ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02103114
Conditions: ATIII Deficiency
Sponsor: Duke University
Start date: 2014-06-01; Completion date: 2016-07-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test whether the administration of ATIII during the intra-operative period results in improved anticoagulation for cardiopulmonary bypass (CPB) and an attenuation of the activation of the coagulation cascade, as represented by a decrease in fibrin degradation products. The investigators believe this benefit would extend into the post-operative period resulting in a decreased incidence of thrombosis generation, as represented by a decrease in fibrin degradation products in the ICU period.

Detailed description:
If Preoperative ATIII functional assay level is less than 70% patients would be enrolled and randomized to either Placebo (normal saline) or ATIII.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Anti-thrombin III intervention 2: Placebo
Intervention descriptions: intervention 1: Intraoperatively- (correcting to 100%) according to the following formula:

Units required = ((100%- baseline ATIII level\*%) X body weight)/1.4

* expressed as a % normal level based on functional ATIII assay intervention 2: Normal saline placebo

Protocol documents:
Clinical trial NCT02121041
Conditions: Hypertension
Keywords: Hypertension Blood Pressure Ambulatory Blood Pressure Monitoring
Sponsor: Anthony J Viera, MD, MPH
Start date: 2014-05-01; Completion date: 2016-07-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness of ambulatory blood pressure monitoring to usual care (blood pressure measurement in the office) in diagnosing and managing hypertension.

Detailed description:
The usual strategy for detecting hypertension-repeated office blood pressure (BP) measurements-is inefficient and inaccurate. When paired with ambulatory BP monitoring (ABPM), which takes a multitude of measurements over 24 hours, it is clear that office BP measurements may convey a falsely positive diagnosis known as white-coat hypertension. What is less well-known is that office BP measurements may also convey a falsely negative diagnosis termed masked hypertension (MH). That is, office BP may measure as normal, yet 24-hour ambulatory measurements show elevated BP. People with MH have cardiovascular risk that is similar to that of people with diagnosed hypertension, yet MH goes unrecognized, and therefore, untreated. Ultimately, identifying the best strategy for accurately detecting hypertension is vital to improving overall BP control and reducing cardiovascular events. Without a feasible ABPM strategy, MH will continue to go unrecognized and untreated.

Participants enrolled in the study will be randomized to either the usual care group or the ABPM-guided group. All participants will have a baseline ABPM. ABPM will be used to make a diagnosis and determine anti-hypertensive treatment in the ABPM-guided group only. Participants in the ABPM-guided group will have a follow-up ABPM in 2 months. All participants will have a final ABPM 4 months after enrollment.

Arms: arm 1: Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care. arm 2: Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.
Interventions: intervention 1: Amlodipine intervention 2: Chlorthalidone intervention 3: Losartan
Intervention descriptions: intervention 1: Amlodipine 5 mg or 10 mg intervention 2: Chlorthalidone 12.5 mg or 25 mg intervention 3: Losartan 50 mg or 100 mg

Protocol documents:
Clinical trial NCT02139007
Conditions: Osteoporosis
Sponsor: University of Alabama at Birmingham
Start date: 2014-06-01; Completion date: 2016-07-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a pilot study evaluating the recruitment strategies for sites and patients, data collection instruments, follow-up procedures, administrative processes, and the proposed management strategy for the future large scale national trial.

Detailed description:

Arms: arm 1: Alendronate continuation arm arm 2: Alendronate discontinuation arm
Interventions: intervention 1: Alendronate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02154347
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus HbA1c
Sponsor: Kissei Pharmaceutical Co., Ltd.
Start date: ; Completion date: 2016-07-01
Enrollment: 178 participants; Allocation: ; Intervention model: 

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of KAD-1229 as combination therapy with insulin for 16 weeks and up to 52 weeks administration in patients with type 2 Diabetes Mellitus who show inadequate glycemic control with diet, and insulin monotherapy, or insulin and oral hypoglycemic agent.

Detailed description:

Arms: arm 1: Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study. arm 2: Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study.
Interventions: intervention 1: KAD-1229 intervention 2: Placebo intervention 3: Insulin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02214615
Conditions: Erythromelalgia
Sponsor: VA Connecticut Healthcare System
Start date: 2014-04-01; Completion date: 2016-07-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This research study is designed to investigate brain response using fMRI scan, and behavioral responses, to treatment with the drug carbamazepine (CBZ) in patients with the painful sodium channelopathy inherited Erythromelalgia (IEM). This study is designed to identify the central nervous system (CNS) regions that are activated during ongoing or evoked pain attacks, and the altered CNS response to CBZ treatment. This will advance our understanding of how IEM affects the brain. We also hope to validate a pharmacogenic approach to the study of IEM by use of an FDA approved drug. We hope, but cannot be sure, that subjects will directly benefit from this study.

Detailed description:

Arms: arm 1: Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days. arm 2: Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.
Interventions: intervention 1: Carbamazepine intervention 2: Placebo
Intervention descriptions: intervention 1: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.

Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days. intervention 2: None

Protocol documents:
Clinical trial NCT02234752
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: Schizophrenia Schizoaffective Disorder Cognition Cognitive Impairment Galantamine Memantine
Sponsor: Sheppard Pratt Health System
Start date: 2014-09-01; Completion date: 2016-07-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Aim: To examine the efficacy of the combination of galantamine and memantine for the treatment of cognitive deficits in outpatients with schizophrenia.

Hypothesis: A combination of galantamine and memantine will improve cognitive impairments in patients with schizophrenia.

This is an open-label study to evaluate whether a six week course of galantamine ER and memantine XR is effective in improving the cognitive performance of patients with schizophrenia or schizoaffective disorder. The primary outcome measure will be the change in level of cognition as measured by the MATRICS Consensus Cognitive Battery (MCCB). The results of the MATRICS collaborative project recommended the need for standardized cognitive tests that better distinguish the different facets of cognitive dysfunction in schizophrenia. The MCCB will assess the following seven domains: attention/vigilance, reasoning and problem solving, processing speed, social cognition, verbal learning and memory, visual learning and memory, and working memory. The MCCB will be administered at baseline and at the end of the study. We will report total score and each domain score in the MCCB at baseline and six weeks.

Detailed description:

Arms: arm 1: Week 1, Galantamine ER 8 mg HS \& Memantine XR 7 mg HS Week 2, Galantamine ER 16 mg HS \& Memantine XR 14 mg HS Weeks 3-6, Galantamine ER 24 mg HS \& Memantine XR 21 mg HS
Interventions: intervention 1: Galantamine ER intervention 2: Memantine XR
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02260791
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
Sponsor: Fujifilm Kyowa Kirin Biologics Co., Ltd.
Start date: 2014-12-01; Completion date: 2016-07-01
Enrollment: 728 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have inadequate disease control on methotrexate.

Detailed description:

Arms: arm 1: Patients will receive FKB327 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks. arm 2: Patients will receive Humira® 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.
Interventions: intervention 1: FKB327 intervention 2: Humira®
Intervention descriptions: intervention 1: Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks. intervention 2: Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.

Protocol documents:
Clinical trial NCT02274558
Conditions: Tardive Dyskinesia
Sponsor: Neurocrine Biosciences
Start date: 2014-10-01; Completion date: 2016-07-01
Enrollment: 234 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

Detailed description:
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel, fixed-dose study to evaluate the efficacy, safety, and tolerability of two doses of NBI-98854 (40 mg and 80 mg) compared to placebo, administered once daily. The study design includes a double-blind, placebo-controlled treatment period for 6 weeks and a double-blind NBI-98854 treatment period for an additional 42 weeks, for a total of 48 weeks of treatment. Final follow-up assessments will be conducted 4 weeks after the last dose of the study drug.

Arms: arm 1: NBI-98854 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning between 7:00am - 10:00am for 6 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and continue with their current dose. arm 2: Subjects randomized to the NBI-98854 80 mg dose will receive NBI-98854 40 mg for the first week (administered as one (1) 40 mg capsule and one (1) placebo capsule), followed by NBI-98854 80 mg administered as two (2) 40 mg capsules, taken by mouth, every morning between 7:00am - 10:00am for 5 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and continue with their current dose. arm 3: Placebo administered as two (2) placebo capsules, taken by mouth, every morning between 7:00am - 10:00am for 6 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and be randomized to either a 40 mg or 80 mg dose. Subjects re-randomized to receive NBI-98854 80 mg will receive 40 mg for the first week.
Interventions: intervention 1: NBI-98854 intervention 2: Placebo
Intervention descriptions: intervention 1: NBI-98854 40 mg capsules intervention 2: NBI-98854 placebo capsules

Protocol documents:
Clinical trial NCT02279108
Conditions: Breast Neoplasms
Keywords: sentinel lymph node indocyanine green fluorescence method radioisotope conventional method breast cancer
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Start date: 2014-11-01; Completion date: 2016-07-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The sentinel node has a fundamental role in the management of early breast cancer.

Currently, the double detection of blue and radioisotope is recommended. A radioactive material requires the presence of a nuclear medicine department and the approval of health authorities. In many centers, this technique is not available. The use of blue is easier to implement technique. However, allergic reactions and prolonged breast tattoo led many teams to stop the practice.

So in common practice, many center use a single method. However, with a single detection, the risk of false negatives and the identification failure rate increased to a significant extent and the number of sentinel lymph node detected and removed is not enough.

Under these conditions, find another method of detection seems crucial. According to the literature, the fluorescence method (ICG) is a technique that seems safe and reliable.

The investigators therefore propose a prospective, randomized study to investigate the interest of fluorescence associated with the isotopic method.

Detailed description:

Arms: arm 1: intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery arm 2: intradermal injection of 20 MBq of technetium 99 before breast surgery
Interventions: intervention 1: indocyanine green intervention 2: isotope
Intervention descriptions: intervention 1: One injection, 2.5 milligrams per patient, intradermal use intervention 2: One injection, 20 MBq techntium99, intradermal use

Protocol documents:
Clinical trial NCT02302716
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2014-12-01; Completion date: 2016-07-01
Enrollment: 493 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as LY2963016 as compared to LANTUS® in adults with type 2 diabetes mellitus who are on 2 or more oral antihyperglycemic medications (OAMs).

Detailed description:

Arms: arm 1: Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine hagedorn (NPH) QD will begin the study at their current dose SC. Participants will self titrate LY2963016 based on fasting blood glucose (FBG). Participants entering on insulin detemir or NPH twice a day will be started at 80% of the total daily dose SC. Participants will continue oral antihyperglycemic medication (OAM). arm 2: Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD will be started at the same dose SC. Participants entering on insulin detemir or NPH twice a day will be started at 80% of the total daily dose SC. Participants will self titrate LANTUS® based on FBG. Participants will continue OAM.
Interventions: intervention 1: LY2963016 intervention 2: LANTUS® intervention 3: Oral Antihyperglycemic Medication
Intervention descriptions: intervention 1: Administered SC intervention 2: Administered SC intervention 3: Administered as per standard-of-care.

Protocol documents:
Clinical trial NCT02351115
Conditions: Epilepsy
Sponsor: Alexza Pharmaceuticals, Inc.
Start date: 2015-01-01; Completion date: 2016-07-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether people who usually have photosensitive epilepsy will show a reduction in epileptic activity when they take a single dose of Staccato Alprazolam as compared to placebo.

Detailed description:
The purpose of this study is to determine whether people who usually have photosensitive epilepsy will show a reduction in epileptic activity when they take a single dose of Staccato Alprazolam as compared to placebo. People with photosensitive epilepsy have changes on their electroencephalogram (EEG) when shown flashing lights. Three dose levels of Staccato Alprazolam will be compared to placebo.

This study will also assess the level of sedation of Staccato Alprazolam compared to placebo.

Arms: arm 1: A=Placebo, B=Inhaled Alprazolam 0.5 mg, C=Inhaled Alprazolam 1 mg, D= Inhaled Alprazolam 2 mg, E=Placebo arm 2: A=Placebo, B=Inhaled Alprazolam 0.5 mg, C=Inhaled Alprazolam 1 mg, D= Inhaled Alprazolam 2 mg, E=Placebo arm 3: A=Placebo, B=Inhaled Alprazolam 0.5 mg, C=Inhaled Alprazolam 1 mg, D= Inhaled Alprazolam 2 mg, E=Placebo arm 4: A=Placebo, B=Inhaled Alprazolam 0.5 mg, C=Inhaled Alprazolam 1 mg, D= Inhaled Alprazolam 2 mg, E=Placebo arm 5: A=Placebo, B=Inhaled Alprazolam 0.5 mg, C=Inhaled Alprazolam 1 mg, D= Inhaled Alprazolam 2 mg, E=Placebo
Interventions: intervention 1: A=Placebo intervention 2: B=Inhaled Alprazolam 0.5 mg intervention 3: C=Inhaled Alprazolam 1 m intervention 4: D= Inhaled Alprazolam 2 mg intervention 5: E=Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT02387710
Conditions: Sleep Apnea, Obstructive
Keywords: arousal threshold phenotype tiagabine slow wave sleep
Sponsor: Brigham and Women's Hospital
Start date: 2015-03-01; Completion date: 2016-07-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Interestingly, the severity of OSA is profoundly reduced in deep sleep (called "slow wave sleep"), potentially via an increase in the stimulus required to arouse from sleep. Here the investigators test the idea that the medication called "tiagabine" improves slow wave sleep and reduces OSA severity. The investigators will also test whether tiagabine raises the arousal threshold (more negative esophageal pressure), and whether detailed OSA "phenotyping" characteristics can predict the improvement in OSA severity with this intervention.

Detailed description:
The current study tests the primary hypothesis that tiagabine improves sleep apnea severity in patients with moderate-to-severe sleep apnea (apnea hypopnea index measured in supine non-REM sleep; hypopneas defined by 3% desaturation or arousal). The investigators test three secondary hypotheses that tiagabine:

1. increases the proportion of total sleep time in slow wave sleep
2. raises the non-REM arousal threshold (more negative esophageal pressure) via (1).
3. is preferentially effective in patients whose OSA phenotype predicts that an increase in the arousal threshold is sufficient to resolve OSA versus those without such favorable physiology. Favorable physiology is defined here as having a low ventilatory drive at which stable breathing is theoretically feasible ("stable Vdrive" is \<100% above eupneic ventilatory drive) due to any combination of a "high" upper airway muscle response, "good" passive anatomy (high Vpassive), and "low" steady-state loop gain (see Owens RL et al SLEEP 2014; Wellman A et al J Appl Physiol 2011, 2013; Eckert DJ et al 2013 AJRCCM).

Arms: arm 1: Tiagabine PO 12 mg before sleep arm 2: Placebo PO before sleep
Interventions: intervention 1: Tiagabine intervention 2: Placebo
Intervention descriptions: intervention 1: GABA reuptake inhibitor intervention 2: Placebo comparator

Protocol documents:
Clinical trial NCT02412644
Conditions: Plaque Psoriasis
Sponsor: Psoriasis Treatment Center of Central New Jersey
Start date: 2015-05-28; Completion date: 2016-07-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
12 weeks open label with Otezla® and NUVB, followed by 6 month double blind Otezla® (apremilast) or placebo to subjects who obtain PASI 75 at week 12 of phototherapy

Detailed description:
Primary Objective: To evaluate the effectiveness of Otezla (apremilast®) in promoting maintenance of response in those subjects who obtained PASI-75 at week 12 of phototherapy.

Arms: arm 1: apremilast 30mg bid for 12 weeks.followed by apremilast 30 mg bid for 24 weeks arm 2: apremilast 30mg bid for 12 weeks followed by placebo bid for 24 weeks
Interventions: intervention 1: apremilast
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02445794
Conditions: Friedreich's Ataxia
Sponsor: Biojiva LLC
Start date: 2015-08-01; Completion date: 2016-07-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of RT001 in patients with Friedreich's ataxia.

Detailed description:
Study RT001-002 is a randomized, double-blind, controlled, ascending dose study to evaluate the safety, tolerability, pharmacokinetic, disease state, and exploratory endpoints in patients with Friedreich's ataxia after oral administration. The study includes 2 dose levels of RT001.

Arms: arm 1: RT001, oral, 1.8 g QD for 28 days or matching comparator arm 2: RT001, oral, 4.5 g BID for 28 days or matching comparator
Interventions: intervention 1: Low dose cohort intervention 2: High dose cohort
Intervention descriptions: intervention 1: RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001. intervention 2: RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.

Protocol documents: