ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00922233
Conditions: Healthy
Keywords: Contraception
Sponsor: FHI 360
Start date: 2010-01-01; Completion date: 2010-11-01
Enrollment: 72 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel

Detailed description:
This is a prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel (LNG). The objectives of the study as stated in the study protocol are as follows:

* To evaluate the efficacy of the study regimen among women who have sex 1-4 days a month and who are relying on the study regimen as their primary method of contraception
* To evaluate the safety of this regimen, with particular emphasis on its effects on vaginal bleeding patterns and anemia
* To evaluate the acceptability of the regimen The study will enroll fertile women of reproductive age who have sex up to 6 days a month, are at low risk for sexually transmitted infections (STIs), have no contraindications to progestin-only oral contraceptives,have no serious contraindications to pregnancy, and are willing to use an investigational method of contraception as their only contraceptive method for 6.5 months (each tablet contains 0.75 mg LNG to be used after every sex act).

Arms: arm 1: 0.75 mg of levonorgestrel within 24 hours of sex
Interventions: intervention 1: levonorgestrel
Intervention descriptions: intervention 1: oral contraceptive pills

Protocol documents:
Clinical trial NCT00928642
Conditions: Ovarian Cancer Primary Peritoneal Cancer
Keywords: ovarian cancer peritoneal endometrioid mucinous serous clear cell
Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Start date: 2009-06-01; Completion date: 2010-11-01
Enrollment: 8 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and tolerability of the combination of Gleevec and Gemzar in patients with ovarian cancer, who have progressed after receiving at least one prior chemotherapy treatment. Gleevec is an oral chemotherapy drug used is this study and Gemzar is an IV chemotherapy drug used. Participation in the treatment portion of the study will continue as long as the patient's tumors shrink or remain stable and as long as the patient is able to tolerate the study drug. The follow-up portion of the study will last for 5 years.

Detailed description:
Each 21 day period will be considered a cycle. Disease status will be assessed with a Cancer Antigen (CA)-125 prior to the start of each new cycle with an assessment of measurable diseased by either CT or MRI every 6 weeks. Treatment will continue until disease progression, unacceptable toxicities, or the patient elects to withdraw from the study. All patients will be followed until disease progression or study withdraw. In addition, following disease progression, patients will be monitored for delayed toxicity and survival for a period of 5 years, unless consent is withdrawn.

Arms: arm 1: All research subjects receive oral imatinib 400mg days 1-5 and 8-12 of a 21 day cycle.

All research subjects received IV gemcitabine 1000mg/m2 days 3 and 10 of a 21-day cycle. .

All subjects had epithelial ovarian cancer or primary peritoneal carcinomatosis and had failed to respond to prior chemotherapy or progressed after prior chemotherapy.
Interventions: intervention 1: imatinib mesylate by mouth intervention 2: Gemcitabine Intravenous
Intervention descriptions: intervention 1: imatinib mesylate - 400mg orally, daily on Days 1-5 and 8-12 of a 21 day cycle. intervention 2: Gemcitabine - 1000 mg/m2 IV on Day 3 and Day 10 of a 21 day cycle

Protocol documents:
Clinical trial NCT00931723
Conditions: Acute Mania
Keywords: Acute Mania Mania, Adults Seroquel Acute Mania in Adult Patients
Sponsor: AstraZeneca
Start date: 2009-06-01; Completion date: 2010-11-01
Enrollment: 356 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if lithium 600-1800 mg/day is effective when added to quetiapine fumarate extended release (quetiapine XR or SEROQUEL® XR) 400-800 mg/day in treating acute mania and if so, how it compares with placebo (a non-active capsule, like a sugar pill, that looks like lithium).

Detailed description:

Arms: arm 1: Seroquel XR and Lithium arm 2: Seroquel XR and placebo
Interventions: intervention 1: Quetiapine fumarate XR intervention 2: Lithium intervention 3: Placebo
Intervention descriptions: intervention 1: Oral treatment, once daily, Day 1 = 300 mg, Day 2 and thereafter 600 mg. Dose might be adjusted as from Day 3 by the discretion of the investigator. intervention 2: Oral treatment, twice daily, Days 1 and 2 = 600 mg/day, Days 3-8 = 900 mg/day. Dose adjustment from day 9 to end of study will be at the discretion of the investigator. intervention 3: Oral treatment twice daily.

Protocol documents:
Clinical trial NCT00934648
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2007-10-01; Completion date: 2010-11-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who have had an inadequate response or were intolerant to treatment with methotrexate. Eligible patients will receive MabThera (1000mg by intravenous infusion) on days 1 and 15, and background methotrexate (oral or subcutaneous dose of 10-25mg weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: methotrexate
Intervention descriptions: intervention 1: 1000mg iv on days 1 and 15 intervention 2: 10-25mg weekly

Protocol documents:
Clinical trial NCT00939094
Conditions: Neuropathic Pain Mechanical Hypersensitivity
Keywords: Pain, Mechanical Hypersensitivity Allodynia Efficacy analgesia Neuropathic
Sponsor: AstraZeneca
Start date: 2009-08-01; Completion date: 2010-11-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate if 28 days of treatment with AZD2066 compared to placebo can relieve the pain arising from the nervous system when the patients are touched by something that should not cause pain or have severe pain when they are touched by something that should only cause a little pain.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AZD2066 intervention 2: Placebo
Intervention descriptions: intervention 1: Capsule, once daily intervention 2: Capsule, once daily

Protocol documents:
Clinical trial NCT00942188
Conditions: Type 2 Diabetes
Keywords: Diabetes Type 2 Diabetes
Sponsor: Eli Lilly and Company
Start date: 2009-06-01; Completion date: 2010-11-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to evaluate the safety, tolerability and efficacy of LY2189102 in patients with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: 0.9% Sodium Chloride
Interventions: intervention 1: LY2189102 intervention 2: Placebo
Intervention descriptions: intervention 1: Participants received 2 subcutaneous (SC) injections weekly for 12 weeks. intervention 2: Participants received 2 SC injections weekly for 12 weeks.

Protocol documents:
Clinical trial NCT00948155
Conditions: Nicotine Dependence
Keywords: smoking nicotine varenicline
Sponsor: University of Pennsylvania
Start date: 2009-01-01; Completion date: 2010-11-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will demonstrate the behavioral responses to varenicline, helping to better understand its mechanisms. Hypotheses for the study are to observe decreases in smoking topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus increasing the efficacy of varenicline.

Detailed description:
This study is designed to examine the behavioral responses a cigarette smoker may have to using varenicline. Behavioral responses may help to better understand its mechanisms which in turn could improve treatment outcomes. The primary hypothesis for the study is to observe decreases in smoking topography, an objective measure of smoking behavior or puffing, on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We will also examine puffing and nicotine cigarette choices during lab visits at baseline, and Days 7 and 21. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus potentially increasing the efficacy of varenicline.

Arms: arm 1: Drug (Varenicline (Chantix)): Placebo

Intervention to be administered is: participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. arm 2: Placebo: Drug Varenicline (Chantix)

Intervention to be administered is: participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

Intervention 'Drug (Varenicline (Chantix)): Placebo'
Interventions: intervention 1: Varenicline
Intervention descriptions: intervention 1: Intervention Drug (Varenicline (Chantix) will be administered in standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.

Protocol documents:
Clinical trial NCT00965081
Conditions: Fibromyalgia, Primary Fibromyalgia, Secondary
Sponsor: Eli Lilly and Company
Start date: 2009-09-01; Completion date: 2010-11-01
Enrollment: 308 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to determine if 30 milligrams (mg) of duloxetine is effective in the treatment of fibromyalgia compared to placebo.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Duloxetine intervention 2: Placebo
Intervention descriptions: intervention 1: 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks intervention 2: QD po at the same time each day for 12 weeks

Protocol documents:
Clinical trial NCT00976495
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2009-10-01; Completion date: 2010-11-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as assessed by glomerular filtration rate.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dapagliflozin intervention 2: Placebo intervention 3: Hydrochlorothiazide
Intervention descriptions: intervention 1: Tablets, Oral, 10 mg, once daily, 12 weeks intervention 2: Tablets, Oral, 0 mg, once daily, 12 weeks intervention 3: Tablets, Oral, 25 mg, once daily, 12 weeks

Protocol documents:
Clinical trial NCT00997139
Conditions: Nasal Carriers of Staphylococcus Aureus
Keywords: healthcare staphylococcus aureus nasal
Sponsor: Northwestern University
Start date: 2009-09-01; Completion date: 2010-11-01
Enrollment: 216 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Staphylococcus aureus, a bacteria that lives commonly in the anterior nostrils, is seen in about 30% of healthcare workers. Applying mupirocin ointment, a prescription, to the nostrils twice daily for 5 days is the current standard of care for treatment to clear this bacteria. This research study is designed to determine the rate of clearance of this bacteria in healthcare workers who are carriers when using triple antibiotic ointment instead of mupirocin ointment.

Detailed description:

Interventions: intervention 1: Neosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg)
Intervention descriptions: intervention 1: 2 1/32oz packages will be dispensed. If positive nasal swab for S. aureus, subjects will apply a small amount to anterior nares twice daily for 5 days.

Protocol documents:
Clinical trial NCT01001494
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease antimuscarinic COPD
Sponsor: AstraZeneca
Start date: 2009-10-01; Completion date: 2010-11-01
Enrollment: 828 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.

Detailed description:

Arms: arm 1: Aclidinium bromide 200 μg twice-daily via inhalation arm 2: Aclidinium bromide 400 μg twice-daily via inhalation arm 3: Placebo
Interventions: intervention 1: Aclidinium bromide 200 μg bid intervention 2: Aclidinium bromide 400 μg bid intervention 3: Placebo
Intervention descriptions: intervention 1: Aclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks intervention 2: Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks intervention 3: Placebo twice-daily by inhalation for 24 weeks

Protocol documents:
Clinical trial NCT01006122
Conditions: Excessive Daytime Sleepiness Narcolepsy
Keywords: Randomized double-blind placebo-controlled crossover study of PF-03654746 in Excessive Daytime Sleepiness associated with Narcolepsy
Sponsor: Pfizer
Start date: 2009-11-01; Completion date: 2010-11-01
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Histaminergic agents are known to be involved with the sleep/wake cycle. This compound is a histaminergic agent which therefore may improve alertness and awakeness in patients with excessive daytime sleepiness (EDS) associated with narcolepsy. Significant improvement in EDS when treated with this compound compared to placebo in patients with narcolepsy is hypothesized.

Detailed description:

Arms: arm 1: None arm 2: At the end of the second arm of the study, the patient will have completed the study and have a 7-10 day follow-up visit.
Interventions: intervention 1: Placebo intervention 2: PF-03654746
Intervention descriptions: intervention 1: Patients receiving placebo will undergo the same procedures as those receiving active treatment. Each patient will receive matching placebo tablets in a fixed dose escalation schedule beginning at 0.25 mg QD for 5 days; then up to 0.50 mg QD for another 5 days; and up to 1.0 mg QD for an additional 5 days. At the end of this fixed titration schedule, the patient will either stay at 1.0 mg; decrease to 0.5 mg or increase to 2.0 mg based upon the clinicians judgment regarding efficacy and side effects at the 1.0 dose level. The patient will then remain at the determined dose for a 3 week stable dosing period, with a 7 (-2/+ 9) day wash out and then crossover to repeat the same sequence for the second arm of the study. intervention 2: Each patient will receive PF-03654746 tablets in a fixed dose titration schedule beginning at 0.25 mg QD for 5 days; then up to 0.50 mg QD for another 5 days; and up to 1.0 mg QD for an additional 5 days. At the end of this fixed titration schedule, the patient will either stay at the 1.0 mg dose; decrease to 0.50 mg or increase to 2.0 mg based upon the clinician's judgement regarding efficacy and side effects at the 1.0 mg dose. The patient will remain at the determined dose for a 3 week stable dosing period.

Protocol documents:
Clinical trial NCT01010399
Conditions: Hypertriglyceridemia HIV Infection
Keywords: HIV triglycerides fosamprenavir
Sponsor: Felizarta, Franco, M.D.
Start date: 2009-09-01; Completion date: 2010-11-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In subjects on boosted protease inhibitor (PI)-regimens who have elevated triglycerides, a switch to fosamprenavir/ritonavir once daily followed by the addition of Lovaza will result in 30% of patients achieving a reduction in fasting triglycerides \< 200 mg /dL while maintaining virologic suppression.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Lovaza intervention 2: fosamprenavir/ritonavir
Intervention descriptions: intervention 1: Lovaza at a dose of 4g per day with each 1g capsule containing 465 mg of eicosapentaenoic acid (EPA) and 375 mg of docosahexaenoic acid (DHA) for 18 weeks intervention 2: Lexiva (fosamprenavir calcium) 1400 mg per day, Norvir (ritonavir) 100 mg per day

Protocol documents:
Clinical trial NCT01017146
Conditions: Acne Vulgaris
Keywords: Ance
Sponsor: Stiefel, a GSK Company
Start date: 2009-10-01; Completion date: 2010-11-01
Enrollment: 744 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.

Detailed description:
A multicenter, randomized, double-blind, vehicle-controlled, parallel-group study comparing tazarotene foam with vehicle foam in subjects with acne vulgaris. Approximately 742 subjects will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene foam: vehicle foam). Subjects will apply tazarotene foam or vehicle foam to the entire face once daily for 12 weeks; study visits will occur at baseline (week 0/day 1) and at weeks 2, 4, 8, and 12.

Arms: arm 1: Tazarotene foam, 0.1% arm 2: Vehicle Foam
Interventions: intervention 1: Tazarotene foam intervention 2: Vehicle Foam
Intervention descriptions: intervention 1: Tazarotene foam once a day application to the face intervention 2: Vehicle Foam once a day application to the face

Protocol documents:
Clinical trial NCT01020903
Conditions: Postoperative Nausea
Sponsor: Northwell Health
Start date: 2009-11-01; Completion date: 2010-11-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Anesthesia, especially for laparoscopic surgery, can cause post-operative nausea and vomiting. Most patients are given two drugs, decadron and ondansetron, to try to minimize this. This study is to determine if a new drug, aprepitant, would add any benefit in terms of post-op nausea prevention. All laparoscopic cholecystectomy study patients will receive decadron and ondansetron. Half the patients will receive aprepitant in addition. The other half will receive placebo. The study will be randomized and double-blind.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aprepitant intervention 2: Placebo
Intervention descriptions: intervention 1: 40 mg po pre-op intervention 2: Orally, pre-op

Protocol documents:
Clinical trial NCT01022762
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2009-11-01; Completion date: 2010-11-01
Enrollment: 440 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood glucose lowering effect and the safety profile of repaglinide given alone compared to gliclazide given alone in Chinese subjects with type 2 diabetes who never have been treated with oral anti-diabetic drugs (OADs). This study also investigates the augment effect of repaglinide on the phases of insulin secretion as a subgroup study.

Detailed description:

Arms: arm 1: 1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily arm 2: 80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
Interventions: intervention 1: repaglinide intervention 2: gliclazide
Intervention descriptions: intervention 1: Individually adjusted dose for 16 weeks intervention 2: Individually adjusted dose for 16 weeks

Protocol documents:
Clinical trial NCT01046110
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2010-01-01; Completion date: 2010-11-01
Enrollment: 458 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will be conducted in Africa, Asia, North America and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec) with sitagliptin, as add-on to subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes inadequately controlled with 1-2 OADs (metformin, sulphonylurea, glinides or pioglitazone).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec intervention 2: sitagliptin
Intervention descriptions: intervention 1: Injected under the skin once daily for 26 weeks. The doses will be individually adjusted. intervention 2: Sitagliptin tablets administered orally once a day at the same time every day for 26 weeks

Protocol documents:
Clinical trial NCT01053000
Conditions: ACTINIC KERATOSES
Keywords: ACTINIC KERATOSES HAND FOREARM
Sponsor: Stewart, Roger H., M.D., P.A.
Start date: 2010-01-01; Completion date: 2010-11-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine and compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment vs ALA-PDT with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.

Detailed description:
Subjects will be randomized such that their RIGHT dorsal hand/forearm will receive one of the following two treatments with the subject's LEFT dorsal hand/forearm receiving the other treatment; Treatment 1 will include pre-treatment of the dorsal hand/forearm with Tazorac 0.1% gel BID for one week, followed by ALA applied to the entire dorsal hand/forearm 60 minutes prior to BLUE light treatment for 16 minutes 40 seconds Treatment 2 will have ALA applied to the entire dorsal hand/forearm and occluded for 60 minutes prior to BLUE light treatment for 16 minutes 40 secondsNote: ALA will be applied to individual dorsal hand/forearm actinic keratoses (AK) lesions followed by broad area application over the entire dorsal hand/forearm surface. The treatment area on the side NOT pre-treated with Tazorac will then be occluded using plastic wrap for 60 minutes. The treatment area of the dorsal hand/forearm is defined as the extensor surface of the hand/forearm between the elbow and the base of the fingers (the fingers are NOT included in the treatment area).

Arms: arm 1: Apply Tazorac 0.1% gel for 1 week to the Left arm only and then receive ALA- PDT Treatment to both arms arm 2: Apply Tazorac 0.1% gel for 1 week to the Right arm only and then receive ALA- PDT Treatment to both arms
Interventions: intervention 1: Tazorac
Intervention descriptions: intervention 1: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment with Tazorac vs ALA-PDT with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.

Protocol documents: