ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01391312
Conditions: Glabellar Frown Lines
Sponsor: Allergan
Start date: 2011-06-01; Completion date: 2011-10-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure.

Detailed description:

Arms: arm 1: Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0. arm 2: Normal Saline (placebo) injected into the glabellar region on Day 0.
Interventions: intervention 1: botulinum toxin Type A intervention 2: normal saline (placebo)
Intervention descriptions: intervention 1: botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0. intervention 2: Normal saline (placebo) injected into the glabellar region on Day 0.

Protocol documents:
Clinical trial NCT01404923
Conditions: Irritable Bowel Syndrome
Sponsor: Laboratoires Mayoly Spindler
Start date: 2009-12-01; Completion date: 2011-10-01
Enrollment: 436 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness of 2 IBS treatment strategies:

* Strategy A = MeteoSpasmyl®, on-demand therapy
* Strategy B = standard of care chosen by the physician

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: anti spasmodic agents intervention 2: alverine citrate, simeticone
Intervention descriptions: intervention 1: best standard of care prescriptions intervention 2: on-demand therapy

Protocol documents:
Clinical trial NCT01413958
Conditions: Seasonal Allergic Rhinitis
Keywords: Nasal Decongestants Rhinitis, Allergic, Seasonal Rhinitis Nose Conditions Respiratory Tract Diseases Phenylephrine
Sponsor: Bayer
Start date: 2011-08-01; Completion date: 2011-10-01
Enrollment: 575 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the nasal congestion symptom relief of phenylephrine extended release tablets and placebo in participants with allergic rhinitis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Phenylephrine intervention 2: Placebo intervention 3: Loratadine
Intervention descriptions: intervention 1: Phenylephrine hydrochloride 30-mg extended-release tablets, one tablet every 12 hours for 7 days intervention 2: Placebo to phenylephrine hydrochloride 30-mg extended release tablets, one tablet every 12 hours for 7 days intervention 3: Loratadine, 10 mg, once daily as rescue medication, only if needed for intolerable allergic rhinitis symptoms

Protocol documents:
Clinical trial NCT01430091
Conditions: Sickle Cell Disease
Sponsor: Eli Lilly and Company
Start date: 2011-09-01; Completion date: 2011-10-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study compares the clinical tablet formulation of prasugrel taken orally with an orally disintegrating tablet (ODT) taken orally. The study will evaluate the amount of prasugrel active metabolite circulating in the blood for each treatment.

Detailed description:

Arms: arm 1: A single 5-milligram (mg) prasugrel tablet administered orally by swallowing it whole on 1 occasion. arm 2: A single 5-mg prasugrel orally disintegrating tablet (ODT) administered orally by placing it on top of the tongue and keeping it there until it disintegrates. arm 3: A single 5-mg prasugrel ODT administered orally by placing it on top of the tongue followed by drinking approximately 180 milliliters (ml) apple juice within 1 minute after the tablet finishes disintegration. arm 4: A single 5-mg prasugrel ODT administered orally by placing it on top of the tongue, but then chewed and swallowed rather than waiting for it to disintegrate. arm 5: A single 5-mg prasugrel ODT administered orally by placing it under (rather than on top of) the tongue and keeping it there until it disintegrates.
Interventions: intervention 1: Prasugrel (clinical formulation) intervention 2: Prasugrel (Orally Disintegrating Tablet [ODT])
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT01430325
Conditions: Traumatic Brain Injury
Keywords: Hyperbaric oxygen
Sponsor: Intermountain Health Care, Inc.
Start date: 2011-07-01; Completion date: 2011-10-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
SCUBA divers and chamber inside attendants will undergo a brief hyperbaric chamber excursion and will be asked to what chamber pressure they were compressed and what gas they breathed.

Detailed description:
In clinical trials evaluating hyperbaric oxygen, blinding can be challenging. Options for participant blinding include offering regular air at a lower pressure than the hyperbaric oxygen intervention, or compressing all participants to the same pressure but providing different gas mixes to the active and sham arms.

In some trials of hyperbaric oxygen for brain injury, investigators offer a sham chamber session (regular air at 1.2 atmospheres absolute \[atm abs\]) compared to the active intervention, hyperbaric oxygen (100% oxygen at 1.5 atm abs). It is unknown whether individuals familiar with pressure changes, such as divers and hyperbaric chamber inside attendants, could discern the difference between these pressures and thereby become unblinded to study allocation.

In this study, 80 experienced divers and chamber inside attendants will be enrolled and randomly assigned to one of four possible chamber pressures and one of two breathing gases. After a brief hyperbaric chamber excursion, they will be asked to what chamber pressure they were compressed and what gas they breathed. If participants can accurately report chamber pressure or breathing gas, pressure-familiar individuals should be excluded from blinded clinical trials of hyperbaric oxygen.

Arms: arm 1: Sham Chamber Session

Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion arm 2: Hyperbaric Oxygen (1.5 atm abs)

Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion arm 3: Sham Chamber Session

Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion arm 4: Hyperbaric Oxygen (1.5 atm abs)

Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion
Interventions: intervention 1: Hyperbaric Oxygen (1.5 atm abs) intervention 2: Sham Chamber Session
Intervention descriptions: intervention 1: Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs. intervention 2: Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs

Protocol documents:
Clinical trial NCT01439815
Conditions: Allergic Rhinitis Allergic Conjunctivitis
Sponsor: ORA, Inc.
Start date: 2011-09-01; Completion date: 2011-10-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the onset of action of fluticasone propionate nasal spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after up to 14 days of at home dosing.

Detailed description:

Arms: arm 1: Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16. arm 2: Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
Interventions: intervention 1: Fluticasone Propionate Nasal Spray intervention 2: Saline Nasal Spray
Intervention descriptions: intervention 1: two sprays in each nostril once daily intervention 2: two sprays in each nostril once daily

Protocol documents:
Clinical trial NCT01478256
Conditions: Blepharitis
Keywords: blepharitis topical erythromycin topical besifloxocin
Sponsor: John, George, M.D.
Start date: 2011-08-01; Completion date: 2011-10-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study looks at the improvements in signs and symptoms in patients with inflammation of the lids, blepharitis, using two different FDA approved topical antibiotic agents, Besifloxocin and Erythromycin. It also evaluates the bacterial cultures in these patients for microbiologic evidence of improvement.

Detailed description:
This is a pilot project involving thirty patients with a specific form of inflammtion of the lids called anterior blepharitis. The patients are graded for their signs a symptoms and then randomized to receive either topical Besifloxocin or Erythromycin in addition to standard lid hygiene measures. All patients have cultures of their eyelids performed prior to initiating therapy and are followed for four weeks. The antibiotics are used for two weeks following which repeat cultures of the lids are obtained. The patients are followed for one additional week to ensure that there is no recurrence of their symptoms once the antibiotics are discontinued.

Only adult patients (age 18-100)and women who are not of child bearing potential are included in this study. Then patients have to have symptoms and signs of the disease, blepharitis. Patient who are on unstable antibiotic or steroid regimens and those who cannot discontinue contact lens use are not included in this study.

Arms: arm 1: Use of topical besifloxocin to treat acute blepharitis arm 2: Topical Erythromycin ointment for treatment of acute blepharitis
Interventions: intervention 1: Erythromycin intervention 2: Besifloxocin
Intervention descriptions: intervention 1: Topical erythromycin ointment twice a day intervention 2: Topical Besifloxocin twice a day

Protocol documents:
Clinical trial NCT01493089
Conditions: Gastroesophageal Reflux
Sponsor: Norgine
Start date: 2011-04-01; Completion date: 2011-10-01
Enrollment: 239 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Heartburn is the main symptom of Gastroesophageal Reflux Disease (GERD), which, accompanied by acid regurgitation and other symptoms, has a substantial negative impact on a patients' quality of life. Although a number of treatment options are available, a more effective therapy is still required. The failure of proton pump inhibitors (PPIs) to completely resolve symptoms is an accepted problem, with approximately 25% of patients with GERD continuing to experience the symptoms of heartburn in spite of treatment. This study aims to demonstrate an earlier onset to relief of symptoms in patients suffering from heartburn associated with GERD using an immediate-release omeprazole/sodium bicarbonate formulation when compared with delayed-release omeprazole (Losec®).

Detailed description:

Arms: arm 1: Treatment of heartburn with Zegerid arm 2: Treatment of heartburn with Losec
Interventions: intervention 1: Zegerid intervention 2: Losec
Intervention descriptions: intervention 1: 20 mg Zegerid suspension to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days. intervention 2: 20 mg Losec capsule to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days.

Protocol documents:
Clinical trial NCT01535443
Conditions: Inflammation Cataract
Keywords: PRO-155 Ocular NSAIDs Safety and tolerability Ocular Inflammation Ocular Paint
Sponsor: Laboratorios Sophia S.A de C.V.
Start date: 2011-09-01; Completion date: 2011-10-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.

Detailed description:
A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.

Arms: arm 1: Drug: Bromfenac ophthalmic solution 1 drop 4 times per day
Interventions: intervention 1: Bromfenac
Intervention descriptions: intervention 1: Drug: Bromfenac Other names: PRO-155

Protocol documents:
Clinical trial NCT01777581
Conditions: Radicular Pain Related to Lumbosacral Disc Disease
Keywords: sciatica radiculopathy lumbar disc lumbosacral disc
Sponsor: Duke University
Start date: 2010-03-01; Completion date: 2011-10-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigates whether milnacipran reduces radicular pain ("sciatica") in patients with lumbosacral disc disease.

Detailed description:
The current study evaluates the potential efficacy of milnacipran in reducing lower extremity radicular pain associated with lumbar disk disease. Milnacipran will be titrated based on efficacy and tolerability aimed at the higher end of the therapeutic range; a recent study of a serotonin norepinephrine reuptake inhibitor in patients with osteoarthritis pain suggests efficacy may be dose related. Patients are likely to have concomitant nociceptive lower back pain, and cotreatment with opioids, muscle relaxants, benzodiazepines, or nonsteroidal anti-inflammatory drugs at stable doses will be permitted. Patients participating in stable regimen of physical therapy or biofeedback will be eligible. Procedural interventions (e.g. epidural steroid injection, nerve block, facet radioablation, acupuncture) during the study and 3 months prior will be exclusionary. Anticonvulsants, tramadol, and other antidepressant drugs will be excluded.

The study is a ten-week randomized, double-blind, placebo-controlled trial (RCT) of milnacipran (100-200 mg/day dosed twice a day) for radicular pain associated with lumbosacral disk disease.

Outcome measures and safety assessments will be obtained at weeks 1, 2, 4, 6, 8, and 10 according to the protocol schedule of assessments.

Arms: arm 1: Milnacipran, flexibly dosed arm 2: Placebo
Interventions: intervention 1: Milnacipran intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02353468
Conditions: Refractory Plasma Cell Myeloma
Sponsor: University of Colorado, Denver
Start date: 2009-12-01; Completion date: 2011-10-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well giving bortezomib, lenalidomide, and dexamethasone together works in treating patients with multiple myeloma undergoing stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib, lenalidomide, and dexamethasone together may kill more cancer cells.

Detailed description:
CONSOLIDATION: Patients receive bortezomib, lenalidomide, and dexamethasone (VLD) therapy comprising bortezomib intravenously (IV) on days 1, 4, 8, and 11, lenalidomide orally (PO) once daily (QD) on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.

In between courses of VLD, patients receive Lenalidomide + Dexamethasone (LD) therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.

MAINTENANCE: Starting in the third year of therapy, patients receive lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: CONSOLIDATION: Patients receive VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.

In between courses of VLD, patients receive LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.

MAINTENANCE: Starting in the third year of therapy, patients receive lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Bortezomib intervention 2: Lenalidomide intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Given IV intervention 2: Given PO intervention 3: Given PO or IV

Protocol documents:
Clinical trial NCT02389361
Conditions: Pain
Sponsor: Astes
Start date: 2011-04-01; Completion date: 2011-10-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol).

Detailed description:
Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. This is the classical approach. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol). This is the new approach.

Arms: arm 1: Postoperative Analgesia with Zaldiar arm 2: Postoperative Analgesia with Paracetamol-Tramadol
Interventions: intervention 1: Zaldiar intervention 2: Paracetamol-Tramadol
Intervention descriptions: intervention 1: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol) intervention 2: Postoperative analgesia with intravenous Paracetamol and Tramadol

Protocol documents:
Clinical trial NCT02635828
Conditions: Postoperative Nausea and Vomiting
Keywords: Palonosetron Craniotomy Nausea Vomiting
Sponsor: Ohio State University
Start date: 2009-10-01; Completion date: 2011-10-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Postoperative nausea and vomiting (PONV) is a displeasing experience that distresses surgical patients during the first 24 hours after a surgical procedure. The incidence of postoperative nausea occurs in about 50%, the incidence of postoperative vomiting is about 30%, and in high-risk patients, the PONV rate could be as high as 80%. Therefore, the study design of this single arm, non-randomized, pilot study assessed the efficacy and safety profile of a triple therapy combination with palonosetron, dexamethasone and promethazine to prevent PONV in patients undergoing craniotomies under general anesthesia.

Detailed description:
At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis. After surgery, subjects were transferred to the surgical intensive care unit (SICU) or post anesthesia care unit as clinically indicated. Ondansetron 4 mg IV was administered as primary rescue medication to subjects with PONV symptoms. PONV was assessed and collected every 24 hours for 5 days via direct interview and/or medical charts review.

Arms: arm 1: At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.
Interventions: intervention 1: Palonosetron 0.075 mg IV intervention 2: Dexamethasone 10 mg IV intervention 3: Promethazine 25 mg IV
Intervention descriptions: intervention 1: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis. intervention 2: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis. intervention 3: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis.

Protocol documents:
Clinical trial NCT03064113
Conditions: Chronic Obstructive Pulmonary Disease, COPD
Keywords: Chronic Obstructive Pulmonary Disease, COPD
Sponsor: Mylan Inc.
Start date: 2011-05-01; Completion date: 2011-10-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Thirty-two subjects diagnosed with COPD were enrolled, received each study treatment and completed the follow-up assessments. During each of the four study periods, subjects were admitted to the clinic on Day -1 and housed overnight until after the last spirometry measurement. Serial pulmonary function tests were performed and PK (pharmacokinetics) samples collected up to 25 hours. Subjects were discharged from the clinic on Day 2 after evaluations.

Detailed description:
Subjects were assigned to one of the 4-treatment sequence groups presented in the table above according to a randomization schedule supplied by the Sponsor before study initiation. The randomization scheme did not include assignments for replacement subjects.

Subjects reported to their respective clinical research unit (CRU) on Admission/Day -1 for pre-randomization procedures and confirmation of eligibility (and continued eligibility for Periods 2 to 4). The unblinded pharmacist prepared and dispensed the nebulizers, according to the randomization schedule for each of the 4 periods. Dosing occurred in the morning, generally between 7 am and 9 am. For Periods 2 to 4, dosing occurred within ±30 minutes of the dosing time established in Period 1.

Study drug was administered in the respective CRU under the supervision of study personnel. Single doses of TD-4208, ipratropium bromide, and placebo were administered in the clinical research unit (CRU) under the supervision of study personnel. Care was taken to avoid eye contact with study drugs. Residual drug solution remaining in the nebulizer (ie, in mL) was measured and recorded.

The investigator or designee was responsible for maintaining accountability records for all study drug(s) in accordance with applicable government regulations and study procedures.

The accountability record included entries for receipt, distribution or dispensing, and destruction of the material(s). Unused and expired study drugs were to be disposed of in accordance with written instructions from the Sponsor.

Arms: arm 1: Period 1 = Placebo; Period 2 = TD-4208 700 μg; Period 3 = TD-4208 350 μg; Period 4 = Ipratropium 500 μg arm 2: Period 1 = TD-4208 700 μg; Period 2 = Ipratropium 500 μg; Period 3 = Placebo; Period 4 = TD-4208 350 μg arm 3: Period 1 = TD-4208 350 μg; Period 2 = Placebo; Period 3 = Ipratropium 500 μg; Period 4 = TD-4208 700 μg arm 4: Period 1 = Ipratropium 500 μg; Period 2 = TD-4208 350 μg; Period 3 = TD-4208 700 μg; Period 4 = Placebo
Interventions: intervention 1: Placebo intervention 2: TD-4208 700 μg intervention 3: TD-4208 350 μg intervention 4: Ipratropium 500 μg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01418365
Conditions: Healthy
Sponsor: Shire
Start date: 2011-08-22; Completion date: 2011-10-05
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Drug interaction study evaluating the pharmacokinetic profiles of Metronidazole administered alone \& in combination with MMX® Mesalazine/mesalamine

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Metronidazole + MMX Mesalazine/mesalamine placebo intervention 2: Metronidazole + MMX Mesalazine/mesalamine
Intervention descriptions: intervention 1: Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine placebo single dose on Day 4 orally intervention 2: Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally

Protocol documents: