ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01498679
Conditions: Asthma
Sponsor: GlaxoSmithKline
Start date: 2012-01-01; Completion date: 2013-07-01
Enrollment: 311 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomised, double-blind, placebo-controlled, parallel group multicentre study to evaluate the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once daily for 12 weeks in the treatment of asthma in adolescent and adult subjects of Asian ancestry currently treated with lowe to mid-strength inhaled corticosteroid or low-strength combination therapy.

Detailed description:
This will be a randomised, double-blind, placebo controlled, parallel group, multi-centre study. At Visit 1 (Screening Visit) subjects who meet all of the inclusion criteria and none of the exclusion criteria will enter a two week run-in period. Subjects will remain on their current ICS therapy throughout the run-in period. At the end of the run-in period (Visit 2) subjects meeting the Randomisation criteria will enter a 12 week treatment period and receive one of the two following treatments: 1) FF/VI (100/25mcg) administered once daily in the evening via a Novel Dry Powder Inhaler (NDPI) 2) Placebo administered once daily in the evening via a NDPI In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to be used as required to treat asthma symptoms.

Subjects who have not met the randomisation criteria at Visit 2 will be withdrawn from the study.

Subjects meeting the randomisation criteria will be randomized to one of the two treatment groups and will attend the clinic for 3 on-treatment visits at Week 4 (Visit 3), Week 8 (Visit 4) and Week 12 (Visit 5). Subjects will receive treatment for 12 weeks. A Follow-up Visit or phone call (Visit 6) will take place 1 week after completing study medication. All clinic visits will take place in the morning. Subjects will participate in the study for a maximum of 15 weeks (Screening to Follow-up inclusive). A subject is regarded to have completed the study if they complete all phases of the study (Screening, treatment, Follow-up).

Arms: arm 1: Inhaled corticosteroid (ICS)/Long-acting beta2-agonist (LABA) combination arm 2: placebo comparator
Interventions: intervention 1: GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate) intervention 2: Placebo
Intervention descriptions: intervention 1: ICS/LABA combination (100/25mcg) administered once daily in the evening via a Novel Dry Powder Inhaler (NDPI) intervention 2: Placebo administered once daily in the evening via a NDPI

Protocol documents:
Clinical trial NCT01516749
Conditions: Hidradenitis Suppurativa
Keywords: hidradenitis suppurativa anakinra
Sponsor: University of California, San Francisco
Start date: 2012-10-01; Completion date: 2013-07-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, proof-of-concept research study to assess the effectiveness of anakinra in the treatment of patients with hidradenitis suppurativa (HS). The planned intervention is to provide about 6 HS patients with anakinra 100mg daily injections to administer subcutaneously for 8 weeks. Then, the study subjects will be followed for a further 8 weeks to monitor for relapse of HS.

Detailed description:

Arms: arm 1: All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.
Interventions: intervention 1: anakinra
Intervention descriptions: intervention 1: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.

Protocol documents:
Clinical trial NCT01527942
Conditions: Obesity Pain
Keywords: Pain Management
Sponsor: Trinity Health Of New England
Start date: 2012-03-01; Completion date: 2013-07-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Bariatric patients usually require the use of either intravenous or oral opioid medications. The use of opioids, however, is often associated with side-effects such as nausea, sedation pruritus, urinary retention and respiratory depression with often delay patient discharge. This study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to determine if this will decrease the use of opioids post-operatively for pain management in morbidly obese patients undergoing laparoscopic bariatric surgery.

Detailed description:

Arms: arm 1: Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. arm 2: Preoperative IV Placebo (0.9 Sodium Chloride 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Interventions: intervention 1: Acetaminophen intervention 2: Placebo
Intervention descriptions: intervention 1: Intravenous Acetaminophen 1,000 mg IV intervention 2: Placebo - IV administration 0.9% 100 ml Sodium Chloride (NaCl)

Protocol documents:
Clinical trial NCT01533259
Conditions: Acquired Immunodeficiency Syndrome HIV Infections
Keywords: HIV-1 HIV Treatment Experienced
Sponsor: Gilead Sciences
Start date: 2012-01-01; Completion date: 2013-07-01
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF)) single-tablet regimen (STR) after switching from a regimen consisting of raltegravir plus Truvada® (FTC/TDF) at baseline in maintaining HIV-1 RNA \< 50 copies/mL at Week 12 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of Stribild over 24 and 48 weeks of treatment.

Detailed description:

Arms: arm 1: Participants will switch to Stribild for 48 weeks.
Interventions: intervention 1: Stribild
Intervention descriptions: intervention 1: Elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily with food

Protocol documents:
Clinical trial NCT01541553
Conditions: Actinic Keratosis
Sponsor: LEO Pharma
Start date: 2012-03-01; Completion date: 2013-07-01
Enrollment: 367 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to compare the rate of complete clearance of actinic keratosis (AK) using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.

Detailed description:

Arms: arm 1: Cryotherapy followed by PEP005 Gel, 0.015% arm 2: Cryotherapy followed by vehicle gel
Interventions: intervention 1: Cryotherapy intervention 2: Vehicle intervention 3: Ingenol metabute
Intervention descriptions: intervention 1: Cryotherapy of all visible AKs (4-8 lesions, "baseline lesions") in the selected treatment area intervention 2: Field treatment with vehicle gel once daily for 3 consecutive days. intervention 3: Field treatment with vehicle gel once daily for 3 consecutive days.

Protocol documents:
Clinical trial NCT01547598
Conditions: Glaucoma, Open-Angle Ocular Hypertension
Sponsor: Allergan
Start date: 2011-12-01; Completion date: 2013-07-01
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This non-inferiority study will assess safety and efficacy of LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) versus DuoTrav® (travoprost 0.004%/timolol 0.5% combination ophthalmic solution) in patients previously on Travatan® Z (travoprost ophthalmic solution 0.004%) monotherapy.

Detailed description:

Arms: arm 1: Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks. arm 2: Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
Interventions: intervention 1: travoprost ophthalmic solution 0.004% intervention 2: travoprost 0.004% / timolol 0.5% combination ophthalmic solution intervention 3: Bimatoprost ophthalmic solution 0.01%
Intervention descriptions: intervention 1: Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. intervention 2: DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks. intervention 3: LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.

Protocol documents:
Clinical trial NCT01549613
Conditions: Cellulitis Skin Infections
Sponsor: University of Cincinnati
Start date: 2012-05-01; Completion date: 2013-07-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, randomized clinical trial comparing daptomycin to vancomycin in the Emergency Department (ED) treatment of complicated skin and skin structure infection in the Rapid Diagnosis and Treatment Center (RDTC). In brief, a convenience sample of patients who are admitted to the RDTC cellulitis protocol in the ED will be randomized to either vancomycin, which is currently an accepted care standard in the RDTC cellulitis protocol, or daptomycin, which is the experimental treatment in this study. The primary hypothesis is that daptomycin treatment is as efficacious as standard therapy in the treatment of ED cellulitis.

Detailed description:
Specific Aim 1: Compare the efficacy of daptomycin to the efficacy of vancomycin for the treatment of complicated skin and skin structure infection in the ED. Patients eligible for the RDTC Cellulitis Treatment Protocol will be screened for inclusion in the study. After informed consent, patients will be randomized to receive either daptomycin or vancomycin (1:1 ratio). A case report form (CRF) detailing medical history, clinical characteristics, and treatments will be completed. The patients will be evaluated for meeting RDTC discharge criteria. The following time points will be collected: 1. actual time patient meets discharge criteria based on the RDTC cellulitis protocol; 2. time of disposition defined as the time treating physician writes discharge orders; and, 3. time the patient actually leaves the emergency department. Subsequently, the patient will be followed up by telephone to ascertain whether a change in antibiotic therapy or a return ED visit for complicated skin and skin structure infection occurred within 30 days of the initial RDTC enrollment Specific Aim 2: Compare the change in area and erythema of the cellulitic lesion between patients treated with daptomycin and patients treated with vancomycin. Patients enrolled in the study will have serial digital photographs of their primary lesion taken. The images will be processed blinded to clinical data and asynchronous to the ED stay. The change in lesion area and erythema will be calculated.

Arms: arm 1: Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol arm 2: Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
Interventions: intervention 1: Daptomycin intervention 2: Vancomycin
Intervention descriptions: intervention 1: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol. intervention 2: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.

Protocol documents:
Clinical trial NCT01555151
Conditions: Asthma
Keywords: Asthma
Sponsor: Novartis Pharmaceuticals
Start date: 2012-07-01; Completion date: 2013-07-01
Enrollment: 739 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy, safety and pharmacokinetics of Mometasone furoate delivered via Concept1 device or Twisthaler® device in adult and adolescent patients with persistent asthma.

Detailed description:

Arms: arm 1: Description: Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 80 ug delivered via the Concept1 device for 4 weeks. arm 2: Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 200 ug delivered via the Twisthaler® device for 4 weeks. arm 3: Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 320 ug delivered via the Concept1 device for 4 weeks. arm 4: Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 800 ug delivered via the Twisthaler® device for 4 weeks.
Interventions: intervention 1: Mometasone furoate intervention 2: Concept 1 intervention 3: Twisthaler
Intervention descriptions: intervention 1: Mometasone furoate (MF) 80 µg once daily delivered via Concept1 device; MF 200 μg once daily delivered via Concept1 device; MF 320μg once daily delivered via Twisthaler® device or 800 μg once daily delivered via Twisthaler® device intervention 2: A single dose dry powder inhaler (SDDPI) intervention 3: A single dose dry powder inhaler (SDDPI)

Protocol documents:
Clinical trial NCT01566370
Conditions: Alcohol Use Disorders Bipolar Disorder
Keywords: alcoholism alcohol use disorder alcohol dependence alcohol abuse bipolar anticonvulsant zonisamide
Sponsor: Yale University
Start date: 2012-05-01; Completion date: 2013-07-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double blind, placebo controlled trial of the medication zonisamide for the purpose of reducing heavy drinking and drinking, as well as reducing mood symptoms, in bipolar subjects that drink excessively and heavily.

Hypotheses: (Primary aims); Add-on zonisamide compared to placebo will result in:

1. significant reduction in heavy drinking days, drinks per week and per drinking day, and significantly greater increase in abstinent days, ii) greater rates of abstinence and abstinence to heavy drinking, greater reduction in biomarkers of heavy alcohol use such as gamma-glutamyl transferase (GGT), and greater reduction in alcohol urge or "craving",
2. Significant reduction in prevalent mood symptoms on the BRMS and BRMeS, CARS, HAMD, or no worsening of euthymic mood, and significant improvement on the Clinical Global Impressions Scale-Severity.
3. (Secondary aims) Add-on zonisamide compared to placebo will result in significant reduction in weight (kilograms) and other secondary weight-related metabolic factors such as fasting glucose, lipid profile, and blood pressure.
4. (Secondary aims) Add-on zonisamide compared to placebo will result in improved clinical global impression, overall functioning, quality of life, and reduced medical symptoms.

5.) (Exploratory Aims) To will examine interactions between genotype and medication on treatment response for allelic variation in genetic loci related to the major neurotransmitter and neurophysiologic pathways that are relevant to bipolar disorder, alcoholism, and zonisamide mechanism of action.

Detailed description:

Arms: arm 1: Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind arm 2: Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group
Interventions: intervention 1: Zonisamide intervention 2: Placebo
Intervention descriptions: intervention 1: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose intervention 2: placebo

Protocol documents:
Clinical trial NCT01569074
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Sponsor: AstraZeneca
Start date: 2012-04-01; Completion date: 2013-07-01
Enrollment: 163 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the effectiveness of four dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 12 weeks.

Detailed description:
(OSKIRA-Asia-1): A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients with Active Rheumatoid Arthritis who are Inadequate Responders to Methotrexate Therapy

Arms: arm 1: Oral treatment arm 2: Oral treatment arm 3: Oral treatment arm 4: Oral treatment arm 5: Oral treatment
Interventions: intervention 1: Fostamatinib intervention 2: Fostamatinib intervention 3: Fostamatinib intervention 4: Fostamatinib intervention 5: Placebo
Intervention descriptions: intervention 1: Fostamatinib 100mg twice daily for 12 weeks intervention 2: Fostamatinib 100mg twice daily for 4 weeks, followed by150mg once daily up to Week 12 intervention 3: Fostamatinib 75mg twice daily for 12 weeks intervention 4: Fostamatinib 50mg twice daily for 12 weeks intervention 5: Placebo twice daily for 12 weeks

Protocol documents:
Clinical trial NCT01575522
Conditions: Estrogen Receptor Negative HER2/Neu Negative Progesterone Receptor Negative Recurrent Breast Carcinoma Stage IV Breast Cancer Triple-Negative Breast Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2012-03-01; Completion date: 2013-07-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well tivantinib works in treating patients with recurrent or metastatic breast cancer. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the activity of tivantinib (ARQ-197) as defined by 6-month progression-free survival (PFS) of participants with triple-negative metastatic breast cancer.

SECONDARY OBJECTIVES:

I. To evaluate objective response based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

II. To evaluate c-Met and phospho c-Met expression in archival tumor tissue. (Exploratory) III. To evaluate the incidence of c-Met-positive circulating tumor cells at baseline. (Exploratory) IV. To evaluate the effect of ARQ-197 on serum markers relevant to c-Met pathway (hepatocyte growth factor \[HGF\] and vascular endothelial growth factor \[VEGF\]). (Exploratory) V. To evaluate phosphatase and tensin homolog (PTEN) loss and PI3K mutations in archival tumor tissue. (Exploratory) VI. To evaluate proportion of participants with basal-like breast cancer. (Exploratory)

OUTLINE: This is a multicenter study.

Patients receive tivantinib orally (PO) twice daily (BID) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by fluorescent in situ hybridization (FISH) and immunohistochemistry (IHC). Archived tumor tissue samples are also analyzed.

After completion of study treatment, patients are followed up every 6 months.

Arms: arm 1: Patients receive tivantinib 360 mg PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Tivantinib
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given PO

Protocol documents:
Clinical trial NCT01591044
Conditions: Asthma
Sponsor: Rigel Pharmaceuticals
Start date: 2012-07-01; Completion date: 2013-07-01
Enrollment: 301 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in the treatment of mild to moderate asthma.

Detailed description:
The study is a multi-center, randomized, double-blind, placebo-controlled, parallel group study comparing 2 doses of inhaled R343 bid to placebo over 8 weeks in patients with mild to moderate allergic asthma. Patients who meet specific inclusion and exclusion criteria after an initial screening evaluation and a single-blind, run-in period will be randomized to receive either R343 or placebo.

Arms: arm 1: R343 2mg, 2 puffs bid arm 2: None arm 3: R343 1mg, 1 puff bid
Interventions: intervention 1: Placebo intervention 2: R940343 1mg intervention 3: R940343 2mg
Intervention descriptions: intervention 1: 1 puff bid or 2 puffs bid intervention 2: R343 1mg, 1 puff bid intervention 3: R343 2mg, 2 puffs bid

Protocol documents:
Clinical trial NCT01591161
Conditions: Cataract Inflammation Surgery
Sponsor: Bausch & Lomb Incorporated
Start date: 2012-07-01; Completion date: 2013-07-01
Enrollment: 369 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Detailed description:

Arms: arm 1: Mapracorat ophthalmic suspension, 3%, arm 2: The vehicle of the mapracorat ophthalmic suspension
Interventions: intervention 1: Mapracorat intervention 2: Placebo
Intervention descriptions: intervention 1: 1 drop of study medication into the study eye QID for 14 days intervention 2: 1 drop of vehicle into the study eye QID for 14 days.

Protocol documents: