ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01916590
Conditions: Post-operative Pain
Keywords: Post-operative pain Anterior Cruciate Ligament repair
Sponsor: University of Colorado, Denver
Start date: 2011-07-01; Completion date: 2014-05-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Both single shot femoral nerve block and continuous femoral nerve block with catheter have been shown to be effective for pain control after anterior cruciate ligament reconstruction (ACLR). Continuous femoral nerve block may be the more effective of the two in reducing pain scores and opioid consumption for the first 48 hours postoperatively.

Detailed description:
The number of ambulatory procedures has steadily increased over the last decade. Postoperative pain is the most common cause of delayed discharge and unexpected admission after ambulatory surgery. Knee surgery was identified as one of the procedures associated with the most pain at 24 hours, with a 45% or higher incidence of moderate or severe pain. Poor pain control can counteract many of the benefits of ambulatory surgery and can lead to the development of chronic pain.

Regional techniques have been shown to be effective after ACL reconstruction, allowing faster patient recovery with fewer side-effects than intravenous administration of opioids. Different regional techniques have been applied and studied after ACLR. Femoral nerve block for ACLR either as a single bolus or as a continuous infusion markedly decreases intravenous analgesic requirements and postoperative pain. To the Investigator's knowledge, no study has compared these two techniques after ACLR with patellar tendon graft or allograft.

Arms: arm 1: All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter. arm 2: All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.
Interventions: intervention 1: Bupivicaine intervention 2: placebo
Intervention descriptions: intervention 1: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter. intervention 2: None

Protocol documents:
Clinical trial NCT01922349
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-08-01; Completion date: 2014-05-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 113608 in healthy Chinese, Japanese and Caucasian male volunteers.

Detailed description:

Arms: arm 1: Placebo arm 2: Low dose arm 3: Medium dose arm 4: High dose arm 5: Low dose arm 6: Medium dose arm 7: High dose arm 8: Placebo
Interventions: intervention 1: BI 113608 intervention 2: Placebo intervention 3: BI 113608 intervention 4: Placebo intervention 5: BI 113608 intervention 6: BI 113608 intervention 7: BI 113608 intervention 8: BI 113608
Intervention descriptions: intervention 1: Medium dose (Multiple dosing) intervention 2: Placebo (Multiple dosing) intervention 3: Low dose (Multiple dosing) intervention 4: Placebo (Single dosing) intervention 5: High dose (Single dosing) intervention 6: Medium dose (Single dosing) intervention 7: Low dose (Single dosing) intervention 8: High dose (Multiple dosing)

Protocol documents:
Clinical trial NCT01926977
Conditions: Neovascular Age-Related Macular Degeneration
Sponsor: Arshad Khanani
Start date: 2013-09-01; Completion date: 2014-05-01
Enrollment: 100 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to compare the post injection inflammation and pain seen after intravitreal injections of Ranibizumab vs Aflibercept.

Detailed description:
This is an open-label, Phase I-II study of post injection pain and inflammation after intravitreally administered Ranibizumab and Aflibercept in 100 subjects with Neovascular Age-Related Macular Degeneration. We will enroll both treatment experienced ( patients who were treated with Lucentis or Eylea, but not Avastin in the past) and treatment naive patients ( new onset Neovascular AMD with no history of intravitreal injections).

The treatment experienced patients will be treated with the intravitreal medication other than what they were receiving in the past, for example, patients treated with Lucentis will switch to Eylea for study purposes and vice versa.

Consented, enrolled subjects will receive open-label intravitreal injection of either 0.5mg Ranibizumab or 2mg Aflibercept. A standard intravitreal injection protocol will be followed. Patients will be reevaluated between 24-48 hours and 5-7 days post injections. A non-injecting physician will evaluate the patients for anterior chamber inflammation; this physician will be blinded about the specific treatment. Anterior chamber inflammation is described as any cell or flare in the anterior chamber. These will be evaluated using Standardization of Uveitis Nomenclature (SUN) working group classifications.

Pain score will be evaluated using a Numerical Rating Scale. Each patient will have a standard script verbally read to them at their visit, and asked to rate their pain based on this scale.

Arms: arm 1: Intravitreal injection of Ranibizumab 0.5mg once arm 2: Intravitreal Aflibercept 2.0mg once
Interventions: intervention 1: Ranibizumab 0.5mg intervention 2: Aflibercept 2.0mg
Intervention descriptions: intervention 1: Patient will receive intravitreal injection of Ranibizumab 0.5mg. intervention 2: Patients will receive intravitreal injection of Aflibercept 2.0mg.

Protocol documents:
Clinical trial NCT01928693
Conditions: Corneal Ulcers
Keywords: infectious corneal ulcers
Sponsor: Cornea Consultants Of Nashville
Start date: 2013-07-01; Completion date: 2014-05-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase II study will evaluate the safety and efficacy of three fluoroquinolone ophthalmic agents to determine the optimal treatment in patients with infectious corneal ulcers.

Detailed description:
This is a prospective, single masked, comparative, mono-therapeutic trial evaluating three fluoroquinolone agents that are approved and marketed for the treatment of conjunctivitis. Approximately 120 patients who have corneal ulcers greater than 2 mm but less than 6 mm in size who meet all other inclusion criteria will be enrolled into this study. Patients will be randomized in a 2:1:1 ratio to receive besifloxacin 0.6% ophthalmic suspension, gatifloxacin 0.5% ophthalmic solution, or moxifloxacin 0.5% ophthalmic solution.

Arms: arm 1: A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis. arm 2: A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. arm 3: A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Interventions: intervention 1: Besivance 0.6% Ophthalmic Suspension intervention 2: Zymaxid 0.5% Ophthalmic Solution intervention 3: Vigamox 0.5% Ophthalmic Solution
Intervention descriptions: intervention 1: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours. intervention 2: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours. intervention 3: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours.

Protocol documents:
Clinical trial NCT01929980
Conditions: Allogeneic Stem Cell Transplantation Refractory Autoimmune Cytopenia(s)
Keywords: HSCT cytopenia immune suppression proteasome inhibitor
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2012-07-01; Completion date: 2014-05-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to study the safety and effectiveness of a drug called Bortezomib for the treatment of low blood cell counts after bone marrow transplant.

Detailed description:
The purpose of this research study is to study the safety and effectiveness of a drug called bortezomib for the treatment of autoimmune cytopenia(s) (low blood cell counts) after bone marrow transplant that are not responding to standard treatments. Autoimmune cytopenias are low blood counts due to antibodies or proteins produced against an individual's own blood cells. Having a low red blood cell count (anemia) can make a person feel tired and require blood transfusions frequently. A low platelet count (blood cells that help blood to clot) can make a person bleed or bruise easily. A low neutrophil (white blood cell) count can make a person have infections.

All of these things can be a serious complication after bone marrow transplant and can cause prolonged hospital stay. Bortezomib is being used in children with certain types of blood cancer, however, bortezomib has not been used in children with autoimmune cytopenia(s) and its use in this study is investigational.

Arms: arm 1: Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.

The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11
Interventions: intervention 1: Bortezomib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01937312
Conditions: Ocular Hypertension Open Angle Glaucoma
Keywords: glaucoma prostaglandin analogue brinzolamide brimonidine
Sponsor: Alcon Research
Start date: 2013-10-01; Completion date: 2014-05-01
Enrollment: 282 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.

Detailed description:
This study was divided into 2 sequential phases. The Screening/Eligibility Phase included one Screening Visit and two Eligibility Visits, during which subjects washed out of all other intraocular pressure (IOP)-lowering medications and dosed with TRAVATAN Z®, XALATAN®, or LUMIGAN®, 1 drop instilled in each eye once daily for 28 days. Subjects who met all inclusion/exclusion criteria were randomized at the second Eligibility Visit. The Treatment Phase consisted of two on-therapy visits (Week 2 and Week 6).

Arms: arm 1: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks arm 2: Inactive ingredients, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
Interventions: intervention 1: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension intervention 2: Vehicle intervention 3: Prostaglandin analogue
Intervention descriptions: intervention 1: None intervention 2: Inactive ingredients used as a placebo comparator intervention 3: None

Protocol documents:
Clinical trial NCT01944371
Conditions: HIV Human Immunodeficiency Virus
Keywords: Latent reservoir
Sponsor: University of California, San Francisco
Start date: 2013-09-01; Completion date: 2014-05-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety, pharmacology and bioactivity of disulfiram in antiretroviral treated HIV-infected adults. The investigators primary hypothesis is that 3 days of disulfiram will result in an increase in HIV transcription in CD4+ T-cells in patients on suppressive antiretroviral therapy (ART).

Detailed description:
Combination antiretroviral therapy for HIV-1 infection can suppress viremia to below the detection limit in the vast majority of motivated individuals with access to these drugs. However, HIV-1 persists in a small pool of latently infected resting memory CD4+ T cells carrying integrated viral genomes. Although other reservoirs for HIV-1 exist, the general consensus among experts is that latent virus (HIV DNA in resting memory CD4+ T cells) is the primary barrier to HIV-1 eradication. A widely discussed approach for eliminating this viral reservoir requires reactivation of latent HIV-1. Disulfiram, an FDA-approved drug used to treat alcoholism was shown to activate HIV-1 gene expression in vitro, suggesting that activation of latently infected cells in vivo may occur. Our primary hypothesis is that the addition of disulfiram to a stable effective antiretroviral drug regimen will result in a dose dependent increase in HIV transcription in CD4+ T-cells in HIV-1 in patients on highly active antiretroviral therapy (HAART).

Arms: arm 1: 500mg disulfiram by mouth per day for 3 days arm 2: 1000mg disulfiram by mouth per day for 3 days arm 3: 2000mg disulfiram per mouth per day for 3 days
Interventions: intervention 1: Disulfiram
Intervention descriptions: intervention 1: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

Protocol documents:
Clinical trial NCT01945944
Conditions: Respiratory Failure
Keywords: pediatric mucolytic respiratory failure atelectasis hypertonic saline
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2013-10-01; Completion date: 2014-05-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Children who need to be on a ventilator often have thick secretions/mucus in their lungs. These secretions can obstruct the breathing tube and their windpipe, which can worsen lung function and prolong the need for the ventilator. Hypertonic saline is a medicine that is used to thin out secretions in patients with cystic fibrosis (and other conditions). We hypothesize that having children on a ventilator inhale this medication will shorten the amount of time that they need to be on the ventilator.

Detailed description:
Recent pediatric data shows that less than 80% of children mechanically ventilated for ≥ 96 hours survived to PICU discharge, while 100% of children mechanically ventilated for \< 96 hours survived to PICU discharge. Interventions that decrease duration of mechanical ventilation may improve outcome by limiting ventilator-induced lung injury, sedative medication usage and ventilator-associated pneumonia. Obstructive airway secretions may prolong mechanical ventilation by causing atelectasis and endotracheal tube obstruction, with resultant cardio-respiratory instability. Nebulized hypertonic saline (HTS) is used to decrease mucus viscosity and increase mucociliary clearance in patients with diseases such as cystic fibrosis and bronchiolitis, and has been used to enhance airway clearance in mechanically ventilated children. Administering nebulized HTS to mechanically ventilated children may facilitate airway clearance and shorten mechanical ventilation.

In a randomized study of children \< 2 years old following cardiac surgery, patients given dornase, another mucolytic agent, had a significantly decreased duration of mechanical ventilation versus those given saline placebo (52 hrs vs. 82 hrs). HTS may be even more effective, as mechanically ventilated newborns with persistent atelectasis had more improvement in radiographic findings and oxygen saturation when randomized to receive hypertonic saline compared to those randomized to receive dornase. This may be because dornase may only be effective in patients with leukocytes or bacterial present in tracheal aspirates, while HTS may be effective in all ventilated patients. Further study of the impact of prophylactic mucolytic therapy on the duration of mechanical ventilation in children is warranted.

Arms: arm 1: Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days arm 2: Hypertonic saline (3%), 3mL every 6hrs for up to 7 days
Interventions: intervention 1: Hypertonic saline (3%) intervention 2: Placebo (0.9% saline)
Intervention descriptions: intervention 1: 3mL of HTS given via nebulizer every 6hrs intervention 2: 3mL of normal saline given via nebulizer every 6hrs

Protocol documents:
Clinical trial NCT01949155
Conditions: Otitis Media With Effusion
Keywords: otitis media otorrhea middle ear effusion tympanostomy tubes
Sponsor: Otonomy, Inc.
Start date: 2013-11-01; Completion date: 2014-05-01
Enrollment: 266 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.

Detailed description:
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study of OTO-201 administered intraoperatively in pediatric subjects with bilateral middle ear effusion requiring TT (tympanostomy tube) placement. One dose level (6 mg) of OTO-201 was evaluated relative to sham (empty syringe).

Study subjects are required to have a clinical diagnosis of bilateral middle ear effusion requiring TT placement. On the day of surgery, prior to surgery, eligible subjects were examined via otoscope to confirm bilateral middle ear effusion. Subjects with bilateral middle ear effusion were randomized to either 6 mg OTO-201 or sham. Subjects without bilateral effusion on the day of surgery were not randomized and were considered screen failures.

Approximately 264 subjects are planned to be randomized to OTO-201 or sham using a 2:1 allocation ratio. Randomization to OTO-201 or sham was stratified by age: 6 months to 2 years or \>2 years.

Subjects are to visit the study site for safety assessments and otoscopic examination on Days 4, 8, 15, and 29. The assessment of otorrhea by the blinded assessor for the primary efficacy endpoint occurred on Days 4, 8, and 15.

Arms: arm 1: OTO-201: Single, intratympanic injection:

One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery. arm 2: Sham: Simulated single, intratympanic injection:

One sham injection into each ear during surgery.
Interventions: intervention 1: OTO-201 intervention 2: Sham
Intervention descriptions: intervention 1: Single, intratympanic injection intervention 2: Simulated single, intratympanic injection

Protocol documents:
Clinical trial NCT01958008
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2013-09-01; Completion date: 2014-05-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The main objective of the current trial is to investigate safety, tolerability and pharmacokinetics of BI 113608 in COPD patients with symptoms of chronic bronchitis.

Detailed description:

Arms: arm 1: Film-coated tablet, oral administration with 240 mL water arm 2: Film-coated tablet, oral administration with 240 mL water arm 3: Film-coated tablet, oral administration with 240 mL water
Interventions: intervention 1: Placebo to BI 113608 high dose b.i.d. intervention 2: Placebo to BI 113608 low dose b.i.d. intervention 3: BI 113608 high dose b.i.d. intervention 4: Placebo to BI 113608 medium dose b.i.d. intervention 5: BI 113608 low dose b.i.d. intervention 6: BI 113608 medium dose b.i.d.
Intervention descriptions: intervention 1: Film-coated tablet intervention 2: Film-coated tablet intervention 3: Film-coated tablet intervention 4: Film-coated tablet intervention 5: Film-coated tablet intervention 6: Film-coated tablet

Protocol documents:
Clinical trial NCT01967550
Conditions: Osteoarthritis, Knee
Keywords: Symptomatic knee OA Kellgren-Lawrence grade 1-3
Sponsor: Novartis
Start date: 2013-10-01; Completion date: 2014-05-01
Enrollment: 304 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of diclofenac DDEA 2.32 % in patient suffering from knee osteoarthritis (OA).

Detailed description:

Arms: arm 1: diclofenac diethylamine, DDEA 2.32% gel arm 2: Vehicle control
Interventions: intervention 1: diclofenac diethylamine, DDEA 2.32% gel intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01986062
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: ADHD AR11 classroom design amphetamine sulfate
Sponsor: Arbor Pharmaceuticals, Inc.
Start date: 2013-12-01; Completion date: 2014-05-01
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a dose-optimized, randomized, double-blind, placebo-controlled crossover study in approximately 100 pediatric patients (aged 6 to 12 years) with ADHD. Eligible patients will enroll to take open-label AR11 BID and undergo dose optimization activities for 8 weeks. Patients who achieve a stable dose during the dose optimization period will continue participation and will be randomized to take double-blind medication (AR11 or placebo) orally twice daily for 1 week. At the end of each double-blind treatment period, patients will be evaluated for ADHD symptoms in a laboratory classroom setting utilizing SKAMP and PERMP assessments.

Detailed description:
This is a dose-optimized, randomized, double-blind, placebo-controlled crossover study in approximately 100 pediatric patients (aged 6 to 12 years) with ADHD. Eligible patients will enroll in the study to take open-label AR11 twice daily and undergo dose optimization activities for 8 weeks. Patients who achieve a stable dose during the dose optimization period will continue participation and will be randomized to take double-blind medication (AR11 or placebo) orally twice daily for 1 week. At the end of the first double-blind treatment period, patients will be evaluated for ADHD symptoms in a laboratory classroom setting utilizing SKAMP and PERMP assessments. At the end of the second double blind treatment period, patients will be evaluated for ADHD symptoms in a second laboratory classroom setting utilizing SKAMP and PERMP assessments.

Arms: arm 1: AR11, administered orally, BID, for one week (crossover to placebo administration week 2) arm 2: Placebo, administered orally, BID, for one week (crossover to AR11 administration week 2)
Interventions: intervention 1: AR11 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: