ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01754766
Conditions: Allergic Conjunctivitis
Sponsor: Allergan
Start date: 2012-10-01; Completion date: 2013-02-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis.

Detailed description:

Arms: arm 1: One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15. arm 2: One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15. arm 3: One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
Interventions: intervention 1: AGN-229666 intervention 2: vehicle of AGN-229666
Intervention descriptions: intervention 1: One drop of AGN-229666 into each eye on Day 1 and Day 15. intervention 2: One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.

Protocol documents:
Clinical trial NCT01761565
Conditions: Plasma Concentrations
Sponsor: Talphera, Inc
Start date: 2013-01-01; Completion date: 2013-02-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs

Detailed description:

Arms: arm 1: Period 1: Single dose of SUF NT 15 mcg

Period 2: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
Interventions: intervention 1: Single dose of SUF NT 15 mcg intervention 2: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01766466
Conditions: Coronary Artery Disease
Sponsor: The Medicines Company
Start date: 2013-01-01; Completion date: 2013-02-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
To demonstrate that patients treated with cangrelor can be directly switched to oral ticagrelor and that patients treated with ticagrelor can be switched to cangrelor without a significant decrease in the extent of inhibition of platelet aggregation.

Detailed description:

Arms: arm 1: On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h after the initiation of cangrelor infusion. arm 2: On Day 1: Following completion of cangrelor and ticagrelor dosing, patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 7 doses (12, 24, 36, 48, 60, 72, and 84 h).

On Day 5: 12 h post last ticagrelor dose (90 mg), patients received another open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. arm 3: On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 1.5 h after the initiation of cangrelor infusion. arm 4: On Day 1: Following completion of cangrelor and ticagrelor dosing, patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 6 doses (12, 24, 36, 48, 60, and 72 h).

On Day 5: 24 h post last ticagrelor dose (90 mg), patients received another open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.
Interventions: intervention 1: cangrelor intervention 2: Ticagrelor
Intervention descriptions: intervention 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. intervention 2: Ticagrelor 180mg dose: administered 0.5 h or 1.5h after the initiation of cangrelor infusion

Ticagrelor 90mg: 6 or 7 doses (depending on study arm) taken every 12 hours post cangrelor infusion.

Protocol documents:
Clinical trial NCT01809054
Conditions: Primary Total Hip and Knee Arthroplasty
Keywords: Hip, Knee, Arthroplasty, venous thromboembolic events, blood loss
Sponsor: LifeBridge Health
Start date: 2012-04-01; Completion date: 2013-02-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a prospective, randomized study from pre-surgery to 6 weeks post-surgery designed to detect changes in coagulability following elective total knee and hip arthroplasty. Patients will be randomized to one of the two standard prophylaxis treatments used at Sinai Hospital:

1. Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks, or
2. Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.

Detailed description:

Arms: arm 1: Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks arm 2: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Interventions: intervention 1: Arixtra intervention 2: Pneumatic compression stockings intervention 3: Aspirin
Intervention descriptions: intervention 1: None intervention 2: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) intervention 3: None

Protocol documents:
Clinical trial NCT01810042
Conditions: Exudative Age-related Macular Degeneration
Keywords: age-related macular degeneration choroidal neovascularization ranibizumab indocyanine angiography
Sponsor: Pusan National University Hospital
Start date: 2010-10-01; Completion date: 2013-02-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Exudative age-related macular degeneration (ARMD) is complicated by choroidal neovascularization (CNV). Although anti-vascular endothelial growth factor treatment is the gold standard treatment, recurrence is the main limitation of the treatment. The changes of the CNV vascular structure is expected to provide information regarding recurrence. In the eyes that the vascular structure is clearly seen in indocyanine green angiography (ICGA), the vascular changes after ranibizumab injections will be investigated prospectively.

Detailed description:
For patients having exudative ARMD with CNV, whose vascular structures are clearly demonstrated in ICGA , ranibizumab is injected monthly three times, then pro re nata to 6 months. Vascular structures of CNV is investigated at baseline, 3 and 6 months using ICGA. Expected number of patients are 48 eyes from 4 centers, competitively.

Arms: arm 1: 0.5mg of ranibizumab is injected into the vitreous cavity monthly 3 times for the 3 months then pro-re-nata (PRN) for following 3 months.
Interventions: intervention 1: ranibizumab
Intervention descriptions: intervention 1: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.

Protocol documents:
Clinical trial NCT01817790
Conditions: Allergic Rhinitis Seasonal Allergic Rhinitis
Sponsor: GlaxoSmithKline
Start date: 2012-12-01; Completion date: 2013-02-01
Enrollment: 626 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to investigate the efficacy of fluticasone propionate (FP) on ocular symptoms associated with allergic rhinitis (AR).

Detailed description:
While the current FP approved indication for GSK marketed formulation is limited to the treatment of nasal symptoms, several large well-controlled studies in which FP maintained adequate control of nasal symptoms when administered in a dose of 200 micrograms (mcg) once-daily (QD) also suggested improvement in ocular symptoms. This study will employ a randomized, double-blind, parallel group, multi-center design that compares FP and placebo nasal sprays in subjects with seasonal allergic rhinitis (SAR) to assess the effectiveness on ocular symptoms associated with AR.

Arms: arm 1: Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning. arm 2: Two sprays of placebo per nostril to be administered in morning.
Interventions: intervention 1: Fluticasone propionate intervention 2: Placebo
Intervention descriptions: intervention 1: Nasal spray formulation (200 mcg/day) intervention 2: Vehicle for Fluticasone propionate aqueous nasal spray

Protocol documents:
Clinical trial NCT01859715
Conditions: Drug Interactions
Keywords: Drug Interactions CYP2D6 opioid efficacy pain nausea
Sponsor: University of Colorado, Denver
Start date: 2012-06-01; Completion date: 2013-02-01
Enrollment: 502 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study examines how hepatic cytochrome CYP2D6 drug interactions affects the efficacy of oxycodone, hydrocodone, and ondansetron in Emergency Department (ED) patients.

Detailed description:
Patients with pain and/or nausea are enrolled in the Emergency Department (ED). They are given either oxycodone, hydrocodone, or ondansetron at the discretion of the Emergency Department (ED) provider or the triage nurse by triage protocol. Detailed prescription, over the counter, herbal, supplement, and illicit drug ingestion histories are taken from the patient or their health care proxy. Serial visual analogue scales are captured prior to study drug administration then between 30 and 90 minutes following drug administration.

Arms: arm 1: Subjects given either oxycodone 5mg by ED provider decision or by triage nurse randomization. arm 2: Patients given ondansetron 4mg by ED provider decision or by triage nurse. This is an observational cohort only. arm 3: Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
Interventions: intervention 1: Oxycodone intervention 2: Hydrocodone intervention 3: Ondansetron
Intervention descriptions: intervention 1: Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization. intervention 2: Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization. intervention 3: Subjects given ondansetron 4mg for reported nausea or vomiting. Treatment determined either by triage nursing protocol or by provider discretion. Observational intervention only.

Protocol documents:
Clinical trial NCT01999894
Conditions: Autism Pediatric Autism
Keywords: Namenda Autism Memantine Pediatric Forest Laboratories
Sponsor: Forest Laboratories
Start date: 2009-11-01; Completion date: 2013-02-01
Enrollment: 102 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of autism in pediatric patients.

Detailed description:
This is a 48-week multicenter extension study comprised of a 6-week double-blind dose-titration period followed by a 42-week open-label maintenance period.

In the Forest autism trials conducted in children ages 6-12, dosing with an extended release formulation of memantine was weight-based. These weight based dose limits were selected to ensure exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng∙h/mL that represented a 10-fold lower exposure than observed at the NOAEL (No observed adverse effect level) of 15 mg/kg/day in juvenile rats.

The weight-based dose limits in these studies were as follows:

* Group A: ≥ 60 kg; max 15 mg/day
* Group B: 40-59 kg; max 9 mg/day
* Group C: 20-39 kg; max 6 mg/day
* Group D: \< 20 kg; max 3 mg/day

Arms: arm 1: Once daily oral administration of memantine for 48 weeks: 6-week double-blind dose-titration period followed by a 42-week maintenance period.
Interventions: intervention 1: Memantine HCl
Intervention descriptions: intervention 1: Memantine extended release 3- and 6-mg capsules; dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for 48 weeks.

Protocol documents:
Clinical trial NCT02003534
Conditions: Glaucoma, Open-Angle Ocular Hypertension
Sponsor: Allergan
Start date: 2010-07-01; Completion date: 2013-02-01
Enrollment: 376 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate 0.15% brimonidine tartrate in patients with primary open angle glaucoma and ocular hypertension.

Detailed description:

Arms: arm 1: 0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
Interventions: intervention 1: 0.15% Brimonidine Tartrate
Intervention descriptions: intervention 1: 0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.

Protocol documents:
Clinical trial NCT02058290
Conditions: Bowel Obstruction
Keywords: laparoscopic colectomy
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2011-12-01; Completion date: 2013-02-01
Enrollment: 122 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospital costs.

Detailed description:
This is a Phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with EXPAREL (bupivacaine liposome injectable suspension) compared with postsurgical administration of standardized intravenous (IV) morphine sulfate or Sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing laparoscopic colectomy with general anesthesia.

Arms: arm 1: Standard of Care (SOC) arm 2: EXPAREL (bupivacaine liposome injectable suspension)
Interventions: intervention 1: IV morphine sulfate or Sponsor-approved equivalent intervention 2: EXPAREL
Intervention descriptions: intervention 1: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU is less than one hour. intervention 2: Patients will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.

All patients will be offered rescue analgesia, as needed.

Protocol documents:
Clinical trial NCT02140788
Conditions: Schizophrenia Schizo-affective Disorder
Keywords: schizophrenia schizo-affective disorder
Sponsor: Duke University
Start date: 2011-05-01; Completion date: 2013-02-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
One purpose of this study is to test whether adding metformin will limit some of the unwanted effects of clozapine, compared to not adding metformin. Metformin is a medication that is approved by the United States Food and Drug Administration (FDA) for the treatment of type-2 diabetes. Studies have found that people with type-2 diabetes often lose some weight when they take metformin, however the FDA has not approved metformin for weight loss, so for this study the use of metformin is investigational. This study will test whether metformin can help people with schizophrenia or schizoaffective disorders lose weight.

Another purpose of this study is to test whether adding fish oil will improve the benefit of clozapine and/or limit some of the unwanted effects of clozapine, compared to not adding fish oil. Fish oil is a medication used to reduce levels of some fats (triglycerides) in blood. Some studies have found that adding fish oil reduces psychosis (voices, suspiciousness). However the FDA has not approved fish oil for reducing psychosis, so for this study the use of fish oil is investigational. This study will test whether fish oil can help people with schizophrenia or schizoaffective disorders have less psychosis. Fish oil is not an antipsychotic medication.

Detailed description:

Arms: arm 1: Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose. arm 2: Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID. arm 3: Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study. arm 4: Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
Interventions: intervention 1: Metformin intervention 2: Fish Oil
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01897077
Conditions: Peanut Allergy
Keywords: Food Allergy Peanut Sublingual Immunotherapy
Sponsor: Johns Hopkins University
Start date: 2012-11-01; Completion date: 2013-02-03
Enrollment: 5 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if a new method of administration of peanut sublingual immunotherapy, a dissolving peanut film, is effective.

Detailed description:
Peanut allergy is a common problem with no current treatment. Recent studies have shown some success with oral or sublingual immunotherapy for the treatment of food allergy. Oral treatment, which requires very high doses, is associated with a small but appreciable risk of systemic reactions. Sublingual immunotherapy, which utilizes much smaller doses, is safer but constraints inherent in the available methods of sublingual administration have limited the utility of this method. Typically sublingual immunotherapy for food allergy has used either fresh foods or a simple liquid extract. These methods are not optimized for practicality or dwell duration in the mouth, and, thus far, dosing has been limited by the ability to make concentrated extracts and by the volume of extract that can be applied to the sublingual space. This study is being conducted to determine if a dissolving peanut extract film, will improve efficacy for immunotherapy for peanut allergy.

Arms: arm 1: Only one intervention will be given. Peanut allergic study subjects, will receive gradually increasing doses of the dissolving peanut film. arm 2: Healthy volunteers will receive active peanut dissolving films in an expedited manner in order to determine safety dissolving films.
Interventions: intervention 1: Peanut Dissolving Film
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01573624
Conditions: Asthma
Keywords: Fluticasone Furoate Vilanterol Adults GSK573719 Asthma
Sponsor: GlaxoSmithKline
Start date: 2012-04-03; Completion date: 2013-02-04
Enrollment: 421 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Brief Summary: The purpose of this study is to characterize the dose response of GSK573719 in combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with inhaled Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active control.

Detailed Description: Long acting muscarinic receptor antagonists (anti-cholinergic bronhcodilator) exert their effects via distinct and complementary bronchodilator mechanisms on large and small airways. Most of the experience with older anti-cholinergics had been with acute use and little is known about their effect in chronic use in asthma. This is a multicenter, randomized, double-blind, crossover study to evaluate 5 doses of inhaled GSK573719 inhaled over 14 days in patients with asthma. Fluticasone furoate (100 mcg) and Fluticasone furoate/Vilanterol (100/59mcg) will be included as an active comparator. Each eligible subject will receive a sequence of 3 of 7 potential treatments for a total of 3 treatment periods per subject. The total duration of subject participation is approximately 14 weeks.

Detailed description:

Arms: arm 1: 100mcg, inhaled arm 2: 100/25mcg inhaled arm 3: 100/15.6-250mcg inhaled
Interventions: intervention 1: FF/GSK573719 intervention 2: FF/GSK573719 intervention 3: FF/GSK573719 intervention 4: FF/GSK573719 intervention 5: FF/GSK573719 intervention 6: FF intervention 7: FF/VI
Intervention descriptions: intervention 1: 100/15.6 intervention 2: 100/31.25 intervention 3: 100/62.5 intervention 4: 100/125 intervention 5: 100/250 intervention 6: 100 intervention 7: 100/25

Protocol documents:
Clinical trial NCT00866333
Conditions: Hodgkin's Lymphoma
Keywords: Hodgkin's Lymphoma Relapsed Hodgkin's Lymphoma Refractory Hodgkin's Lymphoma
Sponsor: Syndax Pharmaceuticals
Start date: 2009-04-13; Completion date: 2013-02-08
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of entinostat, SNDX-275, in patients with relapsed or refractory Hodgkin's lymphoma.

Detailed description:

Arms: arm 1: Regimen determined by protocol version.

Regimen 1: entinostat 10 mg (two 5 mg tablets) orally, once every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity.

Regimen 2: entinostat 10 mg (two 5 mg tablets) orally on Day 1, increased to 15 mg (three 5 mg tablets) beginning on Day 15 of Cycle 1 for participants who had not experienced treatment-related adverse events with severity grade ≥2 (moderate), then continue 15 mg every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity.

Regimen 3: entinostat 15 mg (three 5 mg tablets), orally, once weekly for 3 weeks followed by a 1-week break in a 4-week (28-day) cycle until disease progression or unacceptable toxicity.
Interventions: intervention 1: Entinostat
Intervention descriptions: intervention 1: Entinostat tablets

Protocol documents: