ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01951820
Conditions: Anesthesia of Mucous Membrane
Sponsor: University of Michigan
Start date: 2013-08-01; Completion date: 2014-06-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The efficacy of the topical anesthetics will be determined by how much pain the patient felt (using a Heft-Parker pain analog scale) upon needle penetration.

Detailed description:
This project will be a double blind study comparing the efficacy of two different topical anesthetics used to reduce the pain associated with insertion of dental needles on the palatal mucosa. The two topical anesthetics being compared are 20% Benzocaine, and Pliaglis.

In order to complete a number of different dental procedures, it is often necessary to provide local anesthesia of the palate. Intraoral injections into the palatal mucosa are often uncomfortable and even painful. In an effort to increase patient comfort, a topical anesthetic is often used prior to the injection. Test subjects undergoing routine endodontic treatment on maxillary teeth will have a 27- gauge dental needle inserted into the mucosa of the hard palate as part of the initial step in standard local anesthetic injection. At the injection site and prior to the needle stick, the mucosa will be topically anesthetized by using one of the two different test compounds (Benzocaine or Pliaglis). After the injection, patients will be asked to score the level of discomfort associated with the needle stick.

The purpose of the project is to determine if there is a clinical difference in the level of pain felt upon needle stick, between the two different topical anesthetics.

Arms: arm 1: Benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine. arm 2: Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.
Interventions: intervention 1: Pliaglis intervention 2: Benzocaine intervention 3: Articaine
Intervention descriptions: intervention 1: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic. intervention 2: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic. intervention 3: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed

Protocol documents:
Clinical trial NCT01968707
Conditions: Bacterial Reduction on Skin Flora Post-product Application
Keywords: surgical prep CHG IPA
Sponsor: Solventum US LLC
Start date: 2013-10-01; Completion date: 2014-06-01
Enrollment: 426 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

Detailed description:
The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70%.

On the abdominal sites, a responder is defined as a subject with a 2-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

On the inguinal sites, a responder is defined as a subject with a 3-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

Arms: arm 1: Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. arm 2: Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. arm 3: Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. arm 4: Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Interventions: intervention 1: ChloraPrep Hi-Lite Orange intervention 2: Normal saline intervention 3: 3M CHG/IPA Prep Tint 10.5-mL intervention 4: 3M CHG/IPA Prep Tint 26-mL
Intervention descriptions: intervention 1: Apply topically. intervention 2: Apply topically. intervention 3: Apply topically. intervention 4: Apply topically

Protocol documents:
Clinical trial NCT01975285
Conditions: Foot and Ankle Procedures
Keywords: Pain management Postoperative opioid requirements Perioperative outcomes Dexamethasone Anesthetic adjuvant Analgesic adjuvant
Sponsor: Cedars-Sinai Medical Center
Start date: 2013-08-01; Completion date: 2014-06-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study to evaluate the effects of dexamethasone as an addition to peripheral nerve block (Put the nerve to sleep with Bupivacaine a numbing medication) on length of pain relief (analgesia), postoperative narcotic (opioids) requirements, pain scores, and patient satisfaction after foot and ankle procedures.

Detailed description:

Arms: arm 1: Dexamethasone 4mg(1 ml) per 20cc arm 2: Saline 1 ml per 20cc
Interventions: intervention 1: Dexamethasone intervention 2: Saline
Intervention descriptions: intervention 1: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc intervention 2: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc

Protocol documents:
Clinical trial NCT01981772
Conditions: Orofacial Swelling
Sponsor: Ohio State University
Start date: 2013-03-01; Completion date: 2014-06-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the clinical efficacy of a buffered 4% lidocaine solution for incision and drainage. Ninety patients will be examined clinically to determine a diagnosis of cellulitis or fluctuance. The diagnosis will be confirmed by incision and drainage. Patients will receive either 3.6 ml 4% lidocaine with 1:100,000 epinephrine or 3.6 ml 4% lidocaine with 1:100,000 epinephrine buffered with 8.4% sodium bicarbonate. Patients will rate pain prior to and throughout the procedure.

Detailed description:
Incision and drainage of swellings is painful and anesthetic failure is common. One reason may be related to the lowered pH of inflamed tissue reducing the amount of the base form of anesthetic. A buffered anesthetic solution may result in more effective anesthesia than a non-buffered solution.

Arms: arm 1: administration of 4% buffered lidocaine with 1:100,000 epinephrine arm 2: administration of 4% lidocaine with 1:100,000 epinephrine
Interventions: intervention 1: 4% lidocaine with 1:100,000 epinephrine intervention 2: 4% buffered lidocaine with 1:100,000 epinephrine
Intervention descriptions: intervention 1: see arm/group description intervention 2: see arm/group description

Protocol documents:
Clinical trial NCT01995136
Conditions: Normal Tension Glaucoma Ocular Hypertension
Keywords: Glaucoma Ocular hypertension
Sponsor: Alcon Research
Start date: 2013-09-01; Completion date: 2014-06-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate IOP reduction efficacy of travoprost 0.004% ophthalmic solution (TRAVATAN Z®) in subjects with normal tension glaucoma.

Detailed description:

Arms: arm 1: Travoprost Ophthalmic Solution 0.004%, 1 drop instilled in each eye once daily at 9PM for 3 months.
Interventions: intervention 1: Travoprost Ophthalmic Solution 0.004%
Intervention descriptions: intervention 1: benzalkonium chloride (BAC) free

Protocol documents:
Clinical trial NCT01995461
Conditions: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
Sponsor: Marshfield Clinic Research Foundation
Start date: 2013-05-01; Completion date: 2014-06-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The most common forms of injection used for the treatment of degenerative lumbar spinal stenosis (DLSS) patients with neurogenic claudication (NC) are the caudal and inter-laminar epidural injections of anesthetic and steroid. Unilateral transforaminal epidural steroid injections (TESI) are also used to alleviate patients' symptoms of NC from DLSS, particularly in patients whose level of stenosis is L4-5 or higher. However, these unilateral injections do not cross the midline, so in cases of lower extremity pain and symptoms on both sides, a bilateral TESI would probably be more beneficial.

To date, there have not been any well designed prospective studies to determine the effectiveness of bilateral TESI below the level of stenosis in DLSS patients with NC. Therefore, the goal of this prospective, non-randomized case-series outcome study is to evaluate the effectiveness of BTESI in alleviating symptoms of NC, as well as improving function in patients with DLSS. The hypothesis is that BTESI at the level below the most stenotic segment of the central canal of the lumbar spine decreases symptoms of NC and improves function in patients with DLSS.

Detailed description:

Arms: arm 1: a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)
Interventions: intervention 1: bilateral transforaminal epidural steroid injections
Intervention descriptions: intervention 1: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection.

Protocol documents:
Clinical trial NCT02006056
Conditions: Nausea Vomiting
Sponsor: Sunnybrook Health Sciences Centre
Start date: 2013-11-01; Completion date: 2014-06-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to examine the efficacy of Ondissolve for the prevention/rescue of Acute and Delayed Phase radiation induced nausea and vomiting (RINV) in patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for painful bone metastases. The study population will be 30 patients seen in the RRRP at the Sunnybrook Odette Cancer Centre receiving palliative radiation therapy considered emetogenic for bone metastases. Patients will take the study medication (Ondissolve 8 mg) twice on each day of radiation therapy, at least one hour prior to treatment and repeat approximately 6-8 hours later the same day. Patients undergoing multiple fraction radiation therapy will take Ondissolve on weekends or holidays in between treatment. Secondary objectives include to evaluate key secondary endpoints related to RINV, and to investigate the ease and length of administration of protocol medicine. We hypothesize that Ondissolve will be effective in the prophylaxis of RINV, and the ease of use and administration will provide an appropriate delivery method for those unable to tolerate the oral form of ondansetron.

Detailed description:

Arms: arm 1: Patients already experiencing mild nausea/vomiting within 24 hours before radiotherapy. Intervention is 8mg of ondansetron (Ondissolve) on the day of radiation treatment at least 1 hour prior to treatment and repeated approx. 608 hours later in the day (bid). For patients who are treated with 20Gy/5 fractions, or 30Gy/10 fractions, they will take ondansetron twice (bid) on each day of treatment, at least 1 hour prior to treatment, and also on weekends or holidays in between treatment. arm 2: Patients experiencing no nausea and vomiting 24 hours before commencement of radiotherapy. Intervention is 8mg of ondansetron (Ondissolve) on the day of radiation treatment at least 1 hour prior to treatment and repeated approx. 608 hours later in the day (bid). For patients who are treated with 20Gy/5 fractions, or 30Gy/10 fractions, they will take ondansetron twice (bid) on each day of treatment, at least 1 hour prior to treatment, and also on weekends or holidays in between treatment.
Interventions: intervention 1: Ondansetron
Intervention descriptions: intervention 1: Patients will take Ondissolve (8mg) on the day of the radiation treatment at least one hour prior to treatment and repeat approximately 6-8 hours later in the day (bid). For patients who are being treated with 20Gy in 5 fractions, or 30 Gy in 10 fractions, this group will take Ondissolve twice (bid) on each day of treatment, at least 1 hour prior to treatment and also on weekends or holidays in between treatment.

Protocol documents:
Clinical trial NCT02007863
Conditions: Leukemia Myelodysplasia Acute Lymphocytic Leukemia Acute Myelogenous Leukemia
Keywords: Leukemia Myelodysplasia Acute lymphocytic leukemia ALL Acute myelogenous leukemia AML Pediatric
Sponsor: University of Miami
Start date: 2008-08-01; Completion date: 2014-06-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Unrelated Cord Blood (UCB) transplant in children is a viable stem cell transplant modality for patients with leukemia and myelodysplasia. UCB is now considered "Standard Of Care" in cases where a suitable living bone marrow donor is not available. The survival of UCB is similar to Matched Unrelated Marrow Transplant. This study is considered "Research" since UCB is not a licensed product and requires investigational new drug (IND). THERE ARE NO SPECIFIC RESEARCH QUESTIONS IN THIS PROTOCOL. This protocol merely provides UCB as a stem cell treatment modality to pediatric patients who may require it after a conditioning regimen that excludes Total Body Irradiation.

Detailed description:
The preparative regimen will consist of:

* Fludarabine: 25 mg/m2/day IV x 5 doses on Days -13, to -9
* Busulfan 1mg/kg IV every 6 hrs x 16 doses on Days -8 to -5
* Melphalan 45 mg/m2/day IV x 3 doses on days -4 to -2
* ATGAM 30mg/kg/day x 3 doses on Days -3 to -1
* Day 0 will be the day of the UCB Transplant
* The graft-versus-host-disease (GVHD) prophylaxis will be Cyclosporin A to maintain level 200-400 beginning on Day -3, through 200-400. Solumedrol at 1mg/kg/day on Day 1 until D+4, then solumedrol 2mg/kg/day until Day +19 or till absolute neutrophil count (ANC) reaches 500/mm2, then taper by 0.2 mg/kg/week.

Arms: arm 1: Umbilical Cord Blood transfusion + Chemotherapy (Fludarabine + Busulfan + Melphalan)
Interventions: intervention 1: Umbilical Cord Blood Transfusion intervention 2: Fludarabine intervention 3: Busulfan intervention 4: Melphalan
Intervention descriptions: intervention 1: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0 intervention 2: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days -13 through -9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight. intervention 3: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered. intervention 4: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days -4 through -2 for a total of 3 doses.

Protocol documents:
Clinical trial NCT02013531
Conditions: Major Depressive Disorder Anxiety
Keywords: schizophrenia Major depressive disorder Anxiety Symptoms Mental Disorders Psychotic Disorders emotional withdrawal antipsychotic
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2013-11-01; Completion date: 2014-06-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment in subjects with major depressive disorder and anxiety symptoms, who are experiencing an inadequate selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) response.

Detailed description:

Arms: arm 1: Up to 3 mg/day, once daily dose, tablets, orally
Interventions: intervention 1: Brexpiprazole
Intervention descriptions: intervention 1: Treatment (6 weeks) - Up to 3mg/day, once daily dose, tablets, orally

Protocol documents:
Clinical trial NCT02030535
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2014-01-01; Completion date: 2014-06-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to evaluate the efficacy and safety of orally inhaled tiotropium and olodaterol as both a fixed dose combination and a free combination with respect to lung function and ECG parameters

Detailed description:

Arms: arm 1: patient will receive tiotropium and olodaterol in a fixed dose combination arm 2: patient will receive tiotropium and olodaterol in a free combination arm 3: patient will receive placebo
Interventions: intervention 1: olodaterol intervention 2: tiotropium intervention 3: Placebo intervention 4: tiotropium intervention 5: olodaterol
Intervention descriptions: intervention 1: free combination with tiotropium intervention 2: free combination with olodaterol intervention 3: None intervention 4: fixed dose combination with olodaterol intervention 5: fixed dose combination with tiotropium

Protocol documents:
Clinical trial NCT02076919
Conditions: Age-Related Macular Degeneration
Keywords: LHA510 First in human Safety Tolerability Pharmacokinetics Elderly Age-Related Macular Degeneration AMD Ocular Eye drop
Sponsor: Alcon Research
Start date: 2014-02-01; Completion date: 2014-06-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this first-in-human study is to assess the local ocular and systemic safety and tolerability of LHA510 eye drops when administered at various concentrations and dosing frequencies.

Detailed description:
This first-in-human study was conducted in two parts. Part 1 was a single ascending dose (SAD) design to assess the local ocular and systemic safety and tolerability of a single topical eye drop of LHA510 administered at various concentrations. Four separate cohorts of unique elderly subjects (55 to 80 years) were utilized, with each cohort randomized to receive either topical LHA510 or vehicle in a 3:1 ratio as a single dose. A disposition evaluation was performed 7 days later. Part 2 was a multiple ascending dose (MAD) design to assess the local ocular and systemic safety and tolerability of LHA510 administered at various concentrations and dosing frequencies. Six separate cohorts of unique AMD subjects were utilized, with each cohort randomized to receive either topical LHA510 or vehicle in a 3:1 ratio for 7 days. A disposition evaluation was performed 14 days after the first dose of study drug. A review of all available safety data was conducted by the Sponsor and the PI(s) prior to dose escalation (cohort progression). The same concentrations levels were used in Part 1 and Part 2 and are ordered as Lowest, Next Lowest, Next Highest, and Highest.

Arms: arm 1: LHA510 Ophthalmic Suspension in 1 of 4 concentrations, 1 drop instilled in the study eye as a single dose during Part 1 arm 2: Inactive ingredients, 1 drop instilled in the study eye as a single dose during Part 1 arm 3: LHA510 Ophthalmic Suspension in 1 of 4 concentrations, 1 drop instilled in the study eye once, twice, or three times daily for 7 days during Part 2 arm 4: Inactive ingredients, 1 drop instilled in the study eye once, twice, or 3 times daily for 7 days during Part 2
Interventions: intervention 1: LHA510 Ophthalmic Suspension intervention 2: LHA510 Vehicle
Intervention descriptions: intervention 1: Ophthalmic suspension in 4 concentration levels topically administered in Part 1 and Part 2 intervention 2: Inactive ingredients used for masking purposes

Protocol documents:
Clinical trial NCT02093819
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-04-01; Completion date: 2014-06-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics (PK) of single rising doses of BI 416970. A further objective is to assess the influence of CYP2C9 phenotype on the PK of BI 416970.

Detailed description:

Arms: arm 1: single rising dose given as tablet
Interventions: intervention 1: Placebo to BI 416970 intervention 2: BI 416970
Intervention descriptions: intervention 1: single rising doses intervention 2: single rising doses

Protocol documents:
Clinical trial NCT02096744
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-03-01; Completion date: 2014-06-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To establish the bioequivalence and adhesion properties of transdermal clonidine prepared with Oppanol® brands of polyisobutylene (PIB) vs. transdermal clonidine prepared with VistanexTM brands of polyisobutylene (PIB) in healthy male and female volunteers.

Detailed description:

Arms: arm 1: subject to receive 0.3 mg/24 hr Catapres-TTS-3 Oppanol (T1) first, followed by Catapres-TTS-3 Vistanex (R1) arm 2: subject to receive 0.3 mg/24 hr Catapres-TTS-3 Vistanex (R1) first, followed by Catapres-TTS-3 Oppanol (T1) arm 3: subject to receive 0.1 mg/24 hr Catapres-TTS-1 with Oppanol (T2) and Vistanex (R2) simultaneously
Interventions: intervention 1: Catapres-TTS-1 intervention 2: Intervention 1: Catapres-TTS-3 intervention 3: Intervention 1: Catapres-TTS-3 intervention 4: Intervention 2: Catapres-TTS-3 intervention 5: Catapres-TTS-1 intervention 6: Intervention 2: Catapres-TTS-3
Intervention descriptions: intervention 1: Catapres-TTS-1 Oppanol intervention 2: Catapres-TTS-3 Oppanol intervention 3: Catapres-TTS-3 Oppanol intervention 4: Catapres-TTS-3 Vistanex intervention 5: Catapres-TTS-1 Vistanex intervention 6: Catapres-TTS-3 Vistanex

Protocol documents: