ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01686152
Conditions: Actinic Keratosis
Sponsor: Teva Pharmaceuticals USA
Start date: 2012-09-01; Completion date: 2013-08-01
Enrollment: 589 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the comparability of the safety and efficacy of Imiquimod Cream, 3.75% and Zyclara (imiquimod) Cream, 3.75% (the reference listed drug) in subjects with actinic keratosis (AK) of the face or balding scalp. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the Vehicle cream.

Detailed description:

Arms: arm 1: Imiquimod Cream, 3.75% (Teva) arm 2: Zyclara® (imiquimod Cream), 3.75% (Medicis) arm 3: Vehicle of Test Product (Teva)
Interventions: intervention 1: Imiquimod Cream, 3.75% intervention 2: Zyclara® intervention 3: Vehicle of Test Product
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01694771
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2012-09-01; Completion date: 2013-08-01
Enrollment: 1134 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily, orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium (Spiriva Handihaler®) monotherapy on lung function in patients with COPD.

Detailed description:

Arms: arm 1: 2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered arm 2: 2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Interventions: intervention 1: Tiotropium intervention 2: Placebo matching Olodaterol intervention 3: Olodaterol intervention 4: Tiotropium
Intervention descriptions: intervention 1: Marketed dose intervention 2: One dose intervention 3: One dose intervention 4: Marketed dose

Protocol documents:
Clinical trial NCT01699815
Conditions: Osteoarthritis
Keywords: acetaminophen timing arthroplasty
Sponsor: Duke University
Start date: 2012-10-01; Completion date: 2013-08-01
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to examine the effects of timing of administration of intravenous (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled total hip replacement under general anesthesia will be randomized into one of two arms: 1) the pre-closure group will receive the first dose administered upon onset of skin closure, 2) the preemptive group will receive the first dose administered within 60 minutes prior to incision. Both groups will receive subsequent doses every 6 hours x 24 hours.

Detailed description:
The purpose of the study is to examine the effects of timing of administration of intravenous (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled total hip replacement under general anesthesia will be randomized into one of two arms: 1) the closure group will receive the first dose of one gram of intravenous acetaminophen administered upon onset of skin closure, 2) the preemptive group will receive the first dose of one gram of intravenous acetaminophen administered within 60 minutes prior to incision. Both groups will receive subsequent doses of one gram of intravenous acetaminophen every 6 hours x 24 hours. The maximum dose in a 24 hour period will not exceed 4 grams according to FDA recommendations.

Arms: arm 1: The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert. arm 2: The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.
Interventions: intervention 1: Acetaminophen
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01701115
Conditions: Shoulder Arthroscopy Interscalene Block
Keywords: Interscalene Block
Sponsor: Hospital for Special Surgery, New York
Start date: 2012-08-01; Completion date: 2013-08-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if a decrease in the standard volume of local anesthetic used to numb your shoulder area before shoulder arthroscopy will provide adequate anesthesia for the procedure and decrease the amount of time until you are ready for discharge from the hospital.

Detailed description:
Traditionally, an interscalene block is done either with nerve stimulator or ultrasound guided using 40-60mL of local anesthetic. The study plans to investigate the difference in hand grip strength post-operatively in patients who will receive interscalene blocks with 40mL versus a lower dose (20mL) of local anesthetic. We suspect the lower dose will achieve adequate surgical anesthesia while creating less motor block and thus, increase patient satisfaction, present fewer complications or adverse affects and decrease time in the recovery room.

Arms: arm 1: Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine. arm 2: Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine
Interventions: intervention 1: Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block intervention 2: Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block intervention 3: Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine) intervention 4: Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)
Intervention descriptions: intervention 1: Anesthetic volume:

Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL intervention 2: Anesthetic volume:

Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01710514
Conditions: Luteal Hormone Supplementation
Sponsor: Ferring Pharmaceuticals
Start date: 2012-10-01; Completion date: 2013-08-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of the study are to verify sufficient supplementation of luteal hormone after administrating FE999913 Vaginal Tablet twice a day (BID) or three times a day (TID) and to determine the efficacy and safety of FE999913 Vaginal Tablet in Japanese women undergoing fertility treatment with IVF-ET (a fresh embryo transfer).

Detailed description:

Arms: arm 1: FE 999913 100 mg vaginal tablet BID arm 2: FE 999913 100 mg vaginal tablet TID
Interventions: intervention 1: FE 999913 vaginal tablet
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01727791
Conditions: Healthy Lactating Women
Keywords: pharmacokinetic pregabalin lactation
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2012-12-01; Completion date: 2013-08-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
This is a pharmacokinetic study to determine the safety and tolerability of pregabalin in healthy lactating women. The objectives are to determine whether pregabalin is secreted in breast milk and if so, to characterize pregabalin pharmacokinetics in breast milk. Other objectives are to estimate potential infant exposure to pregabalin if administered to lactating women and to characterize the safety and tolerability of pregabalin in lactating women.

Detailed description:
Post approval commitment for the FDA

Arms: arm 1: None
Interventions: intervention 1: pregabalin (Lyrica)
Intervention descriptions: intervention 1: Subjects will receive a single 150 mg dose of pregabalin in the evening of Day 1, a 150 mg dose of pregabalin in the morning and evening of Day 2 and a 150 mg dose in the morning of Day 3.

Protocol documents:
Clinical trial NCT01748552
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2012-12-01; Completion date: 2013-08-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The aim of this trial is to evaluate the safety of the study drug in healthy participants and participants with diabetes. It will investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.

The study consists of two parts. Part A will study healthy participants in up to 3 dosing periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3 dosing periods over approximately 6 weeks.

Detailed description:

Arms: arm 1: Single oral dose of placebo administered to healthy participants in up to 1 of 3 study periods in Part A arm 2: Single ascending dose of LY2922083 (starting at 0.5 milligrams \[mg\]) administered orally to healthy participants in up to 2 of 3 study periods in Part A arm 3: Single oral dose of placebo administered to participants with type 2 diabetes mellitus (T2DM) in up to 1 of 3 study periods in Part B arm 4: Single ascending dose of LY2922083 administered orally to participants with T2DM in up to 2 of 3 study periods in Part B. Dose determined by Part A
Interventions: intervention 1: Placebo intervention 2: LY2922083
Intervention descriptions: intervention 1: Administered orally as capsules intervention 2: Administered orally as capsules

Protocol documents:
Clinical trial NCT01750294
Conditions: Chronic Kidney Disease Poorly-Controlled Hypertension
Keywords: hypertension kidney disease
Sponsor: Indiana University
Start date: 2012-08-01; Completion date: 2013-08-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
It is estimated that in the United States there are approximately 8 million individuals with moderate to severe chronic kidney disease (CKD), not on dialysis. Volume expansion plays an important role in the pathogenesis of hypertension in patients with CKD. For this pilot study, the investigators hypothesize that administration of chlorthalidone among patients with moderate to severe CKD will improve blood pressure (BP).

Detailed description:

Interventions: intervention 1: Chlorthalidone
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01753115
Conditions: Anthrax
Keywords: post-exposure prophylaxis toxin neutralization assay
Sponsor: Emergent BioSolutions
Start date: 2012-12-01; Completion date: 2013-08-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical trial is to determine whether there is any effect on the antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of BioThrax® (Anthrax Vaccine Adsorbed or AVA).

This study will be conducted in the United States (US) in 154 healthy male and female volunteer subjects ages 18 to 45.

The duration of study participation for each subject will be approximately 76 days (approximately 2.5 months)

Detailed description:
BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. This is a randomized, open-label, Phase 2, multi-center trial to investigate the potential interactions of ciprofloxacin and BioThrax.

Arms: arm 1: BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule.

Ciprofloxacin: 500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48). arm 2: BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule.

Ciprofloxacin: 500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48). arm 3: BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule.
Interventions: intervention 1: BioThrax intervention 2: Ciprofloxacin
Intervention descriptions: intervention 1: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule intervention 2: 500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48).

Protocol documents:
Clinical trial NCT01770652
Conditions: Renal Impairment
Keywords: Renal Impairment Kidney Impairment Kidney Disease Ferriprox Deferiprone DFP (deferiprone) L1
Sponsor: ApoPharma
Start date: 2013-01-01; Completion date: 2013-08-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired renal function on the PK of deferiprone and its 3-O-glucuronide metabolite following a single oral dose of 33mg/kg Ferriprox®.

Detailed description:
Post-marketing study to evaluate the effect of impaired renal function on the pharmacokinetics (PK) of deferiprone and its 3-O-glucuronide metabolite and on the safety of Ferriprox® in subjects with mild, moderate and severe renal impairment as compared to healthy volunteers.

Arms: arm 1: Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m\^2. All subjects received a single 33 mg/kg oral dose of deferiprone. arm 2: Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m\^2. All subjects received a single 33 mg/kg oral dose of deferiprone. arm 3: Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m\^2. All subjects received a single 33 mg/kg oral dose of deferiprone. arm 4: Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m\^2. All subjects received a single 33 mg/kg oral dose of deferiprone.
Interventions: intervention 1: Deferiprone
Intervention descriptions: intervention 1: Oral iron chelator

Protocol documents:
Clinical trial NCT01772147
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: GlaxoSmithKline
Start date: 2013-01-01; Completion date: 2013-08-01
Enrollment: 608 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily and umeclidinium bromide (125mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily with placebo when added to fluticasone propionate (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.

Detailed description:
This is a multicenter, randomized, double-blind, parallel-group study. Subjects who meet the eligibility criteria at screening and meet the randomization criteria at the end of a 4 week run-in period will enter a 12 week treatment period. There will be a 7 day follow-up period after the treatment period.

Arms: arm 1: Long-acting muscarinic antagonist (LAMA) arm 2: Inhaled corticosteroid (ICS)/Long-acting beta agonist (LABA)
Interventions: intervention 1: Umeclidinium bromide 62.5mcg intervention 2: Umeclidinium bromide 125mcg intervention 3: Fluticasone propionate 250mcg/Salmeterol 50mcg
Intervention descriptions: intervention 1: Inhalation powder intervention 2: Inhalation powder intervention 3: Inhalation powder

Protocol documents:
Clinical trial NCT01789476
Conditions: Acute Pain
Keywords: pain acute pain kappa agonis opioid analgesia bunionectomy peripheral nervous system agents physiological effects of drugs surgery post-operative post-operative complications
Sponsor: Cara Therapeutics, Inc.
Start date: 2013-05-01; Completion date: 2013-08-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a single-center, randomized, double blind, placebo controlled, parallel group proof of concept study to evaluate the analgesic efficacy as well as the safety, tolerability and pharmacokinetic profile of CR845 in patients with pain following bunionectomy surgery.

Detailed description:
Currently, the most widely used drugs to treat pain after surgery are opiates, such as morphine. Morphine works mainly by activating one of several types of opiate receptors that control some of our pain sensation - the so-called mu opiate receptors. These receptors are located in many areas of the brain and also outside of the brain. By activating these receptors, morphine provides significant pain relief, but also causes side effects that limit its use. Some of these side effects include: respiratory depression or arrest (slowed or stopped breathing), sedation (a state of calmness or extreme relaxation), euphoria (an exaggerated feeling of physical and mental well-being), constipation, nausea, vomiting, and drug addiction.

In order to avoid the side effects of morphine and other mu opiates, the present experimental drug CR845 was designed to work at a different type of opiate receptor - called kappa - that can also provide pain relief, by acting on sensory nerves outside the brain. CR845 was designed to penetrate the brain much less than other opiate drugs, which should result in pain relief similar to that of morphine, but with fewer side effects. Because CR845 activates kappa receptors instead of mu receptors, the side effects are different than with a morphine-type drug. In particular, kappa opiates, such as CR845, do not cause respiratory depression or arrest, euphoria, constipation, drug tolerance, physical drug dependence or drug addiction. For these reasons, CR845 may present a distinct advantage over other opiates that are currently used for pain relief and post-operative pain in particular.

Arms: arm 1: Peripheral kappa opioid receptor agonist arm 2: Matched placebo
Interventions: intervention 1: CR845 intervention 2: Placebo
Intervention descriptions: intervention 1: CR845 dosage = 0.005 mg/kg per dose, IV bolus. The initial dose was administered upon reaching a qualifying pain intensity score and followed by a supplemental dose, if requested by patient for pain. Additional doses could be administered every 8 hours up to 48 hours. intervention 2: Matching placebo administered using same dosing algorithm as the active arm

Protocol documents:
Clinical trial NCT01798186
Conditions: Cannabis Toxicology
Sponsor: Johns Hopkins University
Start date: 2013-05-01; Completion date: 2013-08-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This primary aim of this study is to assess the effects of passive (second-hand) inhalation of cannabis smoke on toxicological analysis of "native" oral fluid (saliva), urine and blood specimens. The results of this study will help inform the validity of oral fluid as a biomarker of cannabis exposure and to determine whether, and for how long, passive inhalation of cannabis smoke could result in a positive toxicology result.

Detailed description:

Arms: arm 1: Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 5% THC and in a room with no ventilation. arm 2: Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 11% THC and in a room with no ventilation. arm 3: Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 11% THC in a room with active ventilation.
Interventions: intervention 1: Cannabis
Intervention descriptions: intervention 1: Participants will be exposed to cannabis smoke present in ambient air

Protocol documents:
Clinical trial NCT01810939
Conditions: Chronic Kidney Disease (CKD) Hyperkalemia (HK)
Keywords: Chronic Kidney Disease Treatment of Hyperkalemia Hyperkalemia
Sponsor: Relypsa, Inc.
Start date: 2013-02-01; Completion date: 2013-08-01
Enrollment: 243 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer treatment was also evaluated.

Detailed description:
There were two parts in the study, Part A and Part B.

Part A was an assessment of 4 weeks of dosing with patiromer in the treatment of hyperkalemia; Part B was a randomized, placebo-controlled, 8-week assessment of the withdrawal of patiromer in participants with a baseline serum potassium at the beginning of Part A ≥ 5.5 mEq/L who responded to the 4 weeks of treatment with patiromer during Part A.

All participants received patiromer during Part A; Part B participants were randomized to continue patiromer or switch to placebo. Total study participation was up to 14 weeks (including up to 2 weeks of follow up).

The dose of patiromer could be titrated based on participant's serum potassium response.

Arms: arm 1: Patiromer was administered twice a day as a powder mixed with water. arm 2: Placebo was administered twice a day as a powder mixed with water.
Interventions: intervention 1: Patiromer intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01826201
Conditions: Psoriasis
Keywords: psoriasis
Sponsor: Moleculin, LLC
Start date: 2013-03-01; Completion date: 2013-08-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether MOL4239 is effective in adult subjects with mild to moderate plaque psoriasis by comparing two target lesions in which each subject will apply MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days.

Detailed description:
This is a phase 2a, Randomized, Multi-center, Blinded, Paired Psoriasis Lesion, Comparative Placebo-Controlled study to evaluate the safety, preliminary efficacy and pharmacokinetics of MOL4239 in 30 adult subjects with mild to moderate plaque psoriasis. Eligible subject will have a diagnosis of mild to moderate plaque psoriasis affecting 9.9% body surface area (BSA) or less, and two designated similar target lesions with a Psoriasis Severity Score of at least 6 or higher. Each subject will apply 10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days.

Arms: arm 1: 10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
Interventions: intervention 1: MOL4239 intervention 2: Placebo
Intervention descriptions: intervention 1: 10% MOL4239 ointment to one target lesion twice a day for 28.5 consecutive days intervention 2: placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days

Protocol documents: