ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02139943
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus, Type 1 Canagliflozin Continuous Glucose Monitoring
Sponsor: Janssen Research & Development, LLC
Start date: 2014-05-01; Completion date: 2015-06-01
Enrollment: 352 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effects of administration of canagliflozin 100 mg and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of Type 1 Diabetes Mellitus (T1DM).

Detailed description:
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect) parallel-group, multicenter study of canagliflozin as an addition to insulin therapy for participants with type 1 diabetes mellitus and inadequate glycemic control.

Approximately 330 participants will be randomly assigned in a 1:1:1 ratio to either canagliflozin 100 mg, canagliflozin 300 mg, or placebo groups. About 90 participants (30 per treatment group) will be selected for a substudy with a purpose of a continuous glucose monitoring (CGM) assessment for 7 days at baseline and 7 days at the end of treatment.

The total duration of the participation will be about 22 weeks, during which participants will need to return to investigational sites for approximately 9 visits. During the study participants will receive advice on treatment of hypoglycemia and diabetic ketoacidosis (DKA), as well as on compliance with diet and exercise.

Arms: arm 1: Each participant will receive 100 mg of canagliflozin once daily for 18 weeks. arm 2: Each participant will receive 300 mg of canagliflozin once daily for 18 weeks. arm 3: Each participant will receive matching placebo once daily for 18 weeks
Interventions: intervention 1: Canagliflozin 100 mg intervention 2: Canagliflozin 300 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Canagliflozin capsule of 100 mg dose will be taken orally, before the first meal of the day. intervention 2: Canagliflozin capsule of 300 mg dose will be taken orally, before the first meal of the day. intervention 3: Matching placebo capsule will be taken orally, before the first meal of the day.

Protocol documents:
Clinical trial NCT02149264
Conditions: Adult Male Hypogonadism
Sponsor: Ferring Pharmaceuticals
Start date: 2014-07-01; Completion date: 2015-06-01
Enrollment: 160 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and safety of FE 999303 (Testosterone gel) in adult hypogonadal males.

Detailed description:

Arms: arm 1: Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
Interventions: intervention 1: Testosterone gel (FE 999303)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02153476
Conditions: Symptomatic Focal Vitreomacular Adhesion
Sponsor: Allegro Ophthalmics, LLC
Start date: 2014-02-01; Completion date: 2015-06-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG-1001 in human subjects with symptomatic focal vitreomacular adhesion

Detailed description:

Arms: arm 1: 2.0mg of ALG-1001 arm 2: Balanced Salt Solution
Interventions: intervention 1: 2.0mg of ALG-1001 intervention 2: Balanced Salt Solution
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02153489
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: AstraZeneca
Start date: 2014-04-01; Completion date: 2015-06-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the effect of aclidinium bromide compared with placebo in improving dilatation of the airways (bronchodilation), symptoms of chronic obstructive pulmonary disease (COPD), sleep quality and physical activity after 3 weeks of treatment with aclidinium bromide 400 μg administered twice daily in patients with stable moderate-and-severe COPD.

Detailed description:

Arms: arm 1: Aclidinium bromide 400 μg administered via oral inhalation (Genuair® dry powder inhaler) one inhalation twice daily (12 hours apart, morning and evening). arm 2: Placebo administered via oral inhalation (Genuair® dry powder inhaler) one inhalation twice daily (12 hours apart, morning and evening).
Interventions: intervention 1: Aclidinium bromide intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02162446
Conditions: Gastroenteropancreatic Neuroendocrine Tumors
Sponsor: Ipsen
Start date: 2014-06-01; Completion date: 2015-06-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and tolerability of 68Ga-OPS202 used for the diagnosis of gastroenteropancreatic neuroendocrine tumors (GEP NETs).

Detailed description:

Arms: arm 1: Satoreotide trizoxetan will be administered in two sequentially ascending peptide doses
Interventions: intervention 1: satoreotide trizoxetan
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02170298
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD Attention Deficit Hyperactivity Disorder Vyvanse Lisdexamfetamine
Sponsor: University of California, Davis
Start date: 2014-02-01; Completion date: 2015-06-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to identify the effects of lisdexamfetamine (LDX) on the neural and behavioral subcomponents of self-control, that is cognitive control and reward functioning, in adolescents and young adults with attention-deficit/hyperactivity disorder.

The investigators hypothesize that LDX is associated with 1a) decreased task-independent locus coeruleus (LC) activity; 1b) increased task-related activity in LC and the cognitive control network; 2) increased LC connectivity with the cognitive control network and 3) improved task performance and self-control. The investigators will test their hypotheses on fMRI data with linear contrasts of voxel-wise maps of parameter estimates (in both univariate and connectivity analyses).

The investigators will also assess change in brain activity with the LDX in the LC and ventral tegmental areas (VTA) as we hypothesize that they are altered in ADHD and related to cognitive control and self-control dysfunction in ADHD.

The investigators will use a repeated-measures, between-subject design to compare the effects of oral once daily LDX in a double-blind placebo-controlled randomized trial (RCT) on neural (fMRI) and behavioral correlates of cognitive control via a working memory and a reward - delay discounting task in adolescents and young adults.

A new condition has been added which will use a within-subject comparison, cross-over design between a single dose of LDX versus a single dose of placebo.

Detailed description:

Arms: arm 1: Participants may be randomized into the placebo comparator arm. Participants in this group will be given a sugar pill titrated up to 70 mg daily over the course of 9 weeks.

Drug: Placebo arm 2: Participants may be randomized into the experimental arm. Participants in this arm will be given lisdexamfetamine titrated up to 70 mg daily over the course of 9 weeks.

Drug: Lisdexamfetamine
Interventions: intervention 1: Lisdexamfetamine
Intervention descriptions: intervention 1: Participants will be given either the study drug or placebo in tablet form. All participants will start with a 20 mg dose and will be titrated up to a 70 mg daily dose over 9 weeks. Participants between 12-18 years of age will be titrated in 10 mg increments and participants between 18-25 years of age in 10-20 mg increments.

Protocol documents:
Clinical trial NCT02192190
Conditions: Osteoarthritis, Knee
Sponsor: Eli Lilly and Company
Start date: 2014-07-01; Completion date: 2015-06-01
Enrollment: 268 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to test if LY2951742 relieves mild to moderate knee pain. The study drugs will be given as an injection under the skin and as an oral capsule. The study will last about 28 weeks for each participant.

Detailed description:

Arms: arm 1: Placebo capsule orally, once daily for approximately 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks (Treatment period = 16 weeks). arm 2: Celecoxib 200 milligram (mg) capsule orally once daily for approximately 16 weeks. Placebo SC once every 4 weeks for 16 weeks (Treatment period = 16 weeks). arm 3: Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 5 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). arm 4: Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 50 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). arm 5: Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). arm 6: Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks).
Interventions: intervention 1: LY2951742 intervention 2: Placebo- oral intervention 3: Placebo - SC intervention 4: Celecoxib
Intervention descriptions: intervention 1: Administered subcutaneously (SC) intervention 2: Administered orally intervention 3: Administered SC intervention 4: Administered orally

Protocol documents:
Clinical trial NCT02195687
Conditions: Lateral Canthal Lines Crow's Feet Lines
Sponsor: Allergan
Start date: 2014-09-01; Completion date: 2015-06-01
Enrollment: 417 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared with placebo in patients with moderate to severe crow's feet lines (lateral canthal lines).

Detailed description:

Arms: arm 1: 24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1. arm 2: Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
Interventions: intervention 1: botulinum toxin Type A intervention 2: Normal Saline
Intervention descriptions: intervention 1: botulinum toxin Type A (BOTOX®) injected into bilateral crow's feet line areas. intervention 2: Normal Saline (placebo) injected into bilateral Crow's Feet Line areas.

Protocol documents:
Clinical trial NCT02197520
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2014-07-01; Completion date: 2015-06-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will look into insulin sensitivity (how the body responds to insulin) and effects of meals on type 2 diabetics comparing insulin peglispro to insulin glargine. The study has two treatment periods, each of which will last about four weeks. One drug (insulin peglispro or insulin glargine) will be administered in each period. Participants will receive both drugs during the study. Participants may remain on stable dose metformin, as prescribed by their personal physician.

Detailed description:

Arms: arm 1: Insulin peglispro, a once daily subcutaneous(SC) injection at bedtime for 5 weeks arm 2: Insulin glargine, a once daily subcutaneous(SC) injection at bedtime for 5 weeks
Interventions: intervention 1: Insulin Peglispro intervention 2: Insulin Glargine intervention 3: Insulin Lispro
Intervention descriptions: intervention 1: Administered subcutaneously (SC), (U-100 formulation) intervention 2: Administered subcutaneously (SC), (U-100 formulation) intervention 3: Administered subcutaneously (SC), (U-100 formulation)

Protocol documents:
Clinical trial NCT02199574
Conditions: Pain
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2014-08-01; Completion date: 2015-06-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to characterize the pharmacokinetic (PK) profile of a single dose of EXPAREL (133 mg/10 mL) administered intraoperatively per normal infiltration for prolonged analgesia in 12 adult subjects undergoing tonsillectomy with or without removal of the adenoids.

Detailed description:
Blood samples for bupivacaine PK analysis will be obtained from subjects at baseline (within 30 minutes prior to EXPAREL infiltration), 15 minutes, 30 minutes, and 1, 2, 4, 8, 12, 24, 36, 48, and 72 hours after the beginning of EXPAREL infiltration, and on Day 7.

Arms: arm 1: Single administration of EXPAREL 133 mg (10 mL).
Interventions: intervention 1: EXPAREL
Intervention descriptions: intervention 1: 133 mg EXPAREL in 10 mL.

Protocol documents:
Clinical trial NCT02217878
Conditions: ST-segment Elevation Myocardial Infarction Non-ST-segment Elevation Myocardial Infarction VA Drug Interactions
Keywords: ST-segment elevation myocardial infarction non-ST-segment elevation myocardial infarction ticagrelor morphine pharmacokinetics pharmacodynamics drug interactions VASP assay Multiple Electrode Aggregometry VerifyNow
Sponsor: Collegium Medicum w Bydgoszczy
Start date: 2014-08-01; Completion date: 2015-06-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the IMPRESSION study is to determine whether intravenous administration of morphine prior to ticagrelor administration in ST-segment elevation myocardial infarction (STEMI) patients and in non-ST-segment elevation myocardial infarction (NSTEMI) patients alters the plasma concentrations of ticagrelor and its active metabolite and whether it is associated with any negative impact on the antiplatelet effect of ticagrelor.

Detailed description:
The European Society of Cardiology and American Heart Association guidelines recommend use of morphine as a treatment of choice for pain relief in STEMI patients. However, this recommendation, although strong, is only based on expert consensus (class of recommendation I, level of evidence C). Morphine, apart from its analgesic effects, also alleviates the work of breathing and reduces anxiety. On the other hand, despite its favorable analgesic and sedative actions, morphine also exerts adverse effects, which include hypotension, bradycardia, respiratory depression, vomiting and reduction of gastrointestinal motility. Some of the previously listed morphine's side effects could affect the intestinal absorption and thus pharmacokinetics and pharmacodynamics of orally administered drugs which are concomitantly used with morphine. At present, no pharmacokinetic and pharmacodynamic data regarding the concurrent use of morphine and P2Y12 blockers in the STEMI or NSTEMI setting are available. Therefore, evidence-based verification of morphine's influence on pharmacokinetics and pharmacodynamics of ticagrelor and its active metabolite (AR-C124910XX) could provide a valuable insight in the knowledge regarding modern acute myocardial infarction management.

Predefined subanalysis: aimed to investigate which one of platelet reactivity assessment methods utilized in the study (VASP assay, MEA, LTA, VerifyNow) best reflects concentration of ticagrelor and its active metabolite (AR-C124910XX).

Since there is no reference study examining pharmacokinetics of ticagrelor in STEMI or NSTEMI patients, we decided to perform an internal pilot study of approximately 30 patients (15 patients for each arm) for estimating the final sample size.

Arms: arm 1: morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor arm 2: sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor
Interventions: intervention 1: Morphine intervention 2: Placebo intervention 3: Ticagrelor
Intervention descriptions: intervention 1: IV bolus injection intervention 2: IV bolus injection intervention 3: 180 mg loading dose

Protocol documents:
Clinical trial NCT02218307
Conditions: Chronic Rhinosinusitis
Sponsor: University of Miami
Start date: 2011-11-01; Completion date: 2015-06-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Double blind placebo controlled trial to evaluate whether the routine use of nasal irrigation with mupirocin is more effective than saline irrigations alone in reducing symptoms of chronic rhinosinusitis in the early postoperative period.

Detailed description:

Arms: arm 1: topical antibiotic arm 2: Placebo control for mupirocin
Interventions: intervention 1: Mupirocin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02222207
Conditions: Macular Degeneration
Keywords: neovascular Age-related Macular Degeneration
Sponsor: Bayer
Start date: 2014-10-01; Completion date: 2015-06-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Part A (Phase IIa):

Primary objectives:

The study part A is designed to investigate whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study.

Secondary objectives:

The study will also evaluate the safety and tolerability of the regorafenib eye drops.

Part B (Phase IIb):

Primary objectives:

The study part B is designed to investigate:

* how often the regorafenib eye drops need to be given per day
* whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study.

Secondary objectives:

The study will also evaluate how the different dosings of regorafenib eye drops affect patients vision, the safety and the tolerability.

Detailed description:

Arms: arm 1: Part A: Patients will receive Regorafenib eye drops arm 2: Part B: Regorafenib eye drops dose 1; plus sham IVT (Intravitreal therapy) once every 4 weeks arm 3: Part B: Regorafenib eye drops dose 2; plus sham IVT (Intravitreal therapy) once every 4 weeks arm 4: Part B: Regorafenib eye drops dose 3; plus sham IVT (Intravitreal therapy) once every 4 weeks arm 5: Part B: Regorafenib eye drops dose 4; plus sham IVT (Intravitreal therapy) once every 4 weeks arm 6: Part B: Regorafenib eye drops dose 5; plus sham IVT (Intravitreal therapy) once every 4 weeks arm 7: Part B: Regorafenib eye drops dose 6; plus sham IVT (Intravitreal therapy) once every 4 weeks arm 8: Ranibizumab IVT once every 4 weeks; plus placebo eye drops to match the regorafenib eye drop regimens
Interventions: intervention 1: Regorafenib, ophthalmic oily suspension (BAY73-4506) intervention 2: Sham IVT intervention 3: Ranibizumab intervention 4: Placebo
Intervention descriptions: intervention 1: Subjects receive Regorafenib as eye drops intervention 2: Sham injections intervention 3: Subjects receive Ranibizumab as intravitreal injection intervention 4: Placebo eye drops

Protocol documents:
Clinical trial NCT02224625
Conditions: Surgery
Sponsor: Medline Industries
Start date: 2014-08-01; Completion date: 2015-06-01
Enrollment: 249 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product applied to see if they become sensitized to repeated applications.

Detailed description:
For the Irritation Study (30 subjects), patches containing CHG, vehicle, saline, CHG comparator or sodium lauryl sulfate (a product that is expected to produce a slight skin irritation) will be placed on the same spot of your skin every day for 21 days. The skin will be examined every day.

The Sensitization Study (200 total subjects) place patches containing CHG, vehicle, saline, CHG comparator on the skin 3 times a week for 3 weeks. Following a two-week rest period the patches will be reapplied for 48 hours and assessed out to 72 hours thereafter.

Arms: arm 1: Chlorhexidine Gluconate 2% arm 2: Excipients on cloth arm 3: Chlorhexidine Gluconate 2% solution arm 4: 0.9% sodium chloride arm 5: Sodium lauryl sulfate to produce mild irritation as a positive control
Interventions: intervention 1: 2% CHG Cloth solution intervention 2: Vehicle Cloth intervention 3: Active Comparator intervention 4: Saline intervention 5: SLS
Intervention descriptions: intervention 1: Investigational CHG intervention 2: Excipients from CHG cloth only intervention 3: Active comparator intervention 4: Negative control intervention 5: Provides a slight irritation for a positive control

Protocol documents:
Clinical trial NCT02230683
Conditions: Liver Cirrhosis Hepatic Cirrhosis Portal Hypertension
Keywords: Liver Cirrhosis Hepatic Cirrhosis Portal Hypertension
Sponsor: Conatus Pharmaceuticals Inc.
Start date: 2014-08-01; Completion date: 2015-06-01
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label pilot study to evaluate the safety, tolerability, and efficacy of IDN-6556 in treating portal hypertension in subjects with liver cirrhosis.

Detailed description:
Studies in patients with liver disease have demonstrated that cCK18 is elevated in the serum of patients and has been associated with disease severity. Studies have also shown that cCK18 is generally elevated to a higher degree in cirrhosis than in other liver diseases. In addition, increasing stages of cirrhosis from Child-Pugh A, Child-Pugh B to Child-Pugh C are associated with progressively higher levels of caspase cleaved cytokeratin 18. This suggests that apoptosis and caspase activity are associated with the severity of disease. IDN-6556 and its ability to inhibit inflammation and apoptosis may have a beneficial impact on both the dynamic and structural components associated with the pathogenesis of portal hypertension in cirrhosis.

Arms: arm 1: Overall evaluable population treated with IDN-6556 25 mg twice daily arm 2: Subgroup for patients with Baseline HVPG \< 12 mmHg that have been treated with IDN-6556 25 mg twice daily arm 3: Subgroup for patients with Baseline HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
Interventions: intervention 1: IDN-6556
Intervention descriptions: intervention 1: 25 mg BID

Protocol documents: