ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01159769
Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis
Sponsor: Alcon Research
Start date: 2010-06-01; Completion date: 2010-08-01
Enrollment: 215 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate patient perceptions of olopatadine 0.2% dosed once daily in patients previously treated with twice-daily, topical, ocular, anti-allergy medications.

Detailed description:

Arms: arm 1: 1 drop self-administered in each eye once daily in the morning for 7 days
Interventions: intervention 1: Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)
Intervention descriptions: intervention 1: Commercially marketed ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis

Protocol documents:
Clinical trial NCT01171794
Conditions: Altitude Sickness
Sponsor: Stanford University
Start date: 2010-07-01; Completion date: 2010-08-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a research study on Altitude Illness. From the information collected and studied in this project we hope to learn more about Altitude Illness, including factors that may affect and prevent the development and progression of this condition. We hope to learn if the commonly used non-steroidal anti-inflammatory medication, ibuprofen can prevent altitude illness. Possible participants in this study are healthy adults who indicated they would like to participate, learn about altitude illness, and desire to hike Barcroft Peak. Stanford University researchers hope to enroll about 100 participants.

Detailed description:
This study was designed to bring together elements of prior studies and go one step further for definitive data on several points. The trial will employ two pharmaceutical intervention arms, which will compare placebo (the standard of care - information on prevention of altitude sickness) with the widely used NSAID ibuprofen. We will also determine Optic Nerve Sheath Diameter (ONSD) measurements via ultrasound in both the control and interventional arms. We will accomplish these objectives with a prospective, double blinded view of a large population of hikers who are ascending at their own rate in a true hiking environment: The White Mountain Research Station Owen Valley Lab (OVL) and Bancroft Station (BAR).

Primary hypothesis: Ibuprofen 600 mg TID will be superior to placebo in decreasing both the incidence and severity of AMS in high altitude travel.

Arms: arm 1: 600mg ibu TID arm 2: visually identical
Interventions: intervention 1: Ibuprofen intervention 2: Placebo
Intervention descriptions: intervention 1: 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total) intervention 2: identical number of visually identical tasteless pills as ibuprofen arm

Protocol documents:
Clinical trial NCT01176955
Conditions: Acne Vulgaris
Keywords: Acne Acne vulgaris Adherence Compliance MEMS Benzoyl peroxide
Sponsor: Wake Forest University
Start date: 2009-05-01; Completion date: 2010-08-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an investigator-blinded, prospective study of 20 subjects aged 13 through 18 with mild to moderate acne. Study subjects will be randomized to an internet survey group, in which an email link for a survey ascertaining the status of the subject's acne is sent weekly, or to a control group. All study subjects will use benzoyl peroxide 5% gel, and adherence and clinical improvement will be monitored over 12 weeks. The investigators hypothesis is that subjects in the internet survey group will have improved adherence to the study medication and clinical outcomes, because the weekly survey will remind subjects to use their medication.

Detailed description:

Arms: arm 1: Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication. arm 2: Subjects will receive standard-of-care treatment with the study medication, without internet surveys.
Interventions: intervention 1: Internet survey intervention 2: Benzoyl peroxide 5% gel
Intervention descriptions: intervention 1: A weekly email link will be generated to an internet survey which questions subjects about their acne severity, compliance with the study medication, and attitudes toward acne and the study medication. intervention 2: Topical benzoyl peroxide 5% gel, to be used once daily to the face.

Protocol documents:
Clinical trial NCT01188538
Conditions: Acne Vulgaris
Keywords: P. acnes, Acne vulgaris
Sponsor: Galderma R&D
Start date: 2010-03-01; Completion date: 2010-08-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the antibacterial activity of Epiduo® Gel (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) on P. acnes compared to that of Benzoyl Peroxide 2.5% Gel.

Detailed description:

Arms: arm 1: * Dose or Concentration:Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel.
* Mode and Frequency of Administration:Topical to the face, once daily application in the evening.
* Duration of Treatment:12 weeks arm 2: * Dose or Concentration:Adapalene 0% / Benzoyl Peroxide 2.5% Gel.
* Mode and Frequency of Administration:Topical to the face, once daily application in the evening.
* Duration of Treatment:12 weeks
Interventions: intervention 1: Epiduo gel intervention 2: BPO
Intervention descriptions: intervention 1: Once daily application on the face in the evening for 12 weeks intervention 2: Once daily application on the face in the evening for 12 weeks

Protocol documents:
Clinical trial NCT01222299
Conditions: Seasonal Allergic Rhinitis
Sponsor: Bausch & Lomb Incorporated
Start date: 2010-05-01; Completion date: 2010-08-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.

Detailed description:

Arms: arm 1: bepotastine besilate nasal product - low dose arm 2: bepotastine besilate nasal product - medium dose arm 3: bepotastine besilate nasal product - high dose arm 4: placebo comparator nasal product
Interventions: intervention 1: bepotastine besilate nasal product - low dose intervention 2: bepotastine besilate nasal product - medium dose intervention 3: bepotastine besilate nasal product - high dose intervention 4: placebo comparator nasal product
Intervention descriptions: intervention 1: sterile nasal product intervention 2: sterile nasal product intervention 3: sterile nasal product intervention 4: sterile nasal product

Protocol documents:
Clinical trial NCT01227707
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2005-11-01; Completion date: 2010-08-01
Enrollment: 43 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This open-label study will assess the efficacy and safety of Avastin (bevacizumab) plus Xeloda (capecitabine) in combination with standard technique radiotherapy of the pelvic region in the neo-adjuvant setting in patients with locally advanced primary rectal cancer. Patients will receive 4 courses of Avastin at a dose of 5 mg/kg intravenously (iv) every 2 weeks and for 38 days Xeloda at dose of 825 mg/kg twice daily orally, plus radiation therapy. After surgery, adjuvant treatment with 5-fluorouracil/leucovorin and, at the discretion of the investigator, with Avastin 5 mg/kg iv every 2 weeks for at least 6 months will be given.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: capecitabine [Xeloda] intervention 3: Radiation therapy intervention 4: Mesorectal excision intervention 5: bevacizumab [Avastin] intervention 6: 5-fluorouracil intervention 7: leucovorin
Intervention descriptions: intervention 1: 5 mg/kg intravenously every 2 weeks, 4 cycles intervention 2: 825 mg/m2 twice daily orally, 38 days intervention 3: Total dose of 45 Gy over 38 days intervention 4: 6-8 weeks after completion of neoadjuvant treatment intervention 5: Post-surgery adjuvant treatment at the discretion of the investigator: 5 mg/kg iv every 2 weeks for at least 6 months intervention 6: Post-surgery adjuvant therapy: bolus of 400mg/m2 iv plus iv infusion of 600 mg/m2 on Days 1 and 2 of each 2-week cycle for 6 months intervention 7: Post-surgery adjuvant treatment: 100 mg/m2 iv on Days 1 and 2 of each 2-week cycle for 6 months

Protocol documents:
Clinical trial NCT01231230
Conditions: Asthma
Keywords: asthma, corticosteroids, bronchodilator, airway blood flow
Sponsor: University of Miami
Start date: 2007-05-01; Completion date: 2010-08-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The addition of an inhaled long-acting beta-adrenergic agonist to an inhaled glucocorticosteroid improves disease control in persistent asthma. This observation has supported the use of long-acting beta-adrenergic agonist/glucocorticosteroid combination preparations for the management of asthma. Currently, salmeterol/fluticasone and formoterol/budesonide are available for clinical use. The long-term beneficial clinical effects of the two drug classes seem to be synergistic, and several mechanisms of glucocorticoid-beta-adrenergic agonist interactions involving gene transcription have been invoked to explain this phenomenon.This study, wish to address the question whether glucocorticoids can acutely potentiate the bronchodilator response to a long-acting beta-adrenergic agonist.We expect that in patients with asthma, the short-term bronchodilator effect of salmeterol is enhanced by the addition of fluticasone, which by itself has no short-term bronchodilator effect. To test this premise, we will assess the respective short-term effects of salmeterol (50 µg), fluticasone (250 µg), salmeterol/fluticasone (50/250 µg), and placebo/placebo on spirometric parameters. Airway Blood flow will also be measured to ensure that vasoconstriction does not occur.

Detailed description:
Fourteen lifetime nonsmokers with a physician diagnosis of asthma will be recruited for the study. All subjects will be allowed to use short-acting beta-adrenergic agonists as rescue medication.

Inclusion criteria:

1. Males and females, 18 to 65 years of age.
2. FEV1 60-85% of predicted on the screening day.

Exclusion criteria:

1. Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women.
2. Cardiovascular disease and/or use of cardiovascular medications

2\. Subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance 4. Acute respiratory infection within four weeks prior to the study 5. Use, within two weeks prior to the study, of any anti-asthma medication not mentioned above

Arms: arm 1: participants were treated fluticasone/salmeterol, arm 2: participants were treated with salmeterol arm 3: participants were treated with fluticasone arm 4: participants were treated with placebo
Interventions: intervention 1: fluticasone intervention 2: placebo inhalation intervention 3: Salmeterol intervention 4: fluticasone/salmeterol
Intervention descriptions: intervention 1: 220- mcg once intervention 2: placebo inhalation once intervention 3: 50 mcg salmeterol once intervention 4: inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol

Protocol documents:
Clinical trial NCT01468558
Conditions: Healthy
Keywords: Drug Drug Interaction Study in Normal Healthy Volunteers
Sponsor: Allergan
Start date: 2010-07-01; Completion date: 2010-08-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Compare the DHE pharmacokinetic profiles observed following administration of:

1. MAP0004 (oral inhalation DHE)
2. MAP0004 co-administered with oral Ketoconazole
3. Intravenous (IV) DHE (D.H.E.45®, the approved reference therapy)

Compare the tolerability of MAP0004, IV DHE, and MAP0004 with co-administration of Ketoconazole.

Detailed description:

Arms: arm 1: Subjects received MAP0004 on Day 1 of Visit 2, Ketoconazole on Days 3 through 6 of Visit 2, and MAP0004 again on Day 6 of Visit 2. Subjects then returned for Visit 3, 7-11 days from the end of Visit 2. At Visit 3 subjects received 1.0 mg IV DHE (Intravenous Dihydroergotamine Mesylate).
Interventions: intervention 1: MAP0004 intervention 2: IV DHE intervention 3: Ketoconazole
Intervention descriptions: intervention 1: MAP0004 1.0mg via inhalation on Day 1 and Day 6 of Visit 2 intervention 2: IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3 intervention 3: Ketoconazole 400 mg administered once a day on days 3-6 of Visit 2

Protocol documents:
Clinical trial NCT01532141
Conditions: Parkinson Disease
Keywords: Parkinson Disease BIA 9-1067
Sponsor: Bial - Portela C S.A.
Start date: 2009-11-01; Completion date: 2010-08-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate the effect of rasagiline on BIA 9-1067 pharmacokinetics in healthy subjects.

Detailed description:
Single-centre, open-label, randomised, three-way crossover study consisting of 3 single-dose periods separated by a washout of 14 days or more

Arms: arm 1: Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg arm 2: Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg arm 3: Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone
Interventions: intervention 1: BIA 9-1067 intervention 2: Rasagiline
Intervention descriptions: intervention 1: 50 mg BIA 9-1067 (single-dose) intervention 2: 1 mg rasagiline (single-dose)

Protocol documents:
Clinical trial NCT03214406
Conditions: Plaque Gingivitis
Sponsor: Church & Dwight Company, Inc.
Start date: 2010-02-08; Completion date: 2010-08-03
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Parallel, double blind, randomized, Institutional Review Board (IRB) -approved study involving approximately 160 subjects to complete. Subjects were randomly assigned to either the test product (Arm \& Hammer Advance White Brilliant Sparkle) or the control (Crest Cavity Protection Regular) based on baseline mean whole-mouth plaque and gingival scores and age.Subjects brushed with their assigned dentifrice two times (2X) daily and were evaluated for gingivitis, bleeding and plaque at Baseline and after 4-, 8-, and 12-weeks of product use. Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks.

Detailed description:

Arms: arm 1: 2X daily brushing for 12 weeks with Arm \& Hammer Advance White Brilliant Sparkle (Test product). Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks. arm 2: 2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control). Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks.
Interventions: intervention 1: Arm & Hammer Advance White Brilliant Sparkle (Test product) intervention 2: Crest Cavity Protection Regular Toothpaste (Negative Control)
Intervention descriptions: intervention 1: 20% sodium bicarbonate intervention 2: Negative control

Protocol documents:
Clinical trial NCT00886782
Conditions: Advanced Solid Cancers Metastatic Cancer
Keywords: Advanced and/or Metastatic solid cancers
Sponsor: Bristol-Myers Squibb
Start date: 2009-05-31; Completion date: 2010-08-04
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine safety, tolerability and maximum tolerated dose of BMS-863233 in subjects advanced and/or Metastatic solid tumors.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Cdc7-inhibitor
Intervention descriptions: intervention 1: Capsules, Oral, QD x 14 days until MTD is reached, 14d per 28 day cycle/QD 12 months

Protocol documents:
Clinical trial NCT00905424
Conditions: Major Depressive Disorder
Sponsor: Shire
Start date: 2009-07-30; Completion date: 2010-08-04
Enrollment: 246 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of SPD489 when used as augmentation to an antidepressant in the treatment of major depressive disorder (MDD) as measured by mean change in total Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores.

Detailed description:

Arms: arm 1: Antidepressant + SPD489 arm 2: Antidepressant + placebo
Interventions: intervention 1: Antidepressant + SPD489 (lisdexamfetamine dimesylate) intervention 2: Antidepressant + placebo
Intervention descriptions: intervention 1: Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks intervention 2: Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks

Protocol documents:
Clinical trial NCT00927810
Conditions: Gouty Arthritis
Keywords: Gouty Gouty arthritis Gout flares Anti-interleukin-1β monoclonal antibody
Sponsor: Novartis Pharmaceuticals
Start date: 2009-06-05; Completion date: 2010-08-04
Enrollment: 341 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This 24-week open-label extension study is designed to provide additional long-term safety data up to a total of 1-year for patients rolling over from the core study, and to collect further efficacy and tolerability data for all the patients, irrespective whether they have an acute flare of gout or not. Patients will be treated on demand with canakinumab (ACZ885) in this extension study.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Canakinumab
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00289900
Conditions: Mixed Hyperlipidemia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-01-24; Completion date: 2010-08-06
Enrollment: 2340 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 12-week clinical trial in participants with mixed hyperlipidemia to study the effects of MK-0524B on lipids.The primary hypothesis is that MK-0524B (dosed as MK-0524A coadministered with simvastatin) will be superior to atorvastatin on decreasing the low denisity lipoprotein cholesterol (LDL-C)/high-density lipoprotein cholesterol (HDL-C) ratio for the following dose comparisons: 2g/20 mg MK-0524B versus 10 mg atorvastatin, 2g/40 mg MK-0524B versus 20 mg atorvastatin, 2g/40 mg MK-0524B versus 40 mg atorvastatin, and 2g/40 mg MK-0524B versus 80 mg atorvastatin.

Detailed description:

Arms: arm 1: Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks arm 2: Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks arm 3: Atorvastatin 10 mg, orally, once daily for 12 weeks arm 4: Atorvastatin 20 mg, orally, once daily for 12 weeks arm 5: Atorvastatin 40 mg, orally, once daily for 12 weeks arm 6: Atorvastatin 80 mg, orally, once daily for 12 weeks
Interventions: intervention 1: MK-0524A intervention 2: Atorvastatin intervention 3: Simvastatin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00495079
Conditions: Acute Lymphoblastic Leukemia (ALL)
Keywords: acute lymphoblastic lymphocytic leukemia leukaemia lukemia leukimia ALL Marqibo Hana Biosciences vincristine liposomal liposome optisome hematology malignancy hematological relapsed anti-leukemia adult chemotherapy
Sponsor: Spectrum Pharmaceuticals, Inc
Start date: 2007-05-01; Completion date: 2010-08-08
Enrollment: 65 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a Phase 2, international, multicenter, open-label, single-arm trial evaluating Marqibo (VSLI) in adult subjects with: 1) Ph- ALL or lymphoblastic lymphoma in second or greater relapse; or 2) Ph- ALL or lymphoblastic lymphoma who failed 2 or greater treatment lines of anti-leukemia chemotherapy. The original enrollment target for this study was approximately 56 subjects. Per a protocol amendment, enrollment was increased from 56 to 65.

The primary objective of this study was to evaluate:

\- The efficacy of the study treatment as determined by the rate of CR plus CR with incomplete blood count recovery (CRi) in adult subjects with Philadelphia chromosome-negative (Ph-) ALL in second relapse or adult subjects with (Ph-) ALL who failed 2 treatment lines of anti-leukemia chemotherapy. Subjects must have achieved a CR to at least 1 prior anti-leukemia therapy as defined by a leukemia-free interval of ≥ 90 days.

Detailed description:
The secondary objectives of this study were to evaluate:

* Duration of CR plus CRi
* Overall survival
* Safety and tolerability

Arms: arm 1: Eligible subjects received study drug at 2.25 mg/m\^2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
Interventions: intervention 1: Marqibo® (vincristine sulfate liposomes injection)
Intervention descriptions: intervention 1: Dosing was done every 7 days (± 3 days) on Days 1, 8, 15, and 22 with no less than 4 days between dosing days. Dose calculations were based on body surface area using the subject's height (from Screening) and actual weight for each course.

Protocol documents:
Clinical trial NCT00813995
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-12-09; Completion date: 2010-08-09
Enrollment: 395 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Comparator: Sitagliptin phosphate intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate 100 mg tablets once daily (q.d.) and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks. intervention 2: All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate placebo tablets q.d. and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks.

Protocol documents: