Detailed description:
This is a single-blind (blinded expert grader), parallel group, randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, a topical antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product.

The subjects will be entered into a 2-week treatment phase. The once-daily applications for the study medication will be supervised at the site, Monday through Friday of each week. Subjects will apply the study product at home on Saturdays and Sundays.

A blinded expert grader will rate comparative product tolerance on each week day (excluding Saturdays and Sundays) during the study before study product is applied.

Subject questionnaires will be completed along with collection of all adverse events.

Arms: arm 1: Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide (BPO). arm 2: Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide (BPO) and adapalene
Interventions: intervention 1: Clindamycin and benzoyl peroxide intervention 2: benzoyl peroxide 2.5% and adapalene 0.1% gel
Intervention descriptions: intervention 1: Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide gel. This contains a topical antibiotic and benzoyl peroxide gel. intervention 2: Once-daily applications, to the randomized side of the face either left or right,benzoyl peroxide and adapalene gel

Protocol documents:
Clinical trial NCT00953043
Conditions: Healthy
Keywords: lubiprostone colon motility sensation
Sponsor: Mayo Clinic
Start date: 2007-09-01; Completion date: 2009-07-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to evaluate the effects of lubiprostone, a drug approved and used for constipation, on pattern of contractions of the colon and the colon's sensitivity to distension.

Detailed description:
This was a trial of healthy adults to compare the effects of oral lubiprostone, 24 microgram per day and placebo for three days, on sensation and contractions of the colon using validated methods.

On days 1 and 2, participants took the study medication with their breakfast and recorded the time. On day 2 starting at 4:00 pm, participants started a polyethylene glycol-based bowel preparation to cleanse the colon. After overnight bowl preparation, participants reported fasting to the study center at 7:00 am on day 3. Colonic sensorimotor functions were assessed by an endoscopically placed barostat-manometric assembly.

After 30 minutes of rest following tube placement, fasting colonic tone, colonic compliance and colonic sensation were tested. The last dose of medication was ingested and 1 hour later the same colonic functions, as well as colonic response to a standardized meal of a 1,000-kilocalorie chocolate milkshake were assessed. The participant was able to leave the study center in the afternoon, after a meal had been ingested (if desired).

Details on colonic tube placement: A flexible sigmoidoscopy was performed to evaluate the left side of the colon and to place a Teflon-coated guide wire beyond the splenic flexure. The colon was deflated as the sigmoidoscope was removed and a barostat catheter (constructed at Mayo Clinic, Rochester, MN) with six manometric point sensors and a polyethylene balloon was introduced into the colon over the guide wire. The barostat catheter was positioned in the mid-descending or upper sigmoid colon with the aid of fluoroscopy. The final position of the barostatically controlled balloon was confirmed by fluoroscopy. After the colonic tube placement, participants rested for 30 min. The catheter was connected to a rigid piston barostat machine. After transient inflation of the barostat bag to a volume of 75 ml to ensure it was unfolded, it was deflated. Thereafter, it was inflated in 2 mm Hg increments to baseline operating pressure, which was defined as 2 mm Hg above the minimal distension pressure at which respiratory excursions were clearly recorded by the barostat tracing.

Arms: arm 1: Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days. arm 2: Subjects randomized to this arm received placebo medication for three days.
Interventions: intervention 1: lubiprostone intervention 2: Placebo intervention 3: Bowel preparation
Intervention descriptions: intervention 1: Lubiprostone 24 micrograms, one dose daily for three days in 30 subjects intervention 2: Placebo medication given for three days intervention 3: Polyethylene glycol-based bowel preparation

Protocol documents:
Clinical trial NCT01046682
Conditions: HIV Endothelial Dysfunction Inflammation Insulin Resistance
Keywords: HIV Endothelial dysfunction Inflammation Insulin resistance
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2009-01-01; Completion date: 2009-07-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase II, open label, randomized-controlled pilot study designed to study both the efficacy and safety of salsalate in decreasing endothelial cell dysfunction, systemic inflammation, and insulin resistance in HIV-infected adults. The investigators hypothesis is that salsalate will reduce inflammation and therefore endothelial cell activation and insulin resistance. The sample size will be 40, with an equal number of people being randomized to one of two groups. The first arm will be randomized to salsalate therapy. The second arm will act as a control group. The study duration will be 13 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Salsalate
Intervention descriptions: intervention 1: Salsalate 2 grams orally twice a day for 13 weeks. This is the maximum dosage. During the initial 9 days of the study salsalate dose will be titrated to reach this goal dosage.

Protocol documents:
Clinical trial NCT01069627
Conditions: Malignant Melanoma
Sponsor: Hoffmann-La Roche
Start date: 2006-12-01; Completion date: 2009-07-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg intravenously\[IV\]) on Day 1 of every 3 week cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: fotemustine
Intervention descriptions: intervention 1: 15 mg/kg intravenously on day 1 of every 3 week cycle intervention 2: 100 mg/m² intravenously on Days 1, 8, and 15, followed by 4 weeks of rest, then every 21 days up to 4 to 6 cycles

Protocol documents:
Clinical trial NCT01127165
Conditions: Epilepsy
Sponsor: Eisai Korea Inc.
Start date: 2006-03-01; Completion date: 2009-07-01
Enrollment: 125 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in children with epilepsy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: zonisamide low dose group intervention 2: zonisamide high dose group
Intervention descriptions: intervention 1: Initial dose was 2mg/kg/day, increased after 1\~2 weeks to 3\~4mg/kg/day. intervention 2: Initial dose was 2mg/kg/day, increased after 2\~4 weeks to 6\~8mg/kg/day.

Protocol documents: