ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01678820
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-10-10; Completion date: 2013-11-01
Enrollment: 299 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone.

Detailed description:

Arms: arm 1: Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy. arm 2: Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy. arm 3: Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of \>=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
Interventions: intervention 1: Sitagliptin/Simvastatin FDC intervention 2: Sitagliptin intervention 3: Simvastatin intervention 4: Placebo to sitagliptin intervention 5: Placebo to simvastatin intervention 6: Placebo to Sitagliptin/Simvastatin FDC intervention 7: Metformin intervention 8: Glimepiride
Intervention descriptions: intervention 1: Sitagliptin 100 mg/Simvastatin 40 mg fixed-dose combination tablet intervention 2: Sitagliptin 100 mg tablet intervention 3: Simvastatin 40 mg tablet intervention 4: Matching placebo to sitagliptin 100 mg tablet intervention 5: Matching placebo to simvastatin 40 mg tablet intervention 6: Matching placebo to sitagliptin 100 mg/simvastatin 40 mg FDC tablet intervention 7: Participants will continue on their stable, pre-screening metformin daily dose of \>= 1500 mg for at least 12 weeks prior to randomization and during the study intervention 8: Following randomization, participants requiring glycemic rescue may receive open-label glimepiride initiated at a dose of 1 mg/day or 2 mg/day which may be up-titrated to 6 mg/day taken once daily with breakfast or the first main meal of the day.

Protocol documents:
Clinical trial NCT01688830
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-09-01; Completion date: 2013-11-01
Enrollment: 157 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI 655075 following intravenous administration of single rising doses of BI 655075 when administered alone and after administration of dabigatran.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Dabigatran intervention 2: BI 655075 intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01693653
Conditions: Behcet Syndrome
Keywords: Behcet's syndrome oral ulcers
Sponsor: NYU Langone Health
Start date: 2012-09-01; Completion date: 2013-11-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double-blind placebo controlled study targeting individuals with active Behcet's Syndrome who have oral ulcers and are resistant (have not responded after 4 weeks) to conventional treatments. Maximum allowable dose of colchicine (0.6mg twice a day) and stable dose for 4 weeks before enrollment. Prednisone or equivalent (\< 10mg/day) permitted if dose stable for 6 weeks prior to enrollment.

The study will investigate the safety of tocilizumab for this vasculitic condition in addition to its efficacy.

The planned sample size is 30 participants per arm for a total of 60 participants. The study would be for 3 months, with a safety follow up at 2 months after study termination.

Study participants will stay on their current treatments and either tocilizumab or placebo infusions will be given every 4 weeks in addition. Patients will be randomized to Actemra IV 8mg/kg Q 4 weeks X 3 doses or placebo.

Detailed description:
Behcet's syndrome is a vasculitis that causes oral and genital ulcerations, skin lesions, eye disease and arthritis, in addition to vascular complications with thrombophlebitis, thrombosis and rarely central nervous system involvement. IL-6 activity has been suggested in the pathogenesis in some studies. Tocilizumab with its unique mode of action among biologic agents may be a good candidate in this orphan disease.

Arms: arm 1: tocilizumab infusion every 4 weeks over 3 months arm 2: placebo infusion 0.9% sodium chloride every 4 weeks over 3 months
Interventions: intervention 1: Tocilizumab
Intervention descriptions: intervention 1: Intravenous infusions every 4 weeks for 3 doses.

Protocol documents:
Clinical trial NCT01710046
Conditions: Plaque Psoriasis
Keywords: plaque psoriasis tofacitinib biopsy Janus Kinase randomized placebo controlled clinical trial psoriasis vulgaris
Sponsor: Pfizer
Start date: 2013-03-01; Completion date: 2013-11-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There are cells in the skin and blood of humans with chronic moderate to severe plaque psoriasis with specific activities that may determine the effectiveness of treatment. These activities may be described by obtaining samples of skin and blood and analyzing them using a variety of tests.

Detailed description:
The final subject in Cohort 1 completed the study on 19-Nov-2013 (LSLV date). Because the study analyses were novel and exploratory, they required extensive analyses by study team and external experts. As a result of this analysis it was determined on 21-July-2014 that the data from Cohort 1 were sufficiently definitive and that enrollment of Cohort 2 would not be justified. Since this decision resulted in the LSLV for Cohort 1 becoming the LSLV for the study, the full data analysis and reporting is not projected to be complete within 12 Months of LSLV. The final analysis and final reporting is planned to be completed on 18-Feb-2015. Results for this data are anticipated to be released in April 2015.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: (CP-6890,550) Tofacitinib intervention 2: Placebo intervention 3: (CP-690,550) Tofacitinib intervention 4: Placebo
Intervention descriptions: intervention 1: 2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks intervention 2: 2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks intervention 3: 2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 weeks intervention 4: 2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks

Protocol documents:
Clinical trial NCT01710488
Conditions: COPD Exacerbation
Keywords: COPD exacerbation fluoroquinolones,
Sponsor: Fadoi Foundation, Italy
Start date: 2009-05-01; Completion date: 2013-11-01
Enrollment: 258 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine the percentage of patients with "therapeutic success" at the end of the cycle of antibiotic therapy (10 days), in the two treatment groups (levofloxacin and prulifloxacin). The effect of study treatments will be evaluated on the basis of a score determined in relation to the signs-symptoms of acute exacerbation of COPD (sputum purulence, sputum volume, cough, dyspnea, fever)

Detailed description:
The aim of this study was to examine the effects of the use of fluoroquinolones a class of antibiotics introduced relatively recently, in a particular population of patients with acute exacerbation of COPD, previously treated unsuccessfully with other antibiotics, and hospitalized in Internal Medicine. These patients reflect the reality of patients admitted to Internal Medicine, they are characterized by a high frequency of advanced age, polypathology, with multiple treatments.

Arms: arm 1: Levofloxacin 1 tablet 500 mg once a day for 7-10 days. It will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients arm 2: Prulifloxacin 1 tablet 600 mg once a day for 7-10 days. It will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients
Interventions: intervention 1: Levofloxacin 1 tablet 500 mg once a day intervention 2: Prulifloxacin 1 tablet 600 mg once a day
Intervention descriptions: intervention 1: Will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients:

Levofloxacin 500 mg (1 tablet) once daily for 7-10 days. The prescribing and dispensing of the drug will be made by medical personnel not directly involved in the data collection procedures for the study, and nursing staff, and the Medical Investigator will not be aware of the type of treatment to the individual. The drugs will be administered in the morning, about two hours after food. intervention 2: Will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients:

Prulifloxacin 1 tablet 600 mg once daily for 7-10 days. The prescribing and dispensing of the drug will be made by medical personnel not directly involved in the data collection procedures for the study, and nursing staff, and the Medical Investigator will not be aware of the type of treatment to the individual. The drugs will be administered in the morning, about two hours after food.

Protocol documents:
Clinical trial NCT01712360
Conditions: Tinea Pedis Tinea Cruris
Keywords: Tinea Pedis Tinea Cruris Athlete foot Jock itch
Sponsor: Merz North America, Inc.
Start date: 2012-10-01; Completion date: 2013-11-01
Enrollment: 56 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to see how the body is affected when a study drug is applied to both feet if the subject has athlete's foot or to both feet and the groin area if the subject has both athlete's foot and jock itch. Safety of the drug and how well the drug works will also be measured.

Detailed description:
Study population, diagnosis, and main criteria for inclusion:

Tinea pedis and Tinea cruris (NAFT-500):

Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis and Tinea cruris infections confirmed by a positive potassium hydroxide (KOH) analysis from both the feet and bikini area. Both cases (feet and bikini area) must be characterized by clinical evidence of a Tinea pedis and Tinea cruris infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.

Tinea pedis (NAFT-600):

Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis infection confirmed by a positive potassium hydroxide (KOH) analysis from both feet. Both feet must be characterized by clinical evidence of a Tinea pedis infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.

Arms: arm 1: Topical once a day for two weeks arm 2: Topical once a day for two weeks arm 3: Topical once a day for two weeks arm 4: Topical once a day for two weeks
Interventions: intervention 1: NAFT500 (pediatric) intervention 2: NAFT600 (pediatric) intervention 3: NAFT500 (adult) intervention 4: NAFT600 (adult)
Intervention descriptions: intervention 1: Applied to both feet and groin area intervention 2: Applied to both feet only intervention 3: Applied to both feet and groin area intervention 4: Applied to both feet

Protocol documents:
Clinical trial NCT01718691
Conditions: Low-grade B Cell Non-Hodgkin's Lymphoma Mantle Cell Lymphoma Where Hematopoietic Stem Cell Transplantation is Not Indicated
Sponsor: SymBio Pharmaceuticals
Start date: 2011-11-01; Completion date: 2013-11-01
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the efficacy and safety of SyB L-0501 (two-day consecutive 90 mg/m2/day IV drip infusions) in combination with rituximab (375 mg/m2 IV drip infusion) on untreated, low-grade B cell non-Hodgkin's lymphoma and mantle cell lymphoma where hematopoietic stem cell transplantation is not indicated.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: SyB L-0501 intervention 2: rituximab
Intervention descriptions: intervention 1: A dose of 90 mg/m\^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. intervention 2: A dose of 375 mg/m\^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0.

Protocol documents:
Clinical trial NCT01740388
Conditions: Bacterial Conjunctivitis
Sponsor: Bausch & Lomb Incorporated
Start date: 2013-02-01; Completion date: 2013-11-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension, 0.6% (Besifloxacin) administered BID for 3 days compared to vehicle in the treatment of bacterial conjunctivitis.

Detailed description:

Arms: arm 1: besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis arm 2: vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Interventions: intervention 1: Besifloxacin intervention 2: Vehicle
Intervention descriptions: intervention 1: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days. intervention 2: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.

Protocol documents:
Clinical trial NCT01744197
Conditions: Pain Phlebotomy Palliative Care
Keywords: Pain control Needle stick pain Venipuncture pain
Sponsor: US Oncology Research
Start date: 2013-01-01; Completion date: 2013-11-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Synera, which is a heated topical patch containing both lidocaine and tetracaine, is intended to reduce the pain associated with venipuncture and superficial dermatologic procedures by numbing the skin. This study will test the effectiveness of the Synera lidocaine/tetracaine patch when administered for 30 ± 5 minutes to provide dermal anesthesia in adult oncology patients undergoing venipuncture as part of their care, for treatment or diagnostics (laboratory or imaging). Compared to the use of the placebo patch, this study hypothesizes that the difference of 1 cm on the 0-10 visual analogue scale (VAS) will be observed 30 minutes after the use of the Synera patch. Pain intensity will be assessed by a 0-10 VAS

Detailed description:

Arms: arm 1: First application: Synera (lidocaine 70mg/tetracaine 70mg) patch; Second application: Placebo patch arm 2: First application: Placebo patch; Second application: Synera (lidocaine 70mg/tetracaine 70mg) patch
Interventions: intervention 1: Synera (lidocaine 70mg/tetracaine 70mg)
Intervention descriptions: intervention 1: All subjects will receive 2 patch applications during this study: one Synera, one placebo. The 2 patch applications must be done on separate days. Only 1 patch will be used per application. Arm 1 subjects will receive Synera patch for the 1st application, and placebo for the second. Arm 2 patients will receive placebo patch for the 1st application, and Synera patch for the second.

Protocol documents:
Clinical trial NCT01747629
Conditions: Asthma
Keywords: Asthma dry powder inhaler short-acting beta2-agonist SABA bronchoconstriction bronchodilation bronchodilator metered dose inhaler Albuterol Spiromax®
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2012-12-01; Completion date: 2013-11-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax® versus placebo in subjects with persistent asthma.

Detailed description:

Arms: arm 1: Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks. arm 2: Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
Interventions: intervention 1: Placebo MDPI intervention 2: Albuterol MDPI
Intervention descriptions: intervention 1: Placebo MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks. intervention 2: Albuterol MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.

Protocol documents:
Clinical trial NCT01751113
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: GlaxoSmithKline
Start date: 2013-02-01; Completion date: 2013-11-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the effects on lung function of a combination of ADOAIR 50/250mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg once daily alone and ADOAIR 50/250mcg twice daily alone) in Japanese subjects with COPD. The study will utilize a three-way cross-over design with a 2-week wash-out period between each 4-week consecutive treatment period. The aim is to support the rationale for "triple combination" therapy by demonstrating that treatment with both ADOAIR and tiotropium can potentially produce improved, clinically relevant effects compared with either treatment alone.

This study will utilize a range of lung function measures in order to fully assess the benefits of triple therapy. The primary endpoint will be based on airways conductance measured using plethysmography (sGaw measured over 4hours post dose (AUC 0-4hr) on Day 28). Secondary endpoints will include lung function measures based on plethysmography and spirometry. The lung function measures will be supported by measurement of the use of relief salbutamol .

Detailed description:

Arms: arm 1: 250mcg fluticasone + 50 mcg salmeterol, twice daily 4 week treatment in each treatment sequence (crossover design) arm 2: 18 mcg tiotropium bromide, once daily 4 week treatment in each treatment sequence (crossover design) arm 3: 250mcg fluticasone + 50 mcg salmeterol, twice daily plus 18 mcg tiotropium bromide, once daily 4 week treatment in each treatment sequence (crossover design)
Interventions: intervention 1: fluticasone propionate/salmeterol intervention 2: tiotropium bromide intervention 3: fluticasone propionate/salmeterol plus tiotropium bromide
Intervention descriptions: intervention 1: 250mcg fluticasone + 50 mcg salmeterol, twice daily 4 week treatment in each treatment sequence (crossover design) intervention 2: 18 mcg tiotropium bromide, once daily 4 week treatment in each treatment sequence (crossover design) intervention 3: 250mcg fluticasone + 50 mcg salmeterol, twice daily plus 18 mcg tiotropium bromide, once daily 4 week treatment in each treatment sequence (crossover design)

Protocol documents:
Clinical trial NCT01767493
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Sponsor: Institute for Neurodegenerative Disorders
Start date: 2012-11-01; Completion date: 2013-11-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the feasibility of \[18F\]Florbetapir positron emission tomography (PET) for assessment of demyelination in the patients with relapsing remitting multiple sclerosis.

Detailed description:
The underlying goal of this study is to assess the feasibility of \[18F\]Florbetapir as an imaging tool to detect demyelination in the brain of MS research participants and compare to similarly aged healthy subjects.

Arms: arm 1: \[18F\]Florbetapir and PET imaging
Interventions: intervention 1: [18F]Florbetapir PET imaging
Intervention descriptions: intervention 1: \[18F\]Florbetapir and PET imaging

Protocol documents:
Clinical trial NCT01783522
Conditions: Chemotherapeutic Agent Toxicity Multiple Myeloma Peripheral Neuropathy
Sponsor: Beth Faiman
Start date: 2013-02-01; Completion date: 2013-11-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies glutamine in preventing peripheral neuropathy in patients with multiple myeloma who are receiving bortezomib. Glutamine may help prevent peripheral neuropathy in patients receiving chemotherapy

Detailed description:
PRIMARY OBJECTIVES:

I. Estimate the objective effect size of glutamine compared to placebo as a prophylactic intervention to prevent bortezomib-induced peripheral neuropathy in multiple myeloma patients 4 months after their first dose of study drug.

SECONDARY OBJECTIVES:

I. Estimate whether glutamine delays or prevents the onset or worsening of any neuropathy as determined by National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria.

II. Determine if glutamine may improve adherence to bortezomib therapy.

III. Assess response rate (RR) and clinical benefit response rate (CBR) according to uniform international response criteria and modified European Group for Blood and Marrow Transplantation (EBMT) criteria.

IV. Determine if glutamine may improve quality of life (QOL) at 4 months.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive glutamine orally (PO) twice daily (BID). Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: glutamine intervention 2: quality-of-life assessment intervention 3: placebo
Intervention descriptions: intervention 1: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months. intervention 2: Ancillary studies intervention 3: Given PO

Protocol documents: