ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02394600
Conditions: Allergic Rhinoconjunctivitis
Keywords: rhinitis allergy
Sponsor: Queen's University
Start date: 2015-04-01; Completion date: 2016-06-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This pilot study is a Phase IV, single center, placebo-controlled, parallel study design conducted using the Environmental Exposure Unit (EEU). The study will aim to be determine whether there are any benefits from Grastek® for the treatment of birch-pollen induced allergic rhinoconjunctivitis. Grastek® is a Health Canada and FDA approved sublingual immunotherapy (SLIT) for the treatment of grass-pollen induced allergic rhinoconjunctivitis. The EEU provides a closed environment in which participants are exposed to a predetermined, controlled, constant level of airborne pollen. 96 participants will complete this study and will either receive Grastek® or placebo in a 1:1 ratio. The study will consist of a screening visit, a pre-treatment pollen exposure visit, 60 days of treatment with Grastek® or placebo, two treatment visits and a follow-up pollen exposure visit.

Detailed description:

Arms: arm 1: 48 participants will receive Grastek® once per day for 120 days. Grastek® is a standardized sublingual immunotherapy (SLIT) tablet containing 2800 BAU of standardized allergen extract from Timothy grass (Phleum pretense). This SLIT product is approved by Health Canada and the Food and Drug Administration (FDA) for the treatment of grass-pollen induced allergic rhinoconjunctivitis (AR) in Canada and the United States respectively. arm 2: 48 participants will receive placebo once per day for 120 days.
Interventions: intervention 1: Grastek® intervention 2: Placebo
Intervention descriptions: intervention 1: one tablet daily for four months intervention 2: one tablet daily for four months

Protocol documents:
Clinical trial NCT02400346
Conditions: Major Depression Disorder
Sponsor: H. Lundbeck A/S
Start date: 2015-03-01; Completion date: 2016-06-01
Enrollment: 132 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in an elderly population with major depressive disorder and an inadequate response to antidepressant treatment

Detailed description:

Arms: arm 1: All patients continue their current antidepressant treatment (ADT) and receive brexpiprazole in addition
Interventions: intervention 1: Adjunct brexpiprazole intervention 2: ADT
Intervention descriptions: intervention 1: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.

Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg. intervention 2: Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine, agomelatine, bupropion; dosing according to label

Protocol documents:
Clinical trial NCT02402309
Conditions: Sjögren-Larsson Syndrome
Keywords: Sjögren-Larsson Syndrome SLS FALDH Deficiency Neuro-ichthyosis Fatty Alcohol:NAD+ Oxidoreductase Deficiency Fatty Aldehyde Dehydrogenase Deficiency Disease Congenital Icthyosis Mental Retardation Spasticity Syndrome Spastic Neurologic Disorder Oligophrenia Ichthyosis
Sponsor: Aldeyra Therapeutics, Inc.
Start date: 2015-03-01; Completion date: 2016-06-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, randomized, double-blind, vehicle-controlled, parallel-group study designed to evaluate the safety, pharmacokinetic (PK), and exploratory activity of topically-applied NS2 dermatologic cream administered once-daily (QD) to subjects with ichthyosis secondary to Sjögren- Larsson Syndrome (SLS).

NS2 is expected to trap fatty aldehydes that are pathogenic in SLS patients, and thereby diminish the lipid-aldehyde adduct formation that likely results in ichthyosis associated with SLS, and potentially reduce the mild dermal inflammation characteristic of SLS.

Detailed description:

Arms: arm 1: NS2 1% topical cream for dermal application arm 2: Vehicle placebo for dermal application
Interventions: intervention 1: Active topical NS2 1% dermatologic cream intervention 2: Vehicle placebo 0.0% NS2 dermatologic cream
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02423577
Conditions: Influenza
Keywords: antiviral influenza challenge
Sponsor: Autoimmune Technologies, LLC
Start date: 2015-09-01; Completion date: 2016-06-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study are to determine the effect FF-3 in comparison to placebo in subjects who are experimentally inoculated with a live, challenge strain of influenza A virus.

Detailed description:

Arms: arm 1: FF-3 arm 2: None
Interventions: intervention 1: FF-3 dry powder intervention 2: Placebo
Intervention descriptions: intervention 1: FF-3 dry powder administered by nasal inhalation intervention 2: Placebo dry powder administered by nasal inhalation

Protocol documents:
Clinical trial NCT02474082
Conditions: Psoriasis
Sponsor: Novartis Pharmaceuticals
Start date: 2015-04-01; Completion date: 2016-06-01
Enrollment: 202 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, controlled, multicenter, open-label study with blinded assessment of the efficacy of subcutaneous secukinumab compared to Fumaderm®, in 200 adults with moderate to severe plaque type psoriasis who are candidates for systemic therapy. The study consists of 2 periods: a screening period of at least one week and up to four weeks, and a treatment period of 24 weeks. During the screening period eligibility of the patients is confirmed. Eligible patients are randomized 1:1 to treatment arm A or B at week 0. Patients in treatment arm A receive secukinumab administered at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20 and are followed up for assessments of the study endpoints until week 24. Patients in treatment arm B receive daily doses of Fumaderm® p.o.. Safety and efficacy measurements of secukinumab and Fumaderm® will be performed throughout the study and up to week 24.

Detailed description:

Arms: arm 1: Patients in treatment arm A will receive a dose of 300 mg secukinumab administered as 2 subcutaneous injections of 150 mg in a SensoReady pen (i.e. 2 x 150 mg) at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20. arm 2: Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dosetitrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.
Interventions: intervention 1: Secukinumab intervention 2: Fumaric acid
Intervention descriptions: intervention 1: Secukinumab 150 mg, 1 ml liquid formulation in a pre-filled pen for s.c. injection intervention 2: Fumaric acid initial therapy (tablet contains 30 mg dimethylfumarate, 67 mg ethylhydrogenfumarate calcium salt, 5 mg ethylhydrogenfumarate magnesium salt, 3 mg ethylhydrogenfumarate zinc salt) and Fumaric acid maintenance therapy (tablet contains 120 mg dimethylfumarate, 87 mg ethylhydrogenfumarate calcium salt, 5 mg ethylhydrogenfumarate magnesium salt, 3 mg ethylhydrogenfumarate zinc salt)

Protocol documents:
Clinical trial NCT02490293
Conditions: Acute Cholecystitis
Sponsor: Taeho Hong
Start date: 2015-06-01; Completion date: 2016-06-01
Enrollment: 198 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
During the laparoscopic cholecystectomy for acute cholecystitis, most surgeons routinely use the postoperative antibiotics after surgery. However, there is no consensus regarding the actual need of postoperative antibiotics in these cases and the use of postoperative antibiotics remains controversial.

Investigators will compare the surgical outcomes after laparoscopic cholecystectomy to the patients who has no evidence of systemic infection, according to the usage of postoperative antibiotics or not. The investigators expect that the routine use of postoperative antibiotics after laparoscopic cholecystectomy for acute cholecystitis gallbladder will have no effects on the postoperative morbidity.

Detailed description:
Primary outcome of this study is the confirmation of safety in the cases of acute cholecystitis without postoperative antibiotics usage after laparoscopic cholecystectomy. For this purpose, the investigators compare the surgical infectious outcomes including the wound infection or abdominal infections according to the usage of postoperative antibiotics after laparoscopic cholecystectomy.

Secondary outcome of this study is the confirmation of efficacy according to skip the use of postoperative antibiotics after laparoscopic cholecystectomy.

The investigators estimate the efficacy using the comparing the outcomes such as duration of hospitalization according to the use of postoperative antibiotics or not.

Arms: arm 1: During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.

After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days. arm 2: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.

After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.
Interventions: intervention 1: Cephalosporin intervention 2: Placebo
Intervention descriptions: intervention 1: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.

After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days. intervention 2: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.

After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.

Protocol documents:
Clinical trial NCT02556710
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis Osteoarthritis of the Knee
Sponsor: Ampio Pharmaceuticals. Inc.
Start date: 2015-09-01; Completion date: 2016-06-01
Enrollment: 480 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of an intra-articular injection of AMPION™ in adults with pain due to osteoarthritis of the knee

Detailed description:
A Randomized, Placebo-Controlled, Double-Blind Study To Evaluate The Efficacy And Safety Of An Intra-Articular Injection Of AMPION™ In Adults With Pain Due to Osteoarthritis Of The Knee

The primary trial objective is to evaluate the efficacy of 4 mL of AMPION™ versus 4 mL placebo intra-articular (IA) injection in improving knee pain, when applied to patients suffering from OA of the knee.

The secondary trial objective is evaluation of the safety of an intra-articular injection of AMPION™.

Arms: arm 1: 4 mL injection of Ampion arm 2: 4 mL Injection of Placebo
Interventions: intervention 1: 4 mL injection of AMPION™ intervention 2: 4 mL injection of Placebo
Intervention descriptions: intervention 1: 4 mL Injection of Ampion intervention 2: 4 mL Injection of Placebo

Protocol documents:
Clinical trial NCT02582840
Conditions: Type 1 Diabetes Mellitus
Keywords: Japanese patients with type 1 diabetes with inadequate glycemic control on insulin
Sponsor: AstraZeneca
Start date: 2015-10-01; Completion date: 2016-06-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, single-blind, 3 arm, parallel group, placebo controlled PK/PD study will enrol 30 Japanese male and female patients with T1DM and age 18 to 65 years, with inadequate glycemic control on insulin defined as HbA1c ≥ 7.0% and ≤ 10.0% at screening visit. lacebo-controlled design. Patients will be randomized in a 1:1:1 ratio into one of the 3 single-blinded treatment arms; dapagliflozin 5 mg, dapagliflozin 10 mg or placebo. CSII user are excluded.

Detailed description:

Arms: arm 1: dapagliflozin tablet 5mg arm 2: dapagliflozin tablet 10mg arm 3: dapagliflozin tablet 5mg placebo or 10 mg placebo
Interventions: intervention 1: Dapagliflozin 5mg intervention 2: Dapagliflozin 10mg intervention 3: Placebo tablet
Intervention descriptions: intervention 1: Dapagliflozin, a blood glucose lowering drug. Oral dose intervention 2: Dapagliflozin, a blood glucose lowering drug. Oral dose intervention 3: Placebo tablet. Oral dose

Protocol documents:
Clinical trial NCT02596321
Conditions: Allergy Asthma Rhinitis
Keywords: House Dust Mite
Sponsor: Abbott
Start date: 2015-10-01; Completion date: 2016-06-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate superiority of ALK HDM tablets versus placebo in immune response, measured as change of D.farinae specific immunoglobulin G4 (IgG4) from baseline to end of treatment with ALK HDM tablets given once daily over 60 days.

Detailed description:
To demonstrate superiority of ALK HDM tablets versus placebo in the immune response, measured as change of D. Farinae specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days

To evaluate the immune response, measured as change of D. pteronyssinus, D. farinae specific immunoglobulin E (IgE) and D. pteronyssinus specific IgG4 from baseline to end of treatment with ALK HDM tablets given once daily over 60 days, compared to placebo

To evaluate in patients with HDM-allergic respiratory disease the safety and tolerability of 60-day treatment with ALK HDM tablets compared to placebo

Arms: arm 1: Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU) arm 2: Placebo tablet
Interventions: intervention 1: Mitizax intervention 2: Placebo
Intervention descriptions: intervention 1: Allergen extract intervention 2: Placebo tablet

Protocol documents:
Clinical trial NCT02613117
Conditions: Dentinal Hypersensitivity
Sponsor: Procter and Gamble
Start date: 2015-11-01; Completion date: 2016-06-01
Enrollment: 104 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the oral tolerability and immediate post-treatment safety of topical application for two marketed oxalate products as initial care in dental patients to treat or prevent tooth sensitivity pain that may be attributed to dentinal hypersensitivity.

Detailed description:

Arms: arm 1: potassium oxalate gel self applied arm 2: Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied
Interventions: intervention 1: Potassium Oxalate Gel intervention 2: Potassium Oxalate Liquid intervention 3: Stannous fluoride paste
Intervention descriptions: intervention 1: Self applied intervention 2: Professionally Applied intervention 3: SnF2 Paste

Protocol documents:
Clinical trial NCT02648438
Conditions: Asthma Chronic Obstructive Pulmonary Disease (COPD)
Keywords: AZD7594 Bioavailability Healthy male subjects Safety Tolerability Pharmacokinetics Monodose inhaler Multiple-dose dry powder inhaler
Sponsor: AstraZeneca
Start date: 2016-01-12; Completion date: 2016-06-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label,partially randomized, four-period study in healthy male subjects to assess the bioavailability and pharmacokinetics of a single dose of AZD7594 when administered intravenously, orally and inhaled via two different dry powder inhalers (DPIs) and a pressurized meter-dose inhaler (pMDI)

Detailed description:
This study is an open-label, partially randomized, 4-period, 5-treatment study in healthy male subjects, performed at a single study center. All subjects will receive the 4 of the 5 treatments. The IV infusion will be fixed as the first treatment (Period 1), the Monodose inhaler will be fixed as the second treatment (Period 2) and the oral formulation will be fixed as the fourth treatment (Period 4). During Period 3, subjects are split into 2 equal cohorts, multiple-dose DPI and pMDI.

Arms: arm 1: Treatment Period 1:AZD7594 Solution for infusion (150 μg intravenous formulation) Treatment Period 2:AZD7594 Inhalation powder (400 μg) by dry powder inhaler (DPI) Device 1 (monodose inhaler) Treatment Period 3:AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler) Treatment Period 4:AZD7594 Oral suspension (1200 μg oral formulation) arm 2: Treatment Period 1:AZD7594 Solution for infusion (150 μg intravenous formulation) Treatment Period 2:AZD7594 Inhalation powder (400 μg) by dry powder inhaler (DPI) Device 1 (monodose inhaler) Treatment Period 3:AZD7594 Pressurized inhalation suspension (400 μg) by pressurized metered-dose inhaler (pMDI) Treatment Period 4:AZD7594 Oral suspension (1200 μg oral formulation)
Interventions: intervention 1: AZD7594 Solution for infusion (150 μg intravenous formulation) intervention 2: AZD7594 Oral suspension (1200 μg oral formulation) intervention 3: AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler) intervention 4: AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler) intervention 5: AZD7594 Pressurized inhalation suspension (400 μg) by pMDI
Intervention descriptions: intervention 1: Solution for infusion 0.01 mg/ml; AZD7594 150 μg IV intervention 2: 0.1 - 10 mg/g oral solution; AZD7594 1200 μg oral intervention 3: Inhalation powder, hard capsules 400 μg Monodose inhaler; AZD7594 400 μg by dry powder inhaler (DPI) Device 1 (Monodose inhaler) intervention 4: Inhalation powder, multiple-dose dry powder inhaler (DPI) 400 μg; AZD7594 400 μg by DPI Device 2 (multiple-dose DPI) intervention 5: Inhalation suspension 200 μg; AZD7594 400 μg by pressurized metered-dose inhaler (pMDI); 2 puffs x 200 μg = 400 μg

Protocol documents:
Clinical trial NCT02659865
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2016-01-01; Completion date: 2016-06-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The main purpose of this study is to investigate the safety of the study drug known as LY3039478 and evaluate two different formulations of LY3039478 in healthy participants. Part A has three periods. Either LY3039478 or placebo will be given once by mouth in each period. Part B has two periods. Participants will receive both formulations of LY3039478, by mouth, over the course of the study. Both parts of the study will also explore how much LY3039478 gets into the bloodstream and how long it takes the body to get rid of it. Information about any side effects will also be collected. Participants may only enroll in one part. The study will last at least 33 days, not including screening. Screening must be performed up to 30 days before enrollment.

Part B was added by protocol amendment approved in April, 2016.

Detailed description:

Arms: arm 1: Single oral dose of placebo administered in one of three study periods arm 2: Escalating single oral dose of 25 milligram (mg), 50 mg, and 75 mg capsule formulation (formulation 3) LY3039478 administered in two of three study periods arm 3: Single oral 50 mg dose of drug-in capsule (reference, formulation 1) LY3039478 administered in one of two study periods arm 4: Single oral 50 mg dose of formulated capsule (test, formulation 3) LY3039478 administered in one of two study periods
Interventions: intervention 1: Placebo intervention 2: LY3039478 Capsule Formulation (Formulation 3) intervention 3: LY3039478 Drug-in Capsule (Reference, Formulation 1) intervention 4: LY3039478 Formulated Capsule (Test, Formulation 3)
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally intervention 4: Administered orally

Protocol documents:
Clinical trial NCT02671760
Conditions: Short-term Insomnia
Keywords: Short-term insomnia difficulty sleeping sedative hypnotic
Sponsor: Sequential Medicine Ltd
Start date: 2016-02-01; Completion date: 2016-06-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the effect of a combination drug product containing diphenhydramine, zolpidem and lorazepam on total sleep time. Participants will be adults who sometimes have difficulty falling asleep or staying asleep, but who do not have chronic insomnia. The study involves 3 one-night stays in a sleep center in New York City.

Detailed description:
The purpose of this study is to evaluate the effect of a combination drug product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam on total sleep time, and to determine the contribution of diphenhydramine to the combination, using a 5-hour Phase Advance model of sleep challenge. This is a 3-arm cross-over study; each participant will receive 3 single-dose treatments on consecutive visits. The 3 arms are: investigational combination product, placebo, and a 2-drug comparator containing the zolpidem and lorazepam components but not diphenhydramine. Participants will be adults who sometimes have difficulty falling asleep or staying asleep, but who are generally healthy and do not have chronic insomnia or sleep apnea.

A total of 39 subjects are being recruited. Subjects who qualify for participation will be asked to keep a sleep diary to document their sleep times leading up to and during the study, and will be asked to spend 7-8 hours in bed at a regular bedtime during the study. Qualifying participants also will not anticipate significant disruptions in their sleep schedules, for example by traveling across timezones or changing shifts at work, during the study. The study requires 3 one-night stays in a sleep center in New York City, for administration of the study treatments and EEG measurements. Qualifying subjects will anticipate being able to return to the sleep center, located in Manhattan, for a total of 4 visits, including initial screening and 3 treatment times.

During each sleep center visit, subjects will be given their study treatment and be put to bed 5 hours before their usual bedtime, and sleep time will be monitored for 8 hours. Each subject will receive all 3 treatments, although the sequence of the 3 treatments will be randomized. Both subjects and study personnel monitoring the subjects will be blinded to the identity of the treatment administered at each visit.

Arms: arm 1: SM-1 arm 2: 2-drug combination arm 3: Placebo
Interventions: intervention 1: SM-1 intervention 2: Comparator intervention 3: Placebo
Intervention descriptions: intervention 1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam intervention 2: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam intervention 3: Placebo

Protocol documents: