ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02628236
Conditions: Keratosis, Actinic
Keywords: Actinic keratosis
Sponsor: DUSA Pharmaceuticals, Inc.
Start date: 2016-02-01; Completion date: 2016-07-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the potential for systemic exposure of aminolevulinic acid (ALA) and protoporphyrin IX (PpIX) when applied topically under occlusion, in a maximal use setting in patients with multiple actinic keratoses (AK) involving the upper extremities.

Detailed description:

Arms: arm 1: 20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Interventions: intervention 1: Aminolevulinic Acid (ALA) intervention 2: BLU-U
Intervention descriptions: intervention 1: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light intervention 2: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2

Protocol documents:
Clinical trial NCT02631551
Conditions: Seasonal Allergic Rhinitis
Keywords: Seasonal Allergic Rhinitis
Sponsor: Glenmark Specialty S.A.
Start date: 2016-03-01; Completion date: 2016-07-01
Enrollment: 1180 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: GSP 301 NS intervention 2: Olopatadine HCl NS intervention 3: Mometasone furoate NS intervention 4: GSP 301 Placebo NS
Intervention descriptions: intervention 1: FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days intervention 2: 2 sprays in each nostril twice daily for 14 days intervention 3: 2 sprays in each nostril twice daily for 14 days intervention 4: 2 sprays in each nostril twice daily for 14 days

Protocol documents:
Clinical trial NCT02633488
Conditions: Metabolic Syndrome Insulin Sensitivity
Sponsor: University of Virginia
Start date: 2014-06-01; Completion date: 2016-07-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to look at how insulin (a hormone that helps the cells get energy from sugar) in our body affects blood vessels (elasticity in the bigger blood vessels and blood flow in the smaller blood vessels in the arm) and how Metformin (a drug that makes you more sensitive to insulin) affects insulin's action on the blood vessels.

Detailed description:
In our protocol, we will study vascular function using pulse wave velocity (PWV) augmentation index (AI), flow mediated dilation (FMD) and contrast enhanced ultrasound (CEU) as well as insulin sensitivity (euglycemic clamp) in 50 adults with metabolic syndrome, age 18-60 years. They will each be studied 4 times,before and after two 12-wk interventions (randomly assigned) as follows: 1) Placebos and 2) Metformin . This is a cross-over design.

Arms: arm 1: 12 weeks of Placebo tablet 3 x daily arm 2: 12 weeks of Metformin tablet 850 mg 3 x daily
Interventions: intervention 1: Placebos intervention 2: metformin
Intervention descriptions: intervention 1: A 12 week single blind placebos intervention 2: A 12 week single blind metformin

Protocol documents:
Clinical trial NCT02635204
Conditions: Psoriasis
Sponsor: Promius Pharma, LLC
Start date: 2015-12-01; Completion date: 2016-07-01
Enrollment: 267 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.

Detailed description:
This study will be a multicenter (approximately 30 sites), randomized, vehicle-controlled, double-blind, and parallel group design. Approximately 264 subjects with moderate to severe plaque psoriasis will be randomized to treatment with DFD-06 Cream or Vehicle Cream. Subjects will use study product twice daily for 14 days. Subject visits are scheduled at Screening, Baseline (Day 1) and Days 4, 8, and 15. Clinical determinations of disease severity will be performed using the total sign score (TSS) for the target lesion and Investigator Global Assessment (IGA) for overall severity.

Arms: arm 1: DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days. arm 2: Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
Interventions: intervention 1: DFD06 Cream intervention 2: Vehicle Cream
Intervention descriptions: intervention 1: Twice daily topical application for 14 days. intervention 2: Twice daily topical application for 14 days.

Protocol documents:
Clinical trial NCT02656160
Conditions: Sleep Apnea, Obstructive
Sponsor: Brigham and Women's Hospital
Start date: 2016-01-01; Completion date: 2016-07-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
In this protocol the investigators will test the effect of dalfampridine (a potassium channel blocker) on genioglossus muscle activity (EMG GG) during wakefulness and sleep in healthy control subjects.

Detailed description:
Two overnight sleep studies, a placebo night and a drug night, will be performed approximately one week apart in random order. The placebo or drug will be administered 3 hours before lights out. At least 10 minutes of quiet wakefulness will be recorded to quantify the subject's awake EMG GG activity before the administration of placebo/dalfampridine.

EMG GG activity will be measured again 10 mins before lights off and during stable NREM and REM sleep (free of arousals and other artifacts).

During the second part of the night, the subjects will be connected to a modified continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which can provide a wide range of pressures between 20 and -20 cmH2O in order to modify upper airway pressure and measure change in EMG GG as a function of epiglottic pressure (muscle responsiveness).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: Dalfampridine
Intervention descriptions: intervention 1: Placebo 3 hrs before sleep intervention 2: Dalfampridine 10 mg extended release 3 hrs before sleep

Protocol documents:
Clinical trial NCT02660229
Conditions: Cancer Pain
Keywords: Intravenous injection in cancer pain
Sponsor: Mundipharma Korea Ltd
Start date: 2015-11-01; Completion date: 2016-07-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare of difference in NRS scores from baseline to the completion of treatment (5 days) in patients with administration of morphine sulfate versus oxycodone hydrochloride.

Detailed description:
5days, Multi-centers, Randomization, Open label, Parallel, Active Comparator, Phase 4 Study.

Arms: arm 1: Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride arm 2: Brand name: BC Morphine sulfate Generic name: Morphine sulfate
Interventions: intervention 1: Oxycodone Hydrochloride intervention 2: Morphine Sulphate
Intervention descriptions: intervention 1: Oxycodone injection intervention 2: Morphine sulphate injection

Protocol documents:
Clinical trial NCT02662556
Conditions: Acute Moderate-to-severe Pain
Sponsor: Talphera, Inc
Start date: 2016-03-01; Completion date: 2016-07-01
Enrollment: 140 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure.

Patients may receive one dose of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

Detailed description:
This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure.

Upon meeting all entrance criteria, patients will be administered the first dose of ST 30 mcg and will remain in the study for up to 12 hours for safety and efficacy measurements. Patients may receive additional doses of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes.

Arms: arm 1: sufentanil sublingual tablet 30 mcg
Interventions: intervention 1: sufentanil sublingual tablet 30 mcg
Intervention descriptions: intervention 1: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

Protocol documents:
Clinical trial NCT02663752
Conditions: Myelodysplastic Syndrome
Keywords: deferasirox MDS RNA expression predictive biomarker
Sponsor: Novartis Pharmaceuticals
Start date: 2016-05-30; Completion date: 2016-07-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Several previous studies (clinical and non-clinical) hypothesize that treatment with deferasirox causes a hematological improvement in transfused patients with low and intermediate-1 risk myelodysplastic syndrome. The purpose of this study was to assess the presence of genetic biomarkers predictive for hematologic response by the use of gene expression profiling of bone marrow aspirates obtained from MDS patients with or without hematological response.

Detailed description:
This trial was terminated due to low enrollment.

Arms: arm 1: All patients are already on commercial deferasirox before entering the study.
Interventions: intervention 1: Bone marrow aspirate intervention 2: Deferasirox
Intervention descriptions: intervention 1: Patients experiencing a hematological response and patients not experiencing a hematological response while on deferasirox treatment received a new bone marrow aspirate in order to investigate the presence of differential gene expression between those two groups intervention 2: Patients are already on commercial deferasirox before entering the study.

Protocol documents:
Clinical trial NCT02675907
Conditions: Pain, Post-operative
Keywords: Bunion Bunionectomy Pain Analgesia N1539 Phase 3
Sponsor: Baudax Bio
Start date: 2016-01-01; Completion date: 2016-07-01
Enrollment: 201 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the analgesic efficacy of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy.

Detailed description:

Arms: arm 1: N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses. arm 2: IV Placebo every 24 hours for up to 3 doses.
Interventions: intervention 1: N1539 intervention 2: Intravenous Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02677844
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2016-02-01; Completion date: 2016-07-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purposes of this study are to determine:

* The effect of single increasing doses of the study drug, abemaciclib, on healthy participants.
* The relationship between the amount of abemaciclib and the electrical tracing of the heart rhythm when abemaciclib is given.
* How much abemaciclib is found in the bloodstream and how long the body takes to get rid of it.

Information about any side effects that occur will be collected. The study will enroll two groups (cohorts) of participants. Each group will complete 4 study periods. This study is expected to last about 3 months. Screening may occur up to 28 days prior to enrollment. All participants will undergo a follow-up assessment approximately 21 days after administration of their final dose of study drug.

Detailed description:

Arms: arm 1: 200 - 600 mg single increasing oral dose of abemaciclib on Day 1 of up to 3 study periods. arm 2: Single oral dose of placebo on Day 1 of 1 study period. arm 3: Cohort 2, only. 8 mg Loperamide given orally once in 1 of 4 study periods. arm 4: Cohort 2, only. 8 mg Loperamide co-administered with abemaciclib given orally once in up to 1 of 4 study periods. arm 5: Cohort 2, only. 8 mg Loperamide co-administered with placebo given orally once in up to 1 of 4 study periods.
Interventions: intervention 1: Abemaciclib intervention 2: Placebo intervention 3: Loperamide
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally

Protocol documents:
Clinical trial NCT02683577
Conditions: Hepatic Impairment
Sponsor: Ipsen
Start date: 2016-02-01; Completion date: 2016-07-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the protocol is to assess the pharmacokinetics, safety and tolerability of a single dose of telotristat etiprate in subjects with various stages of hepatic impairment compared to healthy control subjects.

Detailed description:

Arms: arm 1: 1 single oral dose (2 x 250-mg tablets)
Interventions: intervention 1: telotristat etiprate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02703350
Conditions: Diabetes Mellitus, Type 1
Sponsor: Eli Lilly and Company
Start date: 2016-03-01; Completion date: 2016-07-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study will be conducted in participants with type1 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will be conducted in two parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in both parts.

Detailed description:

Arms: arm 1: Individualized doses of LY900014 administered by injection under the skin once in each of 3 periods arm 2: Individualized doses of insulin lispro reference formulation administered by injection under the skin once in each of 3 periods arm 3: Individualized doses of LY900014 administered by injection under the skin immediately before each meal for 14 days arm 4: Individualized doses of insulin lispro reference formulation administered by injection under the skin immediately before each meal for 14 days
Interventions: intervention 1: LY900014 intervention 2: Insulin Lispro
Intervention descriptions: intervention 1: Administered subcutaneously (SC) intervention 2: Administered SC

Protocol documents:
Clinical trial NCT02705807
Conditions: Cardiovascular Disease
Keywords: Pulmonary Arterial Hypertension (PAH) safety FLOLAN New Thermostable Formulation dose adjustment reformulated diluents currently marketed diluent
Sponsor: GlaxoSmithKline
Start date: 2016-05-01; Completion date: 2016-07-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is a Phase IV, open-label, single-arm study to assess the safety and the necessity of dose adjustment after switching to FLOLAN injection prepared with the reformulated diluent in Japanese patients with PAH who are receiving higher doses of FLOLAN injection than in other countries. The objective is to evaluate the safety and tolerability of the thermostable formulation of FLOLAN injection (that is \[i.e.\], FLOLAN injection prepared with the reformulated diluent) when switched from the existing FLOLAN injection treatment (i.e., FLOLAN injection prepared with the currently marketed diluent). The study will include a screening visit, a run-in period of a maximum of 4 weeks with the existing FLOLAN treatment (i.e., FLOLAN injection prepared with the currently marketed diluent), a 4-week treatment period with the thermostable formulation of FLOLAN injection (i.e., FLOLAN injection prepared with the reformulated diluent) and a one-week follow-up visit. Adequate number of subjects will be enrolled in the study in order to have 10 subjects to complete assessments at 4 weeks, including at least 5 subjects as a subset of subjects who consent to undergo right heart catheterisation (RHC) over 24-hour and at Week 4. FLOLAN is a registered trademark of the GlaxoSmithKline \[GSK\] group of companies.

Detailed description:

Arms: arm 1: Subjects will receive the existing FLOLAN treatment (i.e., FLOLAN injection prepared with the currently marketed diluent) for a run-in period of a maximum of 4 weeks, the thermostable formulation of FLOLAN injection (i.e., FLOLAN injection prepared with the reformulated diluent) for a 4-week treatment period and there will be a one-week follow-up visit.
Interventions: intervention 1: FLOLAN injection with currently marketed diluent intervention 2: FLOLAN injection with reformulated diluent
Intervention descriptions: intervention 1: FLOLAN injection (epoprostenol 0.5 or 1.5) prepared with the currently marketed diluent (epoprostenol sodium+ powder of hydrogen \[pH\] 10.2 - 10.8 diluent) for Injection. intervention 2: FLOLAN injection (epoprostenol 0.5 or 1.5) prepared with the reformulated diluent (epoprostenol sodium + pH 11.7 - 12.3 diluent) for Injection.

Protocol documents:
Clinical trial NCT02714400
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea Arousal threshold Venlafaxine
Sponsor: University of California, San Diego
Start date: 2016-03-01; Completion date: 2016-07-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low arousal threshold may wake up too early during a respiratory event, before upper airway muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the respiratory arousal threshold could potentially improve the quality of sleep and sleep disordered breathing. Agents that raise arousal threshold are therefore likely to benefit some patients with OSA. The overall goal of this project is to determine the importance of the arousal threshold in OSA, determine which patients might benefit from a raised arousal threshold, and test this hypothesis by using pharmacological manipulation of the arousal threshold to achieve this goal.

Detailed description:
This study is a randomized double-blinded crossover pilot study. The investigators will test whether Venlafaxine has important effects on the apnea hypopnea index. Venlafaxine is a serotonin-norepinephrine reuptake inhibitor (SNRI) for the treatment of depression and anxiety. Venlafaxine increases serum serotonin level, which may affect arousal threshold. Furthermore, higher serotonin level theoretically may improve muscle tone, including upper airway muscle. Therefore, the investigators hypothesize that venlafaxine may decrease arousal threshold and improve muscle tone, leading to improvement of OSA.

Eligible participants will undergo overnight polysomonography as described below and will receive either Venlafaxine(50 mg 2 hour prior to sleep) or placebo (in random order) followed roughly 7 days later with placebo or donepezil. This aim will allow us to test the impact of Venlafaxine on the apnea hypopnea index.

The change in apnea hypopnea index will be compared in the Venlafaxine groups with the placebo group.

Arms: arm 1: 50mg of Venlafaxine before sleep arm 2: One piece of placebo before sleep
Interventions: intervention 1: Venlafaxine intervention 2: Placebo
Intervention descriptions: intervention 1: Venlafaxine 50mg before sleep intervention 2: One piece of placebo before sleep

Protocol documents:
Clinical trial NCT02719158
Conditions: Acute Otitis Media AOMT
Keywords: Acute otitis media with tympanostomy tubes OTIPRIO
Sponsor: Otonomy, Inc.
Start date: 2016-02-01; Completion date: 2016-07-01
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Dose Ranging Study of OTO-201 in AOMT

Detailed description:
This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled, blinded study in which eligible subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201, 12 mg OTO-201, or sham into the affected ear(s).

Arms: arm 1: 6 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.1 mL supra-tympanostomy tube (STT) administration to the affected ear(s) arm 2: 12 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.2 mL supra-tympanostomy tube (STT) administration to the affected ear(s) arm 3: Sham (empty syringe), single 0.1 mL STT administration to the affected ear(s)
Interventions: intervention 1: 6 mg ciprofloxacin intervention 2: 12 mg ciprofloxacin intervention 3: Sham
Intervention descriptions: intervention 1: Single administration of OTO-201 intervention 2: Single administration of OTO-201 intervention 3: None

Protocol documents:
Clinical trial NCT02736175
Conditions: Post-Surgical Ocular Pain Post-Surgical Ocular Inflammation
Sponsor: Ocular Therapeutix, Inc.
Start date: 2015-10-01; Completion date: 2016-07-01
Enrollment: 438 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation

Detailed description:

Arms: arm 1: OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use arm 2: PV (placebo drug delivery vehicle)
Interventions: intervention 1: Dexamethasone intervention 2: Placebo Vehicle
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02739100
Conditions: End Stage Renal Disease
Keywords: pharmacokinetics bioequivalence
Sponsor: Rockwell Medical Technologies, Inc.
Start date: 2016-04-01; Completion date: 2016-07-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered via hemodialysate and via two different intravenous routes in adult patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, randomized single dose study.

Detailed description:

Arms: arm 1: Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic via the hemodialysate over the course of the dialysis treatment.

Intervention Drug: Triferic arm 2: Patients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via the unused heparin infusion line (pre-dialyzer).

Intervention: Drug: Triferic arm 3: Patients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via an infusion port (post-dialyzer).

Intervention: Drug: Triferic
Interventions: intervention 1: Triferic
Intervention descriptions: intervention 1: None

Protocol documents: