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NCT0531xxxx/NCT05319093.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319093</url>
</required_header>
<id_info>
<org_study_id>2021P003284</org_study_id>
<nct_id>NCT05319093</nct_id>
</id_info>
<brief_title>Observational Study of the Effect of Ozanimod on Fatigue in Multiple Sclerosis Patients</brief_title>
<official_title>Observational Study of the Effect of Ozanimod on Fatigue in Multiple Sclerosis Patients</official_title>
<sponsors>
<lead_sponsor>
<agency>Brigham and Women's Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Bristol-Myers Squibb</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>Brigham and Women's Hospital</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Multi-center observational study to assess the short-term response of multiple sclerosis (MS)
patients initiated on Ozanimod with respect to fatigue. Patterns of brain changes on brain
magnetic resonance imaging (MRI) that might modulate the effect of Ozanimod treatment on
fatigue will also be assessed.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Primary objectives:

1. To assess the effect of Ozanimod treatment on the impact of fatigue on physical,
cognitive, and psychosocial functions, as measured by the modified fatigue impact scale
(MFIS).

2. To assess the impact of fronto-striatal damage on the association between Ozanimod
treatment and fatigue.

Secondary objectives:

1. To assess the effect of Ozanimod treatment on fatigue severity, mood symptoms (ie,
depression and anxiety), sleep quality, physical activity, reward responsiveness and
cognitive functions over the first 3-month after treatment initiation with Ozanimod.

2. To assess the time course of changes by daily administration of visual analogue scales
of fatigue, depression, anxiety, and pain, and monthly administration of self-assessment
questionnaires for fatigue, depression and anxiety using a mobile application.

3. In addition to the hypothesis-driven analyses specifically targeting the fronto-striatal
system, the investigators will also perform analyses designed to discover other
potential brain MRI predictors of Ozanimod treatment response (ie, change in primary
and/or secondary endpoints during the 3-month Ozanimod treatment). The investigators
will perform global and regional (e.g., cerebral cortical, deep grey matter,
hippocampal) volumetric measurements as well as well-established voxel-based image
statistics to seek other potential patterns of brain atrophy that identify responders to
Ozanimod. Resting state functional MRI (rsfMRI) will also be performed to seek potential
markers of fatigue related to functional brain connectivity changes.

4. To establish patient compliance in using the aforementioned mobile app, and the
robustness of app-based phenotypic characterization of fatigue and related symptoms on
real-world patients. These observations will lay the basis for future prospective
studies on larger patient cohorts. For this purpose, recruitment will also be expanded
to patients treated with disease modifying drugs other than Ozanimod.

Primary hypothesis:

Patients without significant damage to fronto-striatal circuitry (ie, fronto-striatal
fractional anisotropy (FA)≥0.26 on diffusion tensor MRI (DT-MRI)) show significant decrease
in fatigue score over the first 3-month after treatment initiation with Ozanimod.

Study assessments:

Treatment schedule and dosage of Ozanimod and the other disease-modifying treatments (DMTs)
will be solely based on clinical indication and will be instituted by the patient's treating
neurologist at Brigham and Women's Hospital or Massachusetts General Hospital. The proposed
study is purely observational and will not influence the selection, schedule or dosage of
patient treatments. Therefore, no safety assessment will be performed within the study.

All endpoints and confounders will be assessed using state-of-the art mobile/wearable
technology, while the patient is on her/his/their normal routine at home and/or at work,
including self-isolated quarantine. All patient-reported outcomes (PROs) will be assessed
using a mobile application developed by the study team. The first version of the mobile
application was already tested and used in a prospective brain MRI study of MS-related
fatigue (MGB IRB Protocol number: 2017P001239). The mobile application will be modified and
adapted to make it specifically suitable for the proposed study. The application will be
installed on an Android smartphone that will be provided to each subject. The application
will communicate using end-to-end encryption (https protocol) with a server inside the MGB
firewall. Data will be transmitted between the mobile app and the server in deidentified and
coded form.

Continuous actigraphy will be performed using wrist-worn actigraphic watches to assess
quantitative physical activity (during daytime) and sleep measures (at night) during the
entire 3-months period of the trial. These devices also measure other bio-signals as for
instance skin conductivity and heart rhythm, as well as light exposure.

Presence/absence of obstructive sleep apnea and restless leg syndrome will be assessed once
between day 0 and day 3 of the trial period using a home sleep test (HST) device.

Subjects will receive the study devices in person or via postal mail and will be instructed
how to use the devices in person or via video conference call in compliance with COVID-19
regulations.

Each patient will undergo 3 Tesla brain Magnetic Resonance Imaging, including diffusion
tensor, T1-weighted, T2-weighted, FLAIR and rsfMRI imaging at Brigham and Women's Hospital at
baseline.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">April 2022</start_date>
<completion_date type="Anticipated">December 2023</completion_date>
<primary_completion_date type="Anticipated">July 2023</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Control</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Three-months change in Modified Fatigue Impact Scale (MFIS) score</measure>
<time_frame>3 months</time_frame>
<description>Difference in Modified Fatigue Impact Scale (MFIS) score between baseline (treatment initiation) and month 3. MFIS score will be assessed at baseline, as well as on days 28, 56 and 84 of the trial period. Should the 84-day measurement not be available, the three-months change will be estimated by linear regression extrapolation using available measurements.</description>
</primary_outcome>
<secondary_outcome>
<measure>Three-months change in Chalder Fatigue Scale (CFS) score</measure>
<time_frame>3 months</time_frame>
<description>Difference in Chalder Fatigue Scale (CFS) score between baseline (treatment initiation) and month 3. CFS score will be assessed at baseline, as well as on days 28, 56 and 84 of the trial period. Should the 84-day measurement not be available, the three-months change will be estimated by linear regression extrapolation using available measurements.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Three-months change in Fatigue Severity Scale (FSS) score</measure>
<time_frame>3 months</time_frame>
<description>Difference in Fatigue Severity Scale (FSS) score between baseline (treatment initiation) and month 3. FSS score will be assessed at baseline, as well as on days 28, 56 and 84 of the trial period. Should the 84-day measurement not be available, the three-months change will be estimated by linear regression extrapolation using available measurements.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Three-months change in NeuroQOL-fatigue questionnaire score</measure>
<time_frame>3 months</time_frame>
<description>Difference in NeuroQOL-fatigue scale score between baseline (treatment initiation) and month 3. NeuroQOL-fatigue score will be assessed at baseline, as well as on days 28, 56 and 84 of the trial period. Should the 84-day measurement not be available, the three-months change will be estimated by linear regression extrapolation using available measurements.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Visual Analog Scale (VAS) for fatigue score</measure>
<time_frame>3 months</time_frame>
<description>Change in VAS fatigue score over the observation period. Current fatigue level will be assessed using VAS every four hours while the patient is awake during the trial period.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Three-months change in NeuroQOL-cognitive function questionnaire score</measure>
<time_frame>3 months</time_frame>
<description>Difference in NeuroQOL-cognitive function scale score between baseline (treatment initiation) and month 3. Cognitive function will be assessed at baseline, as well as on days 28, 56 and 84 of the trial period. Should the 84-day measurement not be available, the three-months change will be estimated by linear regression extrapolation using available measurements.</description>
</secondary_outcome>
<other_outcome>
<measure>NeuroQOL-depression scale</measure>
<time_frame>3 months</time_frame>
<description>Level of depression will be assessed using the NeuroQOL-depression scale score. It will be assessed at baseline, as well as on days 28, 56 and 84 of the trial period.</description>
</other_outcome>
<other_outcome>
<measure>NeuroQOL-anxiety scale</measure>
<time_frame>3 months</time_frame>
<description>Level of anxiety will be assessed using the NeuroQOL-anxiety scale score. It will be assessed at baseline, as well as on days 28, 56 and 84 of the trial period.</description>
</other_outcome>
<other_outcome>
<measure>Epworth Sleepiness scale</measure>
<time_frame>3 months</time_frame>
<description>Sleep abnormalities will be assessed using the Epworth Sleepiness scale score. It will be assessed at baseline, as well as on days 28, 56 and 84 of the trial period.</description>
</other_outcome>
<number_of_groups>4</number_of_groups>
<enrollment type="Anticipated">40</enrollment>
<condition>Fatigue</condition>
<condition>Multiple Sclerosis</condition>
<arm_group>
<arm_group_label>Early Ozanimod treatment</arm_group_label>
<description>In this group the effect of Ozanimod will be assessed in patients who initiated on Ozanimod treatment at study baseline (n=10).
Treatment schedule and dosage of Ozanimod and the other disease-modifying treatments (DMTs) will be solely based on clinical indication and will be instituted by the patient's treating neurologist at Brigham and Women's Hospital or Massachusetts General Hospital.</description>
</arm_group>
<arm_group>
<arm_group_label>Medium-term Ozanimod treatment</arm_group_label>
<description>In this group, the effect of Ozanimod will be assessed in patients treated with Ozanimod for ≥6 months at study baseline (n=10).
Treatment schedule and dosage of Ozanimod and the other disease-modifying treatments (DMTs) will be solely based on clinical indication and will be instituted by the patient's treating neurologist at Brigham and Women's Hospital or Massachusetts General Hospital.</description>
</arm_group>
<arm_group>
<arm_group_label>Non-Ozanimod treatment</arm_group_label>
<description>In this group, investigators will involve patients initiated on any disease-modifying drug (other than Ozanimod) at study initiation (n=10).
Treatment schedule and dosage of the disease-modifying treatments (DMTs) will be solely based on clinical indication and will be instituted by the patient's treating neurologist at Brigham and Women's Hospital or Massachusetts General Hospital. The proposed study is purely observational and will not influence the selection, schedule or dosage of patient treatments.</description>
</arm_group>
<arm_group>
<arm_group_label>Untreated</arm_group_label>
<description>In this group, MS patient will be involved who did not receive any disease-modifying drug for at least 3 months before study initiation (i.e., untreated patients, n=10)</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Ozanimod</intervention_name>
<description>Three-months, longitudinal observational period</description>
<arm_group_label>Early Ozanimod treatment</arm_group_label>
<arm_group_label>Medium-term Ozanimod treatment</arm_group_label>
<other_name>ZEPOSIA</other_name>
</intervention>
<eligibility>
<study_pop>
<textblock>
All MS patients seen at Brigham and Women's Hospital and Massachusetts General Hospital who
fit our selection criteria (see below) will be eligible to participate in this study. Since
MS is 2-3 times more common in women, investigators expect that more women than men will
participate.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

1. age≥18

2. diagnosis of MS (according to the 2010 McDonald criteria)

Exclusion Criteria:

1. neurodegenerative disorders other than MS

2. terminal medical condition

3. currently treated for active malignancy

4. alcohol or substance abuse in the past year, except marijuana

5. diagnosis of major depressive disorder based on DSM V criteria

6. non-English speakers (the mobile application is not available in other languages)

7. inability to undergo MRI scan

Patients undergoing COVID-19 vaccination will be allowed to participate in the study if at
least 2 weeks have elapsed from their last dose of vaccine.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Charles RG Guttmann, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Brigham and Women's Hospital, Radiology</affiliation>
</overall_official>
<overall_contact>
<last_name>Diana Pintye, MD</last_name>
<phone>+18574239507</phone>
<email>dpintye@bwh.harvard.edu</email>
</overall_contact>
<link>
<url>http://www.camntech.com/motionwatch-8/?gclid=CjwKCAjwu5CDBhB9EiwA0w6sLasykklM0I-K0nPtxe4WNO8wt4yV8m91jhcsbsbwHDVbSNfnBYuUVhoCpgQQAvD_BwE.</url>
<description>MotionWatch 8</description>
</link>
<link>
<url>http://noxmedical.com/noxt3s/?utm_term=nox%20t3%20sleep%20monitor&utm_campaign=%5BSearch%5D+Brand+-++Product+%5Be%5D&utm_source=adwords&utm_medium=ppc&hsa_acc=7911060515&hsa_cam=1382669894&hsa_grp=60659555971&hsa_ad=267498377165&hsa_src=g&hsa_tgt=kwd-422694661172&hsa_kw=nox%20t3%20sleep%20monitor&hsa_mt=e&hsa_net=adwords&hsa_ver=3&gclid=CjwKCAjwu5CDBhB9EiwA0w6sLQEnEeTrdfAzYAkRsa0tL5cQsoRGr3jaqz1GRp5jbfKeqDvZokx56RoCv8IQAvD_BwE</url>
<description>Nox T3s Home Sleep Device</description>
</link>
<reference>
<citation>Palotai M, Wallack M, Kujbus G, Dalnoki A, Guttmann C. Usability of a Mobile App for Real-Time Assessment of Fatigue and Related Symptoms in Patients With Multiple Sclerosis: Observational Study. JMIR Mhealth Uhealth. 2021 Apr 16;9(4):e19564. doi: 10.2196/19564.</citation>
<PMID>33861208</PMID>
</reference>
<reference>
<citation>Cella M, Chalder T. Measuring fatigue in clinical and community settings. J Psychosom Res. 2010 Jul;69(1):17-22. doi: 10.1016/j.jpsychores.2009.10.007. Epub 2009 Dec 11.</citation>
<PMID>20630259</PMID>
</reference>
<reference>
<citation>Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.</citation>
<PMID>2803071</PMID>
</reference>
<reference>
<citation>Cella D, Lai JS, Nowinski CJ, Victorson D, Peterman A, Miller D, Bethoux F, Heinemann A, Rubin S, Cavazos JE, Reder AT, Sufit R, Simuni T, Holmes GL, Siderowf A, Wojna V, Bode R, McKinney N, Podrabsky T, Wortman K, Choi S, Gershon R, Rothrock N, Moy C. Neuro-QOL: brief measures of health-related quality of life for clinical research in neurology. Neurology. 2012 Jun 5;78(23):1860-7. doi: 10.1212/WNL.0b013e318258f744. Epub 2012 May 9.</citation>
<PMID>22573626</PMID>
</reference>
<reference>
<citation>Palotai M, Guttmann CR. Brain anatomical correlates of fatigue in multiple sclerosis. Mult Scler. 2020 Jun;26(7):751-764. doi: 10.1177/1352458519876032. Epub 2019 Sep 19.</citation>
<PMID>31536461</PMID>
</reference>
<reference>
<citation>Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.</citation>
<PMID>1798888</PMID>
</reference>
<reference>
<citation>Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.</citation>
<PMID>4053261</PMID>
</reference>
<reference>
<citation>Palotai M, Weiner HL, Chitnis T, Duffy JF, and Guttmann CR, SLEEP APNEA AND PERIODIC LIMB MOVEMENTS ARE HIGHLY PREVALENT IN PATIENTS WITH MULTIPLE SCLEROSIS in 34th Annual Meeting of the Associated Professional Sleep Societies; Sleep, Volume 43, Issue Supplement_1, April 2020, Pages A429-A430, 1122. 2020.</citation>
</reference>
<reference>
<citation>Billiard M, Broughton R. Modafinil: its discovery, the early European and North American experience in the treatment of narcolepsy and idiopathic hypersomnia, and its subsequent use in other medical conditions. Sleep Med. 2018 Sep;49:69-72. doi: 10.1016/j.sleep.2018.05.027. Epub 2018 Jun 6.</citation>
<PMID>30174215</PMID>
</reference>
<reference>
<citation>Miller P, Soundy A. The pharmacological and non-pharmacological interventions for the management of fatigue related multiple sclerosis. J Neurol Sci. 2017 Oct 15;381:41-54. doi: 10.1016/j.jns.2017.08.012. Epub 2017 Aug 12.</citation>
<PMID>28991714</PMID>
</reference>
<reference>
<citation>Yang TT, Wang L, Deng XY, Yu G. Pharmacological treatments for fatigue in patients with multiple sclerosis: A systematic review and meta-analysis. J Neurol Sci. 2017 Sep 15;380:256-261. doi: 10.1016/j.jns.2017.07.042. Epub 2017 Jul 28.</citation>
<PMID>28870581</PMID>
</reference>
<reference>
<citation>Induruwa I, Constantinescu CS, Gran B. Fatigue in multiple sclerosis - a brief review. J Neurol Sci. 2012 Dec 15;323(1-2):9-15. doi: 10.1016/j.jns.2012.08.007. Epub 2012 Aug 27.</citation>
<PMID>22935407</PMID>
</reference>
<reference>
<citation>Kos D, Kerckhofs E, Nagels G, D'hooghe MB, Ilsbroukx S. Origin of fatigue in multiple sclerosis: review of the literature. Neurorehabil Neural Repair. 2008 Jan-Feb;22(1):91-100. doi: 10.1177/1545968306298934. Epub 2007 Apr 4.</citation>
<PMID>17409388</PMID>
</reference>
<reference>
<citation>Palotai M, Cavallari M, Healy BC, Guttmann CR. A novel classification of fatigue in multiple sclerosis based on longitudinal assessments. Mult Scler. 2020 May;26(6):725-734. doi: 10.1177/1352458519898112. Epub 2020 Jan 23.</citation>
<PMID>31971067</PMID>
</reference>
<reference>
<citation>Palotai M, Cavallari M, Koubiyr I, Morales Pinzon A, Nazeri A, Healy BC, Glanz B, Weiner HL, Chitnis T, Guttmann CR. Microstructural fronto-striatal and temporo-insular alterations are associated with fatigue in patients with multiple sclerosis independent of white matter lesion load and depression. Mult Scler. 2020 Nov;26(13):1708-1718. doi: 10.1177/1352458519869185. Epub 2019 Aug 16.</citation>
<PMID>31418637</PMID>
</reference>
<reference>
<citation>Palotai M, Nazeri A, Cavallari M, Healy BC, Glanz B, Gold SM, Weiner HL, Chitnis T, Guttmann CRG. History of fatigue in multiple sclerosis is associated with grey matter atrophy. Sci Rep. 2019 Oct 14;9(1):14781. doi: 10.1038/s41598-019-51110-2.</citation>
<PMID>31611598</PMID>
</reference>
<reference>
<citation>Cavallari M, Palotai M, Glanz BI, Egorova S, Prieto JC, Healy BC, Chitnis T, Guttmann CR. Fatigue predicts disease worsening in relapsing-remitting multiple sclerosis patients. Mult Scler. 2016 Dec;22(14):1841-1849. doi: 10.1177/1352458516635874. Epub 2016 Feb 26.</citation>
<PMID>26920374</PMID>
</reference>
<reference>
<citation>Palotai M, Mike A, Cavallari M, Strammer E, Orsi G, Healy BC, Schregel K, Illes Z, Guttmann CR. Changes to the septo-fornical area might play a role in the pathogenesis of anxiety in multiple sclerosis. Mult Scler. 2018 Jul;24(8):1105-1114. doi: 10.1177/1352458517711273. Epub 2017 May 26.</citation>
<PMID>28548605</PMID>
</reference>
<verification_date>April 2022</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>April 15, 2022</last_update_submitted>
<last_update_submitted_qc>April 15, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 22, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
<investigator_full_name>Charles Guttmann, MD</investigator_full_name>
<investigator_title>Director, Center for Neurological Imaging</investigator_title>
</responsible_party>
<keyword>fatigue</keyword>
<keyword>multiple sclerosis</keyword>
<keyword>brain</keyword>
<keyword>ozanimod</keyword>
<keyword>diffusion MRI</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Multiple Sclerosis</mesh_term>
<mesh_term>Sclerosis</mesh_term>
<mesh_term>Fatigue</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Ozanimod</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Multi-center observational study to assess the short-term response of multiple sclerosis (MS)
patients initiated on Ozanimod with respect to fatigue. Patterns of brain changes on brain
magnetic resonance imaging (MRI) that might modulate the effect of Ozanimod treatment on
fatigue will also be assessed.
Primary objectives:
1. To assess the effect of Ozanimod treatment on the impact of fatigue on physical,
cognitive, and psychosocial functions, as measured by the modified fatigue impact scale
(MFIS).
2. To assess the impact of fronto-striatal damage on the association between Ozanimod
treatment and fatigue.
Secondary objectives:
1. To assess the effect of Ozanimod treatment on fatigue severity, mood symptoms (ie,
depression and anxiety), sleep quality, physical activity, reward responsiveness and
cognitive functions over the first 3-month after treatment initiation with Ozanimod.
2. To assess the time course of changes by daily administration of visual analogue scales
of fatigue, depression, anxiety, and pain, and monthly administration of self-assessment
questionnaires for fatigue, depression and anxiety using a mobile application.
3. In addition to the hypothesis-driven analyses specifically targeting the fronto-striatal
system, the investigators will also perform analyses designed to discover other
potential brain MRI predictors of Ozanimod treatment response (ie, change in primary
and/or secondary endpoints during the 3-month Ozanimod treatment). The investigators
will perform global and regional (e.g., cerebral cortical, deep grey matter,
hippocampal) volumetric measurements as well as well-established voxel-based image
statistics to seek other potential patterns of brain atrophy that identify responders to
Ozanimod. Resting state functional MRI (rsfMRI) will also be performed to seek potential
markers of fatigue related to functional brain connectivity changes.
4. To establish patient compliance in using the aforementioned mobile app, and the
robustness of app-based phenotypic characterization of fatigue and related symptoms on
real-world patients. These observations will lay the basis for future prospective
studies on larger patient cohorts. For this purpose, recruitment will also be expanded
to patients treated with disease modifying drugs other than Ozanimod.
Primary hypothesis:
Patients without significant damage to fronto-striatal circuitry (ie, fronto-striatal
fractional anisotropy (FA)≥0.26 on diffusion tensor MRI (DT-MRI)) show significant decrease
in fatigue score over the first 3-month after treatment initiation with Ozanimod.
Study assessments:
Treatment schedule and dosage of Ozanimod and the other disease-modifying treatments (DMTs)
will be solely based on clinical indication and will be instituted by the patient's treating
neurologist at Brigham and Women's Hospital or Massachusetts General Hospital. The proposed
study is purely observational and will not influence the selection, schedule or dosage of
patient treatments. Therefore, no safety assessment will be performed within the study.
All endpoints and confounders will be assessed using state-of-the art mobile/wearable
technology, while the patient is on her/his/their normal routine at home and/or at work,
including self-isolated quarantine. All patient-reported outcomes (PROs) will be assessed
using a mobile application developed by the study team. The first version of the mobile
application was already tested and used in a prospective brain MRI study of MS-related
fatigue (MGB IRB Protocol number: 2017P001239). The mobile application will be modified and
adapted to make it specifically suitable for the proposed study. The application will be
installed on an Android smartphone that will be provided to each subject. The application
will communicate using end-to-end encryption (https protocol) with a server inside the MGB
firewall. Data will be transmitted between the mobile app and the server in deidentified and
coded form.
Continuous actigraphy will be performed using wrist-worn actigraphic watches to assess
quantitative physical activity (during daytime) and sleep measures (at night) during the
entire 3-months period of the trial. These devices also measure other bio-signals as for
instance skin conductivity and heart rhythm, as well as light exposure.
Presence/absence of obstructive sleep apnea and restless leg syndrome will be assessed once
between day 0 and day 3 of the trial period using a home sleep test (HST) device.
Subjects will receive the study devices in person or via postal mail and will be instructed
how to use the devices in person or via video conference call in compliance with COVID-19
regulations.
Each patient will undergo 3 Tesla brain Magnetic Resonance Imaging, including diffusion
tensor, T1-weighted, T2-weighted, FLAIR and rsfMRI imaging at Brigham and Women's Hospital at
baseline.
All MS patients seen at Brigham and Women's Hospital and Massachusetts General Hospital who
fit our selection criteria (see below) will be eligible to participate in this study. Since
MS is 2-3 times more common in women, investigators expect that more women than men will
participate.
Inclusion Criteria:
1. age≥18
2. diagnosis of MS (according to the 2010 McDonald criteria)
Exclusion Criteria:
1. neurodegenerative disorders other than MS
2. terminal medical condition
3. currently treated for active malignancy
4. alcohol or substance abuse in the past year, except marijuana
5. diagnosis of major depressive disorder based on DSM V criteria
6. non-English speakers (the mobile application is not available in other languages)
7. inability to undergo MRI scan
Patients undergoing COVID-19 vaccination will be allowed to participate in the study if at
least 2 weeks have elapsed from their last dose of vaccine.
|
NCT0531xxxx/NCT05319106.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319106</url>
</required_header>
<id_info>
<org_study_id>zsyx1</org_study_id>
<nct_id>NCT05319106</nct_id>
</id_info>
<brief_title>Phase Ⅱ Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Venous Leg</brief_title>
<official_title>Transplantation of Human Umbilical Cord Derived Mesenchymal Stem Cell for Refractory Skin Ulcer Therapy</official_title>
<sponsors>
<lead_sponsor>
<agency>ShiCang Yu</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Southwest Hospital, China</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This project adopts a prospective clinical trial study to compare and evaluate the efficacy
of local transplantation of human umbilical cord mesenchymal stem cells combined with silver
ion dressing and simple silver ion dressing in the treatment of venous lower extremity ulcer
wounds. To improve the healing rate and quality of life of patients.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Chronic wounds refer to the pathological changes such as cell senescence, imbalance of
synthesis and degradation of extracellular matrix, and decreased activity of growth factors
caused by different reasons when the wound is prolonged and does not heal after conventional
treatment for more than 1 month without healing tendency. Chronic wound can be caused by a
variety of diseases, including arterial disease, diabetes, vasculitis, venous disease and
skin malignant tumor, chronic venous insufficiency (CVI) is a disease leading to chronic
wound, Venous ulcer (VLU) of lower limbs is the advanced manifestation of CVI, and the
incidence of this disease ranges from 0.4% to 1.3% in China. 60% of VLU patients' ulcer
wounds heal in 3-6 months, 33% in 12 months, and 7% May be permanently unhealed. The
probability of recurrence is as high as 70% in patients 3-5 months after wound healing, which
not only seriously affects the health and quality of life of patients, but also causes a very
heavy social medical burden. At present, the conventional treatment for VLU mainly includes
drug therapy, stress therapy, wound treatment and surgical treatment, but the therapeutic
effect is not ideal.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">December 15, 2022</start_date>
<completion_date type="Anticipated">March 31, 2027</completion_date>
<primary_completion_date type="Anticipated">June 30, 2026</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Healing time</measure>
<time_frame>Epithelialization of the wound completely or 24 weeks after treatment</time_frame>
<description>The time required for the wound healing rate to reach 100%</description>
</primary_outcome>
<secondary_outcome>
<measure>Wound shrinkage rate</measure>
<time_frame>Epithelialization of the wound completely or 24 weeks after treatment</time_frame>
<description>Grid method was used to calculate the wound area, with 1 decimal place behind the length unit and 2 decimal places behind the area unit. The wound edges before, during and after treatment were depicted on the transparent mesh film respectively, and the original wound area and the unhealed wound area were calculated.
Wound shrinkage rate = (initial area of wound - area measured on the day)/original area of wound × 100%</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">76</enrollment>
<condition>Venous Leg Ulcer</condition>
<arm_group>
<arm_group_label>Stem cell preparation combined with silver ion dressing</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>silver ion dressing</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>stem cell preparation combined with silver ion dressing</intervention_name>
<description>The dosage range of each cm2 ulcer wound is (1～5)×10^6. The dosage of human umbilical cord mesenchymal stem cells for the second treatment is determined according to the severity of the ulcer. Each patient is treated for 2 consecutive times, and the interval between each treatment is 3 days.</description>
<arm_group_label>Stem cell preparation combined with silver ion dressing</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>silver ion dressing</intervention_name>
<description>fter wound debridement, a silver ion dressing suitable for the size of the wound was cut and covered on the wound bed. Sterile gauze was covered on the silver ion dressing and fixed with adhesive tape.</description>
<arm_group_label>silver ion dressing</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Age from 18 to 70, no gender limitation;

2. It met the diagnostic criteria of venous ulcer of lower limbs in Clinical Vascular
Surgery (5th edition), and the following conditions were met: the ulcer lasted for
more than 1 month; The wound area was between 10cm2 and 40cm2. Wound depth: All wounds
were deep tissue ulcers below the epidermis.

3. Participate in the clinical study voluntarily, observe the study procedure, and
observe the curative effect cooperatively.

Exclusion Criteria:

1. Pregnant or lactation women; Women who have planned to have children recently (within
6 months);

2. Patients with peripheral artery disease with ankle-brachial index (ABI) < 0.8;

3. Patients with active clinical systemic infection;

4. Serious skin wound infection is not under control;

5. low immune function and systemic failure; Severe heart, liver, lung, kidney and other
important organ lesions (ALT, AST, Cr & GT; Normal 1.5 times, congestive heart failure
ejection fraction &lt; Normal 30%) and severely impaired hematopoietic function;

6. Abnormal coagulation function or current anticoagulant treatment;

7. Systemic autoimmune diseases in the active stage;

8. With systemic organ or hematological malignancy;

9. PERSONS infected with HIV or addicted to drugs, tobacco and alcohol;

10. Have a clear history of mental illness;

11. Participation in clinical studies of any drug within 1 month prior to treatment (or
the 5 half-life of the investigational drug, whichever is longer).
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>70 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Southwest Hospital, Army Medical University (Third Military Medical University)</name>
<address>
<city>Chongqing</city>
<state>Chongqing</state>
<zip>400038</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>shicang yu, M.D. and Ph.D.</last_name>
<phone>023-68766452</phone>
<email>yushicang@163.com</email>
</contact>
</location>
<location_countries>
<country>China</country>
</location_countries>
<results_reference>
<citation>Alvarez OM, Markowitz L, Parker R, Wendelken ME. Faster Healing and a Lower Rate of Recurrence of Venous Ulcers Treated With Intermittent Pneumatic Compression: Results of a Randomized Controlled Trial. Eplasty. 2020 Jun 5;20:e6. eCollection 2020.</citation>
<PMID>32636985</PMID>
</results_reference>
<results_reference>
<citation>Nicolaides AN. The Most Severe Stage of Chronic Venous Disease: An Update on the Management of Patients with Venous Leg Ulcers. Adv Ther. 2020 Feb;37(Suppl 1):19-24. doi: 10.1007/s12325-020-01219-y. Epub 2020 Jan 22.</citation>
<PMID>31970660</PMID>
</results_reference>
<results_reference>
<citation>Aleksandrowicz H, Owczarczyk-Saczonek A, Placek W. Venous Leg Ulcers: Advanced Therapies and New Technologies. Biomedicines. 2021 Oct 29;9(11):1569. doi: 10.3390/biomedicines9111569.</citation>
<PMID>34829797</PMID>
</results_reference>
<results_reference>
<citation>Kavala AA, Turkyilmaz S. Autogenously derived regenerative cell therapy for venous leg ulcers. Arch Med Sci Atheroscler Dis. 2018 Dec 15;3:e156-e163. doi: 10.5114/amsad.2018.81000. eCollection 2018.</citation>
<PMID>30775606</PMID>
</results_reference>
<results_reference>
<citation>Zollino I, Campioni D, Sibilla MG, Tessari M, Malagoni AM, Zamboni P. A phase II randomized clinical trial for the treatment of recalcitrant chronic leg ulcers using centrifuged adipose tissue containing progenitor cells. Cytotherapy. 2019 Feb;21(2):200-211. doi: 10.1016/j.jcyt.2018.10.012. Epub 2018 Dec 22.</citation>
<PMID>30583949</PMID>
</results_reference>
<verification_date>March 2023</verification_date>
<study_first_submitted>March 18, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>March 13, 2023</last_update_submitted>
<last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">March 15, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>Southwest Hospital, China</investigator_affiliation>
<investigator_full_name>ShiCang Yu</investigator_full_name>
<investigator_title>Director</investigator_title>
</responsible_party>
<keyword>Venous leg ulcer</keyword>
<keyword>human umbilical cord mesenchymal stem cells</keyword>
<keyword>wound healing</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Varicose Ulcer</mesh_term>
<mesh_term>Leg Ulcer</mesh_term>
<mesh_term>Ulcer</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This project adopts a prospective clinical trial study to compare and evaluate the efficacy
of local transplantation of human umbilical cord mesenchymal stem cells combined with silver
ion dressing and simple silver ion dressing in the treatment of venous lower extremity ulcer
wounds. To improve the healing rate and quality of life of patients.
Chronic wounds refer to the pathological changes such as cell senescence, imbalance of
synthesis and degradation of extracellular matrix, and decreased activity of growth factors
caused by different reasons when the wound is prolonged and does not heal after conventional
treatment for more than 1 month without healing tendency. Chronic wound can be caused by a
variety of diseases, including arterial disease, diabetes, vasculitis, venous disease and
skin malignant tumor, chronic venous insufficiency (CVI) is a disease leading to chronic
wound, Venous ulcer (VLU) of lower limbs is the advanced manifestation of CVI, and the
incidence of this disease ranges from 0.4% to 1.3% in China. 60% of VLU patients' ulcer
wounds heal in 3-6 months, 33% in 12 months, and 7% May be permanently unhealed. The
probability of recurrence is as high as 70% in patients 3-5 months after wound healing, which
not only seriously affects the health and quality of life of patients, but also causes a very
heavy social medical burden. At present, the conventional treatment for VLU mainly includes
drug therapy, stress therapy, wound treatment and surgical treatment, but the therapeutic
effect is not ideal.
Inclusion Criteria:
1. Age from 18 to 70, no gender limitation;
2. It met the diagnostic criteria of venous ulcer of lower limbs in Clinical Vascular
Surgery (5th edition), and the following conditions were met: the ulcer lasted for
more than 1 month; The wound area was between 10cm2 and 40cm2. Wound depth: All wounds
were deep tissue ulcers below the epidermis.
3. Participate in the clinical study voluntarily, observe the study procedure, and
observe the curative effect cooperatively.
Exclusion Criteria:
1. Pregnant or lactation women; Women who have planned to have children recently (within
6 months);
2. Patients with peripheral artery disease with ankle-brachial index (ABI) < 0.8;
3. Patients with active clinical systemic infection;
4. Serious skin wound infection is not under control;
5. low immune function and systemic failure; Severe heart, liver, lung, kidney and other
important organ lesions (ALT, AST, Cr & GT; Normal 1.5 times, congestive heart failure
ejection fraction < Normal 30%) and severely impaired hematopoietic function;
6. Abnormal coagulation function or current anticoagulant treatment;
7. Systemic autoimmune diseases in the active stage;
8. With systemic organ or hematological malignancy;
9. PERSONS infected with HIV or addicted to drugs, tobacco and alcohol;
10. Have a clear history of mental illness;
11. Participation in clinical studies of any drug within 1 month prior to treatment (or
the 5 half-life of the investigational drug, whichever is longer).
|
NCT0531xxxx/NCT05319119.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319119</url>
</required_header>
<id_info>
<org_study_id>BHe</org_study_id>
<nct_id>NCT05319119</nct_id>
</id_info>
<brief_title>Fractional Flow Reserve Derived From CT Related Treatment</brief_title>
<official_title>The Impact Of Revascularization Related By Blood Fractional Flow Reserve Calculated By Coronary Artery CTA On Prognosis</official_title>
<sponsors>
<lead_sponsor>
<agency>Henan Institute of Cardiovascular Epidemiology</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Henan Institute of Cardiovascular Epidemiology</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This study is a retrospective, single-center study.This experiment aims to explore the
influence of CT-FFR as a relevant for revascularization on the prognosis of patients with
coronary heart disease, assessing concurrent on different basis the difference of prognosis
of patients with revascularization was analyzed, and the significance of revascularization
related by CT-FFR was analyzed.This study is a retrospective study. The treatment strategies
of all patients are based on the results of CAG，including coronary revascularization.After
calculating the CT-FFR value, the above doctors will formulate treatment strategies based on
the results and formulate treatment strategies retrospectively.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Research Objects and Criteria:Patients who had undergone coronary angiography and Coronary
Artery CTA in Fuwai Central China Cardiovascular Hospital.Preliminary screening of patients
is carried out in the medical record system, CT imaging workstation, and interventional
center imaging workstation to confirm data integrity.

Standard constrain:①Diagnosed or suspected coronary heart disease patients during the
diagnosis and treatment process.②From December 2017 to December 2020, coronary artery CTA and
coronary angiography were performed simultaneously in Fuwai Central China Cardiovascular
Hospital. (coronary artery CTA before the coronary angiography, but no more than 28 days
apart).③Age 18 to 75 years old.

Exclusion criteria:①Severe artefacts, misalignment, or calcifications in coronary CTA images
affect CT-FFR measurements.② Contraindications to antiplatelet drugs③ Patients with acute
myocardial infarction within 6 months.④ PCI or CABG or heart transplantation and other
operations that may affect the outcome⑤ Severe heart failure⑥ Pregnant patients⑦ Combined
tumor patients⑧ Have a history of other serious heart disease⑨Contraindications to coronary
angiography drop out standard:① Abnormal research results ② Failure to achieve the expected
therapeutic effect due to other serious diseases ③ Violation of the research plan④ Lost to
follow-up ⑤ The relevant data is seriously missing, which affects the experimental data

Case grouping method:

1. CT-FFR related Group:①Coronary diseased artery CTFFR>80%, secondary prevention of
coronary heart disease ② Coronary diseased artery CTFFR≤80% revascularization at the
lesion site and regular medication after PCI

2. Coronary angiography related Group:①Coronary diseased artery CTFFR≤80%, coronary
angiography decision does not require revascularization but apply coronary heart disease
secondary prevention medication. ②Coronary diseased artery CTFFR>80%,However,
revascularization was performed according to conventional angiographic decisions and
postoperative regular service was performed.For multivessel disease, although coronary
revascularization is performed, there are still diseased artery with CTFFR≤80% and no
revascularization is performed.

End point：①Primary endpoint: all-cause death/cardiac death,②Secondary endpoints:myocardial
infarction, target vessel repeat revascularization, brain stroke readmission for
cardiovascular events, abnormal laboratory tests, new-onset heart failure, or progression to
severe heart failure Statistics and analysis of research data：The data collected in the group
at different recording times are selected if they satisfy the normal distribution.

Repeated measures ANOVA; if normal distribution is not met, rank sum test is used.The data
between groups were analyzed by one-way analysis of variance. For count data (include rate)
use X² or Fisher's exact probability test.Statistically significant at p < 0.05 Use the
Kaplan-Meier method to describe the survival rate of each group and draw the survival curve,
and then use the Log-rank Test Calculate the test statistic, with p < 0.05 as statistically
significant.The factor p < 0.05 obtained from the univariate Cox analysis was included in the
multivariate Cox proportional wind in the risk model, hazard ratios, 95% confidence intervals
were calculated and multivariate adjustment analysis was performed. Take p < 0.05 as having
statistical significance.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 29, 2022</start_date>
<completion_date type="Anticipated">April 29, 2022</completion_date>
<primary_completion_date type="Anticipated">April 6, 2022</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Other</observational_model>
<time_perspective>Retrospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>All-cause death or Myocardial infarction</measure>
<time_frame>1 year</time_frame>
<description>Cardiovascular, non-cardiovascular and undetermined death or Target vessel related and non-target vessel related MI</description>
</primary_outcome>
<secondary_outcome>
<measure>Heart failure</measure>
<time_frame>1 year,2 years</time_frame>
<description>Heart failure</description>
</secondary_outcome>
<secondary_outcome>
<measure>Non-target vessel revascularization</measure>
<time_frame>1 year,2 years</time_frame>
<description>The ischemia driven and non-ischemia driven non-target vessel revascularization</description>
</secondary_outcome>
<secondary_outcome>
<measure>Cardiac death</measure>
<time_frame>1 year,2 years</time_frame>
<description>Cardiovascular death</description>
</secondary_outcome>
<secondary_outcome>
<measure>Target vessel revascularization</measure>
<time_frame>1 year,2 years</time_frame>
<description>The ischemia driven and non-ischemia driven target vessel revascularization</description>
</secondary_outcome>
<secondary_outcome>
<measure>Myocardial infarction</measure>
<time_frame>1 year,2 years</time_frame>
<description>Target vessel related and non-target vessel related MI</description>
</secondary_outcome>
<secondary_outcome>
<measure>Stroke</measure>
<time_frame>1 year,2 years</time_frame>
<description>Stroke</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Anticipated">1000</enrollment>
<condition>Coronary Angiography</condition>
<condition>Fractional Flow Reserve, Myocardial</condition>
<condition>Coronary Artery Disease</condition>
<arm_group>
<arm_group_label>1.CT-FFR Related Group</arm_group_label>
<description>Coronary diseased artery CTFFR>80%, secondary prevention of coronary heart disease;Coronary diseased artery CTFFR≤80% revascularization at the lesion site and regular medication after PCI</description>
</arm_group>
<arm_group>
<arm_group_label>Coronary Angiography Related Group</arm_group_label>
<description>Coronary diseased artery CTFFR≤80%, coronary angiography decision does not require revascularization but apply coronary heart disease secondary prevention medication;Coronary diseased artery CTFFR>80%,However, revascularization was performed according to conventional angiographic decisions and postoperative regular service was performed.For multivessel disease, although coronary revascularization is performed, there are still diseased artery with CTFFR≤80% and no revascularization is performed.</description>
</arm_group>
<eligibility>
<study_pop>
<textblock>
Diagnosed or suspected coronary heart disease patients with typical symptoms or objective
evidence of ischemia such as ECG, exercise treadmill, coronary CTA or CAG
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- ①Diagnosed or suspected coronary heart disease patients during the diagnosis and
treatment process

- From December 2017 to December 2020, coronary CTA and coronary artery CTA were
performed simultaneously in Huazhong Fuwai Hospital.

Patients with CAG (coronary CTA before coronary angiography after CAG, no more than 28 days
apart).

③Age 18 to 75 years old.

Exclusion Criteria:

- ① The presence of severe artifact, dislocation or calcification in coronary CTA images
affects FFRCT measurement. ② Contraindications to antiplatelet drugs

- Patients with acute myocardial infarction within 6 months④ PCI or CABG or heart
transplantation and other operations that may affect the outcome ⑤ Severe heart
failure⑥ Pregnant patients⑦ Combined tumor patients⑧ Life expectancy < 2 years⑨
Have a history of other serious heart disease⑩ Contraindications for CAG⑪ Not
suitable to participate in this researcher due to other reasons
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>75 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Gao, M.D</last_name>
<phone>8613937165590</phone>
<email>gaocy6802@163.com</email>
</overall_contact>
<location>
<facility>
<name>Fuwai Central China Cardiovascular Hospital</name>
<address>
<city>Zhengzhou</city>
<state>Henan</state>
<zip>450000</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Chanyu Gao, M.D</last_name>
<phone>8613937165590</phone>
<email>gaocy6802@163.com</email>
</contact>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>March 31, 2022</last_update_submitted>
<last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 8, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Henan Institute of Cardiovascular Epidemiology</investigator_affiliation>
<investigator_full_name>Chuanyu Gao</investigator_full_name>
<investigator_title>Professor</investigator_title>
</responsible_party>
<keyword>Fractional Flow Reserve</keyword>
<keyword>CT-FFR</keyword>
<keyword>prognosis</keyword>
<keyword>coronary Revascularization</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Coronary Artery Disease</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This study is a retrospective, single-center study.This experiment aims to explore the
influence of CT-FFR as a relevant for revascularization on the prognosis of patients with
coronary heart disease, assessing concurrent on different basis the difference of prognosis
of patients with revascularization was analyzed, and the significance of revascularization
related by CT-FFR was analyzed.This study is a retrospective study. The treatment strategies
of all patients are based on the results of CAG，including coronary revascularization.After
calculating the CT-FFR value, the above doctors will formulate treatment strategies based on
the results and formulate treatment strategies retrospectively.
Research Objects and Criteria:Patients who had undergone coronary angiography and Coronary
Artery CTA in Fuwai Central China Cardiovascular Hospital.Preliminary screening of patients
is carried out in the medical record system, CT imaging workstation, and interventional
center imaging workstation to confirm data integrity.
Standard constrain:①Diagnosed or suspected coronary heart disease patients during the
diagnosis and treatment process.②From December 2017 to December 2020, coronary artery CTA and
coronary angiography were performed simultaneously in Fuwai Central China Cardiovascular
Hospital. (coronary artery CTA before the coronary angiography, but no more than 28 days
apart).③Age 18 to 75 years old.
Exclusion criteria:①Severe artefacts, misalignment, or calcifications in coronary CTA images
affect CT-FFR measurements.② Contraindications to antiplatelet drugs③ Patients with acute
myocardial infarction within 6 months.④ PCI or CABG or heart transplantation and other
operations that may affect the outcome⑤ Severe heart failure⑥ Pregnant patients⑦ Combined
tumor patients⑧ Have a history of other serious heart disease⑨Contraindications to coronary
angiography drop out standard:① Abnormal research results ② Failure to achieve the expected
therapeutic effect due to other serious diseases ③ Violation of the research plan④ Lost to
follow-up ⑤ The relevant data is seriously missing, which affects the experimental data
Case grouping method:
1. CT-FFR related Group:①Coronary diseased artery CTFFR>80%, secondary prevention of
coronary heart disease ② Coronary diseased artery CTFFR≤80% revascularization at the
lesion site and regular medication after PCI
2. Coronary angiography related Group:①Coronary diseased artery CTFFR≤80%, coronary
angiography decision does not require revascularization but apply coronary heart disease
secondary prevention medication. ②Coronary diseased artery CTFFR>80%,However,
revascularization was performed according to conventional angiographic decisions and
postoperative regular service was performed.For multivessel disease, although coronary
revascularization is performed, there are still diseased artery with CTFFR≤80% and no
revascularization is performed.
End point：①Primary endpoint: all-cause death/cardiac death,②Secondary endpoints:myocardial
infarction, target vessel repeat revascularization, brain stroke readmission for
cardiovascular events, abnormal laboratory tests, new-onset heart failure, or progression to
severe heart failure Statistics and analysis of research data：The data collected in the group
at different recording times are selected if they satisfy the normal distribution.
Repeated measures ANOVA; if normal distribution is not met, rank sum test is used.The data
between groups were analyzed by one-way analysis of variance. For count data (include rate)
use X² or Fisher's exact probability test.Statistically significant at p < 0.05 Use the
Kaplan-Meier method to describe the survival rate of each group and draw the survival curve,
and then use the Log-rank Test Calculate the test statistic, with p < 0.05 as statistically
significant.The factor p < 0.05 obtained from the univariate Cox analysis was included in the
multivariate Cox proportional wind in the risk model, hazard ratios, 95% confidence intervals
were calculated and multivariate adjustment analysis was performed. Take p < 0.05 as having
statistical significance.
Diagnosed or suspected coronary heart disease patients with typical symptoms or objective
evidence of ischemia such as ECG, exercise treadmill, coronary CTA or CAG
Inclusion Criteria:
- ①Diagnosed or suspected coronary heart disease patients during the diagnosis and
treatment process
- From December 2017 to December 2020, coronary CTA and coronary artery CTA were
performed simultaneously in Huazhong Fuwai Hospital.
Patients with CAG (coronary CTA before coronary angiography after CAG, no more than 28 days
apart).
③Age 18 to 75 years old.
Exclusion Criteria:
- ① The presence of severe artifact, dislocation or calcification in coronary CTA images
affects FFRCT measurement. ② Contraindications to antiplatelet drugs
- Patients with acute myocardial infarction within 6 months④ PCI or CABG or heart
transplantation and other operations that may affect the outcome ⑤ Severe heart
failure⑥ Pregnant patients⑦ Combined tumor patients⑧ Life expectancy < 2 years⑨
Have a history of other serious heart disease⑩ Contraindications for CAG⑪ Not
suitable to participate in this researcher due to other reasons
|
NCT0531xxxx/NCT05319132.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319132</url>
</required_header>
<id_info>
<org_study_id>69HCL22_0299</org_study_id>
<nct_id>NCT05319132</nct_id>
</id_info>
<brief_title>Evaluate DF-003 in ex Vivo Assays Using Peripheral Blood Mononuclear Cell From Subjects With ROSAH Syndrome</brief_title>
<acronym>ROSAH</acronym>
<official_title>A Phase 0 Study to Evaluate DF-003 in ex Vivo Assays Using Peripheral Blood Mononuclear Cells (PBMC) From Subjects With Retinal Dystrophy, Optic Nerve Edema, Splenomegaly, Anhidrosis and Headache (ROSAH) Syndrome.</official_title>
<sponsors>
<lead_sponsor>
<agency>Hospices Civils de Lyon</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Hospices Civils de Lyon</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Alpha-1 kinase (ALPK1) has been reported as a potential causative gene for ROSAH Syndrome.

Genetic variants including T237M have been found in ROSAH Syndrome patients. Our in-house
study has found that T237M mutation leads to hyperactivity of ALPK1, which may be the cause
of the inflammatory syndromes found in ROSAH Syndrome patients. We hypothesize that T237M
mutation ALPK1 cause ROSAH Syndrome and an ALPK1 inhibitor can be a potential therapy for
treating this disease. To test our hypothesis, we designed an experiment in which ex vivo
peripheral blood mononuclear cells (PBMCs) from ROSAH Syndrome patients will be exposed to a
potent ALPK1 inhibitor (DF-003) or placebo. We expect to see downregulation of activated
inflammatory genes, chemokine/cytokines and acute phase proteins in the ROSAH Syndrome
patient samples that are exposed DF-003.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">September 6, 2022</start_date>
<completion_date type="Anticipated">January 6, 2024</completion_date>
<primary_completion_date type="Anticipated">January 6, 2024</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Cytokine release assays</measure>
<time_frame>At day 0</time_frame>
<description>The Cytokine release assays will analyzed by ELISA in cells supernatants the Interleukin 8 (IL-8), Tumor Necrosis Factor (TNF) concentrations in the presence/absence of DF-003 and control.</description>
</primary_outcome>
<enrollment type="Anticipated">4</enrollment>
<condition>Unrecognized Condition</condition>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Adult subjects with ROSAH syndrome</intervention_name>
<description>The main objective is to evaluate the ex vivo inhibitory potential of DF-003 on alpha-1 kinase activity.</description>
</intervention>
<biospec_retention>Samples Without DNA</biospec_retention>
<biospec_descr>
<textblock>
4 blood samples of 7 ml for ex-vivo analysis
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
This study concerns adult subjects with ROSAH syndrome
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Male or female aged over 18

- Patient with ROSAH syndrome with the confirm T237M mutation

Exclusion Criteria:

- person under legal protection or under protectives measures

- person unable to express consent

- person in emergency situation (vital or not)

- person infected by Human Immunodeficiency Virus and/or Hepatitis B Virus and/or
Hepatitis C Virus
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>YVAN JAMILLOUX</last_name>
<role>Principal Investigator</role>
<affiliation>Service de medecine interne - Hôpital de la Croix Rousse</affiliation>
</overall_official>
<overall_contact>
<last_name>YVAN JAMILLOUX, MD</last_name>
<phone>04 26 73 26 36</phone>
<phone_ext>+33</phone_ext>
<email>yvan.jamilloux@chu-lyon.fr</email>
</overall_contact>
<overall_contact_backup>
<last_name>Nora MARTEL</last_name>
<phone>04 26 73 28 62</phone>
<phone_ext>+33</phone_ext>
<email>nora.martel@chu-lyon.fr</email>
</overall_contact_backup>
<location>
<facility>
<name>Hôpital Nord Croix Rousse</name>
<address>
<city>Lyon</city>
<state>Rhône-Alpes</state>
<zip>69004</zip>
<country>France</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Yvan Jamilloux, MD</last_name>
<phone>0426732636</phone>
<phone_ext>+33</phone_ext>
<email>yvan.jamilloux@chu-lyon.fr</email>
</contact>
<contact_backup>
<last_name>Nora +33 Martel, PM</last_name>
<phone>0428732862</phone>
<phone_ext>+33</phone_ext>
<email>nora.martel@chu-lyon.fr</email>
</contact_backup>
</location>
<location_countries>
<country>France</country>
</location_countries>
<verification_date>June 2023</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>June 26, 2023</last_update_submitted>
<last_update_submitted_qc>June 26, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">June 27, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>ROSAH Syndrome.</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Syndrome</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Alpha-1 kinase (ALPK1) has been reported as a potential causative gene for ROSAH Syndrome.
Genetic variants including T237M have been found in ROSAH Syndrome patients. Our in-house
study has found that T237M mutation leads to hyperactivity of ALPK1, which may be the cause
of the inflammatory syndromes found in ROSAH Syndrome patients. We hypothesize that T237M
mutation ALPK1 cause ROSAH Syndrome and an ALPK1 inhibitor can be a potential therapy for
treating this disease. To test our hypothesis, we designed an experiment in which ex vivo
peripheral blood mononuclear cells (PBMCs) from ROSAH Syndrome patients will be exposed to a
potent ALPK1 inhibitor (DF-003) or placebo. We expect to see downregulation of activated
inflammatory genes, chemokine/cytokines and acute phase proteins in the ROSAH Syndrome
patient samples that are exposed DF-003.
4 blood samples of 7 ml for ex-vivo analysis
This study concerns adult subjects with ROSAH syndrome
Inclusion Criteria:
- Male or female aged over 18
- Patient with ROSAH syndrome with the confirm T237M mutation
Exclusion Criteria:
- person under legal protection or under protectives measures
- person unable to express consent
- person in emergency situation (vital or not)
- person infected by Human Immunodeficiency Virus and/or Hepatitis B Virus and/or
Hepatitis C Virus
|
NCT0531xxxx/NCT05319145.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319145</url>
</required_header>
<id_info>
<org_study_id>PROFIT Study</org_study_id>
<nct_id>NCT05319145</nct_id>
</id_info>
<brief_title>PeRsonalizing the Approach to the Oncologic Frail Individual Through Tailored Assessment and Intervention (PROFIT Study)</brief_title>
<acronym>PROFIT</acronym>
<official_title>PeRsonalizing the Approach to the Oncologic Frail Individual Through Tailored Assessment and Intervention (PROFIT Study)</official_title>
<sponsors>
<lead_sponsor>
<agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Servicio de Geriatría Complejo Hospitalario de Navarra (CHN)</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Fundación Miguel Servet - Navarrabiomed</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Hospital de la Ribera, Alzira, Valencia</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Institut Català d'Oncologia ICO Girona</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Vall d'Hebron Institute of Oncology (VHIO), Barcelona</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Servei Andorrà d'Atenció Sanitària (SAAS), Andorra</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Gemelli Hospital, Universidad Cattolica del Sacro Cuore, Roma (Italia)</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Hospital Universitari Vall d'Hebron Research Institute</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The PROFIT study has two complementary aims. The first aim is to compare, in a cohort study
enrolling N=257 older adults (>65 years) with lung, gastrointestinal and prostate cancer,
different easy measures of frailty (Geriatric 8 questionnaire (G8), Short physical
Performance Battery (SPPB) and the IF-VIG), testing their ability to predict survival,
functional status (ECOG, Barthel Index), quality of life (EuroQol5D) and resources
utilization (visits, hospital admissions, treatments) at 3, 6 and 12 months. The second aim,
which motivates the registration in ClinicalTrials.gov, is to conduct a randomized controlled
trial (RCT) enrolling N=134 patients per group, with similar characteristics to those
enrolled for aim 1, but with mild-moderate frailty (G8≤14 points); we will compare a
multi-component CGA-based intervention including physical exercise and nutritional
recommendations with usual care, measuring the impact on the same outcomes as for aim 1, at 3
and 6 months. The use of ad hoc eHealth solutions (App/platform for exercise) will foster
patients' empowerment and sustainability of the intervention. We will also assess patients,
caregivers, and professionals' experience with the intervention through focus groups.
Participants will be recruited from outpatients and from post-acute care units.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The impact of the aging of population on cancer incidence and consequences is clear: in very
few years, more than 50% of older adults will be diagnosed with malignant tumors, with a
relevant increase in mortality compared to younger adults, and a dramatic burden of
disability. Many of these patients will be potential candidates for oncospecific treatments,
either curative, adjuvants or palliative. Despite this scenario, many trials on cancers still
exclude patients based on their age or set survival and treatments' toxicity as the main
outcomes, neglecting other meaningful outcomes such as functional status or quality of life.
Therefore, clinical decisions regarding this specific population are not always based on
real-life data. Moreover, older adults are a highly heterogeneous population, based on
clinical, functional, and psychosocial aspects. This is why, in such a population group, the
individualization of treatments is pivotal.

Frailty has been proposed as a better marker of biological age than chronological age. This
concept indicates a reversible state of risk of increased vulnerability to external or
internal stressors, exposing the patients to a higher risk of adverse events, including
disability and mortality. However, there is no agreement on the most suitable frailty tools
to be used in practice. In older adults with cancer, frailty, which is easily measured in any
setting through quick clinical scales, could be an ideal trigger to select candidate patients
for a subsequent more extensive comprehensive geriatric assessment (onwards, CGA) and
potential interventions. Among these interventions, multi-component approaches including
physical exercise and nutritional recommendations have shown a positive impact on both
mortality and functional status in patients with different cancers and could be proposed for
either pre-habilitation or re-habilitation in older cancer patients with mild-moderate
frailty.

Considering these premises, the PROFIT study has two complementary aims. The first aim is to
compare, in a cohort study enrolling N=257 older adults (>65 years) with lung,
gastrointestinal and prostate cancer, different easy measures of frailty (Geriatric 8
questionnaire (G8), Short physical Performance Battery (SPPB) and the IF-VIG), testing their
ability to predict survival, functional status (ECOG, Barthel Index), quality of life
(EuroQol5D) and resources utilization (visits, hospital admissions, treatments) at 3, 6 and
12 months. The second aim is to conduct a randomized controlled trial (RCT) enrolling N=134
patients per group, with similar characteristics to those enrolled for aim 1, but with
mild-moderate frailty (G8≤14 points); we will compare a multi-component CGA-based
intervention including physical exercise and nutritional recommendations with usual care,
measuring the impact on the same outcomes as for aim 1, at 3 and 6 months. The use of ad hoc
eHealth solutions (App/platform for exercise) will foster patients' empowerment and
sustainability of the intervention. We will also assess patients, caregivers, and
professionals' experience with the intervention through focus groups. Participants will be
recruited from outpatients and from post-acute care units.

The PROFIT study will add relevant evidence for the management of older cancer patients. The
impact, for the individual and the society, is high, in light of the aging of the population:
the results will allow providing oncologists and other professionals with tools to improve
the personalization of treatments, to finally provide adequate and tailored care programs.
This might contribute to avoid the exclusion of patients who could benefit from active
treatments and, on the other hand, reducing overtreatment for those who will likely not
benefit from it. The clinical trial will also provide information on the most suitable
content and on the impact of an intervention aimed at strengthening the functional status and
improving the quality of life in older cancer patients with mild-moderate frailty, who might
be potential candidates for subsequent onco-specific treatments. The project will also
deliver adapted materials and eHealth solutions to be potentially scaled up for this profile
of users, as a benefit for the society even beyond this project.
</textblock>
</detailed_description>
<overall_status>Enrolling by invitation</overall_status>
<start_date type="Anticipated">May 1, 2022</start_date>
<completion_date type="Anticipated">January 31, 2023</completion_date>
<primary_completion_date type="Anticipated">December 1, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Short Physical Performance Battery (SPPB)</measure>
<time_frame>Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)</time_frame>
<description>Change in physical function, measured by the difference on SPPB between follow-ups, hand grip and maximum resistance.</description>
</primary_outcome>
<secondary_outcome>
<measure>Barthel</measure>
<time_frame>Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)</time_frame>
<description>Functional status and disability</description>
</secondary_outcome>
<secondary_outcome>
<measure>ECOG</measure>
<time_frame>Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)</time_frame>
<description>Functional status and disability</description>
</secondary_outcome>
<secondary_outcome>
<measure>EQoL-5D</measure>
<time_frame>Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)</time_frame>
<description>Quality of life</description>
</secondary_outcome>
<secondary_outcome>
<measure>Edmonton Symptom Assessment System</measure>
<time_frame>Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)</time_frame>
<description>Intensity of specific symptoms related to cancer</description>
</secondary_outcome>
<secondary_outcome>
<measure>Falls (yes vs. no & number of events)</measure>
<time_frame>Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)</time_frame>
<description>Potential adverse effects of the intervention</description>
</secondary_outcome>
<secondary_outcome>
<measure>Fractures (yes vs. no & number of events)</measure>
<time_frame>Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)</time_frame>
<description>Potential adverse effects of the intervention</description>
</secondary_outcome>
<secondary_outcome>
<measure>Pain (0-10 VAS)</measure>
<time_frame>Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)</time_frame>
<description>Potential adverse effects of the intervention</description>
</secondary_outcome>
<secondary_outcome>
<measure>Cardiovascular events (yes vs. no & number of events)</measure>
<time_frame>Pre-intervention (baseline) and post-intervention at follow-ups (at 3, 6, and 12 months)</time_frame>
<description>Collecting ocurrence of angina, myocardial infarction, TIA and/or stroke</description>
</secondary_outcome>
<secondary_outcome>
<measure>Readmissions to the acute hospital</measure>
<time_frame>Post-intervention at follow-ups (at 3, 6, and 12 months)</time_frame>
<description>Potential adverse effects</description>
</secondary_outcome>
<secondary_outcome>
<measure>Days spent at home (number of days)</measure>
<time_frame>Post-intervention at follow-ups (at 3, 6, and 12 months)</time_frame>
<description>Related to process & resources utilization</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">268</enrollment>
<condition>Older Adults</condition>
<condition>Gastro-Intestinal Cancer</condition>
<condition>Prostate Cancer</condition>
<condition>Lung Cancer</condition>
<condition>Frail Elderly Syndrome</condition>
<arm_group>
<arm_group_label>Control group</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Treatment as usual. Mainly based on standard physical rehabilitation.</description>
</arm_group>
<arm_group>
<arm_group_label>Intervention group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Based on the results of the CGA, a tailored multidisciplinary intervention will be proposed, focused on a multicomponent physical exercise program with nutritional recommendations.</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Intervention group</intervention_name>
<description>1) Multi-component exercise intervention program based on Vivifrail©. It consists of 1 daily-30 minutes session, twice a week, for 10 consecutive weeks supervised by an experienced exercise specialist. Exercises (resistance, gait retraining, balance training) are personalized depending on the person's functional capacity (evaluated by the SPPB and a walking speed test) and the risk of falling. Between sessions, individual, unsupervised training by the own patient, supported in the case by the caregiver, will be stimulated, through the recommendations of ViviFrail©. 2) Nutrition. Personalized recommendations according to nutritional and medical status (active oncologic treatment, remission, or palliative stage) will be offered according to the ESPEN recommendations for cancer patients, aimed at compensating for inadequate energy intake, improving patients' malnutrition risk stage (assessed by means of the MNA-SF).</description>
<arm_group_label>Intervention group</arm_group_label>
<other_name>Tailored multidisciplinary intervention based on CGA, focused on a multicomponent physical exercise program with nutritional recommendations.</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Control group</intervention_name>
<description>General recommendations (written and videos) will be offered.</description>
<arm_group_label>Control group</arm_group_label>
<other_name>Health psycho-education</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1) Older adults (≥65 years) 2) Diagnosed with solid tumors (specifically, prostate, lung,
colon, rectal, hepatic-biliary, pancreatic, and esophagus-gastric cancers), an extension of
T2, T3, T4, involving or not lymph nodes, and either metastatic or not (M0-1), who might or
might not underwent onco-specific treatments or await for new treatments 3) Evidence of
functional impact (ECOG≥2) but overall maintained functional status (Barthel≥50) 4) Life
expectancy ≥3 months 5) Patients with mild-moderate frailty (G8<14) 5) Willing to provide
informed consent to participate.

Exclusion Criteria:

1) Participants with moderate-severe cognitive impairment (Reisberg's Global Deterioration
Scale ≥5).
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>65 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Servei Andorrà d'Atenció Sanitària</name>
<address>
<city>Andorra</city>
<zip>AD500</zip>
<country>Andorra</country>
</address>
</facility>
</location>
<location>
<facility>
<name>NavarraBiomed</name>
<address>
<city>Pamplona</city>
<state>Navarra</state>
<zip>31008</zip>
<country>Spain</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Parc Sanitari Pere Virgili - Vall d'Hebron Institut de Recerca</name>
<address>
<city>Barcelona</city>
<zip>08035</zip>
<country>Spain</country>
</address>
</facility>
</location>
<location_countries>
<country>Andorra</country>
<country>Spain</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>April 12, 2022</last_update_submitted>
<last_update_submitted_qc>April 12, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 13, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Intestinal Neoplasms</mesh_term>
<mesh_term>Gastrointestinal Neoplasms</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The PROFIT study has two complementary aims. The first aim is to compare, in a cohort study
enrolling N=257 older adults (>65 years) with lung, gastrointestinal and prostate cancer,
different easy measures of frailty (Geriatric 8 questionnaire (G8), Short physical
Performance Battery (SPPB) and the IF-VIG), testing their ability to predict survival,
functional status (ECOG, Barthel Index), quality of life (EuroQol5D) and resources
utilization (visits, hospital admissions, treatments) at 3, 6 and 12 months. The second aim,
which motivates the registration in ClinicalTrials.gov, is to conduct a randomized controlled
trial (RCT) enrolling N=134 patients per group, with similar characteristics to those
enrolled for aim 1, but with mild-moderate frailty (G8≤14 points); we will compare a
multi-component CGA-based intervention including physical exercise and nutritional
recommendations with usual care, measuring the impact on the same outcomes as for aim 1, at 3
and 6 months. The use of ad hoc eHealth solutions (App/platform for exercise) will foster
patients' empowerment and sustainability of the intervention. We will also assess patients,
caregivers, and professionals' experience with the intervention through focus groups.
Participants will be recruited from outpatients and from post-acute care units.
The impact of the aging of population on cancer incidence and consequences is clear: in very
few years, more than 50% of older adults will be diagnosed with malignant tumors, with a
relevant increase in mortality compared to younger adults, and a dramatic burden of
disability. Many of these patients will be potential candidates for oncospecific treatments,
either curative, adjuvants or palliative. Despite this scenario, many trials on cancers still
exclude patients based on their age or set survival and treatments' toxicity as the main
outcomes, neglecting other meaningful outcomes such as functional status or quality of life.
Therefore, clinical decisions regarding this specific population are not always based on
real-life data. Moreover, older adults are a highly heterogeneous population, based on
clinical, functional, and psychosocial aspects. This is why, in such a population group, the
individualization of treatments is pivotal.
Frailty has been proposed as a better marker of biological age than chronological age. This
concept indicates a reversible state of risk of increased vulnerability to external or
internal stressors, exposing the patients to a higher risk of adverse events, including
disability and mortality. However, there is no agreement on the most suitable frailty tools
to be used in practice. In older adults with cancer, frailty, which is easily measured in any
setting through quick clinical scales, could be an ideal trigger to select candidate patients
for a subsequent more extensive comprehensive geriatric assessment (onwards, CGA) and
potential interventions. Among these interventions, multi-component approaches including
physical exercise and nutritional recommendations have shown a positive impact on both
mortality and functional status in patients with different cancers and could be proposed for
either pre-habilitation or re-habilitation in older cancer patients with mild-moderate
frailty.
Considering these premises, the PROFIT study has two complementary aims. The first aim is to
compare, in a cohort study enrolling N=257 older adults (>65 years) with lung,
gastrointestinal and prostate cancer, different easy measures of frailty (Geriatric 8
questionnaire (G8), Short physical Performance Battery (SPPB) and the IF-VIG), testing their
ability to predict survival, functional status (ECOG, Barthel Index), quality of life
(EuroQol5D) and resources utilization (visits, hospital admissions, treatments) at 3, 6 and
12 months. The second aim is to conduct a randomized controlled trial (RCT) enrolling N=134
patients per group, with similar characteristics to those enrolled for aim 1, but with
mild-moderate frailty (G8≤14 points); we will compare a multi-component CGA-based
intervention including physical exercise and nutritional recommendations with usual care,
measuring the impact on the same outcomes as for aim 1, at 3 and 6 months. The use of ad hoc
eHealth solutions (App/platform for exercise) will foster patients' empowerment and
sustainability of the intervention. We will also assess patients, caregivers, and
professionals' experience with the intervention through focus groups. Participants will be
recruited from outpatients and from post-acute care units.
The PROFIT study will add relevant evidence for the management of older cancer patients. The
impact, for the individual and the society, is high, in light of the aging of the population:
the results will allow providing oncologists and other professionals with tools to improve
the personalization of treatments, to finally provide adequate and tailored care programs.
This might contribute to avoid the exclusion of patients who could benefit from active
treatments and, on the other hand, reducing overtreatment for those who will likely not
benefit from it. The clinical trial will also provide information on the most suitable
content and on the impact of an intervention aimed at strengthening the functional status and
improving the quality of life in older cancer patients with mild-moderate frailty, who might
be potential candidates for subsequent onco-specific treatments. The project will also
deliver adapted materials and eHealth solutions to be potentially scaled up for this profile
of users, as a benefit for the society even beyond this project.
Inclusion Criteria:
1) Older adults (≥65 years) 2) Diagnosed with solid tumors (specifically, prostate, lung,
colon, rectal, hepatic-biliary, pancreatic, and esophagus-gastric cancers), an extension of
T2, T3, T4, involving or not lymph nodes, and either metastatic or not (M0-1), who might or
might not underwent onco-specific treatments or await for new treatments 3) Evidence of
functional impact (ECOG≥2) but overall maintained functional status (Barthel≥50) 4) Life
expectancy ≥3 months 5) Patients with mild-moderate frailty (G8<14) 5) Willing to provide
informed consent to participate.
Exclusion Criteria:
1) Participants with moderate-severe cognitive impairment (Reisberg's Global Deterioration
Scale ≥5).
|
NCT0531xxxx/NCT05319158.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319158</url>
</required_header>
<id_info>
<org_study_id>2021-2025</org_study_id>
<nct_id>NCT05319158</nct_id>
</id_info>
<brief_title>The Effect of the Movement Imitation Therapy in Preterm (MIT-PB) in Motor Behavior's Quality.</brief_title>
<acronym>MIT-PB</acronym>
<official_title>The Effect of the Movement Imitation Therapy for Preterm Babies (MIT-PB) on Motor Behavior Quality. Quasi-experimental Design.</official_title>
<sponsors>
<lead_sponsor>
<agency>Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Hospital Parc Taulí, Sabadell</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This study aims to assess the effect of a parent-administered intervention program based on
MIT-PB in preterm with abnormal general movements during the preterm period. We will describe
the short and long-term differences between infants exposed to MIT-PB and infants who follow
current standard care.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The quasi-experimental design has been planned to assess the effect of a physiotherapy
program carried out in neonatal intensive care and at home during the first months of life.
Preterm babies born before 32 weeks gestational age (GA) and/or with less than 1500g showing
an abnormal General Movement Assessment (GMA) at 34-36 weeks will be included.

Standardized tests will be performed at baseline, at term, 44 weeks post-menstrual age (PMA),
54 weeks PMA, 6 months, and 12 months.

A qualitative study has been designed to assess the physiotherapy performance and parents'
experience.

Two different Hospitals with similar care protocols and sizes will recruit the sample (n=36).
The Intervention group (n=18) will be located at Hospital Josep Trueta of Girona and the
control group (n=18) will be located at Hospital Parc Taulí of Sabadell (Barcelona).
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 31, 2022</start_date>
<completion_date type="Anticipated">September 1, 2025</completion_date>
<primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Non-Randomized</allocation>
<intervention_model>Sequential Assignment</intervention_model>
<intervention_model_description>The infants will be pre-stratified according to General Movement Optimality Score (GMOs). The Control group will receive standard care and the Intervention group will begin the therapy at 34-36w. The intervention will be explained and guided by the principal researcher and experienced Pediatric Physical therapist. Parents will conduct the intervention until the 50-52 weeks PMA. General Movement Assessment (GMA) will be performed at term, 44w and 54w PMA.
Motor assessment will be carried out at 6 months Corrected Age (CA) and a global assessment at 12 months CA.
Those assessments will be performed by independent and blind professionals at their corresponding Hospitals.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Single (Outcomes Assessor)</masking>
<masking_description>The assessments for the main outcome will be performed by a blinded expert.</masking_description>
</study_design_info>
<primary_outcome>
<measure>The quality of General Movement by General Movements Optimality Score (GMOS) and Motor Optimality Score (MOS).</measure>
<time_frame>Each participant will be assessed from birth to the 54 weeks PMA.</time_frame>
<description>We will videotape General Movements at 34, 38-40, 44 and 54 weeks PMA. The baseline measure( 34w) will be performed by the main researcher and an independent and experienced certified rater. This rater will be blind regarding infant group.
The assessments at 38-40, 44 and 54 weeks will be performed by the independent, blind and certified rater in order to guarantee the study validity.
The GMOS global assessment can be Normal (N), Poor Repertoire (PR), Cramped Syncronized (CS) or Chaotic (CH). On the detailed score ,the maximum value is 42. The MOS global assessment can be classified as Fidgety (F), Abnormal Fidgety (AF) or Absent Fidgety (F-). On the detailed score the maximum value is 28. Higher scores in both scales are correlated with better global outcome.</description>
</primary_outcome>
<secondary_outcome>
<measure>Motor development by Hammersmith Infant Neurological Scale (HINE).</measure>
<time_frame>6 months CA</time_frame>
<description>Infants will assessed at 6 months CA by an independent neuro-pediatrician using the HINE.
It is a standardized neurological exam for infants adjusted age 2 to 24 months. The HINE evaluates nerve function, movements, reflexes and reactions, posture, and tone and can help clinicians identify movement disorders including cerebral palsy (CP)The maximum global score is 78. Higher scores indicate better neurological performance.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Global development by Bayley III</measure>
<time_frame>12 months CA</time_frame>
<description>An independent neuropsychologists will assess Global Development by Bayley III at 12 months CA.
Bayley-III provides information about whether a child's developmental trajectory in the cognitive domain is proceeding as expected, relative to same-age peers. It also includes a motor score, and fine and gross motor subtest scores. The assessment indicates mild, moderate or severe delay.</description>
</secondary_outcome>
<other_outcome>
<measure>Describe families experiences with the MIT-PB</measure>
<time_frame>6 months CA</time_frame>
<description>• Families will fill up a questionnaire at the end of the intervention to give their opinion about their experience with the therapy.</description>
</other_outcome>
<other_outcome>
<measure>Study family's participation and treatment adherence</measure>
<time_frame>6 months CA</time_frame>
<description>Parents will get a software application in order to register the number of treatments achieved during the intervention period.</description>
</other_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">138</enrollment>
<condition>Premature Birth</condition>
<condition>Risk</condition>
<arm_group>
<arm_group_label>Intervention group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>The group intervention will receive MIT-PB.</description>
</arm_group>
<arm_group>
<arm_group_label>control group</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>The control group will receive standard care</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>MIT-PB, movement imitation therapy for preterm.</intervention_name>
<description>The instant an infant showed CS or PR movements, the therapists (or a therapist and a parent) intervened by gently guiding the infants' limbs so as to maneuver and smoothen their movements, thereby imitating normal GM sequences as closely as possible, adding variability to the movement</description>
<arm_group_label>Intervention group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Preterm infants born before 32w GA and less than 1500g weight.

- Infants who show Abnormal General Movements (CS-PR pattern) at 34-36w postmenstrual
age (PMA).

- Families able to understand/speak Catalan, Spanish or English.

- Families willing to participate who have the informed consent

Exclusion Criteria:

- Infants with congenital abnormalities and/or genetic disorders

- Infants with invasive ventilation or Continuous Positive Airway Pressure (CPAP) at 36
weeks PMA.

- Infants with Normal General Movements at 34-36 w PMA.

- Families not willing to participate.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>24 Weeks</minimum_age>
<maximum_age>32 Weeks</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Susana Trallero, MsC</last_name>
<role>Principal Investigator</role>
<affiliation>International University of Catalonia</affiliation>
</overall_official>
<overall_contact>
<last_name>Susana Trallero, MsC</last_name>
<phone>675255810</phone>
<email>sue.trallero@gmail.com</email>
</overall_contact>
<overall_contact_backup>
<last_name>Josep Perapoch, Dr</last_name>
<phone>620015414</phone>
<email>"Perapoch Lopez, Josep" <jperapoch.girona.ics@gencat.cat></email>
</overall_contact_backup>
<location>
<facility>
<name>Hospital Parc Taulí de Sabadell</name>
<address>
<city>Sabadell</city>
<state>Barcelona</state>
<zip>08208</zip>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Susana Trallero, MsC</last_name>
<phone>675255810</phone>
<email>sue.trallero@gmail.com</email>
</contact>
<contact_backup>
<last_name>Monica Domingo, Dr</last_name>
<phone>699273285</phone>
<email>Monica Domingo Puiggrós <mdomingo@tauli.cat></email>
</contact_backup>
</location>
<location>
<facility>
<name>Hospital Universitari Josep Trueta de Girona</name>
<address>
<city>Girona</city>
<zip>17007</zip>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Susana Trallero, MsC</last_name>
<phone>675255810</phone>
<email>sue.trallero@gmail.com</email>
</contact>
<contact_backup>
<last_name>Josep Perapoch, Dr</last_name>
<phone>620015414</phone>
<email>"Perapoch Lopez, Josep" <jperapoch.girona.ics@gencat.cat></email>
</contact_backup>
</location>
<location_countries>
<country>Spain</country>
</location_countries>
<verification_date>September 2023</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>September 5, 2023</last_update_submitted>
<last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">September 6, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta</investigator_affiliation>
<investigator_full_name>Susana Trallero Rodríguez</investigator_full_name>
<investigator_title>PhD candidate, MsC, Physiotherapist Susana Trallero Rodríguez</investigator_title>
</responsible_party>
<keyword>preterm, physiotherapy, early intervention, general movement</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Premature Birth</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This study aims to assess the effect of a parent-administered intervention program based on
MIT-PB in preterm with abnormal general movements during the preterm period. We will describe
the short and long-term differences between infants exposed to MIT-PB and infants who follow
current standard care.
The quasi-experimental design has been planned to assess the effect of a physiotherapy
program carried out in neonatal intensive care and at home during the first months of life.
Preterm babies born before 32 weeks gestational age (GA) and/or with less than 1500g showing
an abnormal General Movement Assessment (GMA) at 34-36 weeks will be included.
Standardized tests will be performed at baseline, at term, 44 weeks post-menstrual age (PMA),
54 weeks PMA, 6 months, and 12 months.
A qualitative study has been designed to assess the physiotherapy performance and parents'
experience.
Two different Hospitals with similar care protocols and sizes will recruit the sample (n=36).
The Intervention group (n=18) will be located at Hospital Josep Trueta of Girona and the
control group (n=18) will be located at Hospital Parc Taulí of Sabadell (Barcelona).
Inclusion Criteria:
- Preterm infants born before 32w GA and less than 1500g weight.
- Infants who show Abnormal General Movements (CS-PR pattern) at 34-36w postmenstrual
age (PMA).
- Families able to understand/speak Catalan, Spanish or English.
- Families willing to participate who have the informed consent
Exclusion Criteria:
- Infants with congenital abnormalities and/or genetic disorders
- Infants with invasive ventilation or Continuous Positive Airway Pressure (CPAP) at 36
weeks PMA.
- Infants with Normal General Movements at 34-36 w PMA.
- Families not willing to participate.
|
NCT0531xxxx/NCT05319171.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319171</url>
</required_header>
<id_info>
<org_study_id>12345</org_study_id>
<nct_id>NCT05319171</nct_id>
</id_info>
<brief_title>Performance of Currently Available traNscaTHEter Aortic Valve Platforms in Inoperable Patients With Pure Aortic regurgitatiON of a Native Valve. The PANTHEON International Project.</brief_title>
<acronym>PANTHEON</acronym>
<official_title>Performance of Currently Available traNscaTHEter Aortic Valve Platforms in Inoperable Patients With Pure Aortic regurgitatiON of a Native Valve. The PANTHEON International Project.</official_title>
<sponsors>
<lead_sponsor>
<agency>IRCCS Policlinico S. Donato</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>IRCCS Policlinico S. Donato</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
- To investigate the performance of currently available THVs in terms of safety and
efficacy

- To evaluate potential predictors of THV embolization or migration (TVEM)

- To assess the impact of TVEM on prognosis
</textblock>
</brief_summary>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">May 2022</start_date>
<completion_date type="Anticipated">November 2022</completion_date>
<primary_completion_date type="Anticipated">October 2022</primary_completion_date>
<study_type>Observational [Patient Registry]</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Other</time_perspective>
</study_design_info>
<target_duration>1 Year</target_duration>
<primary_outcome>
<measure>Overall mortality</measure>
<time_frame>1 year</time_frame>
</primary_outcome>
<enrollment type="Anticipated">100</enrollment>
<condition>Aortic Regurgitation</condition>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>TAVR</intervention_name>
<description>TAVR</description>
</intervention>
<eligibility>
<study_pop>
<textblock>
inoperable patients with severe aortic regurgitation
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- severe aortic regurgitation

- prohibitive surgical risk

Exclusion Criteria:

- surgical candidates
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
</eligibility>
<location>
<facility>
<name>IRCCS Policlinico S. Donato, Milan, Italy</name>
<address>
<city>Milano</city>
<state>Milan</state>
<zip>20097</zip>
<country>Italy</country>
</address>
</facility>
</location>
<location_countries>
<country>Italy</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>March 31, 2022</last_update_submitted>
<last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 8, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>IRCCS Policlinico S. Donato</investigator_affiliation>
<investigator_full_name>Luca Testa</investigator_full_name>
<investigator_title>MD, PhD, Contract Professor of CArdiology</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Aortic Valve Insufficiency</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
- To investigate the performance of currently available THVs in terms of safety and
efficacy
- To evaluate potential predictors of THV embolization or migration (TVEM)
- To assess the impact of TVEM on prognosis
inoperable patients with severe aortic regurgitation
Inclusion Criteria:
- severe aortic regurgitation
- prohibitive surgical risk
Exclusion Criteria:
- surgical candidates
|
NCT0531xxxx/NCT05319184.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319184</url>
</required_header>
<id_info>
<org_study_id>003</org_study_id>
<nct_id>NCT05319184</nct_id>
</id_info>
<brief_title>Acute Effect of Myofascial Release and Kinesiology Taping</brief_title>
<official_title>Acute Effect of Myofascial Release and Kinesiology Taping on Parameters Associated With Chronic Low Back Pain</official_title>
<sponsors>
<lead_sponsor>
<agency>Istanbul University - Cerrahpasa (IUC)</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Istanbul University - Cerrahpasa (IUC)</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Chronic low back pain (LBP) is one of the leading causes of activity limitation and
disability. The prevalence of chronic CBA among young adults is known to increase, and a
recent epidemiological study reported a rate of 42.4% per year among young adults. Studies
show that changes in the paravertebral muscles have an important relationship with the
formation of Chronic LBP, and therefore, evaluation of the mechanical properties of the
paravertebral muscles is of great importance for the clinical diagnosis and treatment of
Chronic LBP.

Mechanical properties of the muscle, such as muscle stiffness and tone, are considered
essential for maintaining efficient muscle contraction. Abnormally high muscle tone blocks
blood flow, leading to faster muscle fatigue and slower muscle recovery. When there is
abnormally high muscle stiffness, stretching the stiffened antagonist muscles requires more
effort, resulting in lower exercise efficiency. Muscle stiffness is one of the critical
indicators of energy storage of the muscle-tendon unit, which has a significant effect on the
control of joint movement. Altered tone and stiffness in the lumbar myofascial region have
been described in association with underlying pathologies and symptoms in people with Chronic
LBP. Rehabilitation interventions such as manual therapy or therapeutic exercises are common
techniques for the treatment of chronic Chronic LBP because of their benefits in altering
muscle tone and stiffness by reducing paraspinal muscle activity.

Although the effectiveness of the myofascial release technique in individuals with Chronic
LBP is supported in the literature, the long-term use of the therapist's hand support creates
difficulties in practice in the clinical setting. The KT technique, on the other hand, seems
to be a method that can be used as an alternative to myofascial release technique in the
treatment of Chronic LBP, since it is an easy-to-use and time-consuming approach. When the
studies conducted to date are examined, no study has been found that compares the
effectiveness of myofascial release and kinesiology taping applied to individuals with
Chronic LBP. The aim of our study is to compare the acute effect of myofascial release and
kinesiology taping in individuals with Chronic LBP.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Anticipated">June 30, 2023</start_date>
<completion_date type="Anticipated">August 30, 2023</completion_date>
<primary_completion_date type="Anticipated">July 30, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Single (Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Muscle Tone and Stiffness</measure>
<time_frame>4 weeks</time_frame>
<description>Muscle tone and stiffness will be evaluated with a myotonometer. The myotonusometer was developed for the objective measurement of mechanical muscle properties. Myotonusometry reflects the viscoelastic properties of the muscle such as tone and stiffness by creating oscillation in the muscle fiber and is an acceptable and reliable method for measuring the mechanical properties of the muscle in young adults with chronic LBP. The device measures muscle tone as the natural oscillation frequency (Hz) calculated as Hz = 1/T; where T is the oscillation time measured in seconds. Muscle stiffness (N/m) is related to the maximum acceleration of oscillation and tissue deformation recorded by the transducer.</description>
</primary_outcome>
<primary_outcome>
<measure>Visual Analogue Scale</measure>
<time_frame>4 weeks</time_frame>
<description>The Visual Analog Scale is a simple, precise and reproducible tool that is often used to assess pain severity. Due to its easy application, it is one of the most frequently used measurement tools to measure the severity of pain in low back pain. It consists of a horizontal or vertical line ten cm long. The starting point of the line, '0', represents no pain, and the ending point, '10', represents the most severe pain imaginable. Pain intensity increases as you go from 0 to 10. The patient is asked to mark the severity of the pain on the line, the point marked by the patient is recorded in cm.</description>
</primary_outcome>
<primary_outcome>
<measure>Joint Range of Motion</measure>
<time_frame>4 weeks</time_frame>
<description>Lumbar region flexion, extension, lateral flexion and rotation movements will be measured bilaterally with a digital goniometer. Measurements will be repeated 3 times and the average value will be recorded in degrees.</description>
</primary_outcome>
<secondary_outcome>
<measure>Mobility</measure>
<time_frame>4 weeks</time_frame>
<description>The Modified Schober Test will be used to evaluate the mobility of the lumbar region. For this test, while the patient is standing, mark 10 cm upwards from the second sacral spinous process and 5 cm downwards from this protrusion (the distance between the two points is 15 cm). The patient has maximum flexion of the trunk and the distance between the two points is measured. The difference is found by subtracting 15 cm (the distance between two points in upright posture) from the value found. The fact that this difference is less than 5 cm indicates that the mobility of the lumbar region is reduced.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Progressive İsoinartial Lifting Evaluation</measure>
<time_frame>4 weeks</time_frame>
<description>The PILE Test will be used to evaluate the general body strength and endurance of the participants. Application of the test: The test starts with a weight of 3.6 kg for women and 5.9 kg for men. These weights are put into the box and the participants are asked to lift this box to a 75 cm high table 4 times within 20 seconds. After each completed lap, a weight of 2.25 kg for women and 4.5 kg for men is added to the box. If the participant fails to complete 4 repetitions within 20 seconds, wishes to discontinue the test due to fatigue or extreme discomfort (psychophysical endpoint), reaches 85% of maximum heart rate (220-years), or reaches the maximum weight that can be safely lifted (55-60% of body weight) i) the test is terminated. The maximum weight lifted and the number of repetitions are recorded. By multiplying the maximum weight lifted and the number of repetitions, the total work done is calculated and recorded.</description>
</secondary_outcome>
<secondary_outcome>
<measure>1 Minute Stepping Test</measure>
<time_frame>4 weeks</time_frame>
<description>The step test will be used to evaluate the physical performance of the participants. During the test, participants will be asked to go up and down a step of 40 cm for 1 minute. The number of repetitions performed in 1 minute will be recorded for the right and left sides.</description>
</secondary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Anticipated">60</enrollment>
<condition>Low Back Pain</condition>
<condition>Kinesio Taping</condition>
<condition>Myofascial Release Technique</condition>
<arm_group>
<arm_group_label>Myofascial Release Group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>The application will be made with the patient in the prone position. By applying a few grams of constant force to the lumbar paravertebral muscles bilaterally with the hand of the physiotherapist in the direction of restriction for 3-5 minutes, the fascia will be stretched and allow the tissue to relax on its own. Thus, it is aimed to decrease the tone and stiffness of the paravertebral muscles.</description>
</arm_group>
<arm_group>
<arm_group_label>Kinesiology Taping Group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>During the application, the participants will be positioned standing and facing backwards due to the ease of application. While taping the lumbar region, the kinesiology tape cut as a long strip (I tape) will be applied paravertebrally to the right and left sides of the spine. Rounded corners will be created to prevent premature loosening and unwanted bends in the belt. The patient will be asked to perform maximum trunk flexion and 2 I-shaped pieces will be taped with 10-15% tension from the lumbar region to the thoracic region. The tape will remain on the patient's skin for 30 minutes.</description>
</arm_group>
<arm_group>
<arm_group_label>Control Group</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>No intervention.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Myofascial Release Technique and Kinesiology Taping</intervention_name>
<description>Myofascial release is a manual release technique that increases the elasticity and glide between soft tissue layers, reduces this increased muscle activity and pain intensity. Myofascial release is usually characterized by prolonged mechanical forces exerted directly or indirectly on the limited fascial layers with low load. Following the direction of the fascial restraint, the therapist's hands slowly maintain the stretch and allow the fascia to relax on its own.
Kinesio Taping is a non-invasive, painless and less time consuming method with fewer side effects. It is an elastic-cotton adhesive tape that is latex-free and can be used on any joint or muscle. It can stretch significantly (130-140% of its original length), which reduces mechanical movement limitations and mimics skin in thickness and elasticity. It is used in the treatment of LBP to reduce muscle tone and stiffness as a rehabilitative taping technique designed to support the body's natural healing process.</description>
<arm_group_label>Kinesiology Taping Group</arm_group_label>
<arm_group_label>Myofascial Release Group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Being between the ages of 18-45

- Being diagnosed with nonspecific chronic low back pain (lasting longer than 3 months)

- Volunteering to participate in the study

Exclusion Criteria:

- Those who have had major surgery or trauma related to the musculoskeletal system,
especially the lumbar region

- Those with neurological disease

- Those with rheumatic disease in the active period

- Those with systemic diseases (Diabetes, hypothyroidism, infection, malignancy...)

- Those with serious psychological problems (BDI score of 30 and above)

- Those with kinesiology tape allergies

- Those with contraindications to myofascial release therapy (acute inflammations, viral
and bacterial infections, infectious diseases, fever, deep vein thrombosis, active
malignant disease, aneurysms)

- Those who received physiotherapeutic intervention to the lumbar region in the last 6
months

- Obesity (BMI≥30 kg/m2)

- Pregnancy
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>45 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Istanbul university Cerrahpasa</name>
<address>
<city>Istanbul</city>
<country>Turkey</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Ayse zengin alpozgen, Ass.Prof.PhD</last_name>
<phone>+902128663700</phone>
<email>azengin@istanbul.edu.tr</email>
</contact>
<investigator>
<last_name>Kubra KARDES, MSc, PT</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Yunus Emre TUTUNEKEN, MSc, PT</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<verification_date>June 2023</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>June 12, 2023</last_update_submitted>
<last_update_submitted_qc>June 12, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">June 13, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
<investigator_full_name>Kubra Kardes, MSc PT</investigator_full_name>
<investigator_title>Lecturer</investigator_title>
</responsible_party>
<keyword>Low Back Pain</keyword>
<keyword>Kinesio Taping</keyword>
<keyword>Myofascial release technique</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Back Pain</mesh_term>
<mesh_term>Low Back Pain</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Chronic low back pain (LBP) is one of the leading causes of activity limitation and
disability. The prevalence of chronic CBA among young adults is known to increase, and a
recent epidemiological study reported a rate of 42.4% per year among young adults. Studies
show that changes in the paravertebral muscles have an important relationship with the
formation of Chronic LBP, and therefore, evaluation of the mechanical properties of the
paravertebral muscles is of great importance for the clinical diagnosis and treatment of
Chronic LBP.
Mechanical properties of the muscle, such as muscle stiffness and tone, are considered
essential for maintaining efficient muscle contraction. Abnormally high muscle tone blocks
blood flow, leading to faster muscle fatigue and slower muscle recovery. When there is
abnormally high muscle stiffness, stretching the stiffened antagonist muscles requires more
effort, resulting in lower exercise efficiency. Muscle stiffness is one of the critical
indicators of energy storage of the muscle-tendon unit, which has a significant effect on the
control of joint movement. Altered tone and stiffness in the lumbar myofascial region have
been described in association with underlying pathologies and symptoms in people with Chronic
LBP. Rehabilitation interventions such as manual therapy or therapeutic exercises are common
techniques for the treatment of chronic Chronic LBP because of their benefits in altering
muscle tone and stiffness by reducing paraspinal muscle activity.
Although the effectiveness of the myofascial release technique in individuals with Chronic
LBP is supported in the literature, the long-term use of the therapist's hand support creates
difficulties in practice in the clinical setting. The KT technique, on the other hand, seems
to be a method that can be used as an alternative to myofascial release technique in the
treatment of Chronic LBP, since it is an easy-to-use and time-consuming approach. When the
studies conducted to date are examined, no study has been found that compares the
effectiveness of myofascial release and kinesiology taping applied to individuals with
Chronic LBP. The aim of our study is to compare the acute effect of myofascial release and
kinesiology taping in individuals with Chronic LBP.
Inclusion Criteria:
- Being between the ages of 18-45
- Being diagnosed with nonspecific chronic low back pain (lasting longer than 3 months)
- Volunteering to participate in the study
Exclusion Criteria:
- Those who have had major surgery or trauma related to the musculoskeletal system,
especially the lumbar region
- Those with neurological disease
- Those with rheumatic disease in the active period
- Those with systemic diseases (Diabetes, hypothyroidism, infection, malignancy...)
- Those with serious psychological problems (BDI score of 30 and above)
- Those with kinesiology tape allergies
- Those with contraindications to myofascial release therapy (acute inflammations, viral
and bacterial infections, infectious diseases, fever, deep vein thrombosis, active
malignant disease, aneurysms)
- Those who received physiotherapeutic intervention to the lumbar region in the last 6
months
- Obesity (BMI≥30 kg/m2)
- Pregnancy
|
NCT0531xxxx/NCT05319197.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319197</url>
</required_header>
<id_info>
<org_study_id>KutahyaHSUozgulogrenmeguclugu</org_study_id>
<nct_id>NCT05319197</nct_id>
</id_info>
<brief_title>HAND FUNCTIONS OF CHILDREN WITH A SPECIFIC LEARNING DISORDER</brief_title>
<official_title>INVESTIGATION OF HAND FUNCTIONS IN CHILDREN WITH SPECIFIC LEARNING DISORDER</official_title>
<sponsors>
<lead_sponsor>
<agency>Kutahya Health Sciences University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Kutahya Health Sciences University</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Children with Specific Learning Difficulties (SLD) may have problems with fine and gross
motor skills compared to their healthy peers. These children may have poor manual dexterity.
Taken together, it is not clear how motor and sensory competence of the hand are affected
together. In this study, it was aimed to evaluate the sensory and motor ability of the hand
and to compare the examined parameters between the SLD group and the healthy control group.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Specific learning disability (SLD) is a common neurodevelopmental disorder that begins at
school age and sometimes goes undetected until adulthood. Its incidence in school-aged
children is about 5-15%. Children with SLD have difficulty in fulfilling academic
qualifications. In addition, there are various problems with fine motor skills,
motor-coordination, balance and gross motor skills.

Upper extremity speed and dexterity affect fine motor performance (as they involve
manipulative tasks that require a certain amount of time and higher motor skills). In the
literature, it is reported that manual dexterity is a stronger predictor than balance on the
functional mobility of children with SLD, and it is emphasized that strategies to improve
dexterity performance should be focused in interventions for fine motor skills for these
children. In addition, it is demonstrated that taking the necessary precautions and planning
by evaluating the gross and fine motor skills in detail in SLD is important for the
independence and achievements of children in their daily living activities.

Weak hand skills are expected in children with SLD. Problems based on hand performance can be
addressed in a more comprehensive way by comparing these children with children with typical
development in terms of motor performance and functional mobility. Similarly, although it is
recommended to evaluate senses such as touch and stereognosia when evaluating fine motor
performance in these children, no comprehensive study including sensory and motor evaluations
has been found in the literature.

In this study, in children with SLD; It is aimed to examine the limitations of hand motor and
sensory functions in daily activities in terms of general motor competencies and hand skills
of the child and to compare them with the healthy control group.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">May 5, 2022</start_date>
<completion_date type="Actual">December 1, 2022</completion_date>
<primary_completion_date type="Actual">September 15, 2022</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Control</observational_model>
<time_perspective>Cross-Sectional</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Bruininks-Oseretsky Motor Proficiency Test- 2 Short Form (BOT-2SF)</measure>
<time_frame>20 minutes</time_frame>
<description>Assesses fine motor precision, fine motor integration, and manual dexterity. Scores are reported as a percentile rank; higher scores indicate better fine motor skills.</description>
</primary_outcome>
<primary_outcome>
<measure>Hand Grip Force</measure>
<time_frame>10 minutes</time_frame>
<description>Changes from the baseline, To measure hand grip strength through Hydraulic Hand held Dynamo-meter. It will be measured in kilograms.</description>
</primary_outcome>
<primary_outcome>
<measure>Pinch Grip Force</measure>
<time_frame>6 minutes</time_frame>
<description>Participants were seated at a table on which the dynamometers were positioned. The subjects were told to keep their elbow flexed without resting their arm or the grip handle of the dynamometer on the table. Results will be evaluated in pounds.</description>
</primary_outcome>
<primary_outcome>
<measure>Abilhand Kids</measure>
<time_frame>5 minutes</time_frame>
<description>to assess for performance of activity. score range 0-42 point, higher scores mean a better outcome.</description>
</primary_outcome>
<primary_outcome>
<measure>Minnesota Manual Dexterity Test</measure>
<time_frame>25 minutes</time_frame>
<description>to assess manual dexterity, higher scores mean a worse outcome.</description>
</primary_outcome>
<primary_outcome>
<measure>Sensory Function</measure>
<time_frame>30 minutes</time_frame>
<description>Proprioception, stereognosis, and two-point discrimination will be tested. Lower scores indicate better sensory function.</description>
</primary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Actual">60</enrollment>
<condition>Specific Learning Disability</condition>
<condition>Specific Learning Disorder</condition>
<condition>Fine Motor Skills</condition>
<condition>Hand Functions</condition>
<arm_group>
<arm_group_label>SLD Group</arm_group_label>
</arm_group>
<arm_group>
<arm_group_label>Healthy Control Group</arm_group_label>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>No Interventions</intervention_name>
<description>No Interventions</description>
<arm_group_label>Healthy Control Group</arm_group_label>
<arm_group_label>SLD Group</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
The convenience sampling will implement for this cross-sectional study. Children who have a
diagnoisis of special learning disability regarding DSM-V criteria and who attends the
Specific Learning Difficulty Support Education Program of the Ministry of National
Education regularly twice a week will screen for eligibility by their physician and were
subsequently requested to participate in this study.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- To have a diagnosis of special learning disability (regarding DSM-V criteria)

- To be in the age range of 8-14

Exclusion Criteria:

- Any acute or chronic orthopedic or neurological disease that may affect walking
performance,

- Any surgery within the last 6 months,

- Severe sensory (hearing, vision, etc.) impairment that prevents him/her from taking
commands

- Cognitive and mental severe impairment
</textblock>
</criteria>
<gender>All</gender>
<gender_based>Yes</gender_based>
<minimum_age>8 Years</minimum_age>
<maximum_age>14 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>İsmail SARAÇOĞLU</last_name>
<role>Principal Investigator</role>
<affiliation>Kutahya Health Sciences University</affiliation>
</overall_official>
<location>
<facility>
<name>Afyonkarahisar Özel Eğitim ve Rehabilitasyon Merkezi</name>
<address>
<city>Afyonkarahisar</city>
<zip>03000</zip>
<country>Turkey</country>
</address>
</facility>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>December 5, 2022</last_update_submitted>
<last_update_submitted_qc>December 5, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">December 6, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Learning Disabilities</mesh_term>
<mesh_term>Specific Learning Disorder</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Children with Specific Learning Difficulties (SLD) may have problems with fine and gross
motor skills compared to their healthy peers. These children may have poor manual dexterity.
Taken together, it is not clear how motor and sensory competence of the hand are affected
together. In this study, it was aimed to evaluate the sensory and motor ability of the hand
and to compare the examined parameters between the SLD group and the healthy control group.
Specific learning disability (SLD) is a common neurodevelopmental disorder that begins at
school age and sometimes goes undetected until adulthood. Its incidence in school-aged
children is about 5-15%. Children with SLD have difficulty in fulfilling academic
qualifications. In addition, there are various problems with fine motor skills,
motor-coordination, balance and gross motor skills.
Upper extremity speed and dexterity affect fine motor performance (as they involve
manipulative tasks that require a certain amount of time and higher motor skills). In the
literature, it is reported that manual dexterity is a stronger predictor than balance on the
functional mobility of children with SLD, and it is emphasized that strategies to improve
dexterity performance should be focused in interventions for fine motor skills for these
children. In addition, it is demonstrated that taking the necessary precautions and planning
by evaluating the gross and fine motor skills in detail in SLD is important for the
independence and achievements of children in their daily living activities.
Weak hand skills are expected in children with SLD. Problems based on hand performance can be
addressed in a more comprehensive way by comparing these children with children with typical
development in terms of motor performance and functional mobility. Similarly, although it is
recommended to evaluate senses such as touch and stereognosia when evaluating fine motor
performance in these children, no comprehensive study including sensory and motor evaluations
has been found in the literature.
In this study, in children with SLD; It is aimed to examine the limitations of hand motor and
sensory functions in daily activities in terms of general motor competencies and hand skills
of the child and to compare them with the healthy control group.
The convenience sampling will implement for this cross-sectional study. Children who have a
diagnoisis of special learning disability regarding DSM-V criteria and who attends the
Specific Learning Difficulty Support Education Program of the Ministry of National
Education regularly twice a week will screen for eligibility by their physician and were
subsequently requested to participate in this study.
Inclusion Criteria:
- To have a diagnosis of special learning disability (regarding DSM-V criteria)
- To be in the age range of 8-14
Exclusion Criteria:
- Any acute or chronic orthopedic or neurological disease that may affect walking
performance,
- Any surgery within the last 6 months,
- Severe sensory (hearing, vision, etc.) impairment that prevents him/her from taking
commands
- Cognitive and mental severe impairment
|
NCT0531xxxx/NCT05319210.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319210</url>
</required_header>
<id_info>
<org_study_id>188972</org_study_id>
<nct_id>NCT05319210</nct_id>
</id_info>
<brief_title>The Effect of Virtual Reality and Buzzy Application on Pain Management in Children</brief_title>
<official_title>Investigation of the Effect of Virtual Reality Glasses and Buzzy Application on Pain Management During Venous Catheter Insertion in Children</official_title>
<sponsors>
<lead_sponsor>
<agency>Suleyman Demirel University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Suleyman Demirel University</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this research; This is a randomized controlled experimental study planned to
examine the effect of virtual reality glasses and buzzy application on pain management during
venous catheter insertion in children.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The purpose of this research; This is a randomized controlled experimental study planned to
examine the effect of virtual reality glasses and buzzy application on pain management during
venous catheter insertion in children.

The universe of the research is all children between the ages of 7 and 12 who applied to
Hospital Emergency Service will be formed. G power analysis program was used to calculate the
sample size of the study. The number of samples was calculated according to 95% power, 0.05
margin of error and 0.80 effect size. It is envisaged that 36 children will be included in
the sample for each group. However, considering that sample losses may be experienced during
the process of the research, it is planned to include 40 participants (120 participants in
total) for each group.

"Child and Parent Diagnosis Form", "Child Fear Scale (CDS)", "Child Anxiety Scale-State
(CAS-D)" and Wong-Baker Faces Pain Scale will be used to collect research data.

In the collection of research data, first of all, patients will be divided into intervention
and control groups in accordance with the randomization scheme. Our research will consist of
two interventions (Buzzy device, virtual reality glasses) and a control group (routine
outpatient procedures).

Before the procedure; Written and verbal "Informed Consent" will be obtained from all
participants in the intervention and control groups. "Child and Parent Diagnosis Form",
"Child Fear Scale (CDS)", "Child Anxiety Scale-State (CAS-D)" and Wong-Baker Faces Pain Scale
will be applied to the participants who agree to participate in the study.

Process Sequence and After; Venous catheter insertion will be done in line with the routine
practice of the outpatient clinic. Venous catheter placement in all children included in the
study will be performed by the researcher working in this one in order to keep the
practitioner-related factors under control. Children who cannot insert a venous catheter in a
single attempt will be excluded from the study.

Licensed SPSS (Statistical Package for the Social Science) 20.0 package program will be used
in the evaluation of the data. Descriptive analyzes such as number, percentage, frequency,
mean, standard deviation and percentile distributions will be used to evaluate the
characteristics of children. Nonparametric tests will be used according to the results of
normal distribution and homogeneity of variance. Mann Whitney U test, Wilcoxon test and
correlation analyzes will be used to evaluate the relationships between dependent and
independent variables. Results will be evaluated at 95% confidence interval and p<0.05
significance level.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">February 1, 2022</start_date>
<completion_date type="Anticipated">July 1, 2022</completion_date>
<primary_completion_date type="Anticipated">July 1, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Supportive Care</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Pain management</measure>
<time_frame>4 month</time_frame>
<description>Management of pain during venous catheter insertion in children. The parameter for pain management will be determined by the Wong Baker Faces Pain Rating Scale.</description>
</primary_outcome>
<secondary_outcome>
<measure>Management of fear in children</measure>
<time_frame>4 month</time_frame>
<description>Management of fear during venous catheter insertion in children. The parameter for fear management will be determined by the Child Fear Scale.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Management of anxiety in children</measure>
<time_frame>4 month</time_frame>
<description>It is the management of anxiety during venous catheter placement in children. The parameter for Anxiety management will be determined by Child Anxiety Scale.</description>
</secondary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Anticipated">120</enrollment>
<condition>Pain Management</condition>
<arm_group>
<arm_group_label>Buzzy application</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>It is fixed on the right upper arm area of the child one minute before the procedure. After cleaning the skin with the appropriate solution, venous catheter placement will be performed. During the procedure, the child's respiratory rate, heart rate and oxygen saturation will be observed.</description>
</arm_group>
<arm_group>
<arm_group_label>Virtual Reality Glasses</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>A dinosaur movie suitable for the 7-12 age group will be watched 2-3 minutes before the venous catheter insertion. In this process, after cleaning the skin with the appropriate solution, a venous catheter will be inserted. During the procedure, the child's respiratory rate, heart rate and oxygen saturation will be observed.</description>
</arm_group>
<arm_group>
<arm_group_label>No intervention</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>The routine venous catheter placement protocol in the institution where the study is conducted will be applied. An evidence-based non-pharmacological method is not used to reduce pain during venous catheter insertion in children in the institution. A venous catheter is inserted by attaching a tourniquet to the child. During the procedure, the child's respiratory rate, heart rate and oxygen saturation will be observed.</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Venous catheter application</intervention_name>
<description>To examine the effect of virtual reality glasses and buzzy application on pain management during venous catheter insertion in children.</description>
<arm_group_label>Buzzy application</arm_group_label>
<arm_group_label>Virtual Reality Glasses</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Those who volunteered to participate in the research

- 7-12 age group

- The child does not have vision, hearing, mental or neurological sequelae.

Exclusion Criteria:

-Children with a history of using sedative, analgesic or narcotic substances with analgesic
effect before admission to the outpatient clinic will not be included in the study.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>7 Years</minimum_age>
<maximum_age>12 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Şerife Tutar T Assistant professor, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Suleyman Demirel University</affiliation>
</overall_official>
<overall_contact>
<last_name>Şerife Tutar T Assistant professor, PhD</last_name>
<phone>+905053126429</phone>
<email>serifeguven@sdu.edu.tr</email>
</overall_contact>
<location>
<facility>
<name>Suleyman Demirel University</name>
<address>
<city>Isparta</city>
<zip>32000</zip>
<country>Turkey</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Şerife Tutar</last_name>
<phone>+0905053126429</phone>
<email>serifeguven@sdu.edu.tr</email>
</contact>
<contact_backup>
<last_name>Tuğçe Karol</last_name>
<phone>+905079346721</phone>
<email>tugcekarol32@gmail.com</email>
</contact_backup>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 21, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>March 31, 2022</last_update_submitted>
<last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 8, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Suleyman Demirel University</investigator_affiliation>
<investigator_full_name>Serife Tutar</investigator_full_name>
<investigator_title>Principal investigator</investigator_title>
</responsible_party>
<keyword>pain</keyword>
<keyword>virtual reality glasses</keyword>
<keyword>buzzy application</keyword>
<keyword>children</keyword>
<keyword>venous catheter</keyword>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this research; This is a randomized controlled experimental study planned to
examine the effect of virtual reality glasses and buzzy application on pain management during
venous catheter insertion in children.
The purpose of this research; This is a randomized controlled experimental study planned to
examine the effect of virtual reality glasses and buzzy application on pain management during
venous catheter insertion in children.
The universe of the research is all children between the ages of 7 and 12 who applied to
Hospital Emergency Service will be formed. G power analysis program was used to calculate the
sample size of the study. The number of samples was calculated according to 95% power, 0.05
margin of error and 0.80 effect size. It is envisaged that 36 children will be included in
the sample for each group. However, considering that sample losses may be experienced during
the process of the research, it is planned to include 40 participants (120 participants in
total) for each group.
"Child and Parent Diagnosis Form", "Child Fear Scale (CDS)", "Child Anxiety Scale-State
(CAS-D)" and Wong-Baker Faces Pain Scale will be used to collect research data.
In the collection of research data, first of all, patients will be divided into intervention
and control groups in accordance with the randomization scheme. Our research will consist of
two interventions (Buzzy device, virtual reality glasses) and a control group (routine
outpatient procedures).
Before the procedure; Written and verbal "Informed Consent" will be obtained from all
participants in the intervention and control groups. "Child and Parent Diagnosis Form",
"Child Fear Scale (CDS)", "Child Anxiety Scale-State (CAS-D)" and Wong-Baker Faces Pain Scale
will be applied to the participants who agree to participate in the study.
Process Sequence and After; Venous catheter insertion will be done in line with the routine
practice of the outpatient clinic. Venous catheter placement in all children included in the
study will be performed by the researcher working in this one in order to keep the
practitioner-related factors under control. Children who cannot insert a venous catheter in a
single attempt will be excluded from the study.
Licensed SPSS (Statistical Package for the Social Science) 20.0 package program will be used
in the evaluation of the data. Descriptive analyzes such as number, percentage, frequency,
mean, standard deviation and percentile distributions will be used to evaluate the
characteristics of children. Nonparametric tests will be used according to the results of
normal distribution and homogeneity of variance. Mann Whitney U test, Wilcoxon test and
correlation analyzes will be used to evaluate the relationships between dependent and
independent variables. Results will be evaluated at 95% confidence interval and p<0.05
significance level.
Inclusion Criteria:
- Those who volunteered to participate in the research
- 7-12 age group
- The child does not have vision, hearing, mental or neurological sequelae.
Exclusion Criteria:
-Children with a history of using sedative, analgesic or narcotic substances with analgesic
effect before admission to the outpatient clinic will not be included in the study.
|
NCT0531xxxx/NCT05319223.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319223</url>
</required_header>
<id_info>
<org_study_id>110-627-21</org_study_id>
<nct_id>NCT05319223</nct_id>
</id_info>
<brief_title>Patient Blood Management in Orthopedic Surgical Patients in Turkey</brief_title>
<acronym>PABMOS</acronym>
<official_title>Patient Blood Management in Orthopedic Surgical Patients in Turkey</official_title>
<sponsors>
<lead_sponsor>
<agency>Prof. Serdar Gunaydin</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>ERAS Turkey Association</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Transfusion practice for surgical patients has changed from replacing surgically lost blood
with allogeneic blood transfusions to implementing strategies that reduce transfusion
requirements. Patient Blood Management (PBM), which is "the timely application of
evidence-based medical and surgical concepts designed to maintain haemoglobin concentration,
optimize hemostasis and minimize blood loss in an effort to improve patient outcome. There is
mounting evidence that multimodal patient blood management (PBM) programmes can be effective
at improving postoperative outcomes and reducing perioperative blood transfusions and costs
The Turkish Society of Anaesthesiologists PBM Task Force has been working on this subject and
studied transfusion practice throughout all through the peri-operative periods. Unfortunately
we documented a high transfusion rate in major surgical patients in Turkey. One of the
surgeries, that has high transfusion rate, was orthopaedic surgery. According to our recent
data we planned to implement PBM in major orthopaedic surgical patients and evaluate the
effects PBM in transfusion rate and patient outcomes. While some elements of PBM have a
strong evidence base in hip or knee replacement, such as the use of tranexamic acid (TXA) the
evidence for preoperative anaemia optimisation with iron is less robust. Implementing PBM all
through the operative period gains more importance.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Active PBM Implementation: Patients undergoing hip or knee arthroplasty will be treated as
follows: PBM will be performed as shown in the graph below "PBM Implementation Group".

Active PBM group will be treated for preoperative anemia at least 3 weeks prior to the
surgical intervention as per the "Anemia Algorithm" below Other pillars of PBM will be also
performed to the treatment group as per the visual graph below. The parameters included in
the PBM pillars will be recorded including preoperative anemia parameters. Postoperative
variables and parameters related to complications will be recorded.

For the control group (Non-PBM group), the data of the patients, will be prospectively
included.

The 1:1 ratio of the control and active groups will be done.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">February 1, 2022</start_date>
<completion_date type="Anticipated">December 1, 2022</completion_date>
<primary_completion_date type="Anticipated">June 1, 2022</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Control</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>red cell transfusion</measure>
<time_frame>3 days</time_frame>
<description>change in red blood cell transfusion rate</description>
</primary_outcome>
<secondary_outcome>
<measure>cost</measure>
<time_frame>3 days</time_frame>
<description>change in total hospital cost</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Anticipated">369</enrollment>
<condition>Arthropathy</condition>
<arm_group>
<arm_group_label>Patient management group</arm_group_label>
<description>patient blood management group</description>
</arm_group>
<arm_group>
<arm_group_label>Control</arm_group_label>
<description>control</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>patient blood management</intervention_name>
<description>three pillars of patient blood management will be applied</description>
<arm_group_label>Patient management group</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
Patients undergoing arthroplasty with anemia
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

In order to be eligible to participate in this trial, an individual must meet all of the
following criteria:

- Signed patient informed consent

- Male or female patient at least 18 years old

- Patients scheduled for an elective major orthopaedic surgery (hip arthroplasty, knee
arthroplasty, primary and revision operations)

- Patients with confirmed iron deficiency anemia (IDA), defined as Hb 100-130 g/L, and
serum ferritin < 100 ng/ml or TSAT < 20%.

Patients with iron deficiency anemia will be taken into surgery at least 3 weeks after the
treatment.

Exclusion Criteria:

- Patients that undergo emergency surgical procedure and trauma cases are excluded from
the study.

- Patients with non-iron deficiency anaemia (thalassemia, sickle cell anaemia and etc.)

- Patients with renal anaemia (Hb < 130 g/L and CCL < 50 mL/min, irrespective of iron
parameters) or any diagnosis that require EPO will be excluded

- Patients with known anaphylactic/hypersensitivity reactions to parenteral iron
products.

- Patients with iron overload or disturbances in utilization of iron (e.g.
haemochromatosis, hemosiderosis)

- Patients with ≥3 times increase in aspartate aminotransferase or alanine
aminotransferase as per reference range.

- Patients with excessive blood loss requiring massive transfusion (≥ 10 more red blood
cell units)

- Patients with known myelodysplastic syndromes.

- Patients with chronic kidney disease with an estimated GFR < 30 ml/min or with
end-stage renal disease requiring scheduled dialysis.

- Patients with known urinary tract infections with urea-splitting bacteria

- Any patient judged to lack the ability to give informed consent or perform the trial
assessments (e.g. due to dementia)

- Women who are pregnant or breast feeding

- Intention to become pregnant during the course of the study,

- Lack of safe contraception, defined as: Female participants of childbearing potential,
not using and not willing to continue using a medically reliable method of
contraception for the entire study duration, such as oral, injectable, or implantable
contraceptives, or intrauterine contraceptive devices, or who are not using any other
method considered sufficiently reliable by the investigator in individual cases
(Female participants who are surgically sterilized / hysterectomized or
post-menopausal for longer than 2 years are not considered as being of child bearing
potential),

- Known or suspected non-compliance, drug or alcohol abuse,

- Participation in another study with investigational drug within the 30 days preceding
and during the present study
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Cigdem YILDIRIM GUCLU</last_name>
<role>Principal Investigator</role>
<affiliation>Ankara University</affiliation>
</overall_official>
<overall_contact>
<last_name>Cigdem YILDIRIM GUCLU</last_name>
<phone>+905324576648</phone>
<email>drcigdemyldrm@yahoo.com.tr</email>
</overall_contact>
<location>
<facility>
<name>Ankara University</name>
<address>
<city>Ankara</city>
<country>Turkey</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Cigdem YILDIRIM GUCLU</last_name>
</contact>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>February 28, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>March 31, 2022</last_update_submitted>
<last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 8, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>ERAS Turkey Association</investigator_affiliation>
<investigator_full_name>Prof. Serdar Gunaydin</investigator_full_name>
<investigator_title>Prof. Dr</investigator_title>
</responsible_party>
<keyword>Arthroplasty</keyword>
<keyword>patient blood management</keyword>
<keyword>anemia</keyword>
<keyword>İron deficiency</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Joint Diseases</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Transfusion practice for surgical patients has changed from replacing surgically lost blood
with allogeneic blood transfusions to implementing strategies that reduce transfusion
requirements. Patient Blood Management (PBM), which is "the timely application of
evidence-based medical and surgical concepts designed to maintain haemoglobin concentration,
optimize hemostasis and minimize blood loss in an effort to improve patient outcome. There is
mounting evidence that multimodal patient blood management (PBM) programmes can be effective
at improving postoperative outcomes and reducing perioperative blood transfusions and costs
The Turkish Society of Anaesthesiologists PBM Task Force has been working on this subject and
studied transfusion practice throughout all through the peri-operative periods. Unfortunately
we documented a high transfusion rate in major surgical patients in Turkey. One of the
surgeries, that has high transfusion rate, was orthopaedic surgery. According to our recent
data we planned to implement PBM in major orthopaedic surgical patients and evaluate the
effects PBM in transfusion rate and patient outcomes. While some elements of PBM have a
strong evidence base in hip or knee replacement, such as the use of tranexamic acid (TXA) the
evidence for preoperative anaemia optimisation with iron is less robust. Implementing PBM all
through the operative period gains more importance.
Active PBM Implementation: Patients undergoing hip or knee arthroplasty will be treated as
follows: PBM will be performed as shown in the graph below "PBM Implementation Group".
Active PBM group will be treated for preoperative anemia at least 3 weeks prior to the
surgical intervention as per the "Anemia Algorithm" below Other pillars of PBM will be also
performed to the treatment group as per the visual graph below. The parameters included in
the PBM pillars will be recorded including preoperative anemia parameters. Postoperative
variables and parameters related to complications will be recorded.
For the control group (Non-PBM group), the data of the patients, will be prospectively
included.
The 1:1 ratio of the control and active groups will be done.
Patients undergoing arthroplasty with anemia
Inclusion Criteria:
In order to be eligible to participate in this trial, an individual must meet all of the
following criteria:
- Signed patient informed consent
- Male or female patient at least 18 years old
- Patients scheduled for an elective major orthopaedic surgery (hip arthroplasty, knee
arthroplasty, primary and revision operations)
- Patients with confirmed iron deficiency anemia (IDA), defined as Hb 100-130 g/L, and
serum ferritin < 100 ng/ml or TSAT < 20%.
Patients with iron deficiency anemia will be taken into surgery at least 3 weeks after the
treatment.
Exclusion Criteria:
- Patients that undergo emergency surgical procedure and trauma cases are excluded from
the study.
- Patients with non-iron deficiency anaemia (thalassemia, sickle cell anaemia and etc.)
- Patients with renal anaemia (Hb < 130 g/L and CCL < 50 mL/min, irrespective of iron
parameters) or any diagnosis that require EPO will be excluded
- Patients with known anaphylactic/hypersensitivity reactions to parenteral iron
products.
- Patients with iron overload or disturbances in utilization of iron (e.g.
haemochromatosis, hemosiderosis)
- Patients with ≥3 times increase in aspartate aminotransferase or alanine
aminotransferase as per reference range.
- Patients with excessive blood loss requiring massive transfusion (≥ 10 more red blood
cell units)
- Patients with known myelodysplastic syndromes.
- Patients with chronic kidney disease with an estimated GFR < 30 ml/min or with
end-stage renal disease requiring scheduled dialysis.
- Patients with known urinary tract infections with urea-splitting bacteria
- Any patient judged to lack the ability to give informed consent or perform the trial
assessments (e.g. due to dementia)
- Women who are pregnant or breast feeding
- Intention to become pregnant during the course of the study,
- Lack of safe contraception, defined as: Female participants of childbearing potential,
not using and not willing to continue using a medically reliable method of
contraception for the entire study duration, such as oral, injectable, or implantable
contraceptives, or intrauterine contraceptive devices, or who are not using any other
method considered sufficiently reliable by the investigator in individual cases
(Female participants who are surgically sterilized / hysterectomized or
post-menopausal for longer than 2 years are not considered as being of child bearing
potential),
- Known or suspected non-compliance, drug or alcohol abuse,
- Participation in another study with investigational drug within the 30 days preceding
and during the present study
|
NCT0531xxxx/NCT05319236.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319236</url>
</required_header>
<id_info>
<org_study_id>R-DND-11 BRIDGE Study_CIP</org_study_id>
<nct_id>NCT05319236</nct_id>
</id_info>
<brief_title>Clinical Use Cases Assessment of the Gabi System in Young Children With Underlying Medical Conditions (BRIDGE Study)</brief_title>
<acronym>BRIDGE</acronym>
<official_title>A Prospective, Multicentric Interventional Study Assessing the Range of Most Clinically Relevant Indications for Use of the Non-invasive Wireless Gabi System for the Recording, in Non-motion Condition, of SpO2, Pulse Rate, Respiratory Rate and Movements of Young Children With Underlying Medical Conditions.</official_title>
<sponsors>
<lead_sponsor>
<agency>Gabi SmartCare</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Gabi SmartCare</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
<is_us_export>No</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
Subjects will use the Gabi system on a daily basis for 3 months, each time the subject is
resting or asleep. The Gabi system will recording the SpO2, pulse rate, respiratory rate and
movements of the subject.

The objective of this study is to perform a first assessment of the range of most potentially
clinically relevant indications for use of the Gabi system for children < 6 years old with
underlying medical conditions.

This is performed by asking HCPs to review the data measured by the Gabi system after taking
a medical decision independently from the Gabi data and to assess the potential clinical
utility of the Gabi system.

The usability of the system will also be assessed throughout questionnaires filled out by the
HCPs and by the caregivers.

*During this study, the data collected by the Gabi system are not intended to be used by
caregivers or HCPs to take any (medical) decisions.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">February 16, 2022</start_date>
<completion_date type="Actual">June 30, 2023</completion_date>
<primary_completion_date type="Actual">November 30, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Other</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Clinical Utility</measure>
<time_frame>Assessed at the end of the 3-month period for each participant</time_frame>
<description>Define the range of most potentially clinically significant indications for use of the Gabi system based on the Gabi system clinical utility assessment per medical condition, assessed throughout Medical Decision Questionnaires and Clinical Utility Questionnaires.</description>
</primary_outcome>
<primary_outcome>
<measure>Caregiver Usability</measure>
<time_frame>Assessed at the end of the 3-month period for each participant</time_frame>
<description>Assess the usability of the Gabi system from the point of view of the caregivers through a Usability Questionnaire.</description>
</primary_outcome>
<primary_outcome>
<measure>HCP Usability</measure>
<time_frame>Assessed at the end of the 3-month period for each participant</time_frame>
<description>Assess the usability of the Gabi system from the point of view of the HCPs through a Usability Questionnaire.</description>
</primary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">101</enrollment>
<condition>Cardiac Disease</condition>
<condition>Respiratory Disease</condition>
<condition>Congenital Cardiac Defect</condition>
<condition>Cardiovascular Diseases</condition>
<condition>Chronic Respiratory Disease</condition>
<condition>Chronic Cardiopulmonary Disease</condition>
<condition>Premature Infant Disease</condition>
<arm_group>
<arm_group_label>Gabi System</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>Subjects will wear the Gabi system each time they go to sleep or are resting, to measure and record their SpO2, pulse rate, respiratory rate and movements.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Gabi System</intervention_name>
<description>See arm description</description>
<arm_group_label>Gabi System</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Infants and children < 6 years old.

2. Subjects who present at least one of the following underlying medical conditions:

1. Subjects who underwent a congenital cardiac or cardiopulmonary surgery recently
and could benefit from an additional post-surgery monitoring at home, per the
investigator's opinion.

2. Subjects at risk awaiting surgery.

3. Subjects hospitalized following a severe respiratory condition within the past 2
weeks requiring invasive or non-invasive ventilation or oxygen therapy.

4. Subjects hospitalized following a severe cardiovascular condition within the past
2 weeks, including severe heart failure, tachycardia or bradycardia.

5. Subjects with chronic respiratory disease, such as asthma, developmental or
cardiovascular conditions who could benefit from medical monitoring at home, per
the investigator's opinion.

6. Subjects with chronic respiratory support at home.

7. Premature babies who required intensive neonatal care.

8. Subjects hospitalized following a Brief Resolved Unexpected Event (BRUE) within
the past 2 weeks.

9. A clinical risk identified by the investigator which justifies the potential
benefit of having a Gabi system used by the subject

3. Subject is (or is willing to be) followed up by an HCP of the investigation site
during the duration of the study.

4. Signed informed consent form prior to performing any study specific procedure.

5. Willing and likely (based on the investigator's judgement) to comply with all study
requirements.

Exclusion Criteria:

1. Weight < 2.5 kg.

2. Subject presenting an anatomical limitation that would prevent the use of the Gabi
system.

3. Subjects presenting a motor disorder that would prevent the use of the Gabi system
(with the exception of epilepsy ).

4. Subjects participating in another interventional clinical study (with the exception of
registries), which may have an impact on this study outcomes, based on the
investigator's judgement.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>5 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Children's National Hospital</name>
<address>
<city>Washington</city>
<state>District of Columbia</state>
<zip>20010</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Columbia University Irving Medical Center</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10032</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Universitair Ziekenhuis Antwerpen (UZA)</name>
<address>
<city>Antwerp</city>
<zip>2610</zip>
<country>Belgium</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Clinique CHC Montlégia</name>
<address>
<city>Liège</city>
<country>Belgium</country>
</address>
</facility>
</location>
<location_countries>
<country>Belgium</country>
<country>United States</country>
</location_countries>
<verification_date>February 2023</verification_date>
<study_first_submitted>March 22, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>September 11, 2023</last_update_submitted>
<last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">September 13, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Respiratory Tract Diseases</mesh_term>
<mesh_term>Respiration Disorders</mesh_term>
<mesh_term>Cardiovascular Diseases</mesh_term>
<mesh_term>Heart Diseases</mesh_term>
<mesh_term>Pulmonary Heart Disease</mesh_term>
<mesh_term>Heart Defects, Congenital</mesh_term>
<mesh_term>Infant, Premature, Diseases</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Subjects will use the Gabi system on a daily basis for 3 months, each time the subject is
resting or asleep. The Gabi system will recording the SpO2, pulse rate, respiratory rate and
movements of the subject.
The objective of this study is to perform a first assessment of the range of most potentially
clinically relevant indications for use of the Gabi system for children < 6 years old with
underlying medical conditions.
This is performed by asking HCPs to review the data measured by the Gabi system after taking
a medical decision independently from the Gabi data and to assess the potential clinical
utility of the Gabi system.
The usability of the system will also be assessed throughout questionnaires filled out by the
HCPs and by the caregivers.
*During this study, the data collected by the Gabi system are not intended to be used by
caregivers or HCPs to take any (medical) decisions.
Inclusion Criteria:
1. Infants and children < 6 years old.
2. Subjects who present at least one of the following underlying medical conditions:
1. Subjects who underwent a congenital cardiac or cardiopulmonary surgery recently
and could benefit from an additional post-surgery monitoring at home, per the
investigator's opinion.
2. Subjects at risk awaiting surgery.
3. Subjects hospitalized following a severe respiratory condition within the past 2
weeks requiring invasive or non-invasive ventilation or oxygen therapy.
4. Subjects hospitalized following a severe cardiovascular condition within the past
2 weeks, including severe heart failure, tachycardia or bradycardia.
5. Subjects with chronic respiratory disease, such as asthma, developmental or
cardiovascular conditions who could benefit from medical monitoring at home, per
the investigator's opinion.
6. Subjects with chronic respiratory support at home.
7. Premature babies who required intensive neonatal care.
8. Subjects hospitalized following a Brief Resolved Unexpected Event (BRUE) within
the past 2 weeks.
9. A clinical risk identified by the investigator which justifies the potential
benefit of having a Gabi system used by the subject
3. Subject is (or is willing to be) followed up by an HCP of the investigation site
during the duration of the study.
4. Signed informed consent form prior to performing any study specific procedure.
5. Willing and likely (based on the investigator's judgement) to comply with all study
requirements.
Exclusion Criteria:
1. Weight < 2.5 kg.
2. Subject presenting an anatomical limitation that would prevent the use of the Gabi
system.
3. Subjects presenting a motor disorder that would prevent the use of the Gabi system
(with the exception of epilepsy ).
4. Subjects participating in another interventional clinical study (with the exception of
registries), which may have an impact on this study outcomes, based on the
investigator's judgement.
|
NCT0531xxxx/NCT05319249.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319249</url>
</required_header>
<id_info>
<org_study_id>NAKIP_01_2022</org_study_id>
<nct_id>NCT05319249</nct_id>
</id_info>
<brief_title>Natural Killer Cell Immunotherapy in Combination With PARP-inhibition in Acute Myeloid Leukemia</brief_title>
<acronym>NAKIP-AML</acronym>
<official_title>Natural Killer Cell Immunotherapy in Combination With PARP-inhibition to Overcome NKG2D Mediated Immune Evasion in Acute Myeloid Leukemia</official_title>
<sponsors>
<lead_sponsor>
<agency>German Cancer Research Center</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>German Cancer Research Center</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Therapy resistance remains the major obstacle to cure in many types of cancer. In particular
in leukemia, therapy resistance depends on leukemic stem cells (LSC) that exhibit inherent
therapy resistance to multiple drugs and contribute to overt leukemic relapse. Cellular
therapies alone or in combination with other targeted or chemotherapeutic approaches can
overcome drug mediated therapy resistance and induce long lasting remissions. Several trials
have shown that adoptive transfer of allogeneic NK cells can induce clinical remission in
patients with myeloid malignancies. In addition, the antileukemic efficacy of alloreactive NK
cells has been shown to facilitate cure after T cell depleted haploidentical stem cell
transplantation. Recently, it was demonstrated that absence of NKGD2 ligand expression on
leukemic stem cells determines therapy resistance and immune escape towards NK cells in AML.
PARP1 inhibitors can induce re-expression of NKG2D ligands. This phase I/II clinical trial
will evaluate the combination of NK cell therapy and PARP inhibition by Talazoparib in
patients with poor prognosis AML as characterized by Minimal Residual Disease (MRD) or overt
relapse with less than 20% bone marrow blasts. The hypothesis that allogeneic NK cell therapy
combined with PARP inhibition will increase the response rate (CR/CRi for relapsed/
refractory patients and MRD-response for MRD positive patients) from 35% to 60% will be
tested. The co-primary endpoints are i) response to treatment defined as complete remission
(CR) for patients with overt leukemia at time of inclusion and MRD decrease >1log10 for
patients with rising MRD at time of inclusion as well as ii) safety and feasibility of the
protocol. Key secondary endpoints are event free survival and overall survival. Two cohorts
will be assessed independently: patients with i) overt leukemia and ii) patients with rising
MRD at time of inclusion. Safety and feasibility will be analyzed continuously during the
entire trial. The NAKIP-AML trial will analyze efficacy and feasibility of NK cell
transplantation together with PARP1 inhibition.
</textblock>
</brief_summary>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">June 2023</start_date>
<completion_date type="Anticipated">June 2027</completion_date>
<primary_completion_date type="Anticipated">June 2027</primary_completion_date>
<phase>Phase 1/Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>complete remission (CR/CRi)</measure>
<time_frame>Collected at a minimum at baseline, day 28 and latest on day 42</time_frame>
<description>response defined as complete remission (CR/CRi) for patients with overt leukemia at time of inclusion and MRD decrease >1log10 for patients with rising MRD at time of inclusion.</description>
</primary_outcome>
<secondary_outcome>
<measure>EFS - Event-free survival</measure>
<time_frame>EFS is defined as the time of entry into the study to the date of primary refractory disease, or relapse from CR, or CRi, or death from any cause, whichever comes first, assessed up to 42 days.</time_frame>
<description>Event-free survival</description>
</secondary_outcome>
<secondary_outcome>
<measure>RFS -Relapse-free survival</measure>
<time_frame>Defined as the time from achieving a remission until the date of relapse or death from any cause, whichever comes first, assessed up to 42 days.</time_frame>
<description>RFS is defined only for patients achieving CR or CRi</description>
</secondary_outcome>
<secondary_outcome>
<measure>OS - Overall survival</measure>
<time_frame>OS is defined as the time from entry into the trial to the date of death from any cause, assessed up to 42 days.</time_frame>
<description>Overall survival</description>
</secondary_outcome>
<secondary_outcome>
<measure>MRD</measure>
<time_frame>Collected at a minimum at baseline, day 28 and latest on day 42</time_frame>
<description>Measurable Residual Disease</description>
</secondary_outcome>
<secondary_outcome>
<measure>QoL - Quality of life - QLQ-C30</measure>
<time_frame>QoL is assessed at baseline and latest on day 42.</time_frame>
<description>Validated 30-item self-assessment questionnaire to assess quality of life aspects. The items are rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much) with higher scores meaning a higher level of fatigue.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">54</enrollment>
<condition>Acute Myeloid Leukemia</condition>
<arm_group>
<arm_group_label>NK cells combined with PARP inhibition</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Combination of NK cell therapy and PARP inhibition by Talazoparib after immunosuppression with cyclophosphamide and fludarabine</description>
</arm_group>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>NK cells</intervention_name>
<description>NK cells will be given as a single intravenous infusion.</description>
<arm_group_label>NK cells combined with PARP inhibition</arm_group_label>
<other_name>Haploidentical human allogeneic NK cells</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Talazoparib 1 MG [Talzenna]</intervention_name>
<description>Subjects will receive treatment with Talazoparib capsules 1 mg/day (4 days) with subsequent intravenous NK cell infusion.</description>
<arm_group_label>NK cells combined with PARP inhibition</arm_group_label>
<other_name>Talzenna</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Patients with confirmed diagnosis of AML according to WHO-2016 (Arber, Orazi et al.
2016) (except acute promyelocytic leukemia) with either de novo AML, AML after
preceding myelodysplastic or myeloproliferative syndrome (MDS/MPD), and therapy-
related AML (t-AML) after previous cytotoxic therapy or radiation are eligible.

A) Relapsed or Refractory AML with less than 20% bone marrow blasts and less than 20%
blasts in peripheral blood.

B) Rising MRD levels (>3 fold) as detected by either molecular genetics or flow
cytometry in patients still in hematologic remission.

2. Patients who received at least one line of AML therapy. This is defined as either stem
cell transplantation or intensive AML therapy or palliative AML therapy containing at
least one of the following drugs Azacitidine, Decitabine, Cytarabine, Venetoclax or an
FLT3 inhibitor..

3. Discontinuation of prior AML treatment before the start of study treatment for at
least 107 days for cytotoxic agents and ≥ 53 half-lives for non-cytotoxic /
investigational drug treatment preceding the first dose of trial medications.

4. Age ≥ 18 years

5. ECOG ≤2

6. Pregnancy and childbearing potential:

- Non-pregnant and non-nursing women of childbearing potential must have a negative
serum or urine ß-HCG pregnancy test within a sensitivity of at least 25 mIU/mL
within 72 hours prior to registration. ("Women of childbearing potential" is
defined as a sexually active mature woman who has not undergone a hysterectomy or
who has had menses at any time in the preceding 24 consecutive months).

- Female patients of reproductive age must agree to avoid getting pregnant while on
therapy.

- Women of child-bearing potential must either commit to continued abstinence from
heterosexual intercourse or begin highly effective methods (referring to
recommendation of the CTFG) of birth control during study and at least 6 months
(women), after end of treatment.

- Men must use a latex condom during any sexual contact with women of childbearing
potential, even if they have undergone a successful vasectomy and must agree to
avoid to father a child during study and until 6 months after end of treatment.

7. Willingness of patients to adhere to protocol specific requirements and capacity to
give written informed consent

8. Ability of patient to understand the character and individual consequences of clinical
trial

9. Following receipt of verbal and written information about the study, the patient must
provide signed informed consent before any study related activity is carried out.

10. Suitable donor for NK cell transplantation

Exclusion Criteria:

Patients presenting with any of the following criteria will not be included in the trial:

1. Acute promyelocytic leukemia (AML M3)

2. AML in which less than 10% of the blasts express the CD34 surface marker expression as
analyzed at the local laboratory.

3. Known central nervous system manifestation of AML

4. Uncontrolled or significant cardiovascular disease, including any of the following:

- Heart failure NYHA class 3 or 4

- Left ventricular ejection fraction (LVEF) ≤ 40% by echocardiogram ECHO)

- History of uncontrolled angina pectoris or myocardial infarction within 12 months
prior to screening

- History of second (Mobitz II) or third-degree heart block or any cardiac
arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are
permitted)

5. Pregnant or nursing women

6. Chronically impaired renal function (creatinine clearance < 30 ml / min)

7. Organ dysfunction (e.g. liver, kidney, lung, heart) which in the opinion of the
treating physician decreases life expectancy to less than three months.

8. Kidney failure with a calculated glomerular filtration rate <30 ml/min or bilirubin
>2-fold the upper reference limit of the local laboratory.

9. HIV infection and/or active hepatitis B or C infection (active hepatitis B defined by
HBs Ag positivity, anti HBs positivity or anti-HBC positivity, active hepatitis C
defined by positive virus load).

10. Evidence or history of severe non-leukemia associated bleeding diathesis or
coagulopathy

11. Uncontrolled active infection

12. Concurrent malignancies other than AML with an estimated life expectancy of less than
two years

13. Known hypersensitivity to PARP inhibitors

14. Isolated extramedullary manifestation of AML

15. Patients < 100 days after allogeneic stem cell transplantation at the time of
screening

16. Expected non-compliance of patient
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Carsten Müller-Tidow, Prof. Dr.</last_name>
<phone>+49622156</phone>
<phone_ext>8001</phone_ext>
<email>carsten.mueller-tidow@med.uni-heidelberg.de</email>
</overall_contact>
<overall_contact_backup>
<last_name>Richard F. Schlenk, Prof.Dr.</last_name>
<phone>+49622156</phone>
<phone_ext>6228</phone_ext>
<email>richard.schlenk@nct-heidelberg.de</email>
</overall_contact_backup>
<verification_date>January 2023</verification_date>
<study_first_submitted>March 21, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>January 9, 2023</last_update_submitted>
<last_update_submitted_qc>January 9, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">January 10, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Leukemia</mesh_term>
<mesh_term>Leukemia, Myeloid</mesh_term>
<mesh_term>Leukemia, Myeloid, Acute</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Talazoparib</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Therapy resistance remains the major obstacle to cure in many types of cancer. In particular
in leukemia, therapy resistance depends on leukemic stem cells (LSC) that exhibit inherent
therapy resistance to multiple drugs and contribute to overt leukemic relapse. Cellular
therapies alone or in combination with other targeted or chemotherapeutic approaches can
overcome drug mediated therapy resistance and induce long lasting remissions. Several trials
have shown that adoptive transfer of allogeneic NK cells can induce clinical remission in
patients with myeloid malignancies. In addition, the antileukemic efficacy of alloreactive NK
cells has been shown to facilitate cure after T cell depleted haploidentical stem cell
transplantation. Recently, it was demonstrated that absence of NKGD2 ligand expression on
leukemic stem cells determines therapy resistance and immune escape towards NK cells in AML.
PARP1 inhibitors can induce re-expression of NKG2D ligands. This phase I/II clinical trial
will evaluate the combination of NK cell therapy and PARP inhibition by Talazoparib in
patients with poor prognosis AML as characterized by Minimal Residual Disease (MRD) or overt
relapse with less than 20% bone marrow blasts. The hypothesis that allogeneic NK cell therapy
combined with PARP inhibition will increase the response rate (CR/CRi for relapsed/
refractory patients and MRD-response for MRD positive patients) from 35% to 60% will be
tested. The co-primary endpoints are i) response to treatment defined as complete remission
(CR) for patients with overt leukemia at time of inclusion and MRD decrease >1log10 for
patients with rising MRD at time of inclusion as well as ii) safety and feasibility of the
protocol. Key secondary endpoints are event free survival and overall survival. Two cohorts
will be assessed independently: patients with i) overt leukemia and ii) patients with rising
MRD at time of inclusion. Safety and feasibility will be analyzed continuously during the
entire trial. The NAKIP-AML trial will analyze efficacy and feasibility of NK cell
transplantation together with PARP1 inhibition.
Inclusion Criteria:
1. Patients with confirmed diagnosis of AML according to WHO-2016 (Arber, Orazi et al.
2016) (except acute promyelocytic leukemia) with either de novo AML, AML after
preceding myelodysplastic or myeloproliferative syndrome (MDS/MPD), and therapy-
related AML (t-AML) after previous cytotoxic therapy or radiation are eligible.
A) Relapsed or Refractory AML with less than 20% bone marrow blasts and less than 20%
blasts in peripheral blood.
B) Rising MRD levels (>3 fold) as detected by either molecular genetics or flow
cytometry in patients still in hematologic remission.
2. Patients who received at least one line of AML therapy. This is defined as either stem
cell transplantation or intensive AML therapy or palliative AML therapy containing at
least one of the following drugs Azacitidine, Decitabine, Cytarabine, Venetoclax or an
FLT3 inhibitor..
3. Discontinuation of prior AML treatment before the start of study treatment for at
least 107 days for cytotoxic agents and ≥ 53 half-lives for non-cytotoxic /
investigational drug treatment preceding the first dose of trial medications.
4. Age ≥ 18 years
5. ECOG ≤2
6. Pregnancy and childbearing potential:
- Non-pregnant and non-nursing women of childbearing potential must have a negative
serum or urine ß-HCG pregnancy test within a sensitivity of at least 25 mIU/mL
within 72 hours prior to registration. ("Women of childbearing potential" is
defined as a sexually active mature woman who has not undergone a hysterectomy or
who has had menses at any time in the preceding 24 consecutive months).
- Female patients of reproductive age must agree to avoid getting pregnant while on
therapy.
- Women of child-bearing potential must either commit to continued abstinence from
heterosexual intercourse or begin highly effective methods (referring to
recommendation of the CTFG) of birth control during study and at least 6 months
(women), after end of treatment.
- Men must use a latex condom during any sexual contact with women of childbearing
potential, even if they have undergone a successful vasectomy and must agree to
avoid to father a child during study and until 6 months after end of treatment.
7. Willingness of patients to adhere to protocol specific requirements and capacity to
give written informed consent
8. Ability of patient to understand the character and individual consequences of clinical
trial
9. Following receipt of verbal and written information about the study, the patient must
provide signed informed consent before any study related activity is carried out.
10. Suitable donor for NK cell transplantation
Exclusion Criteria:
Patients presenting with any of the following criteria will not be included in the trial:
1. Acute promyelocytic leukemia (AML M3)
2. AML in which less than 10% of the blasts express the CD34 surface marker expression as
analyzed at the local laboratory.
3. Known central nervous system manifestation of AML
4. Uncontrolled or significant cardiovascular disease, including any of the following:
- Heart failure NYHA class 3 or 4
- Left ventricular ejection fraction (LVEF) ≤ 40% by echocardiogram ECHO)
- History of uncontrolled angina pectoris or myocardial infarction within 12 months
prior to screening
- History of second (Mobitz II) or third-degree heart block or any cardiac
arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are
permitted)
5. Pregnant or nursing women
6. Chronically impaired renal function (creatinine clearance < 30 ml / min)
7. Organ dysfunction (e.g. liver, kidney, lung, heart) which in the opinion of the
treating physician decreases life expectancy to less than three months.
8. Kidney failure with a calculated glomerular filtration rate <30 ml/min or bilirubin
>2-fold the upper reference limit of the local laboratory.
9. HIV infection and/or active hepatitis B or C infection (active hepatitis B defined by
HBs Ag positivity, anti HBs positivity or anti-HBC positivity, active hepatitis C
defined by positive virus load).
10. Evidence or history of severe non-leukemia associated bleeding diathesis or
coagulopathy
11. Uncontrolled active infection
12. Concurrent malignancies other than AML with an estimated life expectancy of less than
two years
13. Known hypersensitivity to PARP inhibitors
14. Isolated extramedullary manifestation of AML
15. Patients < 100 days after allogeneic stem cell transplantation at the time of
screening
16. Expected non-compliance of patient
|
NCT0531xxxx/NCT05319262.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319262</url>
</required_header>
<id_info>
<org_study_id>234826201</org_study_id>
<nct_id>NCT05319262</nct_id>
</id_info>
<brief_title>Metabolic and Cognitive Consequences of Noise-induced Sleep Disturbance</brief_title>
<official_title>Metabolic and Cognitive Consequences of Noise-induced Sleep Disturbance</official_title>
<sponsors>
<lead_sponsor>
<agency>Göteborg University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>University of Pennsylvania</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of Manitoba</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Göteborg University</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This study will investigate the biological mechanisms linking sleep disruption by noise and
the development of disease. In a laboratory sleep study, we will play traffic sounds of
different types (road, rail and air) and noise levels during the night. We will also have
nights with sound from so-called "white noise machines". These generate a low-level and
continuous noise that may improve sleep by "masking" the traffic noises that would otherwise
disturb sleep. We will also measure objective sleep quality and quantity, cognitive
performance across multiple domains, self-reported sleep and wellbeing outcomes, and blood
samples. Blood samples will be analysed to identify metabolic changes in different nights.
Identifying biomarkers that are impacted by sleep fragmentation will establish the currently
unclear pathways by which chronic noise exposure at night can lead to the development of
diseases in the long term, especially cardiometabolic disorders.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The experimental sleep study has the overarching goal of deepening our understanding of
experimentally-induced disruption of sleep and changes in metabolic and cognitive function,
and to determine the efficacy of a potential non-pharmacological intervention to promote
sleep. To this end, the study will address the following independent aims:

Aim 1: Determine associations between novel physiologic markers of sleep and metabolic and
cognitive function. We will measure the sleep of healthy volunteers using novel and classical
indictors of sleep architecture. Each morning we will obtain blood samples for metabolomics
analysis and administer a neurocognitive test battery.

Aim 2: Determine the biological and neurobehavioral consequences of noise-disrupted sleep. We
will compare effects on sleep, metabolomics and cognitive function between quiet nights and
nights with traffic noise.

Aim 3: Evaluate the effects of continuous pink noise throughout the night. Sub-aim 1: To
determine if continuous noise (pink noise) per se improves or disturbs sleep, we will
investigate changes in novel and classical indictors of sleep architecture and disturbance
induced by pink noise relative to quiet baseline nights. Sub-aim 2: To determine if pink
noise reduces sleep disturbance by traffic noise, we will investigate changes in sleep
fragmentation and continuity, and cortical and autonomic arousal, from nights with both
traffic noise and pink noise compared to nights with traffic noise only.

The study will be conducted at in the University of Gothenburg sound environment laboratory
(SEL). The SEL is a high fidelity research laboratory equipped to simulate a typical
apartment, including three individually light-, sound- and vibration-isolated private
bedrooms. Ceiling mounted speakers in each room allow us to create a realistic acoustic
environment by transmitting sound exposures from the control room to each bedroom
individually.

This study has a prospective within-subjects cross-over design. Participants (N=12) will each
spend five consecutive nights in the SEL with a sleep opportunity between 23:00-07:00.
Daytime sleep will be prohibited, confirmed with measures of daytime activity via wrist
actigraphy monitors worn continuously throughout the study. Three subjects will take part
concurrently, in separate bedrooms. The first night is a habituation period to the study
protocol and for familiarisation with the test procedures. Study nights 2-5 are the
experimental nights and will be randomly assigned across participants using a Latin square
design to avoid first-order carryover effects. Each subject will be exposed to one night of
each of the following:

Quiet night: No noise will be played, serving as a control night to assess individual
baseline sleep, metabolic profile, and cognitive performance; Traffic noise night to
determine consequences of noise-disrupted sleep; Pink noise night: To determine impact of
continuous pink noise on sleep; Traffic + pink noise night: simultaneous traffic and pink
noise at the same sound pressure levels as in the traffic-only and pink noise-only nights, to
determine sleep-protecting effects of pink noise in the face of traffic noise.

Each night we will record physiologic sleep with polysomnography (PSG) and cardiac activity
with electrocardiography (ECG). Each study morning, subjects will provide a 2ml blood sample,
complete cognitive testing and answer questionnaires and will depart the SEL to follow their
normal daytime routine. They will return to the SEL at 20:00 each evening to prepare for
sleep measurements. Caffeine will be prohibited after 15:00 and alcohol will be prohibited at
all times. Because sound-induced auditory fatigue may be affected by noise exposure during
participant's normal routines,60 they will wear a noise dosimeter during the week of the
study to record their daytime noise exposure. Because extreme and/or variable dietary
behaviour can affect the metabolome/lipoprotein profile, participants will be given guidance
that they should eat a similar evening meal on each day of the laboratory study, confirmed
with a food diary, The actual meal itself can be different for different study participants,
because the study has a within-subjects design.

Sleep will be recorded with ambulatory polysomnography (PSG) and cardiac activity with
electrocardiography (ECG) and finger pulse photoplethysmogram. Data are recorded offline onto
the sleep recorder, and will be downloaded and checked every study morning to ensure data
quality. In addition to traditional sleep analysis performed by the research group at the
University of Gothenburg, raw PSG data will be used to calculate the Odds Ratio Project, a
novel metric of sleep depth and stability.

Each study morning subjects will provide a 2 ml blood sample for plasma metabolomics
analysis. To ensure reliable data, blood samples will be taken at the same time every day to
mitigate circadian effects, before eating or drinking anything except water, and each sample
will be handled in the same way i.e. centrifuged, aliquoted and stored in -80C freezers.
Subjects will eat the same food each study evening to mitigate within-subject dietary effects
on the blood metabolome.

Each morning, subjects will complete a computerised cognitive test battery taking
approximately 20 minutes, that includes 10 tests across a range of cognitive domains (motor
praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion
recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor
vigilance). Cognition data will be analysed to determine key measures of cognitive speed and
accuracy, adjusting for practice effects and the difficulty of the stimulus set.

Subjects will complete a battery of one-time validated questionnaires to measure their
general health (SF-36), chronotype, noise sensitivity, habitual sleep quality, environmental
sensitivity, and annoyance and sleep disturbance by noise. Subjects will also answer a
questionnaire each study evening and morning, involving questions on sleepiness (Karolinska
Sleepiness Scale), auditory fatigue, sleep disturbance by noise, and validated sleep and
disturbance questions.

Subjects will wear a noise dosimeter during the week of the study to record their daytime
noise exposure (sound pressure level only, no actual sound recordings).

Participants will wear a wrist actigraphy monitor continuously throughout the study period,
and also for the week before the study, to confirm habitual sleep-wake times and to measure
physical activity levels.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">April 24, 2022</start_date>
<completion_date type="Actual">June 3, 2022</completion_date>
<primary_completion_date type="Actual">June 3, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Crossover Assignment</intervention_model>
<intervention_model_description>All participants will be exposed to each of the different noise exposure conditions. Each study night is treated as a separate arm of the crossover study. The order of the noise exposure conditions will be be randomly assigned across participants using a Latin square design to avoid first-order carryover effects. Each subject will be exposed to one night of each of the following:
Quiet night: No noise will be played, serving as a control night to assess individual baseline sleep, metabolic profile, and cognitive performance; Traffic noise night to determine consequences of noise-disrupted sleep; Pink noise night: To determine impact of continuous pink noise on sleep; Traffic + pink noise night: simultaneous traffic and pink noise at the same sound pressure levels as in the traffic-only and pink noise-only nights, to determine sleep-protecting effects of pink noise in the face of traffic noise.</intervention_model_description>
<primary_purpose>Basic Science</primary_purpose>
<masking>Double (Participant, Outcomes Assessor)</masking>
<masking_description>Participants will be aware that in any given study night they can be exposed to traffic noise and/or pink noise. They will not be informed what noise condition will occur in any given night, but they can become unblinded to the exposure if they are awake, as they will hear the noise.
Study investigators responsible for analysing cognitive performance variables and physiological sleep data will be be blind to which noise interventions were introduced on which study nights.</masking_description>
</study_design_info>
<primary_outcome>
<measure>Metabolomics and lipids</measure>
<time_frame>On each of the five study mornings</time_frame>
<description>Concentrations of 41 metabolites, including amino acids, amines, alcohols, carboxylic acids, choline, keto acids, sugars, and sulfones. Lipoprotein profile, including concentrations of triglycerides, cholesterol, phospholipids, and apolipoproteins.</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline total sleep time</measure>
<time_frame>During the Control night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total sleep time during exposure to nocturnal traffic</measure>
<time_frame>During the traffic noise night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total sleep time during exposure to pink noise</measure>
<time_frame>During the pink noise night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total sleep time during exposure to traffic noise + pink noise</measure>
<time_frame>During the Traffic noise + pink noise night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total amount of baseline N1 sleep</measure>
<time_frame>During the Control night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total amount of baseline N2 sleep</measure>
<time_frame>During the Control night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total amount of baseline N3 sleep</measure>
<time_frame>During the Control night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total amount of baseline rapid eye movement (REM) sleep</measure>
<time_frame>During the Control night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total amount of N1 sleep during exposure to nocturnal traffic</measure>
<time_frame>During the traffic noise night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total amount of N2 sleep during exposure to nocturnal traffic</measure>
<time_frame>During the traffic noise night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total amount of N3 sleep during exposure to nocturnal traffic</measure>
<time_frame>During the traffic noise night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total amount of rapid eye movement (REM) sleep during exposure to nocturnal traffic</measure>
<time_frame>During the traffic noise night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total amount of N1 sleep during exposure to pink noise</measure>
<time_frame>During the pink noise night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total amount of N2 sleep during exposure to pink noise</measure>
<time_frame>During the pink noise night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total amount of N3 sleep during exposure to pink noise</measure>
<time_frame>During the pink noise night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total amount of rapid eye movement (REM) sleep during exposure to pink noise</measure>
<time_frame>During the pink noise night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total amount of N1 sleep during exposure to traffic noise + pink noise</measure>
<time_frame>During the Traffic noise + pink noise night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total amount of N2 sleep during exposure to traffic noise + pink noise</measure>
<time_frame>During the Traffic noise + pink noise night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total amount of N3 sleep during exposure to traffic noise + pink noise</measure>
<time_frame>During the Traffic noise + pink noise night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Total amount of rapid eye movement (REM) sleep during exposure to traffic noise + pink noise</measure>
<time_frame>During the Traffic noise + pink noise night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline wakefulness after sleep onset (WASO)</measure>
<time_frame>During the Control night</time_frame>
<description>Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Wakefulness after sleep onset (WASO) during exposure to nocturnal traffic</measure>
<time_frame>During the Traffic noise night</time_frame>
<description>Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Wakefulness after sleep onset (WASO) during exposure to pink noise</measure>
<time_frame>During the Pink noise night</time_frame>
<description>Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Wakefulness after sleep onset (WASO) during exposure to traffic noise + pink noise</measure>
<time_frame>During the Traffic noise + pink noise night</time_frame>
<description>Total number of minutes awake during the night after the first appearance of sleep of any stage. Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline number of awakenings</measure>
<time_frame>During the Control night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Number of awakenings during exposure to nocturnal traffic</measure>
<time_frame>During the Traffic noise night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Number of awakenings during exposure to pink noise</measure>
<time_frame>During the Pink noise night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Number of awakenings during exposure to traffic noise + pink noise</measure>
<time_frame>During the Traffic noise + pink noise night</time_frame>
<description>Measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline sleep onset latency (SOL)</measure>
<time_frame>During the Control night</time_frame>
<description>Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.</description>
</primary_outcome>
<primary_outcome>
<measure>Sleep onset latency (SOL) during exposure to nocturnal traffic</measure>
<time_frame>During the Traffic noise night</time_frame>
<description>Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.</description>
</primary_outcome>
<primary_outcome>
<measure>Sleep onset latency (SOL) during exposure to pink noise</measure>
<time_frame>During the Pink noise night</time_frame>
<description>Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.</description>
</primary_outcome>
<primary_outcome>
<measure>Sleep onset latency (SOL) during exposure to nocturnal traffic and pink noise</measure>
<time_frame>During the Traffic noise + Pink noise night</time_frame>
<description>Defined as the time from lights out to the first epoch of sleep measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline sleep efficiency</measure>
<time_frame>During the Control night</time_frame>
<description>Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.</description>
</primary_outcome>
<primary_outcome>
<measure>Sleep efficiency during exposure to nocturnal traffic</measure>
<time_frame>During the Traffic noise night</time_frame>
<description>Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.</description>
</primary_outcome>
<primary_outcome>
<measure>Sleep efficiency during exposure to pink noise</measure>
<time_frame>During the Pink noise night</time_frame>
<description>Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.</description>
</primary_outcome>
<primary_outcome>
<measure>Sleep efficiency during exposure to nocturnal traffic and pink noise</measure>
<time_frame>During the Traffic noise + pink noise night</time_frame>
<description>Defined as the percentage of time in bed spent in a non-wake sleep stage, measured via polysomnography/EEG, scored according to American Academy of Sleep Medicine guidelines.</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline sleep depth assessed using the odds ratio product (ORP)</measure>
<time_frame>During the Control night</time_frame>
<description>Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.</description>
</primary_outcome>
<primary_outcome>
<measure>Sleep depth assessed using the odds ratio product (ORP) during exposure to nocturnal traffic</measure>
<time_frame>During the Traffic noise night</time_frame>
<description>Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.</description>
</primary_outcome>
<primary_outcome>
<measure>Sleep depth assessed using the odds ratio product (ORP) during exposure to pink noise</measure>
<time_frame>During the Pink noise night</time_frame>
<description>Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.</description>
</primary_outcome>
<primary_outcome>
<measure>Sleep depth assessed using the odds ratio product (ORP) during exposure to traffic noise and pink noise</measure>
<time_frame>During the Traffic noise + pink noise night</time_frame>
<description>Average ORP over the full night, from 0 (never occurs during wake) to 2.5 (only occurs during wake). Derived via polysomnography/EEG measurements.</description>
</primary_outcome>
<primary_outcome>
<measure>Spontaneous maximal change of odds ratio product (ORP)</measure>
<time_frame>During the Control night</time_frame>
<description>Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over 120 sham noise events during the night.</description>
</primary_outcome>
<primary_outcome>
<measure>Maximal change of odds ratio product (ORP) during exposure to traffic noise events</measure>
<time_frame>During the Traffic noise night</time_frame>
<description>Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.</description>
</primary_outcome>
<primary_outcome>
<measure>Maximal change of odds ratio product (ORP) during exposure to traffic noise events</measure>
<time_frame>During the Traffic noise + pink noise night</time_frame>
<description>Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over all 120 noise events during the night.</description>
</primary_outcome>
<primary_outcome>
<measure>Spontaneous change of odds ratio product (ORP) during exposure to pink noise</measure>
<time_frame>During the Pink noise night</time_frame>
<description>Primary measure of acute sleep disruption by noise, calculated as the difference between the ORP in the 30s prior to noise onset and the maximum ORP during traffic noise. Averaged over 120 sham noise events during the night.</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline morning neurobehavioural speed</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)</description>
</primary_outcome>
<primary_outcome>
<measure>Morning neurobehavioural speed after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)</description>
</primary_outcome>
<primary_outcome>
<measure>Morning neurobehavioural speed after exposure to pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)</description>
</primary_outcome>
<primary_outcome>
<measure>Morning neurobehavioural speed after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline morning neurobehavioural accuracy</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)</description>
</primary_outcome>
<primary_outcome>
<measure>Morning neurobehavioural accuracy after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)</description>
</primary_outcome>
<primary_outcome>
<measure>Morning neurobehavioural accuracy after exposure to pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)</description>
</primary_outcome>
<primary_outcome>
<measure>Morning neurobehavioural accuracy after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Average of one key accuracy indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline evening neurobehavioural speed</measure>
<time_frame>In the evening of the day following the Control night</time_frame>
<description>Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)</description>
</primary_outcome>
<primary_outcome>
<measure>Evening neurobehavioural speed after exposure to nocturnal traffic</measure>
<time_frame>In the evening of the day following the Traffic noise night</time_frame>
<description>Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)</description>
</primary_outcome>
<primary_outcome>
<measure>Evening neurobehavioural speed after exposure to pink noise</measure>
<time_frame>In the evening of the day following the Pink noise night</time_frame>
<description>Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)</description>
</primary_outcome>
<primary_outcome>
<measure>Evening neurobehavioural speed after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the evening of the day following the Traffic noise + pink noise night</time_frame>
<description>Average of one key speed indicator from each of 10 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor vigilance)</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline evening neurobehavioural accuracy</measure>
<time_frame>In the evening of the day following the Control night</time_frame>
<description>Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)</description>
</primary_outcome>
<primary_outcome>
<measure>Evening neurobehavioural accuracy after exposure to nocturnal traffic</measure>
<time_frame>In the evening of the day following the Traffic noise night</time_frame>
<description>Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)</description>
</primary_outcome>
<primary_outcome>
<measure>Evening neurobehavioural accuracy after exposure to pink noise</measure>
<time_frame>In the evening of the day following the Pink noise night</time_frame>
<description>Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)</description>
</primary_outcome>
<primary_outcome>
<measure>Evening neurobehavioural accuracy after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the evening of the day following the Traffic noise + pink noise night</time_frame>
<description>Average of one key speed indicator from each of 9 cognitive tests (motor praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion recognition, matrix reasoning, digit symbol substitution, psychomotor vigilance)</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Ethanol concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Trimethylamine-N-oxide concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline 2-Aminobutyric acid concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Alanine concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Asparagine concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Creatine concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Creatinine concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Glutamic acid concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Glutamine concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Glycine concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Histidine concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Isoleucine concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Leucine concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Lysine concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Methionine concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline N,N-Dimethylglycine concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Ornithine concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Phenylalanine concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Proline concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Sarcosine concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Threonine concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Tyrosine concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Valine concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline 2-Hydroxybutyric acid concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Acetic acid concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Citric acid concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Formic acid concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Lactic acid concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Succinic acid concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Choline concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline 2-Oxoglutaric acid concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline 3-Hydroxybutyric acid concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Acetoacetic acid concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Acetone concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Pyruvic acid concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline D-Galactose concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Glucose concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Glycerol concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Baseline Dimethylsulfone concentration (mmol/L)</measure>
<time_frame>In the morning immediately after the Control night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Ethanol concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Trimethylamine-N-oxide concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>2-Aminobutyric acid concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Alanine concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Asparagine concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Creatine concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Creatinine concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Glutamic acid concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Glutamine concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Glycine concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Histidine concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Isoleucine concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Leucine concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Lysine concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Methionine concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>N,N-Dimethylglycine concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Ornithine concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Phenylalanine concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Proline concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Sarcosine concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Threonine concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Tyrosine concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Valine concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>2-Hydroxybutyric acid concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Acetic acid concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Citric acid concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Formic acid concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Lactic acid concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Succinic acid concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Choline concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>2-Oxoglutaric acid concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>3-Hydroxybutyric acid concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Acetoacetic acid concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Acetone concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Pyruvic acid concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>D-Galactose concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Glucose concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Glycerol concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Dimethylsulfone concentration (mmol/L) after exposure to nocturnal traffic</measure>
<time_frame>In the morning immediately after the Traffic noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Ethanol concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Trimethylamine-N-oxide concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>2-Aminobutyric acid concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Alanine concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Asparagine concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Creatine concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Creatinine concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Glutamic acid concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Glutamine concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Glycine concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Histidine concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Isoleucine concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Leucine concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Lysine concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Methionine concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>N,N-Dimethylglycine concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Ornithine concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Phenylalanine concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Proline concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Sarcosine concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Threonine concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Tyrosine concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Valine concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>2-Hydroxybutyric acid concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Acetic acid concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Citric acid concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Formic acid concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Lactic acid concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Succinic acid concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Choline concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>2-Oxoglutaric acid concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>3-Hydroxybutyric acid concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Acetoacetic acid concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Acetone concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Pyruvic acid concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>D-Galactose concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Glucose concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Glycerol concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Dimethylsulfone concentration (mmol/L) after exposure to nocturnal pink noise</measure>
<time_frame>In the morning immediately after the Pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Ethanol concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Trimethylamine-N-oxide concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>2-Aminobutyric acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Alanine concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Asparagine concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Creatine concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Creatinine concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Glutamic acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Glutamine concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Glycine concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Histidine concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Isoleucine concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Leucine concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Lysine concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Methionine concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>N,N-Dimethylglycine concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Ornithine concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Phenylalanine concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Proline concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Sarcosine concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Threonine concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Tyrosine concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Valine concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>2-Hydroxybutyric acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Acetic acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Citric acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Formic acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Lactic acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Succinic acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Choline concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>2-Oxoglutaric acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>3-Hydroxybutyric acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Acetoacetic acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Acetone concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Pyruvic acid concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>D-Galactose concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Glucose concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Glycerol concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<primary_outcome>
<measure>Dimethylsulfone concentration (mmol/L) after exposure to nocturnal traffic and pink noise</measure>
<time_frame>In the morning immediately after the Traffic noise + pink noise night</time_frame>
<description>Determined from NMR analysis of blood plasma</description>
</primary_outcome>
<secondary_outcome>
<measure>Cardiovascular activation in response to noise</measure>
<time_frame>Event-related, occurring within the time window of each discrete noise event, during each of the five study nights (23:00 to 07:00)</time_frame>
<description>Change in heart rate (ECG)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale</measure>
<time_frame>Every study evening</time_frame>
<description>The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale</measure>
<time_frame>Every study morning</time_frame>
<description>The scale is a 9-level verbal scale from 1 - "Extremely alert" (best outcome) to 9 - "Very sleepy. great effort to keep alert, fighting sleep" (worst outcome)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evening auditory fatigue</measure>
<time_frame>Every study evening</time_frame>
<description>Perceived auditory fatigue, self-reported on a 5-point verbal scale, from 1 - "Not at all" (best outcome) to 5 - "Extremely" (worst outcome)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Morning auditory fatigue</measure>
<time_frame>Every study morning</time_frame>
<description>Perceived auditory fatigue, self-reported on a 5-point verbal scale, from 1 - "Not at all" (best outcome) to 5 - "Extremely" (worst outcome)</description>
</secondary_outcome>
<number_of_arms>4</number_of_arms>
<enrollment type="Actual">12</enrollment>
<condition>Noise Exposure</condition>
<condition>Sleep Disturbance</condition>
<condition>Sleep Hygiene</condition>
<condition>Metabolic Disturbance</condition>
<condition>Cognitive Change</condition>
<arm_group>
<arm_group_label>Control</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>Single study night with no noise exposure, to determine normal baseline sleep</description>
</arm_group>
<arm_group>
<arm_group_label>Traffic noise</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Single study night with traffic noise events, to determine consequences of sleep disturbance by traffic noise</description>
</arm_group>
<arm_group>
<arm_group_label>Pink noise</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Single study night to measure the effects of a non-pharmacological intervention to promote sleep, pink noise.</description>
</arm_group>
<arm_group>
<arm_group_label>Traffic noise + pink noise</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Single study night with concurrent traffic noise events and continuous pink noise sound exposure. Night is used to determine attenuation of sleep disturbance by traffic noise due to introduction of pink noise.</description>
</arm_group>
<intervention>
<intervention_type>Radiation</intervention_type>
<intervention_name>Pink noise exposure</intervention_name>
<description>Continuous pink noise sound exposure at 45 dBA, throughout the whole night</description>
<arm_group_label>Pink noise</arm_group_label>
<arm_group_label>Traffic noise + pink noise</arm_group_label>
</intervention>
<intervention>
<intervention_type>Radiation</intervention_type>
<intervention_name>Traffic noise</intervention_name>
<description>120 traffic noise events (40 each of road, rail and aircraft), introduced at maximum sound pressure levels ranging between 45-65 dB LAS.max.</description>
<arm_group_label>Traffic noise</arm_group_label>
<arm_group_label>Traffic noise + pink noise</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1) live in or around the city of Gothenburg area (Sweden)

Exclusion Criteria:

1. aged <18 or >30 years;

2. habitual sleep and wake timings more than ±1 hour different from the study sleep times
(i.e. habitual sleep time should be 22:00-00:00 and habitual wake time should be
06:00-08:00);

3. BMI>25 kg/m2;

4. regular sleep medication use (prescribed or "over-the-counter");

5. poor hearing acuity (measured during screening via pure tone audiometry);

6. diagnosed with sleep disorders;

7. indications of sleep apnea on the STOP-BANG questionnaire;

8. shift work;

9. smoking, vaping, snus, or other nicotine use;

10. pre-existing use of "white noise machines" as a sleep aid.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>30 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Michael G Smith, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Göteborg University</affiliation>
</overall_official>
<location>
<facility>
<name>University of Gothenburg</name>
<address>
<city>Gothenburg</city>
<state>Västra Götaland</state>
<zip>42650</zip>
<country>Sweden</country>
</address>
</facility>
</location>
<location_countries>
<country>Sweden</country>
</location_countries>
<verification_date>June 2022</verification_date>
<study_first_submitted>March 9, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>June 16, 2022</last_update_submitted>
<last_update_submitted_qc>June 16, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">June 22, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>neurobehavioral performance</keyword>
<keyword>white noise</keyword>
<keyword>auditory fatigue</keyword>
<keyword>polysomnography</keyword>
<keyword>metabolomics</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Dyssomnias</mesh_term>
<mesh_term>Parasomnias</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This study will investigate the biological mechanisms linking sleep disruption by noise and
the development of disease. In a laboratory sleep study, we will play traffic sounds of
different types (road, rail and air) and noise levels during the night. We will also have
nights with sound from so-called "white noise machines". These generate a low-level and
continuous noise that may improve sleep by "masking" the traffic noises that would otherwise
disturb sleep. We will also measure objective sleep quality and quantity, cognitive
performance across multiple domains, self-reported sleep and wellbeing outcomes, and blood
samples. Blood samples will be analysed to identify metabolic changes in different nights.
Identifying biomarkers that are impacted by sleep fragmentation will establish the currently
unclear pathways by which chronic noise exposure at night can lead to the development of
diseases in the long term, especially cardiometabolic disorders.
The experimental sleep study has the overarching goal of deepening our understanding of
experimentally-induced disruption of sleep and changes in metabolic and cognitive function,
and to determine the efficacy of a potential non-pharmacological intervention to promote
sleep. To this end, the study will address the following independent aims:
Aim 1: Determine associations between novel physiologic markers of sleep and metabolic and
cognitive function. We will measure the sleep of healthy volunteers using novel and classical
indictors of sleep architecture. Each morning we will obtain blood samples for metabolomics
analysis and administer a neurocognitive test battery.
Aim 2: Determine the biological and neurobehavioral consequences of noise-disrupted sleep. We
will compare effects on sleep, metabolomics and cognitive function between quiet nights and
nights with traffic noise.
Aim 3: Evaluate the effects of continuous pink noise throughout the night. Sub-aim 1: To
determine if continuous noise (pink noise) per se improves or disturbs sleep, we will
investigate changes in novel and classical indictors of sleep architecture and disturbance
induced by pink noise relative to quiet baseline nights. Sub-aim 2: To determine if pink
noise reduces sleep disturbance by traffic noise, we will investigate changes in sleep
fragmentation and continuity, and cortical and autonomic arousal, from nights with both
traffic noise and pink noise compared to nights with traffic noise only.
The study will be conducted at in the University of Gothenburg sound environment laboratory
(SEL). The SEL is a high fidelity research laboratory equipped to simulate a typical
apartment, including three individually light-, sound- and vibration-isolated private
bedrooms. Ceiling mounted speakers in each room allow us to create a realistic acoustic
environment by transmitting sound exposures from the control room to each bedroom
individually.
This study has a prospective within-subjects cross-over design. Participants (N=12) will each
spend five consecutive nights in the SEL with a sleep opportunity between 23:00-07:00.
Daytime sleep will be prohibited, confirmed with measures of daytime activity via wrist
actigraphy monitors worn continuously throughout the study. Three subjects will take part
concurrently, in separate bedrooms. The first night is a habituation period to the study
protocol and for familiarisation with the test procedures. Study nights 2-5 are the
experimental nights and will be randomly assigned across participants using a Latin square
design to avoid first-order carryover effects. Each subject will be exposed to one night of
each of the following:
Quiet night: No noise will be played, serving as a control night to assess individual
baseline sleep, metabolic profile, and cognitive performance; Traffic noise night to
determine consequences of noise-disrupted sleep; Pink noise night: To determine impact of
continuous pink noise on sleep; Traffic + pink noise night: simultaneous traffic and pink
noise at the same sound pressure levels as in the traffic-only and pink noise-only nights, to
determine sleep-protecting effects of pink noise in the face of traffic noise.
Each night we will record physiologic sleep with polysomnography (PSG) and cardiac activity
with electrocardiography (ECG). Each study morning, subjects will provide a 2ml blood sample,
complete cognitive testing and answer questionnaires and will depart the SEL to follow their
normal daytime routine. They will return to the SEL at 20:00 each evening to prepare for
sleep measurements. Caffeine will be prohibited after 15:00 and alcohol will be prohibited at
all times. Because sound-induced auditory fatigue may be affected by noise exposure during
participant's normal routines,60 they will wear a noise dosimeter during the week of the
study to record their daytime noise exposure. Because extreme and/or variable dietary
behaviour can affect the metabolome/lipoprotein profile, participants will be given guidance
that they should eat a similar evening meal on each day of the laboratory study, confirmed
with a food diary, The actual meal itself can be different for different study participants,
because the study has a within-subjects design.
Sleep will be recorded with ambulatory polysomnography (PSG) and cardiac activity with
electrocardiography (ECG) and finger pulse photoplethysmogram. Data are recorded offline onto
the sleep recorder, and will be downloaded and checked every study morning to ensure data
quality. In addition to traditional sleep analysis performed by the research group at the
University of Gothenburg, raw PSG data will be used to calculate the Odds Ratio Project, a
novel metric of sleep depth and stability.
Each study morning subjects will provide a 2 ml blood sample for plasma metabolomics
analysis. To ensure reliable data, blood samples will be taken at the same time every day to
mitigate circadian effects, before eating or drinking anything except water, and each sample
will be handled in the same way i.e. centrifuged, aliquoted and stored in -80C freezers.
Subjects will eat the same food each study evening to mitigate within-subject dietary effects
on the blood metabolome.
Each morning, subjects will complete a computerised cognitive test battery taking
approximately 20 minutes, that includes 10 tests across a range of cognitive domains (motor
praxis, visual object learning, fractal 2-back, abstract matching, line orientation, emotion
recognition, matrix reasoning, digit symbol substitution, balloon analog risk, psychomotor
vigilance). Cognition data will be analysed to determine key measures of cognitive speed and
accuracy, adjusting for practice effects and the difficulty of the stimulus set.
Subjects will complete a battery of one-time validated questionnaires to measure their
general health (SF-36), chronotype, noise sensitivity, habitual sleep quality, environmental
sensitivity, and annoyance and sleep disturbance by noise. Subjects will also answer a
questionnaire each study evening and morning, involving questions on sleepiness (Karolinska
Sleepiness Scale), auditory fatigue, sleep disturbance by noise, and validated sleep and
disturbance questions.
Subjects will wear a noise dosimeter during the week of the study to record their daytime
noise exposure (sound pressure level only, no actual sound recordings).
Participants will wear a wrist actigraphy monitor continuously throughout the study period,
and also for the week before the study, to confirm habitual sleep-wake times and to measure
physical activity levels.
Inclusion Criteria:
1) live in or around the city of Gothenburg area (Sweden)
Exclusion Criteria:
1. aged <18 or >30 years;
2. habitual sleep and wake timings more than ±1 hour different from the study sleep times
(i.e. habitual sleep time should be 22:00-00:00 and habitual wake time should be
06:00-08:00);
3. BMI>25 kg/m2;
4. regular sleep medication use (prescribed or "over-the-counter");
5. poor hearing acuity (measured during screening via pure tone audiometry);
6. diagnosed with sleep disorders;
7. indications of sleep apnea on the STOP-BANG questionnaire;
8. shift work;
9. smoking, vaping, snus, or other nicotine use;
10. pre-existing use of "white noise machines" as a sleep aid.
|
NCT0531xxxx/NCT05319275.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319275</url>
</required_header>
<id_info>
<org_study_id>Heisco19-301</org_study_id>
<nct_id>NCT05319275</nct_id>
</id_info>
<brief_title>Study of Acetyllevocarnitine Hydrochloride Tablets in Chinese Patients With Paresthesias Caused by DPN</brief_title>
<official_title>A Multicentre, Randomised, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Acetyllevocarnitine Hydrochloride Tablets in Chinese Patients With Paresthesias Caused by Diabetic Peripheral Neuropathy</official_title>
<sponsors>
<lead_sponsor>
<agency>Haisco Pharmaceutical Group Co., Ltd.</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Haisco Pharmaceutical Group Co., Ltd.</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this study is to assess the efficacy of Acetyllevocarnitine Hydrochloride
Tablets compared with placebo after 24 weeks, in chinese patients with paresthesia caused by
Diabetic Peripheral Neuropathy (DPN).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This 24-week, multicentre, randomised, double-blind, placebo-controlled phase III study is to
assess the efficacy and safety of Acetyllevocarnitine Hydrochloride Tablets in Chinese
patients with paresthesia caused by DPN.The trial included a 2-week screening period, a
1-week placebo run-in period, a 24-week randomized treatment period, and a 2-week follow-up
period.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">July 23, 2020</start_date>
<completion_date type="Actual">January 25, 2022</completion_date>
<primary_completion_date type="Actual">December 7, 2021</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Participant, Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>mTCNS total score change from baseline at week 24</measure>
<time_frame>Baseline and week 24</time_frame>
<description>Changes in Modified Toronto Clinical Neuropathy Score (mTCNS) total score from baseline at Week 24. Maximum mTCNS is 33, minimum is 0. And higher points mean more serious condition. However, more points drop from baseline mean a better outcome.</description>
</primary_outcome>
<secondary_outcome>
<measure>mTCNS total score change from baseline at week 12</measure>
<time_frame>Baseline and week 12</time_frame>
<description>Changes in Modified Toronto Clinical Neuropathy Score (mTCNS) total score from baseline at Week 12. Maximum mTCNS is 33, minimum is 0. And higher points mean more serious condition. However, more points drop from baseline mean a better outcome.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in each item score of mTCNS from baseline at week 12 and week 24</measure>
<time_frame>Baseline, Weeks 12 and 24</time_frame>
<description>The mTCNS contains the 11 items that assess symptoms and signs, and each item maximum is 3 points, minimum is 0. And higher points mean more serious condition. However, more points drop from baseline mean a better outcome.</description>
</secondary_outcome>
<secondary_outcome>
<measure>TCNS total score change from baseline at week 12 and week 24</measure>
<time_frame>Baseline, Weeks 12 and 24</time_frame>
<description>Changes in Toronto Clinical Neuropathy Score (TCNS) total score from baseline at Week 12 and Week 24. Maximum TCNS is 19, minimum is 0. And higher points mean more serious condition. However, more points drop from baseline mean a better outcome.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Numeric Rating Scale (NRS) score change from baseline at week 24</measure>
<time_frame>Baseline and week 24</time_frame>
<description>Changes in Numeric Rating Scale (NRS) score from baseline at Week 24. Maximum NRS is 10, minimum is 0. And higher points mean more serious condition. However, more points drop from baseline mean a better outcome.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in Nerve Conduction Velocity (NCV) from baseline at week 24</measure>
<time_frame>Baseline and week 24</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in Nerve Conduction Amplitude from baseline at week 24</measure>
<time_frame>Baseline and week 24</time_frame>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">516</enrollment>
<condition>Diabetic Peripheral Neuropathy (DPN)</condition>
<condition>Paresthesia</condition>
<arm_group>
<arm_group_label>Acetyllevocarnitine Hydrochloride Tablets</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>Placebo</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Acetyllevocarnitine Hydrochloride Tablets</intervention_name>
<description>500 mg (2×250 mg/tablet) after meal, 3 times per day</description>
<arm_group_label>Acetyllevocarnitine Hydrochloride Tablets</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Placebo</intervention_name>
<description>500 mg (2×250 mg/tablet) after meal, 3 times per day</description>
<arm_group_label>Placebo</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Age ≥ 18 and ≤ 70 years, Male and female patients;

- Type 1 or 2 diabetes mellitus on hypoglycemic therapy for 3 months or more, and
clinical diagnosis of DPN;

- HbA1c < 9.0%;

- Toronto Clinical Neuropathy Score ≥ 6 at screening and baseline.

Exclusion Criteria:

- Peripheral neuropathy caused by other diseases;

- History of acute complications of diabetes within the past 6 months, such as diabetic
ketoacidosis, diabetic hyperosmolar hyperglycemia syndrome or lactic acidosis, etc.;

- Severe peripheral arterial disease; severe cardiopulmonary disease; or have a history
of myocardial infarction, cerebrovascular accident or transient ischemic attack within
6 months before enrollment; or uncontrolled asthma or shortness of breath 2 months
before enrollment; World Health Organization (WHO) cardiac function class III-IV;
systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg at screening;

- Any infection at the screening visit that is not suitable for study participation;

- Aspartate Transaminase (AST) or Alanine Transaminase (ALT) or total bilirubin or
creatinine > 2 times Upper Limit of Normal (ULN);

- Known allergy to L-carnitine ingredients;

- Severe systemic or psychiatric illness, history of epilepsy;

- History of malignancy or antitumor therapy;

- Severe bleeding disorder;

- Clinically significant abnormalities in thyroid function tests;

- Triglyceride >5.6 mmol/L;

- Change of 2 points or more in the same item in mTCNS;

- Nursing or pregnant women.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>70 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Lixin Guo</last_name>
<role>Study Chair</role>
<affiliation>Beijing Hospital</affiliation>
</overall_official>
<location>
<facility>
<name>Guangzhou First People's Hospital</name>
<address>
<city>Guangzhou</city>
<state>Guangdong</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Huizhou Central People's Hospital</name>
<address>
<city>Huizhou</city>
<state>Guangdong</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Affiliated Hospital of Zunyi Medical University</name>
<address>
<city>Zunyi</city>
<state>Guizhou</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Hainan Third People's Hospital</name>
<address>
<city>Sanya</city>
<state>Hainan</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Handan Central Hospital</name>
<address>
<city>Handan</city>
<state>Hebei</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Hebei Petro China Center Hospital</name>
<address>
<city>Langfang</city>
<state>Hebei</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The Fourth Affiliated Hospital of Harbin Medical University</name>
<address>
<city>Harbin</city>
<state>Heilongjiang</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Huaihe Hospital of Henan University</name>
<address>
<city>Kaifeng</city>
<state>Henan</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Kaifeng Traditional Chinese Medicine Hospital</name>
<address>
<city>Kaifeng</city>
<state>Henan</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Luoyang Third People's Hospital</name>
<address>
<city>Luoyang</city>
<state>Henan</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The First Affiliated Hospital of Henan University of Science and Technology</name>
<address>
<city>Luoyang</city>
<state>Henan</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Xinxiang First People's Hospital</name>
<address>
<city>Xinxiang</city>
<state>Henan</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Henan Provincial People's Hospital</name>
<address>
<city>Zhengzhou</city>
<state>Henan</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The Medical Group of Zhengzhou First People's Hospital</name>
<address>
<city>Zhengzhou</city>
<state>Henan</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The Second Affiliated Hospital of Zhengzhou University</name>
<address>
<city>Zhengzhou</city>
<state>Henan</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Taihe Hospital</name>
<address>
<city>Shiyan</city>
<state>Hubei</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Affiliated Hospital of Nantong University</name>
<address>
<city>Nantong</city>
<state>Jiangsu</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The Affiliated Hospital of Xuzhou Medical University</name>
<address>
<city>Xuzhou</city>
<state>Jiangsu</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Jiujiang Traditional Chinese Medicine Hospital</name>
<address>
<city>Jiujiang</city>
<state>Jiangxi</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The Fourth Affiliated Hospital of Nanchang University</name>
<address>
<city>Nanchang</city>
<state>Jiangxi</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Yichun People's Hospital</name>
<address>
<city>Yichun</city>
<state>Jiangxi</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Affiliated Hospital of Yanbian University</name>
<address>
<city>Yanbian</city>
<state>Jilin</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The First People's Hospital of Yinchuan</name>
<address>
<city>Yinchuan</city>
<state>Ningxia Hui Autonomous Region</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Binzhou Medical University Hospital</name>
<address>
<city>Binzhou</city>
<state>Shandong</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Qingdao Central Hospital</name>
<address>
<city>Qingdao</city>
<state>Shandong</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Weihai Central Hospital</name>
<address>
<city>Weihai</city>
<state>Shandong</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine</name>
<address>
<city>Hangzhou</city>
<state>Zhejiang</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The Second Affiliated Hospital of Wenzhou Medical University</name>
<address>
<city>Wenzhou</city>
<state>Zhejiang</state>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Beijing Hospital</name>
<address>
<city>Beijing</city>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Beijing Luhe Hospital, Capital Medical University</name>
<address>
<city>Beijing</city>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Beijing Pinggu Hospital</name>
<address>
<city>Beijing</city>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Chongqing People's Hospital</name>
<address>
<city>Chongqing</city>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Yongchuan Hospital of Chongqing Medical University</name>
<address>
<city>Chongqing</city>
<country>China</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Tianjin First Central Hospital</name>
<address>
<city>Tianjin</city>
<country>China</country>
</address>
</facility>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 22, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>March 31, 2022</last_update_submitted>
<last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 8, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Peripheral Nervous System Diseases</mesh_term>
<mesh_term>Diabetic Neuropathies</mesh_term>
<mesh_term>Paresthesia</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this study is to assess the efficacy of Acetyllevocarnitine Hydrochloride
Tablets compared with placebo after 24 weeks, in chinese patients with paresthesia caused by
Diabetic Peripheral Neuropathy (DPN).
This 24-week, multicentre, randomised, double-blind, placebo-controlled phase III study is to
assess the efficacy and safety of Acetyllevocarnitine Hydrochloride Tablets in Chinese
patients with paresthesia caused by DPN.The trial included a 2-week screening period, a
1-week placebo run-in period, a 24-week randomized treatment period, and a 2-week follow-up
period.
Inclusion Criteria:
- Age ≥ 18 and ≤ 70 years, Male and female patients;
- Type 1 or 2 diabetes mellitus on hypoglycemic therapy for 3 months or more, and
clinical diagnosis of DPN;
- HbA1c < 9.0%;
- Toronto Clinical Neuropathy Score ≥ 6 at screening and baseline.
Exclusion Criteria:
- Peripheral neuropathy caused by other diseases;
- History of acute complications of diabetes within the past 6 months, such as diabetic
ketoacidosis, diabetic hyperosmolar hyperglycemia syndrome or lactic acidosis, etc.;
- Severe peripheral arterial disease; severe cardiopulmonary disease; or have a history
of myocardial infarction, cerebrovascular accident or transient ischemic attack within
6 months before enrollment; or uncontrolled asthma or shortness of breath 2 months
before enrollment; World Health Organization (WHO) cardiac function class III-IV;
systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg at screening;
- Any infection at the screening visit that is not suitable for study participation;
- Aspartate Transaminase (AST) or Alanine Transaminase (ALT) or total bilirubin or
creatinine > 2 times Upper Limit of Normal (ULN);
- Known allergy to L-carnitine ingredients;
- Severe systemic or psychiatric illness, history of epilepsy;
- History of malignancy or antitumor therapy;
- Severe bleeding disorder;
- Clinically significant abnormalities in thyroid function tests;
- Triglyceride >5.6 mmol/L;
- Change of 2 points or more in the same item in mTCNS;
- Nursing or pregnant women.
|
NCT0531xxxx/NCT05319288.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319288</url>
</required_header>
<id_info>
<org_study_id>Acupuncture for ALBP</org_study_id>
<nct_id>NCT05319288</nct_id>
</id_info>
<brief_title>Treating ALBP With Acupuncture - Comparison of the Efficacy Between Distal Points and Local Points</brief_title>
<official_title>Treating Acute Low Back Pain With Acupuncture - Comparison of the Efficacy Between Distal Points and Local Points</official_title>
<sponsors>
<lead_sponsor>
<agency>Hong Kong Baptist University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Hong Kong Baptist University</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This study is a randomized controlled trial on acupuncture for Acute Low Back Pain(ALBP).
According to literature, using distal acupoints only to treat ALBP is mostly recognized, but
in our daily clinical practice, it is common to use local acupoints mainly combined with
distal acupoints. Which method leads to better effect is one important clinical question in
treating Low Back Pain(LBP) by acupuncture.

In this proposed study, the investigators aim to compare the efficacy of using "distal
acupoints only" and "local acupoints mainly combined with distal acupoints" on ALBP.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
It will be a randomized controlled trial on acupuncture for ALBP, conducted at the Pok Oi
Hospital - Hong Kong Baptist University Chinese Medicine Clinic cum Training and Research
Centre (Kowloon City District) (KCDCMCTR). Registered Chinese Medicine Practitioner(RCMP)
with at least two years of clinical experience and trained to treat participants in
accordance with study protocols. 102 (18-65 years in age) participants with ALBP will be
recruited from the public through advertisement and from the clinic (KCDCMCTR). Eligible
participants will be randomly assigned to two groups. The participants are randomly allocated
into two groups: distal acupoints only group(DPOG) and local acupoints mainly combined with
distal acupoints group(LPMG). The DPOG (n=51) will receive acupuncture of distal acupoints
only(SI3, EX-UE7). The LPMG (n=51) will receive acupuncture of local acupoints mainly(BL23,
BL25, BL32) combined with distal points(BL40). Participants will be treated twice a week for
a total of four weeks. Every participant will be administered 8 sessions of acupuncture. The
primary outcome will be the change in low back pain intensity(in VAS scores) before and after
the treatment. The secondary outcomes will be the Oswestry Disability Index. All outcomes
will be evaluated at every session of treatment and the follow up period. Follow-up will be
scheduled 1 month and 3 months after the completion of treatments. This clinical trial lasts
4 months.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">September 1, 2022</start_date>
<completion_date type="Anticipated">March 31, 2024</completion_date>
<primary_completion_date type="Anticipated">March 31, 2024</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Randomized controlled trial</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>low back pain intensity(in VAS scores)</measure>
<time_frame>before and four weeks after the treatment</time_frame>
<description>The primary outcome will be the change in low back pain intensity(in VAS scores) before and after the treatment.</description>
</primary_outcome>
<secondary_outcome>
<measure>Oswestry Disability Index</measure>
<time_frame>before and four weeks after the treatment</time_frame>
<description>The secondary outcomes will be the Oswestry Disability Index.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">102</enrollment>
<condition>Low Back Pain</condition>
<arm_group>
<arm_group_label>Distal acupoints only group</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>The DPOG (n=51) will receive acupuncture of distal acupoints only(SI3, EX-UE7) for ALBP.</description>
</arm_group>
<arm_group>
<arm_group_label>Local acupoints mainly combined with distal acupoints group</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>LPMG (n=51) will receive acupuncture of local acupoints mainly(BL23, BL25, BL32) combined with distal points(BL40) for ALBP.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Acupuncture</intervention_name>
<description>In DPOG, motion style acupuncture would be used; in LPMG, Traditional Chinese Medicine acupuncture is used.</description>
<arm_group_label>Distal acupoints only group</arm_group_label>
<arm_group_label>Local acupoints mainly combined with distal acupoints group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Low Back Pain as chief complaint: pain and discomfort, localized below the costal
margin and above the inferior gluteal folds, with or without leg pain;

- Participants' aged between 18 and 65 years old;

- Acute onset of symptom: lasting less than 6 weeks;

- Provided informed consent prior to the study.

Exclusion Criteria:

- Low back pain lasting more than 6 weeks;

- Alerting features (Red Flags) or serious conditions associated with acute low back
pain: Significant trauma, unexplained weight loss, past history of malignancy, fever,
age >65 years old, severe and unremitting night-time pain;

- Contraindication of acupuncture, including needle phobia, severe cutaneous condition,
excessive hunger/exhaustion/overeat, emotional instability, pregnancy(relative
contraindication) etc.;

- Received acupuncture treatment during the last month.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>65 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Zhong Lidan</name>
<address>
<city>Kowloon Tong</city>
<state>Kowloon</state>
<zip>637551</zip>
<country>Hong Kong</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Zhong Lidan, Ph.D, MD</last_name>
<phone>34116523</phone>
<email>ldzhong0305@gmail.com</email>
</contact>
</location>
<location_countries>
<country>Hong Kong</country>
</location_countries>
<verification_date>March 2023</verification_date>
<study_first_submitted>March 16, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>March 5, 2023</last_update_submitted>
<last_update_submitted_qc>March 5, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">March 7, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Hong Kong Baptist University</investigator_affiliation>
<investigator_full_name>Zhong Lidan</investigator_full_name>
<investigator_title>Assistant Professor</investigator_title>
</responsible_party>
<keyword>Acute</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Back Pain</mesh_term>
<mesh_term>Low Back Pain</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This study is a randomized controlled trial on acupuncture for Acute Low Back Pain(ALBP).
According to literature, using distal acupoints only to treat ALBP is mostly recognized, but
in our daily clinical practice, it is common to use local acupoints mainly combined with
distal acupoints. Which method leads to better effect is one important clinical question in
treating Low Back Pain(LBP) by acupuncture.
In this proposed study, the investigators aim to compare the efficacy of using "distal
acupoints only" and "local acupoints mainly combined with distal acupoints" on ALBP.
It will be a randomized controlled trial on acupuncture for ALBP, conducted at the Pok Oi
Hospital - Hong Kong Baptist University Chinese Medicine Clinic cum Training and Research
Centre (Kowloon City District) (KCDCMCTR). Registered Chinese Medicine Practitioner(RCMP)
with at least two years of clinical experience and trained to treat participants in
accordance with study protocols. 102 (18-65 years in age) participants with ALBP will be
recruited from the public through advertisement and from the clinic (KCDCMCTR). Eligible
participants will be randomly assigned to two groups. The participants are randomly allocated
into two groups: distal acupoints only group(DPOG) and local acupoints mainly combined with
distal acupoints group(LPMG). The DPOG (n=51) will receive acupuncture of distal acupoints
only(SI3, EX-UE7). The LPMG (n=51) will receive acupuncture of local acupoints mainly(BL23,
BL25, BL32) combined with distal points(BL40). Participants will be treated twice a week for
a total of four weeks. Every participant will be administered 8 sessions of acupuncture. The
primary outcome will be the change in low back pain intensity(in VAS scores) before and after
the treatment. The secondary outcomes will be the Oswestry Disability Index. All outcomes
will be evaluated at every session of treatment and the follow up period. Follow-up will be
scheduled 1 month and 3 months after the completion of treatments. This clinical trial lasts
4 months.
Inclusion Criteria:
- Low Back Pain as chief complaint: pain and discomfort, localized below the costal
margin and above the inferior gluteal folds, with or without leg pain;
- Participants' aged between 18 and 65 years old;
- Acute onset of symptom: lasting less than 6 weeks;
- Provided informed consent prior to the study.
Exclusion Criteria:
- Low back pain lasting more than 6 weeks;
- Alerting features (Red Flags) or serious conditions associated with acute low back
pain: Significant trauma, unexplained weight loss, past history of malignancy, fever,
age >65 years old, severe and unremitting night-time pain;
- Contraindication of acupuncture, including needle phobia, severe cutaneous condition,
excessive hunger/exhaustion/overeat, emotional instability, pregnancy(relative
contraindication) etc.;
- Received acupuncture treatment during the last month.
|
NCT0531xxxx/NCT05319301.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319301</url>
</required_header>
<id_info>
<org_study_id>IIBSP-OXI-2021-112</org_study_id>
<nct_id>NCT05319301</nct_id>
</id_info>
<brief_title>Identification and Clinical Relevance of an Oxytocin Deficient State (Melatonin Study)</brief_title>
<official_title>Identification and Clinical Relevance of an Oxytocin Deficient State Following Melatonin Administration in Patients With Hypopituitarism: a Proof-of-concept, Physiopathological Study With a Control Group</official_title>
<sponsors>
<lead_sponsor>
<agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Oxytocin (OT) is a hypothalamic peptide that enters the peripheral circulation via the
posterior pituitary gland. OT plays a key role in regulating appetite, psychopathology,
prosocial behavior and sexual function. Hypopituitarism is associated with increased obesity,
increased psychopathology, sexual and prosocial dysfunction despite appropriate hormone
replacement. A few studies suggest the existence of a possible OT deficient state in
hypopituitarism. In animal models, melatonin has shown to increase OT release.

This study is designed to evaluate oxytocin values after administration of melatonin in
adults (healthy volunteers and patients with hypopituitarism).

The investigators hypothesize that OT response will be blunted following melatonin in
patients with hypopituitarism compared to healthy controls.
</textblock>
</brief_summary>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">April 1, 2022</start_date>
<completion_date type="Anticipated">September 1, 2023</completion_date>
<primary_completion_date type="Anticipated">April 1, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Non-Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Diagnostic</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Change in oxytocin concentration</measure>
<time_frame>Baseline blood exam (timepoint 0) and further blood collections after 30, 60, 90 and 120 minutes after baseline blood collection</time_frame>
<description>Change in oxytocin concentration (pg/mL) after administration of 1.9 mg of melatonin orally.</description>
</primary_outcome>
<secondary_outcome>
<measure>Maximal change in oxytocin concentration (pg/mL)</measure>
<time_frame>Within the two hours after the injection</time_frame>
<description>Maximal change in oxytocin concentration (pg/mL) after administration of 1.9 mg of melatonin administered orally.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Overall oxytocin secretion</measure>
<time_frame>Within the two hours after the injection</time_frame>
<description>Oxytocin area under the curve after administration of 1.9 melatonin administered orally</description>
</secondary_outcome>
<secondary_outcome>
<measure>Mood assessment</measure>
<time_frame>At baseline</time_frame>
<description>Correlation between Beck Depression Inventory-2 score (range from 0 to 63, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Quality of life assessment</measure>
<time_frame>At baseline</time_frame>
<description>Correlation between 36 item- Short Form Health Survey score (range from 0 to 100, the higher scores indicate better health status) and baseline oxytocin concentration (pg/mL)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Impulsivity assessment</measure>
<time_frame>At baseline</time_frame>
<description>Correlation between Barratt Impulsiveness Scale (range from 30 to 120, higher scores indicate greater impulsivity) and baseline oxytocin concentration (pg/mL)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Alexithymia assessment</measure>
<time_frame>At baseline</time_frame>
<description>Correlation between Toronto Alexithymia scales-20 score (range from 20 to 100, higher scores mean a worse outcome) and baseline oxytocin concentration (pg/mL)</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">40</enrollment>
<condition>Oxytocin Deficiency</condition>
<condition>Hypopituitarism</condition>
<condition>Hypothalamic Obesity</condition>
<condition>Pituitary Dysfunction</condition>
<condition>Central Diabetes Insipidus</condition>
<condition>Social Isolation</condition>
<arm_group>
<arm_group_label>Patients with hypopituitarism</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>A single dose of melatonin administration</description>
</arm_group>
<arm_group>
<arm_group_label>Healthy controls</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>A single dose of melatonin administration</description>
</arm_group>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Melatonin</intervention_name>
<description>A single dose of melatonin (1.9 mg)</description>
<arm_group_label>Healthy controls</arm_group_label>
<arm_group_label>Patients with hypopituitarism</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Patients with hypopituitarism (HYPO) (>1 pituitary hormone deficiency) and stable
hormone replacement for the prior three months

- At least one clinical sign of hypothalamic damage

Exclusion Criteria:

- uncorrected hormone deficiency

- creatinine >1.5mg/dL

- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5x upper limit
of normal

- hematocrit less than 30%

- suicidality or active psychosis

- participation in a trial with investigational drugs within 30 days

- using a high glucocorticoid dose

- vigorous physical exercise

- alcohol intake within 24 hours before the study participation

- evidence of any acute illness or any illness that the Investigator determines could
interfere with study participation or safety

- pregnancy or breastfeeding for last 8 weeks

- known allergies towards melatonin

- patients refusing or unable to give written informed consent

- patients receiving fluvoxamine and/or impossibility to stop hypnotics 48 hours prior
to the study visit.

- Additionally for healthy controls: the presence of brain or pituitary tumor, radiation
involving the hypothalamus or pituitary, history of hypopituitarism or receiving
testosterone or glucocorticoids esters.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Anna Aulinas, MD PhD</last_name>
<phone>+34932919000</phone>
<phone_ext>7917</phone_ext>
<email>aaulinas@santpau.cat</email>
</overall_contact>
<overall_contact_backup>
<last_name>Claudia Delgado</last_name>
<phone>+34932919000</phone>
<phone_ext>7634</phone_ext>
<email>cdelgadoe@santpau.cat</email>
</overall_contact_backup>
<location>
<facility>
<name>Hospital de la Santa Creu i Sant Pau</name>
<address>
<city>Barcelona</city>
<zip>08041</zip>
<country>Spain</country>
</address>
</facility>
</location>
<location_countries>
<country>Spain</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 17, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>March 31, 2022</last_update_submitted>
<last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 8, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>oxytocin</keyword>
<keyword>melatonin</keyword>
<keyword>hypopituitarism</keyword>
<keyword>vasopresin deficiency</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Hypopituitarism</mesh_term>
<mesh_term>Diabetes Insipidus</mesh_term>
<mesh_term>Diabetes Insipidus, Neurogenic</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Melatonin</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Oxytocin (OT) is a hypothalamic peptide that enters the peripheral circulation via the
posterior pituitary gland. OT plays a key role in regulating appetite, psychopathology,
prosocial behavior and sexual function. Hypopituitarism is associated with increased obesity,
increased psychopathology, sexual and prosocial dysfunction despite appropriate hormone
replacement. A few studies suggest the existence of a possible OT deficient state in
hypopituitarism. In animal models, melatonin has shown to increase OT release.
This study is designed to evaluate oxytocin values after administration of melatonin in
adults (healthy volunteers and patients with hypopituitarism).
The investigators hypothesize that OT response will be blunted following melatonin in
patients with hypopituitarism compared to healthy controls.
Inclusion Criteria:
- Patients with hypopituitarism (HYPO) (>1 pituitary hormone deficiency) and stable
hormone replacement for the prior three months
- At least one clinical sign of hypothalamic damage
Exclusion Criteria:
- uncorrected hormone deficiency
- creatinine >1.5mg/dL
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5x upper limit
of normal
- hematocrit less than 30%
- suicidality or active psychosis
- participation in a trial with investigational drugs within 30 days
- using a high glucocorticoid dose
- vigorous physical exercise
- alcohol intake within 24 hours before the study participation
- evidence of any acute illness or any illness that the Investigator determines could
interfere with study participation or safety
- pregnancy or breastfeeding for last 8 weeks
- known allergies towards melatonin
- patients refusing or unable to give written informed consent
- patients receiving fluvoxamine and/or impossibility to stop hypnotics 48 hours prior
to the study visit.
- Additionally for healthy controls: the presence of brain or pituitary tumor, radiation
involving the hypothalamus or pituitary, history of hypopituitarism or receiving
testosterone or glucocorticoids esters.
|
NCT0531xxxx/NCT05319314.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319314</url>
</required_header>
<id_info>
<org_study_id>ICT-GCC19CART-US-001</org_study_id>
<nct_id>NCT05319314</nct_id>
</id_info>
<brief_title>GCC19CART for Patients With Metastatic Colorectal Cancer</brief_title>
<acronym>CARAPIA-1</acronym>
<official_title>A Phase 1 Multicenter Study Evaluating the Safety and Tolerability of GCC19CART for Subjects With Relapsed or Refractory Metastatic Colorectal Cancer</official_title>
<sponsors>
<lead_sponsor>
<agency>Innovative Cellular Therapeutics Inc.</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Innovative Cellular Therapeutics Inc.</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Study ICT-GCC19CART-US-001 (CARAPIA-1) is a Phase 1 study evaluating the safety,
tolerability, clinical activity, pharmacokinetics and pharmacodynamics of GCC19CART in
subjects with relapsed or refractory metastatic colorectal cancer.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">August 1, 2022</start_date>
<completion_date type="Anticipated">October 2024</completion_date>
<primary_completion_date type="Anticipated">October 2023</primary_completion_date>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Sequential Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Incidence of adverse events (AEs) defined as dose-limiting toxicities (DLTs) during 3+3 dose escalation study</measure>
<time_frame>Infusion (Day 0) up to Day 28</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Maximum tolerable dose (MTD) based on incidence of dose-limiting toxicities (DLTs) during 3+3 dose escalation study</measure>
<time_frame>Infusion (Day 0) up to Day 28</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Recommended Phase 2 dose (RP2D) based on incidence of dose-limiting toxicities (DLTs) during 3+3 dose escalation study</measure>
<time_frame>Infusion (Day 0) up to Day 28</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>Best overall response as measured by overall response rate based on the tumor size per Response Evaluation Criteria in Solid Tumors RECIST Version 1.1</measure>
<time_frame>Infusion (Day 0) up to approximately 12 months or until disease progression/recurrence</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Duration of Response (DOR)</measure>
<time_frame>Infusion (Day 0) up to approximately 12 months</time_frame>
<description>The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Progression Free Survival (PFS)</measure>
<time_frame>Day 30 (date of leukapheresis) up to approximately 13 months or until the earliest date of disease progression per RECIST 1.1, or death from any cause, whichever comes first.</time_frame>
<description>Progression free survival (PFS) time which is defined as time from date of leukapheresis until the earliest date of disease progression per RECIST 1.1, or death from any cause, whichever comes first.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Overall Survival (OS)</measure>
<time_frame>Day 30 (date of leukapheresis) up to approximately 13 months or until death from any cause</time_frame>
<description>Overall survival (OS) is defined as the time from the date of leukapheresis until death from any cause.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Copy number of Guanylate Cyclase C (GCC) by Quantitative Polymerase Chain Reaction (qPCR)</measure>
<time_frame>Infusion, Inpatient Monitoring and Post Treatment Period (Up to 12 months)</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Copy number of each individual CD19 by Quantitative Polymerase Chain Reaction (qPCR)</measure>
<time_frame>Infusion, Inpatient Monitoring and Post Treatment Period (Up to 12 months)</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Cytokine level in serum</measure>
<time_frame>Infusion (Day 0) up to 12 months post treatment</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>AUC0 - Tmax: The area under curve (AUC) from time zero to Tmax in peripheral blood (days x copies/μg)</measure>
<time_frame>Infusion (Day 0) up to 12 months post treatment</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>AUCTmax - 28d and/or AUCTmax - 84d: The area under curve (AUC) from time Tmax to day 28 and/or AUCTmax - 84d or other disease assessment days, in peripheral blood (days x copies/μg)</measure>
<time_frame>Infusion (Day 0) up to 12 months post treatment</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>AUC0 - 28d and/or AUC0 - 84d: The area under curve (AUC) from time zero to day 28 and/or day 84 in peripheral blood (days x copies/μg)</measure>
<time_frame>Infusion (Day 0) up to 12 months post treatment</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Cmax: The maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration (copies/μg)</measure>
<time_frame>Infusion (Day 0) up to 12 months post treatment</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Tmax: The time to reach maximum(peak) in peripheral blood or other body fluid drug concentration after single dose administration (days)</measure>
<time_frame>Infusion (Day 0) up to 12 months post treatment</time_frame>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">30</enrollment>
<condition>Colorectal Cancer</condition>
<arm_group>
<arm_group_label>GCC19CART</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Single infusion of GCC19CART at the dose assigned to an individual subject.
All subjects will receive the same investigational therapy with the dose administered dependent upon the dose level they are assigned to in a sequential manner.
Two dose level escalations are planned with one dose de-escalation listed if needed.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>GCC19CART</intervention_name>
<description>Single infusion of Chimeric Antigen Receptor (CAR) transduced autologous T cells administered intravenously (i.v.)</description>
<arm_group_label>GCC19CART</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Adults > 18 years old

- Clinical and histopathological diagnosis of metastatic colorectal cancer

- Guanylate Cyclase (GCC) positive disease as determined by immunohistochemistry (IHC).
Positivity on staining of archival tumor tissue is adequate.

- Limited liver disease (less than 7 lesions with largest lesion less than 3 cm)

- No surgical options with curative intent.

- Received prior therapy with fluoropyrimidine-, oxaliplatin-, and irinotecan-based
chemotherapy in the advanced or metastatic setting, an anti-vascular endothelial
growth factor (anti-VEGF) biological therapy if not contraindicated, and if RAS
wild-type an anti-epidermal growth factor receptor (anti-EGFR) therapy in a manner
consistent with National Comprehensive Cancer Network (NCCN) guidelines. Treatment
must have been discontinued for disease progression or intolerance to therapy.

- Have at least one extracranial measurable target lesions according to the Response
Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard.

Exclusion Criteria:

- Subjects with tumor lesion(s) in a location that may cause perforation of an organ or
structure (such as the digestive track, urinary bladder, or blood vessel) with
GCC19CART therapy.

- No active infectious diseases or comorbid conditions that would interfere with safety
or data quality.

- Subjects with active infection requiring systemic therapy or causing fever
(temperature > 38.1˚C) or subjects with unexplained fever (temperature > 38.1˚C)
within 7 days prior to enrollment (leukapheresis) and reconfirmed prior to the day of
investigational product administration.

- Pregnant or breast-feeding women

Other protocol defined Inclusion/Exclusion criteria may apply
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>City of Hope Comprehensive Cancer Center</name>
<address>
<city>Duarte</city>
<state>California</state>
<zip>91010</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Marwan Fakih</last_name>
<phone>877-467-3411</phone>
<email>mfakih@coh.org</email>
</contact>
</location>
<location>
<facility>
<name>University of California San Francisco Medical Center</name>
<address>
<city>San Francisco</city>
<state>California</state>
<zip>94143</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Harika Gopi</last_name>
<phone>415-818-4579</phone>
<email>HDFCCC.CIP@ucsf.edu</email>
</contact>
</location>
<location>
<facility>
<name>University of Colorado Hospital - Anschutz Cancer Pavilion</name>
<address>
<city>Aurora</city>
<state>Colorado</state>
<zip>80045</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Meredith Waring</last_name>
<phone>720-848-9457</phone>
<email>meredith.waring@cuanschutz.edu</email>
</contact>
<contact_backup>
<last_name>Nadine Salvador</last_name>
<phone>720-848-5097</phone>
<email>nadine.salvador@cuanschutz.edu</email>
</contact_backup>
</location>
<location>
<facility>
<name>Dana-Farber Cancer Institute</name>
<address>
<city>Boston</city>
<state>Massachusetts</state>
<zip>02215-5418</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Christopher Simmons</last_name>
<phone>617-632-6218</phone>
<email>Christopher_Simmons@dfci.harvard.edu</email>
</contact>
</location>
<location>
<facility>
<name>University of Michigan Comprehensive Cancer Center</name>
<address>
<city>Ann Arbor</city>
<state>Michigan</state>
<zip>48109</zip>
<country>United States</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Patricia Boykin</last_name>
<email>Patricia.Boykin@Labcorp.com</email>
</contact>
</location>
<location>
<facility>
<name>Baylor Scott & White Research Institute</name>
<address>
<city>Dallas</city>
<state>Texas</state>
<zip>75204</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>CORC Solid Tumor</last_name>
<phone>214-820-6168</phone>
<email>corcsolidtumor@BSWHealth.org</email>
</contact>
<contact_backup>
<last_name>Tyler Clifford</last_name>
<phone>214-820-6168</phone>
<email>Tyler.clifford@bswhealth.org</email>
</contact_backup>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>June 2023</verification_date>
<study_first_submitted>March 23, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>June 2, 2023</last_update_submitted>
<last_update_submitted_qc>June 2, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">June 5, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>relapsed metastatic colorectal cancer</keyword>
<keyword>refractory metastatic colorectal cancer</keyword>
<keyword>chimeric antigen receptors (CAR)</keyword>
<keyword>colorectal cancer</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Colorectal Neoplasms</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Study ICT-GCC19CART-US-001 (CARAPIA-1) is a Phase 1 study evaluating the safety,
tolerability, clinical activity, pharmacokinetics and pharmacodynamics of GCC19CART in
subjects with relapsed or refractory metastatic colorectal cancer.
Inclusion Criteria:
- Adults > 18 years old
- Clinical and histopathological diagnosis of metastatic colorectal cancer
- Guanylate Cyclase (GCC) positive disease as determined by immunohistochemistry (IHC).
Positivity on staining of archival tumor tissue is adequate.
- Limited liver disease (less than 7 lesions with largest lesion less than 3 cm)
- No surgical options with curative intent.
- Received prior therapy with fluoropyrimidine-, oxaliplatin-, and irinotecan-based
chemotherapy in the advanced or metastatic setting, an anti-vascular endothelial
growth factor (anti-VEGF) biological therapy if not contraindicated, and if RAS
wild-type an anti-epidermal growth factor receptor (anti-EGFR) therapy in a manner
consistent with National Comprehensive Cancer Network (NCCN) guidelines. Treatment
must have been discontinued for disease progression or intolerance to therapy.
- Have at least one extracranial measurable target lesions according to the Response
Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard.
Exclusion Criteria:
- Subjects with tumor lesion(s) in a location that may cause perforation of an organ or
structure (such as the digestive track, urinary bladder, or blood vessel) with
GCC19CART therapy.
- No active infectious diseases or comorbid conditions that would interfere with safety
or data quality.
- Subjects with active infection requiring systemic therapy or causing fever
(temperature > 38.1˚C) or subjects with unexplained fever (temperature > 38.1˚C)
within 7 days prior to enrollment (leukapheresis) and reconfirmed prior to the day of
investigational product administration.
- Pregnant or breast-feeding women
Other protocol defined Inclusion/Exclusion criteria may apply
|
NCT0531xxxx/NCT05319327.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319327</url>
</required_header>
<id_info>
<org_study_id>IMD: PI-048</org_study_id>
<nct_id>NCT05319327</nct_id>
</id_info>
<brief_title>Targeting DNA-methylation Fingerprints Linked to Ultra-Processed Foods Consumption to Prevent Non-communicable Diseases: the METHYL-UP Study</brief_title>
<acronym>METHYL-UP</acronym>
<official_title>Targeting DNA-methylation Fingerprints Linked to Ultra-Processed Foods Consumption to Prevent Non-communicable Diseases: the METHYL-UP Study</official_title>
<sponsors>
<lead_sponsor>
<agency>IMDEA Food</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>IMDEA Food</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Non-communicable diseases (NCD) are the main health challenge in industrialized countries.
However, these diseases are preventable if an intervention based on lifestyle is implemented
at the population level. Diet has a great impact on the onset and progression of NCD. In this
regard, ultra-processed food (UPF) consumption has been related to higher morbidity and
mortality. UPF are defined as "formulations made mostly or entirely from substances derived
from foods and additives, with little if any intact unprocessed or minimally processed foods"
(NOVA definition). UPF are rich in saturated fats and additives and poor in fiber other
nutrients. UPF consumption has raised in the last decades in the industrialized countries and
this increase has been associated with higher prevalence of metabolic disorders such as
diabetes, obesity, metabolic syndrome, cardiovascular disease, and cancer. However,
mechanisms that link UPF consumption with NCD are poorly understood and clinical trials are
needed to unravel these mechanisms and how to impact on them through lifestyle interventions.
The investigators have previously identified DNA methylation marks associated with UPF
consumption. DNA methylation marks are modifiable. The aim of the study is to assay if DNA
methylation marks related to UPF consumption are reversible by reducing UPF consumption in a
population of adults with overweight or obesity and with a high basal UPF consumption (>35%
of total food consumption in g/day).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The investigators propose a controlled, randomized, parallel groups intervention study based
on nutritional counseling to reduce UPF consumption. Eligible participants are adults (18-50
years old), men and women, with overweight or obesity (BMI 25-40 Kg/m2) with a high basal
consumption of UPF (>35% of total intake in g/day).

Recruited participants will be randomly allocated into a control group or an intervention
group. Participants in the control group will be provided with nutritional guidelines to
follow a healthy diet based on a Mediterranean diet. Participants in the intervention group
will follow a nutritional intervention program aimed to reduce UPF consumption. Nutritional
intervention will not modify basal caloric intake but will record energy intake along the
intervention. Nutritional counseling will be based on nutritional educational material such
as encourage and discourage food items, recipes, menus and food shopping lists based on
unprocessed or minimally processed foods.

Total intervention will last 6 months for both groups. During the intervention phase, a
monthly interview with nutritionist/dietitian is scheduled. Face-to-face interviews will be
carried out in months 2 and 4. Phone interviews will be carried out in months 1, 3 and 5. In
the baseline and final visits (months 0 and 6) a sample and data collection will be
performed.

Data collected will include general socio-demographical data (age, sex, educational level,
working status, civil status, rural/urban status), lifestyle data (smoking habits, dietary
habits, physical activity, sleeping habits), anthropometric data (height, weight, waist
circumference, body composition), and clinic-phenotypical parameters (blood pressure,
medication, adverse effects, disease prevalence). Biological sample collection will include
blood, urine, saliva and feces. Biochemical and blood cells parameters will be measured
(blood cell count, glucose, lipid and hepatic profiles).
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">June 6, 2021</start_date>
<completion_date type="Actual">December 31, 2022</completion_date>
<primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Controlled, randomized, parallel groups intervention</intervention_model_description>
<primary_purpose>Prevention</primary_purpose>
<masking>Single (Investigator)</masking>
<masking_description>The investigator who will analyze data will be provided with blinded data regarding the groups. Control and intervention groups will be randomly designated as group A and B. Investigator responsible for the analyses of the effect of the intervention on primary outcomes will compared groups A and B in a blinded manner.</masking_description>
</study_design_info>
<primary_outcome>
<measure>UPF</measure>
<time_frame>6 months</time_frame>
<description>Ultra-processed food consumption</description>
</primary_outcome>
<secondary_outcome>
<measure>Weight</measure>
<time_frame>6 months</time_frame>
<description>Weight change (Kg)</description>
</secondary_outcome>
<secondary_outcome>
<measure>BMI</measure>
<time_frame>6 months</time_frame>
<description>Change in body mass index (Kg/m2)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Obesity</measure>
<time_frame>6 months</time_frame>
<description>Percentage of participants who reverse obesity condition (BMI < 30 Kg/m2)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Body composition</measure>
<time_frame>6 months</time_frame>
<description>Change in % of fat mass</description>
</secondary_outcome>
<other_outcome>
<measure>DNA methylation</measure>
<time_frame>12 months</time_frame>
<description>Reversibility of DNA methylation marks</description>
</other_outcome>
<other_outcome>
<measure>Glucose</measure>
<time_frame>9 months</time_frame>
<description>Change in fastin glucose levels (mg/dL)</description>
</other_outcome>
<other_outcome>
<measure>Glycated haemoglobin</measure>
<time_frame>9 months</time_frame>
<description>Change in fastin glycated haemoglobin levels (%)</description>
</other_outcome>
<other_outcome>
<measure>Triglycerides</measure>
<time_frame>9 months</time_frame>
<description>Change in fasting triglycerides levels (mg/dL)</description>
</other_outcome>
<other_outcome>
<measure>LDL-cholesterol</measure>
<time_frame>9 months</time_frame>
<description>Change in fasting LDL-cholesterol levels (mg/dL)</description>
</other_outcome>
<other_outcome>
<measure>HDL-cholesterol</measure>
<time_frame>9 months</time_frame>
<description>Change in fasting HDL-cholesterol levels (mg/dL)</description>
</other_outcome>
<other_outcome>
<measure>Liver profile</measure>
<time_frame>9 months</time_frame>
<description>Change in HSI liver function index</description>
</other_outcome>
<other_outcome>
<measure>Microbiota</measure>
<time_frame>24 months</time_frame>
<description>Changein microbiota diversity</description>
</other_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">33</enrollment>
<condition>Obesity</condition>
<condition>Overweight</condition>
<arm_group>
<arm_group_label>Control Group</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Participants in the control group will be provided with nutritional guidelines to follow a healthy diet based on a Mediterranean diet.</description>
</arm_group>
<arm_group>
<arm_group_label>Intervention group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants in the intervention group will follow a nutritional intervention program aimed to reduce UPF consumption. Nutritional intervention will not modify basal caloric intake but will record energy intake along the intervention. Nutritional counseling will be based on nutritional educational material such as encouraged and discouraged food items, recipes, menus and food shopping lists based on unprocessed or minimally processed foods.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Nutritional intervention</intervention_name>
<description>A nutritional intervention program aimed to reduce UPF consumption. Nutritional intervention will not modify basal caloric intake but will record energy intake along the intervention. Nutritional counseling will be based on nutritional educational material such as encouraged and discouraged food items, recipes, menus and food shopping lists based on unprocessed or minimally processed foods.
Total intervention will last 6 months for both groups. During the intervention phase, a monthly interview with nutritionist/dietitian is scheduled. Face-to-face interviews will be carried out in months 2 and 4. Phone interviews will be carried out in months 1, 3 and 5. In the baseline and final visits (months 0 and 6) a sample and data collection will be performed.</description>
<arm_group_label>Intervention group</arm_group_label>
<other_name>Reduction of UPF consumption</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Control</intervention_name>
<description>General counseling to adhere to a healthy Mediterranean diet</description>
<arm_group_label>Control Group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Men/women

- 18-50 years old

- BMI 25-40 Kg/m2

- UPF consumption > 35% of total intake in g/day

Exclusion Criteria:

- Pregnancy

- Menopause

- IMC <25 Kg/m2 or > 40 Kg/m2

- Excessive alcohol consumption

- Prevalent cardiovascular, renal, lung, pancreatic or liver disease

- Type 1 diabetes

- Type 2 diabetes with poor glucose control or unstable medication during last 3 months

- Prevalent endocrine disease

- Changes in anti-hypertensive medication during last 3 months

- Insulin, systemic anti-inflammatory, or glucocorticoid medication during last 3 months

- Food allergies or intolerances

- Psychosocial or cultural factors that prevent from following the intervention
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>50 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>José M Ordovás, PhD</last_name>
<role>Study Director</role>
<affiliation>Fundación IMDEA Alimentación</affiliation>
</overall_official>
<location>
<facility>
<name>IMDEA Food</name>
<address>
<city>Madrid</city>
<zip>28049</zip>
<country>Spain</country>
</address>
</facility>
</location>
<location_countries>
<country>Spain</country>
</location_countries>
<link>
<url>https://www.food.imdea.org/nutritional-genomics-and-epigenomics-group</url>
<description>Research team profile</description>
</link>
<link>
<url>https://www.food.imdea.org/nutritional-control-epignome</url>
<description>Research team profile</description>
</link>
<reference>
<citation>Martinez-Perez C, Daimiel L, Climent-Mainar C, Martinez-Gonzalez MA, Salas-Salvado J, Corella D, Schroder H, Martinez JA, Alonso-Gomez AM, Warnberg J, Vioque J, Romaguera D, Lopez-Miranda J, Estruch R, Tinahones FJ, Lapetra J, Serra-Majem L, Bueno-Cavanillas A, Tur JA, Sanchez VM, Pinto X, Delgado-Rodriguez M, Matia-Martin P, Vidal J, Vazquez C, Ros E, Basterra J, Babio N, Guillem-Saiz P, Zomeno MD, Abete I, Vaquero-Luna J, Baron-Lopez FJ, Gonzalez-Palacios S, Konieczna J, Garcia-Rios A, Bernal-Lopez MR, Santos-Lozano JM, Bes-Rastrollo M, Khoury N, Saiz C, Perez-Vega KA, Zulet MA, Tojal-Sierra L, Ruiz ZV, Martinez MA, Malcampo M, Ordovas JM, San-Cristobal R. Integrative development of a short screening questionnaire of highly processed food consumption (sQ-HPF). Int J Behav Nutr Phys Act. 2022 Jan 24;19(1):6. doi: 10.1186/s12966-021-01240-6.</citation>
<PMID>35073909</PMID>
</reference>
<reference>
<citation>Konieczna J, Morey M, Abete I, Bes-Rastrollo M, Ruiz-Canela M, Vioque J, Gonzalez-Palacios S, Daimiel L, Salas-Salvado J, Fiol M, Martin V, Estruch R, Vidal J, Martinez-Gonzalez MA, Canudas S, Jover AJ, Fernandez-Villa T, Casas R, Olbeyra R, Buil-Cosiales P, Babio N, Schroder H, Martinez JA, Romaguera D; PREDIMED-Plus investigators. Contribution of ultra-processed foods in visceral fat deposition and other adiposity indicators: Prospective analysis nested in the PREDIMED-Plus trial. Clin Nutr. 2021 Jun;40(6):4290-4300. doi: 10.1016/j.clnu.2021.01.019. Epub 2021 Jan 28.</citation>
<PMID>33610419</PMID>
</reference>
<reference>
<citation>Martinez-Perez C, San-Cristobal R, Guallar-Castillon P, Martinez-Gonzalez MA, Salas-Salvado J, Corella D, Castaner O, Martinez JA, Alonso-Gomez AM, Warnberg J, Vioque J, Romaguera D, Lopez-Miranda J, Estruch R, Tinahones FJ, Lapetra J, Serra-Majem L, Bueno-Cavanillas A, Tur JA, Sanchez VM, Pinto X, Gaforio JJ, Matia-Martin P, Vidal J, Vazquez C, Ros E, Bes-Rastrollo M, Babio N, Sorli JV, Lassale C, Perez-Sanz B, Vaquero-Luna J, Bazan MJA, Barcelo-Iglesias MC, Konieczna J, Rios AG, Bernal-Lopez MR, Santos-Lozano JM, Toledo E, Becerra-Tomas N, Portoles O, Zomeno MD, Abete I, Moreno-Rodriguez A, Lecea-Juarez O, Nishi SK, Munoz-Martinez J, Ordovas JM, Daimiel L. Use of Different Food Classification Systems to Assess the Association between Ultra-Processed Food Consumption and Cardiometabolic Health in an Elderly Population with Metabolic Syndrome (PREDIMED-Plus Cohort). Nutrients. 2021 Jul 20;13(7):2471. doi: 10.3390/nu13072471.</citation>
<PMID>34371982</PMID>
</reference>
<verification_date>February 2023</verification_date>
<study_first_submitted>March 21, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>February 9, 2023</last_update_submitted>
<last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">February 13, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>IMDEA Food</investigator_affiliation>
<investigator_full_name>Lidia Daimiel Ruiz</investigator_full_name>
<investigator_title>Senior Researcher</investigator_title>
</responsible_party>
<keyword>Epigenetics</keyword>
<keyword>Methylation</keyword>
<keyword>Clinical trial</keyword>
<keyword>Causal inference</keyword>
<keyword>Non-communicable diseases</keyword>
<keyword>Precision nutrition</keyword>
<keyword>Ultra-processed food</keyword>
<keyword>NOVA</keyword>
<keyword>Obesity</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Overweight</mesh_term>
<mesh_term>Noncommunicable Diseases</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
<ipd_description>Informed consent does not allow to make data publicly available. Nevertheless, data could be share upon request to the investigators.</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Non-communicable diseases (NCD) are the main health challenge in industrialized countries.
However, these diseases are preventable if an intervention based on lifestyle is implemented
at the population level. Diet has a great impact on the onset and progression of NCD. In this
regard, ultra-processed food (UPF) consumption has been related to higher morbidity and
mortality. UPF are defined as "formulations made mostly or entirely from substances derived
from foods and additives, with little if any intact unprocessed or minimally processed foods"
(NOVA definition). UPF are rich in saturated fats and additives and poor in fiber other
nutrients. UPF consumption has raised in the last decades in the industrialized countries and
this increase has been associated with higher prevalence of metabolic disorders such as
diabetes, obesity, metabolic syndrome, cardiovascular disease, and cancer. However,
mechanisms that link UPF consumption with NCD are poorly understood and clinical trials are
needed to unravel these mechanisms and how to impact on them through lifestyle interventions.
The investigators have previously identified DNA methylation marks associated with UPF
consumption. DNA methylation marks are modifiable. The aim of the study is to assay if DNA
methylation marks related to UPF consumption are reversible by reducing UPF consumption in a
population of adults with overweight or obesity and with a high basal UPF consumption (>35%
of total food consumption in g/day).
The investigators propose a controlled, randomized, parallel groups intervention study based
on nutritional counseling to reduce UPF consumption. Eligible participants are adults (18-50
years old), men and women, with overweight or obesity (BMI 25-40 Kg/m2) with a high basal
consumption of UPF (>35% of total intake in g/day).
Recruited participants will be randomly allocated into a control group or an intervention
group. Participants in the control group will be provided with nutritional guidelines to
follow a healthy diet based on a Mediterranean diet. Participants in the intervention group
will follow a nutritional intervention program aimed to reduce UPF consumption. Nutritional
intervention will not modify basal caloric intake but will record energy intake along the
intervention. Nutritional counseling will be based on nutritional educational material such
as encourage and discourage food items, recipes, menus and food shopping lists based on
unprocessed or minimally processed foods.
Total intervention will last 6 months for both groups. During the intervention phase, a
monthly interview with nutritionist/dietitian is scheduled. Face-to-face interviews will be
carried out in months 2 and 4. Phone interviews will be carried out in months 1, 3 and 5. In
the baseline and final visits (months 0 and 6) a sample and data collection will be
performed.
Data collected will include general socio-demographical data (age, sex, educational level,
working status, civil status, rural/urban status), lifestyle data (smoking habits, dietary
habits, physical activity, sleeping habits), anthropometric data (height, weight, waist
circumference, body composition), and clinic-phenotypical parameters (blood pressure,
medication, adverse effects, disease prevalence). Biological sample collection will include
blood, urine, saliva and feces. Biochemical and blood cells parameters will be measured
(blood cell count, glucose, lipid and hepatic profiles).
Inclusion Criteria:
- Men/women
- 18-50 years old
- BMI 25-40 Kg/m2
- UPF consumption > 35% of total intake in g/day
Exclusion Criteria:
- Pregnancy
- Menopause
- IMC <25 Kg/m2 or > 40 Kg/m2
- Excessive alcohol consumption
- Prevalent cardiovascular, renal, lung, pancreatic or liver disease
- Type 1 diabetes
- Type 2 diabetes with poor glucose control or unstable medication during last 3 months
- Prevalent endocrine disease
- Changes in anti-hypertensive medication during last 3 months
- Insulin, systemic anti-inflammatory, or glucocorticoid medication during last 3 months
- Food allergies or intolerances
- Psychosocial or cultural factors that prevent from following the intervention
|
NCT0531xxxx/NCT05319340.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319340</url>
</required_header>
<id_info>
<org_study_id>678657</org_study_id>
<nct_id>NCT05319340</nct_id>
</id_info>
<brief_title>I.M. Sechenov First Moscow State Medical University (Sechenov University)</brief_title>
<official_title>Optimization of Anticoagulant Therapy in Outpatient Practice</official_title>
<sponsors>
<lead_sponsor>
<agency>I.M. Sechenov First Moscow State Medical University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>I.M. Sechenov First Moscow State Medical University</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Single-institution uncontrolled open-label trial.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The single-institution uncontrolled open-label trial is to optimize the anticoagulant therapy
in the out-patient practice.

The study embraces patients who are advised to take the anticoagulant therapy for some
reasons. The study has two phases - a retrospective part and a concurrent part. At the first
phase, researchers analyze the compliance with the anticoagulant therapy in the real clinical
practice. At the concurrent phase, researchers conduct a single-institution uncontrolled
open-label trial to evaluate the effectiveness, safety of the anticoagulant therapy and
compliance with it at the antithrombotic therapy control ward, and estimate the glomerular
filtration rate in patients taking the anticoagulant therapy.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>January 15, 2014</start_date>
<completion_date type="Actual">March 2, 2021</completion_date>
<primary_completion_date type="Actual">March 2, 2021</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>kidney compliance with the anticoagulant therapy and its safety and trends in the kidney function</measure>
<time_frame>Evaluation of GFR, bleeding and thrombotic complications after 2 years</time_frame>
<description>During a visit to the clinic, the patient will be surveyed and tested for the creatinine level</description>
</primary_outcome>
<primary_outcome>
<measure>death due to any cause</measure>
<time_frame>in six years after the anticoagulant therapy is prescribed</time_frame>
<description>phone survey when patients are invited to the clinic</description>
</primary_outcome>
<primary_outcome>
<measure>cardiovascular mortality</measure>
<time_frame>Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 2 years</time_frame>
<description>Phone survey when patients are invited to the clinic. The term cardiovascular mortality means a set of fatal heart attacks, fatal strokes, sudden death, fatal thromboembolism.</description>
</primary_outcome>
<primary_outcome>
<measure>kidney function trend</measure>
<time_frame>Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 3 years</time_frame>
<description>phone survey when patients are invited to the clinic for testing the creatinine level and further estimation of the glomerular filtration rate</description>
</primary_outcome>
<primary_outcome>
<measure>intensive bleeding</measure>
<time_frame>Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 6 years</time_frame>
<description>phone survey when patients are invited to the clinic.</description>
</primary_outcome>
<secondary_outcome>
<measure>frequency of thromboembolic events</measure>
<time_frame>in 1-2-3-6 years after the anticoagulant therapy is prescribed</time_frame>
<description>patients will be surveyed upon their visit to the clinic. Thromboembolic events shall mean non-fatal embolic strokes, systemic embolism, acute coronary syndrome (to be corroborated with documents).</description>
</secondary_outcome>
<other_outcome>
<measure>minor bleeding</measure>
<time_frame>in 1-2-3-6 years after the anticoagulant therapy is prescribed</time_frame>
<description>Minor bleeding shall mean any visually observed bleeding, including that discovered with various imaging methods, which cause a decrease in HB by less than 30 GM/DL or Ht by less than 9%.</description>
</other_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">1000</enrollment>
<condition>Anticoagulants</condition>
<arm_group>
<arm_group_label>anticoagulants arm</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>The study embraces patients who are advised to take the anticoagulant therapy (as per the European Society of Cardiology Guidelines). The study evaluates the compliance with the anticoagulant therapy, safety and effectiveness, mortality</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>prescribing anticoagulant therapy</intervention_name>
<description>Patients who need anticoagulants were consulted by a cardiologist with subsequent recommendations</description>
<arm_group_label>anticoagulants arm</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- the age above 18

- indications for the anticoagulant therapy

- informed consent for inclusion into trials

Exclusion Criteria:

- denial to proceed in the trial

Non-inclusion criteria:

pregnancy and lactation

- Intracerebral hemorrhage within three preceding months

- severe mental disorders* which could possibly affect the anticoagulant therapy dosage
schedule

- anemia and a decrease in Hb by ˂100 GM/DL*

- active gastroduodenal ulcer

- active bleeding during the preceding month

- other intensive bleeding instances as per the TIMI Score within three weeks before the
inclusion

- severe hepatic impairment for over 10 points under the Child-Pugh Score

- oncology disease with the life expectancy less than one year
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>120 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Zukhra Salpagarova</last_name>
<role>Principal Investigator</role>
<affiliation>I.M. Sechenov First Moscow State Medical University (Sechenov University)</affiliation>
</overall_official>
<reference>
<citation>Chashkina MI, Kozlovskaya NL, Andreev DA, Ananicheva NA, Bykova AA, Salpagarova ZK, Syrkin AL. [Prevalence of Advanced Chronic Kidney Disease in Patients with Nonvalvular Atrial Fibrillation Hospitalized in Cardiology Departments]. Kardiologiia. 2020 Mar 5;60(2):41-46. doi: 10.18087/cardio.2020.2.n823. Russian.</citation>
<PMID>32345197</PMID>
</reference>
<verification_date>March 2021</verification_date>
<study_first_submitted>March 3, 2021</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>March 31, 2022</last_update_submitted>
<last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 8, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Rivaroxaban Dabigatran Apixaban</keyword>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Anticoagulants</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
<ipd_description>ethics committee requirement</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Single-institution uncontrolled open-label trial.
The single-institution uncontrolled open-label trial is to optimize the anticoagulant therapy
in the out-patient practice.
The study embraces patients who are advised to take the anticoagulant therapy for some
reasons. The study has two phases - a retrospective part and a concurrent part. At the first
phase, researchers analyze the compliance with the anticoagulant therapy in the real clinical
practice. At the concurrent phase, researchers conduct a single-institution uncontrolled
open-label trial to evaluate the effectiveness, safety of the anticoagulant therapy and
compliance with it at the antithrombotic therapy control ward, and estimate the glomerular
filtration rate in patients taking the anticoagulant therapy.
Inclusion Criteria:
- the age above 18
- indications for the anticoagulant therapy
- informed consent for inclusion into trials
Exclusion Criteria:
- denial to proceed in the trial
Non-inclusion criteria:
pregnancy and lactation
- Intracerebral hemorrhage within three preceding months
- severe mental disorders* which could possibly affect the anticoagulant therapy dosage
schedule
- anemia and a decrease in Hb by ˂100 GM/DL*
- active gastroduodenal ulcer
- active bleeding during the preceding month
- other intensive bleeding instances as per the TIMI Score within three weeks before the
inclusion
- severe hepatic impairment for over 10 points under the Child-Pugh Score
- oncology disease with the life expectancy less than one year
|
NCT0531xxxx/NCT05319353.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319353</url>
</required_header>
<id_info>
<org_study_id>TAK-620-2004</org_study_id>
<secondary_id>2021-004279-15</secondary_id>
<nct_id>NCT05319353</nct_id>
</id_info>
<brief_title>A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Children and Teenage Transplant Recipients With CMV Infection</brief_title>
<official_title>A Phase 3, Open-label, Single-arm, Repeated-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Children and Adolescents Who Have Received a Hematopoietic Stem Cell Transplant (HSCT) or a Solid Organ Transplant (SOT)</official_title>
<sponsors>
<lead_sponsor>
<agency>Takeda</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
<collaborator>
<agency>Takeda Development Center Americas, Inc.</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>Takeda</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
<is_us_export>Yes</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
The main aim of this study is to find out the safety, tolerability and pharmacokinetics (PK)
of maribavir for the treatment of CMV infection in children and teenagers after HSCT or SOT
and to identify the optimal dose of maribavir using a 200 milligrams (mg) adult tablet
formulation or other formulation based on PK modeling.

The participants will be treated with maribavir for 8 weeks.

Participants need to visit their doctor during 12-week follow-up period.
</textblock>
</brief_summary>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">August 29, 2023</start_date>
<completion_date type="Anticipated">November 22, 2026</completion_date>
<primary_completion_date type="Anticipated">November 22, 2026</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Non-Randomized</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<intervention_model_description>Three dosing cohorts based on participant's age.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Maximum Observed Plasma Concentration (Cmax) of Maribavir</measure>
<time_frame>Pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)</time_frame>
<description>Cmax of maribavir will be evaluated.</description>
</primary_outcome>
<primary_outcome>
<measure>Time to Maximum Observed Concentration (Tmax) of Maribavir</measure>
<time_frame>Pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)</time_frame>
<description>Tmax of maribavir will be evaluated.</description>
</primary_outcome>
<primary_outcome>
<measure>Minimum Plasma Concentration (Cmin) of Maribavir</measure>
<time_frame>Pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1); Pre-dose on Day 28 (Week 4); Pre-dose and 2 to 4 hours post-dose on Day 56 (Week 8)</time_frame>
<description>Cmin of maribavir will be evaluated.</description>
</primary_outcome>
<primary_outcome>
<measure>Area Under the Plasma Concentration-Time Curve Over the 1 Dosing Interval of 12 Hours at Steady State (AUC0-tau) of Maribavir</measure>
<time_frame>Pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)</time_frame>
<description>AUC0-tau of maribavir will be evaluated.</description>
</primary_outcome>
<primary_outcome>
<measure>Half-Life (t1/2) of Maribavir</measure>
<time_frame>Pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)</time_frame>
<description>t1/2 of maribavir will be evaluated.</description>
</primary_outcome>
<primary_outcome>
<measure>Terminal Elimination Rate Constant (lambdaz) of Maribavir</measure>
<time_frame>Pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)</time_frame>
<description>Lambdaz of maribavir will be evaluated.</description>
</primary_outcome>
<primary_outcome>
<measure>Apparent Volume of Distribution (Vz/F) of Maribavir</measure>
<time_frame>Pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)</time_frame>
<description>Vz/F of maribavir will be evaluated.</description>
</primary_outcome>
<primary_outcome>
<measure>Apparent Oral Clearance (CL/F) of Maribavir</measure>
<time_frame>Pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)</time_frame>
<description>CL/F of maribavir will be evaluated.</description>
</primary_outcome>
<primary_outcome>
<measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs</measure>
<time_frame>From start of study drug administration up to follow-up (Week 20)</time_frame>
<description>An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the investigational product or medicinal product. An SAE is any untoward medical occurrence (whether considered related to investigational product or not and at any dose) that at any dose results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality or birth defect, an important medical event. TEAEs included serious and non-serious AEs.</description>
</primary_outcome>
<secondary_outcome>
<measure>Percentage of Participants With Confirmed CMV viremia Clearance at Week 8</measure>
<time_frame>At Week 8</time_frame>
<description>Confirmed CMV viremia clearance is defined as plasma CMV DNA concentration below the lower limit of quantification (LLOQ) at a central specialty laboratory, in 2 consecutive postbaseline samples, separated by at least 5 days at Week 8 regardless of the length of study treatment. Percentage of participants with confirmed CMV viremia clearance at Week 8 will be reported.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Percentage of Participants who Achieve Maintenance of Confirmed CMV Viremia Clearance and Symptom Control at Week 8 Through Weeks 12, 16 and 20</measure>
<time_frame>At Week 8 through Weeks 12, 16, and 20</time_frame>
<description>Confirmed CMV viremia clearance is defined as plasma CMV DNA concentration below the lower LLOQ at a central specialty laboratory, in 2 consecutive postbaseline samples, separated by at least 5 days regardless of the length of study treatment. CMV infection symptom control is defined as resolution or improvement of tissue invasive disease or CMV syndrome for symptomatic participants at baseline, or no new symptoms for asymptomatic participants at baseline. Percentage of participants who achieve maintenance of confirmed CMV viremia clearance and symptom control at Week 8 through Weeks 12, 16 and 20 will be reported.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Percentage of Participants With Confirmed Recurrence of CMV Viremia on Study Treatment and Off Study Treatment</measure>
<time_frame>Up to Week 20</time_frame>
<description>Confirmed recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (>=) LLOQ when assessed in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with confirmed recurrence of viremia on study treatment and off study treatment will be reported.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Time to First Confirmed Viremia Clearance</measure>
<time_frame>Up to Week 20</time_frame>
<description>Confirmed CMV viremia clearance is defined as plasma CMV DNA concentration below the lower LLOQ when assessed at a central specialty laboratory, in 2 consecutive postbaseline samples, separated by at least 5 days. Time to first confirmed viremia clearance at any time during the study will be summarized using the Kaplan-Meier method.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Percentage of Participants With Confirmed Recurrence of CMV Viremia Treated With Alternative Anti-CMV Treatment During 12-Week Follow-up Period in Participants With Confirmed Viremia Clearance at Week 8</measure>
<time_frame>From Week 8 through Week 20</time_frame>
<description>Confirmed recurrence of CMV viremia is defined as plasma CMV DNA concentration >= LLOQ when assessed in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with confirmed recurrence of CMV viremia treated with alternative anti-CMV treatment in the 12-Week follow-up period in participants with confirmed viremia clearance at Week 8 will be reported.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change From Baseline in Log10 Plasma CMV Deoxyribonucleic Acid (DNA) Load</measure>
<time_frame>Baseline up to Week 20</time_frame>
<description>Change from baseline in log10 plasma CMV DNA on study after receiving study treatment by study week will be reported.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of Participants who Develop CMV Resistance to Maribavir</measure>
<time_frame>Up to Week 12</time_frame>
<description>CMV DNA genotyping will be performed for the UL97, UL54, UL56, and UL27 genes known to confer resistance to conventional anti-CMV therapies or Maribavir. Number of participants who developed post-baseline CMV resistance to maribavir up to Week 12 will be reported.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Summary Scores for Palatability Assessment of Maribavir</measure>
<time_frame>At Weeks 1, 4, and 8</time_frame>
<description>Palatability (taste, feel, smell, ease of swallowing and after-taste) is being measured using a 5-point facial hedonic scale correlated with a 100-point linear visual analogue scale (VAS) ranges from 0: very bad to 100: very good. Scores will be summarized descriptively at Weeks 1, 4 and 8.</description>
</secondary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Anticipated">80</enrollment>
<condition>Cytomegalovirus (CMV)</condition>
<arm_group>
<arm_group_label>Cohort 1: Maribavir 400 or 200 mg</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants with greater than or equal to (>=) 12 to less than (<) 18 years of age will receive maribavir 400 milligrams (mg) (2*200 mg tablets) twice daily (BID) based on body weight >= 25 kilogram (kg) or 200 mg tablet BID based on body weight 10 to < 25 kg orally for up to 8 weeks treatment period (Day 0/Week 0 to Day 56/Week 8). The dosing regimen will be based on the participant's body weight and may be updated over the course of the study based on the internal interim analyses on PK, safety, and tolerability of at least 5 participants in each cohort.</description>
</arm_group>
<arm_group>
<arm_group_label>Cohort 2: Maribavir 400 or 200 mg</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants with >= 6 to < 12 years of age will receive maribavir 400 mg (2*200 mg tablets) BID based on body weight >= 25 kg or 200 mg tablet BID based on body weight 10 to < 25 kg orally for up to 8 weeks treatment period (Day 0/Week 0 to Day 56/Week 8). The dosing regimen will be based on the participant's body weight and may be updated over the course of the study based on the internal interim analyses on PK, safety, and tolerability of at least 5 participants in each cohort.</description>
</arm_group>
<arm_group>
<arm_group_label>Cohort 3: Maribavir</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants with 0 to < 6 years of age will receive maribavir based on PK modeling.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Maribavir</intervention_name>
<description>Participants will receive maribavir.</description>
<arm_group_label>Cohort 1: Maribavir 400 or 200 mg</arm_group_label>
<arm_group_label>Cohort 2: Maribavir 400 or 200 mg</arm_group_label>
<arm_group_label>Cohort 3: Maribavir</arm_group_label>
<other_name>TAK-620</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Parent/both parents or legally authorized representative (LAR) must provide signature
of informed consent and there must be documentation of assent by the participant, as
age appropriate, before completing any study-related procedures. During the COVID-19
public health emergency, informed consent from a potential or current trial
participant may, if permitted by local laws and regulations, be obtained via
electronic informed consent capabilities or an electronic face-to-face consent
interview when these individuals are unable to travel to the site.

- Be a male or female child or adolescent < 18 years of age at the time of consent. For
participants in Cohort 3 only, must have a gestational age of at least 38 weeks and a
minimum weight of 5 kg.

- Be a recipient of an SOT or an HSCT that is functioning at the time of screening.

- Have a documented CMV infection, with a CMV deoxyribonucleic acid (DNA) screening
value of >= 1365 International Units per milliliter (IU/mL) in whole blood or >= 455
IU/mL in plasma in 2 consecutive assessments separated by at least 1 day, as
determined by local or central specialty laboratory quantitative polymerase chain
reaction (qPCR) or comparable quantitative CMV DNA results. Both samples must be taken
within 14 days of first dose of study drug, with the second sample obtained within 5
days prior to first dose of study drug. The same laboratory and same sample type
(whole blood or plasma) must be used for both assessments.

- Have all the following results as part of screening laboratory assessments:

- Absolute neutrophil count >= 500 per cubic millimeter (/mm^3) (0.5 × 10^9 per
liter [/L])

- Platelet count >= 15,000/mm^3 (15 × 10^9/L)

- Hemoglobin >= 8 grams per deciliter (g/dL)

- Have an estimated glomerular filtration rate (creatinine-based Bedside Schwartz
equation) >= 30 milliliters per minute (mL/min) /1.73 meter square (m^2).

- Be a female of nonchildbearing potential. If a female of childbearing potential, have
a negative serum human chorionic gonadotropin (hCG) or beta-human chorionic
gonadotropin (β-hCG) pregnancy test at screening. Males, or nonpregnant, nonlactating
females who are sexually active must agree to comply with the applicable contraceptive
requirements of this protocol during the study treatment administration period and for
90 days after the last dose of study treatment.

- Have life expectancy of >= 8 weeks.

- Be willing and have an understanding and ability to fully comply with the study
procedures and restrictions defined in the protocol. For younger children, the
parent/both parents or LAR must meet this criterion.

Exclusion Criteria:

- Have CMV tissue invasive disease involving the central nervous system (CNS) or retina
as assessed by the investigator at the time of screening.

- Have uncontrolled other type of infection as assessed by the investigator on the date
of enrollment.

- Have a history of clinically relevant alcohol or drug abuse that may interfere with
treatment compliance or assessments with the protocol as determined by the
investigator.

- Be receiving valganciclovir, ganciclovir, cidofovir, foscarnet, leflunomide,
letermovir, or artesunate when study treatment is initiated, or anticipated to require
one of these agents during the 8-week treatment period.

- Have a known hypersensitivity to maribavir or to any excipients.

- Have severe vomiting, diarrhea, or other severe gastrointestinal (GI) illness within
24 hours prior to the first dose of study treatment or a GI absorption abnormality
that would preclude administration of oral medication.

- Require mechanical ventilation or vasopressors for hemodynamic support at baseline
(Week 0).

- Be pregnant (or expecting to conceive) or nursing.

- Have previously completed, discontinued, or have been withdrawn from this study.

- Have received any investigational agent or device within 30 days before initiation of
study treatment (includes CMV specific T-cells). Previously approved agents under
investigation for additional indications are not exclusionary.

- Have previously received maribavir or CMV vaccine at any time.

- Have any clinically significant medical or surgical condition that, in the
investigator's opinion, could interfere with interpretation of study results,
contraindicate the administration of the study treatment, or compromise the safety or
well-being of the participant.

- Have severe liver disease (Child-Pugh score of >= 10).

- Have serum aspartate aminotransferase greater than (>) 5 times upper limit of normal
(ULN) at screening, or serum alanine aminotransferase > 5 times ULN at screening, or
total bilirubin >= 3.0 times ULN at screening (except for documented Gilbert's
syndrome), as analyzed by local laboratory.

- Have positive results for human immunodeficiency virus (HIV). Participants must have a
confirmed negative HIV test result within 3 months of study entry or, if unavailable,
be tested by a local laboratory during the screening period.

- Have active malignancy with the exception of nonmelanoma skin cancer, as determined by
the investigator. Participants who experience relapse or progression of their
underlying malignancy (for which HSCT or SOT was performed), as determined by the
investigator, are not to be enrolled.

- Be undergoing treatment for acute or chronic hepatitis B or hepatitis C.

- Requiring ongoing treatment with or an anticipated need for treatment with a strong
cytochrome P450 3A (CYP3A) inducer.

- Have a low body weight where total blood volume (TBV) required during study
participation will exceed 1 percent (%) TBV per study visit or 3% TBV over 30-day
period.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>17 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Study Director</last_name>
<role>Study Director</role>
<affiliation>Takeda</affiliation>
</overall_official>
<overall_contact>
<last_name>Takeda Contact</last_name>
<phone>+1-877-825-3327</phone>
<email>medinfoUS@takeda.com</email>
</overall_contact>
<link>
<url>https://clinicaltrials.takeda.com/study-detail/d024b354976f4ddb?idFilter=%5B%22TAK-620-2004%22%5D</url>
<description>To obtain more information on the study, click here/on this link</description>
</link>
<verification_date>June 2023</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>June 16, 2023</last_update_submitted>
<last_update_submitted_qc>June 16, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">June 18, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cytomegalovirus Infections</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Maribavir</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
<ipd_info_type>Study Protocol</ipd_info_type>
<ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
<ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
<ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
<ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
<ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The main aim of this study is to find out the safety, tolerability and pharmacokinetics (PK)
of maribavir for the treatment of CMV infection in children and teenagers after HSCT or SOT
and to identify the optimal dose of maribavir using a 200 milligrams (mg) adult tablet
formulation or other formulation based on PK modeling.
The participants will be treated with maribavir for 8 weeks.
Participants need to visit their doctor during 12-week follow-up period.
Inclusion Criteria:
- Parent/both parents or legally authorized representative (LAR) must provide signature
of informed consent and there must be documentation of assent by the participant, as
age appropriate, before completing any study-related procedures. During the COVID-19
public health emergency, informed consent from a potential or current trial
participant may, if permitted by local laws and regulations, be obtained via
electronic informed consent capabilities or an electronic face-to-face consent
interview when these individuals are unable to travel to the site.
- Be a male or female child or adolescent < 18 years of age at the time of consent. For
participants in Cohort 3 only, must have a gestational age of at least 38 weeks and a
minimum weight of 5 kg.
- Be a recipient of an SOT or an HSCT that is functioning at the time of screening.
- Have a documented CMV infection, with a CMV deoxyribonucleic acid (DNA) screening
value of >= 1365 International Units per milliliter (IU/mL) in whole blood or >= 455
IU/mL in plasma in 2 consecutive assessments separated by at least 1 day, as
determined by local or central specialty laboratory quantitative polymerase chain
reaction (qPCR) or comparable quantitative CMV DNA results. Both samples must be taken
within 14 days of first dose of study drug, with the second sample obtained within 5
days prior to first dose of study drug. The same laboratory and same sample type
(whole blood or plasma) must be used for both assessments.
- Have all the following results as part of screening laboratory assessments:
- Absolute neutrophil count >= 500 per cubic millimeter (/mm^3) (0.5 × 10^9 per
liter [/L])
- Platelet count >= 15,000/mm^3 (15 × 10^9/L)
- Hemoglobin >= 8 grams per deciliter (g/dL)
- Have an estimated glomerular filtration rate (creatinine-based Bedside Schwartz
equation) >= 30 milliliters per minute (mL/min) /1.73 meter square (m^2).
- Be a female of nonchildbearing potential. If a female of childbearing potential, have
a negative serum human chorionic gonadotropin (hCG) or beta-human chorionic
gonadotropin (β-hCG) pregnancy test at screening. Males, or nonpregnant, nonlactating
females who are sexually active must agree to comply with the applicable contraceptive
requirements of this protocol during the study treatment administration period and for
90 days after the last dose of study treatment.
- Have life expectancy of >= 8 weeks.
- Be willing and have an understanding and ability to fully comply with the study
procedures and restrictions defined in the protocol. For younger children, the
parent/both parents or LAR must meet this criterion.
Exclusion Criteria:
- Have CMV tissue invasive disease involving the central nervous system (CNS) or retina
as assessed by the investigator at the time of screening.
- Have uncontrolled other type of infection as assessed by the investigator on the date
of enrollment.
- Have a history of clinically relevant alcohol or drug abuse that may interfere with
treatment compliance or assessments with the protocol as determined by the
investigator.
- Be receiving valganciclovir, ganciclovir, cidofovir, foscarnet, leflunomide,
letermovir, or artesunate when study treatment is initiated, or anticipated to require
one of these agents during the 8-week treatment period.
- Have a known hypersensitivity to maribavir or to any excipients.
- Have severe vomiting, diarrhea, or other severe gastrointestinal (GI) illness within
24 hours prior to the first dose of study treatment or a GI absorption abnormality
that would preclude administration of oral medication.
- Require mechanical ventilation or vasopressors for hemodynamic support at baseline
(Week 0).
- Be pregnant (or expecting to conceive) or nursing.
- Have previously completed, discontinued, or have been withdrawn from this study.
- Have received any investigational agent or device within 30 days before initiation of
study treatment (includes CMV specific T-cells). Previously approved agents under
investigation for additional indications are not exclusionary.
- Have previously received maribavir or CMV vaccine at any time.
- Have any clinically significant medical or surgical condition that, in the
investigator's opinion, could interfere with interpretation of study results,
contraindicate the administration of the study treatment, or compromise the safety or
well-being of the participant.
- Have severe liver disease (Child-Pugh score of >= 10).
- Have serum aspartate aminotransferase greater than (>) 5 times upper limit of normal
(ULN) at screening, or serum alanine aminotransferase > 5 times ULN at screening, or
total bilirubin >= 3.0 times ULN at screening (except for documented Gilbert's
syndrome), as analyzed by local laboratory.
- Have positive results for human immunodeficiency virus (HIV). Participants must have a
confirmed negative HIV test result within 3 months of study entry or, if unavailable,
be tested by a local laboratory during the screening period.
- Have active malignancy with the exception of nonmelanoma skin cancer, as determined by
the investigator. Participants who experience relapse or progression of their
underlying malignancy (for which HSCT or SOT was performed), as determined by the
investigator, are not to be enrolled.
- Be undergoing treatment for acute or chronic hepatitis B or hepatitis C.
- Requiring ongoing treatment with or an anticipated need for treatment with a strong
cytochrome P450 3A (CYP3A) inducer.
- Have a low body weight where total blood volume (TBV) required during study
participation will exceed 1 percent (%) TBV per study visit or 3% TBV over 30-day
period.
|
NCT0531xxxx/NCT05319366.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319366</url>
</required_header>
<id_info>
<org_study_id>H-21029011</org_study_id>
<nct_id>NCT05319366</nct_id>
</id_info>
<brief_title>Atherosclerotic Lesion Proteomics by Harvesting Angioplasty Balloons (ALPHA).</brief_title>
<official_title>Proteomics- og Metabolomics-undersøgelse af Materiale Ekstraheret Fra Ballonkatetre Anvendt Til Ballon-udvidelsesbehandling Hos Patienter Med Symptomatisk åreforkalkningssygdom</official_title>
<sponsors>
<lead_sponsor>
<agency>Rigshospitalet, Denmark</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>University of Copenhagen</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Herlev and Gentofte Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Rigshospitalet, Denmark</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The purpose of the study is to identify proteins, metabolites and signal pathways related
directly to symptomatic atherosclerosis and to disease progression. In the study, we use
residual material from angioplasty catheter balloons and from vascular surgery plus blood
samples. It is the hypothesis that material left on the catheter balloons used for
angioplasty can be used for proteomics and metabolomics evaluation that will identify
inflammation-associated proteins and signaling pathways directly in the diseased vessel. The
tissue samples will be collected after the procedure and blood samples will be collected at
the procedure plus after 6-12 months. The tissue and blood samples will be analyzed using
mass spectrometry methods and a standard panel of biomarkers will also be analyzed using
standardized methods. The analyses will include study of inflammation-associated peptides
observed in autoinflammation as well as thrombogenic signaling pathways and local expression
of biomarkers. The analyses of proteins, metabolites and/or biomarkers will be compared
between cases (stable angina, unstable angina/non-STEMI, STEMI and vascular surgery) and
controls (procedures not related to coronary artery diseases) to identify molecular processes
related directly to symptomatic atherosclerosis and will be associated with disease
progression using data from medical journals and National Health registries. The study will
recruit 225 patients from Rigshospitalet University Hospital, Copenhagen, and Herlev-Gentofte
Hospital.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">December 1, 2021</start_date>
<completion_date type="Anticipated">July 31, 2024</completion_date>
<primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Other</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Protein composition in tissue</measure>
<time_frame>Baseline</time_frame>
<description>Difference in protein composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups.</description>
</primary_outcome>
<primary_outcome>
<measure>Metabolomic composition</measure>
<time_frame>Baseline</time_frame>
<description>Difference in metabolite composition in tissue (residual material from angioplasty balloons) and blood samples compaired between study groups.</description>
</primary_outcome>
<secondary_outcome>
<measure>Biomarker composition</measure>
<time_frame>Baseline</time_frame>
<description>Differences in biomarker composition between groups</description>
</secondary_outcome>
<secondary_outcome>
<measure>Biomarker composition</measure>
<time_frame>Within 12 months</time_frame>
<description>Differences in biomarker composition between groups</description>
</secondary_outcome>
<secondary_outcome>
<measure>Disease progression in relation to protein, metabolite and biomarker compostion</measure>
<time_frame>With 12 months</time_frame>
<description>Changes in disease progression in relation to the protein, metabolite and biomarker composition</description>
</secondary_outcome>
<secondary_outcome>
<measure>Disease progression in relation to protein, metabolite and biomarker compostion</measure>
<time_frame>3 years</time_frame>
<description>Changes in disease progression in relation to the protein, metabolite and biomarker composition</description>
</secondary_outcome>
<secondary_outcome>
<measure>Protein composition</measure>
<time_frame>Within 12 months</time_frame>
<description>Difference in protein composition in blood samples</description>
</secondary_outcome>
<secondary_outcome>
<measure>Metabolomic composition</measure>
<time_frame>Within 12 months</time_frame>
<description>Difference in metabolite composition in blood samples</description>
</secondary_outcome>
<number_of_groups>5</number_of_groups>
<enrollment type="Anticipated">225</enrollment>
<condition>Angina, Stable</condition>
<condition>Angina, Unstable</condition>
<condition>Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)</condition>
<condition>ST-segment Elevation Myocardial Infarction (STEMI)</condition>
<condition>Vascular Diseases</condition>
<arm_group>
<arm_group_label>Stable angina</arm_group_label>
<description>50 patients with stable angina will be included and tissue samples from balloon cathether and blood samples will be collected</description>
</arm_group>
<arm_group>
<arm_group_label>Unstable angina/non-ST-segment elevation myocardial infarction</arm_group_label>
<description>50 patients with unstable angina/non-ST-segment elevation myocardial infarction will be included and tissue samples from balloon cathether and blood samples will be collected</description>
</arm_group>
<arm_group>
<arm_group_label>ST-segment elevation myocardial infarction</arm_group_label>
<description>50 patients with ST-segment elevation myocardial infarction will be included and tissue samples from balloon cathether and blood samples will be collected</description>
</arm_group>
<arm_group>
<arm_group_label>Controls</arm_group_label>
<description>50 patients without corornary arthery-related treatment will be included and tissue samples from balloon cathether and blood samples will be collected</description>
</arm_group>
<arm_group>
<arm_group_label>Vascular surgery</arm_group_label>
<description>25 patients who undergo will be included and tissue samples and blood samples will be collected</description>
</arm_group>
<biospec_retention>Samples With DNA</biospec_retention>
<biospec_descr>
<textblock>
Tissue samples from the baloon catherther or vascular surgery and blood samples
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
Patients who have their angioplasty or vascular surgery at the Copenhagen University
hospital (Rigshospitalet) or Herlev-Gentofte hospital
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Symptomatic atherosclerotic disease

- 18 years or older

- Angioplasty or vascular surgery

Exclusion Criteria:

- Not willing or unable to give informed consent
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Gorm M Hansen, MD, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>The Heart Center, Rigshospitalet</affiliation>
</overall_official>
<overall_contact>
<last_name>Gorm M Hansen, MD, PhD</last_name>
<phone>+45 35454452</phone>
<email>gorm.moerk.hansen@regionh.dk</email>
</overall_contact>
<overall_contact_backup>
<last_name>Henning Bundgaard, PhD, DMSci</last_name>
<phone>+4535450512</phone>
<email>Henning.Bundgaard@regionh.dk</email>
</overall_contact_backup>
<location>
<facility>
<name>The Heart Centre</name>
<address>
<city>Copenhagen</city>
<zip>2100</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Gorm M Hansen, MD, PHD</last_name>
<phone>+4535454452</phone>
<email>gorm.moerk.hansen@regionh.dk</email>
</contact>
<contact_backup>
<last_name>Henning Bundgaard, PhD, DMSc</last_name>
<phone>+4535450512</phone>
<email>Henning.Bundgaard@regionh.dk</email>
</contact_backup>
</location>
<location>
<facility>
<name>Herlev-Gentofte</name>
<address>
<city>Gentofte</city>
<zip>2820</zip>
<country>Denmark</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Kasper K Iversen, MD, DMSc</last_name>
<phone>+45 38683647</phone>
<email>Kasper.Karmark.Iversen@regionh.dk</email>
</contact>
<contact_backup>
<last_name>Sune A Haahr-Pedersen, MD, PhD</last_name>
<phone>+45 38672267</phone>
<email>sune.ammentorp.haahr-pedersen@regionh.dk</email>
</contact_backup>
<investigator>
<last_name>Kasper K Iversen, MD, DMSc</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Sune A Haahr-Pedersen, MD, PhD</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location_countries>
<country>Denmark</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>March 31, 2022</last_update_submitted>
<last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 8, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
<investigator_full_name>Gorm Mork</investigator_full_name>
<investigator_title>MD, PhD</investigator_title>
</responsible_party>
<keyword>Proteomics</keyword>
<keyword>Metabolomics</keyword>
<keyword>Atherosclerosis</keyword>
<keyword>Angioplasty</keyword>
<keyword>Vascular surgery</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Myocardial Infarction</mesh_term>
<mesh_term>Angina Pectoris</mesh_term>
<mesh_term>Vascular Diseases</mesh_term>
<mesh_term>ST Elevation Myocardial Infarction</mesh_term>
<mesh_term>Angina, Unstable</mesh_term>
<mesh_term>Angina, Stable</mesh_term>
<mesh_term>Infarction</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of the study is to identify proteins, metabolites and signal pathways related
directly to symptomatic atherosclerosis and to disease progression. In the study, we use
residual material from angioplasty catheter balloons and from vascular surgery plus blood
samples. It is the hypothesis that material left on the catheter balloons used for
angioplasty can be used for proteomics and metabolomics evaluation that will identify
inflammation-associated proteins and signaling pathways directly in the diseased vessel. The
tissue samples will be collected after the procedure and blood samples will be collected at
the procedure plus after 6-12 months. The tissue and blood samples will be analyzed using
mass spectrometry methods and a standard panel of biomarkers will also be analyzed using
standardized methods. The analyses will include study of inflammation-associated peptides
observed in autoinflammation as well as thrombogenic signaling pathways and local expression
of biomarkers. The analyses of proteins, metabolites and/or biomarkers will be compared
between cases (stable angina, unstable angina/non-STEMI, STEMI and vascular surgery) and
controls (procedures not related to coronary artery diseases) to identify molecular processes
related directly to symptomatic atherosclerosis and will be associated with disease
progression using data from medical journals and National Health registries. The study will
recruit 225 patients from Rigshospitalet University Hospital, Copenhagen, and Herlev-Gentofte
Hospital.
Tissue samples from the baloon catherther or vascular surgery and blood samples
Patients who have their angioplasty or vascular surgery at the Copenhagen University
hospital (Rigshospitalet) or Herlev-Gentofte hospital
Inclusion Criteria:
- Symptomatic atherosclerotic disease
- 18 years or older
- Angioplasty or vascular surgery
Exclusion Criteria:
- Not willing or unable to give informed consent
|
NCT0531xxxx/NCT05319379.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319379</url>
</required_header>
<id_info>
<org_study_id>22020104-IRB01</org_study_id>
<nct_id>NCT05319379</nct_id>
</id_info>
<brief_title>Clinician Assessment of Patient Dyspnea</brief_title>
<official_title>Clinician Assessment of Patient Dyspnea</official_title>
<sponsors>
<lead_sponsor>
<agency>Rush University Medical Center</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Rush University Medical Center</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Background: Dyspnea, like pain, is subjective and challenging to assess despite the large
number of patients that report shortness of breath. Several studies have shown that
physicians and nurses inaccurately assess patient dyspnea. Since respiratory therapists care
for many patients at risk for dyspnea, an evaluation of their abilities to evaluate dyspnea
is needed. Thus, the plan is to evaluate respiratory therapists' ability to assess a
patient's dyspnea level, in addition to nurses and physicians.

Methods: This is a prospective study to evaluate the agreement between dyspnea assessment by
a patient and respiratory therapist, nurses, and physicians. The primary aim of this study
will be to evaluate clinician ability to assess a patients dyspnea level. The secondary aim
of this study is to identify patient characteristics that might influence clinician ability
to assess dyspnea.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
According to the American Thoracic Society (ATS), the term dyspnea characterizes the
subjective experience of breathing discomfort of patients. Dyspnea, like pain, is subjective.
Currently, there is no single standard evaluation of dyspnea despite the large number of
tools designed to help patients accurately quantify patients who report breathing
discomfort.2 Many patients report dyspnea, and studies have shown significant physiological
responses associated with breathing discomfort. For example, the amygdala is activated with
dyspnea and elicits a sense of impending doom. This is concerning because the prevalence of
dyspnea varies widely, from as high as 65% in lung cancer patients to as low as 16% in
low-risk population. It appears that the prevalence of dyspnea varies vastly between disease
processes, but it not clear if clinicians are able to accurately detect breathing discomfort
on routine assessments.

Various efforts have been made to understand how well physicians and nurses assess the
dyspnea status of patients. In 2017, Binks et al assessed physicians, nurses, and respiratory
therapists on their ability to rate dyspnea in patients requiring mechanical ventilation. The
study found that those patients experienced dyspnea and at a significantly higher prevalence
than any professional had rated. There was also positive correlation between the amount of
discomfort and the degree of underestimation, thus undertreatment which can lead to patient
suffering. In a prospective observational study conducted by Puntillo et al, 171 patients
considered high risk of dying were assessed for symptoms experienced while in the intensive
care unit (ICU). In that study, they found that a significant number of patients had
unaddressed symptoms that contributed to unnecessary suffering. Dyspnea was found to be the
most distressing symptom that patients experienced. Interestingly, dyspnea was noted in
patients that required mechanical ventilation and those that did not.

Stefan et al conducted a study to evaluate the agreement of dyspnea in spontaneously
breathing patients with that of the physicians or nurses' assessment. The researchers found
that physicians underestimated patients' dyspnea 37.9 % of the time and overestimated 25.8%
while nurses underestimated 43.5% and overestimated 12.4%. This is worrisome considering the
number of patients that suffer from dyspnea.

Several studies have shown that clinicians responsible for respiratory assessments, like
physicians and nurses, often inaccurately assess breathing discomfort. Since respiratory
therapists care for many patients at risk for dyspnea, an evaluation of their abilities to
assess it should be made. Findings from a study involving respiratory therapists, along with
findings from other medical professionals, will provide valuable information for future
efforts to better train clinicians on how to best assess dyspnea. The primary aim of this
study will be to evaluate clinician (respiratory therapist, nurse, and physician) ability to
assess patient dyspnea level. The secondary aims of this study are to identify patient
characteristics that might influence clinician ability to assess dyspnea.
</textblock>
</detailed_description>
<overall_status>Active, not recruiting</overall_status>
<start_date type="Actual">April 1, 2022</start_date>
<completion_date type="Anticipated">April 1, 2024</completion_date>
<primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Agreement between patient and clinician assessment of dyspnea</measure>
<time_frame>1 year</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>Patient characteristics that might influence clinician ability to assess dyspnea</measure>
<time_frame>1 year</time_frame>
</secondary_outcome>
<enrollment type="Anticipated">100</enrollment>
<condition>Dyspnea</condition>
<eligibility>
<study_pop>
<textblock>
Patients admitted to Rush University Medical Center
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Adult subjects 18 years and older,

- Admitted to RUMC

- Non-intubated,

- Admitted with a diagnosis of heart failure (HF), chronic obstructive pulmonary disease
(COPD), asthma, pneumonia, a generic diagnosis of shortness of breath, or requiring
supplemental oxygen support.

Exclusion Criteria:

- Less than 18 years old,

- Non-English-speaking,

- Subjects unable to answer questions about dyspnea for any reason.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
</eligibility>
<location>
<facility>
<name>Rush University Medical Center</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<zip>60187</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>May 2023</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>May 3, 2023</last_update_submitted>
<last_update_submitted_qc>May 3, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 6, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Rush University Medical Center</investigator_affiliation>
<investigator_full_name>Brady Scott</investigator_full_name>
<investigator_title>Associate Professor</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Dyspnea</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Background: Dyspnea, like pain, is subjective and challenging to assess despite the large
number of patients that report shortness of breath. Several studies have shown that
physicians and nurses inaccurately assess patient dyspnea. Since respiratory therapists care
for many patients at risk for dyspnea, an evaluation of their abilities to evaluate dyspnea
is needed. Thus, the plan is to evaluate respiratory therapists' ability to assess a
patient's dyspnea level, in addition to nurses and physicians.
Methods: This is a prospective study to evaluate the agreement between dyspnea assessment by
a patient and respiratory therapist, nurses, and physicians. The primary aim of this study
will be to evaluate clinician ability to assess a patients dyspnea level. The secondary aim
of this study is to identify patient characteristics that might influence clinician ability
to assess dyspnea.
According to the American Thoracic Society (ATS), the term dyspnea characterizes the
subjective experience of breathing discomfort of patients. Dyspnea, like pain, is subjective.
Currently, there is no single standard evaluation of dyspnea despite the large number of
tools designed to help patients accurately quantify patients who report breathing
discomfort.2 Many patients report dyspnea, and studies have shown significant physiological
responses associated with breathing discomfort. For example, the amygdala is activated with
dyspnea and elicits a sense of impending doom. This is concerning because the prevalence of
dyspnea varies widely, from as high as 65% in lung cancer patients to as low as 16% in
low-risk population. It appears that the prevalence of dyspnea varies vastly between disease
processes, but it not clear if clinicians are able to accurately detect breathing discomfort
on routine assessments.
Various efforts have been made to understand how well physicians and nurses assess the
dyspnea status of patients. In 2017, Binks et al assessed physicians, nurses, and respiratory
therapists on their ability to rate dyspnea in patients requiring mechanical ventilation. The
study found that those patients experienced dyspnea and at a significantly higher prevalence
than any professional had rated. There was also positive correlation between the amount of
discomfort and the degree of underestimation, thus undertreatment which can lead to patient
suffering. In a prospective observational study conducted by Puntillo et al, 171 patients
considered high risk of dying were assessed for symptoms experienced while in the intensive
care unit (ICU). In that study, they found that a significant number of patients had
unaddressed symptoms that contributed to unnecessary suffering. Dyspnea was found to be the
most distressing symptom that patients experienced. Interestingly, dyspnea was noted in
patients that required mechanical ventilation and those that did not.
Stefan et al conducted a study to evaluate the agreement of dyspnea in spontaneously
breathing patients with that of the physicians or nurses' assessment. The researchers found
that physicians underestimated patients' dyspnea 37.9 % of the time and overestimated 25.8%
while nurses underestimated 43.5% and overestimated 12.4%. This is worrisome considering the
number of patients that suffer from dyspnea.
Several studies have shown that clinicians responsible for respiratory assessments, like
physicians and nurses, often inaccurately assess breathing discomfort. Since respiratory
therapists care for many patients at risk for dyspnea, an evaluation of their abilities to
assess it should be made. Findings from a study involving respiratory therapists, along with
findings from other medical professionals, will provide valuable information for future
efforts to better train clinicians on how to best assess dyspnea. The primary aim of this
study will be to evaluate clinician (respiratory therapist, nurse, and physician) ability to
assess patient dyspnea level. The secondary aims of this study are to identify patient
characteristics that might influence clinician ability to assess dyspnea.
Patients admitted to Rush University Medical Center
Inclusion Criteria:
- Adult subjects 18 years and older,
- Admitted to RUMC
- Non-intubated,
- Admitted with a diagnosis of heart failure (HF), chronic obstructive pulmonary disease
(COPD), asthma, pneumonia, a generic diagnosis of shortness of breath, or requiring
supplemental oxygen support.
Exclusion Criteria:
- Less than 18 years old,
- Non-English-speaking,
- Subjects unable to answer questions about dyspnea for any reason.
|
NCT0531xxxx/NCT05319392.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319392</url>
</required_header>
<id_info>
<org_study_id>2021-240-PhD-EXP-42</org_study_id>
<nct_id>NCT05319392</nct_id>
</id_info>
<brief_title>Transcriptomic Signatures in Gastric Adenocarcinoma</brief_title>
<acronym>GAC</acronym>
<official_title>Exploring the Transcriptomic Signatures and Their Relevance in Gastric Adenocarcinoma</official_title>
<sponsors>
<lead_sponsor>
<agency>Sanjay Gandhi Postgraduate Institute of Medical Sciences</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Sanjay Gandhi Postgraduate Institute of Medical Sciences</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Gastric Adenocarcinoma (GAC) accounting for the major percentage of all stomach malignancies
is associated with a poor overall survival of 25-30% despite the advancement in treatment
strategies. Several factors associated with tumor microenvironment (TME) are thought to play
an important role in tumorigenesis and acquired chemoresistance to therapies that are not
otherwise addressed by the comprehensive molecular classification of GAC given by TCGA and
ACRG. In the present study investigators intend to do transcriptome profiling of GAC tumor
tissue and adjacent normal tissue to investigate differentially expressed genes between the
two in relation to TME which might help in identification of gene signatures that are
clinically relevant with survival outcome in Gastric Adenocarcinoma.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This study on Gastric adenocarcinoma is retrospective as well as prospective that will be
conducted at SGPGIMS, Lucknow, India. Patients undergoing gastric resection at the department
of surgical gastroenterology who are diagnosed with GAC based on the endoscopic biopsy in the
department of pathology will be recruited for the study. For the retrospective part of study,
cases will be selected based on histological findings retrieved from hospital information
system and patient records.

For sample collection, surgically resected fresh specimens will be collected in RNAlater and
stored at -80⁰C. Archived formalin fixed paraffin embedded (FFPE) tissue blocks for
retrospective cases will be retrieved and reviewed histopathologically. After a confirmed
diagnosis of GAC, tissues will be processed to obtain tumor and normal tissue for
experimental part.

RNA from the tumor and normal area will be extracted from FFPE blocks and fresh tissue
specimens. Whole transcriptomic next generation sequencing will be performed after successful
quality check, library preparation and amplification. The gene expression data obtained from
sequencing will be bioinformatically analyzed to elucidate differential gene expression
between tumor and adjacent normal tissue in relation to TME. The significantly differentially
expressed genes between the tumor and normal areas will be annotated and identified using
bioinformatic packages for gene annotation. Using statistical analysis, the differentially
expressed genes will be correlated with the patient's clinical features and outcome to
identify TME genes with significant prognostic value.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">August 6, 2021</start_date>
<completion_date type="Anticipated">October 6, 2025</completion_date>
<primary_completion_date type="Anticipated">April 6, 2025</primary_completion_date>
<study_type>Observational [Patient Registry]</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Only</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<target_duration>2 Years</target_duration>
<primary_outcome>
<measure>Transcriptome profiling of Gastric adenocarcinoma</measure>
<time_frame>Range of 6 months to 5 years of patient recruitment</time_frame>
<description>To obtain gene expression data of cancerous and normal tissue through RNA - sequencing</description>
</primary_outcome>
<primary_outcome>
<measure>Differential gene expression analysis in Gastric adenocarcinoma</measure>
<time_frame>Range of 6 months to 5 years of patient recruitment</time_frame>
<description>To determine differentially expressed gene between tumor and normal tissue through bioinformatic analysis of gene expression data</description>
</primary_outcome>
<primary_outcome>
<measure>Influence of tumor microenvironment on gene expression profile of gastric adenocarcinoma</measure>
<time_frame>Range of 6 months to 5 years of patient recruitment</time_frame>
<description>To identify tumor microenvironment related genes and their functional annotation using bioinformatic packages</description>
</primary_outcome>
<primary_outcome>
<measure>Correlation of tumor microenvironment related genes with patient's clinical features</measure>
<time_frame>Range of 6 months to 5 years of patient recruitment</time_frame>
<description>To correlate differentially expressed tumor microenvironment related gene with outcome in patients to identify genes significantly related with overall survival</description>
</primary_outcome>
<secondary_outcome>
<measure>Patient risk stratification based on correlation between gene expression and overall survival</measure>
<time_frame>Range of 6 months to 5 years of patient recruitment</time_frame>
<description>To stratify patients based on gene signatures related to overall survival in gastric adenocarcinoma patients</description>
</secondary_outcome>
<number_of_groups>1</number_of_groups>
<enrollment type="Anticipated">48</enrollment>
<condition>Gastric Adenocarcinoma</condition>
<arm_group>
<arm_group_label>Patients with Gastric Adenocarcinoma</arm_group_label>
<description>Patients with origin of tumor in distal part of stomach who underwent total or partial gastrectomy after biopsy examination with availability of follow-up and archived FFPE tissue will be considered for this study.</description>
</arm_group>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>Observational study</intervention_name>
<description>Exploration of transcriptomic signatures related to tumor microenvironment having a significant role in prognosis of gastric adenocarcinoma patients</description>
<arm_group_label>Patients with Gastric Adenocarcinoma</arm_group_label>
</intervention>
<biospec_retention>Samples With DNA</biospec_retention>
<biospec_descr>
<textblock>
Surgically resected fresh tissue samples and FFPE blocks of surgical specimens from gastric
adenocarcinoma patients
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
Subjects diagnosed with distal Gastric Adenocarcinoma at SGPGIMS will be recruited for this
study
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Patients with origin of tumor in distal part of stomach

- Patients who underwent Total or partial Gastrectomy after Biopsy examination

- Availability of follow up in Radiotherapy or Gastro department

- Availability of FFPE gastrectomy specimen tissue of selected cases in Histopathology

Exclusion Criteria:

- Patients with origin of tumor in proximal part of stomach

- Patients with only biopsy available

- Patients whose follow-up is not available

- Unavailability of FFPE tissue blocks
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>80 Years</maximum_age>
</eligibility>
<overall_official>
<last_name>Raghavendra Lingaiah</last_name>
<role>Principal Investigator</role>
<affiliation>SGPGIMS</affiliation>
</overall_official>
<overall_contact>
<last_name>Raghavendra Lingaiah</last_name>
<phone>+91-522-2494250</phone>
<email>raghulingaiah@gmail.com</email>
</overall_contact>
<overall_contact_backup>
<last_name>Shalini Singh</last_name>
<email>shal_singh@yahoo.co.uk</email>
</overall_contact_backup>
<location>
<facility>
<name>Sanjay Gandhi Postgraduate Institute of Medical Sciences</name>
<address>
<city>Lucknow</city>
<state>Uttar Pradesh</state>
<zip>226014</zip>
<country>India</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Raghavendra Lingaiah</last_name>
<phone>+91-522-2494250</phone>
<email>raghulingaiah@gmail.com</email>
</contact>
<contact_backup>
<last_name>Shalini Singh</last_name>
<email>shal_singh@yahoo.co.uk</email>
</contact_backup>
</location>
<location_countries>
<country>India</country>
</location_countries>
<reference>
<citation>Ahn B, Chae YS, Kim CH, Lee Y, Lee JH, Kim JY. Tumor microenvironmental factors have prognostic significances in advanced gastric cancer. APMIS. 2018 Oct;126(10):814-821. doi: 10.1111/apm.12889.</citation>
<PMID>30264431</PMID>
</reference>
<reference>
<citation>Zhang S, Zeng Z, Liu Y, Huang J, Long J, Wang Y, Peng X, Hu Z, Ouyang Y. Prognostic landscape of tumor-infiltrating immune cells and immune-related genes in the tumor microenvironment of gastric cancer. Aging (Albany NY). 2020 Sep 23;12(18):17958-17975. doi: 10.18632/aging.103519. Epub 2020 Sep 23.</citation>
<PMID>32969836</PMID>
</reference>
<reference>
<citation>Qiu XT, Song YC, Liu J, Wang ZM, Niu X, He J. Identification of an immune-related gene-based signature to predict prognosis of patients with gastric cancer. World J Gastrointest Oncol. 2020 Aug 15;12(8):857-876. doi: 10.4251/wjgo.v12.i8.857.</citation>
<PMID>32879664</PMID>
</reference>
<reference>
<citation>Ren N, Liang B, Li Y. Identification of prognosis-related genes in the tumor microenvironment of stomach adenocarcinoma by TCGA and GEO datasets. Biosci Rep. 2020 Oct 30;40(10):BSR20200980. doi: 10.1042/BSR20200980.</citation>
<PMID>33015704</PMID>
</reference>
<reference>
<citation>Cai WY, Dong ZN, Fu XT, Lin LY, Wang L, Ye GD, Luo QC, Chen YC. Identification of a Tumor Microenvironment-relevant Gene set-based Prognostic Signature and Related Therapy Targets in Gastric Cancer. Theranostics. 2020 Jul 9;10(19):8633-8647. doi: 10.7150/thno.47938. eCollection 2020.</citation>
<PMID>32754268</PMID>
</reference>
<reference>
<citation>Li T, Gao X, Han L, Yu J, Li H. Identification of hub genes with prognostic values in gastric cancer by bioinformatics analysis. World J Surg Oncol. 2018 Jun 19;16(1):114. doi: 10.1186/s12957-018-1409-3.</citation>
<PMID>29921304</PMID>
</reference>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>April 8, 2022</last_update_submitted>
<last_update_submitted_qc>April 8, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 15, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Sanjay Gandhi Postgraduate Institute of Medical Sciences</investigator_affiliation>
<investigator_full_name>raghavendra</investigator_full_name>
<investigator_title>Assistant professor (Clinical chemistry)</investigator_title>
</responsible_party>
<keyword>Gastric cancer</keyword>
<keyword>Tumor microenvironment</keyword>
<keyword>Transcriptomics</keyword>
<keyword>Differential gene expression</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Adenocarcinoma</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Gastric Adenocarcinoma (GAC) accounting for the major percentage of all stomach malignancies
is associated with a poor overall survival of 25-30% despite the advancement in treatment
strategies. Several factors associated with tumor microenvironment (TME) are thought to play
an important role in tumorigenesis and acquired chemoresistance to therapies that are not
otherwise addressed by the comprehensive molecular classification of GAC given by TCGA and
ACRG. In the present study investigators intend to do transcriptome profiling of GAC tumor
tissue and adjacent normal tissue to investigate differentially expressed genes between the
two in relation to TME which might help in identification of gene signatures that are
clinically relevant with survival outcome in Gastric Adenocarcinoma.
This study on Gastric adenocarcinoma is retrospective as well as prospective that will be
conducted at SGPGIMS, Lucknow, India. Patients undergoing gastric resection at the department
of surgical gastroenterology who are diagnosed with GAC based on the endoscopic biopsy in the
department of pathology will be recruited for the study. For the retrospective part of study,
cases will be selected based on histological findings retrieved from hospital information
system and patient records.
For sample collection, surgically resected fresh specimens will be collected in RNAlater and
stored at -80⁰C. Archived formalin fixed paraffin embedded (FFPE) tissue blocks for
retrospective cases will be retrieved and reviewed histopathologically. After a confirmed
diagnosis of GAC, tissues will be processed to obtain tumor and normal tissue for
experimental part.
RNA from the tumor and normal area will be extracted from FFPE blocks and fresh tissue
specimens. Whole transcriptomic next generation sequencing will be performed after successful
quality check, library preparation and amplification. The gene expression data obtained from
sequencing will be bioinformatically analyzed to elucidate differential gene expression
between tumor and adjacent normal tissue in relation to TME. The significantly differentially
expressed genes between the tumor and normal areas will be annotated and identified using
bioinformatic packages for gene annotation. Using statistical analysis, the differentially
expressed genes will be correlated with the patient's clinical features and outcome to
identify TME genes with significant prognostic value.
Surgically resected fresh tissue samples and FFPE blocks of surgical specimens from gastric
adenocarcinoma patients
Subjects diagnosed with distal Gastric Adenocarcinoma at SGPGIMS will be recruited for this
study
Inclusion Criteria:
- Patients with origin of tumor in distal part of stomach
- Patients who underwent Total or partial Gastrectomy after Biopsy examination
- Availability of follow up in Radiotherapy or Gastro department
- Availability of FFPE gastrectomy specimen tissue of selected cases in Histopathology
Exclusion Criteria:
- Patients with origin of tumor in proximal part of stomach
- Patients with only biopsy available
- Patients whose follow-up is not available
- Unavailability of FFPE tissue blocks
|
NCT0531xxxx/NCT05319405.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319405</url>
</required_header>
<id_info>
<org_study_id>Pro00119759</org_study_id>
<secondary_id>CLN-013-A</secondary_id>
<nct_id>NCT05319405</nct_id>
</id_info>
<brief_title>Effectiveness of Sana Treatment in Post-Traumatic Stress Disorder (PTSD)</brief_title>
<official_title>A Pilot Investigation of the Effectiveness of the Sana Device in Management of PTSD: A Blinded Randomized Controlled Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Sana Health</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
<collaborator>
<agency>Ralph H. Johnson VA Medical Center</agency>
<agency_class>U.S. Fed</agency_class>
</collaborator>
</sponsors>
<source>Sana Health</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>Yes</is_fda_regulated_device>
<is_us_export>No</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this study is to assess the effectiveness of the Sana Device when added to
Treatment as Usual in participants with a diagnosis of post-traumatic stress disorder (PTSD)
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This is a study designed to assess the effectiveness of the Sana Device when added to
Treatment as Usual in participants with a diagnosis of post-traumatic stress disorder (PTSD)
on severity of symptoms as measured by CAPS-5. We will use a 2-arm repeated measures
randomized controlled design in which participants will be randomly assigned to either Sana
plus Treatment as Usual (Sana+TAU) or Treatment as Usual (TAU).
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">April 19, 2023</start_date>
<completion_date type="Anticipated">September 29, 2023</completion_date>
<primary_completion_date type="Anticipated">September 29, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Parallel 2-arm study in which participants will be randomly assigned to either Sana plus Treatment as Usual (Sana+TAU) or Treatment as Usual (TAU)</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Triple (Participant, Care Provider, Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>To examine the difference between Sana plus Treatment as Usual (Sana+TAU) and Treatment as Usual (TAU) on changes in PTSD symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) after 28 days.</measure>
<time_frame>Baseline and Day 28</time_frame>
<description>A 30-item structured interview that can be used to diagnosis and assess PTSD symptoms and severity.</description>
</primary_outcome>
<secondary_outcome>
<measure>To examine the difference between Sana+TAU and TAU on changes in PTSD symptoms as measured by the PTSD Checklist - 20-item scale for DSM-5 (PCL-5) after 28 days.</measure>
<time_frame>Baseline, Days 14 and 28</time_frame>
<description>A 20-item self-reported measure that assesses the 20 DSM-5 symptoms of PTSD.</description>
</secondary_outcome>
<secondary_outcome>
<measure>To examine the difference between Sana+TAU and TAU on anxiety symptoms as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7) after 28 days.</measure>
<time_frame>Baseline, Days 14 and 28</time_frame>
<description>The GAD-7 is a self-reported questionnaire for screening and measuring severity of generalized anxiety disorder.</description>
</secondary_outcome>
<secondary_outcome>
<measure>To examine the difference between Sana+TAU and TAU on depression symptoms as measured by the Patient Health Questionnaire 9 (PHQ-9) after 28 days.</measure>
<time_frame>Baseline, Days 14 and 28</time_frame>
<description>A self-reported questionnaire for screening and measuring severity of generalized anxiety disorder.</description>
</secondary_outcome>
<secondary_outcome>
<measure>To examine the difference between Sana+TAU compared to TAU on perceived change in quality of life over TAU as measured by the Patient Global Impression of Change scale (PGIC) after 28 days.</measure>
<time_frame>Baseline, Days 14 and 28</time_frame>
<description>A validated tool for screening, diagnosing, monitoring and measuring depression severity and scores each of the 9 Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition (DSM-IV) related criteria.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">40</enrollment>
<condition>Post Traumatic Stress Disorder</condition>
<arm_group>
<arm_group_label>Sana plus Treatment as Usual</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Subjects will be loaned a Sana Device to use for 28 days and will also receive mental health care through the Ralph H. Johnson VA Medical Center.</description>
</arm_group>
<arm_group>
<arm_group_label>Treatment as Usual</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>Subjects will receive mental health care at the Ralph H. Johnson VA Medical Center or community-based outpatient clinic (CBOC).</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Sana Device</intervention_name>
<description>Externally worn mask that physically contacts the skin of the face. The Sana Device delivers Audio Visual Stimulation (AVS) in the form of coordinated pulses of light (through closed eyelids) and sound at various frequencies.</description>
<arm_group_label>Sana plus Treatment as Usual</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Having served, or are currently serving, in the US military with a VA CPRS record.

- Willing to and capable of providing written electronic informed consent prior to the
conduct of any study-related procedures.

- Adults, of any sex or gender, 18 to 65 years of age.

- Diagnosis of PTSD as determined by a Clinician Administered PTSD Scale for DSM-5
(CAPS-5) clinical interview or CAPS-5 severity ≥ 25.

- Must be in good physical health based on self-report.

- Any psychotropic drug therapy regimen must be stable (unchanging) for at least 4 weeks
prior to enrollment and remain steady throughout the study.

- Willing and able to comply with the study requirements, complete study assessments,
and participate at scheduled times for the duration of the study.

- Able to understand, speak, and read English sufficient for the completion of study
assessments.

- Provision of appropriate storage and charging for study equipment in a generally safe
and dry condition.

Exclusion Criteria:

- Pregnant, intending to become pregnant, or lactating females as self-reported.

- History or presence of photo-sensitive epilepsy or other photo-sensitive conditions as
self-reported.

- History or presence of condition(s) that may affect balance, such as seizure disorders
or vertigo as self-reported.

- History or presence of severe and continuous tinnitus, at investigator discretion

- Surgery or trauma requiring rehabilitation within the last 12 weeks as self-reported.
Presence of cancer pain, acute pain following injury or other severe pain that would
be anticipated to change during the course of the study, at discretion of the
investigator.

- Vision impairments that affect perception of light, color, or brightness in one or
both eyes, and differences in visual perception between eyes, per patient self-report.

- Deafness in one or both ears, perceived differences in hearing between ears, per
patient self-report.

- Current ear or eye infection, untreated allergies, or acute illness that may affect
eyes or hearing (e.g., due to congestion), per patient self-report.

- Presence of inflammation or broken skin around the eyes in the area of the mask, per
patient self-report.

- Presence of narcolepsy or untreated sleep apnea, per patient self-report. Note:
presence of sleep apnea is permitted, so long as patients feel comfortable to use both
apnea mask and Sana device in conjunction.

- Participation in any other clinical study in which medication(s) are being delivered
or have used an investigational drug or device within the last 30 days.

- Any pending legal action that could prohibit participation or compliance in the study,
per patient self-report.

- Recent history of or current evidence of suicidal intent or active suicidal behavior
based on patient self-report at investigator discretion.

- Significant medical conditions or other circumstances which, in the opinion of the
investigator, would preclude compliance with the protocol, adequate cooperation in the
study or obtaining informed consent, or may prevent the patient from safely
participating in study.

- Employment by the investigator or the study site, with direct involvement in the
proposed study or other studies under the direction of the investigator or study site,
or a family member of an employee or of the investigator.

- Use of drugs that can produce hallucinogenic effects (i.e., Ketamine or psilocybin
mushrooms) within the past 4 weeks.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>65 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Ronald Acierno, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Ralph H. Johnson VA Medical Center</affiliation>
</overall_official>
<overall_contact>
<last_name>Mark Robberson, MBEE</last_name>
<phone>602-448-7127</phone>
<email>mark.robberson@sana.io</email>
</overall_contact>
<location>
<facility>
<name>Ralph H. Johnson Veteran Affairs Medical Center/Lowcountry Center for Veterans Research</name>
<address>
<city>Charleston</city>
<state>South Carolina</state>
<zip>29401</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Stephanie Hart, MPH, CCRC</last_name>
</contact>
<investigator>
<last_name>Ronald Acierno, PhD</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Wendy Muzzy, MRA, MLIS</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>May 2022</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>May 23, 2023</last_update_submitted>
<last_update_submitted_qc>May 23, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 24, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Stress Disorders, Traumatic</mesh_term>
<mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this study is to assess the effectiveness of the Sana Device when added to
Treatment as Usual in participants with a diagnosis of post-traumatic stress disorder (PTSD)
This is a study designed to assess the effectiveness of the Sana Device when added to
Treatment as Usual in participants with a diagnosis of post-traumatic stress disorder (PTSD)
on severity of symptoms as measured by CAPS-5. We will use a 2-arm repeated measures
randomized controlled design in which participants will be randomly assigned to either Sana
plus Treatment as Usual (Sana+TAU) or Treatment as Usual (TAU).
Inclusion Criteria:
- Having served, or are currently serving, in the US military with a VA CPRS record.
- Willing to and capable of providing written electronic informed consent prior to the
conduct of any study-related procedures.
- Adults, of any sex or gender, 18 to 65 years of age.
- Diagnosis of PTSD as determined by a Clinician Administered PTSD Scale for DSM-5
(CAPS-5) clinical interview or CAPS-5 severity ≥ 25.
- Must be in good physical health based on self-report.
- Any psychotropic drug therapy regimen must be stable (unchanging) for at least 4 weeks
prior to enrollment and remain steady throughout the study.
- Willing and able to comply with the study requirements, complete study assessments,
and participate at scheduled times for the duration of the study.
- Able to understand, speak, and read English sufficient for the completion of study
assessments.
- Provision of appropriate storage and charging for study equipment in a generally safe
and dry condition.
Exclusion Criteria:
- Pregnant, intending to become pregnant, or lactating females as self-reported.
- History or presence of photo-sensitive epilepsy or other photo-sensitive conditions as
self-reported.
- History or presence of condition(s) that may affect balance, such as seizure disorders
or vertigo as self-reported.
- History or presence of severe and continuous tinnitus, at investigator discretion
- Surgery or trauma requiring rehabilitation within the last 12 weeks as self-reported.
Presence of cancer pain, acute pain following injury or other severe pain that would
be anticipated to change during the course of the study, at discretion of the
investigator.
- Vision impairments that affect perception of light, color, or brightness in one or
both eyes, and differences in visual perception between eyes, per patient self-report.
- Deafness in one or both ears, perceived differences in hearing between ears, per
patient self-report.
- Current ear or eye infection, untreated allergies, or acute illness that may affect
eyes or hearing (e.g., due to congestion), per patient self-report.
- Presence of inflammation or broken skin around the eyes in the area of the mask, per
patient self-report.
- Presence of narcolepsy or untreated sleep apnea, per patient self-report. Note:
presence of sleep apnea is permitted, so long as patients feel comfortable to use both
apnea mask and Sana device in conjunction.
- Participation in any other clinical study in which medication(s) are being delivered
or have used an investigational drug or device within the last 30 days.
- Any pending legal action that could prohibit participation or compliance in the study,
per patient self-report.
- Recent history of or current evidence of suicidal intent or active suicidal behavior
based on patient self-report at investigator discretion.
- Significant medical conditions or other circumstances which, in the opinion of the
investigator, would preclude compliance with the protocol, adequate cooperation in the
study or obtaining informed consent, or may prevent the patient from safely
participating in study.
- Employment by the investigator or the study site, with direct involvement in the
proposed study or other studies under the direction of the investigator or study site,
or a family member of an employee or of the investigator.
- Use of drugs that can produce hallucinogenic effects (i.e., Ketamine or psilocybin
mushrooms) within the past 4 weeks.
|
NCT0531xxxx/NCT05319418.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319418</url>
</required_header>
<id_info>
<org_study_id>61821</org_study_id>
<nct_id>NCT05319418</nct_id>
</id_info>
<brief_title>Effectiveness of BP Remote Monitoring With Virtual Physician Management in Hypertensive Patients.</brief_title>
<official_title>PILOT: Effectiveness of BP Remote Monitoring Software With Virtual Physician Management in Stage 2 Hypertension Patients With History of Stroke or TIA.</official_title>
<sponsors>
<lead_sponsor>
<agency>AIRx Health, Inc.</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Stanford University</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>AIRx Health, Inc.</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
<is_us_export>No</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
To assess the feasibility and adoptability of DailyDoctor's remote monitoring clinical
decision support software tool in helping physicians virtually manage systolic blood
pressures among patients with history of stroke or TIA to a target systolic blood pressure
(<140 mmHg or a lower target range specified by referring physicians) using remote monitoring
and independent clinical judgement.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
To assess the feasibility and adoptability of DailyDoctor's remote monitoring clinical
decision support software tool in helping physicians virtually manage systolic blood
pressures among patients with history of stroke or TIA to a target systolic blood pressure
(<140 mmHg or a lower target range specified by referring physicians) using remote monitoring
and independent clinical judgement.

To assess the feasibility and adoptability of DailyDoctor's digital platform in helping
Stanford Stroke Center lower and maintain systolic blood pressures among patients with
history of stroke or TIA to a target systolic blood pressure (<140 mmHg or a lower target
range specified by referring physicians) using remote monitoring and a virtual medical team
focused on BP management.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">April 2022</start_date>
<completion_date type="Anticipated">March 2023</completion_date>
<primary_completion_date type="Anticipated">March 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Prevention</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Percent patients within target BP</measure>
<time_frame>24 Weeks</time_frame>
<description>The change in the percentage of patients who are within their target blood pressure range between baseline (based on the average of the first 5 BP readings recorded by the patient using the DailyDoctor platform) and at the completion of the 24 week interv</description>
</primary_outcome>
<secondary_outcome>
<measure>Change in average systolic blood pressure</measure>
<time_frame>24 Weeks</time_frame>
<description>The average systolic blood pressure of the first 5 BP readings recorded by a patient using the DailyDoctor platform will be compared to the average of the last 5 readings of systolic blood pressure reported by the patient using the DailyDoctor platform.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Proportion of patients within target BP range</measure>
<time_frame>Every 4-week period over 24 weeks.</time_frame>
<description>Proportions of patients who are within their target blood pressure range during every 4-week period over 24 weeks.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Time taken to achieve a clinically significant reduction in blood pressure</measure>
<time_frame>Varies, recorded over 24 weeks</time_frame>
<description>Time taken to achieve a clinically significant reduction in blood pressure (5mmHg for systolic blood pressure or 2.5 mmHg in diastolic blood pressure)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Participant compliance</measure>
<time_frame>Recorded over 24 weeks</time_frame>
<description>Participant compliance, defined as the percentage of days that a patient transmits a vital sign reading on a monthly or weekly basis.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Rate of blood pressure decline</measure>
<time_frame>Recorded over 24 weeks</time_frame>
<description>Rate of blood pressure decline</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in number of antihypertensive drugs</measure>
<time_frame>24 Weeks</time_frame>
<description>Change in number of antihypertensive drugs prescribed between baseline and the final assessment</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in number of classes of antihypertensive drugs</measure>
<time_frame>24 Weeks</time_frame>
<description>Change in number of classes of antihypertensive drugs prescribed between baseline and the final assessment with 5 predefined classes: diuretics, angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, calcium channel blockers, β-blockers, and others (α-blockers, hydralazine, minoxidil, clonidine, reserpine, guanethidine, and methyldopa).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number and types of AEs & SAEs</measure>
<time_frame>Recorded over 24 weeks</time_frame>
<description>Number and types of AEs & SAEs</description>
</secondary_outcome>
<secondary_outcome>
<measure>Proportions of patients of various BP categories</measure>
<time_frame>Recorded over 24 weeks</time_frame>
<description>Based on weekly and 4-weekly blood pressure averages, the proportions of patients who are classified as:
Normal (<120 mmHg systolic/ <80 mmHg diastolic) Elevated (120-129 mmHg systolic/ <80 mmHg diastolic). Stage 1 hypertensive: systolic pressure ranging from 130 to 139 mm Hg or a diastolic pressure ranging from 80 to 89 mm Hg.
Stage 2 hypertensive: systolic pressure ≥140 mm Hg or a diastolic pressure ≥90 mm Hg.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">50</enrollment>
<condition>Hypertension</condition>
<condition>Stroke (CVA) or TIA</condition>
<arm_group>
<arm_group_label>Hypertensive Patients Monitored Daily</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Physicians utilize DailyDoctor remote monitoring platform to virtually monitor daily BP of patients. Physicians use their independent medical judgement to recommend any clinical follow up or adjustment in medications/prescriptions for any patients whose daily reporting of BP triggers an alert based on physician-driven alert thresholds.</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Daily Blood Pressure Monitoring</intervention_name>
<description>Patients are provided standard off-the-shelf blood pressure monitors and take their BP vitals daily. Patients report their daily BP through phone or online. BP data is viewed online by physicians who use their independent medical judgement for any changes in medical management.</description>
<arm_group_label>Hypertensive Patients Monitored Daily</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

Age 18 years or older. A history of ischemic or hemorrhagic stroke, or transient ischemic
attack. The ability to report blood pressure values by phone (either a patient or
designated caregiver may call to report values).

At least 2 BP measurements that are ≥140 mmHg systolic or ≥90 mmHg diastolic obtained on
different days in the last 6 months in any setting (including at home, in clinic, or in the
hospital setting).

The referring physician feels the patient would benefit from BP optimization. Consent to
receive care from telehealth physicians available through the DailyDoctor monitoring
platform.

English or Spanish speaking.

Exclusion Criteria:

Currently enrolled in another interventional research study Inability to comply with study
protocol Have a planned surgical procedure during the study period Upper arm circumference
> 20 inches Has diagnosis of end-stage renal disease (GFR < 15 mL/min), Serum creatinine >
2.0 mg/dL (176.8 μmol/L), or currently undergoing dialysis treatment (10) Women who are
pregnant or who are planning to become pregnant during the study period.

Blood pressure reduction is not indicated (e.g. patients who have a high blood pressure
target to augment cerebral perfusion).

Any other reason that, in the opinion of the investigator, makes the person a poor
candidate for participation in this study
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Maarten Lansberg, MD, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Stanford University</affiliation>
</overall_official>
<overall_contact>
<last_name>Michelle Howard</last_name>
<phone>(408) 837-2211</phone>
<email>support@mydailydoctor.com</email>
</overall_contact>
<overall_contact_backup>
<last_name>Vijay Rajasekhar, MD</last_name>
<email>support@mydailydoctor.com</email>
</overall_contact_backup>
<location>
<facility>
<name>Stanford Stroke Center</name>
<address>
<city>Stanford</city>
<state>California</state>
<zip>94304</zip>
<country>United States</country>
</address>
</facility>
<contact>
<last_name>Lironn Kraler, MD</last_name>
<email>lkraler@stanford.edu</email>
</contact>
<contact_backup>
<last_name>Maarten Lansberg, MD PhD</last_name>
<email>lansberg@stanford.edu</email>
</contact_backup>
<investigator>
<last_name>Lironn Kraler, MD</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>https://www.mgma.com/MGMA/media/files/fellowship%20papers/2018%20Fellows%20Papers/Neurology-Workforce-Shortage-KB-FACMPE-FINAL-9-20-2018.pdf?ext=.pdf</url>
<description>Citation 14</description>
</link>
<link>
<url>https://www.cdc.gov/stroke/facts.htm</url>
<description>Citation 13</description>
</link>
<link>
<url>https://www.aamc.org/system/files/2020-06/stratcomm-aamc-physician-workforce-projections-june-2020.pdf</url>
<description>Citation 12</description>
</link>
<link>
<url>https://cardio.jmir.org/2019/1/e130/</url>
<description>Citation 11</description>
</link>
<reference>
<citation>Kitagawa K, Yamamoto Y, Arima H, Maeda T, Sunami N, Kanzawa T, Eguchi K, Kamiyama K, Minematsu K, Ueda S, Rakugi H, Ohya Y, Kohro T, Yonemoto K, Okada Y, Higaki J, Tanahashi N, Kimura G, Umemura S, Matsumoto M, Shimamoto K, Ito S, Saruta T, Shimada K; Recurrent Stroke Prevention Clinical Outcome (RESPECT) Study Group. Effect of Standard vs Intensive Blood Pressure Control on the Risk of Recurrent Stroke: A Randomized Clinical Trial and Meta-analysis. JAMA Neurol. 2019 Nov 1;76(11):1309-1318. doi: 10.1001/jamaneurol.2019.2167.</citation>
<PMID>31355878</PMID>
</reference>
<reference>
<citation>Spruill TM, Williams O, Teresi JA, Lehrer S, Pezzin L, Waddy SP, Lazar RM, Williams SK, Jean-Louis G, Ravenell J, Penesetti S, Favate A, Flores J, Henry KA, Kleiman A, Levine SR, Sinert R, Smith TY, Stern M, Valsamis H, Ogedegbe G. Comparative effectiveness of home blood pressure telemonitoring (HBPTM) plus nurse case management versus HBPTM alone among Black and Hispanic stroke survivors: study protocol for a randomized controlled trial. Trials. 2015 Mar 15;16:97. doi: 10.1186/s13063-015-0605-5.</citation>
<PMID>25873044</PMID>
</reference>
<reference>
<citation>SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9. Erratum In: N Engl J Med. 2017 Dec 21;377(25):2506.</citation>
<PMID>26551272</PMID>
</reference>
<reference>
<citation>Ho TW, Huang CT, Chiu HC, Ruan SY, Tsai YJ, Yu CJ, Lai F; HINT Study Group. Effectiveness of Telemonitoring in Patients with Chronic Obstructive Pulmonary Disease in Taiwan-A Randomized Controlled Trial. Sci Rep. 2016 Mar 31;6:23797. doi: 10.1038/srep23797.</citation>
<PMID>27029815</PMID>
</reference>
<reference>
<citation>Achelrod D, Schreyogg J, Stargardt T. Health-economic evaluation of home telemonitoring for COPD in Germany: evidence from a large population-based cohort. Eur J Health Econ. 2017 Sep;18(7):869-882. doi: 10.1007/s10198-016-0834-x. Epub 2016 Oct 3. Erratum In: Eur J Health Econ. 2021 Jun;22(4):659-660.</citation>
<PMID>27699567</PMID>
</reference>
<reference>
<citation>Weissman GE, Kerlin MP, Yuan Y, Kohn R, Anesi GL, Groeneveld PW, Werner RM, Halpern SD. Potentially Preventable Intensive Care Unit Admissions in the United States, 2006-2015. Ann Am Thorac Soc. 2020 Jan;17(1):81-88. doi: 10.1513/AnnalsATS.201905-366OC.</citation>
<PMID>31581801</PMID>
</reference>
<reference>
<citation>Logan AG, McIsaac WJ, Tisler A, Irvine MJ, Saunders A, Dunai A, Rizo CA, Feig DS, Hamill M, Trudel M, Cafazzo JA. Mobile phone-based remote patient monitoring system for management of hypertension in diabetic patients. Am J Hypertens. 2007 Sep;20(9):942-8. doi: 10.1016/j.amjhyper.2007.03.020.</citation>
<PMID>17765133</PMID>
</reference>
<reference>
<citation>Stevens LA, Greene T, Levey AS. Surrogate end points for clinical trials of kidney disease progression. Clin J Am Soc Nephrol. 2006 Jul;1(4):874-84. doi: 10.2215/CJN.00600206. Epub 2006 Jun 14. No abstract available.</citation>
<PMID>17699300</PMID>
</reference>
<verification_date>April 2022</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>April 1, 2022</last_update_submitted>
<last_update_submitted_qc>April 1, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 8, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>remote patient monitoring</keyword>
<keyword>digital health monitoring</keyword>
<keyword>blood pressure monitoring</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Hypertension</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
To assess the feasibility and adoptability of DailyDoctor's remote monitoring clinical
decision support software tool in helping physicians virtually manage systolic blood
pressures among patients with history of stroke or TIA to a target systolic blood pressure
(<140 mmHg or a lower target range specified by referring physicians) using remote monitoring
and independent clinical judgement.
To assess the feasibility and adoptability of DailyDoctor's remote monitoring clinical
decision support software tool in helping physicians virtually manage systolic blood
pressures among patients with history of stroke or TIA to a target systolic blood pressure
(<140 mmHg or a lower target range specified by referring physicians) using remote monitoring
and independent clinical judgement.
To assess the feasibility and adoptability of DailyDoctor's digital platform in helping
Stanford Stroke Center lower and maintain systolic blood pressures among patients with
history of stroke or TIA to a target systolic blood pressure (<140 mmHg or a lower target
range specified by referring physicians) using remote monitoring and a virtual medical team
focused on BP management.
Inclusion Criteria:
Age 18 years or older. A history of ischemic or hemorrhagic stroke, or transient ischemic
attack. The ability to report blood pressure values by phone (either a patient or
designated caregiver may call to report values).
At least 2 BP measurements that are ≥140 mmHg systolic or ≥90 mmHg diastolic obtained on
different days in the last 6 months in any setting (including at home, in clinic, or in the
hospital setting).
The referring physician feels the patient would benefit from BP optimization. Consent to
receive care from telehealth physicians available through the DailyDoctor monitoring
platform.
English or Spanish speaking.
Exclusion Criteria:
Currently enrolled in another interventional research study Inability to comply with study
protocol Have a planned surgical procedure during the study period Upper arm circumference
> 20 inches Has diagnosis of end-stage renal disease (GFR < 15 mL/min), Serum creatinine >
2.0 mg/dL (176.8 μmol/L), or currently undergoing dialysis treatment (10) Women who are
pregnant or who are planning to become pregnant during the study period.
Blood pressure reduction is not indicated (e.g. patients who have a high blood pressure
target to augment cerebral perfusion).
Any other reason that, in the opinion of the investigator, makes the person a poor
candidate for participation in this study
|
NCT0531xxxx/NCT05319431.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319431</url>
</required_header>
<id_info>
<org_study_id>AK104-216</org_study_id>
<nct_id>NCT05319431</nct_id>
</id_info>
<brief_title>A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC</brief_title>
<official_title>An Open Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AK104 Plus Lenvatinib and TACE in the Treatment of Unresectable, Non-metastatic Hepatocellular Carcinoma</official_title>
<sponsors>
<lead_sponsor>
<agency>Akeso</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Akeso</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
To evaluate the efficacy and safety of AK104 plus lenvatinib combined with on-demand TACE in
participants with unresectable, non-metastatic hepatocellular carcinoma
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">June 28, 2022</start_date>
<completion_date type="Anticipated">June 30, 2025</completion_date>
<primary_completion_date type="Anticipated">April 17, 2023</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Progression-free survival (PFS)</measure>
<time_frame>Up to 2 years</time_frame>
<description>Progression-free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, which ever occurs first.</description>
</primary_outcome>
<secondary_outcome>
<measure>Objective response rate (ORR</measure>
<time_frame>Up to 2 years</time_frame>
<description>ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Disease control rate (DCR)</measure>
<time_frame>Up to 2 years</time_frame>
<description>The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Duration of response (DoR)</measure>
<time_frame>Up to 2 years</time_frame>
<description>Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of participants with adverse events (AEs)</measure>
<time_frame>the time of informed consent signed through 90 days after the last dose</time_frame>
<description>An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">60</enrollment>
<condition>Unresectable, Non-metastatic Hepatocellular Carcinoma</condition>
<arm_group>
<arm_group_label>AK104+Lenvatinib+TACE</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive AK104 IV every 3 weeks (Q3W) and Lenvatinib 12mg weight≥60kg or 8mg weight<60kg,PO QD The first Transarterial chemoembolization will be performed at the beginning of study.</description>
</arm_group>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>AK104</intervention_name>
<description>Subjects will receive AK104 until disease progression or for a maximum of 24 months</description>
<arm_group_label>AK104+Lenvatinib+TACE</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Lenvatinib</intervention_name>
<description>Subjects will receive lenvatinib until disease progression or for a maximum of 24 months</description>
<arm_group_label>AK104+Lenvatinib+TACE</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>TACE</intervention_name>
<description>On demand TACE</description>
<arm_group_label>AK104+Lenvatinib+TACE</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Signed written informed consent form voluntarily.

- Histologically or cytologically documented hepatocellular carcinoma.

- CNLC IIa IIb or IIIa

- The main portal vein was not completely obstructed,

- Child-Pugh A or B

- At least one measurable lesion according to RECIST criteria

- ECOG PS 0-1

- Adequate organ function

- Estimated life expectancy of ≥3 months

- For women of childbearing potential: agreement to remain abstinent; For men: agreement
to remain abstinent

Exclusion Criteria:

- Histologically or cytologically documented fibrolamellar hepatocellular carcinoma,
sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc

- For HCC lesions ≥ 10 cm in any dimension, imaging evaluation showed that there were
more than 10 lesions

- The main portal vein and the left and right primary branches were clogged with cancer
thrombus

- History of hepatic encephalopathy or liver transplantation

- Any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under
thrombolytic therapy.

- Occurred arteriovenous thromboembolic events within 6 months before the first
administration.

- Inadequately controlled hypertension.

- Attack of symptomatic congestive heart failure (LVEF<50%); History of congenital long
QT syndrome.

- Known presence or history of interstitial lung disease or required hormone treatment
interstitial lung disease.

- Severe infections.

- Receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy,

- Enrollment of another clinical study within 4 weeks prior to the first administration
of study drugs.

- Unable to receive an enhanced CT or MRI scan of the liver.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>75 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Guoliang Shao, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Zhejiang Cancer Hospital</affiliation>
</overall_official>
<overall_contact>
<last_name>Ting Liu, MD</last_name>
<phone>(0760)89873999</phone>
<email>clinicaltrials@akesobio.com</email>
</overall_contact>
<location>
<facility>
<name>The First Hospital of Beijing University</name>
<address>
<city>Beijing</city>
<state>Beijing</state>
<zip>100034</zip>
<country>China</country>
</address>
</facility>
<status>Not yet recruiting</status>
</location>
<location>
<facility>
<name>Nanfang Hospital, Southern Medical University</name>
<address>
<city>Guangzhou</city>
<state>Guangdong</state>
<zip>510515</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Henan Cancer Hospital</name>
<address>
<city>Zhengzhou</city>
<state>Henan</state>
<zip>450003</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Hunan Cancer Hospital</name>
<address>
<city>Changsha</city>
<state>Hunan</state>
<zip>410013</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location>
<facility>
<name>Shandong Cancer Hospital</name>
<address>
<city>Jinan</city>
<state>Shandong</state>
<zip>250117</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>August 2022</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>August 11, 2022</last_update_submitted>
<last_update_submitted_qc>August 11, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">August 15, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Carcinoma</mesh_term>
<mesh_term>Carcinoma, Hepatocellular</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Lenvatinib</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
To evaluate the efficacy and safety of AK104 plus lenvatinib combined with on-demand TACE in
participants with unresectable, non-metastatic hepatocellular carcinoma
Inclusion Criteria:
- Signed written informed consent form voluntarily.
- Histologically or cytologically documented hepatocellular carcinoma.
- CNLC IIa IIb or IIIa
- The main portal vein was not completely obstructed,
- Child-Pugh A or B
- At least one measurable lesion according to RECIST criteria
- ECOG PS 0-1
- Adequate organ function
- Estimated life expectancy of ≥3 months
- For women of childbearing potential: agreement to remain abstinent; For men: agreement
to remain abstinent
Exclusion Criteria:
- Histologically or cytologically documented fibrolamellar hepatocellular carcinoma,
sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc
- For HCC lesions ≥ 10 cm in any dimension, imaging evaluation showed that there were
more than 10 lesions
- The main portal vein and the left and right primary branches were clogged with cancer
thrombus
- History of hepatic encephalopathy or liver transplantation
- Any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under
thrombolytic therapy.
- Occurred arteriovenous thromboembolic events within 6 months before the first
administration.
- Inadequately controlled hypertension.
- Attack of symptomatic congestive heart failure (LVEF<50%); History of congenital long
QT syndrome.
- Known presence or history of interstitial lung disease or required hormone treatment
interstitial lung disease.
- Severe infections.
- Receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy,
- Enrollment of another clinical study within 4 weeks prior to the first administration
of study drugs.
- Unable to receive an enhanced CT or MRI scan of the liver.
|
NCT0531xxxx/NCT05319444.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319444</url>
</required_header>
<id_info>
<org_study_id>RFarah</org_study_id>
<nct_id>NCT05319444</nct_id>
</id_info>
<brief_title>Cleansing Device for the Treatment of Scalp and Hair Conditions</brief_title>
<official_title>Cleansing Device for the Treatment of Scalp and Hair Conditions</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Minnesota</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of Minnesota</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>Yes</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The objective of this study is to evaluate an improvement of scalp health after the use of an
investigational off-label WaterPik and brush device aimed to massage and cleanse the scalp.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Seborrheic dermatitis and dandruff are skin conditions that present with common features and
respond similarly to treatments. Dandruff involves flaking skin that can cause irritation and
itching. Dandruff only involves the scalp, whereas seborrheic dermatitis can occur on the
scalp, face, chest, and retro-auricular areas. Seborrheic dermatitis can also result in
itching and flaking, as well as inflammation and erythema. Both dandruff and seborrheic
dermatitis are known to be harmful to the scalp.

Despite shampoo and washing, one may still continue to have flaking and scale present on the
scalp. There are numerous scalp massages and brushes on the consumer market. Waterpik® was
FDA approved in 2018 to provide pressured water combined with a powered toothbrush for
optimal plaque and particle removal when cleaning the mouth and teeth. Waterpik® now has
several products on the market designed for oral health, pet care, and washing in the shower.
The off-label design utilizes the Waterpik® device, but with adjustments optimized for scalp
health.

Through the investigational use of the off-label WaterPik® and brush device, the
investigators propose the technique of massage and gentle water pressure will reduce
seborrheic dermatitis and dandruff on the scalp.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">June 30, 2022</start_date>
<completion_date type="Anticipated">July 2024</completion_date>
<primary_completion_date type="Anticipated">July 2024</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Single (Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Change in Adherent Scalp Flaking Scale (ASFS)</measure>
<time_frame>4 weeks</time_frame>
<description>The presence of dandruff flakes adhereing to the scalp in 8 defined areas is rated on a scale of 0-10 per area, where 0 indicates no flakes and 10 indicates heavy flaking. This is combined for total scores ranging from 0-80.</description>
</primary_outcome>
<secondary_outcome>
<measure>Change in Erythema Score</measure>
<time_frame>4 weeks</time_frame>
<description>The presence of erythema is rated on a scale of 0-4, where 0 indicates None, 1 indicates Minimal - barely perceptible erythema, 2 indicates Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema, 3 indicates Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red), and 4 indicates Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema. The higher score means a worse outcome.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in Patient Sensory Assessment of Scalp & Hair Score</measure>
<time_frame>4 weeks</time_frame>
<description>This Score is based on 12 descriptions that patients rate 0-10 to assess the condition of their scalp and hair. A higher score means a worse outcome.</description>
</secondary_outcome>
<number_of_arms>8</number_of_arms>
<enrollment type="Anticipated">40</enrollment>
<condition>Dandruff</condition>
<condition>Seborrheic Dermatitis</condition>
<condition>Hair Loss</condition>
<arm_group>
<arm_group_label>Healthy Scalp and one treatment</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants with healthy scalps who will receive one treatment with the device and complete one in-person follow-up.</description>
</arm_group>
<arm_group>
<arm_group_label>Healthy Scalp and three treatments</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants with healthy scalps who will receive three treatments with the device and complete one in-person follow-up.</description>
</arm_group>
<arm_group>
<arm_group_label>Dandruff and one treatment</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants with dandruff who will receive one treatment with the device and complete one in-person follow-up.</description>
</arm_group>
<arm_group>
<arm_group_label>Dandruff and three treatments</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants with dandruff who will receive three treatments with the device and complete one in-person follow-up.</description>
</arm_group>
<arm_group>
<arm_group_label>Hair loss disease and one treatment</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants with hair loss disease who will receive one treatment with the device and complete one in-person follow-up.</description>
</arm_group>
<arm_group>
<arm_group_label>Seborrheic Dermatitis with one treatment</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants with seborrheic dermatitis disease who will receive one treatment with the device and complete one in-person follow-up.</description>
</arm_group>
<arm_group>
<arm_group_label>Seborrheic Dermatitis and three treatments</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants with seborrheic dermatitis who will receive three treatments with the device and complete one in-person follow-up.</description>
</arm_group>
<arm_group>
<arm_group_label>Hair loss disease and three treatments</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants with hair loss disease who will receive three treatments with the device and complete one in-person follow-up.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Off-brand Waterpik®</intervention_name>
<description>Study staff will use the Waterpik® device and brush for approximately two to five minutes on the participant's scalp until all scale and other debris appears to be resolved. Their scalp will then be rinsed and gently dried with a towel.
The off-label design utilizes the Waterpik® device, but with adjustments optimized for scalp health. The device settings are adjustable during the treatment, ranging from settings of 2-10. Study staff plan to utilize the setting of 10 unless the participant indicates discomfort. Investigators attached a small Losophy brush in replacement of the Waterpik® toothbrush. The small Losophy brush was connected to the device via PVC heat shrink and a hole was drilled on the brush in order to deliver water while simultaneously utilizing the brush on the scalp.</description>
<arm_group_label>Dandruff and one treatment</arm_group_label>
<arm_group_label>Dandruff and three treatments</arm_group_label>
<arm_group_label>Hair loss disease and one treatment</arm_group_label>
<arm_group_label>Hair loss disease and three treatments</arm_group_label>
<arm_group_label>Healthy Scalp and one treatment</arm_group_label>
<arm_group_label>Healthy Scalp and three treatments</arm_group_label>
<arm_group_label>Seborrheic Dermatitis and three treatments</arm_group_label>
<arm_group_label>Seborrheic Dermatitis with one treatment</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Participants must qualify for one of the following scalp conditions based on clinical
opinion of a board-certified dermatologist: healthy scalp, dandruff, seborrheic
dermatitis, or hair loss disease

- All Women of Child Bearing Potential must indicate use of two of the following
contraceptive methods. The WaterPik device uses an ultrasonic technology which
includes ultrasound. Unnecessary ultrasound is not recommended for pregnant women.

- Combined (estrogen and progestogen containing) hormonal contraception associated
with inhibition of ovulation (oral, intravaginal, or transdermal)

- Progestogen-only hormonal contraception associated with inhibition of ovulation
(oral, injectable, or implantable)

- Intrauterine device (IUD)

- Intraurerine hormone-releasing system (IUS)

- Vasectomized partner

- Sexual abstinence

- Barrier method, such as a condom

Exclusion Criteria:

- Non-English speaking

- Exclusion related to pregnancy, lactation, or plans to become pregnant over the course
of the study (based on self-report from the participant)

- Current clinical condition that, in the opinion of the site investigator, would
interfere with adherence to study requirements
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Ronda Farah, MD</last_name>
<role>Principal Investigator</role>
<affiliation>University of Minnesota Medical School Department of Dermatology</affiliation>
</overall_official>
<overall_official>
<last_name>Maria Hordinsky, MD</last_name>
<role>Principal Investigator</role>
<affiliation>University of Minnesota Medical School Department of Dermatology</affiliation>
</overall_official>
<overall_contact>
<last_name>Ronda Farah, MD</last_name>
<phone>(612)-625-8625</phone>
<email>dermresearch@umn.edu</email>
</overall_contact>
<overall_contact_backup>
<last_name>Maria Hordinsky, MD</last_name>
<phone>(612)-625-8625</phone>
<email>dermresearch@umn.edu</email>
</overall_contact_backup>
<location>
<facility>
<name>University of Minnesota</name>
<address>
<city>Minneapolis</city>
<state>Minnesota</state>
<zip>55455</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Ronda Farah, MD</last_name>
<phone>612-625-8625</phone>
<email>dermresearch@umn.edu</email>
</contact>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>August 2023</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>August 16, 2023</last_update_submitted>
<last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">August 18, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Dermatitis</mesh_term>
<mesh_term>Dermatitis, Seborrheic</mesh_term>
<mesh_term>Dandruff</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The objective of this study is to evaluate an improvement of scalp health after the use of an
investigational off-label WaterPik and brush device aimed to massage and cleanse the scalp.
Seborrheic dermatitis and dandruff are skin conditions that present with common features and
respond similarly to treatments. Dandruff involves flaking skin that can cause irritation and
itching. Dandruff only involves the scalp, whereas seborrheic dermatitis can occur on the
scalp, face, chest, and retro-auricular areas. Seborrheic dermatitis can also result in
itching and flaking, as well as inflammation and erythema. Both dandruff and seborrheic
dermatitis are known to be harmful to the scalp.
Despite shampoo and washing, one may still continue to have flaking and scale present on the
scalp. There are numerous scalp massages and brushes on the consumer market. Waterpik® was
FDA approved in 2018 to provide pressured water combined with a powered toothbrush for
optimal plaque and particle removal when cleaning the mouth and teeth. Waterpik® now has
several products on the market designed for oral health, pet care, and washing in the shower.
The off-label design utilizes the Waterpik® device, but with adjustments optimized for scalp
health.
Through the investigational use of the off-label WaterPik® and brush device, the
investigators propose the technique of massage and gentle water pressure will reduce
seborrheic dermatitis and dandruff on the scalp.
Inclusion Criteria:
- Participants must qualify for one of the following scalp conditions based on clinical
opinion of a board-certified dermatologist: healthy scalp, dandruff, seborrheic
dermatitis, or hair loss disease
- All Women of Child Bearing Potential must indicate use of two of the following
contraceptive methods. The WaterPik device uses an ultrasonic technology which
includes ultrasound. Unnecessary ultrasound is not recommended for pregnant women.
- Combined (estrogen and progestogen containing) hormonal contraception associated
with inhibition of ovulation (oral, intravaginal, or transdermal)
- Progestogen-only hormonal contraception associated with inhibition of ovulation
(oral, injectable, or implantable)
- Intrauterine device (IUD)
- Intraurerine hormone-releasing system (IUS)
- Vasectomized partner
- Sexual abstinence
- Barrier method, such as a condom
Exclusion Criteria:
- Non-English speaking
- Exclusion related to pregnancy, lactation, or plans to become pregnant over the course
of the study (based on self-report from the participant)
- Current clinical condition that, in the opinion of the site investigator, would
interfere with adherence to study requirements
|
NCT0531xxxx/NCT05319457.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319457</url>
</required_header>
<id_info>
<org_study_id>CTR radon PCF</org_study_id>
<nct_id>NCT05319457</nct_id>
</id_info>
<brief_title>Testing Radon Com Methods: Clinical Trial Smartphone App vs Print Brochures</brief_title>
<official_title>Testing Radon Com Methods: Clinical Trial Smartphone App vs Print Brochures</official_title>
<sponsors>
<lead_sponsor>
<agency>University of North Dakota</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of North Dakota</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this research study is to compare the effectiveness of radon information
delivered via the radon app vs. a traditional approach (printed brochure). The prevalence of
exceptionally high levels of residential radon in ND, coupled with public's poor
understanding of this hazard, is a critical public health problem.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">May 5, 2022</start_date>
<completion_date type="Actual">September 1, 2022</completion_date>
<primary_completion_date type="Actual">August 5, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Prevention</primary_purpose>
<masking>Double (Participant, Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Ordering a free radon test kit</measure>
<time_frame>Through the study completion - 3 months</time_frame>
<description>The rate at which participants order a free radon test kit</description>
</primary_outcome>
<primary_outcome>
<measure>Using the radon test kit</measure>
<time_frame>Through the study completion - 3 months</time_frame>
<description>The rate at which participants use the radon test kit to test their houses</description>
</primary_outcome>
<primary_outcome>
<measure>Change from baseline radon knowledge at 3 months</measure>
<time_frame>Change from baseline knowledge level to the completion of study at 3 months</time_frame>
<description>Participants' knowledge about radon and its dangers, how to protect themselves from radon, etc.</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">130</enrollment>
<condition>Lung Cancer</condition>
<arm_group>
<arm_group_label>Print brochures</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>Participants assigned to the print brochure group will receive three educational print brochures about radon published by EPA via postal mails for three months (one per each month).</description>
</arm_group>
<arm_group>
<arm_group_label>The radon app</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants assigned to the radon app group will be asked to use the radon app for three months where they will be exposed to mobile friendly educational content that is repurposed from educational print brochures about radon published by EPA.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>The radon app</intervention_name>
<description>Participants will be asked to use the radon app.</description>
<arm_group_label>The radon app</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Print brochure</intervention_name>
<description>Participants will receive print brochures.</description>
<arm_group_label>Print brochures</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- The principal eligibility criterion is that participants own a smartphone.

Exclusion Criteria:

- The principal exclusion criterion is previous testing for radon within the past two
years.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Soojung Kim</last_name>
<role>Study Director</role>
<affiliation>University of North Dakota</affiliation>
</overall_official>
<overall_official>
<last_name>Gary G Schwartz</last_name>
<role>Principal Investigator</role>
<affiliation>University of North Dakota</affiliation>
</overall_official>
<location>
<facility>
<name>University of North Dakota</name>
<address>
<city>Grand Forks</city>
<state>North Dakota</state>
<zip>58202</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>November 2022</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>November 1, 2022</last_update_submitted>
<last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">November 2, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of North Dakota</investigator_affiliation>
<investigator_full_name>Soojung Kim</investigator_full_name>
<investigator_title>Associate Professor</investigator_title>
</responsible_party>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this research study is to compare the effectiveness of radon information
delivered via the radon app vs. a traditional approach (printed brochure). The prevalence of
exceptionally high levels of residential radon in ND, coupled with public's poor
understanding of this hazard, is a critical public health problem.
Inclusion Criteria:
- The principal eligibility criterion is that participants own a smartphone.
Exclusion Criteria:
- The principal exclusion criterion is previous testing for radon within the past two
years.
|
NCT0531xxxx/NCT05319470.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319470</url>
</required_header>
<id_info>
<org_study_id>ES3/Th11/03-02-2022</org_study_id>
<nct_id>NCT05319470</nct_id>
</id_info>
<brief_title>Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives</brief_title>
<official_title>Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives</official_title>
<sponsors>
<lead_sponsor>
<agency>Democritus University of Thrace</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Democritus University of Thrace</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Primary objective of this study is to study the efficacy of travoprost without preservatives
in the treatment of glaucoma patients and to monitor the ocular surface.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This is a prospective study including patients visiting the outpatient glaucoma clinic of the
University General Hospital of Alexandroupolis for their standard evaluation. Study
population is already under treatment with a travoprost preparation without preservatives.
They will be fully informed about the procedure and the purpose of the study and a written
consent will be obtained. For every patient included in the study intraocular pressure will
be measured using a Goldman applanation tonometer, according to the standard way of practice
at our clinic. Also, Tear Break-Up-Time (BUT), conjunctival hyperemia grading and Schirmer
testing will be used to assess the ocular surface state. Visual field tests and OCT RNFL
measurements will also be obtained. The above measurements will be repeated 6 months after
the initial examination.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">March 15, 2022</start_date>
<completion_date type="Actual">May 15, 2023</completion_date>
<primary_completion_date type="Actual">April 15, 2023</primary_completion_date>
<study_type>Observational [Patient Registry]</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<target_duration>6 Months</target_duration>
<primary_outcome>
<measure>Intraocular Pressure (IOP)</measure>
<time_frame>6 months</time_frame>
<description>Intraocular pressure measurement in both eyes using the Goldman applanation tonometer.</description>
</primary_outcome>
<primary_outcome>
<measure>Ocular Surface Disease</measure>
<time_frame>6 months</time_frame>
<description>Tear breakup time (TBUT), conjuctival hyperemia scoring and Schirmer testing will be used to assess the ocular surface state of the study population.</description>
</primary_outcome>
<number_of_groups>1</number_of_groups>
<enrollment type="Actual">25</enrollment>
<condition>Glaucoma</condition>
<condition>Glaucoma; Drugs</condition>
<condition>Ocular Surface Disease</condition>
<arm_group>
<arm_group_label>Study Group</arm_group_label>
<description>100 patients with diagnosed glaucoma receiving travoprost without preservatives</description>
</arm_group>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>Intraocular pressure (IOP)</intervention_name>
<description>Measurement of intraocular pressure in both eyes of the study population using the Goldman applanation tonometer.</description>
<arm_group_label>Study Group</arm_group_label>
</intervention>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>Tear Break-up Time (TBUT)</intervention_name>
<description>TBUT will be calculated after instillation of a drop of fluorescein dye, by slit lamp biomicroscopy.</description>
<arm_group_label>Study Group</arm_group_label>
</intervention>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>Conjuctival Hyperemia</intervention_name>
<description>Conjunctival hyperemia will be assessed by slit lamp biomicroscopy using a validated grading system.</description>
<arm_group_label>Study Group</arm_group_label>
</intervention>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>Schirmer Test</intervention_name>
<description>Schirmer test will be performed on both eyes to asses tear production.</description>
<arm_group_label>Study Group</arm_group_label>
</intervention>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>Visual Fields and OCT RNFL</intervention_name>
<description>Visual field examination using a Humphrey perimeter and measurement of peripapillary retinal nerve fiber layer thickness with optical coherence tomography.</description>
<arm_group_label>Study Group</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
Adult glaucoma patients already under treatment with travoprost without preservatives.
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Patients with glaucoma treated with travoprost without preservatives.

Exclusion Criteria:

- Co-administration of another anti-glaucoma preparation with or without preservatives,
Sjogren's syndrome, poor eyelid occlusion of any etiology.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>35 Years</minimum_age>
<maximum_age>90 Years</maximum_age>
</eligibility>
<overall_official>
<last_name>Georgios Labiris, MD,PhD</last_name>
<role>Study Chair</role>
<affiliation>Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece</affiliation>
</overall_official>
<location>
<facility>
<name>Department of Ophthalmology, University Hospital of Alexandroupolis</name>
<address>
<city>Alexandroupolis</city>
<state>Evros</state>
<zip>68100</zip>
<country>Greece</country>
</address>
</facility>
</location>
<location_countries>
<country>Greece</country>
</location_countries>
<verification_date>June 2023</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>June 30, 2023</last_update_submitted>
<last_update_submitted_qc>June 30, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">July 5, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Democritus University of Thrace</investigator_affiliation>
<investigator_full_name>Georgios Labiris</investigator_full_name>
<investigator_title>Professor (Associate) of Democritus University of Thrace</investigator_title>
</responsible_party>
<keyword>glaucoma</keyword>
<keyword>travoprost</keyword>
<keyword>prostaglandin without preservatives</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Glaucoma</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Primary objective of this study is to study the efficacy of travoprost without preservatives
in the treatment of glaucoma patients and to monitor the ocular surface.
This is a prospective study including patients visiting the outpatient glaucoma clinic of the
University General Hospital of Alexandroupolis for their standard evaluation. Study
population is already under treatment with a travoprost preparation without preservatives.
They will be fully informed about the procedure and the purpose of the study and a written
consent will be obtained. For every patient included in the study intraocular pressure will
be measured using a Goldman applanation tonometer, according to the standard way of practice
at our clinic. Also, Tear Break-Up-Time (BUT), conjunctival hyperemia grading and Schirmer
testing will be used to assess the ocular surface state. Visual field tests and OCT RNFL
measurements will also be obtained. The above measurements will be repeated 6 months after
the initial examination.
Adult glaucoma patients already under treatment with travoprost without preservatives.
Inclusion Criteria:
- Patients with glaucoma treated with travoprost without preservatives.
Exclusion Criteria:
- Co-administration of another anti-glaucoma preparation with or without preservatives,
Sjogren's syndrome, poor eyelid occlusion of any etiology.
|
NCT0531xxxx/NCT05319483.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319483</url>
</required_header>
<id_info>
<org_study_id>8850 PTE 2021</org_study_id>
<nct_id>NCT05319483</nct_id>
</id_info>
<brief_title>The Clinical, Epidemiological and Treatment Characteristics of Head and Neck Cancer Patients</brief_title>
<official_title>The Clinical, Epidemiological and Treatment Characteristics of Head and Neck Cancer Patients Presenting to Different Levels of the Health Care System</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Pecs</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of Pecs</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The aim of our study is to prospectively collect information regarding (1) the demographic,
lifestyle-related and clinical characteristics of patients with head and neck cancer and (2)
the waiting times to diagnosis and therapy, and the 1-, 3- and 5-year survival of patients.
We plan to gain insight into the characteristics and pathways of head and neck cancer
patients in Baranya County, which can in turn help to identify factors that lead to improved
or worse disease outcomes. (Thus, these factors can subsequently eliminated or lessened to
improve the outcome of head and neck cancer patients. )
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The aim of our study is to prospectively collect information regarding (1) the demographic,
lifestyle-related and clinical characteristics of patients (including initial symptoms) with
head and neck cancer and (2) the patient pathways and waiting times to diagnosis and therapy,
the 1-, 3- and 5-year survival, and time to metastasis of patients.

Study design:

Prospective data collection and analysis, based on data collected from the clinic's
electronic eMedSol database and questionnaire (regarding demographic, lifestyle and patient
pathway-related data) filled in by interviewing patient.

We plan to monitor lifestyle parameters of patients (such as oral hygiene, alcohol
consumption and smoking, the knowledge of patients about risk factors of head and neck
cancers,etc) and clinical parameters such as time and type of first symptom, ECOG state,
comorbidities, clinical stage, diagnostic workups, etc. at predetermined time intervals (upon
first ENT presentation, and at 3-, 6-, 12-, and 24 month intervals.

Disease progression (time to metastasis) and overall survival will be assessed at the given
time points.

By gathering data and gaining insight into the characteristics, pathways and survival of head
and neck cancer patients we aim to identify factors that may lead to improved or worse
disease outcomes.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">October 1, 2021</start_date>
<completion_date type="Anticipated">October 1, 2029</completion_date>
<primary_completion_date type="Anticipated">October 1, 2024</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Characterization of patient pathways</measure>
<time_frame>2021-2024</time_frame>
<description>Initial symptoms, waiting times to diagnosis and treatment, type of healthcare provision</description>
</primary_outcome>
<primary_outcome>
<measure>Lifestyle-related factors</measure>
<time_frame>2021-2026</time_frame>
<description>The effects of demographic and lifestyle-related factors on clinical outcome(s) using follow-up data</description>
</primary_outcome>
<primary_outcome>
<measure>Hard endpoint outcomes: Overall survival, time to metastasis, disease-free survival</measure>
<time_frame>2021-2029</time_frame>
<description>Assessment of overall survival, time to metastasis, disease-free survival</description>
</primary_outcome>
<enrollment type="Anticipated">100</enrollment>
<condition>Waiting Times, Patient Pathways, Effect of Lifestyle-related, Clinical and Demographic Parameters on Outcomes</condition>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>No intervention</intervention_name>
<description>No intervention.</description>
</intervention>
<eligibility>
<study_pop>
<textblock>
Patients 18 years or over with primary head-neck cancer (with morphology of squamocellular
carcinoma, ICD codes: C00-C14, C32) and no previously documented cancer.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Patients 18 years or over presenting with head and neck cancer (with morphology of
squamocellular carcinoma), who are subsequently given one of the following ICD-10
codes: Malignant neoplasms of lip, oral cavity and pharynx (C00-C14), Malignant
neoplasm of larynx (C32) and for whom this is their first cancer.

Exclusion Criteria:

- Patients who do not meet the inclusion criteria and patients who meet the inclusion
criteria but for whom this is a second or recurrent cancer (they already have an
"ICD-C" code) are excluded from the study
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>University of Pécs, Clinical Centre</name>
<address>
<city>Pécs</city>
<state>Baranya</state>
<zip>7623</zip>
<country>Hungary</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Éva Dr. Szabó</last_name>
<phone>+36207788375</phone>
<email>szabo.eva3@pte.hu</email>
</contact>
<contact_backup>
<last_name>Éva Dr. Pozsgai, PhD.</last_name>
<phone>+36306248176</phone>
<email>pozsgay83@gmail.com</email>
</contact_backup>
</location>
<location_countries>
<country>Hungary</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>March 31, 2022</last_update_submitted>
<last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 8, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Head and neck cancer, Survival, Waiting times, Patient pathways</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Head and Neck Neoplasms</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The aim of our study is to prospectively collect information regarding (1) the demographic,
lifestyle-related and clinical characteristics of patients with head and neck cancer and (2)
the waiting times to diagnosis and therapy, and the 1-, 3- and 5-year survival of patients.
We plan to gain insight into the characteristics and pathways of head and neck cancer
patients in Baranya County, which can in turn help to identify factors that lead to improved
or worse disease outcomes. (Thus, these factors can subsequently eliminated or lessened to
improve the outcome of head and neck cancer patients. )
The aim of our study is to prospectively collect information regarding (1) the demographic,
lifestyle-related and clinical characteristics of patients (including initial symptoms) with
head and neck cancer and (2) the patient pathways and waiting times to diagnosis and therapy,
the 1-, 3- and 5-year survival, and time to metastasis of patients.
Study design:
Prospective data collection and analysis, based on data collected from the clinic's
electronic eMedSol database and questionnaire (regarding demographic, lifestyle and patient
pathway-related data) filled in by interviewing patient.
We plan to monitor lifestyle parameters of patients (such as oral hygiene, alcohol
consumption and smoking, the knowledge of patients about risk factors of head and neck
cancers,etc) and clinical parameters such as time and type of first symptom, ECOG state,
comorbidities, clinical stage, diagnostic workups, etc. at predetermined time intervals (upon
first ENT presentation, and at 3-, 6-, 12-, and 24 month intervals.
Disease progression (time to metastasis) and overall survival will be assessed at the given
time points.
By gathering data and gaining insight into the characteristics, pathways and survival of head
and neck cancer patients we aim to identify factors that may lead to improved or worse
disease outcomes.
Patients 18 years or over with primary head-neck cancer (with morphology of squamocellular
carcinoma, ICD codes: C00-C14, C32) and no previously documented cancer.
Inclusion Criteria:
- Patients 18 years or over presenting with head and neck cancer (with morphology of
squamocellular carcinoma), who are subsequently given one of the following ICD-10
codes: Malignant neoplasms of lip, oral cavity and pharynx (C00-C14), Malignant
neoplasm of larynx (C32) and for whom this is their first cancer.
Exclusion Criteria:
- Patients who do not meet the inclusion criteria and patients who meet the inclusion
criteria but for whom this is a second or recurrent cancer (they already have an
"ICD-C" code) are excluded from the study
|
NCT0531xxxx/NCT05319496.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319496</url>
</required_header>
<id_info>
<org_study_id>Pro00119503</org_study_id>
<nct_id>NCT05319496</nct_id>
</id_info>
<brief_title>isCGM With Education and Feedback for Non-Insulin Dependent Type 2 Diabetes</brief_title>
<acronym>iCUDE</acronym>
<official_title>Intermittently Scanned CGM Versus Usual Care With Diabetes Education and Feedback, in Adults With Non-Insulin Dependent Type 2 Diabetes (iCUDE): A Randomized Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Alberta</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Epidemiology Coordinating and Research Centre, Canada</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>University of Alberta</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>Yes</is_fda_regulated_device>
<is_us_export>Yes</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
Glycemic control is an important for adults with diabetes. Self-monitoring of glucose can
help adults with type 2 diabetes (T2DM) meet their glucose targets. Continuous glucose
monitoring (CGM), an alternative to traditional capillary (finger-stick) blood glucose, uses
a wearable sensor that continuously measures glucose levels under the skin. With
intermittently scanned CGM (isCGM), patients scanning the sensor to obtain readings. isCGM is
painless, provides information on glucose trends, and has improves patient satisfaction.

Most adults with diabetes are not on insulin. Yet, the effectiveness of CGM is not well
studied in this population. In this randomized trial, we are looking for adults with type 2
diabetes, who need further blood glucose lowering (HbA1c > 7.0%), who are not yet on insulin.
Participants randomized to the treatment group (50%) will receive isCGM with individual
coaching; those in the the enhanced usual care group (50%) will receive diabetes coaching
only. The intervention will feature three FreeStyle Libre 2 (Abbott Laboratories, IL) sensors
(6 weeks), and is intended to be affordable and applicable to a wide range of adults with
diabetes under real world conditions.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Objective: To evaluate the effectiveness of intermittently scanned continuous glucose
monitoring (isCGM) with education and feedback on glycemic control at 12 weeks, in adults
with type 2 diabetes and uncontrolled HbA1c (> 7.0%) not on insulin therapy.

Background: Continuous glucose monitoring (CGM) has been shown to reduce hypoglycemia in
adults on insulin. The effectiveness of CGM in adults with type 2 diabetes not on insulin
therapy has not been well studied. We hypothesize that isCGM linked to structured education -
specifically one-on-one review and feedback of glucose values with a diabetes educator - can
improve HbA1c via a combination of improved lifestyle choices and accelerated medication
intensification, in adults with earlier T2DM. To test this hypothesis, we propose a
randomized controlled trial of isCGM + structured education, versus enhanced usual care with
structured education only.

Methods: Open-label, 12-week, single-center randomized controlled trial. Included adults will
be randomized 1:1 to intervention or enhanced usual care. Intervention participants will
receive three FreeStyle Libre 2 (Abbott Laboratories, IL) isCGM sensors to be applied over
weeks 1-6. Diabetes education and coaching will be provided at the beginning and end of the
sensor period. The control group will receive diabetes education and coaching during weeks
1-2 and 5-6, but not the isCGM sensors. The primary outcome (HbA1c change from baseline) will
be measured by venous blood draw at 12 weeks. Participants will be asked to complete
patient-reported outcome instruments for secondary outcomes, e.g.: diabetes self-empowerment,
diet, and physical activity - at baseline, 6 weeks, and 12 weeks.

Significance: This trial will examine the effectiveness of scheduled, intermittent use of
isCGM sensors for type 2 diabetes, when combined with education and feedback. The
intervention is designed to be affordable and applicable to a wide range of adults with
diabetes, and may have significant implications for the use of isCGM.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">October 5, 2022</start_date>
<completion_date type="Anticipated">December 2023</completion_date>
<primary_completion_date type="Anticipated">December 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Change in HbA1c</measure>
<time_frame>12 weeks</time_frame>
<description>Change in HbA1c assessed by venous blood draw, compared to baseline.</description>
</primary_outcome>
<secondary_outcome>
<measure>Diabetes treatment satisfaction</measure>
<time_frame>6 weeks and 12 weeks</time_frame>
<description>Difference in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score from baseline (DTSQs scores range 0-36, higher indicating better treatment satisfaction); DTSQc "change" score at 6 weeks.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Diabetes self-care empowerment</measure>
<time_frame>6 weeks and 12 weeks</time_frame>
<description>Change in Diabetes Empowerment Scale - Short Form (DES-SF) score from baseline. DES-SF score ranges 1-5, higher scores indicating greater self-care empowerment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Diabetes-related distress</measure>
<time_frame>6 weeks and 12 weeks</time_frame>
<description>Change in Problem Areas in Diabetes Questionnaire (PAID) score from baseline. PAID score ranges 0-100, a score above 40 indicates severe diabetes distress.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Healthy diet</measure>
<time_frame>6 weeks and 12 weeks</time_frame>
<description>Change in UK Diabetes and Diet Questionnaire (UKDDQ) score from baseline. UKDDQ score ranges 0-5 with higher scores indicating more healthy dietary choices.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Physical activity</measure>
<time_frame>6 weeks and 12 weeks</time_frame>
<description>Change in International Physical Activity Questionnaire (IPAQ) short form score. IPAQ score estimates total metabolic equivalent-minutes per week, with higher scores indicating more a more physically active individual.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Health-related quality of life</measure>
<time_frame>6 weeks and 12 weeks</time_frame>
<description>Change in Euroqol EQ-5D-5L health utility score from baseline. EQ-5D scores range from 0-100, with 100 indicating a state of perfect health.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Emergency department visits</measure>
<time_frame>12 weeks</time_frame>
<description>Number of emergency department visits during the 12-week trial period.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Hospital admissions</measure>
<time_frame>12 weeks</time_frame>
<description>Number of hospital admissions during the 12-week trial period.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">120</enrollment>
<condition>Diabetes Mellitus, Type 2</condition>
<arm_group>
<arm_group_label>isCGM with education and feedback</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Intervention subjects will receive three isCGM sensors (FreeStyle Libre 2, Abbott Laboratories) for use over weeks 1-6. They will have encounters with a diabetes educator for individualized education and coaching during weeks 1-2 and 5-6.</description>
</arm_group>
<arm_group>
<arm_group_label>Enhanced usual care with education and feedback only</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Enhanced usual care subjects will receive two encounters with a diabetes educator for individualized education and coaching, during weeks 1-2 and 5-6. They will not be provided with isCGM sensors.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Intermittently scanned continuous glucose monitor (isCGM)</intervention_name>
<description>A wearable sensor the size of 2 stacked quarters, that allows individuals to "scan" their glucose levels on demand. No fingerstick is required. The device measure interstitial glucose through a filament that is inserted under the skin. The application process is painless, and each sensor lasts 90 days. Sensors can be scanned with certain smart phones. This device is marketed as the FreeStyle Libre 2 glucometer (Abbott Laboratories, IL).</description>
<arm_group_label>isCGM with education and feedback</arm_group_label>
<other_name>Flash glucose monitor</other_name>
</intervention>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Education and coaching</intervention_name>
<description>Two encounters with a certified diabetes educator, who will assess lifestyle and medications, and provide individualized advice on diet, physical activity, and medication changes to improve glycemic control.</description>
<arm_group_label>Enhanced usual care with education and feedback only</arm_group_label>
<arm_group_label>isCGM with education and feedback</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Age >= 18 years with type 2 diabetes.

- HbA1c > 7.0% within the last 6 months.

- Non-insulin therapy.

- Able to attend two in-person study visits.

- English-speaking.

- Community-dwelling

- In possession of a cell phone capable of accessing the internet and receiving
FreeStyle Libre 2 sensor readings

- Has a primary care provider who has been in contact with the patient for diabetes in
the last 12 months.

Exclusion Criteria:

- Type 1 diabetes or diabetes clearly identified as having monogenetic etiology (e.g.:
MODY).

- Steroid-induced diabetes if steroid use is on-going or most recently taken within the
last 3 months.

- Pregnancy; plans to become pregnant within 6 months; breast-feeding.

- Any use of insulin in the previous year.

- Current or previous use of isCGM or rtCGM within the last 6 months.

- Cognitive dysfunction (SPMSQ score >= 5).

- Symptoms of acute metabolic decompensation (extreme thirst, high urinary output, and
weight loss, accompanied by acute fatigue or dyspnea).

- Any terminal condition that would limit life expectancy to < 1 year.

- Inability to use isCGM (e.g.: afraid of the device).

- Inability to be reached by telephone.

- Concurrent participation in a different diabetes-related trial.

- Has not already received two doses of a Health Canada-approved vaccine against
SARS-CoV-2.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Darren Lau, MD/PhD</last_name>
<role>Principal Investigator</role>
<affiliation>University of Alberta</affiliation>
</overall_official>
<overall_contact>
<last_name>Darren Lau, MD/PhD</last_name>
<phone>780-492-7387</phone>
<email>darren.lau@ualberta.ca</email>
</overall_contact>
<location>
<facility>
<name>University of Alberta Hospital / Kaye Edmonton Clinic</name>
<address>
<city>Edmonton</city>
<state>Alberta</state>
<zip>T6G 1Z1</zip>
<country>Canada</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Darren Lau, MD</last_name>
<phone>7808872811</phone>
<email>darren.lau@ualberta.ca</email>
</contact>
<investigator>
<last_name>Roseanne O Yeung, MD</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Donna P Manca, MD</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location_countries>
<country>Canada</country>
</location_countries>
<verification_date>July 2023</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>July 12, 2023</last_update_submitted>
<last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">July 14, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>continuous glucose monitoring</keyword>
<keyword>flash glucose monitoring</keyword>
<keyword>intermittently scanned continuous glucose monitoring</keyword>
<keyword>CGM</keyword>
<keyword>non-insulin dependent diabetes</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Diabetes Mellitus</mesh_term>
<mesh_term>Diabetes Mellitus, Type 2</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<provided_document_section>
<provided_document>
<document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
<document_has_protocol>Yes</document_has_protocol>
<document_has_icf>Yes</document_has_icf>
<document_has_sap>Yes</document_has_sap>
<document_date>September 12, 2022</document_date>
<document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT05319496/Prot_SAP_ICF_001.pdf</document_url>
</provided_document>
</provided_document_section>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Glycemic control is an important for adults with diabetes. Self-monitoring of glucose can
help adults with type 2 diabetes (T2DM) meet their glucose targets. Continuous glucose
monitoring (CGM), an alternative to traditional capillary (finger-stick) blood glucose, uses
a wearable sensor that continuously measures glucose levels under the skin. With
intermittently scanned CGM (isCGM), patients scanning the sensor to obtain readings. isCGM is
painless, provides information on glucose trends, and has improves patient satisfaction.
Most adults with diabetes are not on insulin. Yet, the effectiveness of CGM is not well
studied in this population. In this randomized trial, we are looking for adults with type 2
diabetes, who need further blood glucose lowering (HbA1c > 7.0%), who are not yet on insulin.
Participants randomized to the treatment group (50%) will receive isCGM with individual
coaching; those in the the enhanced usual care group (50%) will receive diabetes coaching
only. The intervention will feature three FreeStyle Libre 2 (Abbott Laboratories, IL) sensors
(6 weeks), and is intended to be affordable and applicable to a wide range of adults with
diabetes under real world conditions.
Objective: To evaluate the effectiveness of intermittently scanned continuous glucose
monitoring (isCGM) with education and feedback on glycemic control at 12 weeks, in adults
with type 2 diabetes and uncontrolled HbA1c (> 7.0%) not on insulin therapy.
Background: Continuous glucose monitoring (CGM) has been shown to reduce hypoglycemia in
adults on insulin. The effectiveness of CGM in adults with type 2 diabetes not on insulin
therapy has not been well studied. We hypothesize that isCGM linked to structured education -
specifically one-on-one review and feedback of glucose values with a diabetes educator - can
improve HbA1c via a combination of improved lifestyle choices and accelerated medication
intensification, in adults with earlier T2DM. To test this hypothesis, we propose a
randomized controlled trial of isCGM + structured education, versus enhanced usual care with
structured education only.
Methods: Open-label, 12-week, single-center randomized controlled trial. Included adults will
be randomized 1:1 to intervention or enhanced usual care. Intervention participants will
receive three FreeStyle Libre 2 (Abbott Laboratories, IL) isCGM sensors to be applied over
weeks 1-6. Diabetes education and coaching will be provided at the beginning and end of the
sensor period. The control group will receive diabetes education and coaching during weeks
1-2 and 5-6, but not the isCGM sensors. The primary outcome (HbA1c change from baseline) will
be measured by venous blood draw at 12 weeks. Participants will be asked to complete
patient-reported outcome instruments for secondary outcomes, e.g.: diabetes self-empowerment,
diet, and physical activity - at baseline, 6 weeks, and 12 weeks.
Significance: This trial will examine the effectiveness of scheduled, intermittent use of
isCGM sensors for type 2 diabetes, when combined with education and feedback. The
intervention is designed to be affordable and applicable to a wide range of adults with
diabetes, and may have significant implications for the use of isCGM.
Inclusion Criteria:
- Age >= 18 years with type 2 diabetes.
- HbA1c > 7.0% within the last 6 months.
- Non-insulin therapy.
- Able to attend two in-person study visits.
- English-speaking.
- Community-dwelling
- In possession of a cell phone capable of accessing the internet and receiving
FreeStyle Libre 2 sensor readings
- Has a primary care provider who has been in contact with the patient for diabetes in
the last 12 months.
Exclusion Criteria:
- Type 1 diabetes or diabetes clearly identified as having monogenetic etiology (e.g.:
MODY).
- Steroid-induced diabetes if steroid use is on-going or most recently taken within the
last 3 months.
- Pregnancy; plans to become pregnant within 6 months; breast-feeding.
- Any use of insulin in the previous year.
- Current or previous use of isCGM or rtCGM within the last 6 months.
- Cognitive dysfunction (SPMSQ score >= 5).
- Symptoms of acute metabolic decompensation (extreme thirst, high urinary output, and
weight loss, accompanied by acute fatigue or dyspnea).
- Any terminal condition that would limit life expectancy to < 1 year.
- Inability to use isCGM (e.g.: afraid of the device).
- Inability to be reached by telephone.
- Concurrent participation in a different diabetes-related trial.
- Has not already received two doses of a Health Canada-approved vaccine against
SARS-CoV-2.
|
NCT0531xxxx/NCT05319509.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319509</url>
</required_header>
<id_info>
<org_study_id>HSC-SPH-21-0935</org_study_id>
<nct_id>NCT05319509</nct_id>
</id_info>
<brief_title>Pilot Study of Virtual Reality Therapy for Students With Anxiety</brief_title>
<official_title>Pilot Study of Virtual Reality Therapy for Students With Anxiety</official_title>
<sponsors>
<lead_sponsor>
<agency>The University of Texas Health Science Center, Houston</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>The University of Texas Health Science Center, Houston</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>Yes</is_fda_regulated_device>
<is_unapproved_device>Yes</is_unapproved_device>
<is_us_export>No</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this study is to assess changes in self-reported anxiety over the course of
six virtual reality (VR) sessions and to assess changes in academic self-efficacy, as well as
examine the feasibility and acceptability of a relatively short and time intensive VR
intervention (i.e.,six sessions over the course of three weeks) for reducing anxiety symptoms
in college students.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">April 1, 2022</start_date>
<completion_date type="Anticipated">August 1, 2024</completion_date>
<primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Change in state anxiety as assessed by the Liebowitz Social Anxiety Scale-Self Report version (LSAS-SR)</measure>
<time_frame>before first session in week 1, before third session in week 2 and before sixth session in week 3</time_frame>
<description>The LSAS-SR questionnaire is composed of 24 items divided into 2 subscales, 13 concerning performance anxiety, and 11 pertaining to social situations. The 24 items are first rated on a Likert Scale from 0(none) to 3(severe) on fear felt during the situations, and then the same items are rated from 0(never)-3(usually)regarding avoidance of the situation. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points. Score of 30 or less indicates social anxiety disorder(SAD) is unlikely, score of 30-60 shows that SAD is probable and score 60-90 indicates that SAD is highly probable.</description>
</primary_outcome>
<primary_outcome>
<measure>Change in depressive symptoms as assessed by score on the Patient Health Questionnaire-4 (PHQ-4)</measure>
<time_frame>Baseline(before the first session in week 1)</time_frame>
<description>The PHQ-4 questionnaire consists of 4 questions and each is rated on a 4 point scale from 0(not at all) to 3(every day) for a maximum score of 12,a higher number indicating a worse outcome.</description>
</primary_outcome>
<primary_outcome>
<measure>Change in anxiety related behaviors such as rate of speech</measure>
<time_frame>Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)</time_frame>
<description>Anxiety-related behaviors will be recorded using an event sampling observation guide</description>
</primary_outcome>
<primary_outcome>
<measure>Change in anxiety related behaviors such as volume of speech</measure>
<time_frame>Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)</time_frame>
<description>Anxiety-related behaviors will be recorded using an event sampling observation guide</description>
</primary_outcome>
<primary_outcome>
<measure>Change in anxiety related behaviors such as Negative self-talk</measure>
<time_frame>Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)</time_frame>
<description>Anxiety-related behaviors will be recorded using an event sampling observation guide</description>
</primary_outcome>
<primary_outcome>
<measure>Change in anxiety related behaviors such as Utterances about experience</measure>
<time_frame>Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)</time_frame>
<description>Anxiety-related behaviors will be recorded using an event sampling observation guide</description>
</primary_outcome>
<primary_outcome>
<measure>Change in anxiety related behaviors such as Laughter</measure>
<time_frame>Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)</time_frame>
<description>Anxiety-related behaviors will be recorded using an event sampling observation guide</description>
</primary_outcome>
<primary_outcome>
<measure>Change in Psychomotor agitation such as pacing</measure>
<time_frame>Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)</time_frame>
<description>Anxiety-related behaviors will be recorded using an event sampling observation guide</description>
</primary_outcome>
<primary_outcome>
<measure>Change in Psychomotor agitation such as Fidgeting</measure>
<time_frame>Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)</time_frame>
<description>Anxiety-related behaviors will be recorded using an event sampling observation guide</description>
</primary_outcome>
<primary_outcome>
<measure>Change in Psychomotor agitation such as Rubbing hands/neck/head</measure>
<time_frame>Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)</time_frame>
<description>Anxiety-related behaviors will be recorded using an event sampling observation guide</description>
</primary_outcome>
<primary_outcome>
<measure>Change in physiology such as perspiration</measure>
<time_frame>Week 1(session1 and session 2), week 2( session 3 and session 4), week 3 (session 5 and session 6)</time_frame>
<description>Anxiety-related behaviors will be recorded using an event sampling observation guide</description>
</primary_outcome>
<secondary_outcome>
<measure>Change in self-reported academic performance as assessed by the Motivated Strategies for Learning Questionnaire (MSLQ)</measure>
<time_frame>before first session in week 1, before third session in week 2 and before sixth session in week 3</time_frame>
<description>The MSLQ questionnaire consists of 9 questions each one is scored from 1= not at all true of me to 7=very true of me, a higher number indicating a better outcome with a maximum score of 63</description>
</secondary_outcome>
<secondary_outcome>
<measure>change in feasibility as assessed by the rating on a short questionnaire</measure>
<time_frame>after the third session in week 2 , after sixth session in week 3</time_frame>
<description>The usability questionnaire is developed by gameChange about the ease of VR software use, believability of VR environment, and level of engagement. this consists of 5 questions and each one is scored form 1(very difficult) to 5(very easy) for a maximum score of 25, a higher number indicating more easiness in using the VR software</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in acceptability as assessed by the rating on a short questionnaire</measure>
<time_frame>after the third session in week 2 , after sixth session in week 3</time_frame>
<description>The usability questionnaire is developed by gameChange about the ease of VR software use, believability of VR environment, and level of engagement. this consists of 5 questions and each is scored form 1(strongly disagree) to 5(strongly agree) for a maximum score of 25</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in perceived presence in the virtual environment (as indicated by continuous score on the Igroup Presence Questionnaire (IPQ)</measure>
<time_frame>after the third session in week 2 and the sixth session in week 3</time_frame>
<description>There are 14 questions and each one is scored form -3 to +3. A total negative score indicates that the participant personally felt very disconnected from VR world, and that they lacked believable presence within world, and rather felt like they were manipulating a machine from an outside perspective.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">100</enrollment>
<condition>Anxiety</condition>
<arm_group>
<arm_group_label>gameChange</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>gameChange</intervention_name>
<description>Staff will explain the rationale behind gameChange, and briefly explain the different scenarios: a doctor's office, a waiting room, a pub, a café, a grocery store, a public street and a bus. Each scenario contains five levels, each increasing with anxiety stimuli and certain tasks the participant must complete. The participant will put on the Oculus headset, and go through a preliminary orientation game. The headset will be casted to an external monitor. Once they start gameChange, it will take the participants to the virtual therapist's room. They will be asked to choose which scenario they would like to participate in first and will complete all five levels for one scenario. Research staff will be taking event sampling-style observations of the participant. After completion of the levels, the participant will return to the virtual therapist's room for debriefing, and then will be asked to exit the game.</description>
<arm_group_label>gameChange</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- enrolled in The University of Texas Health Science Center School of Public Health San
Antonio regional campus

- competent in English

- total score of at least 3 on the Generalized Anxiety Disorder (GAD-2)

Exclusion Criteria:

- Currently receiving psychological treatment for anxiety symptoms, or has received
treatment in the last year.

- Report photosensitive epilepsy.

- Report stereoscopic vision or balance problems
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>30 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Tsai Jack, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>The University of Texas Health Science Center, Houston</affiliation>
</overall_official>
<overall_contact>
<last_name>Tsai Jack, PhD</last_name>
<phone>210-276-9022</phone>
<email>Jack.Tsai@uth.tmc.edu</email>
</overall_contact>
<overall_contact_backup>
<last_name>Abigail Lipe</last_name>
<phone>210-722-8218</phone>
<email>Abigail.R.Lipe@uth.tmc.edu</email>
</overall_contact_backup>
<location>
<facility>
<name>The University of Texas Health Science Center at Houston</name>
<address>
<city>Houston</city>
<state>Texas</state>
<zip>77030</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Tsai Jack, PhD</last_name>
<phone>210-276-9022</phone>
<email>Jack.Tsai@uth.tmc.edu</email>
</contact>
<contact_backup>
<last_name>Abigail Lipe</last_name>
<phone>210-722-8218</phone>
<email>Abigail.R.Lipe@uth.tmc.edu</email>
</contact_backup>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>May 2023</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>May 10, 2023</last_update_submitted>
<last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 12, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
<investigator_full_name>Jack Tsai</investigator_full_name>
<investigator_title>Professor</investigator_title>
</responsible_party>
<keyword>virtual reality</keyword>
<keyword>college students</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Anxiety Disorders</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this study is to assess changes in self-reported anxiety over the course of
six virtual reality (VR) sessions and to assess changes in academic self-efficacy, as well as
examine the feasibility and acceptability of a relatively short and time intensive VR
intervention (i.e.,six sessions over the course of three weeks) for reducing anxiety symptoms
in college students.
Inclusion Criteria:
- enrolled in The University of Texas Health Science Center School of Public Health San
Antonio regional campus
- competent in English
- total score of at least 3 on the Generalized Anxiety Disorder (GAD-2)
Exclusion Criteria:
- Currently receiving psychological treatment for anxiety symptoms, or has received
treatment in the last year.
- Report photosensitive epilepsy.
- Report stereoscopic vision or balance problems
|
NCT0531xxxx/NCT05319522.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319522</url>
</required_header>
<id_info>
<org_study_id>B3641-M</org_study_id>
<nct_id>NCT05319522</nct_id>
</id_info>
<brief_title>The Relationship Between Irisin and Bone Health in Individuals With Spinal Cord Injury</brief_title>
<acronym>IBSCI</acronym>
<official_title>The Influence of Irisin/FNDC5 on Bone Mineral Density and Fracture Risk in Individuals With Spinal Cord Injury</official_title>
<sponsors>
<lead_sponsor>
<agency>VA Office of Research and Development</agency>
<agency_class>U.S. Fed</agency_class>
</lead_sponsor>
</sponsors>
<source>VA Office of Research and Development</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
<is_us_export>No</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
This study will examine the relationship between circulating irisin and bone health
individuals with spinal cord injury. Additionally, this study seeks to examine the influence
of muscle fiber type on circulating irisin and identify an exercise-based means to increase
irisin concentrations.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
After spinal cord injury (SCI), the severe sub-lesion bone loss increases lower-limb fracture
risk. In addition to mechanical loading, bone homeostasis is mediated by myokines, skeletal
muscle secreted factors, including irisin. This project aims to demonstrate that irisin is a
key determinant of bone mineral density in sub-lesion bone, that impaired irisin mechanisms
contribute to post-SCI bone loss, and identify novel modalities to leverage the osteogenic
effects of irisin to improve musculoskeletal rehabilitation strategies for individuals with
SCI.

The first aim of this project seeks to determine the relationship between circulating irisin
and bone mineral density (BMD) in sub-lesion bones of individuals with SCI. Past research has
reported positive correlations between irisin and BMD indicating that irisin is important
factor in bone homeostasis. To date, the relationship between irisin and BMD, absent
mechanical loading, as seen in individuals with SCI, has not been examined. Of note, irisin
increases have been demonstrated to increase bone mass in healthy mice and prevent or reduce
bone loss in mouse SCI models.

The second aim of this study seeks to determine if irisin concentrations are impaired as a
result of pathologic changes in sub-lesion skeletal muscle after SCI. Irisin is released into
circulation following cleavage of its precursor protein which is highly expressed in skeletal
muscle. Generally, healthy human muscle demonstrates a mix of type I and type II muscle
fibers, however, after SCI, there is a pathological transformation from type I to type II
muscle. Given that irisin's precursor protein is more highly expressed in type I muscle, the
post-SCI fiber type transformation could significantly attenuate circulating irisin
concentrations and impair its downstream signaling effects. Understanding whether post-SCI
fiber type shifts are associated with reduced circulating irisin could help explain the
inefficacy of current rehabilitation methods.

The third aim of this study seeks to measure the irisin response to arm ergometer high
intensity interval exercise. If circulating irisin concentrations are important to bone
health, as current research suggests, then identifying a means in increase circulating irisin
is essential to developing better musculoskeletal rehabilitation methods. While exercise has
been demonstrated to increase circulating irisin, the exercise modalities performed (running,
whole body resistance training) are not feasible for individuals with SCI. Arm ergometry
exercise could provide a means to increase circulating concentrations of this osteogenic
factor.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">May 5, 2023</start_date>
<completion_date type="Anticipated">December 1, 2023</completion_date>
<primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Non-Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Irisin - Bone measure correlations</measure>
<time_frame>Baseline; at rest</time_frame>
<description>Circulating irisin concentrations will be correlated with DXA and HR-pQCT bone measures</description>
</primary_outcome>
<primary_outcome>
<measure>FNDC5 gene expression</measure>
<time_frame>Baseline; at rest</time_frame>
<description>FNDC5 gene expression will be measured in vastus lateralis skeletal muscle biopsies via RT-PCR to determine if potential differences in circulating irisin concentrations may be attributed to differential gene expression.</description>
</primary_outcome>
<primary_outcome>
<measure>Exercise induced change in irisin concentration</measure>
<time_frame>baseline and immediately post-exercise</time_frame>
<description>Circulating irisin concentrations will be measured before and immediately following an arm ergometer high-intensity interval exercise bout to determine if this exercise modality can increased circulating irisin concentrations in individuals with SCI and controls</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">44</enrollment>
<condition>Spinal Cord Injury</condition>
<arm_group>
<arm_group_label>Individuals with SCI</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Male and female, Veteran and non-Veteran participants with traumatic SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.</description>
</arm_group>
<arm_group>
<arm_group_label>Controls (No SCI)</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Male and female Veterans, age and sex-matched to participants with SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Acute Exercise</intervention_name>
<description>Participants with and without SCI will complete an arm ergometer, high-intensity interval exercise bout. The exercise bout will be performed at a relative intensity based on previously determined peak power output during an arm ergometer graded exercise test.</description>
<arm_group_label>Controls (No SCI)</arm_group_label>
<arm_group_label>Individuals with SCI</arm_group_label>
<other_name>Arm Ergometer Exercise; High-Intensity Interval Exercise</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

Participants with SCI:

- age 18 years or older

- traumatic SCI at the cervical level 4 or lower that occurred at least 12 months prior
to the start of the study

- American Spinal Injury Association Impairment Scale A, B or C

- uses a manual wheelchair as primary means of mobility (30+ hours per week)

- is able to perform a transfer independently to and from a wheelchair

- has adequate strength and upper extremity function to operate an arm ergometer

Control Participants:

- age and sex-matched to participant with SCI

Exclusion Criteria:

Participants with SCI:

- active use of medications which potentially affect bone metabolism, including:
parathyroid hormone and analogs, androgenic or estrogenic steroids, bisphosphonates,
oral glucocorticoids (use for more than 3 months)

- history of fractures or dislocations in the upper extremity from which the participant
has not fully recovered

- upper limb pain or injury that interferes with the ability to perform aerobic exercise

- recent hospitalization for any reason (within the past three months)

- history of coronary artery disease, coronary bypass surgery or other cardiorespiratory
events or conditions

- likely to experience clinically significant autonomic dysreflexia and/ or orthostatic
hypotension in response to vigorous exercise

- endocrinopathy or metabolic disorders of the bone

- e.g. Paget's disease, renal bone disease

- history of allergic reaction to lidocaine

- any other conditions that the person's primary care physician deems is a
contraindication to participation in arm ergometry exercise stress testing or vigorous
exercise

- pregnant

- participation in another "Greater than Minimal Risk" study.

Control Participants:

- active use of medications which potentially affect bone metabolism, including:
parathyroid hormone and analogs, androgenic or estrogenic steroids, bisphosphonates,
oral glucocorticoids (use for more than 3 months)

- history of neuromuscular conditions which could influence muscle gene expression

- history of lower body musculoskeletal injuries from which the participant has not
fully recovered

- recent hospitalization for any reason (within the past three months)

- history of allergic reaction to lidocaine

- any other conditions that the person's primary care physician deems is a
contraindication to the performance of a vastus lateralis muscle biopsy

- pregnant

- participation in another "Greater than Minimal Risk" study
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Adam J. Sterczala, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA</affiliation>
</overall_official>
<overall_contact>
<last_name>Adam J Sterczala, PhD</last_name>
<phone>(617) 784-2831</phone>
<email>adam.sterczala@va.gov</email>
</overall_contact>
<location>
<facility>
<name>VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA</name>
<address>
<city>Pittsburgh</city>
<state>Pennsylvania</state>
<zip>15240</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Adam J Sterczala, PhD</last_name>
<phone>617-784-2831</phone>
<email>adam.sterczala@va.gov</email>
</contact>
<investigator>
<last_name>Adam J. Sterczala, PhD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>May 2023</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>May 8, 2023</last_update_submitted>
<last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 9, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Spinal cord injuries</keyword>
<keyword>Irisin</keyword>
<keyword>Bone mineral density</keyword>
<keyword>Exercise</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Spinal Cord Injuries</mesh_term>
<mesh_term>Wounds and Injuries</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This study will examine the relationship between circulating irisin and bone health
individuals with spinal cord injury. Additionally, this study seeks to examine the influence
of muscle fiber type on circulating irisin and identify an exercise-based means to increase
irisin concentrations.
After spinal cord injury (SCI), the severe sub-lesion bone loss increases lower-limb fracture
risk. In addition to mechanical loading, bone homeostasis is mediated by myokines, skeletal
muscle secreted factors, including irisin. This project aims to demonstrate that irisin is a
key determinant of bone mineral density in sub-lesion bone, that impaired irisin mechanisms
contribute to post-SCI bone loss, and identify novel modalities to leverage the osteogenic
effects of irisin to improve musculoskeletal rehabilitation strategies for individuals with
SCI.
The first aim of this project seeks to determine the relationship between circulating irisin
and bone mineral density (BMD) in sub-lesion bones of individuals with SCI. Past research has
reported positive correlations between irisin and BMD indicating that irisin is important
factor in bone homeostasis. To date, the relationship between irisin and BMD, absent
mechanical loading, as seen in individuals with SCI, has not been examined. Of note, irisin
increases have been demonstrated to increase bone mass in healthy mice and prevent or reduce
bone loss in mouse SCI models.
The second aim of this study seeks to determine if irisin concentrations are impaired as a
result of pathologic changes in sub-lesion skeletal muscle after SCI. Irisin is released into
circulation following cleavage of its precursor protein which is highly expressed in skeletal
muscle. Generally, healthy human muscle demonstrates a mix of type I and type II muscle
fibers, however, after SCI, there is a pathological transformation from type I to type II
muscle. Given that irisin's precursor protein is more highly expressed in type I muscle, the
post-SCI fiber type transformation could significantly attenuate circulating irisin
concentrations and impair its downstream signaling effects. Understanding whether post-SCI
fiber type shifts are associated with reduced circulating irisin could help explain the
inefficacy of current rehabilitation methods.
The third aim of this study seeks to measure the irisin response to arm ergometer high
intensity interval exercise. If circulating irisin concentrations are important to bone
health, as current research suggests, then identifying a means in increase circulating irisin
is essential to developing better musculoskeletal rehabilitation methods. While exercise has
been demonstrated to increase circulating irisin, the exercise modalities performed (running,
whole body resistance training) are not feasible for individuals with SCI. Arm ergometry
exercise could provide a means to increase circulating concentrations of this osteogenic
factor.
Inclusion Criteria:
Participants with SCI:
- age 18 years or older
- traumatic SCI at the cervical level 4 or lower that occurred at least 12 months prior
to the start of the study
- American Spinal Injury Association Impairment Scale A, B or C
- uses a manual wheelchair as primary means of mobility (30+ hours per week)
- is able to perform a transfer independently to and from a wheelchair
- has adequate strength and upper extremity function to operate an arm ergometer
Control Participants:
- age and sex-matched to participant with SCI
Exclusion Criteria:
Participants with SCI:
- active use of medications which potentially affect bone metabolism, including:
parathyroid hormone and analogs, androgenic or estrogenic steroids, bisphosphonates,
oral glucocorticoids (use for more than 3 months)
- history of fractures or dislocations in the upper extremity from which the participant
has not fully recovered
- upper limb pain or injury that interferes with the ability to perform aerobic exercise
- recent hospitalization for any reason (within the past three months)
- history of coronary artery disease, coronary bypass surgery or other cardiorespiratory
events or conditions
- likely to experience clinically significant autonomic dysreflexia and/ or orthostatic
hypotension in response to vigorous exercise
- endocrinopathy or metabolic disorders of the bone
- e.g. Paget's disease, renal bone disease
- history of allergic reaction to lidocaine
- any other conditions that the person's primary care physician deems is a
contraindication to participation in arm ergometry exercise stress testing or vigorous
exercise
- pregnant
- participation in another "Greater than Minimal Risk" study.
Control Participants:
- active use of medications which potentially affect bone metabolism, including:
parathyroid hormone and analogs, androgenic or estrogenic steroids, bisphosphonates,
oral glucocorticoids (use for more than 3 months)
- history of neuromuscular conditions which could influence muscle gene expression
- history of lower body musculoskeletal injuries from which the participant has not
fully recovered
- recent hospitalization for any reason (within the past three months)
- history of allergic reaction to lidocaine
- any other conditions that the person's primary care physician deems is a
contraindication to the performance of a vastus lateralis muscle biopsy
- pregnant
- participation in another "Greater than Minimal Risk" study
|
NCT0531xxxx/NCT05319535.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319535</url>
</required_header>
<id_info>
<org_study_id>QUX 21-002</org_study_id>
<nct_id>NCT05319535</nct_id>
</id_info>
<brief_title>Implementing a Skills-Based Caregiver Training Program (Caregivers FIRST): Function QUERI 2.0</brief_title>
<official_title>Implementing a Caregiver Skills Training Program (Caregivers FIRST): Function QUERI 2.0 (QUE 20-023)</official_title>
<sponsors>
<lead_sponsor>
<agency>VA Office of Research and Development</agency>
<agency_class>U.S. Fed</agency_class>
</lead_sponsor>
</sponsors>
<source>VA Office of Research and Development</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
<is_us_export>No</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
Implementing a Skills-Based Caregiver Training (Caregivers FIRST): Function QUERI 2.0 aims to
compare implementation strategies for large-scale spread of Caregivers FIRST, a group
training for friend or family caregivers of Veterans. The goal is to use a type III
effectiveness-implementation hybrid design framework to compare continuation of
implementation strategies for 24 sites that do not meet implementation adoption benchmarks.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Background/Purpose. Over 5 million former or current military personnel receive informal care
in the home from family members or friends. Unintended impacts on caregivers can include
strain, burden, burnout, and depression. Additionally, half of caregivers of Veterans with
functional/cognitive limitations report unmet needs for training.

Caregivers FIRST (Caregivers Finding Important Resources, Support, and Training) is an
evidence-based skills training program for caregivers of Veterans with cognitive and/or
functional limitations. Caregivers FIRST promotes Veteran function and independence through
caregiver skill training and support in a series of 4 proactive group classes to help general
caregivers build self-care and psychological coping, health system navigation, and hands-on
clinical skills.

As part of Implementing a Skills-Based Caregiver Training (Caregivers FIRST), the
investigators plan to implement the Caregivers FIRST clinical program nationally in
partnership with the VA Caregiver Support Program (maximum 150 VA medical centers). The
investigators then plan to use a type III effectiveness-implementation hybrid design
framework with 24 sites that do not meet implementation adoption benchmarks. Those enrolled
sites will be randomized to receive standard implementation support (foundational Replicating
Effective Programs or REP) or a higher-intensity implementation support (enhanced REP
including additional facilitation, self-organization, and team building support). The
investigators will compare continuation of foundational REP versus addition of higher
intensity strategies.

Key questions: What VA Central Office and regional (VISN) partnerships and activities will
enhance national dissemination of Caregivers FIRST? How should Caregivers FIRST clinical
program be adapted to leverage site-specific resources and optimize sustainability? Are there
differences in implementation outcomes (penetration, fidelity) at 6, 12, or 18 months between
arms? What is the impact on effectiveness outcomes/quality metrics (quality of VA General
Caregiver Program, Veteran days in the community) at implementing sites? How do sites
experience implementation strategies in each arm? The investigators also plan to conduct an
explanatory sequential mixed method design that includes qualitative data collection and
analysis that will not be reported here.

Methodology. To evaluate implementation, the investigators will randomize sites (n=24) 1:1 to
either foundational REP or enhanced REP. The investigators will use generalized linear models
to examine the effect of foundational vs. enhanced REP on implementation outcomes at 12
months.
</textblock>
</detailed_description>
<overall_status>Active, not recruiting</overall_status>
<start_date type="Actual">April 25, 2022</start_date>
<completion_date type="Anticipated">September 30, 2025</completion_date>
<primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Parallel cluster-randomized trial (parallel-CRT): used in pragmatic evaluations of health program or policy interventions, where half the clusters (in this case, VA medical centers) are randomly assigned to two interventions: Foundational REP (active comparator) vs. Enhanced REP (experimental).</intervention_model_description>
<primary_purpose>Health Services Research</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Penetration</measure>
<time_frame>12 months (cumulative)</time_frame>
<description>Penetration is defined as the 1) proportion of caregivers who received consults for VA caregiver education and training services who attended at least one class and 2) number of classes delivered by site.</description>
</primary_outcome>
<secondary_outcome>
<measure>Fidelity</measure>
<time_frame>12 months (cumulative)</time_frame>
<description>Fidelity will be measured by 1) the proportion of number of recommended classes delivered by site; 2) number of caregivers attended at least one class by site; 3) mean number of classes attended per caregiver.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Adoption</measure>
<time_frame>12 months (cumulative)</time_frame>
<description>Adoption is defined as meeting a threshold of four or more training classes delivered to a minimum of five caregivers.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">25</enrollment>
<condition>Cognitive Function</condition>
<condition>Functional Status</condition>
<arm_group>
<arm_group_label>Foundational REP</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Foundational REP uses the Replicating Effective Program implementation strategy and includes 5 elements that were developed and tested in the investigators' prior Function QUERI work: Stakeholder engagement; Toolkit; SharePoint access for clinical program training materials; Data dashboard to assist sites with tracking their own data; and Diffusion Networks to promote peer-to-peer sharing and implementation support.</description>
</arm_group>
<arm_group>
<arm_group_label>Enhanced REP</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Enhanced REP begins with the same activities as Foundational REP. Sites randomized to receive Enhanced REP will continue with Foundational REP and also receive higher intensity support for a period of approximately 4 months. The higher intensity support will consist of facilitation, a process of interactive problem solving and support that occurs in a context of a supportive interpersonal relationship and CONNECT, a complexity science-based bundle of interaction-oriented activities designed to supplement implementation efforts by promoting team function and readiness for change. Facilitation will be provided by Function QUERI team members.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Implementation Strategy: Foundational REP</intervention_name>
<description>Among Caregivers FIRST sites that do not meet implementation adoption benchmarks, the goal is to test implementation intensification approaches, specifically Foundational REP vs. Enhanced REP. The investigators propose that low intensity implementation support that promotes adapting Caregivers FIRST for context and provides tools for ongoing Caregivers FIRST evaluation (defined as foundational REP), will be sufficient for some but not all sites to successfully incorporate Caregivers FIRST into routine practice.</description>
<arm_group_label>Foundational REP</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Implementation Strategy: Enhanced REP</intervention_name>
<description>Among Caregivers FIRST sites that do not meet implementation adoption benchmarks, the goal is to test implementation intensification approaches, specifically Foundational REP vs. Enhanced REP. The investigators posit that higher intensity strategies (defined as Enhanced REP) that directly influence teams' capacity and skills to effectively self-organize and problem-solve will lead to higher implementation adoption, penetration, fidelity, and value.</description>
<arm_group_label>Enhanced REP</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Site inclusion criteria includes sites not meeting benchmarks for adoption of
Caregivers FIRST and submission of a signed participation agreement.

- Enrolled sites will all be exposed to Foundational REP.

- Half of sites will be randomized to receive higher-intensity implementation support
(Enhanced REP).

Exclusion Criteria:

- The eight Caregivers FIRST (formerly called iHI-FIVES) sites that have previously
participated in Function QUERI (ClinicalTrials.gov Identifier: NCT03474380) will be
excluded from enrollment in this study.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Courtney H Van Houtven, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Durham VA Medical Center, Durham, NC</affiliation>
</overall_official>
<overall_official>
<last_name>Kelli Dominick Allen, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Durham VA Medical Center, Durham, NC</affiliation>
</overall_official>
<overall_official>
<last_name>Susan N. Hastings, MD MHSc</last_name>
<role>Principal Investigator</role>
<affiliation>Durham VA Medical Center, Durham, NC</affiliation>
</overall_official>
<location>
<facility>
<name>Durham VA Medical Center, Durham, NC</name>
<address>
<city>Durham</city>
<state>North Carolina</state>
<zip>27705-3875</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>https://www.durham.hsrd.research.va.gov/Function_Independence_QUERI.asp</url>
<description>Durham VA Optimizing Function & Independence QUERI</description>
</link>
<verification_date>June 2023</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>June 21, 2023</last_update_submitted>
<last_update_submitted_qc>June 21, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">June 23, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Caregivers</keyword>
<keyword>Veterans</keyword>
<keyword>Training Programs</keyword>
<keyword>Informal Care</keyword>
<keyword>Implementation Science</keyword>
<keyword>Functional Independence</keyword>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>A de-identified, anonymized dataset may be created upon request. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format.
Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication.
No data or statistical code that could lead to re-identification of individuals will be released.
Data will be stored & maintained in an approved, secured location as described in the VA Research Data Inventory Form.
Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re-identify any individual whose data are included in the dataset.</ipd_description>
<ipd_time_frame>Available upon request.</ipd_time_frame>
<ipd_access_criteria>Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re- identify any individual whose data are included in the dataset.</ipd_access_criteria>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Implementing a Skills-Based Caregiver Training (Caregivers FIRST): Function QUERI 2.0 aims to
compare implementation strategies for large-scale spread of Caregivers FIRST, a group
training for friend or family caregivers of Veterans. The goal is to use a type III
effectiveness-implementation hybrid design framework to compare continuation of
implementation strategies for 24 sites that do not meet implementation adoption benchmarks.
Background/Purpose. Over 5 million former or current military personnel receive informal care
in the home from family members or friends. Unintended impacts on caregivers can include
strain, burden, burnout, and depression. Additionally, half of caregivers of Veterans with
functional/cognitive limitations report unmet needs for training.
Caregivers FIRST (Caregivers Finding Important Resources, Support, and Training) is an
evidence-based skills training program for caregivers of Veterans with cognitive and/or
functional limitations. Caregivers FIRST promotes Veteran function and independence through
caregiver skill training and support in a series of 4 proactive group classes to help general
caregivers build self-care and psychological coping, health system navigation, and hands-on
clinical skills.
As part of Implementing a Skills-Based Caregiver Training (Caregivers FIRST), the
investigators plan to implement the Caregivers FIRST clinical program nationally in
partnership with the VA Caregiver Support Program (maximum 150 VA medical centers). The
investigators then plan to use a type III effectiveness-implementation hybrid design
framework with 24 sites that do not meet implementation adoption benchmarks. Those enrolled
sites will be randomized to receive standard implementation support (foundational Replicating
Effective Programs or REP) or a higher-intensity implementation support (enhanced REP
including additional facilitation, self-organization, and team building support). The
investigators will compare continuation of foundational REP versus addition of higher
intensity strategies.
Key questions: What VA Central Office and regional (VISN) partnerships and activities will
enhance national dissemination of Caregivers FIRST? How should Caregivers FIRST clinical
program be adapted to leverage site-specific resources and optimize sustainability? Are there
differences in implementation outcomes (penetration, fidelity) at 6, 12, or 18 months between
arms? What is the impact on effectiveness outcomes/quality metrics (quality of VA General
Caregiver Program, Veteran days in the community) at implementing sites? How do sites
experience implementation strategies in each arm? The investigators also plan to conduct an
explanatory sequential mixed method design that includes qualitative data collection and
analysis that will not be reported here.
Methodology. To evaluate implementation, the investigators will randomize sites (n=24) 1:1 to
either foundational REP or enhanced REP. The investigators will use generalized linear models
to examine the effect of foundational vs. enhanced REP on implementation outcomes at 12
months.
Inclusion Criteria:
- Site inclusion criteria includes sites not meeting benchmarks for adoption of
Caregivers FIRST and submission of a signed participation agreement.
- Enrolled sites will all be exposed to Foundational REP.
- Half of sites will be randomized to receive higher-intensity implementation support
(Enhanced REP).
Exclusion Criteria:
- The eight Caregivers FIRST (formerly called iHI-FIVES) sites that have previously
participated in Function QUERI (ClinicalTrials.gov Identifier: NCT03474380) will be
excluded from enrollment in this study.
|
NCT0531xxxx/NCT05319548.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319548</url>
</required_header>
<id_info>
<org_study_id>2021-1544</org_study_id>
<secondary_id>Protocol Version 6/9/2022</secondary_id>
<secondary_id>A074600</secondary_id>
<secondary_id>59-5090-2-003</secondary_id>
<nct_id>NCT05319548</nct_id>
</id_info>
<brief_title>Plant Pigments for Human Health: Impact of Lycopene and Anthocyanins on Bioefficacy of Provitamin A Carotenoids From Carrots</brief_title>
<official_title>Plant Pigments for Human Health: Determining the Interactions the Impact of Co-ingestion of Carotenoids and Anthocyanins From Multicolored Carrots on the Bioavailability of Provitamin A Carotenoids and the Impact on Each Pigment Groups' Respective Antidiabetic Activity in Humans</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Wisconsin, Madison</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of Wisconsin, Madison</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The proposed research will help characterize the impact that simultaneous consumption of
anthocyanins and carotenoids has on the bioavailability of the provitamin A carotenoids
a-carotene and b-carotene and the non-provitamin A carotenoid lycopene, and on their
respective antidiabetic activity in humans. The central hypothesis is that provitamin A
carotenoids will be bioavailable from purple-red multicolored carrots in humans, and the
co-ingestion of carotenoids and anthocyanins from these carrots will have synergistic impacts
on their respective antioxidant and antidiabetic effects. This hypothesis will be assessed
through a 53 day randomized crossover time course study that consists of three arms in which
healthy males and females ages 18-40 (n = 12) will consume carrot juice prepared from red,
purple-red, or purple carrots. During each arm, participants will switch the type of juice
they consume and by the end of the third arm, all participants will have ingested juice made
from all three carrot varieties. Blood will be collected at multiple time points over 72
hours following consumption.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">October 31, 2022</start_date>
<completion_date type="Actual">May 11, 2023</completion_date>
<primary_completion_date type="Actual">May 11, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Crossover Assignment</intervention_model>
<primary_purpose>Prevention</primary_purpose>
<masking>Triple (Participant, Care Provider, Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Change in serum retinol concentration</measure>
<time_frame>Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours</time_frame>
<description>Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)</description>
</primary_outcome>
<primary_outcome>
<measure>Change in serum carotenoid concentration</measure>
<time_frame>Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours</time_frame>
<description>Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)</description>
</primary_outcome>
<primary_outcome>
<measure>Change in serum anthocyanin concentration</measure>
<time_frame>Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours</time_frame>
<description>Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)</description>
</primary_outcome>
<secondary_outcome>
<measure>Change in antioxidant capacity of the carrots and carrot juice measured by enzyme activity assay</measure>
<time_frame>up to 1 month</time_frame>
<description>Three different antioxidant activity assays will be used including the Oxygen Radical Absorbance Capacity (ORAC), 2,2'-azino-bis-3-ethylbenzthiazoline-6-sulphonic acid (ABTS+), and 1,1-diphenyl-2-picrylhydrazyl (DPPH) assays, all of which will be analyzed by Ultraviolet (UV) spec. Each method analyzes different ways anthocyanins and carotenoids may act as antioxidants, and a combination of the three will more accurately represent the parameters of human biology. Data will be expressed as Trolox equivalent antioxidant capacity (TEAC).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in alpha-glucosidase inhibition activities of the carrots and carrot juice measured by enzyme activity assay</measure>
<time_frame>up to 1 month</time_frame>
<description>Enzyme inhibition will be assessed using specific enzymatic assay kits for alpha-glucosidase and alpha-amylase, analyzed using Enzyme-Linked Immunosorbent Assay (ELISA), and results will be expressed as IC50 (% inhibition).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in alpha-amylase inhibition activities of the carrots and carrot juice measured by enzyme activity assay</measure>
<time_frame>up to 1 month</time_frame>
<description>Enzyme inhibition will be assessed using specific enzymatic assay kits for alpha-glucosidase and alpha-amylase, analyzed using ELISA, and results will be expressed as IC50 (% inhibition).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in serum glucose concentration</measure>
<time_frame>Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours</time_frame>
<description>Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in serum insulin concentration</measure>
<time_frame>Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours</time_frame>
<description>Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in serum incretin concentration</measure>
<time_frame>Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours</time_frame>
<description>Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)</description>
</secondary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Actual">12</enrollment>
<condition>Healthy</condition>
<arm_group>
<arm_group_label>Starting with Purple-Red Carrot Juice</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Participants are randomized to consume purple-red carrot juice first (250 mL) in under 2 minutes. They will crossover to red carrot juice and to purple carrot juice.</description>
</arm_group>
<arm_group>
<arm_group_label>Starting with Purple Carrot Juice</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Participants are randomized to consume purple carrot juice first (250 mL) in under 2 minutes. They will crossover to red carrot juice and to purple-red carrot juice.</description>
</arm_group>
<arm_group>
<arm_group_label>Starting with Red Carrot Juice</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Participants are randomized to consume red carrot juice first (250 mL) in under 2 minutes. They will crossover to purple-red carrot juice and to purple carrot juice.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Purple-Red Carrot Juice</intervention_name>
<description>Purple-Red carrot juice contains provitamin A carotenoids (beta-carotene, alpha-carotene), the non-provitamin A carotenoid, lycopene, as well as anthocyanins</description>
<arm_group_label>Starting with Purple Carrot Juice</arm_group_label>
<arm_group_label>Starting with Purple-Red Carrot Juice</arm_group_label>
<arm_group_label>Starting with Red Carrot Juice</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Red Carrot Juice</intervention_name>
<description>Red carrot juice contains provitamin A carotenoids (beta-carotene, alpha-carotene), and the non-provitamin A carotenoid, lycopene, but does NOT contain anthocyanins..</description>
<arm_group_label>Starting with Purple Carrot Juice</arm_group_label>
<arm_group_label>Starting with Purple-Red Carrot Juice</arm_group_label>
<arm_group_label>Starting with Red Carrot Juice</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Purple Carrot Juice</intervention_name>
<description>Purple carrot juice does NOT contain provitamin A carotenoids (beta-carotene, alpha-carotene), nor the non-provitamin A carotenoid, lycopene, but contains anthocyanins.</description>
<arm_group_label>Starting with Purple Carrot Juice</arm_group_label>
<arm_group_label>Starting with Purple-Red Carrot Juice</arm_group_label>
<arm_group_label>Starting with Red Carrot Juice</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Healthy

- Non-smoking

- Not pregnant (or planning to become pregnant)

- Body Mass Index (BMI) greater than 18.5 and less than 30

Exclusion Criteria:

- Major comorbidities (cardiovascular disease (CVD), diabetes, cancer,
kidney/liver/bowel disease)

- History of malabsorptive/GI disorders

- Abnormal diet

- BMI less than 18.5 or greater than 30

- Food intolerances/allergies/hypersensitivities

- History of substance abuse or alcoholism

- Unwilling to restrict consumption of specific foods prior to study

- Unwilling to participate in blood draws

- History of difficulty drawing blood/health issues associated with blood draws (gets
dizzy, etc).
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>40 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>UW-Madison Department of Nutritional Sciences</name>
<address>
<city>Madison</city>
<state>Wisconsin</state>
<zip>53706</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>May 2023</verification_date>
<study_first_submitted>March 29, 2022</study_first_submitted>
<study_first_submitted_qc>April 7, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>May 22, 2023</last_update_submitted>
<last_update_submitted_qc>May 22, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 23, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The proposed research will help characterize the impact that simultaneous consumption of
anthocyanins and carotenoids has on the bioavailability of the provitamin A carotenoids
a-carotene and b-carotene and the non-provitamin A carotenoid lycopene, and on their
respective antidiabetic activity in humans. The central hypothesis is that provitamin A
carotenoids will be bioavailable from purple-red multicolored carrots in humans, and the
co-ingestion of carotenoids and anthocyanins from these carrots will have synergistic impacts
on their respective antioxidant and antidiabetic effects. This hypothesis will be assessed
through a 53 day randomized crossover time course study that consists of three arms in which
healthy males and females ages 18-40 (n = 12) will consume carrot juice prepared from red,
purple-red, or purple carrots. During each arm, participants will switch the type of juice
they consume and by the end of the third arm, all participants will have ingested juice made
from all three carrot varieties. Blood will be collected at multiple time points over 72
hours following consumption.
Inclusion Criteria:
- Healthy
- Non-smoking
- Not pregnant (or planning to become pregnant)
- Body Mass Index (BMI) greater than 18.5 and less than 30
Exclusion Criteria:
- Major comorbidities (cardiovascular disease (CVD), diabetes, cancer,
kidney/liver/bowel disease)
- History of malabsorptive/GI disorders
- Abnormal diet
- BMI less than 18.5 or greater than 30
- Food intolerances/allergies/hypersensitivities
- History of substance abuse or alcoholism
- Unwilling to restrict consumption of specific foods prior to study
- Unwilling to participate in blood draws
- History of difficulty drawing blood/health issues associated with blood draws (gets
dizzy, etc).
|
NCT0531xxxx/NCT05319561.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319561</url>
</required_header>
<id_info>
<org_study_id>IIR 20-246</org_study_id>
<secondary_id>HX003364</secondary_id>
<nct_id>NCT05319561</nct_id>
</id_info>
<brief_title>Dissemination and Implementation of a Videoconference Antimicrobial Stewardship Team</brief_title>
<acronym>VAST</acronym>
<official_title>Dissemination and Implementation of a Videoconference Antimicrobial Stewardship Team (VAST)</official_title>
<sponsors>
<lead_sponsor>
<agency>VA Office of Research and Development</agency>
<agency_class>U.S. Fed</agency_class>
</lead_sponsor>
</sponsors>
<source>VA Office of Research and Development</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
<is_us_export>No</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
Antimicrobial-resistant and healthcare-associated pathogens are a global health threat. The
goals of antimicrobial stewardship are to minimize unnecessary and inappropriate
antimicrobial use as a means to combat antimicrobial resistance. Previously, the
investigators implemented a Videoconference Antimicrobial Stewardship Team (VAST) at 2 VA
Medical Centers (VAMCs), using telehealth to connect clinicians at a rural VAMC to a
geographically distant infectious disease expert Both VASTs successfully decreased overall
antibiotic use in acute and long-term care units. This project will expand the VAST approach
to other VAMCs and test the hypothesis that quarterly reports that quantify facility-level
antibiotic use will enhance the efficacy of VASTs to support antimicrobial stewardship. This
work will directly increase access to antimicrobial stewardship consultation at rural VA
facilities, which are often underserved by infectious disease expertise.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Background: Antimicrobial stewardship guidelines call for a multidisciplinary team with an
infectious disease (ID) physician and ID-trained clinical pharmacist as core members.
Unfortunately, there are insufficient ID-trained specialists to staff on-site antimicrobial
stewardship programs throughout VA.

Significance: This proposal is highly significant for Veterans and the goals of VA. Veterans
experience many of the risk factors associated with development of antimicrobial resistant
and healthcare-associated infections. The unprecedented effects of the novel Coronavirus
disease 2019 (COVID-19) on the health of Veterans and on the entire healthcare system makes
the demand for ID expertise even more apparent, especially in long-term care. Also, this
study directly addresses the VA MISSION ACT to improve access to care, timeliness and quality
of care, using telehealth services. Finally, this project is aligned with the priorities of
operation partners: VA Antimicrobial Stewardship Taskforce (ASTF), the VA National Infectious
Disease Service (NIDS), VA Pharmacy Benefits Management (PBM) Services, and the Office of
Rural Health.

Innovation and Impact: The design is innovative because the investigators will systematically
test and assess implementation barriers to telehealth for antimicrobial stewardship, a novel
approach that has not been implemented in VA facilities, other than in the investigators'
previous pilot study. Further, the Antibiotic Use Reports (AURs) are an innovative adaptation
of peer-comparison, an antibiotic stewardship strategy successful in outpatient settings.
This project will provide findings for a scalable model that could be deployed nationally to
all applicable VAMCs, continuing the role of VHA as a leader in implementing large-scale
interventions focused on prevention and management of ID and stewardship.

Specific Aims: The goal is to implement a multidisciplinary videoconference antimicrobial
stewardship team (VAST) in VAMCs using SCAN-ECHO. The central hypothesis is that feedback
reports that quantify facility-level antibiotic use will enhance the efficacy of VASTs to
support antimicrobial stewardship. The investigators propose a Type 2 hybrid
effectiveness-implementation design, comparing clinical effectiveness in sites that implement
the VAST alone (VAST-) to sites that implement the VAST augmented by facility-level
Antibiotic Use Reports (VAST+). Aims are: 1) Identify and test effective strategies for
implementing the VAST; 2) Determine the influence of the VAST overall and VAST+ on the care
of Veterans with suspected infections; 3) Determine the influence of the VAST overall and
VAST+ on antibiotic use at each VAMC.

Methodology: The investigators will randomize rural VAMCs that do not have ID-trained
professionals on staff to implement the VAST alone (VAST-) versus VAST + antibiotic use
feedback (VAST+). Aim 1: The investigators will assess modification and adaptations at the
intervention sites and by the infectious disease experts. Methods will include process maps
and semi-structured interviews to gather qualitative data about what key VAST members
perceive as facilitators, barriers and burden to VAST implementation. The investigators will
also evaluate costs of implementation. Aim 2: The investigators will evaluate the Veteran
population served, clinical activities, and user perceptions of the VAST. The investigators
will assess the concordance of clinical care with recommendations from evidence-based
clinical practice guidelines. VAST members' perceptions of the quality and timeliness of care
will be evaluated. Aim 3: The primary outcome measure will be overall rates of antibiotic
use. Secondary outcomes will be changes in the rates of broad-spectrum antibiotic use,
antibiotic starts, and length of antibiotic therapy.

Next steps/Implementation: Testing effective implementation of the VAST at additional VAMCs
is an important step toward augmenting antimicrobial stewardship in both acute- and long-term
care settings. In collaboration with VA clinical operation partners, outcomes from this trial
will be used to roll-out an implementation playbook to be used by other VAMCs, as well as
non-VA settings.
</textblock>
</detailed_description>
<overall_status>Enrolling by invitation</overall_status>
<start_date type="Actual">March 28, 2022</start_date>
<completion_date type="Anticipated">March 31, 2026</completion_date>
<primary_completion_date type="Anticipated">March 31, 2025</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>The Practical, Robust Implementation and Sustainability Model (PRISM) is an expansion of the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) model. Briefly, PRISM expands RE-AIM to further consider key contextual factors related to implementation, evaluation and dissemination of health services programs. The investigators will use PRISM and RE-AIM to inform implementation, evaluation and maintenance of the intervention as the investigators seek to disseminate the VAST beyond the 2 pilot sites</intervention_model_description>
<primary_purpose>Health Services Research</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Days of Antibiotic Therapy / 1000 Bed Days of Care</measure>
<time_frame>2.25 years</time_frame>
<description>Days of antibiotic therapy per 1000 days of care (DOT/1000 DOC), measures the overall rate of antibiotic use and is a common metric that accounts for dose adjustments, including for people who receive dialysis. Administration of any dose of an antimicrobial on a given day represents a single DOT for that agent, regardless of the number of times the doses are administered or the dose strength.</description>
</primary_outcome>
<secondary_outcome>
<measure>Rate of broad-spectrum antibiotics</measure>
<time_frame>2.25 years</time_frame>
<description>The investigators will specifically examine the rate of broad-spectrum antibiotics, defining broad-spectrum agents as those with an Antibiotic Spectrum Index score of 8. This scale ranges from 1 to 13; the ASIs for penicillin, doxycycline, ciprofloxacin, and ertapenem are 2, 5, 8 and 9, respectively.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Antibiotic Starts</measure>
<time_frame>2.25 years</time_frame>
<description>The investigators will measure the rate of antibiotic starts (new prescriptions), calculated as the number of starts per 1000 DOC. The fourth metric is the length of antibiotic therapy in days. For people on hemodialysis, up to 72 hours may occur between doses of specific agents (e.g. vancomycin, aminoglycosides, several cephalosporins); these will be considered as a single course.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">10</enrollment>
<condition>Common Infections</condition>
<condition>Urinary Tract Infections</condition>
<condition>Pneumonia</condition>
<arm_group>
<arm_group_label>VAST+</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Sites that implement the VAST augmented by quarterly facility-level Antibiotic Use Reports (VAST+).</description>
</arm_group>
<arm_group>
<arm_group_label>VAST -</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>to sites that implement the VAST and do NOT receive a quarterly facility-level Antibiotic Use Reports (VAST-).</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Antibiotic Use Report</intervention_name>
<description>The Antibiotic Use Report uses both text and graphics to communicate successes and improvement opportunities specific to the VAMC for which it is prepared. The graphs summarize overall antibiotic use over the previous year, with additional information regarding use of broad- and narrow-spectrum agents. Further, each Antibiotic Use Report compares or "benchmarks" the individual VAMC for which it is prepared to other VAMCs in the same Medical Complexity Group. This approach adapts and expands peer comparison, which has proven effective at reducing inappropriate antibiotic use in outpatient settings.</description>
<arm_group_label>VAST+</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- VA medical centers without local ID expertise that pair with an ID-expert from another
VA medical center.

Exclusion Criteria:

- (none)
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Robin Lynn Paige Jump, MD PhD</last_name>
<role>Principal Investigator</role>
<affiliation>VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA</affiliation>
</overall_official>
<overall_official>
<last_name>Charlesnika Tyon Evans, PhD MPH BS</last_name>
<role>Principal Investigator</role>
<affiliation>Edward Hines Jr. VA Hospital, Hines, IL</affiliation>
</overall_official>
<location>
<facility>
<name>Louis Stokes VA Medical Center, Cleveland, OH</name>
<address>
<city>Cleveland</city>
<state>Ohio</state>
<zip>44106-1702</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA</name>
<address>
<city>Pittsburgh</city>
<state>Pennsylvania</state>
<zip>15240</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>March 2023</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>March 15, 2023</last_update_submitted>
<last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">March 17, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>antimicrobial stewardship</keyword>
<keyword>telehealth</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Infections</mesh_term>
<mesh_term>Communicable Diseases</mesh_term>
<mesh_term>Urinary Tract Infections</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Anti-Bacterial Agents</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
<ipd_description>Final data sets underlying all publications resulting from the proposed research will not be shared outside VA, except as required under the Freedom of Information Act (FOIA). Reasons for this are (i) the sample size will be too large to obtain informed consents and HIPAA authorizations and (ii) public disclosure of the final study data containing protected health information (PHI) is inconsistent with the IRB approved waiver of informed consent and waiver of HIPAA authorization that will be sought.</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Antimicrobial-resistant and healthcare-associated pathogens are a global health threat. The
goals of antimicrobial stewardship are to minimize unnecessary and inappropriate
antimicrobial use as a means to combat antimicrobial resistance. Previously, the
investigators implemented a Videoconference Antimicrobial Stewardship Team (VAST) at 2 VA
Medical Centers (VAMCs), using telehealth to connect clinicians at a rural VAMC to a
geographically distant infectious disease expert Both VASTs successfully decreased overall
antibiotic use in acute and long-term care units. This project will expand the VAST approach
to other VAMCs and test the hypothesis that quarterly reports that quantify facility-level
antibiotic use will enhance the efficacy of VASTs to support antimicrobial stewardship. This
work will directly increase access to antimicrobial stewardship consultation at rural VA
facilities, which are often underserved by infectious disease expertise.
Background: Antimicrobial stewardship guidelines call for a multidisciplinary team with an
infectious disease (ID) physician and ID-trained clinical pharmacist as core members.
Unfortunately, there are insufficient ID-trained specialists to staff on-site antimicrobial
stewardship programs throughout VA.
Significance: This proposal is highly significant for Veterans and the goals of VA. Veterans
experience many of the risk factors associated with development of antimicrobial resistant
and healthcare-associated infections. The unprecedented effects of the novel Coronavirus
disease 2019 (COVID-19) on the health of Veterans and on the entire healthcare system makes
the demand for ID expertise even more apparent, especially in long-term care. Also, this
study directly addresses the VA MISSION ACT to improve access to care, timeliness and quality
of care, using telehealth services. Finally, this project is aligned with the priorities of
operation partners: VA Antimicrobial Stewardship Taskforce (ASTF), the VA National Infectious
Disease Service (NIDS), VA Pharmacy Benefits Management (PBM) Services, and the Office of
Rural Health.
Innovation and Impact: The design is innovative because the investigators will systematically
test and assess implementation barriers to telehealth for antimicrobial stewardship, a novel
approach that has not been implemented in VA facilities, other than in the investigators'
previous pilot study. Further, the Antibiotic Use Reports (AURs) are an innovative adaptation
of peer-comparison, an antibiotic stewardship strategy successful in outpatient settings.
This project will provide findings for a scalable model that could be deployed nationally to
all applicable VAMCs, continuing the role of VHA as a leader in implementing large-scale
interventions focused on prevention and management of ID and stewardship.
Specific Aims: The goal is to implement a multidisciplinary videoconference antimicrobial
stewardship team (VAST) in VAMCs using SCAN-ECHO. The central hypothesis is that feedback
reports that quantify facility-level antibiotic use will enhance the efficacy of VASTs to
support antimicrobial stewardship. The investigators propose a Type 2 hybrid
effectiveness-implementation design, comparing clinical effectiveness in sites that implement
the VAST alone (VAST-) to sites that implement the VAST augmented by facility-level
Antibiotic Use Reports (VAST+). Aims are: 1) Identify and test effective strategies for
implementing the VAST; 2) Determine the influence of the VAST overall and VAST+ on the care
of Veterans with suspected infections; 3) Determine the influence of the VAST overall and
VAST+ on antibiotic use at each VAMC.
Methodology: The investigators will randomize rural VAMCs that do not have ID-trained
professionals on staff to implement the VAST alone (VAST-) versus VAST + antibiotic use
feedback (VAST+). Aim 1: The investigators will assess modification and adaptations at the
intervention sites and by the infectious disease experts. Methods will include process maps
and semi-structured interviews to gather qualitative data about what key VAST members
perceive as facilitators, barriers and burden to VAST implementation. The investigators will
also evaluate costs of implementation. Aim 2: The investigators will evaluate the Veteran
population served, clinical activities, and user perceptions of the VAST. The investigators
will assess the concordance of clinical care with recommendations from evidence-based
clinical practice guidelines. VAST members' perceptions of the quality and timeliness of care
will be evaluated. Aim 3: The primary outcome measure will be overall rates of antibiotic
use. Secondary outcomes will be changes in the rates of broad-spectrum antibiotic use,
antibiotic starts, and length of antibiotic therapy.
Next steps/Implementation: Testing effective implementation of the VAST at additional VAMCs
is an important step toward augmenting antimicrobial stewardship in both acute- and long-term
care settings. In collaboration with VA clinical operation partners, outcomes from this trial
will be used to roll-out an implementation playbook to be used by other VAMCs, as well as
non-VA settings.
Inclusion Criteria:
- VA medical centers without local ID expertise that pair with an ID-expert from another
VA medical center.
Exclusion Criteria:
- (none)
|
NCT0531xxxx/NCT05319574.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319574</url>
</required_header>
<id_info>
<org_study_id>SYSUCC B2022-159-01</org_study_id>
<nct_id>NCT05319574</nct_id>
</id_info>
<brief_title>SBRT Followed by Neoadjuvant Immunochemotherapy in Resectable Stage IB to III Non-small Cell Lung Cancer</brief_title>
<acronym>SACTION01</acronym>
<official_title>Preoperative Stereotactic Body Radiotherapy and Platinum-based Doublet Chemotherapy Plus Tislelizumab (Immunotherapy) for Operable Stage IB to III EGFR Wild-type Non-small Cell Lung Cancer</official_title>
<sponsors>
<lead_sponsor>
<agency>Sun Yat-sen University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Sun Yat-sen University</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this study is to find out the effectiveness stereotactic body radiation
therapy (SBRT) followed by two cycles of Tislelizumab (PD-1 inhibitor) with chemotherapy as
treatment for operable stage IB (tumors > 4cm) to III non-small cell lung cancer (NSCLC)
prior to surgery.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">April 24, 2022</start_date>
<completion_date type="Anticipated">April 2024</completion_date>
<primary_completion_date type="Anticipated">April 2024</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Major Pathological Response (MPR)</measure>
<time_frame>From date of enrollment until one month after resection</time_frame>
<description>MPR is defined as ≤10% residual viable tumor in the resected specimen</description>
</primary_outcome>
<secondary_outcome>
<measure>Pathologic Complete response (PCR)</measure>
<time_frame>From date of enrollment until one month after resection</time_frame>
<description>PCR is defined as no residual viable tumor in the resected specimen</description>
</secondary_outcome>
<secondary_outcome>
<measure>Resected rate</measure>
<time_frame>From date of enrollment to an average of 18 weeks after the first dose</time_frame>
<description>Resected rate is defined as the percentage of patients that undergo surgical resection after neoadjuvant treatment</description>
</secondary_outcome>
<secondary_outcome>
<measure>Disease-free survival</measure>
<time_frame>From date of SBRT start date until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 months for 2 years , then yearly thereafter till year 5</time_frame>
<description>Disease recurrence or death from any cause assessed using history, physical examination and CT scanning, histologically or cytologically confirmed whenever possible</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">46</enrollment>
<condition>Carcinoma, Non-Small-Cell Lung</condition>
<arm_group>
<arm_group_label>Neoadjuvant SBRT plus immunochemotherapy</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Stereotactic body radiation therapy (8Gy*3d) followed by Tislelizumab (200mg) with platinum-based doublet chemotherapy administered pre-operatively every 3 weeks for 2 cycles before surgical resection</description>
</arm_group>
<intervention>
<intervention_type>Radiation</intervention_type>
<intervention_name>SBRT</intervention_name>
<description>Stereotactic body radiation therapy delivered with a fixed dose (8Gy) in 3 daily fractions 1-7 days before the first cycle of immunochemotherapy</description>
<arm_group_label>Neoadjuvant SBRT plus immunochemotherapy</arm_group_label>
<other_name>stereotactic body radiation therapy</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Tislelizumab</intervention_name>
<description>200mg q3w for two cycles administrated concurrently with chemotherapy</description>
<arm_group_label>Neoadjuvant SBRT plus immunochemotherapy</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Patient has histologically or cytologically proven clinical stages I (tumors ≥ 4 cm),
II, and IIIA NSCLC and is considered eligible for surgical resection with curative
intent. Besides, T3-4N2 stage III disease deemed potentially resectable by MDT group
is also allowed.

2. Measureable disease, as defined by RECIST v1.1.

3. Written informed consent and HIPAA obtained from the subject prior to performing any
protocol-related procedures.

4. EGFR mutational status should be tested in all non-squamous carcinoma, and only
patients with non-EGFR-TKI sensitizing mutation (19del or L858R) are allowed. For
squamous cell carcinoma, EGFR mutational test is not required.

5. Age > 18 years at time of study entry

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

7. Adequate normal organ and marrow function as defined below:

- Haemoglobin ≥ 9.0 g/dL

- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (> 1500 per mm3)

- Platelet count ≥ 100 x 109/L (>100,000 per mm3)

- Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). This will not
apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent
hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis
or hepatic pathology), who will be allowed only in consultation with their
physician.

- AST (SGOT)/ALT (SGPT), and alkaline phosphatase ≤ 2.5 x institutional upper limit
of normal (ULN).

- Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault
1976) or by 24-hour urine collection for determination of creatinine clearance:

8. Evidence of post-menopausal status or negative urinary or serum pregnancy test for
female pre-menopausal patients. Women will be considered post-menopausal if they have
been amenorrheic for 12 months without an alternative medical cause. The following
age-specific requirements apply:

Women <50 years of age would be considered post-menopausal if they have been
amenorrheic for 12 months or more following cessation of exogenous hormonal treatments
and if they have luteinizing hormone and follicle-stimulating hormone levels in the
post-menopausal range for the institution or underwent surgical sterilization
(bilateral oophorectomy or hysterectomy).

Women ≥50 years of age would be considered post-menopausal if they have been
amenorrheic exogenous hormonal treatments, had radiation-induced menopause with last
menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago,
or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy
or hysterectomy).

9. Subject is willing and able to comply with the protocol for the duration of the study
including undergoing treatment and scheduled visits and examinations including follow
up.

10. No prior therapy for their lung cancer.

Exclusion Criteria:

1. Participation in another clinical study with an investigational product during the
last 3 weeks.

2. History of another primary malignancy except for:

- Malignancy treated with curative intent and with no known active disease ≥3 years
before the first dose of study drug and of low potential risk for recurrence.

- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
of disease.

- Adequately treated carcinoma in situ without evidence of disease eg, cervical
cancer in situ, in-situ urinary bladder cancer , treated localized prostate
cancer and ductal carcinoma-in situ.

- Indolent hematological malignancies

3. Current or prior use of immunosuppressive medication within 14 days before the first
dose of durvalumab, with the exceptions of intranasal,inhaled, topical steroids, or
local steroid injections (e.g., intra articular injection), corticosteroids or
systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of
prednisone, or an equivalent corticosteroid, and steroids as premedication for
hypersensitivity reactions (e.g., CT scan premedication).

4. Any unresolved toxicity (CTCAE grade 2) from therapy for a prior malignancy with the
exception of alopecia, vitiligo, and the laboratory values defined in the inclusion
criteria.

- Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after
consultation with the Study Physician.

- Subjects with irreversible toxicity that is not reasonably expected to be
exacerbated by the investigational product may be included (e.g., hearing loss,
peripherally neuropathy).

5. Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous
immunotherapy agent, or any unresolved irAE >Grade 1.

6. Active or prior documented autoimmune or inflammatory disorders (including
inflammatory bowel disease [e.g., colitis or Crohn's disease systemic lupus
erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with
polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). No
active diverticulitis within the previous 3 months. The following are exceptions to
this criterion:

- Patients with vitiligo or alopecia

- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on
hormone replacement

- Any chronic skin condition that does not require systemic therapy

- Patients without active disease in the last 5 years may be included but only
after consultation with the study physician

- Patients with celiac disease controlled by diet alone

7. Active or prior documented inflammatory bowel disease (e.g., Crohn's disease,
ulcerative colitis).

8. History of active primary immunodeficiency.

9. History of allogeneic organ transplant.

10. History of hypersensitivity to tislelizumab or any excipient.

11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
angina pectoris, cardiac arrhythmia, serious chronic gastrointestinal conditions
associated with diarrhea, or psychiatric illness/social situations that would limit
compliance with study requirement, substantially increase risk of incurring AEs or
compromise the ability of the patient to give written informed consent.

12. Active infection including tuberculosis (clinical evaluation that includes clinical
history, physical examination and radiographic findings, and TB testing in line with
local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result),
hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients
with a past or resolved HBV infection (defined as the presence of hepatitis B core
antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for
hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative
for HCV RNA.

13. History of leptomeningeal carcinomatosis.

14. Any condition that, in the opinion of the investigator, would interfere with
evaluation of study treatment or interpretation of patient safety or study results

15. Subjects with uncontrolled seizures.

16. History of interstitial lung disease, idiopathic pulmonary fibrosis, pneumonitis
(including drug induced), or evidence of active pneumonitis on screening chest CT
scan.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>75 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Sun Yat-sen University Cancer Center</name>
<address>
<city>Guangzhou</city>
<state>Guangdong</state>
<zip>510060</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Hong Yang, Ph.D.,M.D.</last_name>
<phone>008613560405144</phone>
<email>yanghong@sysucc.org.cn</email>
</contact>
<contact_backup>
<last_name>Jiyang Chen</last_name>
<phone>008618826238208</phone>
<email>chenjy1@sysucc.org.cn</email>
</contact_backup>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>May 2022</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>May 17, 2022</last_update_submitted>
<last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">May 18, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
<investigator_full_name>Yang Hong</investigator_full_name>
<investigator_title>Prof.</investigator_title>
</responsible_party>
<keyword>Non small cell lung cancer</keyword>
<keyword>Neoadjuvant</keyword>
<keyword>Immunotherapy</keyword>
<keyword>SBRT</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Lung Neoplasms</mesh_term>
<mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Tislelizumab</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this study is to find out the effectiveness stereotactic body radiation
therapy (SBRT) followed by two cycles of Tislelizumab (PD-1 inhibitor) with chemotherapy as
treatment for operable stage IB (tumors > 4cm) to III non-small cell lung cancer (NSCLC)
prior to surgery.
Inclusion Criteria:
1. Patient has histologically or cytologically proven clinical stages I (tumors ≥ 4 cm),
II, and IIIA NSCLC and is considered eligible for surgical resection with curative
intent. Besides, T3-4N2 stage III disease deemed potentially resectable by MDT group
is also allowed.
2. Measureable disease, as defined by RECIST v1.1.
3. Written informed consent and HIPAA obtained from the subject prior to performing any
protocol-related procedures.
4. EGFR mutational status should be tested in all non-squamous carcinoma, and only
patients with non-EGFR-TKI sensitizing mutation (19del or L858R) are allowed. For
squamous cell carcinoma, EGFR mutational test is not required.
5. Age > 18 years at time of study entry
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Adequate normal organ and marrow function as defined below:
- Haemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (> 1500 per mm3)
- Platelet count ≥ 100 x 109/L (>100,000 per mm3)
- Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). This will not
apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent
hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis
or hepatic pathology), who will be allowed only in consultation with their
physician.
- AST (SGOT)/ALT (SGPT), and alkaline phosphatase ≤ 2.5 x institutional upper limit
of normal (ULN).
- Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault
1976) or by 24-hour urine collection for determination of creatinine clearance:
8. Evidence of post-menopausal status or negative urinary or serum pregnancy test for
female pre-menopausal patients. Women will be considered post-menopausal if they have
been amenorrheic for 12 months without an alternative medical cause. The following
age-specific requirements apply:
Women <50 years of age would be considered post-menopausal if they have been
amenorrheic for 12 months or more following cessation of exogenous hormonal treatments
and if they have luteinizing hormone and follicle-stimulating hormone levels in the
post-menopausal range for the institution or underwent surgical sterilization
(bilateral oophorectomy or hysterectomy).
Women ≥50 years of age would be considered post-menopausal if they have been
amenorrheic exogenous hormonal treatments, had radiation-induced menopause with last
menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago,
or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy
or hysterectomy).
9. Subject is willing and able to comply with the protocol for the duration of the study
including undergoing treatment and scheduled visits and examinations including follow
up.
10. No prior therapy for their lung cancer.
Exclusion Criteria:
1. Participation in another clinical study with an investigational product during the
last 3 weeks.
2. History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥3 years
before the first dose of study drug and of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
of disease.
- Adequately treated carcinoma in situ without evidence of disease eg, cervical
cancer in situ, in-situ urinary bladder cancer , treated localized prostate
cancer and ductal carcinoma-in situ.
- Indolent hematological malignancies
3. Current or prior use of immunosuppressive medication within 14 days before the first
dose of durvalumab, with the exceptions of intranasal,inhaled, topical steroids, or
local steroid injections (e.g., intra articular injection), corticosteroids or
systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of
prednisone, or an equivalent corticosteroid, and steroids as premedication for
hypersensitivity reactions (e.g., CT scan premedication).
4. Any unresolved toxicity (CTCAE grade 2) from therapy for a prior malignancy with the
exception of alopecia, vitiligo, and the laboratory values defined in the inclusion
criteria.
- Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after
consultation with the Study Physician.
- Subjects with irreversible toxicity that is not reasonably expected to be
exacerbated by the investigational product may be included (e.g., hearing loss,
peripherally neuropathy).
5. Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous
immunotherapy agent, or any unresolved irAE >Grade 1.
6. Active or prior documented autoimmune or inflammatory disorders (including
inflammatory bowel disease [e.g., colitis or Crohn's disease systemic lupus
erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with
polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). No
active diverticulitis within the previous 3 months. The following are exceptions to
this criterion:
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on
hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included but only
after consultation with the study physician
- Patients with celiac disease controlled by diet alone
7. Active or prior documented inflammatory bowel disease (e.g., Crohn's disease,
ulcerative colitis).
8. History of active primary immunodeficiency.
9. History of allogeneic organ transplant.
10. History of hypersensitivity to tislelizumab or any excipient.
11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
angina pectoris, cardiac arrhythmia, serious chronic gastrointestinal conditions
associated with diarrhea, or psychiatric illness/social situations that would limit
compliance with study requirement, substantially increase risk of incurring AEs or
compromise the ability of the patient to give written informed consent.
12. Active infection including tuberculosis (clinical evaluation that includes clinical
history, physical examination and radiographic findings, and TB testing in line with
local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result),
hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients
with a past or resolved HBV infection (defined as the presence of hepatitis B core
antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for
hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative
for HCV RNA.
13. History of leptomeningeal carcinomatosis.
14. Any condition that, in the opinion of the investigator, would interfere with
evaluation of study treatment or interpretation of patient safety or study results
15. Subjects with uncontrolled seizures.
16. History of interstitial lung disease, idiopathic pulmonary fibrosis, pneumonitis
(including drug induced), or evidence of active pneumonitis on screening chest CT
scan.
|
NCT0531xxxx/NCT05319587.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319587</url>
</required_header>
<id_info>
<org_study_id>MB-106</org_study_id>
<secondary_id>2020-005493-10</secondary_id>
<nct_id>NCT05319587</nct_id>
</id_info>
<brief_title>Study of Liposomal Annamycin in Combination With Cytarabine for the Treatment of Subjects With Acute Myeloid Leukemia (AML)</brief_title>
<official_title>Phase 1/2 Study of Liposomal Annamycin in Combination With Cytarabine for the Treatment of Subjects With Acute Myeloid Leukemia (AML)</official_title>
<sponsors>
<lead_sponsor>
<agency>Moleculin Biotech, Inc.</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Moleculin Biotech, Inc.</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This is a Phase 1/2, multicenter, open-label, dose-escalation study that will determine the
MTD and RP2D of L-Annamycin in combination with cytarabine for the treatment of subjects with
AML.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
During Phase 1b, dose escalation will proceed according to a standard 3+3 design. An initial
group of 3 subjects will be treated with an intravenous infusion of 190-mg/m2 L-Annamycin
(Dose Level 1) for 3 consecutive days. Dose escalation will take place on the basis of safety
assessments in sequential cohorts of 3 subjects each. Provided that there are no DLT's in the
initial cohort of subjects treated at the 190 mg/m2/day dose level, the next cohort of
subjects will receive the next highest L-Annamycin dose incremented by 40 mg/m2. In the
absence of DLTs, dose escalation by 40 mg/m2 will continue in subsequent cohorts until an MTD
is reached.

The dose and schedule of cytarabine during Cycle 1 (2.0 g/m2/day for 5 consecutive days) will
remain constant for all cohorts. Enrolled subjects will receive cytarabine at a dose of 2.0
g/m2/day via intravenous infusion over 4 hours for 5 consecutive days (total dose cytarabine
= 10.0 g/m2; starting on the first day of L-Annamycin treatment).

If no subject experiences a dose-limiting toxicity (DLT), based on National Cancer Institute
(NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5, which constitutes a study
drug-related irreversible or not medically manageable Grade 3 or higher toxicity during the
initial treatment through Day 28, the subsequent group of 3 subjects will receive the next
higher L-Annamycin dose. However, if 1 of the 3 initial subjects experiences a DLT, the
cohort of subjects at that dose level will be expanded to 6. If at least 2 of the 6 subjects
experience a DLT, this will be considered a non-tolerated dose and the next 3 subjects will
be treated at a lower dose. The dose of L-Annamycin will be de-escalated by 20- mg/m2/day. As
such, if at least 2 out of 6 subjects receiving 230 mg/m2/day experience a DLT, the next 3
subjects will receive L-Annamycin at a dose of 210 mg/m2/day. If 1 of the 3 initial subjects
experiences a DLT, the cohort of subjects will be expanded to 6 subjects. If at least 2 of
the 6 subjects experience a DLT, this will be considered a toxic dose and the MTD will be the
previously proven safe dose level (i.e., the next lowest dose level at which no DLTs occurred
in a cohort of 3 subjects or at which fewer than 2 subjects in a cohort of 6 experienced a
DLT).

In the expansion phase, up to 21 subjects will be enrolled at the MTD/RP2D to better define
toxicity and evaluate efficacy.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">September 29, 2022</start_date>
<completion_date type="Anticipated">April 30, 2025</completion_date>
<primary_completion_date type="Anticipated">February 28, 2024</primary_completion_date>
<phase>Phase 1/Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Sequential Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Evaluate the safety and identify the MTD/RP2D of L-Annamycin in combination with a standard regimen of cytarabine (Ara-C, cytosine arabinoside)</measure>
<time_frame>Day 1 through Day 28</time_frame>
<description>The number of patients who experience dose-limiting toxicities (DLT) will be captured at each dose level of LAnnamycin in order to determine the MTD/RP2D</description>
</primary_outcome>
<secondary_outcome>
<measure>Pharmacokinetics - Area under the plasma concentration</measure>
<time_frame>Pre-dose and at 0.25, 0.5, 1, 2, 4, 8,12 and 24 hours after the start of liposomal annamycin infusion on Day 1 and Day 3</time_frame>
<description>Area under the plasma concentration - time curve (AUC) of annamycin and its metabolite, annamycinol, and of cytarabine, when administered.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Anti-leukemic activity</measure>
<time_frame>15-35 Days after the start of therapy</time_frame>
<description>Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML (Cheson, 2003). Leukemia response rate will be evaluated by the investigator at the end of each L-Annamycin cycle based on bone marrow aspirate and peripheral blood evaluations.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">63</enrollment>
<condition>Leukemia, Myeloid, Acute</condition>
<arm_group>
<arm_group_label>Liposomal annamycin</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Liposomal Annamycin</intervention_name>
<description>2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).</description>
<arm_group_label>Liposomal annamycin</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Cytarabine</intervention_name>
<description>Administered during cycle 1 at a dose of 2.0 g/m2/day by 4 hours IV infusion for 5 consecutive days and this dose will remain constant for all cohorts, including the expansion phase.</description>
<arm_group_label>Liposomal annamycin</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. The subject has a pathologically confirmed diagnosis of AML by World Health
Organization classification. This must be in the form of either a bone marrow aspirate
or biopsy or a CBC that demonstrates >5% myeloblasts.

2. The subject has AML and has not received prior therapy or is refractory to or relapsed
after induction therapy. To be defined as relapse, there must be >5% blasts in the
bone marrow.

3. For the expansion phase only (i.e., after the MTD/RP2D is established), subjects must
be treated with L-Annamycin as first- second- or third-line therapy (i.e., subjects
will not have received more than two prior therapies).

4. The subject is age ≥18 years at the time of signing informed consent.

5. The subject has received no chemotherapy, radiation, or major surgery within 2 weeks
prior to first dose of study drug and/or has recovered from the toxic side effects of
that therapy unless treatment is indicated as a result of progressive disease, such as
hydroxyurea.

6. The subject has received no investigational therapy within 4 weeks of the first dose
of study drug.

7. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status 0 to
2.

8. The subject has adequate laboratory results including the following:

1. Bilirubin ≤2 times the upper limit of normal unless due to Gilbert Syndrome or
leukemic infiltration of the liver.

2. Serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic
transaminase (SGPT), and alkaline phosphatase <2.5 times the upper limit of
normal unless due to organ involvement.

3. Adequate renal function with creatinine levels ≤2 times the upper limit of
normal.

9. The subject can understand and sign the informed consent document, can communicate
with the Investigator, and can understand and comply with the requirements of the
protocol.

10. Women of childbearing potential must have a negative serum or urine beta-human
chorionic gonadotropin test within 72 hours prior to first dose of study drug to rule
out pregnancy.

11. All men and women must agree to practice effective contraception during the entire
study period and after discontinuing study drug, unless documentation of infertility
exists.

1. Sexually active, fertile women must use 2 effective forms of contraception
(abstinence, intrauterine device, oral contraceptive, or double barrier device)
from the time of informed consent until at least 6 months after discontinuing
study drug.

2. Sexually active men and their sexual partners must use effective contraceptive
methods from the time of subject informed consent until at least 3 months after
discontinuing study drug.

Exclusion Criteria:

1. The subject was diagnosed with acute promyelocytic leukemia.

2. The subject is receiving concomitant therapy that includes other chemotherapy that is
or may be active against AML except for agents such as hydroxyurea, just to control
the WBC count until chemotherapy or prophylaxis and/or treatment of opportunistic or
other infection with antibiotics, antifungals, and/or antiviral agents, including
therapy for meningeal disease (i.e., intrathecal chemotherapy), supportive measures,
and medications as per standard of care up to Day 1 of L-Annamycin administration.

3. The subject received prior mediastinal radiotherapy.

4. The subject has central nervous system involvement.

5. The subject has any condition that, in the opinion of the Investigator, places the
subject at unacceptable risk if he/she were to participate in the study.

6. The subject has an LVEF <50%, valvular heart disease, or severe hypertension. Cardiac
subjects with a New York Heart Association classification of 3 or 4 will be excluded.
(Cardiology consultation should be requested if any question arises about cardiac
function). This also includes subjects with baseline QT/QTc interval >480 msec, a
history of additional risk factors for torsade des pointes (e.g., heart failure,
hypokalemia, family history of Long QT Syndrome), and use of concomitant medications
that significantly prolong the QT/QTc interval.

7. The subject has clinically relevant serious comorbid medical conditions including, but
not limited to, active infection, recent (less than or equal to 6 months) myocardial
infarction, unstable angina, symptomatic congestive heart failure, uncontrolled
hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic
restrictive pulmonary disease, known positive status for human immunodeficiency virus
and/or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations
that would limit compliance with study requirements.

a. Subjects with a documented COVID diagnosis within 14 days of screening must have a
documented negative PCR test and remain asymptomatic for 14 days from that test result
before starting study medication.

8. The subject is pregnant, lactating, or not using adequate contraception.

9. The subject has a known allergy to anthracyclines and/or hypersensitivity to
cytarabine, its excipients, or to any contrast media needed for imaging required per
protocol.

10. The subject has any evidence of mucositis/stomatitis at the time of study entry or
previous history of severe (≥Grade 3) mucositis from prior therapy.

11. The subject is required to use moderate or strong inhibitors and inducers of
Cytochrome P450 family of enzymes (CYP) and transporters that cannot be held for 3
days prior to Day 1 and during treatment days
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Wolfram Dempke, MD, PhD</last_name>
<role>Study Director</role>
<affiliation>Moleculin Biotech, Inc.</affiliation>
</overall_official>
<overall_contact>
<last_name>Wolfram Dempke, MD,PhD</last_name>
<phone>+41-797-836-706</phone>
<email>WDempke@moleculin.com</email>
</overall_contact>
<overall_contact_backup>
<last_name>Cynthia Abbate</last_name>
<phone>713-300-5160</phone>
<email>cabbate@moleculin.com</email>
</overall_contact_backup>
<location>
<facility>
<name>IRCCS Azienda Ospedaliero-Universitaria di Bologna</name>
<address>
<city>Bologna</city>
<zip>40138</zip>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Cinzia Bonajuto</last_name>
<phone>+39 051 2144177</phone>
<email>cinzia.bonajuto@studio.unibo.it</email>
</contact>
<contact_backup>
<last_name>Miriam Traficante</last_name>
<phone>+39 051 2144177</phone>
<email>Miriam.Traficante2@unibo.it</email>
</contact_backup>
<investigator>
<last_name>Cristina Papayannidis, M.D.</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Fondazione Policlinico Universitario A. Gemelli IRCCS</name>
<address>
<city>Roma</city>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Giulietta Calabria</last_name>
<phone>+39 06 30156016</phone>
<email>Giulietta.Calabria@gmail.com</email>
</contact>
<contact_backup>
<last_name>Laura Palladini</last_name>
<phone>+39 06 30156309</phone>
<email>laura.palladini@unicatt.it</email>
</contact_backup>
<investigator>
<last_name>Simona Sica, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Apteka Szpitalna</name>
<address>
<city>Gdańsk</city>
<country>Poland</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Agnieszka Religa</last_name>
<phone>48585844357</phone>
<email>areliga@uck.gda.pl</email>
</contact>
<investigator>
<last_name>Aleksandra Wadolowska, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego</name>
<address>
<city>Poznań</city>
<country>Poland</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Lidia Gil, MD, PhD</last_name>
<phone>+48 669 349 039</phone>
</contact>
<contact_backup>
<last_name>Agnieszka Nowak-Potoczek</last_name>
<phone>+48 669 349 039</phone>
</contact_backup>
</location>
<location>
<facility>
<name>Samodzielny Publiczny Szpital Kliniczny nr 1 im. Prof. Tadeusza Sokołowskiego w Szczecinie, Klinika Hematologii z Oddziałem Transplantacji Szpiku, Szczecin</name>
<address>
<city>Szczecin</city>
<country>Poland</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Boguslaw Machalinski, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Instytut Hematologii i Transfuzjologii, Klinika Hematologii, Warsaw</name>
<address>
<city>Warsaw</city>
<country>Poland</country>
</address>
</facility>
<status>Recruiting</status>
<investigator>
<last_name>Ewa Lech-Maranda, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>Italy</country>
<country>Poland</country>
</location_countries>
<verification_date>June 2023</verification_date>
<study_first_submitted>February 22, 2022</study_first_submitted>
<study_first_submitted_qc>April 5, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>June 29, 2023</last_update_submitted>
<last_update_submitted_qc>June 29, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">July 3, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Leukemia</mesh_term>
<mesh_term>Leukemia, Myeloid</mesh_term>
<mesh_term>Leukemia, Myeloid, Acute</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cytarabine</mesh_term>
<mesh_term>Annamycin</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This is a Phase 1/2, multicenter, open-label, dose-escalation study that will determine the
MTD and RP2D of L-Annamycin in combination with cytarabine for the treatment of subjects with
AML.
During Phase 1b, dose escalation will proceed according to a standard 3+3 design. An initial
group of 3 subjects will be treated with an intravenous infusion of 190-mg/m2 L-Annamycin
(Dose Level 1) for 3 consecutive days. Dose escalation will take place on the basis of safety
assessments in sequential cohorts of 3 subjects each. Provided that there are no DLT's in the
initial cohort of subjects treated at the 190 mg/m2/day dose level, the next cohort of
subjects will receive the next highest L-Annamycin dose incremented by 40 mg/m2. In the
absence of DLTs, dose escalation by 40 mg/m2 will continue in subsequent cohorts until an MTD
is reached.
The dose and schedule of cytarabine during Cycle 1 (2.0 g/m2/day for 5 consecutive days) will
remain constant for all cohorts. Enrolled subjects will receive cytarabine at a dose of 2.0
g/m2/day via intravenous infusion over 4 hours for 5 consecutive days (total dose cytarabine
= 10.0 g/m2; starting on the first day of L-Annamycin treatment).
If no subject experiences a dose-limiting toxicity (DLT), based on National Cancer Institute
(NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5, which constitutes a study
drug-related irreversible or not medically manageable Grade 3 or higher toxicity during the
initial treatment through Day 28, the subsequent group of 3 subjects will receive the next
higher L-Annamycin dose. However, if 1 of the 3 initial subjects experiences a DLT, the
cohort of subjects at that dose level will be expanded to 6. If at least 2 of the 6 subjects
experience a DLT, this will be considered a non-tolerated dose and the next 3 subjects will
be treated at a lower dose. The dose of L-Annamycin will be de-escalated by 20- mg/m2/day. As
such, if at least 2 out of 6 subjects receiving 230 mg/m2/day experience a DLT, the next 3
subjects will receive L-Annamycin at a dose of 210 mg/m2/day. If 1 of the 3 initial subjects
experiences a DLT, the cohort of subjects will be expanded to 6 subjects. If at least 2 of
the 6 subjects experience a DLT, this will be considered a toxic dose and the MTD will be the
previously proven safe dose level (i.e., the next lowest dose level at which no DLTs occurred
in a cohort of 3 subjects or at which fewer than 2 subjects in a cohort of 6 experienced a
DLT).
In the expansion phase, up to 21 subjects will be enrolled at the MTD/RP2D to better define
toxicity and evaluate efficacy.
Inclusion Criteria:
1. The subject has a pathologically confirmed diagnosis of AML by World Health
Organization classification. This must be in the form of either a bone marrow aspirate
or biopsy or a CBC that demonstrates >5% myeloblasts.
2. The subject has AML and has not received prior therapy or is refractory to or relapsed
after induction therapy. To be defined as relapse, there must be >5% blasts in the
bone marrow.
3. For the expansion phase only (i.e., after the MTD/RP2D is established), subjects must
be treated with L-Annamycin as first- second- or third-line therapy (i.e., subjects
will not have received more than two prior therapies).
4. The subject is age ≥18 years at the time of signing informed consent.
5. The subject has received no chemotherapy, radiation, or major surgery within 2 weeks
prior to first dose of study drug and/or has recovered from the toxic side effects of
that therapy unless treatment is indicated as a result of progressive disease, such as
hydroxyurea.
6. The subject has received no investigational therapy within 4 weeks of the first dose
of study drug.
7. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status 0 to
2.
8. The subject has adequate laboratory results including the following:
1. Bilirubin ≤2 times the upper limit of normal unless due to Gilbert Syndrome or
leukemic infiltration of the liver.
2. Serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic
transaminase (SGPT), and alkaline phosphatase <2.5 times the upper limit of
normal unless due to organ involvement.
3. Adequate renal function with creatinine levels ≤2 times the upper limit of
normal.
9. The subject can understand and sign the informed consent document, can communicate
with the Investigator, and can understand and comply with the requirements of the
protocol.
10. Women of childbearing potential must have a negative serum or urine beta-human
chorionic gonadotropin test within 72 hours prior to first dose of study drug to rule
out pregnancy.
11. All men and women must agree to practice effective contraception during the entire
study period and after discontinuing study drug, unless documentation of infertility
exists.
1. Sexually active, fertile women must use 2 effective forms of contraception
(abstinence, intrauterine device, oral contraceptive, or double barrier device)
from the time of informed consent until at least 6 months after discontinuing
study drug.
2. Sexually active men and their sexual partners must use effective contraceptive
methods from the time of subject informed consent until at least 3 months after
discontinuing study drug.
Exclusion Criteria:
1. The subject was diagnosed with acute promyelocytic leukemia.
2. The subject is receiving concomitant therapy that includes other chemotherapy that is
or may be active against AML except for agents such as hydroxyurea, just to control
the WBC count until chemotherapy or prophylaxis and/or treatment of opportunistic or
other infection with antibiotics, antifungals, and/or antiviral agents, including
therapy for meningeal disease (i.e., intrathecal chemotherapy), supportive measures,
and medications as per standard of care up to Day 1 of L-Annamycin administration.
3. The subject received prior mediastinal radiotherapy.
4. The subject has central nervous system involvement.
5. The subject has any condition that, in the opinion of the Investigator, places the
subject at unacceptable risk if he/she were to participate in the study.
6. The subject has an LVEF <50%, valvular heart disease, or severe hypertension. Cardiac
subjects with a New York Heart Association classification of 3 or 4 will be excluded.
(Cardiology consultation should be requested if any question arises about cardiac
function). This also includes subjects with baseline QT/QTc interval >480 msec, a
history of additional risk factors for torsade des pointes (e.g., heart failure,
hypokalemia, family history of Long QT Syndrome), and use of concomitant medications
that significantly prolong the QT/QTc interval.
7. The subject has clinically relevant serious comorbid medical conditions including, but
not limited to, active infection, recent (less than or equal to 6 months) myocardial
infarction, unstable angina, symptomatic congestive heart failure, uncontrolled
hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic
restrictive pulmonary disease, known positive status for human immunodeficiency virus
and/or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations
that would limit compliance with study requirements.
a. Subjects with a documented COVID diagnosis within 14 days of screening must have a
documented negative PCR test and remain asymptomatic for 14 days from that test result
before starting study medication.
8. The subject is pregnant, lactating, or not using adequate contraception.
9. The subject has a known allergy to anthracyclines and/or hypersensitivity to
cytarabine, its excipients, or to any contrast media needed for imaging required per
protocol.
10. The subject has any evidence of mucositis/stomatitis at the time of study entry or
previous history of severe (≥Grade 3) mucositis from prior therapy.
11. The subject is required to use moderate or strong inhibitors and inducers of
Cytochrome P450 family of enzymes (CYP) and transporters that cannot be held for 3
days prior to Day 1 and during treatment days
|
NCT0531xxxx/NCT05319600.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319600</url>
</required_header>
<id_info>
<org_study_id>STUDY00001482</org_study_id>
<nct_id>NCT05319600</nct_id>
</id_info>
<brief_title>Technology-delivered Physical Activity Program for Adolescents With Type 1 Diabetes</brief_title>
<acronym>Activate</acronym>
<official_title>Does a Behavior Change Skills and Physical Activity Program Improve Self-regulation and Health Outcomes in Adolescents With Type 1 Diabetes?</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Vermont</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of Vermont</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This project is comprised of a two-arm randomized control trial (RCT) testing the
feasibility, acceptability, and preliminary efficacy of a nationally scalable program,
Activate, a 12-week, technology-delivered diabetes behavior-change skills training and
physical activity promotion program for adolescents with type 1 diabetes. The researchers
have a recruitment goal of 30 participants, but will enroll beyond 30 to address any
withdrawal and ensure sample size is met. A primary goal of the study is assessing the
feasibility and acceptability of the program, which combines two previously piloted
components. Then, the investigators will compare the 12-week Activate program to a treatment
as usual control group on proximal outcomes of behavior-change skills and daily active
minutes. The investigators will also explore the impact of the Activate program on secondary
mechanisms and outcomes linked with later type 1 diabetes health disparities: adolescent
diabetes behavior regulation, psychological distress, inflammation, glycemic outcomes, and
cardiovascular disease risk. It is hypothesized that a diabetes behavior-change skills
training and physical activity intervention will be acceptable, and effective at improving
behavior-change skills and daily active minutes, as well as other mechanisms and outcomes
linked with later type 1 diabetes health disparities.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Adolescents with type 1 diabetes and socioeconomic disadvantage experience significant health
disparities in glycemic outcomes in adolescence and cardiovascular disease and
diabetes-related death later in adulthood. Socioeconomic disadvantage is associated with
elevated glycosylated hemoglobin (HbA1c) and 3x risk of repeat hospitalizations for diabetic
ketoacidosis as well as 2-3x risk of cardiovascular disease and diabetes-related death.
Suboptimal glycemic outcomes are a powerful determinant of long-term health complications and
costs, with a 1% reduction in HbA1c contributing to up to a 40% reduction in risk for later
nephropathy, retinopathy, and macrovascular disease. Given the substantial health disparities
for persons with type 1 diabetes and socioeconomic disadvantage and the many challenges that
adolescents face with achieving optimal glycemic levels (<20% nationally meet American
Diabetes Association HbA1c targets), this is a critical population to support in health
behavior change via psychosocial intervention during adolescence. Unfortunately, existing
evidence-based psychosocial type 1 diabetes interventions for adolescents, including robust
multi-system approaches, have demonstrated limited efficacy for behavior change that results
in improved glycemic outcomes and none have directly targeted cardiovascular health outside
of glycemic outcomes. In this project, the researchers pursue a new avenue for intervention
innovation by testing a nationally-scalable diabetes behavior-change skills training and
physical activity intervention program to improve glycemic outcomes and decrease
cardiovascular disease risks for adolescents with type 1 diabetes including those with
socioeconomic disadvantage .

In this study the researchers will conduct a two-arm randomized trial with 30 adolescents
with type 1 diabetes, comparing the 12-week Activate program to a treatment-as-usual control
group. This study has 2 primary aims. First, the investigators will assess acceptability of
the Activate program by examining participant engagement with the Activate program
components. To assess the preliminary efficacy of the Activate program the investigators will
examine changes in proximal outcomes of behavior-change skills (goal setting,
problem-solving, and coping skills), and active minutes compared between treatment and
control groups from baseline to a 12-week follow-up assessment. Second, the investigators
will explore the impact of the Activate program on secondary mechanisms and outcomes linked
with longer-term type 1 diabetes health disparities.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 23, 2022</start_date>
<completion_date type="Anticipated">December 2024</completion_date>
<primary_completion_date type="Anticipated">March 2024</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Adolescents (aged 13-17) diagnosed with type 1 diabetes will all complete a baseline assessment where they will be randomized to complete a 12-week physical activity and behavior-change skills training intervention, or to follow their usual diabetes care plan for 12 weeks. Both groups will receive a Garmin fitness activity tracker wrist watch to track their physical activity over the 12-week study period. Follow-up assessments for all participants will take place after 12 weeks.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Change from Baseline in Coping Skills Assessed by the Coping Self-Efficacy Scale</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Assesses adolescents' coping skill self-efficacy. Indexes participants confidence in using different strategies to cope with challenges in daily life. The Coping Self-Efficacy Scale includes 26-items rated on an 11-point scale (0 ('cannot do at all'), 5 ('moderately certain can do') and 10 ('certain can do')). Higher scores indicate higher coping self-efficacy.</description>
</primary_outcome>
<primary_outcome>
<measure>Change from Baseline in Goal Setting Assessed by Goal-Directed Planning</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Participants will be asked to identify their most important diabetes, academic, social, and career/family goals. Following this, participants will be asked to identify which of their three non-diabetes goals most interfered with their diabetes goal. Participants will also complete the four-item planning subscale from the Goal System Assessment Battery to determine goal-directed planning activity for both their diabetes goal and their interfering goal identified in the goal assessment. The Goal System Assessment Battery is rated on a 5-point scale (1 = not at all true, 5 = extremely true). Higher scores indicated higher goal directed planning. Average levels of goal-directed planning will be used as the outcome variable for goal setting.</description>
</primary_outcome>
<primary_outcome>
<measure>Change from Baseline in Physical Activity</measure>
<time_frame>daily for all days from week 1 through week 12</time_frame>
<description>The Garmin fitness activity tracker tracking will be used to determine the average number of daily minutes with moderate to vigorous physical activity, metabolic equivalents (METs) greater than or equal to 3 METs.</description>
</primary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Self-Regulation Assessed by The Functional Assessment of Maladaptive Behaviors</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Assesses perceptions of the extent to which a person's behavior was sensitive to a particular reinforcer by rating 8 statements regarding the function of the behavior on a 4-point scale (0 = never, 3 = often). Higher scores indicate higher diabetes self-regulation.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Self-Regulation Assessed by the Diabetes Habit Strength (DHS) Measure</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Measures perceived habitual responding for glucose checking, insulin dosing, and carbohydrate counting and predicts daily treatment engagement in adolescents with type 1 diabetes. The Diabetes Habit Strength Measure includes 16 items on a 7-point scale (0 = strongly disagree, 7 = strongly agree). Higher scores indicate higher habit strength and thus higher self-regulation.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Self-Regulation Assessed by the Self Care Inventory (SCI)</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Measures diabetes treatment engagement. The Self Care Inventory includes 21 items about frequency of treatment engagement rated on a 5-point scale (0 = never, 5 = always). Higher scores indicate higher diabetes self care and thus higher self-regulation.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Self-Regulation Assessed by the Effortful Control Scale Short</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Measures challenges with self-regulation including inhibitory control, attention, and activation control. The Effortful Control Scale Short includes 16 items rated on a 5-point scale (1 = almost always untrue, 5 = almost always true). Higher scores indicate higher self-regulation.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Self-Regulation Assessed by the Delay Discounting Task</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Assesses preference for immediate over delayed rewards. The Delay Discounting Task includes 5 items. In each item participants will be asked if the'd prefer to receive $500 now or wait to receive $1000 after a specified delay in time.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Diet and Physical Activity Habit Strength Assessed by the Eating and Activity Behavioral Automaticity Scale (EABA)</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Measures perceived habitual responding for food and physical activity. The Eating and Activity Behavioral Automaticity Scale includes 14 items rated on a 7-point scale (1 = never, 7 = every time). Higher scores indicate higher diet and physical activity habit strength and thus higher self-regulation.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Distress Assessed by the Patient Health Questionnaire for Adolescents (PHQ-A)</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Measures how often participants have been bothered by specified symptoms of depression during the past two weeks. The Patient Health Questionnaire for Adolescents includes 8 items (excluding item 9 for suicidal ideation) rated on a 4-point scale (0 = not at all, 3 = nearly every day). Higher scores indicated higher distress.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Distress Assessed by the Pediatric Symptom Checklist (PSC-17)</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Indexes internalizing, externalizing, and attention symptoms in children. The Pediatric Symptom Checklist includes 17 items regarding the frequency of specified symptoms rated on a 3-point scale (never, sometimes, often). A score ≥ 15 indicates a positive symptom score and thus higher distress.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Distress Assessed by the Motivation and Energy Inventory (MEI)</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Measures the extent of diminished engagement in reward motivated cognition, physical behavior, and social interactions. The Motivation and Energy Inventory includes 26 items rated on various scales (5-point scale 0 = never, 5 = everyday or nearly every day; 6-point scale 0 = never, 6 = all of the time; 5-point scale 0 = never, 5 = at least 7 times a week; 4-point scale 0 = not interested at all, 4 = extremely interested) which measure mental energy, physical energy, and social motivation.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Distress Assessed by the Perceived Stress Scale (PSS)</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Measures perceived stress; asks participants have often they've had certain feelings or thoughts during the past month. The Perceived Stress Scale includes 10 items rated on a 5-point scale (0 = never, 4 = very often). Higher scores indicate higher perceived stress.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Distress Assessed by the Diabetes Stress Questionnaire - Short Form (DSQ)</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Measures how stressful, upsetting, difficult, or much of a problem specified diabetes-specific stressors are. The Diabetes Stress Questionnaire - Short Form includes 24 items rated on a 4-point scale (0 = not at all, 3 = very much). Higher scores indicate higher diabetes stress.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Distress Assessed by the Type 1 Diabetes Quality of Life (T1DAL) Measure</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Measures diabetes-related quality of life by asking how often specified statements regarding diabetes are true. The Type 1 Diabetes Quality of Life measure includes 23 items rated on a 5-point scale (0 = no, not at all true, 5 = yes, very true). Higher scores indicate higher diabetes quality of life and thus lower distress.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Inflammation Assessed by C-Reactive Protein</measure>
<time_frame>week 1 and week 12</time_frame>
<description>C-reactive protein will be measured through dried blood spot assay.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Glycosylated Hemoglobin (HbA1c) Percentage</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Measured through dried blood spot assay.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Mean Daily Blood Glucose (MBG)</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Assessed by participant report from diabetes device data from glucose meters and continuous glucose monitors (CGMs). This will include data from the 7 days prior to the baseline assessment and 7 days prior to the follow-up assessment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Mean Variability in Blood Glucose</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Assessed by participant report from diabetes device data from glucose meters and continuous glucose monitors (CGMs). This will include data from the 7 days prior to the baseline assessment and 7 days prior to the follow-up assessment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Cardiovascular Disease Risk Score Assessed by Weight</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Assessed per the American Heart Association Life's Simple 7 index, which includes weight. Cardiovascular health risks will be summarized through a single risk score. For each risk indicator, meeting ideal, intermediate, or poor health status will be associated with a score of 2 to 0, respectively, creating a 0 to 14 scale of cardiovascular disease risk.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Cardiovascular Disease Risk Score Assessed by Blood Pressure</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Assessed per the American Heart Association Life's Simple 7 index, which includes blood pressure. Cardiovascular health risks will be summarized through a single risk score. For each risk indicator, meeting ideal, intermediate, or poor health status will be associated with a score of 2 to 0, respectively, creating a 0 to 14 scale of cardiovascular disease risk.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Cardiovascular Disease Risk Score Assessed by Diet</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Assessed per the American Heart Association Life's Simple 7 index, which includes diet. Adolescents will report on diet habit using the standardized healthy diet questions from that match the American Health Association Healthy diet recommendations (intake of sodium, whole grains, fruits, vegetables, sugar-sweetened beverages, and fish) and they will report if they've tried or currently smoke. Cardiovascular health risks will be summarized through a single risk score. For each risk indicator, meeting ideal, intermediate, or poor health status will be associated with a score of 2 to 0, respectively, creating a 0 to 14 scale of cardiovascular disease risk.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Cardiovascular Disease Risk Score Assessed by Physical Activity</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Assessed per the American Heart Association Life's Simple 7 index, which includes physical activity. To measure physical activity, the Garmin fitness activity tracker tracking will be used to determine the average number of daily minutes with moderate to vigorous physical activity, metabolic equivalents (METs) greater than or equal to 3 METs, in week 1 and week 12. Cardiovascular health risks will be summarized through a single risk score. For each risk indicator, meeting ideal, intermediate, or poor health status will be associated with a score of 2 to 0, respectively, creating a 0 to 14 scale of cardiovascular disease risk.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Cardiovascular Disease Risk Score Assessed by Blood Sugar</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Assessed per the American Heart Association Life's Simple 7 index, which includes blood sugar. Assessed via glycosylated hemoglobin percentage through the dried blood spot assay. Cardiovascular health risks will be summarized through a single risk score. For each risk indicator, meeting ideal, intermediate, or poor health status will be associated with a score of 2 to 0, respectively, creating a 0 to 14 scale of cardiovascular disease risk.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline in Cardiovascular Disease Risk Score Assessed by Total Cholesterol</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Assessed per the American Heart Association Life's Simple 7 index, which includes cholesterol. Assessed through the dried blood spot assay. Cardiovascular health risks will be summarized through a single risk score. For each risk indicator, meeting ideal, intermediate, or poor health status will be associated with a score of 2 to 0, respectively, creating a 0 to 14 scale of cardiovascular disease risk.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in insulin requirements</measure>
<time_frame>week 1 and week 12</time_frame>
<description>Assessed by participant report from diabetes device data from insulin pumps or injection logs. This will include data from the 7 days prior to the baseline assessment and 7 days prior to the follow-up assessment.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">30</enrollment>
<condition>Type 1 Diabetes</condition>
<arm_group>
<arm_group_label>Intervention</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>This arm will complete an intervention delivered remotely via an online website and online communication from the research team across the 12-week intervention period. This intervention has two parts, taking place simultaneously over the 12 weeks. First, participants will complete 8 web-delivered online behavior-change skills learning sessions which include reading and activities. Second, participants will be given daily and weekly personalized physical activity goals to meet, which will be tracked via their Garmin activity tracker and weekday text and if indicated video support. They have the opportunity to win money each week for meeting activity goals.</description>
</arm_group>
<arm_group>
<arm_group_label>Treatment as usual - Control</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>This arm will not complete an intervention. Participants will be instructed to wear a Garmin activity tracker but will be given no other specific instructions, other than to continue to follow their normal daily diabetes care plan.</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Diabetes behavior change skills training</intervention_name>
<description>Behavior-change skills training will be provided through eight web-delivered content and activity sessions across the 12-week program. Sessions 1 through 4 will occur weekly and sessions 5 through 8 biweekly. Each session takes approximately 15-20 minutes for the adolescent to complete both content learning and related activities. These learning sessions focus on skills like problem solving and goal setting.</description>
<arm_group_label>Intervention</arm_group_label>
</intervention>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Physical activity promotion program</intervention_name>
<description>The physical activity incentives program includes 12 weeks of personalized goals and incentives for increasing physically active minutes along with weekday text-based support. Active minutes, defined as minutes with moderate to vigorous physical activity, will be tracked via a Garmin fitness activity tracker.</description>
<arm_group_label>Intervention</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Aged 13-17 years old

- At least 18 months post-diagnosis for type 1 diabetes

- Parent reported moderate to no physical activity for adolescent

- Ability to complete measures and intervention program in English

- Access to broadband or cellular internet

- Resides in and receives healthcare in the United States

Exclusion Criteria:

- Ward of state

- Active psychosis

- Severe medical or psychiatric illness that limit participation (including any
contraindications for physical activity)
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>13 Years</minimum_age>
<maximum_age>17 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Amy Hughes Lansing, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>University of Vermont</affiliation>
</overall_official>
<overall_contact>
<last_name>Amy Hughes Lansing, PhD</last_name>
<phone>802-656-3801</phone>
<email>Amy.Hughes.Lansing@uvm.edu</email>
</overall_contact>
<overall_contact_backup>
<last_name>Bridget Clark, MS</last_name>
<phone>802-656-2692</phone>
<email>bridget.clark@uvm.edu</email>
</overall_contact_backup>
<location>
<facility>
<name>University of Vermont</name>
<address>
<city>Burlington</city>
<state>Vermont</state>
<zip>05401</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Amy Hughes Lansing, PhD</last_name>
<phone>802-656-3801</phone>
<email>Amy.Hughes.Lansing@uvm.edu</email>
</contact>
<investigator>
<last_name>Amy Hughes Lansing, PhD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Wood JR, Miller KM, Maahs DM, Beck RW, DiMeglio LA, Libman IM, Quinn M, Tamborlane WV, Woerner SE; T1D Exchange Clinic Network. Most youth with type 1 diabetes in the T1D Exchange Clinic Registry do not meet American Diabetes Association or International Society for Pediatric and Adolescent Diabetes clinical guidelines. Diabetes Care. 2013 Jul;36(7):2035-7. doi: 10.2337/dc12-1959. Epub 2013 Jan 22.</citation>
<PMID>23340893</PMID>
</reference>
<reference>
<citation>Clements MA, Foster NC, Maahs DM, Schatz DA, Olson BA, Tsalikian E, Lee JM, Burt-Solorzano CM, Tamborlane WV, Chen V, Miller KM, Beck RW; T1D Exchange Clinic Network. Hemoglobin A1c (HbA1c) changes over time among adolescent and young adult participants in the T1D exchange clinic registry. Pediatr Diabetes. 2016 Aug;17(5):327-36. doi: 10.1111/pedi.12295. Epub 2015 Jul 8.</citation>
<PMID>26153338</PMID>
</reference>
<reference>
<citation>Menzin J, Korn JR, Cohen J, Lobo F, Zhang B, Friedman M, Neumann PJ. Relationship between glycemic control and diabetes-related hospital costs in patients with type 1 or type 2 diabetes mellitus. J Manag Care Pharm. 2010 May;16(4):264-75. doi: 10.18553/jmcp.2010.16.4.264.</citation>
<PMID>20433217</PMID>
</reference>
<reference>
<citation>Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group. J Pediatr. 1994 Aug;125(2):177-88. doi: 10.1016/s0022-3476(94)70190-3.</citation>
<PMID>8040759</PMID>
</reference>
<reference>
<citation>Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.</citation>
<PMID>8366922</PMID>
</reference>
<reference>
<citation>Hood KK, Rohan JM, Peterson CM, Drotar D. Interventions with adherence-promoting components in pediatric type 1 diabetes: meta-analysis of their impact on glycemic control. Diabetes Care. 2010 Jul;33(7):1658-64. doi: 10.2337/dc09-2268.</citation>
<PMID>20587726</PMID>
</reference>
<reference>
<citation>Ellis DA, Templin T, Naar-King S, Frey MA, Cunningham PB, Podolski CL, Cakan N. Multisystemic therapy for adolescents with poorly controlled type I diabetes: Stability of treatment effects in a randomized controlled trial. J Consult Clin Psychol. 2007 Feb;75(1):168-74. doi: 10.1037/0022-006X.75.1.168.</citation>
<PMID>17295576</PMID>
</reference>
<reference>
<citation>Stanger C, Lansing AH, Scherer E, Budney A, Christiano AS, Casella SJ. A Web-Delivered Multicomponent Intervention for Adolescents with Poorly Controlled Type 1 Diabetes: A Pilot Randomized Controlled Trial. Ann Behav Med. 2018 Nov 12;52(12):1010-1022. doi: 10.1093/abm/kay005.</citation>
<PMID>30418521</PMID>
</reference>
<verification_date>May 2023</verification_date>
<study_first_submitted>March 25, 2022</study_first_submitted>
<study_first_submitted_qc>April 5, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>May 9, 2023</last_update_submitted>
<last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 10, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of Vermont</investigator_affiliation>
<investigator_full_name>Amy Hughes Lansing</investigator_full_name>
<investigator_title>Assistant Professor</investigator_title>
</responsible_party>
<keyword>adolescents</keyword>
<keyword>physical activity intervention</keyword>
<keyword>diabetes self-management</keyword>
<keyword>behavior-change skills training</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Diabetes Mellitus</mesh_term>
<mesh_term>Diabetes Mellitus, Type 1</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
<ipd_description>Overall analyses and de-identified data can be shared as described in participant consent, however, individual participant data will not be shared.</ipd_description>
</patient_data>
<provided_document_section>
<provided_document>
<document_type>Informed Consent Form</document_type>
<document_has_protocol>No</document_has_protocol>
<document_has_icf>Yes</document_has_icf>
<document_has_sap>No</document_has_sap>
<document_date>March 16, 2022</document_date>
<document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT05319600/ICF_000.pdf</document_url>
</provided_document>
</provided_document_section>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This project is comprised of a two-arm randomized control trial (RCT) testing the
feasibility, acceptability, and preliminary efficacy of a nationally scalable program,
Activate, a 12-week, technology-delivered diabetes behavior-change skills training and
physical activity promotion program for adolescents with type 1 diabetes. The researchers
have a recruitment goal of 30 participants, but will enroll beyond 30 to address any
withdrawal and ensure sample size is met. A primary goal of the study is assessing the
feasibility and acceptability of the program, which combines two previously piloted
components. Then, the investigators will compare the 12-week Activate program to a treatment
as usual control group on proximal outcomes of behavior-change skills and daily active
minutes. The investigators will also explore the impact of the Activate program on secondary
mechanisms and outcomes linked with later type 1 diabetes health disparities: adolescent
diabetes behavior regulation, psychological distress, inflammation, glycemic outcomes, and
cardiovascular disease risk. It is hypothesized that a diabetes behavior-change skills
training and physical activity intervention will be acceptable, and effective at improving
behavior-change skills and daily active minutes, as well as other mechanisms and outcomes
linked with later type 1 diabetes health disparities.
Adolescents with type 1 diabetes and socioeconomic disadvantage experience significant health
disparities in glycemic outcomes in adolescence and cardiovascular disease and
diabetes-related death later in adulthood. Socioeconomic disadvantage is associated with
elevated glycosylated hemoglobin (HbA1c) and 3x risk of repeat hospitalizations for diabetic
ketoacidosis as well as 2-3x risk of cardiovascular disease and diabetes-related death.
Suboptimal glycemic outcomes are a powerful determinant of long-term health complications and
costs, with a 1% reduction in HbA1c contributing to up to a 40% reduction in risk for later
nephropathy, retinopathy, and macrovascular disease. Given the substantial health disparities
for persons with type 1 diabetes and socioeconomic disadvantage and the many challenges that
adolescents face with achieving optimal glycemic levels (<20% nationally meet American
Diabetes Association HbA1c targets), this is a critical population to support in health
behavior change via psychosocial intervention during adolescence. Unfortunately, existing
evidence-based psychosocial type 1 diabetes interventions for adolescents, including robust
multi-system approaches, have demonstrated limited efficacy for behavior change that results
in improved glycemic outcomes and none have directly targeted cardiovascular health outside
of glycemic outcomes. In this project, the researchers pursue a new avenue for intervention
innovation by testing a nationally-scalable diabetes behavior-change skills training and
physical activity intervention program to improve glycemic outcomes and decrease
cardiovascular disease risks for adolescents with type 1 diabetes including those with
socioeconomic disadvantage .
In this study the researchers will conduct a two-arm randomized trial with 30 adolescents
with type 1 diabetes, comparing the 12-week Activate program to a treatment-as-usual control
group. This study has 2 primary aims. First, the investigators will assess acceptability of
the Activate program by examining participant engagement with the Activate program
components. To assess the preliminary efficacy of the Activate program the investigators will
examine changes in proximal outcomes of behavior-change skills (goal setting,
problem-solving, and coping skills), and active minutes compared between treatment and
control groups from baseline to a 12-week follow-up assessment. Second, the investigators
will explore the impact of the Activate program on secondary mechanisms and outcomes linked
with longer-term type 1 diabetes health disparities.
Inclusion Criteria:
- Aged 13-17 years old
- At least 18 months post-diagnosis for type 1 diabetes
- Parent reported moderate to no physical activity for adolescent
- Ability to complete measures and intervention program in English
- Access to broadband or cellular internet
- Resides in and receives healthcare in the United States
Exclusion Criteria:
- Ward of state
- Active psychosis
- Severe medical or psychiatric illness that limit participation (including any
contraindications for physical activity)
|
NCT0531xxxx/NCT05319613.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319613</url>
</required_header>
<id_info>
<org_study_id>21-2514</org_study_id>
<nct_id>NCT05319613</nct_id>
</id_info>
<brief_title>Reducing Disparities in Rural HIV Prevention</brief_title>
<official_title>Reducing Disparities in Rural HIV Prevention With Telemedicine PrEP and Postal Lab Kits</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Colorado, Denver</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Gilead Sciences</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>University of Colorado, Denver</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
HIV and Sexually Transmitted Infection (STI) rates are increasing in rural areas including
rural Colorado. Many rural residents find it difficult to access HIV and STI prevention
services.

In this study, an online survey on HIV and STI Prevention and best practices to provide
access to prevention will be administered to rural residents in three zip 3 zones in rural
Colorado. In addition to the baseline survey, study participants who are interested and
medically eligible may initiate PrEP services with the University of Colorado HIV Prevention
Program and receive PrEP through telemedicine visits, mailed home lab kits, and mailed
medication. Persistence in PrEP care, acceptability, and feasibility of telemedicine and home
lab kits will be measured.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
HIV and Sexually Transmitted Infection (STI) rates are increasing in rural areas including
rural Colorado. Many rural residents find it difficult to access HIV and STI prevention
services. The goal of this study is to understand the risk for HIV and STIs, views on PrEP,
and to determine if access to telemedicine visits and home lab kits increases engagement in
PrEP services and persistence in care for at-risk rural populations.

An online survey on HIV and STI Prevention and best practices to provide access to prevention
will be administered to rural residents in three zip 3 zones in rural Colorado, comprised of
increased proportions of minority residents (Hispanic, Native American, and Black). In
addition to the baseline survey, study participants who are interested and medically eligible
may initiate PrEP services with the University of Colorado HIV Prevention Program and receive
PrEP through telemedicine visits, mailed home lab kits, and mailed medication. Persistence in
PrEP care, acceptability, and feasibility of telemedicine and home lab kits will be measured
through baseline and follow-up survey questionnaires and clinical chart reviews for those
engaged in PrEP care.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 9, 2022</start_date>
<completion_date type="Anticipated">December 31, 2023</completion_date>
<primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<intervention_model_description>Convenience sample of baseline community survey participants who elect to enter clinical PrEP care</intervention_model_description>
<primary_purpose>Health Services Research</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Persistence in PrEP care</measure>
<time_frame>12 months</time_frame>
<description>The proportion of study participants persisting in PrEP care at 12 months, stratified by race, ethnicity, zip 3 region, and type of insurance coverage.</description>
</primary_outcome>
<secondary_outcome>
<measure>Medication adherence</measure>
<time_frame>12 months</time_frame>
<description>Describe PrEP medication adherence rates at 12 months (as determined by pharmacy refill data) for rural CO PrEP users who utilize Telemedicine PrEP services and postal lab kits.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Feasibility of Telemedicine visits</measure>
<time_frame>12 months</time_frame>
<description>Describe feasibility of Telemedicine visits as determined by survey response and completion of quarterly visits.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of Telemedicine visits</measure>
<time_frame>12 months</time_frame>
<description>Describe acceptability of Telemedicine visits as determined by survey response and completion of quarterly visits.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Feasibility of postal lab kits</measure>
<time_frame>12 months</time_frame>
<description>Describe feasibility of postal lab kits, as determined by survey response and completion of quarterly lab monitoring.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Acceptability of postal lab kits</measure>
<time_frame>12 months</time_frame>
<description>Describe acceptability of postal lab kits, as determined by survey response and completion of quarterly lab monitoring.</description>
</secondary_outcome>
<secondary_outcome>
<measure>HIV seroconversion</measure>
<time_frame>12 months</time_frame>
<description>Describe rate of HIV seroconversion in cohort at 12 months.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">100</enrollment>
<condition>HIV Infections</condition>
<condition>Sexually Transmitted Infections</condition>
<arm_group>
<arm_group_label>Telemedicine Clinical Care</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>Rural participants who enter PrEP clinical care with University of Colorado HIV Prevention Program will receive care via telemedicine with mailed lab kits and mailed HIV PrEP.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Virtual clinical visits with home lab kits and mailed HIV PrEP</intervention_name>
<description>Rural participants who enter PrEP care with University of Colorado HIV Prevention Program will receive PrEP services via telemedicine with home lab kits and mailed HIV PrEP</description>
<arm_group_label>Telemedicine Clinical Care</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Colorado rural or frontier county residents, Adults (age 18+)

2. Access to internet, smart phone or tablet to participate in online surveys

3. Able to complete online surveys in English or Spanish

Exclusion Criteria:

1. Residence in an urban Colorado county

2. HIV positive status

3. No internet, smart phone, or tablet access

4. Unable to complete online surveys in English or Spanish
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Donna V McGregor, MSN</last_name>
<phone>720-848-0191</phone>
<email>donna.mcgregor@cuanschutz.edu</email>
</overall_contact>
<overall_contact_backup>
<last_name>Lisa Lawrence, MSW</last_name>
<phone>720-848-0191</phone>
<email>lisa.lawrence@cuanschutz.edu</email>
</overall_contact_backup>
<location>
<facility>
<name>University of Colorado Hospital</name>
<address>
<city>Aurora</city>
<state>Colorado</state>
<zip>80045</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Donna V McGregor, MSN</last_name>
<phone>720-848-0191</phone>
<email>donna.mcgregor@cuanschutz.edu</email>
</contact>
<contact_backup>
<last_name>Lisa Lawrence</last_name>
<phone>720-848-0191</phone>
<email>lisa.lawrence@cuanschutz.edu</email>
</contact_backup>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>August 2022</verification_date>
<study_first_submitted>March 11, 2022</study_first_submitted>
<study_first_submitted_qc>April 5, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>August 11, 2022</last_update_submitted>
<last_update_submitted_qc>August 11, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">August 15, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>HIV Prevention, Access, Rural Communities</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Infections</mesh_term>
<mesh_term>Communicable Diseases</mesh_term>
<mesh_term>Sexually Transmitted Diseases</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
<ipd_description>Individual participant data will not be shared with other researchers. De-identified aggregate data will be shared at completion of study.</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
HIV and Sexually Transmitted Infection (STI) rates are increasing in rural areas including
rural Colorado. Many rural residents find it difficult to access HIV and STI prevention
services.
In this study, an online survey on HIV and STI Prevention and best practices to provide
access to prevention will be administered to rural residents in three zip 3 zones in rural
Colorado. In addition to the baseline survey, study participants who are interested and
medically eligible may initiate PrEP services with the University of Colorado HIV Prevention
Program and receive PrEP through telemedicine visits, mailed home lab kits, and mailed
medication. Persistence in PrEP care, acceptability, and feasibility of telemedicine and home
lab kits will be measured.
HIV and Sexually Transmitted Infection (STI) rates are increasing in rural areas including
rural Colorado. Many rural residents find it difficult to access HIV and STI prevention
services. The goal of this study is to understand the risk for HIV and STIs, views on PrEP,
and to determine if access to telemedicine visits and home lab kits increases engagement in
PrEP services and persistence in care for at-risk rural populations.
An online survey on HIV and STI Prevention and best practices to provide access to prevention
will be administered to rural residents in three zip 3 zones in rural Colorado, comprised of
increased proportions of minority residents (Hispanic, Native American, and Black). In
addition to the baseline survey, study participants who are interested and medically eligible
may initiate PrEP services with the University of Colorado HIV Prevention Program and receive
PrEP through telemedicine visits, mailed home lab kits, and mailed medication. Persistence in
PrEP care, acceptability, and feasibility of telemedicine and home lab kits will be measured
through baseline and follow-up survey questionnaires and clinical chart reviews for those
engaged in PrEP care.
Inclusion Criteria:
1. Colorado rural or frontier county residents, Adults (age 18+)
2. Access to internet, smart phone or tablet to participate in online surveys
3. Able to complete online surveys in English or Spanish
Exclusion Criteria:
1. Residence in an urban Colorado county
2. HIV positive status
3. No internet, smart phone, or tablet access
4. Unable to complete online surveys in English or Spanish
|
NCT0531xxxx/NCT05319626.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319626</url>
</required_header>
<id_info>
<org_study_id>2021-844</org_study_id>
<nct_id>NCT05319626</nct_id>
</id_info>
<brief_title>Immediate Effects of Two Different Lower Limb Sensory Stimulation Strategies on Balance and Mobility in Older Adults</brief_title>
<official_title>Immediate Effects of Two Different Lower Limb Sensory Stimulation Strategies on Balance and Mobility in Older Adults</official_title>
<sponsors>
<lead_sponsor>
<agency>Gazi University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Gazi University</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Falls are a major public health problem worldwide. As a result of changes in sensory system
capacity with aging, postural control decreases and the risk of falling increases. Various
lower-limb sensory stimulation strategies are applied to compensate for these changes in
sensory system capacity. It has been determined that these practices can have positive
effects on postural control. Among these stimulation strategies, compression stockings and
textured insoles are frequently preferred because of their cost-effectiveness and ease of
application. For these purpose, this study aims to examine the immediate effects of wearing
textured insoles and compression stockings on balance and mobility in older adults. Thus, we
will sight to discern whether interventions of the textured insoles and compression materials
improve sensory afferent feedback in the foot.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Within-subject experimental design with all participants tests under each of four randomly
organized conditions: (i) Compression socks with textured insoles, (ii) Compression socks
with smooth insoles, (iii) Smooth socks with textured insoles, (iv) Smooth socks with smooth
insoles. With each condition, the participants are given a 5-minute warm-up period to get
used to the insoles and stocking conditions, and then the testing process consisting of
balance, mobility and foot sensation assessments is started. All data are collected randomly
in a single testing session by the same researcher blind to the conditions.Before all data
collection, each participant has a practice of test process to ensure familiarity with the
devices and the procedures. A rest period of 10 minutes are given between applications.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">October 18, 2021</start_date>
<completion_date type="Actual">June 20, 2023</completion_date>
<primary_completion_date type="Actual">April 18, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Crossover Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Participant, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Foot sensation test</measure>
<time_frame>in an average of one and half hour</time_frame>
<description>Foot plantar sense will be assessed with Semmes-Weinstein monofilament test. The foot sensation test will be performed (barefoot) immediately after each condition to determine the effect of the condition. 4 times in total.</description>
</primary_outcome>
<primary_outcome>
<measure>Balance test</measure>
<time_frame>in an average of one and half hour</time_frame>
<description>Balance will be assessed using the Biodex-BioSway™ Portable Balance System, in different visual situations and support surfaces during bilateral standing. It will be measured with each condition, 4 times in total.</description>
</primary_outcome>
<primary_outcome>
<measure>Mobility test</measure>
<time_frame>in an average of one and half hour</time_frame>
<description>Mobility will be assessed by selecting Time Up and Go and Walk parameters in the BTS G-Walk wearable motion analysis system. Time Up and Go test determines functional mobility, and fall risk. Walk test evaluates quantitative analysis for the performance of walking. It will be measured with each condition, 4 times in total.</description>
</primary_outcome>
<number_of_arms>4</number_of_arms>
<enrollment type="Actual">24</enrollment>
<condition>Elderly</condition>
<condition>Balance</condition>
<arm_group>
<arm_group_label>Intervention group 1</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Compression socks with Textured insoles</description>
</arm_group>
<arm_group>
<arm_group_label>Intervention group 2</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Compression socks with Smooth insoles</description>
</arm_group>
<arm_group>
<arm_group_label>Intervention group 3</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Smooth socks with Textured insoles</description>
</arm_group>
<arm_group>
<arm_group_label>Control group</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>Smooth socks with Smooth insoles</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>compression socks</intervention_name>
<description>The compression socks have a clinical pressure of 23-30 mm Hg. The socks are dressed to the participants based on the manufacturer's sizing guidelines.</description>
<arm_group_label>Intervention group 1</arm_group_label>
<arm_group_label>Intervention group 2</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>textured insoles</intervention_name>
<description>The textured insoles have small, pyramidal peaks with centre-to-centre distances of approximately 2.5 mm (Evalite Pyramid EVA, 3 mm thickness, shore value A50, black). The insoles cut to a range of men's and women's standard EU shoe sizes. During the testing process, they are worn within a standardised shoe.</description>
<arm_group_label>Intervention group 1</arm_group_label>
<arm_group_label>Intervention group 3</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>smooth socks</intervention_name>
<description>The smooth socks are a commercial stocking that does not have a compression feature, but has a similar thickness and color to the compression stocking. They have standard size.</description>
<arm_group_label>Control group</arm_group_label>
<arm_group_label>Intervention group 3</arm_group_label>
<other_name>control socks</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>smooth insoles</intervention_name>
<description>The smooth insoles have a completely flat surface (Evalite Pyramid EVA, 3 mm thickness, shore value A50, black). The insoles cut to a range of men's and women's standard EU shoe sizes. During the testing process, they are worn within a standardised shoe.</description>
<arm_group_label>Control group</arm_group_label>
<arm_group_label>Intervention group 2</arm_group_label>
<other_name>control insoles</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Community-dwelling older adults over the 65 years old with ability to stand
independently without using any assistive devices

- No history of falls in the last 12 months

- Mini Mental State Examination (MMSE) score > 24 (normal)

- Berg Balance Test score > 40

Exclusion Criteria:

- Self-reported neurological, vestibular or neuromuscular diseases

- Current history of peripheral neuropathy

- Presence of severe visual impairment (such as cataracts or glaucoma)
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>65 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Sevim Beyza Ölmez</last_name>
<role>Principal Investigator</role>
<affiliation>Gazi University</affiliation>
</overall_official>
<overall_official>
<last_name>Selda Başar</last_name>
<role>Study Director</role>
<affiliation>Gazi University</affiliation>
</overall_official>
<overall_official>
<last_name>Tuğçe Çoban</last_name>
<role>Principal Investigator</role>
<affiliation>Gazi University</affiliation>
</overall_official>
<location>
<facility>
<name>Gazi University, Faculty of Health Sciences</name>
<address>
<city>Çankaya</city>
<state>Ankara</state>
<zip>06490</zip>
<country>Turkey</country>
</address>
</facility>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<reference>
<citation>Woo MT, Davids K, Liukkonen J, Orth D, Chow JY, Jaakkola T. Effects of different lower-limb sensory stimulation strategies on postural regulation-A systematic review and meta-analysis. PLoS One. 2017 Mar 29;12(3):e0174522. doi: 10.1371/journal.pone.0174522. eCollection 2017.</citation>
<PMID>28355265</PMID>
</reference>
<reference>
<citation>Kenny RPW, Atkinson G, Eaves DL, Martin D, Burn N, Dixon J. The effects of textured materials on static balance in healthy young and older adults: A systematic review with meta-analysis. Gait Posture. 2019 Jun;71:79-86. doi: 10.1016/j.gaitpost.2019.04.017. Epub 2019 Apr 17.</citation>
<PMID>31022658</PMID>
</reference>
<reference>
<citation>Woo MT, Davids K, Chow JY, Jaakkola T. Acute effects of wearing compression knee-length socks on ankle joint position sense in community-dwelling older adults. PLoS One. 2021 Feb 8;16(2):e0245979. doi: 10.1371/journal.pone.0245979. eCollection 2021.</citation>
<PMID>33556067</PMID>
</reference>
<verification_date>June 2023</verification_date>
<study_first_submitted>March 28, 2022</study_first_submitted>
<study_first_submitted_qc>April 6, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>June 20, 2023</last_update_submitted>
<last_update_submitted_qc>June 20, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">June 22, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Gazi University</investigator_affiliation>
<investigator_full_name>Sevim Beyza Ölmez</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Falls are a major public health problem worldwide. As a result of changes in sensory system
capacity with aging, postural control decreases and the risk of falling increases. Various
lower-limb sensory stimulation strategies are applied to compensate for these changes in
sensory system capacity. It has been determined that these practices can have positive
effects on postural control. Among these stimulation strategies, compression stockings and
textured insoles are frequently preferred because of their cost-effectiveness and ease of
application. For these purpose, this study aims to examine the immediate effects of wearing
textured insoles and compression stockings on balance and mobility in older adults. Thus, we
will sight to discern whether interventions of the textured insoles and compression materials
improve sensory afferent feedback in the foot.
Within-subject experimental design with all participants tests under each of four randomly
organized conditions: (i) Compression socks with textured insoles, (ii) Compression socks
with smooth insoles, (iii) Smooth socks with textured insoles, (iv) Smooth socks with smooth
insoles. With each condition, the participants are given a 5-minute warm-up period to get
used to the insoles and stocking conditions, and then the testing process consisting of
balance, mobility and foot sensation assessments is started. All data are collected randomly
in a single testing session by the same researcher blind to the conditions.Before all data
collection, each participant has a practice of test process to ensure familiarity with the
devices and the procedures. A rest period of 10 minutes are given between applications.
Inclusion Criteria:
- Community-dwelling older adults over the 65 years old with ability to stand
independently without using any assistive devices
- No history of falls in the last 12 months
- Mini Mental State Examination (MMSE) score > 24 (normal)
- Berg Balance Test score > 40
Exclusion Criteria:
- Self-reported neurological, vestibular or neuromuscular diseases
- Current history of peripheral neuropathy
- Presence of severe visual impairment (such as cataracts or glaucoma)
|
NCT0531xxxx/NCT05319639.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319639</url>
</required_header>
<id_info>
<org_study_id>SYLT-023</org_study_id>
<nct_id>NCT05319639</nct_id>
</id_info>
<brief_title>Phase I/II Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab</brief_title>
<official_title>Phase I/II Study of the Combination of Irinotecan and POF (Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin) and Tislelizumab</official_title>
<sponsors>
<lead_sponsor>
<agency>Fujian Cancer Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Fujian Cancer Hospital</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The purpose of the phase I/II study is to establish the safety of Combination of Irinotecan
and paclitaxel with 5-FU, leucovorin, oxaliplatin and Tislelizumab.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">February 16, 2023</start_date>
<completion_date type="Anticipated">December 31, 2024</completion_date>
<primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
<phase>Phase 1/Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>The maximum dose tolerated</measure>
<time_frame>1 month</time_frame>
<description>To determine the maximum tolerated dose of POFI with different doses of irinotecan and paclitaxel combined with Tislelizumab in the first month.</description>
</primary_outcome>
<secondary_outcome>
<measure>Overall Response Rate</measure>
<time_frame>2 years</time_frame>
<description>Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Progression-free survival</measure>
<time_frame>2 years</time_frame>
<description>The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Overall survival</measure>
<time_frame>2 years</time_frame>
<description>The length of time from enrollment until the time of death (OS, overall survival).</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">20</enrollment>
<condition>Gastric Cancer Stage IV</condition>
<arm_group>
<arm_group_label>POFI and Tislelizumab</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>This study will include a sequential evaluation of 3 subjects per cohort. Irinotecan 135 → 150 and paclitaxel 45 → 67.5 → 90 mg/m2 on day 1.
The rest of regimen is that oxaliplatin (85 mg/m2) and Lev-leucovolin (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days. Tislelizumab 200mg，repeating the cycle every 14 days.
A dose limiting toxicity (DLT) event is defined as any of the following events in the first 4-week period:
CTCAE Grade 4 event (except for neutropenia lasting for ≤ 5 days); Grade 3 non-hematologic toxicity (except for nausea and vomiting that could be improved with optimal supportive care, escalation of alkaline phosphatase) If a DLT is experienced in any cohort, the cohort will be expanded to 6 subjects. If 2 DLTs are experienced in any cohort, the dose escalation ceased. The MTD was defined as the dose having at most two out of six patients experience DLT.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Oxaliplatin</intervention_name>
<description>Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days.</description>
<arm_group_label>POFI and Tislelizumab</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Levo-Leucovorin</intervention_name>
<description>Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days.</description>
<arm_group_label>POFI and Tislelizumab</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>5-fluorouracil</intervention_name>
<description>5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days.</description>
<arm_group_label>POFI and Tislelizumab</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Paclitaxel</intervention_name>
<description>Paclitaxel will be administered on day 1 of each cycle at 45mg/m2 at dose level 1; 67.5 mg/m2 at dose level 2 ; 90 mg/m2 at dose level 3; 112.5 mg/m2 at dose level 4 once every 14 days.</description>
<arm_group_label>POFI and Tislelizumab</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Irinotecan</intervention_name>
<description>Irinotecan will be administered on day 1 of each cycle at 135 mg/m2 at dose level 1; 150 mg/m2 at dose level 2 once every 14 days.</description>
<arm_group_label>POFI and Tislelizumab</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Tislelizumab</intervention_name>
<description>Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.</description>
<arm_group_label>POFI and Tislelizumab</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Patients with advanced unresectable, histologically confirmed adenocarcinoma of the
gastric or gastroesophageal junction.

2. With or without measurable lesions.

3. Patients must have a performance status of 0-1 on the Eastern Cooperative Oncology
Group (ECOG) scale.

4. Without serious system dysfunction and could tolerate chemotherapy. With normal
marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood
transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of
≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a
creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min
(Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase
(ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.

5. Life expectancy ≥3 months.

6. With normal electrocardiogram results and no history of congestive heart failure.

7. With normal coagulation function: activated partial thromboplastin time (APTT),
prothrombin time (PT) and INR, each ≤ 1.5 x ULN.

8. Female subjects of child-bearing potential must agree to use contraceptive measures
starting 1 week before the administration of the first dose of Tislelizumab until 8
weeks after discontinuing study drug. Male subjects must agree to use contraceptive
measures during the study and 8 weeks after last dose of study drug

9. With written informed consent signed voluntarily by patients themselves or their
supervisors witted by doctors.

10. With good compliance and agree to accept follow-up of disease progression and adverse
events.

Exclusion Criteria:

1. Patients with a history of another neoplastic disease within the past three years,
excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or
nonmetastatic prostate cancer.

2. Patients with brain or central nervous system metastases, including leptomeningeal
disease.

3. Pregnant (positive pregnancy test) or breast feeding.

4. Serious, non-healing wound, ulcer, or bone fracture.

5. Significant cardiac disease as defined as: unstable angina, New York Heart Association
(NYHA) grade II or greater, congestive heart failure, history of myocardial infarction
within 6 months Evidence of bleeding diathesis or coagulopathy.

6. History of a stroke or CVA within 6 months.

7. Clinically significant peripheral vascular disease.

8. Inability to comply with study and/or follow-up procedures.

9. Patients with any other medical condition or reason, in that investigator's opinion,
makes the patient unstable to participate in a clinical trial.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>75 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>lin rong bo, bachelor</last_name>
<phone>13705919382</phone>
<phone_ext>86</phone_ext>
<email>rongbo_lin@163.com</email>
</overall_contact>
<location>
<facility>
<name>Fujian cancer hospital</name>
<address>
<city>Fuzhou</city>
<state>Fujian</state>
<zip>350500</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>lin R bo</last_name>
<phone>13705919382</phone>
<phone_ext>86</phone_ext>
<email>rongbo_lin@163.com</email>
</contact>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>September 2023</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>September 15, 2023</last_update_submitted>
<last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">September 18, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Stomach Neoplasms</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Leucovorin</mesh_term>
<mesh_term>Paclitaxel</mesh_term>
<mesh_term>Fluorouracil</mesh_term>
<mesh_term>Oxaliplatin</mesh_term>
<mesh_term>Irinotecan</mesh_term>
<mesh_term>Tislelizumab</mesh_term>
<mesh_term>Levoleucovorin</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of the phase I/II study is to establish the safety of Combination of Irinotecan
and paclitaxel with 5-FU, leucovorin, oxaliplatin and Tislelizumab.
Inclusion Criteria:
1. Patients with advanced unresectable, histologically confirmed adenocarcinoma of the
gastric or gastroesophageal junction.
2. With or without measurable lesions.
3. Patients must have a performance status of 0-1 on the Eastern Cooperative Oncology
Group (ECOG) scale.
4. Without serious system dysfunction and could tolerate chemotherapy. With normal
marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood
transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of
≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a
creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min
(Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase
(ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
5. Life expectancy ≥3 months.
6. With normal electrocardiogram results and no history of congestive heart failure.
7. With normal coagulation function: activated partial thromboplastin time (APTT),
prothrombin time (PT) and INR, each ≤ 1.5 x ULN.
8. Female subjects of child-bearing potential must agree to use contraceptive measures
starting 1 week before the administration of the first dose of Tislelizumab until 8
weeks after discontinuing study drug. Male subjects must agree to use contraceptive
measures during the study and 8 weeks after last dose of study drug
9. With written informed consent signed voluntarily by patients themselves or their
supervisors witted by doctors.
10. With good compliance and agree to accept follow-up of disease progression and adverse
events.
Exclusion Criteria:
1. Patients with a history of another neoplastic disease within the past three years,
excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or
nonmetastatic prostate cancer.
2. Patients with brain or central nervous system metastases, including leptomeningeal
disease.
3. Pregnant (positive pregnancy test) or breast feeding.
4. Serious, non-healing wound, ulcer, or bone fracture.
5. Significant cardiac disease as defined as: unstable angina, New York Heart Association
(NYHA) grade II or greater, congestive heart failure, history of myocardial infarction
within 6 months Evidence of bleeding diathesis or coagulopathy.
6. History of a stroke or CVA within 6 months.
7. Clinically significant peripheral vascular disease.
8. Inability to comply with study and/or follow-up procedures.
9. Patients with any other medical condition or reason, in that investigator's opinion,
makes the patient unstable to participate in a clinical trial.
|
NCT0531xxxx/NCT05319652.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319652</url>
</required_header>
<id_info>
<org_study_id>2022-6312</org_study_id>
<nct_id>NCT05319652</nct_id>
</id_info>
<brief_title>Feasibility Study of an Online Self-management Program for Chronic Non-cancer Pain</brief_title>
<official_title>Co-development and Assessment of the Feasibility and Potential Effects of an Online Self-management Program for Chronic Non-cancer Pain</official_title>
<sponsors>
<lead_sponsor>
<agency>CHU de Quebec-Universite Laval</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>CHU de Quebec-Universite Laval</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Based on a mixed-methods design, the objective of this trial is to assess the feasibility and
acceptability of the "Agir pour moi" program, an 8-week online self-management program for
chronic non-cancer pain (CNCP). The investigators will also explore its potential effects on
self-efficacy, pain interference, pain severity, anxiety, depression, catastrophizing, and
global impression of change in adults with CNCP awaiting services from a chronic pain
multidisciplinary treatment center.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The mixed-methods sequential explanatory design combines a quantitative questionnaire-based
study with a subsequent in depth qualitative approach.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">June 6, 2022</start_date>
<completion_date type="Actual">March 23, 2023</completion_date>
<primary_completion_date type="Actual">March 23, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Other</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Feasibility of the recruitment</measure>
<time_frame>Baseline</time_frame>
<description>Number of potentially eligible adults referred by the multidisciplinary treatment center over the recruitment period
Number of referred adults who respond to the invitation
Number of referred adults who consent to participate in the study
Number of interested adults excluded based on inclusion/exclusion criteria</description>
</primary_outcome>
<primary_outcome>
<measure>Feasibility of data collection</measure>
<time_frame>Baseline</time_frame>
<description>Rate of response to the questionnaires
Rate of completed questionnaires (no missing data)</description>
</primary_outcome>
<primary_outcome>
<measure>Feasibility of data collection</measure>
<time_frame>Post-intervention (8 weeks)</time_frame>
<description>Rate of response to the questionnaires
Rate of completed questionnaires (no missing data)</description>
</primary_outcome>
<primary_outcome>
<measure>Feasibility of data collection</measure>
<time_frame>3 months post-intervention</time_frame>
<description>Rate of response to the questionnaires
Rate of completed questionnaires (no missing data)</description>
</primary_outcome>
<primary_outcome>
<measure>Acceptability</measure>
<time_frame>Post-intervention (8 Weeks)</time_frame>
<description>The Acceptability E-scale includes 6 items regarding how easy and enjoyable the program was to use, how understandable were the lessons, how helpful was completing the program, whether the participant liked the program, whether the amount of time to complete the program was acceptable, and overall satisfaction with the program. Scores can range from 6 to 30. Higher scores reprensent a high level of acceptability.</description>
</primary_outcome>
<primary_outcome>
<measure>Acceptability</measure>
<time_frame>4 months post-intervention</time_frame>
<description>Qualitative data from semi-structured interviews</description>
</primary_outcome>
<primary_outcome>
<measure>Adherence to the program</measure>
<time_frame>Post-intervention (8 weeks)</time_frame>
<description>Completion rate of the program (completion is following ≥ 75% of the lessons)</description>
</primary_outcome>
<secondary_outcome>
<measure>Change in self-efficacy: French version of the Pain Self-Efficacy Questionnaire (PSEQ)</measure>
<time_frame>Baseline; Post-intervention (8 weeks); 3 months post-intervention</time_frame>
<description>The PSEQ is a ten item questionnaire which assesses an individual's confidence in their ability to perform a variety of activities or tasks despite pain. Scores can range from 0 to 60. Higher scores represent lower confidence to function with pain.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in pain severity and pain interference: French version of the Brief Pain Inventory (BPI)</measure>
<time_frame>Baseline; Post-intervention (8 weeks); 3 months post-intervention</time_frame>
<description>The BPI includes a pain severity subscale and a pain interference subscale. The pain interference subscale measures the extent to which pain interferes with functions such as general activity, walking ability, normal work, mood, relationships with people, enjoyment of life and sleep. For each scale, the total score is the average of all items. Scores can range from 0 to 10 for each subscale. Higher scores indicate greater severity and more interference.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in anxiety and depression: French version of the Hospital Anxiety and Depression Scale (HADS)</measure>
<time_frame>Baseline; Post-intervention (8 weeks); 3 months post-intervention</time_frame>
<description>The HADS is a 14-item scale. Seven items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in pain catastrophizing: French version of the Pain Catastrophizing Scale (PCS)</measure>
<time_frame>Baseline; Post-intervention (8 weeks); 3 months post-intervention</time_frame>
<description>The PCS is a 13-item questionnaire designed to assess catastrophic thinking in relation to pain. It yields a total score and three subscale scores assessing rumination, magnification and helplessness. Scores can range from 0 to 52. Higher scores represent higher pain catastrophizing.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Patient Global Impression of Change Scale (PGIC)</measure>
<time_frame>Post-intervention (8 weeks); 3 months post-intervention</time_frame>
<description>The PGIC measures a patient's rating of overall improvement or lack thereof due to the intervention. It is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">63</enrollment>
<condition>Chronic Pain</condition>
<arm_group>
<arm_group_label>Pain self-management program</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants log in to the online program and develop practical strategies to manage CNCP.</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Pain self-management program</intervention_name>
<description>Each week for eight weeks, participants are invited to complete self-directed lessons on particular themes. The program covers goal setting, stress management through relaxation, breathing and mindfulness, pacing, physical activity, thoughts and emotions, sleep, nutrition, flare-up management, and planning. Through pain education, positive testimonials from individuals with CNCP applying the suggested strategies, reflective activities, goal setting and monitoring, and the gradual development of a personal plan, the program supports self-efficacy building to manage CNCP.</description>
<arm_group_label>Pain self-management program</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Age ≥ 18 years;

- live with CNCP for more than 3 months;

- read and understand French easily;

- have access to a computer and high-speed Internet;

- be available to take part in the project for 6 to 8 months;

- not having started a new treatment for pain within the last month;

- agree to notify the team before starting a new treatment;

- be able to give informed consent.

Exclusion Criteria:

- be supported by a multidisciplinary treatment center or be likely to be in the short
term;

- having participated in a CNCP self-management program within the last year;

- be awaiting scheduled surgical treatment within six months.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Anne Marie Pinard, MD, M(Ed.)</last_name>
<role>Principal Investigator</role>
<affiliation>CHU de Quebec-Universite Laval</affiliation>
</overall_official>
<location>
<facility>
<name>CHU de Québec</name>
<address>
<city>Québec</city>
<state>Quebec</state>
<zip>G1V 4G2</zip>
<country>Canada</country>
</address>
</facility>
</location>
<location_countries>
<country>Canada</country>
</location_countries>
<verification_date>July 2023</verification_date>
<study_first_submitted>March 21, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>July 21, 2023</last_update_submitted>
<last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">July 24, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>CHU de Quebec-Universite Laval</investigator_affiliation>
<investigator_full_name>Anne-Marie-Pinard</investigator_full_name>
<investigator_title>Anesthesiologist</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Chronic Pain</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Based on a mixed-methods design, the objective of this trial is to assess the feasibility and
acceptability of the "Agir pour moi" program, an 8-week online self-management program for
chronic non-cancer pain (CNCP). The investigators will also explore its potential effects on
self-efficacy, pain interference, pain severity, anxiety, depression, catastrophizing, and
global impression of change in adults with CNCP awaiting services from a chronic pain
multidisciplinary treatment center.
The mixed-methods sequential explanatory design combines a quantitative questionnaire-based
study with a subsequent in depth qualitative approach.
Inclusion Criteria:
- Age ≥ 18 years;
- live with CNCP for more than 3 months;
- read and understand French easily;
- have access to a computer and high-speed Internet;
- be available to take part in the project for 6 to 8 months;
- not having started a new treatment for pain within the last month;
- agree to notify the team before starting a new treatment;
- be able to give informed consent.
Exclusion Criteria:
- be supported by a multidisciplinary treatment center or be likely to be in the short
term;
- having participated in a CNCP self-management program within the last year;
- be awaiting scheduled surgical treatment within six months.
|
NCT0531xxxx/NCT05319665.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319665</url>
</required_header>
<id_info>
<org_study_id>2022-00215</org_study_id>
<nct_id>NCT05319665</nct_id>
</id_info>
<brief_title>"Connected Caesarean Section": Creating a Virtual Link Between Mothers and Their Infants to Improve Maternal Childbirth Experience: A Pilot Trial</brief_title>
<acronym>e-motion-pilot</acronym>
<official_title>"connEcted Caesarean Section": Creating a Virtual Link Between MOthers and Their infanTs to ImprOve Maternal Childbirth experieNce: a PILOT Trial (E-motion-pilot)</official_title>
<sponsors>
<lead_sponsor>
<agency>Centre Hospitalier Universitaire Vaudois</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>University of Lausanne</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Centre Hospitalier Universitaire Vaudois</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
One third of mothers rate their childbirth as traumatic. The prevalence of childbirth-related
posttraumatic stress disorder (CB-PTSD) is of 4.7% and the prevalence of childbirth-related
posttraumatic stress symptoms (CB-PTSS) of 12.3%. Skin-to-skin contact is a protective factor
against CB-PTSD. However, during a caesarean section (CS), skin-to-skin contact is not always
feasible and mothers and infants are often separated. In those cases, there is no validated
and available solution to substitute this unique protective factor. Based on the results
observed in studies using virtual reality (VR) and head-mounted displays (HMDs) and studies
on childbirth experience, we hypothesize that enabling the mother to have a visual and
auditory contact with her baby could improve her childbirth experience whilst she and her
baby are separated. To facilitate this connection, we will use a 2D 360° camera filming the
baby linked securely to a head-mounted device (HMD) that the mother can wear during the end
of the surgery.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">April 8, 2022</start_date>
<completion_date type="Actual">November 17, 2022</completion_date>
<primary_completion_date type="Actual">November 1, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Non-Randomized</allocation>
<intervention_model>Sequential Assignment</intervention_model>
<intervention_model_description>The study will consist of two phases. During the first phase, the participants will be the control group and will have the standard-of-care. During the second phase, the participants will be the interventional group and will have a head-mounted display airing a live video of their newborn filmed by a 2D 360° camera to enable a visual and auditory contact.</intervention_model_description>
<primary_purpose>Prevention</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Childbirth Experience Questionnaire 2 (CEQ-2)</measure>
<time_frame>1 week after the birth</time_frame>
<description>Standardised questionnaire of childbirth experience. This self-reported questionnaire measures the maternal childbirth experience with four different subscales: own capacity, perceived safety, professional support and participation. There are 19 items rated on a 4 point Likert scale ranging from 1=totally disagree to 4=totally agree and 3 items rated on a VAS from 1 to 100. Rating of negatively worded statements are reversed. Higher scores indicates a better childbirth experience. The minimum value is 1 and the maximum is 4 points.</description>
</primary_outcome>
<secondary_outcome>
<measure>Perceived Pain Item</measure>
<time_frame>During the caesarean section</time_frame>
<description>Evaluation of experienced pain using the Pain Item during the caesarean section.
A visual analogue scale from 0 to 10 will be shown to the participant. She will be asked to evaluate her pain level on that scale. 0 means no pain at all, 10 is the worst pain imaginable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Perceived Stress Item</measure>
<time_frame>At the end of the caesarean section</time_frame>
<description>Evaluation of experienced the stress using the Stress Item. A visual analogue scale from 0 to 10 will be shown to the participant. She will be asked to evaluate her stess level on that scale. 0 means no stress at all, 10 is the worst stress imaginable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Perceived Pain Item</measure>
<time_frame>At the end of the caesarean section</time_frame>
<description>Evaluation of experienced pain using the Pain Item. A visual analogue scale from 0 to 10 will be shown to the participant. She will be asked to evaluate her pain level on that scale. 0 means no pain at all, 10 is the worst pain imaginable.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Satisfaction of the intervention</measure>
<time_frame>1 week after the caesarean section</time_frame>
<description>For the interventional group, their satisfaction of the intervention will be assessed.
12 questions will be asked to the participants of the interventional group on their global satisfaction of the intervention, the utility of the intervention, the comfort of the HMD, the quality of the images, sound and camera-HMD connection, advantages and disadvantages of the HMD. 3 questions will be evaluated on a 5-point Likert-scale. 4 questions will require a yes-no answer and 5 questions will be open questions.
This questionnaire is used as a qualitative questionnaire.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Maternal symptoms of anxiety or depression</measure>
<time_frame>1 week after the caesarean section</time_frame>
<description>Hospital Anxiety and Depression Scale (HADS-A and HADS-D) This self-reported questionnaire measures the severity of anxiety and depression symptoms during the week before replying to the questions. There are two subscales; anxiety and depression. Each of them consists of seven items scored on a four point Likert scale (0= never, 3=most of the time). Higher score reflects greater severity. The minimum value is 0 and the maximum is 42 points.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Mother-infant bonding</measure>
<time_frame>1 week after the caesarean section</time_frame>
<description>Mother-Infant Bonding Scale (MIBS) This eight points self-reported questionnaire assesses the mother's feelings towards her newborn in the first week after birth. The eights items are statements describing an emotional response and are rated on a four point Likert scale (0=very much, 3=not at all). Higher score denote worse bonding. The minimum value is 0 and the maximum is 24 points.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Satisfaction of the birth</measure>
<time_frame>1 week after the caesarean section</time_frame>
<description>Birth Satisfaction Scale-Revised (BSS-R) The BSS-R is a 10-item self-reported questionnaire assessing the perceptions of the birth in order to determine women's satisfaction of their birth experience. It consists of one higher-order factor, experience of childbearing, containing three lower-order factors: quality of care provision, women's personal attributes and stress experienced during labor. The items are evaluated on a Likert-type scale that requests participants to rate their level of agreement with each item (1=strongly disagree, 5=strongly agree). Four of the items are reverse-coded. Higher score denotes a worse satisfaction of the birth. The minimum value is 10 and the maximum is 50 points.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Maternal symptoms of anxiety or depression</measure>
<time_frame>1 month after the caesarean section</time_frame>
<description>Hospital Anxiety and Depression Scale (HADS-A and HADS-D) This self-reported questionnaire measures the severity of anxiety and depression symptoms during the week before replying to the questions. There are two subscales; anxiety and depression. Each of them consists of seven items scored on a four point Likert scale (0= never, 3=most of the time). Higher score reflects greater severity. The minimum value is 0 and the maximum is 42 points.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Maternal symptoms of PTSD</measure>
<time_frame>1 month after the caesarean section</time_frame>
<description>City Birth Trauma Scale (CityBiTS) (CityBiTS). The City Birth Trauma Scale is a 29-item questionnaire measuring birth-related post-traumatic stress disorder (PTSD) according to DSM-5 criteria of (A) stressor criteria, (B) symptoms of re-experiencing, (C) avoidance, (D) negative cognitions and mood, (E) hyperarousal, (F) duration of symptoms, (E) signification distress or impairment and (F) exclusion criteria or other causes. Items are evaluated with yes/no/maybe or by frequency of the symptoms. A higher score indicates a higher level of PTSD symptoms. The minimum value is 0 and the maximum is 78 points.</description>
</secondary_outcome>
<other_outcome>
<measure>Evolution of the haemodynamic parameters during the caesarean section</measure>
<time_frame>During the caesarean section</time_frame>
<description>The investigators will monitor the haemodynamic parameters during the caesarean section.
anesthesia, use of medication, Perceived Pain Item</description>
</other_outcome>
<other_outcome>
<measure>Presence of perioperative shivers during the caesarean section</measure>
<time_frame>During the caesarean section</time_frame>
<description>The investigators will assess if there is a presence of perioperative shivers or not during the caesarean section.</description>
</other_outcome>
<other_outcome>
<measure>Presence of nausea related to the surgery or the anesthesia during the caesarean section.</measure>
<time_frame>During the caesarean section</time_frame>
<description>The investigators will assess if there is a presence of nausea or not during the caesarean section.</description>
</other_outcome>
<other_outcome>
<measure>Use of medication during the caesarean section.</measure>
<time_frame>During the caesarean section</time_frame>
<description>The investigators will monitor the use of medication during the caesarean section.</description>
</other_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">71</enrollment>
<condition>Post Traumatic Stress Disorder</condition>
<condition>Childbirth Experience</condition>
<arm_group>
<arm_group_label>Control</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>The control group will have the standard-of-care treatment.</description>
</arm_group>
<arm_group>
<arm_group_label>Interventional</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>The interventional group will have a head-mounted display whilst still in the operating theatre airing a live video of their newborn filmed by a 2D 360° camera to enable a visual and auditory contact.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Head-mounted display</intervention_name>
<description>The intervention is a visual and auditory contact via a head-mounted display (HMD) worn by the mother airing a live video of her newborn filmed by a 2D 360° camera during and after a caesarean section. The HMD will be worn by the new mother from the moment that her newborn is moved to an adjacent room to receive the initial care until the moment when they can be reunited again. The camera will be placed in the adjacent room where the newborn, the mother's partner and a midwife will be. The camera will film the newborn and transmit the live images and the sound to the HMD worn by the mother. The mother will be able to see and hear what happens in the next room and change her angle of view by moving her head from one side to another.</description>
<arm_group_label>Interventional</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Women aged 18 years old or older

- Planned or unplanned CS at ≥ 34 weeks gestation

- Gave birth to a healthy baby according to pediatric evaluation (APGAR score ≥ 7 at 5
minutes)

- Gave oral consent followed by a written confirmation of consent

- Skin-to-skin contact is not possible or was prematurely interrupted

- Speaks French well enough to participate in study assessments

- Eligibility confirmed by an independent physician for the intervention group

- Partner gave oral consent to be filmed for the intervention group.

Exclusion Criteria:

- Has an established intellectual disability or psychotic illness

- Has photosensitive epilepsy

- Caesarean section under general anesthesia
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Prof. Antje Horsch</name>
<address>
<city>Lausanne</city>
<zip>1010</zip>
<country>Switzerland</country>
</address>
</facility>
</location>
<location_countries>
<country>Switzerland</country>
</location_countries>
<verification_date>July 2023</verification_date>
<study_first_submitted>March 25, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>July 28, 2023</last_update_submitted>
<last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">August 1, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Centre Hospitalier Universitaire Vaudois</investigator_affiliation>
<investigator_full_name>Antje Horsch</investigator_full_name>
<investigator_title>Associate Professor</investigator_title>
</responsible_party>
<keyword>Mother-infant bonding</keyword>
<keyword>Birth satisfaction</keyword>
<keyword>HMD</keyword>
<keyword>Virtual reality</keyword>
<keyword>Caesarean section</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Stress Disorders, Traumatic</mesh_term>
<mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
One third of mothers rate their childbirth as traumatic. The prevalence of childbirth-related
posttraumatic stress disorder (CB-PTSD) is of 4.7% and the prevalence of childbirth-related
posttraumatic stress symptoms (CB-PTSS) of 12.3%. Skin-to-skin contact is a protective factor
against CB-PTSD. However, during a caesarean section (CS), skin-to-skin contact is not always
feasible and mothers and infants are often separated. In those cases, there is no validated
and available solution to substitute this unique protective factor. Based on the results
observed in studies using virtual reality (VR) and head-mounted displays (HMDs) and studies
on childbirth experience, we hypothesize that enabling the mother to have a visual and
auditory contact with her baby could improve her childbirth experience whilst she and her
baby are separated. To facilitate this connection, we will use a 2D 360° camera filming the
baby linked securely to a head-mounted device (HMD) that the mother can wear during the end
of the surgery.
Inclusion Criteria:
- Women aged 18 years old or older
- Planned or unplanned CS at ≥ 34 weeks gestation
- Gave birth to a healthy baby according to pediatric evaluation (APGAR score ≥ 7 at 5
minutes)
- Gave oral consent followed by a written confirmation of consent
- Skin-to-skin contact is not possible or was prematurely interrupted
- Speaks French well enough to participate in study assessments
- Eligibility confirmed by an independent physician for the intervention group
- Partner gave oral consent to be filmed for the intervention group.
Exclusion Criteria:
- Has an established intellectual disability or psychotic illness
- Has photosensitive epilepsy
- Caesarean section under general anesthesia
|
NCT0531xxxx/NCT05319678.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319678</url>
</required_header>
<id_info>
<org_study_id>PI-4447</org_study_id>
<nct_id>NCT05319678</nct_id>
</id_info>
<brief_title>Analysis of Musical and Voice Skills in Children and Adult Cochlear Implant Users</brief_title>
<official_title>Analysis of Musical and Voice Skills in Children and Adult Cochlear Implant Users</official_title>
<sponsors>
<lead_sponsor>
<agency>Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Instituto de Salud Carlos III</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Aims: To evaluate the perception and enjoyment of music in cochlear implant (CI) users using
specific questionnaires, and comparing their results with a control group of subjects with
normal hearing (NH). To analyze the musical abilities of implantees using the musical tool
Meludia, and compare the results with the control group. To perfom a voice analysis in
implanted patients, compare it with their NH peers, and check if an association with musical
perception is observed.

Design: Cross-sectional study, both the CI recipients and NH control subjects were assessed
once.

Setting and subjects: Pre-or perilingual patients aged 6 to 17 years old, and postlingual
adults who underwent cochlear implantation from 2000 to January 2023 at La Paz University
Hospital. Control group is set up with their NH peers.

Study Variables: Socio-demographic and clinical (current age, age at implantation, sex,
educational level) variables will be collected, as well as hearing loss (aetiology, duration
of deafness), and surgical (type of implant, complete or partial insertion of the electrodes,
date of surgery) data. Data from CI fitting (number of active electrodes, type of audio
processor) and hearing outcomes with the CI will also be reviewed.

Outcome variables: Specific musical skills questionnaires for adults: Munich Music
Questionnaire (MuMu) and Music Related Quality of Life Questionnaire (MuRQoL), which will be
validated. Musical questionnaire developed specifically for subjects between 6-17 years old.
Musical tool (Meludia) to assess musical perception. Praat software for voice analysis.
Analysis of the impact of the different audiological, sociodemographic and clinical variables
on hearing outcomes, and on musical perception after cochlear implantation, and comparison
with the NH control group.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
METHODOLOGY

Design Cross-sectional study in which both implanted patients and control subjects without
hearing loss were tested only once.

Scope and study subjects Prior to the inclusion of subjects in the study, the approval of the
Ethics Committee of the Hospital Universitario La Paz (HULP) will be required.

STUDY GROUP (Implanted group) Adult patients (≥18 years) with postlingual hearing loss and
children (between 6 and 17 years) with prelingual or perilingual hearing loss who have
received a CI before the age of 3 years.

Patients who have received a CI from 2000 to January 2023 will be included as potential
candidates for participation. Currently 76 subjects aged 6-17 years implanted before the age
of 3 years and 231 post-lingual adults are identified in the database, to which post-lingual
adults implanted in the next 2 years should be added, so that after one year of follow up
they can participate in the study.

Inclusion criteria:

- Minimum age of 6 years.

- Patients aged 6-17 years must have been implanted before the age of 3 years (to ensure
adequate CI performance).

- Minimum 12 months experience with the device

- Indications: unilateral (one CI), bilateral (two CIs), bimodal (one CI in one ear and a
hearing aid in the other)

- At least 80% of electrodes active at the time of assessment.

- Fluency in Spanish

- Signed and dated informed consent prior to starting any study procedure.

Exclusion criteria:

- Not meet inclusion criteria.

- Prelingual or perilingual adults.

- Disability in addition to hearing impairment (e.g., mental disability). Routine visits
in the HULP or at their CI fitting sessions will be used as an opportunity to contact
patients and propose their participation.

CONTROL GROUP The control group will be composed of subjects over 6 years of age without
hearing impairment, without a disability that prevents them from taking the tests and who
have socio-demographic characteristics similar to those of the study group. They will be
included from the ENT Department where they will have come either with another type of
medical condition other than hearing loss, or accompanying patients. Hospital La Paz staff
(or family members) who wish to carry out the tests may also be included. They must be fluent
in Spanish to ensure that they understand the study and its purpose. To confirm that the
control group does not have hearing impairment, they will undergo tonal audiometry in both
ears, whose tonal threshold should be ≤30dB in the conversational frequencies of 500, 1000
and 2000Hz.

Socio-demographic and clinical variables Study group: affiliation data (current age, age at
implantation, sex, education level), hearing loss data (aetiology, duration of hearing loss,
type and degree of hearing loss, worst ear), surgery data (type of implant and electrode
array used, complete or incomplete insertion, side implanted, date of intervention),
postoperative complications. These data will be collected from the patients' medical records.
In addition, fititing data (number of active electrodes, processor model) and audiological
tests with the CI will be collected.

Control group: age, sex, associated pathology(ies), level of education.

Outcome variables

1. Scoring of the music-related quality of life questionnaire (MuRQoL), the Munich music
questionnaire (MuMu) and the questionnaire developed for subjects aged 6-17 years (see
description).

2. Validation of the music-related quality of life questionnaire (MuRQoL) in adult
population.

3. Score obtained in the "discovery" level with the Meludia music tool (see description).

4. Parameters to assess voice quality:

Spoken voice: Vocal inability index, Maximum phonation time, Fundamental voice
frequency, Jitter, Shimmer, Harmonics to noise ratio (HNR), Smoothed cepstral peak
(CPPS) and Spectrogram according to Yanagihara's classification.

Sung voice: Pitch (relative to the note emitted by a keyboard), CPPS and Singing power
ratio (SPR).

5. Impact of demographic and audiological factors on the results of the music perception
questionnaires as well as on the results of the Meludia tool and the acoustic analysis
of the implanted patients and comparison with the normal hearing control group.

Description of the measurement instruments

1. - MuMu Questionnaire: The Munich Music Questionnaire was especially developed for the
adult CI users population with postlingual hearing loss. It includes questions that
address past and present activities related to the habit of listening to music. We will
use the abbreviated version which contains 9 questions on music listening habits in
relation to various musical styles, different instruments and participation in musical
activities at different times in the life of implanted patients. It offers many response
options, from the "yes or no" format to rating scales and multiple choice questions with
the possibility to tick as many options as necessary (e.g. "How often do you listen
and/or have you listened to music", on a scale of 0-10; "Why do you listen to music",
with the options of "for pleasure", "professional reasons", "emotional satisfaction",
"to relax"). It is translated and validated in Spanish (developed by S.J. Brockmeier and
adapted by Ana Fuster. Info:
https://www.medel.com/support/rehab/rehabilitation-downloads).

2. MuRQoL Questionnaire: The concept of music related quality of life (MuRQoL) was
initially defined as the impact of listening skills on the quality of life of implanted
patients. To work on this concept, groups of adult CI users created the questions, thus
ensuring content validity, differing from previous studies in that users were not
involved in the initial question generation process. The MuRQoL questionnaire addresses
novel aspects of musical experience, such as the ability to hear whether one is singing
at the right pitch. It uses a 5-point Likert-type scale or satisfaction scale, which
includes a range of opinions allowing for a greater degree of specificity than a yes/no
question. Five of the 18 questions included are novel among music questionnaires
designed for adult CI users, (question 4 - "can you recognise words in songs?", 6, 9, 10
and 15 - "do you listen to music while travelling, e.g. in the car?"). This is important
for assessing musical experiences that have not been measured by previous
questionnaires. On the other hand, several questions are similar to those of other
questionnaires, e.g. question 18 is also reflected in the MuMu test ("Do you sing, play
a musical instrument or whistle?"). The questionnaire consists of two parts with the
same 18 questions each, divided into musical perception and musical engagement. Part I
of the questionnaire asks about musical experiences, e.g. "Can you differentiate between
different rhythms in music? Part II asks about the importance of music listening skills,
attitudes towards music and musical activities for the implant recipient, e.g. "How
important is it for you to be able to distinguish different rhythms in music?" Dritsakis
G, van Besouw RM, Kitterick P, Verschuur CA. A Music-Related Quality of Life Measure to
Guide Music Rehabilitation for Adult Cochlear Implant Users. American journal of
audiology 2017;26:268-282.

3. Questionnaire for subjects aged 6-17 years: After reviewing the existing literature, we
did not find any questionnaire suitable both in language and in the form of scores for
subjects aged 6-17 years. Therefore, we have made a selection of questions that have
already been used by other authors and that encompass aspects of musical interests,
musical profile, role of music and music-related activities [Pacheco et al., 2020;
Vannatta-Hall, 2010; Waaramaa et al., 2018] (See Annex).Pacheco L, Miguel JHS, Gil D.
Musical stimulation proposal for hearing impaired children: case reports. CoDAS
2020;32:e20190139; Vannatta-Hall JE: Music education in early childhood teacher
education: the impact of a music methods course on pre-service teachers' perceived
confidence and competence to teach music. University of Illinois at Urbana-Champaign,
2010; Waaramaa T, Kukkonen T, Mykkänen S, Geneid A. Vocal Emotion Identification by
Children Using Cochlear Implants, Relations to Voice Quality, and Musical Interests.
Journal of speech, language, and hearing research : JSLHR 2018;61:973-985.

4. Meludia: The music tool Meludia (www.meludia.com), available in Spanish, uses
interactive music listening exercises of progressive difficulty for both children and
adults. It is based on listening and responding. Meludia poses questions using sounds
and colourful graphic designs, which after listening carefully (patients controlled
directly and those implanted through the connection cable that allows direct listening
through the audio processor) are selected with the PC mouse by clicking on the button
that best corresponds to what has just been heard. Different categories are evaluated:
Rhythm (indicate how many percussion beats are heard, from 1 to 8), Melody (indicate
whether the melody heard is ascending or descending), Density (indicate how many sounds
are heard simultaneously, one or several), Stability (indicate whether the sound heard
is chaotic or not; that is, whether it gives a feeling of stability or instability) and
Spatialisation (indicate whether the second note has a higher or lower pitch than the
first one). The tool consists of 4 modules: Discovery, Intermediate, Advanced and
Expert. In this study we will initially work with the Discovery module, which consists
of 25 exercises (5 for each of the 5 categories indicated above) (see appendix). Scores
(between 1 and 3) will be collected for each of the exercises, as well as whether or not
each category is completed. A maximum of 4 attempts will be allowed in each of the
exercises. If after the 4 attempts the subject is not able to obtain at least a score of
1, the test shall stop in that category and move on to the next category. The test shall
start with the "rhythm" category, which is considered the easiest category.

5. Acoustic analysis of the voice: the Praat programme will be used (developed by Paul
Boersma and David Weenink of the University of Amsterdam), which is the most widely used
in publications related to the subject 6 and whose values have been compared with other
programmes validated in Spanish 7.

The sound signal will be collected with a Saramonic International microphone (3.5 mm)
and a spoken voice recording will be made according to the protocol of the European
Society of Laryngology 8:

- Vowel /a/ held for at least 3 seconds.

- Phonetically balanced text ("Platero y yo" by Juan Ramón Jiménez).

- Voice recording sung with the first phrase of the popular song "Cumpleaños feliz"
prolonging the last vowel /i/ for at least 3 seconds.

The parameters to be analysed in order to evaluate the quality of the voice are the
following:

Spoken voice: Vocal incapacity index, Maximum phonation time, Fundamental frequency of
the voice, Jitter, Shimmer, Harmonics to noise ratio (HNR), Smoothed cepstral peak
(CPPS) and Spectrogram according to Yanagihara's classification.

Sung voice: Pitch (with respect to the note emitted by a keyboard), CPPS and Singing
power ratio (SPR).

6. - Description of the audiological tests: the study group will undergo tonal and speech
audiometry in free field to obtain objective values of their CI performance. This will
be carried out in a double-walled acoustically insulated booth and the subjects will be
seated 1 m away from the speakers at 0º azimuth. If a patient has better hearing in the
non-implanted ear, this ear will be masked during the test thus eliminating the
perception of the "good ear" and assessing CI performance only, and if the patient is
wearing a hearing aid it will be removed for the test. For tonal audiometry the
frequencies of 250, 500, 1000, 2000, 4000 and 6000Hz will be evaluated and for
statistical purposes the PTA4 value (average thresholds at 500,1000, 2000 and 4000Hz)
will be used. Speech perception will be evaluated with the % of disyllables both in
quiet and in noise, without lip reading, at 65dB SPL, and with a signal to noise ratio
of 10dB SPL below the signal; the recorded tracks of Cardenas and Marrero will be used.

Procedure for completion of the questionnaires and performance of the musical and voice test
*Study group: After receiving information about the study, both oral and written, and signing
the informed consent form, patients will fill in the MuMu and MuRQoL questionnaires (adults)
and the questionnaire developed for subjects aged 6-17 years with the help of a member of the
research team (children will also be assisted by their parents or guardians).

The musical test with the Meludia tool, which we estimate to last approximately 1 hour, will
be carried out after completing the questionnaires, or else they will be scheduled for
another day within the following 30 days. The audio input of the CI processor will be
connected to the audio output of the laptop computer, in order to completely isolate the
signal from external noise. Once all the Meludia exercises have been completed, the voice
will be analysed with the Praat programme.

*Control group: normal hearing patients will receive oral and written information about the
study and after signing the informed consent they will fill in the MuRQoL questionnaire if
they are over 18 years old or the one developed for subjects between 6-17 years old. They
will then be assessed with the Meludia tool and subsequently with the Praat programme.

Both the questionnaires and the test with the Meludia tool will be administered to each
patient individually in a quiet environment. If the youngest children do not manage to
complete all the exercises in a single session, they will be scheduled for the following
days, always within the next 30 days, taking advantage of one of their routine check-ups.

Given the current pandemic situation due to SARS-COV2, in order to minimise the time it takes
for both the study group and the controls to visit the hospital, a self-completing version of
the questionnaires would be created so that they can be filled in online. Assessment with
Meludia can also be performed remotely via Webex, Zoom or Teams; in this case, implanted
patients would have the cable connecting the processor(s) to the audio output of the PC
delivered to their homes. In the same way as the voice analysis, which, after sending the
corresponding microphone to the subjects, could be carried out remotely.

Since the study tests (Meludia music tool, questionnaires and voice analysis) will only be
tested once on each subject, there is no need to follow up the groups. While all implantees
have an annual check-up throughout their lifetime, no changes in performance are expected
unless there is an accident or device failure. Therefore, the results of the study are not
expected to change over time. The control group, on the other hand, is made up of normal
hearing subjects, with the ability to perform the tests correctly, i.e. without a disability
that prevents them from doing so (e.g. mental impairment) and this ability should not vary
substantially over time. As there is no follow-up on the subjects (the "measures" are only
performed once in time) there will be no losses in the study.

Translation of the MuRQoL questionnaire Initially, the questionnaire will be translated from
English to Spanish by a suitably qualified person. This will be followed by translation from
Spanish to English (back-translation) by another qualified person from outside the clinical
study. This will ensure that the Spanish version faithfully reproduces the original English
version.

Statistical analysis Quantitative variables will be expressed as mean, standard deviation and
range, and qualitative variables as absolute frequencies and percentages. For the analysis of
the results of the MuMu music perception test before and after the CI, the Wilcoxon test for
paired data will be used. To assess the influence of socio-demographic and clinical variables
on the results of music perception after the hearing implant, comparisons of means between
groups will be made using non-parametric methods (Kruskall-Wallis for more than two groups
and Mann-Whitney for two groups) or parametric methods (ANOVA for more than two groups and
Student's t-test for two groups), depending on the sample sizes, the homogeneity of the data
and the adjustment to the normality of the distribution. Spearman's correlation coefficient
will be used to analyse the relationship between verbal discrimination after CI and the
measurement of music perception and enjoyment. All analyses will be performed at a two-tailed
p<0.05 level of statistical significance. The statistical package SPSS v.24 will be used for
the proposed analyses.

For the validation of the MuRQoL questionnaire, the method of Rust & Golombok, 2000 will be
used. Reliability and validity will be taken into account. Reliability is assessed through
consistency (assessed through Cronbach's alpha coefficient), temporal stability (test-retest
reliability, calculated with the intraclass correlation coefficient) and inter-observer
agreement (analysed through the percentage of agreement and the Kappa index), and validity
through content validity (qualitative assessments to be made by expert researchers),
construct validity (factor analysis and multitrait-multimethod matrix) and criterion validity
(relation of each subject's score to a Gold Standard, in this case to the scores obtained in
the original item [Dritsakis et al. , 2017]).

Dritsakis G, van Besouw RM, Kitterick P, Verschuur CA. A Music-Related Quality of Life
Measure to Guide Music Rehabilitation for Adult Cochlear Implant Users. American journal of
audiology 2017;26:268-282.

Regarding sample size determination, this is the first study with the Meludia music tool in a
child population, so it is not possible to know with certainty the sample size needed to find
significant differences between the study group and the control group. But based on a recent
study published by our group where there is an implanted population and their control peers
("matched" by gender, age, educational level...), the number of patients in the study group
and 24 controls was set at 24 (Mertens G., et al. 2020. Cognitive Improvement After Cochlear
Implantation in Older Adults With Severe or Profound Hearing Impairment: A Prospective,
Longitudinal, Controlled, Multicenter Study. Ear and hearing), with 75% power to detect a
difference of 14 standard deviations (= Cohen's d; Claes, A. J., et al. 2018. Cognitive
performance of severely hearing-impaired older adults before and after cochlear implantation:
Preliminary results of a prospective, longitudinal cohort study using the RBANS-H. Otol
Neurotol, 39, e765-e773).

Limitations of the study The retrospective design for the selection of patients is not an
obstacle since the data collection, the completion of the questionnaires and the musical test
with Meludia are evaluated prospectively, allowing us to control possible biases related to
this type of design, such as the loss of information.

One of the possible limitations we might encounter is the refusal of some patients to stay
longer than necessary in a hospital room. This could be solved by offering them the
possibility of doing the exercises online, with an internet connection at home, and we could
guide them through the exercises.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">February 10, 2022</start_date>
<completion_date type="Anticipated">December 31, 2024</completion_date>
<primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
<study_type>Observational [Patient Registry]</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Control</observational_model>
<time_perspective>Cross-Sectional</time_perspective>
</study_design_info>
<target_duration>12 Months</target_duration>
<primary_outcome>
<measure>Scoring on a specific musical questionnaire for adults: MuMu</measure>
<time_frame>3 years</time_frame>
<description>Change in the musical experience and degree of enjoyment of music before and after CI in adult (≥18 years) post-lingual patients with the Munich Music Questionnaire (MuMu).</description>
</primary_outcome>
<primary_outcome>
<measure>Scoring on a specific musical questionnaire for adults: MuRQoL</measure>
<time_frame>3 years</time_frame>
<description>Change in music perception with the Music Related Quality of Life (MuRQoL) questionnaire in postlingually hearing adults (≥18 years) with CI and compare it with the results in subjects with normal hearing.</description>
</primary_outcome>
<primary_outcome>
<measure>Translation and validation the MuRQoL questionnaire in Spanish.</measure>
<time_frame>3 years</time_frame>
<description>Translation of the MuRQoL questionnaire:
Initially, the questionnaire will be translated from English to Spanish by a suitably qualified person. This will be followed by translation from Spanish to English (back-translation) by another qualified person from outside the clinical study. This will ensure that the Spanish version faithfully reproduces the original English version.</description>
</primary_outcome>
<primary_outcome>
<measure>Score on a questionnaire created specifically for individuals aged between 6-17 years that encompasses aspects of musical interests, musical profile, role of music and music-related activities.</measure>
<time_frame>3 years</time_frame>
<description>The newly created questionnaire will be in an easily understandable language. The responses of implanted patients will be compared with those of their normal hearing peers.</description>
</primary_outcome>
<primary_outcome>
<measure>Score obtained in the "discovery" level with the Meludia music tool</measure>
<time_frame>3 years</time_frame>
<description>To analyse the musical abilities of implanted patients over 6 years of age using the musical tool "Meludia" with its 5 musical categories: rhythm, melody, density, stability and spatialisation, and to compare their results with those obtained in subjects with normal hearing.</description>
</primary_outcome>
<primary_outcome>
<measure>Change in voice quality of CI users compared with their normal hearing control peers.</measure>
<time_frame>3 years</time_frame>
<description>Voice analysis: In implanted patients over 6 years, study various parameters to evaluate voice quality, e.g. vocal incapacity index, maximum phonation time, fundamental voice frequency, pitch... and compare them with the results in their normal hearing control peers.
Parameters to assess voice quality:
Spoken voice: Vocal inability index, Maximum phonation time, Fundamental voice frequency, Jitter, Shimmer, Harmonics to noise ratio (HNR), Smoothed cepstral peak (CPPS) and Spectrogram according to Yanagihara's classification.
Sung voice: Pitch (relative to the note emitted by a keyboard), CPPS and Singing power ratio (SPR).</description>
</primary_outcome>
<secondary_outcome>
<measure>The impact of hearing with CI on the perception and enjoyment of music.</measure>
<time_frame>3 years</time_frame>
<description>To study the impact of factors unrelated to CI performance (educational level, previous musical experience, listening habits, musical training and culture, or mood), on the results of the music questionnaires, the score on the Meludia music tool and the fundamental vocal parameters.</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Anticipated">80</enrollment>
<condition>Cochlear Implant</condition>
<condition>Music</condition>
<condition>Voice</condition>
<arm_group>
<arm_group_label>Cochlear implant users</arm_group_label>
<description>Pre-or perilingual patients aged 6 to 17 years old, and postlingual adults who underwent cochlear implantation from 2000 to January 2023 at La Paz University Hospital</description>
</arm_group>
<arm_group>
<arm_group_label>Normal hearing subjects</arm_group_label>
<description>Control group is set up with the normal hearing peers of cochlear implant users</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>evaluation with Meludia music software</intervention_name>
<description>Measurement instruments:
- MuMu Questionnaire
MuRQoL Questionnaire
Questionnaire for subjects aged 6-17 years
Music tool Meludia (www.meludia.com)
Acoustic analysis of the voice: the Praat programme
Audiological tests</description>
<arm_group_label>Cochlear implant users</arm_group_label>
<arm_group_label>Normal hearing subjects</arm_group_label>
<other_name>voice analysis with Praat software</other_name>
</intervention>
<eligibility>
<study_pop>
<textblock>
Adult patients (≥18 years) with postlingual hearing loss and children (between 6 and 17
years) with prelingual or perilingual hearing loss who have received a CI before the age of
3 years.

Patients who have received a CI from 2000 to January 2023 will be included as potential
candidates for participation
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Minimum age of 6 years.

- Patients aged 6-17 years must have been implanted before the age of 3 years (to ensure
adequate CI performance).

- Minimum 12 months experience with the device

- Indications: unilateral (one CI), bilateral (two CIs), bimodal (one CI in one ear and
a hearing aid in the other)

- At least 80% of electrodes active at the time of assessment.

- Fluency in Spanish

- Signed and dated informed consent prior to starting any study procedure.

Exclusion Criteria:

- Not meet inclusion criteria.

- Prelingual or perilingual adults.

- Disability in addition to hearing impairment (e.g., mental disability).
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>6 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Luis Lassaletta</last_name>
<role>Principal Investigator</role>
<affiliation>Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz</affiliation>
</overall_official>
<overall_contact>
<last_name>Luis Lassaletta</last_name>
<phone>+34917277262</phone>
<email>llasaletta@salud.madrid.org</email>
</overall_contact>
<overall_contact_backup>
<last_name>Miryam Calvino</last_name>
<email>miryamcf@yahoo.com</email>
</overall_contact_backup>
<location>
<facility>
<name>Hospital Universitario de La Paz</name>
<address>
<city>Madrid</city>
<zip>28046</zip>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Miryam Calvino</last_name>
<email>miryamcf@yahoo.com</email>
</contact>
</location>
<location_countries>
<country>Spain</country>
</location_countries>
<verification_date>September 2023</verification_date>
<study_first_submitted>March 23, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>September 1, 2023</last_update_submitted>
<last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">September 5, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz</investigator_affiliation>
<investigator_full_name>Luis Lassaletta</investigator_full_name>
<investigator_title>Principal Investigador. PhD</investigator_title>
</responsible_party>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Aims: To evaluate the perception and enjoyment of music in cochlear implant (CI) users using
specific questionnaires, and comparing their results with a control group of subjects with
normal hearing (NH). To analyze the musical abilities of implantees using the musical tool
Meludia, and compare the results with the control group. To perfom a voice analysis in
implanted patients, compare it with their NH peers, and check if an association with musical
perception is observed.
Design: Cross-sectional study, both the CI recipients and NH control subjects were assessed
once.
Setting and subjects: Pre-or perilingual patients aged 6 to 17 years old, and postlingual
adults who underwent cochlear implantation from 2000 to January 2023 at La Paz University
Hospital. Control group is set up with their NH peers.
Study Variables: Socio-demographic and clinical (current age, age at implantation, sex,
educational level) variables will be collected, as well as hearing loss (aetiology, duration
of deafness), and surgical (type of implant, complete or partial insertion of the electrodes,
date of surgery) data. Data from CI fitting (number of active electrodes, type of audio
processor) and hearing outcomes with the CI will also be reviewed.
Outcome variables: Specific musical skills questionnaires for adults: Munich Music
Questionnaire (MuMu) and Music Related Quality of Life Questionnaire (MuRQoL), which will be
validated. Musical questionnaire developed specifically for subjects between 6-17 years old.
Musical tool (Meludia) to assess musical perception. Praat software for voice analysis.
Analysis of the impact of the different audiological, sociodemographic and clinical variables
on hearing outcomes, and on musical perception after cochlear implantation, and comparison
with the NH control group.
METHODOLOGY
Design Cross-sectional study in which both implanted patients and control subjects without
hearing loss were tested only once.
Scope and study subjects Prior to the inclusion of subjects in the study, the approval of the
Ethics Committee of the Hospital Universitario La Paz (HULP) will be required.
STUDY GROUP (Implanted group) Adult patients (≥18 years) with postlingual hearing loss and
children (between 6 and 17 years) with prelingual or perilingual hearing loss who have
received a CI before the age of 3 years.
Patients who have received a CI from 2000 to January 2023 will be included as potential
candidates for participation. Currently 76 subjects aged 6-17 years implanted before the age
of 3 years and 231 post-lingual adults are identified in the database, to which post-lingual
adults implanted in the next 2 years should be added, so that after one year of follow up
they can participate in the study.
Inclusion criteria:
- Minimum age of 6 years.
- Patients aged 6-17 years must have been implanted before the age of 3 years (to ensure
adequate CI performance).
- Minimum 12 months experience with the device
- Indications: unilateral (one CI), bilateral (two CIs), bimodal (one CI in one ear and a
hearing aid in the other)
- At least 80% of electrodes active at the time of assessment.
- Fluency in Spanish
- Signed and dated informed consent prior to starting any study procedure.
Exclusion criteria:
- Not meet inclusion criteria.
- Prelingual or perilingual adults.
- Disability in addition to hearing impairment (e.g., mental disability). Routine visits
in the HULP or at their CI fitting sessions will be used as an opportunity to contact
patients and propose their participation.
CONTROL GROUP The control group will be composed of subjects over 6 years of age without
hearing impairment, without a disability that prevents them from taking the tests and who
have socio-demographic characteristics similar to those of the study group. They will be
included from the ENT Department where they will have come either with another type of
medical condition other than hearing loss, or accompanying patients. Hospital La Paz staff
(or family members) who wish to carry out the tests may also be included. They must be fluent
in Spanish to ensure that they understand the study and its purpose. To confirm that the
control group does not have hearing impairment, they will undergo tonal audiometry in both
ears, whose tonal threshold should be ≤30dB in the conversational frequencies of 500, 1000
and 2000Hz.
Socio-demographic and clinical variables Study group: affiliation data (current age, age at
implantation, sex, education level), hearing loss data (aetiology, duration of hearing loss,
type and degree of hearing loss, worst ear), surgery data (type of implant and electrode
array used, complete or incomplete insertion, side implanted, date of intervention),
postoperative complications. These data will be collected from the patients' medical records.
In addition, fititing data (number of active electrodes, processor model) and audiological
tests with the CI will be collected.
Control group: age, sex, associated pathology(ies), level of education.
Outcome variables
1. Scoring of the music-related quality of life questionnaire (MuRQoL), the Munich music
questionnaire (MuMu) and the questionnaire developed for subjects aged 6-17 years (see
description).
2. Validation of the music-related quality of life questionnaire (MuRQoL) in adult
population.
3. Score obtained in the "discovery" level with the Meludia music tool (see description).
4. Parameters to assess voice quality:
Spoken voice: Vocal inability index, Maximum phonation time, Fundamental voice
frequency, Jitter, Shimmer, Harmonics to noise ratio (HNR), Smoothed cepstral peak
(CPPS) and Spectrogram according to Yanagihara's classification.
Sung voice: Pitch (relative to the note emitted by a keyboard), CPPS and Singing power
ratio (SPR).
5. Impact of demographic and audiological factors on the results of the music perception
questionnaires as well as on the results of the Meludia tool and the acoustic analysis
of the implanted patients and comparison with the normal hearing control group.
Description of the measurement instruments
1. - MuMu Questionnaire: The Munich Music Questionnaire was especially developed for the
adult CI users population with postlingual hearing loss. It includes questions that
address past and present activities related to the habit of listening to music. We will
use the abbreviated version which contains 9 questions on music listening habits in
relation to various musical styles, different instruments and participation in musical
activities at different times in the life of implanted patients. It offers many response
options, from the "yes or no" format to rating scales and multiple choice questions with
the possibility to tick as many options as necessary (e.g. "How often do you listen
and/or have you listened to music", on a scale of 0-10; "Why do you listen to music",
with the options of "for pleasure", "professional reasons", "emotional satisfaction",
"to relax"). It is translated and validated in Spanish (developed by S.J. Brockmeier and
adapted by Ana Fuster. Info:
https://www.medel.com/support/rehab/rehabilitation-downloads).
2. MuRQoL Questionnaire: The concept of music related quality of life (MuRQoL) was
initially defined as the impact of listening skills on the quality of life of implanted
patients. To work on this concept, groups of adult CI users created the questions, thus
ensuring content validity, differing from previous studies in that users were not
involved in the initial question generation process. The MuRQoL questionnaire addresses
novel aspects of musical experience, such as the ability to hear whether one is singing
at the right pitch. It uses a 5-point Likert-type scale or satisfaction scale, which
includes a range of opinions allowing for a greater degree of specificity than a yes/no
question. Five of the 18 questions included are novel among music questionnaires
designed for adult CI users, (question 4 - "can you recognise words in songs?", 6, 9, 10
and 15 - "do you listen to music while travelling, e.g. in the car?"). This is important
for assessing musical experiences that have not been measured by previous
questionnaires. On the other hand, several questions are similar to those of other
questionnaires, e.g. question 18 is also reflected in the MuMu test ("Do you sing, play
a musical instrument or whistle?"). The questionnaire consists of two parts with the
same 18 questions each, divided into musical perception and musical engagement. Part I
of the questionnaire asks about musical experiences, e.g. "Can you differentiate between
different rhythms in music? Part II asks about the importance of music listening skills,
attitudes towards music and musical activities for the implant recipient, e.g. "How
important is it for you to be able to distinguish different rhythms in music?" Dritsakis
G, van Besouw RM, Kitterick P, Verschuur CA. A Music-Related Quality of Life Measure to
Guide Music Rehabilitation for Adult Cochlear Implant Users. American journal of
audiology 2017;26:268-282.
3. Questionnaire for subjects aged 6-17 years: After reviewing the existing literature, we
did not find any questionnaire suitable both in language and in the form of scores for
subjects aged 6-17 years. Therefore, we have made a selection of questions that have
already been used by other authors and that encompass aspects of musical interests,
musical profile, role of music and music-related activities [Pacheco et al., 2020;
Vannatta-Hall, 2010; Waaramaa et al., 2018] (See Annex).Pacheco L, Miguel JHS, Gil D.
Musical stimulation proposal for hearing impaired children: case reports. CoDAS
2020;32:e20190139; Vannatta-Hall JE: Music education in early childhood teacher
education: the impact of a music methods course on pre-service teachers' perceived
confidence and competence to teach music. University of Illinois at Urbana-Champaign,
2010; Waaramaa T, Kukkonen T, Mykkänen S, Geneid A. Vocal Emotion Identification by
Children Using Cochlear Implants, Relations to Voice Quality, and Musical Interests.
Journal of speech, language, and hearing research : JSLHR 2018;61:973-985.
4. Meludia: The music tool Meludia (www.meludia.com), available in Spanish, uses
interactive music listening exercises of progressive difficulty for both children and
adults. It is based on listening and responding. Meludia poses questions using sounds
and colourful graphic designs, which after listening carefully (patients controlled
directly and those implanted through the connection cable that allows direct listening
through the audio processor) are selected with the PC mouse by clicking on the button
that best corresponds to what has just been heard. Different categories are evaluated:
Rhythm (indicate how many percussion beats are heard, from 1 to 8), Melody (indicate
whether the melody heard is ascending or descending), Density (indicate how many sounds
are heard simultaneously, one or several), Stability (indicate whether the sound heard
is chaotic or not; that is, whether it gives a feeling of stability or instability) and
Spatialisation (indicate whether the second note has a higher or lower pitch than the
first one). The tool consists of 4 modules: Discovery, Intermediate, Advanced and
Expert. In this study we will initially work with the Discovery module, which consists
of 25 exercises (5 for each of the 5 categories indicated above) (see appendix). Scores
(between 1 and 3) will be collected for each of the exercises, as well as whether or not
each category is completed. A maximum of 4 attempts will be allowed in each of the
exercises. If after the 4 attempts the subject is not able to obtain at least a score of
1, the test shall stop in that category and move on to the next category. The test shall
start with the "rhythm" category, which is considered the easiest category.
5. Acoustic analysis of the voice: the Praat programme will be used (developed by Paul
Boersma and David Weenink of the University of Amsterdam), which is the most widely used
in publications related to the subject 6 and whose values have been compared with other
programmes validated in Spanish 7.
The sound signal will be collected with a Saramonic International microphone (3.5 mm)
and a spoken voice recording will be made according to the protocol of the European
Society of Laryngology 8:
- Vowel /a/ held for at least 3 seconds.
- Phonetically balanced text ("Platero y yo" by Juan Ramón Jiménez).
- Voice recording sung with the first phrase of the popular song "Cumpleaños feliz"
prolonging the last vowel /i/ for at least 3 seconds.
The parameters to be analysed in order to evaluate the quality of the voice are the
following:
Spoken voice: Vocal incapacity index, Maximum phonation time, Fundamental frequency of
the voice, Jitter, Shimmer, Harmonics to noise ratio (HNR), Smoothed cepstral peak
(CPPS) and Spectrogram according to Yanagihara's classification.
Sung voice: Pitch (with respect to the note emitted by a keyboard), CPPS and Singing
power ratio (SPR).
6. - Description of the audiological tests: the study group will undergo tonal and speech
audiometry in free field to obtain objective values of their CI performance. This will
be carried out in a double-walled acoustically insulated booth and the subjects will be
seated 1 m away from the speakers at 0º azimuth. If a patient has better hearing in the
non-implanted ear, this ear will be masked during the test thus eliminating the
perception of the "good ear" and assessing CI performance only, and if the patient is
wearing a hearing aid it will be removed for the test. For tonal audiometry the
frequencies of 250, 500, 1000, 2000, 4000 and 6000Hz will be evaluated and for
statistical purposes the PTA4 value (average thresholds at 500,1000, 2000 and 4000Hz)
will be used. Speech perception will be evaluated with the % of disyllables both in
quiet and in noise, without lip reading, at 65dB SPL, and with a signal to noise ratio
of 10dB SPL below the signal; the recorded tracks of Cardenas and Marrero will be used.
Procedure for completion of the questionnaires and performance of the musical and voice test
*Study group: After receiving information about the study, both oral and written, and signing
the informed consent form, patients will fill in the MuMu and MuRQoL questionnaires (adults)
and the questionnaire developed for subjects aged 6-17 years with the help of a member of the
research team (children will also be assisted by their parents or guardians).
The musical test with the Meludia tool, which we estimate to last approximately 1 hour, will
be carried out after completing the questionnaires, or else they will be scheduled for
another day within the following 30 days. The audio input of the CI processor will be
connected to the audio output of the laptop computer, in order to completely isolate the
signal from external noise. Once all the Meludia exercises have been completed, the voice
will be analysed with the Praat programme.
*Control group: normal hearing patients will receive oral and written information about the
study and after signing the informed consent they will fill in the MuRQoL questionnaire if
they are over 18 years old or the one developed for subjects between 6-17 years old. They
will then be assessed with the Meludia tool and subsequently with the Praat programme.
Both the questionnaires and the test with the Meludia tool will be administered to each
patient individually in a quiet environment. If the youngest children do not manage to
complete all the exercises in a single session, they will be scheduled for the following
days, always within the next 30 days, taking advantage of one of their routine check-ups.
Given the current pandemic situation due to SARS-COV2, in order to minimise the time it takes
for both the study group and the controls to visit the hospital, a self-completing version of
the questionnaires would be created so that they can be filled in online. Assessment with
Meludia can also be performed remotely via Webex, Zoom or Teams; in this case, implanted
patients would have the cable connecting the processor(s) to the audio output of the PC
delivered to their homes. In the same way as the voice analysis, which, after sending the
corresponding microphone to the subjects, could be carried out remotely.
Since the study tests (Meludia music tool, questionnaires and voice analysis) will only be
tested once on each subject, there is no need to follow up the groups. While all implantees
have an annual check-up throughout their lifetime, no changes in performance are expected
unless there is an accident or device failure. Therefore, the results of the study are not
expected to change over time. The control group, on the other hand, is made up of normal
hearing subjects, with the ability to perform the tests correctly, i.e. without a disability
that prevents them from doing so (e.g. mental impairment) and this ability should not vary
substantially over time. As there is no follow-up on the subjects (the "measures" are only
performed once in time) there will be no losses in the study.
Translation of the MuRQoL questionnaire Initially, the questionnaire will be translated from
English to Spanish by a suitably qualified person. This will be followed by translation from
Spanish to English (back-translation) by another qualified person from outside the clinical
study. This will ensure that the Spanish version faithfully reproduces the original English
version.
Statistical analysis Quantitative variables will be expressed as mean, standard deviation and
range, and qualitative variables as absolute frequencies and percentages. For the analysis of
the results of the MuMu music perception test before and after the CI, the Wilcoxon test for
paired data will be used. To assess the influence of socio-demographic and clinical variables
on the results of music perception after the hearing implant, comparisons of means between
groups will be made using non-parametric methods (Kruskall-Wallis for more than two groups
and Mann-Whitney for two groups) or parametric methods (ANOVA for more than two groups and
Student's t-test for two groups), depending on the sample sizes, the homogeneity of the data
and the adjustment to the normality of the distribution. Spearman's correlation coefficient
will be used to analyse the relationship between verbal discrimination after CI and the
measurement of music perception and enjoyment. All analyses will be performed at a two-tailed
p<0.05 level of statistical significance. The statistical package SPSS v.24 will be used for
the proposed analyses.
For the validation of the MuRQoL questionnaire, the method of Rust & Golombok, 2000 will be
used. Reliability and validity will be taken into account. Reliability is assessed through
consistency (assessed through Cronbach's alpha coefficient), temporal stability (test-retest
reliability, calculated with the intraclass correlation coefficient) and inter-observer
agreement (analysed through the percentage of agreement and the Kappa index), and validity
through content validity (qualitative assessments to be made by expert researchers),
construct validity (factor analysis and multitrait-multimethod matrix) and criterion validity
(relation of each subject's score to a Gold Standard, in this case to the scores obtained in
the original item [Dritsakis et al. , 2017]).
Dritsakis G, van Besouw RM, Kitterick P, Verschuur CA. A Music-Related Quality of Life
Measure to Guide Music Rehabilitation for Adult Cochlear Implant Users. American journal of
audiology 2017;26:268-282.
Regarding sample size determination, this is the first study with the Meludia music tool in a
child population, so it is not possible to know with certainty the sample size needed to find
significant differences between the study group and the control group. But based on a recent
study published by our group where there is an implanted population and their control peers
("matched" by gender, age, educational level...), the number of patients in the study group
and 24 controls was set at 24 (Mertens G., et al. 2020. Cognitive Improvement After Cochlear
Implantation in Older Adults With Severe or Profound Hearing Impairment: A Prospective,
Longitudinal, Controlled, Multicenter Study. Ear and hearing), with 75% power to detect a
difference of 14 standard deviations (= Cohen's d; Claes, A. J., et al. 2018. Cognitive
performance of severely hearing-impaired older adults before and after cochlear implantation:
Preliminary results of a prospective, longitudinal cohort study using the RBANS-H. Otol
Neurotol, 39, e765-e773).
Limitations of the study The retrospective design for the selection of patients is not an
obstacle since the data collection, the completion of the questionnaires and the musical test
with Meludia are evaluated prospectively, allowing us to control possible biases related to
this type of design, such as the loss of information.
One of the possible limitations we might encounter is the refusal of some patients to stay
longer than necessary in a hospital room. This could be solved by offering them the
possibility of doing the exercises online, with an internet connection at home, and we could
guide them through the exercises.
Adult patients (≥18 years) with postlingual hearing loss and children (between 6 and 17
years) with prelingual or perilingual hearing loss who have received a CI before the age of
3 years.
Patients who have received a CI from 2000 to January 2023 will be included as potential
candidates for participation
Inclusion Criteria:
- Minimum age of 6 years.
- Patients aged 6-17 years must have been implanted before the age of 3 years (to ensure
adequate CI performance).
- Minimum 12 months experience with the device
- Indications: unilateral (one CI), bilateral (two CIs), bimodal (one CI in one ear and
a hearing aid in the other)
- At least 80% of electrodes active at the time of assessment.
- Fluency in Spanish
- Signed and dated informed consent prior to starting any study procedure.
Exclusion Criteria:
- Not meet inclusion criteria.
- Prelingual or perilingual adults.
- Disability in addition to hearing impairment (e.g., mental disability).
|
NCT0531xxxx/NCT05319691.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319691</url>
</required_header>
<id_info>
<org_study_id>22-132</org_study_id>
<nct_id>NCT05319691</nct_id>
</id_info>
<brief_title>Yoga for Chronic Low Back Pain in the Cleveland Clinic Employee Health Plan</brief_title>
<official_title>Yoga for Chronic Low Back Pain: A Type 1 Hybrid Implementation-Effectiveness Pragmatic Randomized Control Trial in the Cleveland Clinic Employee Health Plan</official_title>
<sponsors>
<lead_sponsor>
<agency>Robert Saper</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>The Cleveland Clinic</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>The Cleveland Clinic</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This study uses clinical trial and implementation science methodology to specifically assess
the effectiveness of yoga into the management of chronic low back pain (cLBP) within the
Cleveland Clinic Employee Health Plan. The study will use a type 1 hybrid
effectiveness-implementation design, which tests a clinical intervention while collecting
data on implementation. Studying and implementing evidence-based, non-pharmacologic
interventions is an important strategy for improving pain management and reducing opioid use
disorder.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The investigators will use a single (investigators) blinded two-arm randomized control trial
(RCT) design. The trial will be 24 weeks long and divided into two distinct parts: an initial
12-week Treatment Phase followed by a 12-week Follow-up Phase. Participants will be
randomized 1:1 into weekly virtual yoga classes (Yoga Now group) or a wait-list control (Yoga
Later group) who will receive usual care. After the 24 week study period, participants in the
Yoga Later Group will be offered the yoga intervention in a non-study format as well as a
free yoga mat and access to online yoga for LBP videos.

The screening and enrollment process will all occur remotely and involves the following: 1) A
telephone or Information Technology approved, The Health Insurance Portability and
Accountability Act (HIPAA-secure), virtual meeting platform where participants provide
consent for completion of eligibility screening through a standardized questionnaire; 2) if
eligible, provision of information about the study presented by study personnel with use of
an Institutional Review Board approved information page for informed consent, answering all
questions about the study, and assuring participant understanding through the "teach back"
method.

Randomization occurs after administering the baseline survey. Investigators will use a
computerized randomization procedure built into the study management system, RedCap, to
randomize each enrolled participant using a 1:1 ratio to the Yoga Now group or Yoga Later
group. Permuted variably-sized block randomization with block sizes of 6, 12 and 18 will be
used.

The study interventions start within approximately one week of baseline data collection and
randomization. Participants will be asked to complete questionnaire forms at baseline, weeks
6, 12 and 24. All participants throughout the entire 24-week study can continue to receive
routine medical care including doctor visits and pain medication.

The hatha yoga intervention, a term for yoga that pairs poses and breathing techniques, is
structured and reproducible. The full instructor manual and participant manual are available
online. Originally, it was developed by an expert panel led by Rob Saper, MD and Master of
Public Health (MPH) in 2007 and used in a pilot study of 30 participants with cLBP. It was
further refined in 2011 in a dosing study of 95 participants and a larger non-inferiority
trial of 320. It is designed specifically for the yoga-naïve individual for effectiveness and
safety in cLBP. Each class is 75 minutes long and will be delivered virtually to a maximum
class size of 12. Yoga instructors will complete an 8-hour training on the protocol directed
by the Cleveland Clinic lead yoga instructor.

Class begins with a relaxation exercise, yoga breathing exercises, and a brief discussion of
yoga philosophy. The class proceeds with warm-up yoga exercises and then yoga postures. Yoga
breathing is emphasized throughout. The class ends with a relaxation exercise. The 12 weeks
are divided into four 3-week segments. Each segment is given a theme (e.g., "Listening to the
Wisdom of the Body"). Participants are frequently advised to go slowly and carefully. The
degree of difficulty of postures learned increases with each segment. For each segment, the
participants gradually learn a sequence of 12-15 poses. The protocol provides variations and
uses various aids (e.g., chair, strap) to accommodate a range of physical abilities.
Participants are strongly encouraged to practice at home for 30 minutes daily on days which
they do not attend yoga class. To facilitate home practice, participants will be given a free
yoga mat, participant manual, and provided access to online videos prepared by the study
instructors.

Ten percent of online yoga classes will be virtually observed and assessed by a study team
member for instructor fidelity to the protocol using a checklist. A 12-week follow-up phase
consisting of larger optional classes for maintenance will follow.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">May 3, 2022</start_date>
<completion_date type="Actual">August 15, 2023</completion_date>
<primary_completion_date type="Actual">May 30, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Investigators will use a single-blinded (investigator) two-arm randomized control trial (RCT) design. The trial will be 24 weeks long and divided into two distinct parts: an initial 12-week Treatment Phase followed by a 12-week Follow-up Phase. Participants will be randomized 1:1 into weekly virtual yoga classes (Yoga Now) or a wait-list control (Yoga Later) who will receive usual care. After the 24 week study period, participants in Yoga Later will be offered the yoga intervention in a non-study format.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Single (Investigator)</masking>
<masking_description>Investigators will use a single-blinded (investigator) two-arm randomized control trial (RCT) design.</masking_description>
</study_design_info>
<primary_outcome>
<measure>Self-reported average pain intensity for the previous week</measure>
<time_frame>Baseline</time_frame>
<description>11 point numerical rating scale ranging from 0=no pain to 10=worst possible pain</description>
</primary_outcome>
<primary_outcome>
<measure>Change of self-reported average pain intensity for the previous week</measure>
<time_frame>Week 12</time_frame>
<description>11 point numerical rating scale ranging from 0=no pain to 10=worst possible pain</description>
</primary_outcome>
<primary_outcome>
<measure>Self-reported back-related function</measure>
<time_frame>Baseline</time_frame>
<description>Modified Roland Morris Disability Questionnaire ranging from 0=no functional impairment to 23=worst impairment of function</description>
</primary_outcome>
<primary_outcome>
<measure>Change of self-reported back-related function</measure>
<time_frame>Week 12</time_frame>
<description>Modified Roland Morris Disability Questionnaire ranging from 0=no functional impairment to 23=worst impairment of function</description>
</primary_outcome>
<secondary_outcome>
<measure>Change of self-reported average pain intensity for the previous week</measure>
<time_frame>Week 24</time_frame>
<description>11 point numerical rating scale ranging from 0=no pain to 10=worst possible pain</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change of self-reported back-related function</measure>
<time_frame>Week 24</time_frame>
<description>Modified Roland Morris Disability Questionnaire ranging from 0=no functional impairment to 23=worst impairment of function</description>
</secondary_outcome>
<secondary_outcome>
<measure>Analgesic use</measure>
<time_frame>Baseline</time_frame>
<description>Self-reported pain medications usage; dosage reported in milligrams</description>
</secondary_outcome>
<secondary_outcome>
<measure>Analgesic use</measure>
<time_frame>Week 12</time_frame>
<description>Change of self-reported pain medications usage; dosage reported in milligrams</description>
</secondary_outcome>
<secondary_outcome>
<measure>Analgesic use</measure>
<time_frame>Week 24</time_frame>
<description>Change of self-reported pain medications usage; dosage reported in milligrams</description>
</secondary_outcome>
<secondary_outcome>
<measure>Global improvement</measure>
<time_frame>Weeks 12 and 24</time_frame>
<description>Overall improvement by self-report (6-point Likert scale, 1 = very worse to 6 = very improved).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Pain Interference - Short Form 4a</measure>
<time_frame>Weeks 12 and 24</time_frame>
<description>PROMIS Pain domain asks 4 questions. Each question is rated from 1 to 5. Values are summed to create a total raw score. Raw scores are minimum 4 to maximum 20 and translate to a T score with a minimum 41.6 to maximum 75.6. A higher score equates to a higher pain interference.</description>
</secondary_outcome>
<other_outcome>
<measure>Total Medical Expenditures for low back pain</measure>
<time_frame>Baseline to Week 24</time_frame>
<description>Total and back-related medical expenditures for all participants for the six month study period will be compared between the yoga (Arm 1) and wait-list (Arm 2) control groups.
Cost of implementing the intervention will be measured to demonstrate the feasibility of evaluating cost-effectiveness of yoga compared to usual care for cLBP from the perspective of the payer.</description>
</other_outcome>
<other_outcome>
<measure>Participant Satisfaction</measure>
<time_frame>Baseline to week 24</time_frame>
<description>Acceptability will be measured by participant satisfaction with treatment (5-point Likert scale, 1 = very dissatisfied to 5 = very satisfied) and answers to open-ended questions about the effect of yoga, facilitators and barriers.</description>
</other_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">140</enrollment>
<condition>Chronic Pain</condition>
<condition>Back Pain</condition>
<arm_group>
<arm_group_label>Yoga Now (Treatment Group)</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>An initial 12-week Treatment Phase of weekly virtual yoga classes (Yoga Now) followed by a 12-week Follow-up Phase.</description>
</arm_group>
<arm_group>
<arm_group_label>Yoga Later (Wait List Control Group)</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>A wait-list control group (Yoga Later) will receive usual care. After the 24 week study period, participants in Yoga Later will be offered the yoga intervention in a non-study format.</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Yoga</intervention_name>
<description>The trial will be 24 weeks long and divided into two distinct parts: an initial 12-week Treatment Phase during which, yoga participants will receive a reproducible standardized weekly yoga intervention delivered virtually with additional resources for home practice, followed by a 12-week Follow-up Phase.</description>
<arm_group_label>Yoga Now (Treatment Group)</arm_group_label>
<other_name>Treatment Group</other_name>
<other_name>Yoga Now</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- 18-64 years old

- Current non-specific LBP persisting ≥12 weeks with average pain intensity ≥4 for the
previous week on an 11-point numerical rating scale

- Ability to speak and understand English

Exclusion Criteria:

- Any severe psychiatric or medical comorbidity in the Principal Investigator's judgment
that would make study participation unsafe or not feasible.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>64 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Robert B Saper, MD</last_name>
<role>Principal Investigator</role>
<affiliation>The Cleveland Clinic</affiliation>
</overall_official>
<location>
<facility>
<name>Cleveland Clinic</name>
<address>
<city>Cleveland</city>
<state>Ohio</state>
<zip>44195</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.</citation>
<PMID>22310560</PMID>
</reference>
<reference>
<citation>Saper RB, Sherman KJ, Delitto A, Herman PM, Stevans J, Paris R, Keosaian JE, Cerrada CJ, Lemaster CM, Faulkner C, Breuer M, Weinberg J. Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial. Trials. 2014 Feb 26;15:67. doi: 10.1186/1745-6215-15-67.</citation>
<PMID>24568299</PMID>
</reference>
<reference>
<citation>Saper RB, Sherman KJ, Cullum-Dugan D, Davis RB, Phillips RS, Culpepper L. Yoga for chronic low back pain in a predominantly minority population: a pilot randomized controlled trial. Altern Ther Health Med. 2009 Nov-Dec;15(6):18-27.</citation>
<PMID>19943573</PMID>
</reference>
<reference>
<citation>Saper RB, Boah AR, Keosaian J, Cerrada C, Weinberg J, Sherman KJ. Comparing Once- versus Twice-Weekly Yoga Classes for Chronic Low Back Pain in Predominantly Low Income Minorities: A Randomized Dosing Trial. Evid Based Complement Alternat Med. 2013;2013:658030. doi: 10.1155/2013/658030. Epub 2013 Jun 26.</citation>
<PMID>23878604</PMID>
</reference>
<reference>
<citation>Saper RB, Lemaster C, Delitto A, Sherman KJ, Herman PM, Sadikova E, Stevans J, Keosaian JE, Cerrada CJ, Femia AL, Roseen EJ, Gardiner P, Gergen Barnett K, Faulkner C, Weinberg J. Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial. Ann Intern Med. 2017 Jul 18;167(2):85-94. doi: 10.7326/M16-2579. Epub 2017 Jun 20.</citation>
<PMID>28631003</PMID>
</reference>
<verification_date>September 2023</verification_date>
<study_first_submitted>February 4, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>September 7, 2023</last_update_submitted>
<last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">September 11, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
<investigator_full_name>Robert Saper</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Back Pain</mesh_term>
<mesh_term>Low Back Pain</mesh_term>
<mesh_term>Chronic Pain</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This study uses clinical trial and implementation science methodology to specifically assess
the effectiveness of yoga into the management of chronic low back pain (cLBP) within the
Cleveland Clinic Employee Health Plan. The study will use a type 1 hybrid
effectiveness-implementation design, which tests a clinical intervention while collecting
data on implementation. Studying and implementing evidence-based, non-pharmacologic
interventions is an important strategy for improving pain management and reducing opioid use
disorder.
The investigators will use a single (investigators) blinded two-arm randomized control trial
(RCT) design. The trial will be 24 weeks long and divided into two distinct parts: an initial
12-week Treatment Phase followed by a 12-week Follow-up Phase. Participants will be
randomized 1:1 into weekly virtual yoga classes (Yoga Now group) or a wait-list control (Yoga
Later group) who will receive usual care. After the 24 week study period, participants in the
Yoga Later Group will be offered the yoga intervention in a non-study format as well as a
free yoga mat and access to online yoga for LBP videos.
The screening and enrollment process will all occur remotely and involves the following: 1) A
telephone or Information Technology approved, The Health Insurance Portability and
Accountability Act (HIPAA-secure), virtual meeting platform where participants provide
consent for completion of eligibility screening through a standardized questionnaire; 2) if
eligible, provision of information about the study presented by study personnel with use of
an Institutional Review Board approved information page for informed consent, answering all
questions about the study, and assuring participant understanding through the "teach back"
method.
Randomization occurs after administering the baseline survey. Investigators will use a
computerized randomization procedure built into the study management system, RedCap, to
randomize each enrolled participant using a 1:1 ratio to the Yoga Now group or Yoga Later
group. Permuted variably-sized block randomization with block sizes of 6, 12 and 18 will be
used.
The study interventions start within approximately one week of baseline data collection and
randomization. Participants will be asked to complete questionnaire forms at baseline, weeks
6, 12 and 24. All participants throughout the entire 24-week study can continue to receive
routine medical care including doctor visits and pain medication.
The hatha yoga intervention, a term for yoga that pairs poses and breathing techniques, is
structured and reproducible. The full instructor manual and participant manual are available
online. Originally, it was developed by an expert panel led by Rob Saper, MD and Master of
Public Health (MPH) in 2007 and used in a pilot study of 30 participants with cLBP. It was
further refined in 2011 in a dosing study of 95 participants and a larger non-inferiority
trial of 320. It is designed specifically for the yoga-naïve individual for effectiveness and
safety in cLBP. Each class is 75 minutes long and will be delivered virtually to a maximum
class size of 12. Yoga instructors will complete an 8-hour training on the protocol directed
by the Cleveland Clinic lead yoga instructor.
Class begins with a relaxation exercise, yoga breathing exercises, and a brief discussion of
yoga philosophy. The class proceeds with warm-up yoga exercises and then yoga postures. Yoga
breathing is emphasized throughout. The class ends with a relaxation exercise. The 12 weeks
are divided into four 3-week segments. Each segment is given a theme (e.g., "Listening to the
Wisdom of the Body"). Participants are frequently advised to go slowly and carefully. The
degree of difficulty of postures learned increases with each segment. For each segment, the
participants gradually learn a sequence of 12-15 poses. The protocol provides variations and
uses various aids (e.g., chair, strap) to accommodate a range of physical abilities.
Participants are strongly encouraged to practice at home for 30 minutes daily on days which
they do not attend yoga class. To facilitate home practice, participants will be given a free
yoga mat, participant manual, and provided access to online videos prepared by the study
instructors.
Ten percent of online yoga classes will be virtually observed and assessed by a study team
member for instructor fidelity to the protocol using a checklist. A 12-week follow-up phase
consisting of larger optional classes for maintenance will follow.
Inclusion Criteria:
- 18-64 years old
- Current non-specific LBP persisting ≥12 weeks with average pain intensity ≥4 for the
previous week on an 11-point numerical rating scale
- Ability to speak and understand English
Exclusion Criteria:
- Any severe psychiatric or medical comorbidity in the Principal Investigator's judgment
that would make study participation unsafe or not feasible.
|
NCT0531xxxx/NCT05319704.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319704</url>
</required_header>
<id_info>
<org_study_id>RBHP 2018 RICHARD</org_study_id>
<secondary_id>2019-A00082-55</secondary_id>
<nct_id>NCT05319704</nct_id>
</id_info>
<brief_title>Specificities of the Eccentric Exercise: Energy Expenditure and Nature of Oxidized Substrates</brief_title>
<acronym>Speed-Enso</acronym>
<official_title>Specificities of the Eccentric Exercise: Energy Expenditure and Nature of Oxidized Substrates</official_title>
<sponsors>
<lead_sponsor>
<agency>University Hospital, Clermont-Ferrand</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University Hospital, Clermont-Ferrand</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Main objective of this clinical trial is to compare the oxidation rates of main carbohydrate
and lipid substrates during exercises carried out in eccentric dynamic pedaling mode on a
cycloergometer compared to concentric exercises (classic pedaling) at the same oxygen
consumption (VO2).

The hypothesis is that lipid oxidation during an eccentric exercise is higher than lipid
oxidation during a concentric exercise, done in humans at the capacity of 30% of VO2max.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The written agreement of the subjects will be obtained after information on the aims, nature
and possible risks of the study.

Before inclusion, the volunteers will be subjected to a medical check-up at the Nutritional
Exploration Unit which includes an examination of personal and family history and current
drug treatments, as well as a standard medical examination and a blood test for a biological
check-up. Also, the volunteers will be subjected to a check-up with dietetics. Compliance
with the inclusion/ exclusion criteria will be verified during this review. Volunteers
included in the protocol will go to the Sports Medicine service, or the Nutritional
Exploration Unit, or the Clinical Pharmacology Center (CPC) to perform the 11 interventions.

The study will be conducted in 6 periods:

T0 : A standard maximal exercices test performed on an cycloergometer to determine the
subject's abilities (VO2) and to set the target powers of the experimental clinical tests.
This test will take place in the Sports Medicine service.

T1 : A period of habituation to eccentric exercise, starting from 6 sessions of habituation
realized over a period of 15 days where the sessions are gradually increased in duration and
intensity. This test will take place in the Sports Medicine service. Before each session of
habituation, a Visual Analogue Scale (VAS) will be performed. If the result will be greater
than or equal to 3, the session will be rescheduled for another session after 48 hours.

T2 & 3 : Two tests of effort, sub-maximal, progressive, carried out in eccentric mode and
concentric mode (each spaced at least 48 hours) to determine the carbohydrate and lipid
oxidation rates. Both tests will take place in the Sports Medicine service. The day before
each visit, the evening meal will be standardized and eaten before 8 pm. Moreover, the day of
both visits, the breakfast will be standardized and eaten 2 hours before the subject will go
to Nutritional Exploration Unit.

T4 & 5 : Two exercises tests during 30min performed at 30% VO2max and followed by indirect
oxygen calorimetry (with canopy) extended over a period of 6 hours to measure the energy
expenditure, the nature of the oxidized substrates (carbohydrates and lipids) and oxidation
rates. The day before each visit, the evening meal will be standardized and eaten before 8
pm. Moreover, the day of both visits, the breakfast will be standardized and eaten 2 hours
before the subject will go to Nutritional Exploration Unit. In addition, for each kinetic, 7
blood samples will be collected at several times. On these samples, insulin and blood sugar
will be measured.
</textblock>
</detailed_description>
<overall_status>Unknown status</overall_status>
<last_known_status>Recruiting</last_known_status>
<start_date type="Actual">February 17, 2021</start_date>
<completion_date type="Anticipated">August 2023</completion_date>
<primary_completion_date type="Anticipated">August 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Crossover Assignment</intervention_model>
<intervention_model_description>participants may receive 4 differents interventions sequentially during the protocol</intervention_model_description>
<primary_purpose>Prevention</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Measures of oxidation rate of lipid substrates at T2 visit and T3 visit</measure>
<time_frame>Through effort test</time_frame>
<description>The oxidation rate of lipid substrates is measured at 10% of VO2max, 20% of VO2max, 40% of VO2max and 50% of VO2max</description>
</primary_outcome>
<secondary_outcome>
<measure>Measures of oxidation rate of carbohydrates at T2 visit and T3 visit</measure>
<time_frame>Through effort test</time_frame>
<description>The oxidation rate of carbohydrates is measured at10% of VO2max, 20% of VO2max, 40% of VO2max and 50% of VO2max</description>
</secondary_outcome>
<secondary_outcome>
<measure>Measure of total energy expenditure at T2 visit and T3 visit</measure>
<time_frame>Trough exercise</time_frame>
<description>At the T2 visit and T3 visit, the total energy expenditure is measured</description>
</secondary_outcome>
<secondary_outcome>
<measure>Measure of total energy expenditure at T2 visit and T3 visit</measure>
<time_frame>immediatly after exercise</time_frame>
<description>At the T2 visit and T3 visit, the total energy expenditure is measured</description>
</secondary_outcome>
<secondary_outcome>
<measure>Measure of total energy expenditure at T2 visit and T3 visit</measure>
<time_frame>through recovery after exercise, an average of 1 hour</time_frame>
<description>At the T2 visit and T3 visit, the total energy expenditure is measured</description>
</secondary_outcome>
<secondary_outcome>
<measure>Measure of total energy expenditure</measure>
<time_frame>30 min</time_frame>
<description>the total energy expenditure is measured during constant-power cycle ergometer tests. This secondary outcome measure will be measured during eccentric and concentric exercises.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Measure of energy expenditure during 6 hours of recovery after exercises</measure>
<time_frame>6 hours</time_frame>
<description>the energy expenditure is measured during constant-power cycle ergometer tests. This secondary outcome measure will be measured during both kinetics</description>
</secondary_outcome>
<secondary_outcome>
<measure>Measures of substrates oxidation rates at T4 visit and T5 visit</measure>
<time_frame>through effort test</time_frame>
<description>The oxidation rates of substrates are measured during exercises performed at 30% of VO2max</description>
</secondary_outcome>
<secondary_outcome>
<measure>Measures of quantities of oxidized substrates at T4 visit and T5 visit</measure>
<time_frame>through effort test</time_frame>
<description>The quantities of oxidized substrates (carbohydrates, fats, proteins) are measured during exercises</description>
</secondary_outcome>
<secondary_outcome>
<measure>Measures of quantities of carbohydrates at T4 visit and T5 visit</measure>
<time_frame>Through energy expenditure measurment an average of 6 hours</time_frame>
<description>The quantities of oxidized carbohydrates are measured during the measure of energy expenditure</description>
</secondary_outcome>
<secondary_outcome>
<measure>Measures of quantities of fats at T4 visit and T5 visit</measure>
<time_frame>Through energy expenditure measurment an average of 6 hours</time_frame>
<description>The quantities of fats are measured during the measure of energy expenditure</description>
</secondary_outcome>
<number_of_arms>4</number_of_arms>
<enrollment type="Anticipated">12</enrollment>
<condition>Overweight</condition>
<condition>Healthy</condition>
<condition>Men</condition>
<arm_group>
<arm_group_label>Test of effort, sub-maximal, progressive, carried out in eccentric mode</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>The exercise will start at 10% of VO2max. However, every six minutes, the level of VO2max will be increased by 10%, up to 50%.</description>
</arm_group>
<arm_group>
<arm_group_label>Test of effort, sub-maximal, progressive, carried out in concentric mode</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>The exercise will start at 10% of VO2max. However, every six minutes, the level of VO2max will be increased by 10%, up to 50%.</description>
</arm_group>
<arm_group>
<arm_group_label>Kinetic in eccentric mode</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>The subjects will have to carry out a test of effort in eccentric or concentric mode during 30 minutes performed at 30% of VO2max.
The exercise will be followed by indirect oxygen calorimetry (with canopy) extended over a period of 6 hours to measure the energy expenditure, the nature of the oxidized substrates (carbohydrates and lipids) and oxidation rates. During each kinetic, 6 other blood samples will be collected at several times. On these samples, insulin and blood sugar will be measured.</description>
</arm_group>
<arm_group>
<arm_group_label>Kinetic in concentric mode</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>The subjects will have to carry out a test of effort in eccentric or concentric mode during 30 minutes performed at 30% of VO2max.
The exercise will be followed by indirect oxygen calorimetry (with canopy) extended over a period of 6 hours to measure the energy expenditure, the nature of the oxidized substrates (carbohydrates and lipids) and oxidation rates. During each kinetic, 6 other blood samples will be collected at several times. On these samples, insulin and blood sugar will be measured.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Test of effort on cycle on concentric or excentric mode</intervention_name>
<description>participants may receive 4 interventions sequentially during the protocol</description>
<arm_group_label>Kinetic in concentric mode</arm_group_label>
<arm_group_label>Kinetic in eccentric mode</arm_group_label>
<arm_group_label>Test of effort, sub-maximal, progressive, carried out in concentric mode</arm_group_label>
<arm_group_label>Test of effort, sub-maximal, progressive, carried out in eccentric mode</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Kinetics on concentric or excentric mode during test of effort</intervention_name>
<description>participants may receive 4 interventions sequentially during the protocol</description>
<arm_group_label>Kinetic in concentric mode</arm_group_label>
<arm_group_label>Kinetic in eccentric mode</arm_group_label>
<arm_group_label>Test of effort, sub-maximal, progressive, carried out in concentric mode</arm_group_label>
<arm_group_label>Test of effort, sub-maximal, progressive, carried out in eccentric mode</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Male volunteers between 20 and 40 years old (20 ≥ years ≤ 40)

- Subjects considered healthy by investigator based on the examination, medical and
clinical examination

- Body Mass Index between 27 and 35 kg/m² (27 < BMI < 35)

- Biological check up considered compatible with study participation

- Physical check up considered compatible with study participation (no bones, articular
or muscular problems)

- Person who don't smoke and has no treatment

- Person who is in the position to sign informed consent

Exclusion Criteria:

- Smoking

- Person who take any kind of treatments except Paracétamol

- All conditions who have interaction with this clinical trial, or who can deteriorate
the exercise capacity or the realization of canopy (claustrophobia)

- Criteria

- Administrative and legal factors

- Person who isn't consent

- Subject not affiliated with social security

- Subject during the exclusion period of a previous study (after verification in the
Biomedical Research Volunteers File).
</textblock>
</criteria>
<gender>Male</gender>
<minimum_age>20 Years</minimum_age>
<maximum_age>40 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Fabrice RANNOU</last_name>
<role>Principal Investigator</role>
<affiliation>University Hospital, Clermont-Ferrand</affiliation>
</overall_official>
<overall_contact>
<last_name>Lise Laclautre</last_name>
<phone>334.73.754.963</phone>
<email>promo_interne_drci@chu-clermontferrand.fr</email>
</overall_contact>
<location>
<facility>
<name>CHU clermont-ferrand</name>
<address>
<city>Clermont-Ferrand</city>
<country>France</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Lise Laclautre</last_name>
</contact>
<investigator>
<last_name>Fabrice RANNOU</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>France</country>
</location_countries>
<verification_date>June 2021</verification_date>
<study_first_submitted>June 30, 2021</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>April 4, 2022</last_update_submitted>
<last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 8, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Energy expenditure</keyword>
<keyword>eccentric training</keyword>
<keyword>concentric training</keyword>
<keyword>oxidized substrates</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Overweight</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Main objective of this clinical trial is to compare the oxidation rates of main carbohydrate
and lipid substrates during exercises carried out in eccentric dynamic pedaling mode on a
cycloergometer compared to concentric exercises (classic pedaling) at the same oxygen
consumption (VO2).
The hypothesis is that lipid oxidation during an eccentric exercise is higher than lipid
oxidation during a concentric exercise, done in humans at the capacity of 30% of VO2max.
The written agreement of the subjects will be obtained after information on the aims, nature
and possible risks of the study.
Before inclusion, the volunteers will be subjected to a medical check-up at the Nutritional
Exploration Unit which includes an examination of personal and family history and current
drug treatments, as well as a standard medical examination and a blood test for a biological
check-up. Also, the volunteers will be subjected to a check-up with dietetics. Compliance
with the inclusion/ exclusion criteria will be verified during this review. Volunteers
included in the protocol will go to the Sports Medicine service, or the Nutritional
Exploration Unit, or the Clinical Pharmacology Center (CPC) to perform the 11 interventions.
The study will be conducted in 6 periods:
T0 : A standard maximal exercices test performed on an cycloergometer to determine the
subject's abilities (VO2) and to set the target powers of the experimental clinical tests.
This test will take place in the Sports Medicine service.
T1 : A period of habituation to eccentric exercise, starting from 6 sessions of habituation
realized over a period of 15 days where the sessions are gradually increased in duration and
intensity. This test will take place in the Sports Medicine service. Before each session of
habituation, a Visual Analogue Scale (VAS) will be performed. If the result will be greater
than or equal to 3, the session will be rescheduled for another session after 48 hours.
T2 & 3 : Two tests of effort, sub-maximal, progressive, carried out in eccentric mode and
concentric mode (each spaced at least 48 hours) to determine the carbohydrate and lipid
oxidation rates. Both tests will take place in the Sports Medicine service. The day before
each visit, the evening meal will be standardized and eaten before 8 pm. Moreover, the day of
both visits, the breakfast will be standardized and eaten 2 hours before the subject will go
to Nutritional Exploration Unit.
T4 & 5 : Two exercises tests during 30min performed at 30% VO2max and followed by indirect
oxygen calorimetry (with canopy) extended over a period of 6 hours to measure the energy
expenditure, the nature of the oxidized substrates (carbohydrates and lipids) and oxidation
rates. The day before each visit, the evening meal will be standardized and eaten before 8
pm. Moreover, the day of both visits, the breakfast will be standardized and eaten 2 hours
before the subject will go to Nutritional Exploration Unit. In addition, for each kinetic, 7
blood samples will be collected at several times. On these samples, insulin and blood sugar
will be measured.
Inclusion Criteria:
- Male volunteers between 20 and 40 years old (20 ≥ years ≤ 40)
- Subjects considered healthy by investigator based on the examination, medical and
clinical examination
- Body Mass Index between 27 and 35 kg/m² (27 < BMI < 35)
- Biological check up considered compatible with study participation
- Physical check up considered compatible with study participation (no bones, articular
or muscular problems)
- Person who don't smoke and has no treatment
- Person who is in the position to sign informed consent
Exclusion Criteria:
- Smoking
- Person who take any kind of treatments except Paracétamol
- All conditions who have interaction with this clinical trial, or who can deteriorate
the exercise capacity or the realization of canopy (claustrophobia)
- Criteria
- Administrative and legal factors
- Person who isn't consent
- Subject not affiliated with social security
- Subject during the exclusion period of a previous study (after verification in the
Biomedical Research Volunteers File).
|
NCT0531xxxx/NCT05319717.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319717</url>
</required_header>
<id_info>
<org_study_id>CSU IRB#:1823</org_study_id>
<nct_id>NCT05319717</nct_id>
</id_info>
<brief_title>Rice Bran-based Supplemental Foods for the Treatment of Childhood Malnutrition</brief_title>
<official_title>Rice Bran in Ready-to-use Therapeutic Foods for Microbiota-targeted Treatment of Childhood Malnutrition</official_title>
<sponsors>
<lead_sponsor>
<agency>Colorado State University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Thrasher Research Fund</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Savica, Indonesia</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Institute of Research for Development, France</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Colorado State University</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this study is to assess the efficacy of treating children with severe acute
malnutrition (SAM) with a locally produced ready-to-use therapeutic food (RUTF) with or
without rice bran.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Rice bran is a nutrient dense food ingredient with prebiotics and phytochemicals, as well as
vitamins, fatty acids, and amino acids. The investigators will determine if the inclusion of
rice bran to locally produced RUTFs will improve SAM treatment for children in Indonesia.
This will be assessed by standard anthropometric measures and determining the modulation of
the malnourished child's gut microbiome and metabolome. The study will also assess rates of
relapse in the entire cohort.

This study will yield new information of direct importance and impact to public health
nutrition and advance our knowledge and treatment of SAM in Indonesia. Investigation of the
gut-microbiota metabolism following consumption of rice bran provided in RUTFs compared to
RUTF without rice bran included will provide key mechanistic insights for repairing nutrient
absorptive functions in the gut, sustaining gut health in treated children and inform
long-term treatment solutions for SAM.
</textblock>
</detailed_description>
<overall_status>Active, not recruiting</overall_status>
<start_date type="Actual">December 1, 2022</start_date>
<completion_date type="Anticipated">February 2024</completion_date>
<primary_completion_date type="Anticipated">February 2024</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Control study arm: Locally produced Ready to use therapeutic food (RUTF)
Intervention study arm: Locally produced Ready to use therapeutic food plus rice bran (RUTF+RB)</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Efficacy of the locally produced ready-to-use therapeutic food + heat stabilized rice bran as compared to locally produced ready-to-use therapeutic food alone in the treatment of severe acute malnutrition as determined by child weight.</measure>
<time_frame>Baseline, week 4, week 8, and week 16</time_frame>
<description>This will be assessed by measures of:
- Weight</description>
</primary_outcome>
<primary_outcome>
<measure>Efficacy of the locally produced ready-to-use therapeutic food + heat stabilized rice bran as compared to locally produced ready-to-use therapeutic food alone in the treatment of severe acute malnutrition as determined by mid-upper arm circumference.</measure>
<time_frame>Changes between baseline, week 4, week 8, and week 16</time_frame>
<description>This will be assessed by measures of:
-Mid-upper arm circumference</description>
</primary_outcome>
<primary_outcome>
<measure>Efficacy of the locally produced ready-to-use therapeutic food + heat stabilized rice bran as compared to locally produced ready-to-use therapeutic food alone in the treatment of severe acute malnutrition as determined by morbidity.</measure>
<time_frame>Changes between baseline, week 4, week 8, and week 16</time_frame>
<description>This will be assessed by measures of:
- Morbidity (diarrhea, fever, vomiting, upper or lower respiratory infection)</description>
</primary_outcome>
<secondary_outcome>
<measure>Stool microbiota composition</measure>
<time_frame>Changes between baseline, week 4, week 8, and week 16</time_frame>
<description>Determine stool microbiota composition of infants in both arms over time using 16S rRNA sequencing and shotgun metagenomic sequencing.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Dried blood spot metabolite profile</measure>
<time_frame>Changes between baseline, week 4, week 8, and week 16</time_frame>
<description>Dried blood spots will be analyzed for metabolites.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Relapse</measure>
<time_frame>Week 16 (end of study)</time_frame>
<description>Determine the number of participants that experience severe acute malnutrition relapse 4 weeks after the treatment/intervention has ended.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Percent of children recovered</measure>
<time_frame>Baseline, week 4, week 8, and week 16</time_frame>
<description>The number of children recovered in the 4 week treatment period will be determined as well as the time to recovery (days).</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">200</enrollment>
<condition>Severe Acute Malnutrition</condition>
<arm_group>
<arm_group_label>Ready-to-use therapeutic food, no rice bran (control/comparator)</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Randomized participants will receive a locally produced ready-to-use therapeutic food to be consumed daily.</description>
</arm_group>
<arm_group>
<arm_group_label>Ready-to-use therapeutic food, with heat stabilized rice bran (Experimental)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Randomized participants will receive a locally produced ready-to-use therapeutic food with 5% heat stabilized rice bran to be consumed daily.</description>
</arm_group>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Ready-to-use therapeutic food with heat stabilized rice bran</intervention_name>
<description>Children assigned to the experimental group will be treated for severe acute malnutrition with a novel ready-to-use therapeutic food that contains 5% heat stabilized rice bran.</description>
<arm_group_label>Ready-to-use therapeutic food, with heat stabilized rice bran (Experimental)</arm_group_label>
</intervention>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Ready-to-use therapeutic food (no rice bran)</intervention_name>
<description>Children assigned to the active comparator group will be treated for severe acute malnutrition with a novel ready-to-use therapeutic food (no rice bran).</description>
<arm_group_label>Ready-to-use therapeutic food, no rice bran (control/comparator)</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Willing to participate in the study, with parent(s) signing the informed consent. If
the caretaker denies the participation of the child, the child will be enrolled for
treatment through the health system, but the information will be not considered for
the purpose of the trial.

- Child identified with a weight-for-height z-score WHZ of < -2.5 (SAM children and
children with advanced moderate acute malnutrition) and/or mid-upper arm circumference
(MUAC) <115 mm) or a child with mild to moderate nutritional edema (regardless of
anthropometry).

- Being qualified for outpatient treatment.

- Aged 6-59 months old upon enrolment

- Pass appetite test (taste test) (as stipulated by WHO guidelines on the treatment of
SAM). See appetite test document attached.

- Not having consumed RUTF in the last two months

Exclusion Criteria:

- Children detected with severe acute malnutrition younger than 6 months of age will be
excluded from the project, as well as any child with a body weight <4.0 kg.

- Children 6-59 months old who, when diagnosed with SAM, have been detected with medical
complications, with TB, HIV positive status, one or more signs from the Integrated
Management of Childhood Illness (IMCI) guidelines, severe oedema (+++) or who have
failed the appetite test (see appetite test document attached).

- Medical complications include: Cough/difficulty in breathing; Diarrhea; Fever; Ear
Problems. IMCI signs will be identified according to WHO definition and include not
able to drink or breastfeed; vomiting; convulsions; lethargy.

- Participating in another clinical trial

- Any congenital disorder that interferes with normal nutrient intake; chronic
conditions including but not exclusively disorders of heart, kidney or liver (children
to be screened by a physician).

- SAM with complications requiring hospital treatment. (Upon discharge from hospital,
the child will be re-evaluated for inclusion in the study).

- Siblings will not be allowed to participate in the trial

Withdrawal criteria:

- Not consuming the RUTF supplementation at all in >4 days a week in 2 consecutive
weeks.

- Not providing samples or completing forms/questionnaires at study visits

- Developing medical complications requiring hospitalization

- Not gaining weight after 1 month of treatment

- Major reactions to intervention
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>6 Months</minimum_age>
<maximum_age>59 Months</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Damayanti Soekarjo, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Savica, Indonesia</affiliation>
</overall_official>
<location>
<facility>
<name>Savica</name>
<address>
<city>Jember</city>
<state>East Java</state>
<country>Indonesia</country>
</address>
</facility>
</location>
<location_countries>
<country>Indonesia</country>
</location_countries>
<verification_date>June 2023</verification_date>
<study_first_submitted>February 5, 2022</study_first_submitted>
<study_first_submitted_qc>April 4, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>June 1, 2023</last_update_submitted>
<last_update_submitted_qc>June 1, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">June 2, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Colorado State University</investigator_affiliation>
<investigator_full_name>Elizabeth P Ryan</investigator_full_name>
<investigator_title>Associate Professor</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Malnutrition</mesh_term>
<mesh_term>Severe Acute Malnutrition</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>IRB approved study protocol and informed consent forms will be shared.</ipd_description>
<ipd_info_type>Study Protocol</ipd_info_type>
<ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
<ipd_time_frame>Protocol and informed consent will be shared after enrollment of the first 100 participants</ipd_time_frame>
<ipd_access_criteria>Sharing access will be made available from the investigative team directly</ipd_access_criteria>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this study is to assess the efficacy of treating children with severe acute
malnutrition (SAM) with a locally produced ready-to-use therapeutic food (RUTF) with or
without rice bran.
Rice bran is a nutrient dense food ingredient with prebiotics and phytochemicals, as well as
vitamins, fatty acids, and amino acids. The investigators will determine if the inclusion of
rice bran to locally produced RUTFs will improve SAM treatment for children in Indonesia.
This will be assessed by standard anthropometric measures and determining the modulation of
the malnourished child's gut microbiome and metabolome. The study will also assess rates of
relapse in the entire cohort.
This study will yield new information of direct importance and impact to public health
nutrition and advance our knowledge and treatment of SAM in Indonesia. Investigation of the
gut-microbiota metabolism following consumption of rice bran provided in RUTFs compared to
RUTF without rice bran included will provide key mechanistic insights for repairing nutrient
absorptive functions in the gut, sustaining gut health in treated children and inform
long-term treatment solutions for SAM.
Inclusion Criteria:
- Willing to participate in the study, with parent(s) signing the informed consent. If
the caretaker denies the participation of the child, the child will be enrolled for
treatment through the health system, but the information will be not considered for
the purpose of the trial.
- Child identified with a weight-for-height z-score WHZ of < -2.5 (SAM children and
children with advanced moderate acute malnutrition) and/or mid-upper arm circumference
(MUAC) <115 mm) or a child with mild to moderate nutritional edema (regardless of
anthropometry).
- Being qualified for outpatient treatment.
- Aged 6-59 months old upon enrolment
- Pass appetite test (taste test) (as stipulated by WHO guidelines on the treatment of
SAM). See appetite test document attached.
- Not having consumed RUTF in the last two months
Exclusion Criteria:
- Children detected with severe acute malnutrition younger than 6 months of age will be
excluded from the project, as well as any child with a body weight <4.0 kg.
- Children 6-59 months old who, when diagnosed with SAM, have been detected with medical
complications, with TB, HIV positive status, one or more signs from the Integrated
Management of Childhood Illness (IMCI) guidelines, severe oedema (+++) or who have
failed the appetite test (see appetite test document attached).
- Medical complications include: Cough/difficulty in breathing; Diarrhea; Fever; Ear
Problems. IMCI signs will be identified according to WHO definition and include not
able to drink or breastfeed; vomiting; convulsions; lethargy.
- Participating in another clinical trial
- Any congenital disorder that interferes with normal nutrient intake; chronic
conditions including but not exclusively disorders of heart, kidney or liver (children
to be screened by a physician).
- SAM with complications requiring hospital treatment. (Upon discharge from hospital,
the child will be re-evaluated for inclusion in the study).
- Siblings will not be allowed to participate in the trial
Withdrawal criteria:
- Not consuming the RUTF supplementation at all in >4 days a week in 2 consecutive
weeks.
- Not providing samples or completing forms/questionnaires at study visits
- Developing medical complications requiring hospitalization
- Not gaining weight after 1 month of treatment
- Major reactions to intervention
|
NCT0531xxxx/NCT05319730.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319730</url>
</required_header>
<id_info>
<org_study_id>3475-06B</org_study_id>
<secondary_id>jRCT2031220582</secondary_id>
<secondary_id>2021-005443-76</secondary_id>
<nct_id>NCT05319730</nct_id>
</id_info>
<brief_title>A Study to Evaluate Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment</brief_title>
<official_title>A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06B</official_title>
<sponsors>
<lead_sponsor>
<agency>Merck Sharp & Dohme LLC</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Merck Sharp & Dohme LLC</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study to evaluate
the safety and efficacy of investigational agents with pembrolizumab, with or without
chemotherapy, for the treatment of participants with second line (2L) esophageal squamous
cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 based treatment.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The master protocol is MK-3475-U06.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">May 16, 2023</start_date>
<completion_date type="Anticipated">December 31, 2026</completion_date>
<primary_completion_date type="Anticipated">February 17, 2025</primary_completion_date>
<phase>Phase 1/Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) During Safety Lead-in Phase</measure>
<time_frame>Up to approximately 3 weeks</time_frame>
<description>A DLT is defined as any drug-related AE according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle.</description>
</primary_outcome>
<primary_outcome>
<measure>Number of Participants Experiencing Adverse Events (AEs) During Safety Lead-in Phase</measure>
<time_frame>Up to approximately 3 weeks</time_frame>
<description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.</description>
</primary_outcome>
<primary_outcome>
<measure>Number of Participants Who Discontinue Study Treatment Due to an AE During Safety Lead-in Phase</measure>
<time_frame>Up to approximately 3 weeks</time_frame>
<description>An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.</description>
</primary_outcome>
<primary_outcome>
<measure>Objective Response (OR)</measure>
<time_frame>Up to approximately 92 weeks</time_frame>
<description>ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.</description>
</primary_outcome>
<secondary_outcome>
<measure>Progression-Free Survival (PFS)</measure>
<time_frame>Up to approximately 189 weeks</time_frame>
<description>PFS is defined as the time from allocation to the first documented progressive disease (PD) as assessed by RECIST 1.1 or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Duration of Response (DOR)</measure>
<time_frame>Up to approximately 189 weeks</time_frame>
<description>For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Overall Survival (OS)</measure>
<time_frame>Up to approximately 189 weeks</time_frame>
<description>OS is defined as the time from the date of allocation to death from any cause.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of Participants Experiencing at Least One Adverse Event (AE) During the Efficacy Phase</measure>
<time_frame>Up to approximately 189 weeks</time_frame>
<description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of Participants Who Discontinue Study Treatment Due to An AE During the Efficacy Phase</measure>
<time_frame>Up to approximately 104 weeks</time_frame>
<description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.</description>
</secondary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Anticipated">300</enrollment>
<condition>Esophageal Squamous Cell Carcinoma</condition>
<arm_group>
<arm_group_label>Paclitaxel or irinotecan</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Participants receive paclitaxel 80-100 mg/m^2 intravenously (IV) on days 1, 8, and 15 every 28-day cycle until progressive disease (PD) or discontinuation, or irinotecan 180 mg/m^2 IV on day 1 of every 14-day cycle until PD or discontinuation.</description>
</arm_group>
<arm_group>
<arm_group_label>Pembrolizumab + MK-4830 + paclitaxel or irinotecan</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants receive pembrolizumab 200 mg IV once every 3 weeks (Q3W) for up to 35 cycles (cycle=21 days) or until PD or discontinuation + MK-4830 800 mg IV Q3W up to 35 infusions + paclitaxel 80-100 mg/m^2 IV on days 1, 8, and 15 every 28-day cycle until PD or discontinuation or irinotecan 180 mg/m^2 180 mg/m^2 on day 1 every 14-day cycle until PD or discontinuation.</description>
</arm_group>
<arm_group>
<arm_group_label>Pembrolizumab + MK-4830 + lenvatinib</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants receive pembrolizumab 200 mg IV Q3W up to 35 cycles (cycle=21 days) until PD or discontinuation + MK-4830 800 mg IV Q3W up to 35 infusions + lenvatinib 20 mg oral administration every day until PD or discontinuation.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Paclitaxel</intervention_name>
<description>80-100 mg/m2 IV infusion, administered on days 1, 8, and 15 of every 28-day cycle.</description>
<arm_group_label>Paclitaxel or irinotecan</arm_group_label>
<arm_group_label>Pembrolizumab + MK-4830 + paclitaxel or irinotecan</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Irinotecan</intervention_name>
<description>180 mg/m2 IV infusion, administered on day 1 of every 14-day cycle.</description>
<arm_group_label>Paclitaxel or irinotecan</arm_group_label>
<arm_group_label>Pembrolizumab + MK-4830 + paclitaxel or irinotecan</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Pembrolizumab</intervention_name>
<description>200 mg IV infusion, administered every Q3W.</description>
<arm_group_label>Pembrolizumab + MK-4830 + lenvatinib</arm_group_label>
<arm_group_label>Pembrolizumab + MK-4830 + paclitaxel or irinotecan</arm_group_label>
<other_name>MK-3475</other_name>
<other_name>KEYTRUDA®</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>MK-4830</intervention_name>
<description>800 mg IV infusion, administered Q3W up to 35 infusions.</description>
<arm_group_label>Pembrolizumab + MK-4830 + lenvatinib</arm_group_label>
<arm_group_label>Pembrolizumab + MK-4830 + paclitaxel or irinotecan</arm_group_label>
<other_name>anti- immunoglobulin-like transcript 4 (anti-ILT4)</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Lenvatinib</intervention_name>
<description>20 mg oral administration every day.</description>
<arm_group_label>Pembrolizumab + MK-4830 + lenvatinib</arm_group_label>
<other_name>MK-7902</other_name>
<other_name>LENVIMA®</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of metastatic or locally advanced
unresectable ESCC.

- Has experienced investigator documented radiographic or clinical disease progression
on one prior line of standard therapy, that includes a platinum agent and previous
exposure to an anti-PD1/PD-L1 based therapy.

- Has an evaluable baseline tumor sample (newly obtained or archival) for analysis.

- Has adequately controlled blood pressure (BP) with or without antihypertensive
medications.

- Participants who have adverse events (AEs) due to previous anticancer therapies must
have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who
are adequately treated with hormone replacement or participants who have ≤Grade 2
neuropathy are eligible.

Exclusion Criteria:

- Direct invasion into adjacent organs such as the aorta or trachea.

- Has experienced weight loss >10% over approximately 2 months prior to first dose of
study therapy.

- Currently participating in or has participated in a study of an investigational agent
or has used an investigational device within 4 weeks before the first dose of study
intervention.

- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any
other form of immunosuppressive therapy within 7 days prior to the first dose of study
medication.

- Known additional malignancy that is progressing or has required active treatment
within the past 3 years, except basal cell carcinoma of the skin, squamous cell
carcinoma of the skin, or carcinoma in situ that has undergone potentially curative
therapy.

- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

- Active autoimmune disease that has required systemic treatment in past 2 years.

- History of human immunodeficiency virus (HIV) infection.

- History of Hepatitis B or known active Hepatitis C virus infection.

- History of allogenic tissue/solid organ transplant.

- Clinically significant cardiovascular disease within 12 months from first dose of
study intervention.

- Gastrointestinal (GI) obstruction, poor oral intake, or difficulty in taking oral
medication.

- Has risk for significant GI bleeding, such as:

- Has had a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days
prior to allocation/randomization.

- Has significant bleeding disorders, vasculitis, or has had a significant bleeding
episode from the GI tract within 12 weeks prior to allocation/randomization.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Medical Director</last_name>
<role>Study Director</role>
<affiliation>Merck Sharp & Dohme LLC</affiliation>
</overall_official>
<overall_contact>
<last_name>Toll Free Number</last_name>
<phone>1-888-577-8839</phone>
<email>Trialsites@merck.com</email>
</overall_contact>
<location>
<facility>
<name>Liga Norte Riograndense Contra o Câncer ( Site 4303)</name>
<address>
<city>Natal</city>
<state>Rio Grande Do Norte</state>
<zip>59062-000</zip>
<country>Brazil</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>55 84 991191032</phone>
</contact>
</location>
<location>
<facility>
<name>Hospital Nossa Senhora da Conceição ( Site 4301)</name>
<address>
<city>Porto Alegre</city>
<state>Rio Grande Do Sul</state>
<zip>91350-200</zip>
<country>Brazil</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+5551993590437</phone>
</contact>
</location>
<location>
<facility>
<name>ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 4300)</name>
<address>
<city>São Paulo</city>
<state>Sao Paulo</state>
<zip>01246-000</zip>
<country>Brazil</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>5511993103312</phone>
</contact>
</location>
<location>
<facility>
<name>FALP-UIDO ( Site 4400)</name>
<address>
<city>Santiago</city>
<state>Region M. De Santiago</state>
<zip>7500921</zip>
<country>Chile</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>56224457254</phone>
</contact>
</location>
<location>
<facility>
<name>Clínica las Condes ( Site 4403)</name>
<address>
<city>Santiago</city>
<state>Region M. De Santiago</state>
<zip>7591047</zip>
<country>Chile</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>56995993148</phone>
</contact>
</location>
<location>
<facility>
<name>Anhui Provincil Hospital South District ( Site 3501)</name>
<address>
<city>Hefei</city>
<state>Anhui</state>
<zip>230036</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>13955195511</phone>
</contact>
</location>
<location>
<facility>
<name>Beijing Cancer hospital-Digestive Oncology ( Site 3500)</name>
<address>
<city>Beijing</city>
<state>Beijing</state>
<zip>100142</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>010-88121122</phone>
</contact>
</location>
<location>
<facility>
<name>The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 3510)</name>
<address>
<city>Xinxiang</city>
<state>Henan</state>
<zip>453100</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>8613663030446</phone>
</contact>
</location>
<location>
<facility>
<name>First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 3506)</name>
<address>
<city>Huai'an</city>
<state>Jiangsu</state>
<zip>223300</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>8613861597105</phone>
</contact>
</location>
<location>
<facility>
<name>Shanghai Chest Hospital-Esophageal surgery department ( Site 3513)</name>
<address>
<city>Shanghai</city>
<state>Shanghai</state>
<zip>200030</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+86 21 22200000</phone>
</contact>
</location>
<location>
<facility>
<name>Zhejiang Cancer Hospital-Thoracic oncology ( Site 3511)</name>
<address>
<city>Hangzhou</city>
<state>Zhejiang</state>
<zip>310022</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>86 13858182310</phone>
</contact>
</location>
<location>
<facility>
<name>Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 4801)</name>
<address>
<city>Frankfurt</city>
<state>Hessen</state>
<zip>60488</zip>
<country>Germany</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>496976014187</phone>
</contact>
</location>
<location>
<facility>
<name>Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 4804)</name>
<address>
<city>Berlin</city>
<zip>13353</zip>
<country>Germany</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+4930450657306</phone>
</contact>
</location>
<location>
<facility>
<name>Ospedale San Raffaele-Oncologia Medica ( Site 3202)</name>
<address>
<city>Milano</city>
<state>Lombardia</state>
<zip>20132</zip>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+393400005069</phone>
</contact>
</location>
<location>
<facility>
<name>Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3200)</name>
<address>
<city>Milan</city>
<state>Lombardia</state>
<zip>20133</zip>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>390223903835</phone>
</contact>
</location>
<location>
<facility>
<name>Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (</name>
<address>
<city>Milano</city>
<zip>20141</zip>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>390257490439</phone>
</contact>
</location>
<location>
<facility>
<name>Aichi Cancer Center Hospital ( Site 3702)</name>
<address>
<city>Nagoya</city>
<state>Aichi</state>
<zip>464-8681</zip>
<country>Japan</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+81-52-762-6111</phone>
</contact>
</location>
<location>
<facility>
<name>National Cancer Center Hospital East ( Site 3701)</name>
<address>
<city>Kashiwa</city>
<state>Chiba</state>
<zip>277-8577</zip>
<country>Japan</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+81-4-7133-1111</phone>
</contact>
</location>
<location>
<facility>
<name>Saitama Prefectural Cancer Center ( Site 3703)</name>
<address>
<city>Ina-machi</city>
<state>Saitama</state>
<zip>362-0806</zip>
<country>Japan</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+81-48-722-1111</phone>
</contact>
</location>
<location>
<facility>
<name>Shizuoka Cancer Center ( Site 3704)</name>
<address>
<city>Nagaizumi-cho,Sunto-gun</city>
<state>Shizuoka</state>
<zip>411-8777</zip>
<country>Japan</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+81-55-989-5222</phone>
</contact>
</location>
<location>
<facility>
<name>National Cancer Center Hospital ( Site 3700)</name>
<address>
<city>Chuo-ku</city>
<state>Tokyo</state>
<zip>104-0045</zip>
<country>Japan</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+81-3-3542-2511</phone>
</contact>
</location>
<location>
<facility>
<name>Asan Medical Center-Department of Oncology ( Site 3901)</name>
<address>
<city>Seoul</city>
<zip>05505</zip>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+82230107179</phone>
</contact>
</location>
<location>
<facility>
<name>Samsung Medical Center-Division of Hematology/Oncology ( Site 3900)</name>
<address>
<city>Seoul</city>
<zip>06351</zip>
<country>Korea, Republic of</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+82234106518</phone>
</contact>
</location>
<location>
<facility>
<name>Oslo universitetssykehus, Radiumhospitalet ( Site 4501)</name>
<address>
<city>Oslo</city>
<zip>0379</zip>
<country>Norway</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>4723026600</phone>
</contact>
</location>
<location>
<facility>
<name>National University Hospital ( Site 3800)</name>
<address>
<city>Singapore</city>
<state>South West</state>
<zip>119074</zip>
<country>Singapore</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+65 6779 5555</phone>
</contact>
</location>
<location>
<facility>
<name>Hôpitaux Universitaires de Genève (HUG) ( Site 4702)</name>
<address>
<city>Genève</city>
<state>Geneve</state>
<zip>1211</zip>
<country>Switzerland</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>41223729861</phone>
</contact>
</location>
<location>
<facility>
<name>Kantonsspital Graubünden-Medizin ( Site 4700)</name>
<address>
<city>Chur</city>
<state>Grisons</state>
<zip>7000</zip>
<country>Switzerland</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>41812566884</phone>
</contact>
</location>
<location>
<facility>
<name>Chang Gung Memorial Hospital at Kaohsiung ( Site 4003)</name>
<address>
<city>Kaohsiung Niao Sung Dist</city>
<state>Kaohsiung</state>
<zip>83301</zip>
<country>Taiwan</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>886773171233267</phone>
</contact>
</location>
<location>
<facility>
<name>China Medical University Hospital ( Site 4007)</name>
<address>
<city>Taichung</city>
<zip>404332</zip>
<country>Taiwan</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+886975680932</phone>
</contact>
</location>
<location>
<facility>
<name>Taichung Veterans General Hospital-Radiation Oncology ( Site 4008)</name>
<address>
<city>Taichung</city>
<zip>407</zip>
<country>Taiwan</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>8864235925255613</phone>
</contact>
</location>
<location>
<facility>
<name>National Cheng Kung University Hospital ( Site 4001)</name>
<address>
<city>Tainan</city>
<zip>704</zip>
<country>Taiwan</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+886972401107</phone>
</contact>
</location>
<location>
<facility>
<name>National Taiwan University Hospital ( Site 4000)</name>
<address>
<city>Taipei</city>
<zip>10002</zip>
<country>Taiwan</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+886223123456</phone>
</contact>
</location>
<location>
<facility>
<name>Taipei Veterans General Hospital ( Site 4005)</name>
<address>
<city>Taipei</city>
<zip>11217</zip>
<country>Taiwan</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+8862287121212573</phone>
</contact>
</location>
<location>
<facility>
<name>Chang Gung Medical Foundation-Linkou Branch ( Site 4006)</name>
<address>
<city>Taoyuan</city>
<zip>333</zip>
<country>Taiwan</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+88633281200</phone>
</contact>
</location>
<location>
<facility>
<name>Faculty of Medicine Siriraj Hospital ( Site 4102)</name>
<address>
<city>Bangkok</city>
<state>Krung Thep Maha Nakhon</state>
<zip>10700</zip>
<country>Thailand</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+6624194488</phone>
</contact>
</location>
<location>
<facility>
<name>Hacettepe Universite Hastaneleri-oncology hospital ( Site 3402)</name>
<address>
<city>Ankara</city>
<zip>06230</zip>
<country>Turkey</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>+903123052910</phone>
</contact>
</location>
<location>
<facility>
<name>Ankara Bilkent City Hospital-Medical Oncology ( Site 3405)</name>
<address>
<city>Ankara</city>
<zip>06800</zip>
<country>Turkey</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>905555306271</phone>
</contact>
</location>
<location>
<facility>
<name>TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3403)</name>
<address>
<city>Istanbul</city>
<zip>34722</zip>
<country>Turkey</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Study Coordinator</last_name>
<phone>00905063509061</phone>
</contact>
</location>
<location_countries>
<country>Brazil</country>
<country>Chile</country>
<country>China</country>
<country>Germany</country>
<country>Italy</country>
<country>Japan</country>
<country>Korea, Republic of</country>
<country>Norway</country>
<country>Singapore</country>
<country>Switzerland</country>
<country>Taiwan</country>
<country>Thailand</country>
<country>Turkey</country>
</location_countries>
<link>
<url>https://www.merckclinicaltrials.com/</url>
<description>Merck Clinical Trials Information</description>
</link>
<verification_date>September 2023</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>September 8, 2023</last_update_submitted>
<last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">September 11, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Esophageal cancer</keyword>
<keyword>Programmed Cell Death 1 (PD1, PD-1)</keyword>
<keyword>Programmed Cell Death 1 Ligand 1 (PDL-1, PD-L1)</keyword>
<keyword>Programmed Cell Death 1 Ligand 2 (PDL-2, PD-L2)</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Esophageal Neoplasms</mesh_term>
<mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Paclitaxel</mesh_term>
<mesh_term>Pembrolizumab</mesh_term>
<mesh_term>Irinotecan</mesh_term>
<mesh_term>Lenvatinib</mesh_term>
<mesh_term>Immunoglobulins</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
<ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study to evaluate
the safety and efficacy of investigational agents with pembrolizumab, with or without
chemotherapy, for the treatment of participants with second line (2L) esophageal squamous
cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 based treatment.
The master protocol is MK-3475-U06.
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of metastatic or locally advanced
unresectable ESCC.
- Has experienced investigator documented radiographic or clinical disease progression
on one prior line of standard therapy, that includes a platinum agent and previous
exposure to an anti-PD1/PD-L1 based therapy.
- Has an evaluable baseline tumor sample (newly obtained or archival) for analysis.
- Has adequately controlled blood pressure (BP) with or without antihypertensive
medications.
- Participants who have adverse events (AEs) due to previous anticancer therapies must
have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who
are adequately treated with hormone replacement or participants who have ≤Grade 2
neuropathy are eligible.
Exclusion Criteria:
- Direct invasion into adjacent organs such as the aorta or trachea.
- Has experienced weight loss >10% over approximately 2 months prior to first dose of
study therapy.
- Currently participating in or has participated in a study of an investigational agent
or has used an investigational device within 4 weeks before the first dose of study
intervention.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any
other form of immunosuppressive therapy within 7 days prior to the first dose of study
medication.
- Known additional malignancy that is progressing or has required active treatment
within the past 3 years, except basal cell carcinoma of the skin, squamous cell
carcinoma of the skin, or carcinoma in situ that has undergone potentially curative
therapy.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Active autoimmune disease that has required systemic treatment in past 2 years.
- History of human immunodeficiency virus (HIV) infection.
- History of Hepatitis B or known active Hepatitis C virus infection.
- History of allogenic tissue/solid organ transplant.
- Clinically significant cardiovascular disease within 12 months from first dose of
study intervention.
- Gastrointestinal (GI) obstruction, poor oral intake, or difficulty in taking oral
medication.
- Has risk for significant GI bleeding, such as:
- Has had a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days
prior to allocation/randomization.
- Has significant bleeding disorders, vasculitis, or has had a significant bleeding
episode from the GI tract within 12 weeks prior to allocation/randomization.
|
NCT0531xxxx/NCT05319743.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319743</url>
</required_header>
<id_info>
<org_study_id>22-001139</org_study_id>
<nct_id>NCT05319743</nct_id>
</id_info>
<brief_title>Evaluating Quality and Value of US Ambulatory Care Delivered Among Medicaid Expansion/Non-Expansion States, 2012-2015</brief_title>
<official_title>Evaluating the Quality and Value of U.S. Ambulatory Care Delivered Among Medicaid Expansion States and Non-Expansion States, 2012-2015</official_title>
<sponsors>
<lead_sponsor>
<agency>University of California, Los Angeles</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>University of Michigan</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>University of California, Los Angeles</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Quasi-experimental pre-post analysis of the rate of high-value and low-value care services
between states that expanded Medicaid and states that did not expand Medicaid January 1,
2014, for adult ambulatory visits, using visit-level survey data from the National Ambulatory
Medical Care Survey January 1, 2012 - December 31, 2015.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Data Source: Visit level data obtained from the National Ambulatory Medical Care Survey
(NAMCS) between January 1, 2012-December 31, 2015.

Identification of Observations (Visits) for Primary Analysis: Adult visits in states that did
expand Medicaid January 1, 2014 (experimental group) and states that did not expand Medicaid
January 1, 2014 (control group). Eight Medicaid expansion states (experimental group):
Arizona, California, Illinois, Massachusetts, New Jersey, Ohio, Washington Five states that
did not expand Medicaid (control group): Florida, Georgia, North Carolina, Texas, Virginia.
Visits will be included only if they could receive a low value service (visits for back pain,
headache, general medical exam, URI) or high value service (visits with patients who have
CAD, DM, CVD, Depression, CHF, Osteoporosis and no exclusion to receive the indicated high
value service) when evaluating low value service counts and high value service counts
respectively as opposed to all adult visits regardless of the opportunity to receive a high
value or low value care service (e.g. visit for hand pain and none of the high or low value
areas above.)

Identification of Observations (Visits) for Secondary Analyses: Medicaid patient
subpopulation will be defined as those visits for primary analysis that are coded with
Medicaid as a pay type for the visit. "New" Medicaid patient subpopulation will be defined as
those visits for primary analysis that are coded with Medicaid as a pay type, have not seen
before, to a provider who is accepting new patients and accepts Medicaid for new patients.

Create Indicator Variables for Primary and Secondary Outcome Analyses: Develop a set of low
value and high value services with distinct inclusion and exclusion criteria for each
service. Create indicator variable for each high value and low value service. Low value care
measures (Imaging for Low Back Pain, Opioid for Low Back Pain, Opioid for Headache, Imaging
for Headache, Antibiotic for Upper Respiratory Infection, General Medical Examination with
ECG ordered, General Medical Examination with Urinalysis ordered.) High value care measures
(Antiplatelet for CAD, Beta Blocker for CAD, Statin for CAD, Anticoagulation for Atrial
Fibrillation, Statin for DM, Antiplatelet CVD, Treatment for Depression, Beta Blocker for
CHF, ACE/ARB/ARNI for CHF, Treatment for Osteoporosis)

Analysis: Evaluate for pre-intervention (Medicaid Expansion) parallel trends (This has
already been established). Then perform pre-post difference-in-differences analyses of
primary and secondary outcomes between the experimental group (states that expanded Medicaid)
and control group (states that did not expand Medicaid). Regression analysis will be
performed to adjust for respondent age, sex, race/ethnicity, number of chronic illnesses, and
clinic rural/urban location. Stratified models based on payer type will allow for analyses of
the Medicaid population. Perform sensitivity analyses of primary and secondary outcomes.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">October 1, 2021</start_date>
<completion_date type="Actual">May 1, 2022</completion_date>
<primary_completion_date type="Actual">May 1, 2022</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Retrospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Rate of low-value and high-value services for adult ambulatory visits.</measure>
<time_frame>pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion</time_frame>
<description>Ex. Numerator = count of high value services provided for adult visits in Medicaid expansion states in 2012/ Denominator = Count of adult visits in Medicaid expansion state in 2012 that had the potential to receive a high value service.</description>
</primary_outcome>
<secondary_outcome>
<measure>Adult ambulatory visit volume changes</measure>
<time_frame>pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion</time_frame>
<description>All adults, Medicaid adults, "New" Medicaid adults</description>
</secondary_outcome>
<secondary_outcome>
<measure>Rate of low-value and high-value services for Medicaid adult ambulatory visits</measure>
<time_frame>pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion</time_frame>
<description>Ex. Numerator = count of high value services provided for Medicaid adult visits in Medicaid expansion states in 2012/ Denominator = Count of Medicaid adult visits in Medicaid expansion state in 2012 that had the potential to receive a high value service</description>
</secondary_outcome>
<secondary_outcome>
<measure>Rate of low-value and high-value services for "New" Medicaid adult ambulatory visits.</measure>
<time_frame>pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion</time_frame>
<description>Ex. Numerator = count of high value services provided for "New" Medicaid adult visits in Medicaid expansion states in 2012/ Denominator = Count of "New" Medicaid adult visits in Medicaid expansion state in 2012 that had the potential to receive a high value service.</description>
</secondary_outcome>
<other_outcome>
<measure>Sensitivity analysis: repeat primary and secondary analysis with all adult visits, Medicaid visits, and "New" Medicaid visits</measure>
<time_frame>pre (01/01/2012 - 12/31/2013) and post (01/01/2014 - 12/31/2015) Medicaid expansion</time_frame>
<description>1. Repeat primary and secondary analysis with all adult visits, Medicaid visits and "New" Medicaid visits with a denominator of all visits (not the denominator of visits with potential to receive low or high value service as described for the primary analyses)</description>
</other_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Actual">200000</enrollment>
<condition>Medicaid Expansion</condition>
<arm_group>
<arm_group_label>Medicaid expansion states</arm_group_label>
<description>Eight Medicaid expansion states: (experimental group): Arizona, California, Illinois, Massachusetts, New Jersey, Ohio, Washington</description>
</arm_group>
<arm_group>
<arm_group_label>Non-Medicaid expansion states</arm_group_label>
<description>Five states that did not expand Medicaid (control group): Florida, Georgia, North Carolina, Texas, Virginia</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Medicaid Expansion</intervention_name>
<description>Expansion of Medicaid, 01/01/2014</description>
<arm_group_label>Medicaid expansion states</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
NAMCS Adult Visits between 01/01/2012 and 12/31/2015. The data source is a nationally
representative probability sample of U.S. ambulatory care visits
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- ≥18 years old

- Visits between 01/01/2012 and 12/31/2015

Exclusion Criteria:

- <18 years old

- Visits before 01/01/2012

- Visits after 12/31/2015
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>The University of Michigan</name>
<address>
<city>Ann Arbor</city>
<state>Michigan</state>
<zip>48109</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>February 2023</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>February 1, 2023</last_update_submitted>
<last_update_submitted_qc>February 1, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">February 3, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
<investigator_full_name>John N. Mafi, MD, MPH</investigator_full_name>
<investigator_title>Associate Professor of Medicine</investigator_title>
</responsible_party>
<keyword>High-value care</keyword>
<keyword>Low-value care</keyword>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>Publicly available NAMCS data</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Quasi-experimental pre-post analysis of the rate of high-value and low-value care services
between states that expanded Medicaid and states that did not expand Medicaid January 1,
2014, for adult ambulatory visits, using visit-level survey data from the National Ambulatory
Medical Care Survey January 1, 2012 - December 31, 2015.
Data Source: Visit level data obtained from the National Ambulatory Medical Care Survey
(NAMCS) between January 1, 2012-December 31, 2015.
Identification of Observations (Visits) for Primary Analysis: Adult visits in states that did
expand Medicaid January 1, 2014 (experimental group) and states that did not expand Medicaid
January 1, 2014 (control group). Eight Medicaid expansion states (experimental group):
Arizona, California, Illinois, Massachusetts, New Jersey, Ohio, Washington Five states that
did not expand Medicaid (control group): Florida, Georgia, North Carolina, Texas, Virginia.
Visits will be included only if they could receive a low value service (visits for back pain,
headache, general medical exam, URI) or high value service (visits with patients who have
CAD, DM, CVD, Depression, CHF, Osteoporosis and no exclusion to receive the indicated high
value service) when evaluating low value service counts and high value service counts
respectively as opposed to all adult visits regardless of the opportunity to receive a high
value or low value care service (e.g. visit for hand pain and none of the high or low value
areas above.)
Identification of Observations (Visits) for Secondary Analyses: Medicaid patient
subpopulation will be defined as those visits for primary analysis that are coded with
Medicaid as a pay type for the visit. "New" Medicaid patient subpopulation will be defined as
those visits for primary analysis that are coded with Medicaid as a pay type, have not seen
before, to a provider who is accepting new patients and accepts Medicaid for new patients.
Create Indicator Variables for Primary and Secondary Outcome Analyses: Develop a set of low
value and high value services with distinct inclusion and exclusion criteria for each
service. Create indicator variable for each high value and low value service. Low value care
measures (Imaging for Low Back Pain, Opioid for Low Back Pain, Opioid for Headache, Imaging
for Headache, Antibiotic for Upper Respiratory Infection, General Medical Examination with
ECG ordered, General Medical Examination with Urinalysis ordered.) High value care measures
(Antiplatelet for CAD, Beta Blocker for CAD, Statin for CAD, Anticoagulation for Atrial
Fibrillation, Statin for DM, Antiplatelet CVD, Treatment for Depression, Beta Blocker for
CHF, ACE/ARB/ARNI for CHF, Treatment for Osteoporosis)
Analysis: Evaluate for pre-intervention (Medicaid Expansion) parallel trends (This has
already been established). Then perform pre-post difference-in-differences analyses of
primary and secondary outcomes between the experimental group (states that expanded Medicaid)
and control group (states that did not expand Medicaid). Regression analysis will be
performed to adjust for respondent age, sex, race/ethnicity, number of chronic illnesses, and
clinic rural/urban location. Stratified models based on payer type will allow for analyses of
the Medicaid population. Perform sensitivity analyses of primary and secondary outcomes.
NAMCS Adult Visits between 01/01/2012 and 12/31/2015. The data source is a nationally
representative probability sample of U.S. ambulatory care visits
Inclusion Criteria:
- ≥18 years old
- Visits between 01/01/2012 and 12/31/2015
Exclusion Criteria:
- <18 years old
- Visits before 01/01/2012
- Visits after 12/31/2015
|
NCT0531xxxx/NCT05319756.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319756</url>
</required_header>
<id_info>
<org_study_id>A9451180</org_study_id>
<nct_id>NCT05319756</nct_id>
</id_info>
<brief_title>Study Evaluating the Abuse Potential of NEURONTIN® in Healthy Non-drug Dependent, Recreational Opioid Users</brief_title>
<official_title>A Phase 4 Randomized Double-blind Double-dummy Placebo & Active-controlled Single-dose Six-way Crossover Study Evaluating Abuse Potential of NEURONTIN® Taken Orally With Oxycodone HCL in Healthy Non-drug Dependent Recreational Opioid Users</official_title>
<sponsors>
<lead_sponsor>
<agency>Viatris Specialty LLC</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Viatris Inc.</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This will be a randomized, double-blind, double-dummy, placebo- and active-controlled, 6
treatment, 6-period crossover single-dose, Williams square design study in healthy male
and/or female adult, non-drug-dependent recreational opioid users.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The study includes Screening, a Qualification Phase consisting of a Naloxone Challenge and
Drug Discrimination crossover study, a Treatment Phase and Follow-up. Following successful
completion of the Qualification Phase the participants will be enrolled in the Treatment
phase. The Treatment Phase is a randomized, double-blind, double dummy, placebo- and active
controlled, 6 treatment, 10-sequence, 6 period crossover, single-dose, Williams square design
study in healthy male and/or female adult, non drug-dependent recreational users. On Day 1 of
each of the Treatment Phase 6 periods, which will be separated by a washout of at least 14
days, participants will receive an oral dose of either gabapentin 600 mg or 1200 mg alone, or
concomitantly with a 20 mg dose of oxycodone HCl or 20 mg monotherapy of oxycodone HCl or a
placebo. Study treatments will be administered under fasted conditions (overnight fast and no
food until 4 hours after dosing). Water will be allowed without restriction until 1 hour
prior to dosing and 1 hour after dosing.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">April 30, 2021</start_date>
<completion_date type="Actual">December 31, 2021</completion_date>
<primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
<phase>Phase 4</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Crossover Assignment</intervention_model>
<primary_purpose>Other</primary_purpose>
<masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Bipolar Visual Analog Scale (VAS) for "Drug Liking" Maximum Effect (Emax).</measure>
<time_frame>up to 48 hours after treatments</time_frame>
<description>Drug liking assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
</primary_outcome>
<secondary_outcome>
<measure>Bipolar VAS for "Drug Liking" - Time to Maximum Effect (TEmax)</measure>
<time_frame>up to 48 hours after treatments</time_frame>
<description>Time after dosing when the maximum effect for Drug Liking VAS is reached</description>
</secondary_outcome>
<secondary_outcome>
<measure>Bipolar VAS for "Drug Liking": Area Under the Effect Curve From Time 0 to the Last Available Data (AUEClast)</measure>
<time_frame>Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<description>Area under the effect-time profile from time 0 to the time of the last available data for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
</secondary_outcome>
<secondary_outcome>
<measure>Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 1 Hour (AUEC1)</measure>
<time_frame>Up to 1 hour post-dose (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, and 1 hour)</time_frame>
<description>Area under the effect-time profile from time 0 to 1 hour post-dose for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
</secondary_outcome>
<secondary_outcome>
<measure>Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 2 Hours (AUEC2)</measure>
<time_frame>Up to 2 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, and 2 hours)</time_frame>
<description>Area under the effect-time profile from time 0 to 2 hours post-dose for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
</secondary_outcome>
<secondary_outcome>
<measure>Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 3 Hours (AUEC3)</measure>
<time_frame>up to 3 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, and 3 hours)</time_frame>
<description>Area under the effect-time profile from time 0 to 3 hours post-dose for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
</secondary_outcome>
<secondary_outcome>
<measure>Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 4 Hours (AUEC4)</measure>
<time_frame>Up to 4 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours)</time_frame>
<description>Area under the effect-time profile from time 0 to 4 hours post-dose for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
</secondary_outcome>
<secondary_outcome>
<measure>Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 8 Hours (AUEC8)</measure>
<time_frame>Up to 8 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours)</time_frame>
<description>Area under the effect-time profile from time 0 to 8 hours post-dose for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
</secondary_outcome>
<secondary_outcome>
<measure>Unipolar VAS for "High" - Maximum Effect (Emax)</measure>
<time_frame>up to 48 hours after treatments</time_frame>
<description>Maximum effect on the 100 mm visual analog scale for the question "I am feeling high" where 0 = "not at all" and 100 = "extremely"</description>
</secondary_outcome>
<secondary_outcome>
<measure>Unipolar VAS for "High": Time to Maximum Effect (TEmax)</measure>
<time_frame>up to 48 hours after treatments</time_frame>
<description>Time after dosing when the maximum effect for "High" VAS is reached</description>
</secondary_outcome>
<secondary_outcome>
<measure>Area Under the Effect Curve for "High" VAS (AUEClast)</measure>
<time_frame>Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<description>Area under the effect-time profile from time 0 to the time of the last available data for the "High" visual analog scale which measures on a 100 mm visual analog scale the subject's response to the question "I am feeling high" where 0 = "not at all" and 100 ="extremely"</description>
</secondary_outcome>
<secondary_outcome>
<measure>Bipolar VAS for "Take Drug Again"</measure>
<time_frame>Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)</time_frame>
<description>100 mm visual analog scale at 24, 36, and 48 hours post-dose for the question "I would take this drug again" where 0 = "definitely not", 50 = "neutral", and 100 = "definitely so". The data from the 24, 36, and 48 hours postdose measurements were combined into a single overall model-adjusted value for 24 to 48 hours post-treatment timeframe by estimation from a mixed model with treatment, period, treatment sequence, time, and treatment*time as fixed effects, subject nested within sequence as a random effect. The compound symmetric covariance matrix was employed. Data from all time points were included</description>
</secondary_outcome>
<secondary_outcome>
<measure>Bipolar VAS for "Overall Drug Liking"</measure>
<time_frame>Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)</time_frame>
<description>100 mm visual analog scale at 24, 36, and 48 hours post-dose for the question "Overall, my liking for this drug is" where 0 = "definitely not", 50 = "neutral", and 100 = "definitely so". The data from the 24, 36, and 48 hours postdose measurements were combined into a single overall model-adjusted value for 24 to 48 hours post-treatment timeframe by estimation from a mixed model with treatment, period, treatment sequence, time, and treatment*time as fixed effects, subject nested within sequence as a random effect. The compound symmetric covariance matrix was employed. Data from all time points were included</description>
</secondary_outcome>
<secondary_outcome>
<measure>Unipolar VAS for "Good Drug Effect"</measure>
<time_frame>up to 48 hours after treatments</time_frame>
<description>100 mm visual analog scale for the question "At this moment, I can feel good drug effects" where 0 = "not at all" and 100 = "extremely"</description>
</secondary_outcome>
<secondary_outcome>
<measure>Unipolar VAS for "Bad Drug Effect"</measure>
<time_frame>up to 48 hours after treatments</time_frame>
<description>100 mm visual analog scale for the question "At this moment, I can feel bad drug effects" where 0 = "not at all" and 100 = "extremely"</description>
</secondary_outcome>
<secondary_outcome>
<measure>Unipolar VAS for "Any Drug Effect"</measure>
<time_frame>up to 48 hours after treatments</time_frame>
<description>100 mm visual analog scale for the question "At this moment, I can feel any drug effects" where 0 = "not at all" and 100 = "extremely"</description>
</secondary_outcome>
<secondary_outcome>
<measure>Cmax of Gabapentin</measure>
<time_frame>Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<description>Maximum plasma concentration of gabapentin</description>
</secondary_outcome>
<secondary_outcome>
<measure>Tmax of Gabapentin</measure>
<time_frame>Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<description>Time when the maximum concentration of gabapentin is reached</description>
</secondary_outcome>
<secondary_outcome>
<measure>AUCinf of Gabapentin</measure>
<time_frame>Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<description>Area under the plasma concentration/time curve from time 0 extrapolated to infinity time of gabapentin</description>
</secondary_outcome>
<secondary_outcome>
<measure>AUClast of Gabapentin</measure>
<time_frame>Up to 48 hours after treatment (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<description>Area under the plasma concentration/time profile from time 0 to the time of the last quantifiable concentration of gabapentin</description>
</secondary_outcome>
<secondary_outcome>
<measure>Half-life (t½) of Gabapentin</measure>
<time_frame>Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<description>Half-life (t½) of gabapentin</description>
</secondary_outcome>
<secondary_outcome>
<measure>Cmax of Oxycodone</measure>
<time_frame>Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<description>Maximum plasma concentration of Oxycodone</description>
</secondary_outcome>
<secondary_outcome>
<measure>Tmax of Oxycodone</measure>
<time_frame>Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<description>Time when the maximum concentration of Oxycodone is reached</description>
</secondary_outcome>
<secondary_outcome>
<measure>AUCinf of Oxycodone</measure>
<time_frame>Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<description>Area under the plasma concentration/time curve from time 0 extrapolated to infinity time of Oxycodone</description>
</secondary_outcome>
<secondary_outcome>
<measure>AUClast of Oxycodone</measure>
<time_frame>Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<description>Area under the plasma concentration/time profile from time 0 to the time of the last quantifiable concentration of Oxycodone</description>
</secondary_outcome>
<secondary_outcome>
<measure>Half-life (t½) of Oxycodone</measure>
<time_frame>Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<description>Half-life (t½) of Oxycodone</description>
</secondary_outcome>
<number_of_arms>6</number_of_arms>
<enrollment type="Actual">54</enrollment>
<condition>Abuse Potential</condition>
<arm_group>
<arm_group_label>gabapentin 600 mg single dose</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>gabapentin 1200 mg single dose</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>gabapentin 600 mg and oxycodone HCl 20 mg</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>gabapentin 1200 mg and oxycodone HCl 20 mg</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>oxycodone HCl 20 mg single dose</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>placebo single dose</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>gabapentin 600 mg</intervention_name>
<description>Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
<arm_group_label>gabapentin 600 mg single dose</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>gabapentin 1200 mg</intervention_name>
<description>Participants will receive a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
<arm_group_label>gabapentin 1200 mg single dose</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>gabapentin 600 mg and oxycodone HCl 20 mg</intervention_name>
<description>Participants will receive a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
<arm_group_label>gabapentin 600 mg and oxycodone HCl 20 mg</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>gabapentin 1200 mg and oxycodone HCl 20 mg</intervention_name>
<description>Participants will receive a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
<arm_group_label>gabapentin 1200 mg and oxycodone HCl 20 mg</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>oxycodone HCl 20 mg</intervention_name>
<description>Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
<arm_group_label>oxycodone HCl 20 mg single dose</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>placebo</intervention_name>
<description>Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl</description>
<arm_group_label>placebo single dose</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Male and female participants must be 18 to 55 years of age, inclusive, at the time of
screening. Participants must meet reproductive criteria as outlined in the protocol.

2. Male and female participants who are overtly healthy. Healthy is defined as no
clinically relevant abnormalities identified by a detailed medical history, complete
physical examination, vital signs, 12-lead ECG, and/or clinical laboratory tests.

3. Participants must have drug abuse experience with opioids; ie, must have used opioids
for non-therapeutic purposes (ie, for psychoactive effects) on at least 10 occasions
within the last year and at least once in the 8 weeks before the Screening Visit
(Visit 1).

4. Participants must satisfactorily complete both the Naloxone Challenge and the Drug
Discrimination.

5. Participants who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, lifestyle considerations, and other study procedures.

6. Body mass index (BMI) of 17.5 to 34 kg/m2, inclusive; and a total body weight ≥50 kg
(110 lb).

7. Capable of giving signed informed consent as described in the protocol, which includes
compliance with the requirements and restrictions listed in the informed consent
document (ICD) and in this protocol.

Exclusion Criteria:

1. Current or past diagnosis of any type of drug dependence within the past year.
Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine)
will be assessed by the Investigator using the Diagnostic and Statistical Manual of
Mental Disorders-IV (DSM-IV) criteria performed at Screening. Current drug use will be
allowed if the candidate can produce a negative urine sample and are free of any
signs/symptoms of withdrawal. The candidate will be informed if they have a positive
breathalyzer test.

2. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).

3. Any condition possibly affecting drug absorption (eg, gastrectomy) excluding
cholecystectomy within 1 year prior to study.

4. Abnormal baseline EtCO2 <35mm Hg or >45 mm Hg.

5. Clinical or laboratory evidence of active hepatitis A infection or a history of human
immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C, and/or positive
testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody
(HBcAb), or hepatitis C antibody (HCVAb).

6. Participants with active suicidal ideation or suicidal behavior within 5 years prior
to Screening as determined through the use of the Columbia Suicide Severity Rating
Scale (C-SSRS) or active ideation identified at Screening or on Day 0.

7. Participants with any history of sleep apnea, myasthenia gravis or glaucoma.

8. Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the participant inappropriate for entry into
this study.

9. Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half lives (whichever is longer) prior to the first dose of investigational product.
(Refer to Section 6.5 for additional details).

10. Herbal supplements, herbal medications and hormone replacement therapy must be
discontinued at least 28 days prior to the first dose of study medication.

11. Previous administration with an investigational drug within 30 days (or as determined
by the local requirement) or 5 half lives (whichever is longer) preceding the first
dose of investigational product used in this study.

12. Positive urine drug screen (UDS) for substances of abuse at each admission in
Qualification and Treatment Phase, excluding tetrahydrocannabinol (THC). If a
participant presents with a positive UDS excluding THC at any admission or any visit,
the investigator, at his/her discretion, may reschedule a repeat of UDS until the UDS
is negative, excluding THC, before the participate is permitted to participate in any
phase of the study.

13. Unable to abstain from using THC during the Qualification and Treatment Phase of the
study.

14. Has participated in, is currently participating in, or is seeking treatment for
substance and/or alcohol related disorders (excluding nicotine and caffeine).

15. Has a positive alcohol breathalyzer or urine test at each admission to the study
center during Qualification and Treatment Phases. Positive results may be repeated
and/or participants re scheduled at the Investigator's discretions.

16. Participants are heavy smokers or users of other types of nicotine products (>20
cigarettes equivalents per day).

17. Participants are unable to abstain from smoking for at least 2 hours before and at
least 8 hours after study drug administration.

18. Screening sitting blood pressure (BP) >=140 mm Hg (systolic) or >=90 mm Hg
(diastolic), following at least 5 minutes rest. If BP is >=140 mm Hg (systolic) or
>=90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the
3 BP values should be used to determine the participant's eligibility. Repeated BP
tests should be spaced at least 5 minutes apart.

19. Baseline (screening) 12 lead electrocardiogram (ECG) that demonstrates clinically
relevant abnormalities that may affect participant safety or interpretation of study
results (eg, baseline corrected QT (QTc) interval as determined by the Fridericia
method (QTcF) >450 msec, complete left bundle branch block [LBBB], signs of an acute
or indeterminate age myocardial infarction, ST T interval changes suggestive of
myocardial ischemia, second or third degree atrioventricular [AV] block, or serious
bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450
msec, this interval should be rate corrected using the Fridericia method and the
resulting QTcF should be used for decision making and reporting. If QTcF exceeds 450
msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average
of the 3 QTcF or QRS values should be used to determine the participant's eligibility.
Computer interpreted ECGs should be overread by a physician experienced in reading
ECGs before excluding participants.

20. Participants with ANY of the following abnormalities in clinical laboratory tests at
screening, as assessed by the study specific laboratory and confirmed by a single
repeat test, if deemed necessary:

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >=1.5 ×
upper limit of normal (ULN);

- Total bilirubin level >=1.5 × ULN; participants with a history of Gilbert's
syndrome may have direct bilirubin measured and would be eligible for this study
provided the direct bilirubin level is <= ULN.

21. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.

22. History of sensitivity to heparin or heparin induced thrombocytopenia.

23. Unwilling or unable to comply with the criteria in the Lifestyle Considerations
section of this protocol.

24. History of hypersensitivity to gabapentin or oxycodone or any of the components in the
formulation of the study products.

25. Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
Sponsor employees, including their family members, directly involved in the conduct of
the study.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>55 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Dik WH NG, PhD</last_name>
<role>Study Director</role>
<affiliation>Viatris Inc.</affiliation>
</overall_official>
<location>
<facility>
<name>Hassman Research Institute</name>
<address>
<city>Marlton</city>
<state>New Jersey</state>
<zip>080503</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>July 2023</verification_date>
<study_first_submitted>March 8, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<results_first_submitted>April 17, 2023</results_first_submitted>
<results_first_submitted_qc>July 21, 2023</results_first_submitted_qc>
<results_first_posted type="Actual">August 14, 2023</results_first_posted>
<last_update_submitted>July 21, 2023</last_update_submitted>
<last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">August 14, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Neurontin</keyword>
<keyword>Oxycodone</keyword>
<keyword>Abuse Liability</keyword>
<keyword>Gabapentin</keyword>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Oxycodone</mesh_term>
<mesh_term>Gabapentin</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<provided_document_section>
<provided_document>
<document_type>Study Protocol</document_type>
<document_has_protocol>Yes</document_has_protocol>
<document_has_icf>No</document_has_icf>
<document_has_sap>No</document_has_sap>
<document_date>March 12, 2021</document_date>
<document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT05319756/Prot_000.pdf</document_url>
</provided_document>
<provided_document>
<document_type>Statistical Analysis Plan</document_type>
<document_has_protocol>No</document_has_protocol>
<document_has_icf>No</document_has_icf>
<document_has_sap>Yes</document_has_sap>
<document_date>September 14, 2022</document_date>
<document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT05319756/SAP_001.pdf</document_url>
</provided_document>
</provided_document_section>
<clinical_results>
<participant_flow>
<pre_assignment_details>Subjects were entered into a Qualification phase involving a naloxone challenge test (to exclude subjects who were opioid dependent) and a drug discrimination test (to confirm they can tell the difference between oxycodone and placebo). Only subjects who passed the tests in the Qualification phase were randomized into the Treatment phase where they received the 6 different single dose study treatments, each separated by a washout of at least 4 days, in the order specified for Sequences 1-6 below</pre_assignment_details>
<group_list>
<group group_id="P1">
<title>Sequence 1</title>
<description>Period 1: Oxycodone 20 mg; Period 2: Placebo; Period 3: Gabapentin 1200 mg plus Oxycodone 20 mg; Period 4: Gabapentin 600 mg; Period 5: Gabapentin 600 mg plus Oxycodone 20 mg; Period 6: Gabapentin 1200 mg</description>
</group>
<group group_id="P2">
<title>Sequence 2</title>
<description>Period 1: Placebo; Period 2: Gabapentin 600 mg; Period 3: Oxycodone 20 mg; Period 4: Gabapentin 1200 mg; Period 5: Gabapentin 1200 mg plus Oxycodone 20 mg; Period 6: Gabapentin 600 mg plus Oxycodone 20 mg</description>
</group>
<group group_id="P3">
<title>Sequence 3</title>
<description>Period 1: Gabapentin 600 mg; Period 2: Gabapentin 1200 mg; Period 3: Placebo; Period 4 Gabapentin 600 mg plus Oxycodone 20 mg; Period 5: Oxycodone 20 mg; Period 6: Gabapentin 1200 mg plus Oxycodone 20 mg</description>
</group>
<group group_id="P4">
<title>Sequence 4</title>
<description>Period 1: Gabapentin 1200 mg; Period 2: Gabapentin 600 mg plus Oxycodone 20 mg; Period 3: Gabapentin 600 mg; Period 4: Gabapentin 1200 mg plus Oxycodone 20 mg; Period 5: Placebo; Period 6: Oxycodone 20 mg</description>
</group>
<group group_id="P5">
<title>Sequence 5</title>
<description>Period 1: Gabapentin 600 mg plus Oxycodone 20 mg; Period 2: Gabapentin 1200 mg plus Oxycodone 20 mg; Period 3: Gabapentin 1200 mg; Period 4: Oxycodone 20 mg; Period 5: Gabapentin 600 mg; Period 6: Placebo</description>
</group>
<group group_id="P6">
<title>Sequence 6</title>
<description>Period 1: Gabapentin 1200 mg plus Oxycodone 20 mg; Period 2: Oxycodone 20 mg; Period 3: Gabapentin 600 mg plus Oxycodone 20 mg; Period 4: Placebo; Period 5: Gabapentin 1200 mg; Period 6: Gabapentin 600 mg</description>
</group>
</group_list>
<period_list>
<period>
<title>Overall Study</title>
<milestone_list>
<milestone>
<title>STARTED</title>
<participants_list>
<participants group_id="P1" count="9"/>
<participants group_id="P2" count="9"/>
<participants group_id="P3" count="9"/>
<participants group_id="P4" count="9"/>
<participants group_id="P5" count="9"/>
<participants group_id="P6" count="9"/>
</participants_list>
</milestone>
<milestone>
<title>COMPLETED</title>
<participants_list>
<participants group_id="P1" count="8"/>
<participants group_id="P2" count="8"/>
<participants group_id="P3" count="9"/>
<participants group_id="P4" count="9"/>
<participants group_id="P5" count="8"/>
<participants group_id="P6" count="8"/>
</participants_list>
</milestone>
<milestone>
<title>NOT COMPLETED</title>
<participants_list>
<participants group_id="P1" count="1"/>
<participants group_id="P2" count="1"/>
<participants group_id="P3" count="0"/>
<participants group_id="P4" count="0"/>
<participants group_id="P5" count="1"/>
<participants group_id="P6" count="1"/>
</participants_list>
</milestone>
</milestone_list>
</period>
</period_list>
</participant_flow>
<baseline>
<population>The randomized population included all participants who were randomized to a treatment sequence in the Treatment Phase.</population>
<group_list>
<group group_id="B1">
<title>Randomized Population</title>
<description>All participants who were randomized to a treatment sequence in the Treatment Phase.</description>
</group>
</group_list>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Overall</scope>
<count_list>
<count group_id="B1" value="54"/>
</count_list>
</analyzed>
</analyzed_list>
<measure_list>
<measure>
<title>Age</title>
<units>Years</units>
<param>Mean</param>
<dispersion>Standard Deviation</dispersion>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="B1" value="33.3" spread="8.41"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<measure>
<title>Sex: Female, Male</title>
<units>Participants</units>
<param>Count of Participants</param>
<class_list>
<class>
<category_list>
<category>
<title>Female</title>
<measurement_list>
<measurement group_id="B1" value="16"/>
</measurement_list>
</category>
<category>
<title>Male</title>
<measurement_list>
<measurement group_id="B1" value="38"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<measure>
<title>Ethnicity (NIH/OMB)</title>
<units>Participants</units>
<param>Count of Participants</param>
<class_list>
<class>
<category_list>
<category>
<title>Hispanic or Latino</title>
<measurement_list>
<measurement group_id="B1" value="12"/>
</measurement_list>
</category>
<category>
<title>Not Hispanic or Latino</title>
<measurement_list>
<measurement group_id="B1" value="42"/>
</measurement_list>
</category>
<category>
<title>Unknown or Not Reported</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<measure>
<title>Race (NIH/OMB)</title>
<units>Participants</units>
<param>Count of Participants</param>
<class_list>
<class>
<category_list>
<category>
<title>American Indian or Alaska Native</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
</measurement_list>
</category>
<category>
<title>Asian</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
</measurement_list>
</category>
<category>
<title>Native Hawaiian or Other Pacific Islander</title>
<measurement_list>
<measurement group_id="B1" value="1"/>
</measurement_list>
</category>
<category>
<title>Black or African American</title>
<measurement_list>
<measurement group_id="B1" value="35"/>
</measurement_list>
</category>
<category>
<title>White</title>
<measurement_list>
<measurement group_id="B1" value="13"/>
</measurement_list>
</category>
<category>
<title>More than one race</title>
<measurement_list>
<measurement group_id="B1" value="4"/>
</measurement_list>
</category>
<category>
<title>Unknown or Not Reported</title>
<measurement_list>
<measurement group_id="B1" value="1"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<measure>
<title>Region of Enrollment</title>
<units>participants</units>
<param>Number</param>
<class_list>
<class>
<title>United States</title>
<category_list>
<category>
<measurement_list>
<measurement group_id="B1" value="54"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</measure_list>
</baseline>
<outcome_list>
<outcome>
<type>Primary</type>
<title>Bipolar Visual Analog Scale (VAS) for "Drug Liking" Maximum Effect (Emax).</title>
<description>Drug liking assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
<time_frame>up to 48 hours after treatments</time_frame>
<population>The analysis population was the modified completer population which included subjects who completed all 6 treatment periods but excluded those identified during data review as having maximum Drug Liking scores that were similar for all 6 treatments or who had high placebo responses</population>
<group_list>
<group group_id="O1">
<title>Placebo</title>
<description>Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O5">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O6">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Bipolar Visual Analog Scale (VAS) for "Drug Liking" Maximum Effect (Emax).</title>
<description>Drug liking assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
<population>The analysis population was the modified completer population which included subjects who completed all 6 treatment periods but excluded those identified during data review as having maximum Drug Liking scores that were similar for all 6 treatments or who had high placebo responses</population>
<units>Score on a 100 mm scale</units>
<param>Mean</param>
<dispersion>Standard Error</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="42"/>
<count group_id="O2" value="42"/>
<count group_id="O3" value="42"/>
<count group_id="O4" value="42"/>
<count group_id="O5" value="42"/>
<count group_id="O6" value="42"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="54.89" spread="2.116"/>
<measurement group_id="O2" value="87.40" spread="3.156"/>
<measurement group_id="O3" value="57.89" spread="3.142"/>
<measurement group_id="O4" value="63.62" spread="3.334"/>
<measurement group_id="O5" value="88.43" spread="3.216"/>
<measurement group_id="O6" value="92.17" spread="2.713"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<analysis_list>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O2</group_id>
</group_id_list>
<groups_desc>The sensitivity and integrity of the study was validated by comparing the mean responses of oxycodone HCl, the positive control (C), to the placebo (P):
H0: μC - μP ≤ δ1 versus Ha: μC - μP > δ1 where δ1 =15</groups_desc>
<non_inferiority_type>Superiority</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>32.8</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>4.00</dispersion_value>
<ci_percent>95</ci_percent>
<ci_n_sides>1-Sided</ci_n_sides>
<ci_lower_limit>26.1</ci_lower_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O2</group_id>
<group_id>O5</group_id>
</group_id_list>
<groups_desc>The primary analysis evaluated whether gabapentin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):
H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC <0.2(μC - μP).</groups_desc>
<non_inferiority_type>Non-Inferiority</non_inferiority_type>
<non_inferiority_desc>Non-inferiority margin = 0</non_inferiority_desc>
<p_value>0.1041</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-5.6</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>4.46</dispersion_value>
<ci_percent>95</ci_percent>
<ci_n_sides>1-Sided</ci_n_sides>
<ci_upper_limit>1.7</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O2</group_id>
<group_id>O6</group_id>
</group_id_list>
<groups_desc>The primary analysis evaluated whether gabapentin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):
H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC <0.2(μC - μP).</groups_desc>
<non_inferiority_type>Non-Inferiority</non_inferiority_type>
<non_inferiority_desc>Non-inferiority margin = 0</non_inferiority_desc>
<p_value>0.3373</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-1.9</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>4.46</dispersion_value>
<ci_percent>95</ci_percent>
<ci_n_sides>1-Sided</ci_n_sides>
<ci_upper_limit>5.5</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O3</group_id>
</group_id_list>
<groups_desc>The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show less abuse potential than oxycodone HCl (C) were:
H0: μC - μG ≤ 0.2(μC - 50) versus Ha: μC - μG >0.2(μC - 50)</groups_desc>
<non_inferiority_type>Non-Inferiority</non_inferiority_type>
<non_inferiority_desc>Non-inferiority margin = 10</non_inferiority_desc>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-12.3</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>3.63</dispersion_value>
<ci_percent>95</ci_percent>
<ci_n_sides>1-Sided</ci_n_sides>
<ci_upper_limit>-6.3</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O4</group_id>
</group_id_list>
<groups_desc>The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show less abuse potential than oxycodone HCl (C) were:
H0: μC - μG ≤ 0.2(μC - 50) versus Ha: μC - μG >0.2(μC - 50)</groups_desc>
<non_inferiority_type>Non-Inferiority</non_inferiority_type>
<non_inferiority_desc>Non-inferiority margin = 10</non_inferiority_desc>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-6.7</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>3.64</dispersion_value>
<ci_percent>95</ci_percent>
<ci_n_sides>1-Sided</ci_n_sides>
<ci_upper_limit>-0.6</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O3</group_id>
</group_id_list>
<groups_desc>The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show abuse potential similar to placebo(P) were:
H0: μG - μP ≥ δ2 versus Ha: μG - μP < δ2 where δ2 =11</groups_desc>
<non_inferiority_type>Non-Inferiority</non_inferiority_type>
<non_inferiority_desc>Non-inferiority margin = 11</non_inferiority_desc>
<p_value>0.0232</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>3.0</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>4.00</dispersion_value>
<ci_percent>95</ci_percent>
<ci_n_sides>1-Sided</ci_n_sides>
<ci_upper_limit>9.6</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O4</group_id>
</group_id_list>
<groups_desc>The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show abuse potential similar to placebo(P) were:
H0: μG - μP ≥ δ2 versus Ha: μG - μP < δ2 where δ2 =11.</groups_desc>
<non_inferiority_type>Non-Inferiority</non_inferiority_type>
<non_inferiority_desc>Non-inferiority margin = 11</non_inferiority_desc>
<p_value>0.2767</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>8.6</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>4.01</dispersion_value>
<ci_percent>95</ci_percent>
<ci_n_sides>1-Sided</ci_n_sides>
<ci_upper_limit>15.2</ci_upper_limit>
</analysis>
</analysis_list>
</outcome>
<outcome>
<type>Secondary</type>
<title>Bipolar VAS for "Drug Liking" - Time to Maximum Effect (TEmax)</title>
<description>Time after dosing when the maximum effect for Drug Liking VAS is reached</description>
<time_frame>up to 48 hours after treatments</time_frame>
<population>Modified completer population</population>
<group_list>
<group group_id="O1">
<title>Placebo Single Dose</title>
<description>placebo: Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>oxycodone HCl 20 mg: Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg Single Dose</title>
<description>gabapentin 600 mg: Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg Single Dose</title>
<description>gabapentin 1200 mg: Participants will receive a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O5">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>gabapentin 600 mg and oxycodone HCl 20 mg: Participants will receive a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O6">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>gabapentin 1200 mg and oxycodone HCl 20 mg: Participants will receive a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Bipolar VAS for "Drug Liking" - Time to Maximum Effect (TEmax)</title>
<description>Time after dosing when the maximum effect for Drug Liking VAS is reached</description>
<population>Modified completer population</population>
<units>hours</units>
<param>Median</param>
<dispersion>Full Range</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="42"/>
<count group_id="O2" value="42"/>
<count group_id="O3" value="42"/>
<count group_id="O4" value="42"/>
<count group_id="O5" value="42"/>
<count group_id="O6" value="42"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="0.25" lower_limit="0.2" upper_limit="24.0"/>
<measurement group_id="O2" value="1.00" lower_limit="0.2" upper_limit="3.5"/>
<measurement group_id="O3" value="0.25" lower_limit="0.25" upper_limit="2.5"/>
<measurement group_id="O4" value="0.28" lower_limit="0.1" upper_limit="12.1"/>
<measurement group_id="O5" value="1.00" lower_limit="0.2" upper_limit="12.0"/>
<measurement group_id="O6" value="1.50" lower_limit="0.2" upper_limit="4.0"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
<outcome>
<type>Secondary</type>
<title>Bipolar VAS for "Drug Liking": Area Under the Effect Curve From Time 0 to the Last Available Data (AUEClast)</title>
<description>Area under the effect-time profile from time 0 to the time of the last available data for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
<time_frame>Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<population>Modified completer population</population>
<group_list>
<group group_id="O1">
<title>Placebo Single Dose</title>
<description>Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants will receive a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O5">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants will receive a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O6">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants will receive a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Bipolar VAS for "Drug Liking": Area Under the Effect Curve From Time 0 to the Last Available Data (AUEClast)</title>
<description>Area under the effect-time profile from time 0 to the time of the last available data for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
<population>Modified completer population</population>
<units>units on a scale * hour</units>
<param>Mean</param>
<dispersion>Standard Error</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="42"/>
<count group_id="O2" value="42"/>
<count group_id="O3" value="42"/>
<count group_id="O4" value="42"/>
<count group_id="O5" value="42"/>
<count group_id="O6" value="42"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="2394.21" spread="65.274"/>
<measurement group_id="O2" value="2661.43" spread="84.274"/>
<measurement group_id="O3" value="2422.37" spread="85.855"/>
<measurement group_id="O4" value="2444.4" spread="83.580"/>
<measurement group_id="O5" value="2744.86" spread="76.342"/>
<measurement group_id="O6" value="2759.57" spread="74.589"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<analysis_list>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O2</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0016</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>267.1</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>83.688</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>128.8</ci_lower_limit>
<ci_upper_limit>405.4</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O3</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.7276</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>29.19</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>83.688</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-109</ci_lower_limit>
<ci_upper_limit>167.5</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O4</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.5481</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>50.41</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>83.785</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-88.0</ci_lower_limit>
<ci_upper_limit>188.9</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O5</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>350.7</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>84.023</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>211.8</ci_lower_limit>
<ci_upper_limit>489.5</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O6</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>364.4</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>83.785</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>225.9</ci_lower_limit>
<ci_upper_limit>502.8</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O3</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0050</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-238</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>83.785</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-376</ci_lower_limit>
<ci_upper_limit>-99.4</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O4</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0106</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-217</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>84.023</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-356</ci_lower_limit>
<ci_upper_limit>-77.8</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O5</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.3196</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>83.60</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>83.785</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-54.9</ci_lower_limit>
<ci_upper_limit>222.1</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O6</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.2464</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>97.29</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>83.688</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-41.0</ci_lower_limit>
<ci_upper_limit>235.6</ci_upper_limit>
</analysis>
</analysis_list>
</outcome>
<outcome>
<type>Secondary</type>
<title>Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 1 Hour (AUEC1)</title>
<description>Area under the effect-time profile from time 0 to 1 hour post-dose for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
<time_frame>Up to 1 hour post-dose (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, and 1 hour)</time_frame>
<population>Modified completer population</population>
<group_list>
<group group_id="O1">
<title>Placebo</title>
<description>Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O5">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O6">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 1 Hour (AUEC1)</title>
<description>Area under the effect-time profile from time 0 to 1 hour post-dose for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
<population>Modified completer population</population>
<units>units on a scale * hour</units>
<param>Mean</param>
<dispersion>Standard Error</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="42"/>
<count group_id="O2" value="42"/>
<count group_id="O3" value="42"/>
<count group_id="O4" value="42"/>
<count group_id="O5" value="42"/>
<count group_id="O6" value="42"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="50.17" spread="0.317"/>
<measurement group_id="O2" value="58.86" spread="1.478"/>
<measurement group_id="O3" value="51.28" spread="1.440"/>
<measurement group_id="O4" value="50.61" spread="0.568"/>
<measurement group_id="O5" value="57.02" spread="1.771"/>
<measurement group_id="O6" value="55.76" spread="1.390"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
<outcome>
<type>Secondary</type>
<title>Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 2 Hours (AUEC2)</title>
<description>Area under the effect-time profile from time 0 to 2 hours post-dose for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
<time_frame>Up to 2 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, and 2 hours)</time_frame>
<population>Modified completer population</population>
<group_list>
<group group_id="O1">
<title>Placebo</title>
<description>Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O5">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O6">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 2 Hours (AUEC2)</title>
<description>Area under the effect-time profile from time 0 to 2 hours post-dose for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
<population>Modified completer population</population>
<units>units on a scale * hour</units>
<param>Mean</param>
<dispersion>Standard Error</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="42"/>
<count group_id="O2" value="42"/>
<count group_id="O3" value="42"/>
<count group_id="O4" value="42"/>
<count group_id="O5" value="42"/>
<count group_id="O6" value="42"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="102.62" spread="1.791"/>
<measurement group_id="O2" value="140.44" spread="4.434"/>
<measurement group_id="O3" value="105.20" spread="4.017"/>
<measurement group_id="O4" value="107.19" spread="2.449"/>
<measurement group_id="O5" value="138.72" spread="4.340"/>
<measurement group_id="O6" value="133.84" spread="4.010"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
<outcome>
<type>Secondary</type>
<title>Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 3 Hours (AUEC3)</title>
<description>Area under the effect-time profile from time 0 to 3 hours post-dose for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
<time_frame>up to 3 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, and 3 hours)</time_frame>
<population>Modified completer population</population>
<group_list>
<group group_id="O1">
<title>Placebo</title>
<description>Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O5">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O6">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 3 Hours (AUEC3)</title>
<description>Area under the effect-time profile from time 0 to 3 hours post-dose for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
<population>Modified completer population</population>
<units>units on a scale * hour</units>
<param>Mean</param>
<dispersion>Standard Error</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="42"/>
<count group_id="O2" value="42"/>
<count group_id="O3" value="42"/>
<count group_id="O4" value="42"/>
<count group_id="O5" value="42"/>
<count group_id="O6" value="42"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="155.48" spread="3.651"/>
<measurement group_id="O2" value="219.31" spread="7.614"/>
<measurement group_id="O3" value="161.07" spread="6.535"/>
<measurement group_id="O4" value="164.03" spread="4.819"/>
<measurement group_id="O5" value="223.22" spread="7.326"/>
<measurement group_id="O6" value="214.99" spread="6.567"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
<outcome>
<type>Secondary</type>
<title>Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 4 Hours (AUEC4)</title>
<description>Area under the effect-time profile from time 0 to 4 hours post-dose for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
<time_frame>Up to 4 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours)</time_frame>
<population>Modified completer population</population>
<group_list>
<group group_id="O1">
<title>Placebo</title>
<description>Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O5">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O6">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 4 Hours (AUEC4)</title>
<description>Area under the effect-time profile from time 0 to 4 hours post-dose for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
<population>Modified completer population</population>
<units>units on a scale * hour</units>
<param>Mean</param>
<dispersion>Standard Error</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="42"/>
<count group_id="O2" value="42"/>
<count group_id="O3" value="42"/>
<count group_id="O4" value="42"/>
<count group_id="O5" value="42"/>
<count group_id="O6" value="42"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="208.32" spread="5.171"/>
<measurement group_id="O2" value="294.28" spread="10.329"/>
<measurement group_id="O3" value="214.53" spread="8.878"/>
<measurement group_id="O4" value="220.08" spread="6.896"/>
<measurement group_id="O5" value="305.08" spread="10.423"/>
<measurement group_id="O6" value="293.99" spread="8.810"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
<outcome>
<type>Secondary</type>
<title>Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 8 Hours (AUEC8)</title>
<description>Area under the effect-time profile from time 0 to 8 hours post-dose for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
<time_frame>Up to 8 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours)</time_frame>
<population>Modified completer population</population>
<group_list>
<group group_id="O1">
<title>Placebo</title>
<description>Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O5">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O6">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 8 Hours (AUEC8)</title>
<description>Area under the effect-time profile from time 0 to 8 hours post-dose for the "Drug liking" visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"</description>
<population>Modified completer population</population>
<units>units on a scale * hour</units>
<param>Mean</param>
<dispersion>Standard Error</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="42"/>
<count group_id="O2" value="42"/>
<count group_id="O3" value="42"/>
<count group_id="O4" value="42"/>
<count group_id="O5" value="42"/>
<count group_id="O6" value="42"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="411.58" spread="12.224"/>
<measurement group_id="O2" value="551.53" spread="19.517"/>
<measurement group_id="O3" value="421.12" spread="17.144"/>
<measurement group_id="O4" value="438.30" spread="13.862"/>
<measurement group_id="O5" value="599.96" spread="22.312"/>
<measurement group_id="O6" value="574.98" spread="18.952"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
<outcome>
<type>Secondary</type>
<title>Unipolar VAS for "High" - Maximum Effect (Emax)</title>
<description>Maximum effect on the 100 mm visual analog scale for the question "I am feeling high" where 0 = "not at all" and 100 = "extremely"</description>
<time_frame>up to 48 hours after treatments</time_frame>
<population>Modified completer population</population>
<group_list>
<group group_id="O1">
<title>Placebo Single Dose</title>
<description>Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants will receive a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O5">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants will receive a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O6">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants will receive a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Unipolar VAS for "High" - Maximum Effect (Emax)</title>
<description>Maximum effect on the 100 mm visual analog scale for the question "I am feeling high" where 0 = "not at all" and 100 = "extremely"</description>
<population>Modified completer population</population>
<units>Score on a 100 mm scale</units>
<param>Mean</param>
<dispersion>Standard Error</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="42"/>
<count group_id="O2" value="42"/>
<count group_id="O3" value="42"/>
<count group_id="O4" value="42"/>
<count group_id="O5" value="42"/>
<count group_id="O6" value="42"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="13.45" spread="4.854"/>
<measurement group_id="O2" value="77.36" spread="5.8160"/>
<measurement group_id="O3" value="28.61" spread="6.551"/>
<measurement group_id="O4" value="25.21" spread="6.412"/>
<measurement group_id="O5" value="81.86" spread="5.620"/>
<measurement group_id="O6" value="88.74" spread="4.210"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<analysis_list>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O2</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>64.67</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>7.581</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>52.15</ci_lower_limit>
<ci_upper_limit>77.20</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O3</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0546</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>14.66</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>7.581</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>2.13</ci_lower_limit>
<ci_upper_limit>27.1</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O4</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.1286</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>11.58</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>7.589</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-0.96</ci_lower_limit>
<ci_upper_limit>24.12</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O5</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>68.99</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>7.611</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>56.42</ci_lower_limit>
<ci_upper_limit>81.57</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O6</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>76.37</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>7.589</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>63.83</ci_lower_limit>
<ci_upper_limit>88.91</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O3</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-50.0</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>7.589</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-62.6</ci_lower_limit>
<ci_upper_limit>-37.5</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O4</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-53.1</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>7.611</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-65.7</ci_lower_limit>
<ci_upper_limit>-40.5</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O5</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.5699</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>4.32</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>7.589</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-8.22</ci_lower_limit>
<ci_upper_limit>16.86</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O6</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.1243</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>11.70</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>7.581</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-0.83</ci_lower_limit>
<ci_upper_limit>24.23</ci_upper_limit>
</analysis>
</analysis_list>
</outcome>
<outcome>
<type>Secondary</type>
<title>Unipolar VAS for "High": Time to Maximum Effect (TEmax)</title>
<description>Time after dosing when the maximum effect for "High" VAS is reached</description>
<time_frame>up to 48 hours after treatments</time_frame>
<population>Modified completer population</population>
<group_list>
<group group_id="O1">
<title>Placebo Single Dose</title>
<description>placebo: Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>oxycodone HCl 20 mg: Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg Single Dose</title>
<description>gabapentin 600 mg: Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg Single Dose</title>
<description>gabapentin 1200 mg: Participants will receive a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O5">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>gabapentin 600 mg and oxycodone HCl 20 mg: Participants will receive a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O6">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>gabapentin 1200 mg and oxycodone HCl 20 mg: Participants will receive a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Unipolar VAS for "High": Time to Maximum Effect (TEmax)</title>
<description>Time after dosing when the maximum effect for "High" VAS is reached</description>
<population>Modified completer population</population>
<units>hours</units>
<param>Median</param>
<dispersion>Full Range</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="42"/>
<count group_id="O2" value="42"/>
<count group_id="O3" value="42"/>
<count group_id="O4" value="42"/>
<count group_id="O5" value="42"/>
<count group_id="O6" value="42"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="0.25" lower_limit="0.2" upper_limit="8.0"/>
<measurement group_id="O2" value="1.00" lower_limit="0.3" upper_limit="4.0"/>
<measurement group_id="O3" value="0.26" lower_limit="0.2" upper_limit="8.0"/>
<measurement group_id="O4" value="0.27" lower_limit="0.1" upper_limit="144.9"/>
<measurement group_id="O5" value="1.00" lower_limit="0.2" upper_limit="48.1"/>
<measurement group_id="O6" value="1.50" lower_limit="0.2" upper_limit="4.1"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
<outcome>
<type>Secondary</type>
<title>Area Under the Effect Curve for "High" VAS (AUEClast)</title>
<description>Area under the effect-time profile from time 0 to the time of the last available data for the "High" visual analog scale which measures on a 100 mm visual analog scale the subject's response to the question "I am feeling high" where 0 = "not at all" and 100 ="extremely"</description>
<time_frame>Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<population>Modified completer population</population>
<group_list>
<group group_id="O1">
<title>Placebo Single Dose</title>
<description>Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants will receive a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O5">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants will receive a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O6">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants will receive a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Area Under the Effect Curve for "High" VAS (AUEClast)</title>
<description>Area under the effect-time profile from time 0 to the time of the last available data for the "High" visual analog scale which measures on a 100 mm visual analog scale the subject's response to the question "I am feeling high" where 0 = "not at all" and 100 ="extremely"</description>
<population>Modified completer population</population>
<units>units on a scale * hour</units>
<param>Mean</param>
<dispersion>Standard Error</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="42"/>
<count group_id="O2" value="42"/>
<count group_id="O3" value="42"/>
<count group_id="O4" value="42"/>
<count group_id="O5" value="42"/>
<count group_id="O6" value="42"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="33.45" spread="14.904"/>
<measurement group_id="O2" value="321.75" spread="46.346"/>
<measurement group_id="O3" value="86.41" spread="31.541"/>
<measurement group_id="O4" value="123.74" spread="50.060"/>
<measurement group_id="O5" value="512.08" spread="66.299"/>
<measurement group_id="O6" value="425.01" spread="52.651"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<analysis_list>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O2</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>286.7</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>50.879</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>202.6</ci_lower_limit>
<ci_upper_limit>370.8</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O3</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.2912</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>53.85</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>50.879</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-30.2</ci_lower_limit>
<ci_upper_limit>137.9</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O4</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0563</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>97.80</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>50.938</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>13.62</ci_lower_limit>
<ci_upper_limit>182.0</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O5</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>484.5</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>51.083</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>400.1</ci_lower_limit>
<ci_upper_limit>569.0</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O6</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>396.6</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>50.938</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>312.4</ci_lower_limit>
<ci_upper_limit>480.8</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O3</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-233</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>50.938</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-317</ci_lower_limit>
<ci_upper_limit>-149</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O4</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0003</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-189</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>51.083</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-273</ci_lower_limit>
<ci_upper_limit>-105</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O5</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>197.8</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>50.938</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>113.7</ci_lower_limit>
<ci_upper_limit>282.0</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O6</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0320</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>109.9</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>50.879</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>25.80</ci_lower_limit>
<ci_upper_limit>194.0</ci_upper_limit>
</analysis>
</analysis_list>
</outcome>
<outcome>
<type>Secondary</type>
<title>Bipolar VAS for "Take Drug Again"</title>
<description>100 mm visual analog scale at 24, 36, and 48 hours post-dose for the question "I would take this drug again" where 0 = "definitely not", 50 = "neutral", and 100 = "definitely so". The data from the 24, 36, and 48 hours postdose measurements were combined into a single overall model-adjusted value for 24 to 48 hours post-treatment timeframe by estimation from a mixed model with treatment, period, treatment sequence, time, and treatment*time as fixed effects, subject nested within sequence as a random effect. The compound symmetric covariance matrix was employed. Data from all time points were included</description>
<time_frame>Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)</time_frame>
<population>Modified completer population</population>
<group_list>
<group group_id="O1">
<title>Placebo Single Dose</title>
<description>placebo: Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>oxycodone HCl 20 mg: Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg Single Dose</title>
<description>gabapentin 600 mg: Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg Single Dose</title>
<description>gabapentin 1200 mg: Participants will receive a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O5">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>gabapentin 600 mg and oxycodone HCl 20 mg: Participants will receive a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O6">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>gabapentin 1200 mg and oxycodone HCl 20 mg: Participants will receive a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Bipolar VAS for "Take Drug Again"</title>
<description>100 mm visual analog scale at 24, 36, and 48 hours post-dose for the question "I would take this drug again" where 0 = "definitely not", 50 = "neutral", and 100 = "definitely so". The data from the 24, 36, and 48 hours postdose measurements were combined into a single overall model-adjusted value for 24 to 48 hours post-treatment timeframe by estimation from a mixed model with treatment, period, treatment sequence, time, and treatment*time as fixed effects, subject nested within sequence as a random effect. The compound symmetric covariance matrix was employed. Data from all time points were included</description>
<population>Modified completer population</population>
<units>Score on a 100 mm scale</units>
<param>Least Squares Mean</param>
<dispersion>Standard Error</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="42"/>
<count group_id="O2" value="42"/>
<count group_id="O3" value="42"/>
<count group_id="O4" value="42"/>
<count group_id="O5" value="42"/>
<count group_id="O6" value="42"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="53.43" spread="2.928"/>
<measurement group_id="O2" value="72.16" spread="2.918"/>
<measurement group_id="O3" value="55.19" spread="2.942"/>
<measurement group_id="O4" value="58.05" spread="2.935"/>
<measurement group_id="O5" value="79.16" spread="2.940"/>
<measurement group_id="O6" value="77.85" spread="2.910"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<analysis_list>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O2</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>18.73</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>2.276</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>14.98</ci_lower_limit>
<ci_upper_limit>22.48</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O3</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.5056</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>1.76</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>2.302</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-2.03</ci_lower_limit>
<ci_upper_limit>5.56</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O4</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0760</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>4.62</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>2.307</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>0.82</ci_lower_limit>
<ci_upper_limit>8.42</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O5</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>25.73</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>2.315</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>21.92</ci_lower_limit>
<ci_upper_limit>29.54</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O6</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>24.42</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>2.270</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>20.68</ci_lower_limit>
<ci_upper_limit>28.16</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O3</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-17.0</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>2.297</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-20.8</ci_lower_limit>
<ci_upper_limit>-13.2</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O4</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-14.1</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>2.299</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-17.9</ci_lower_limit>
<ci_upper_limit>-10.3</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O5</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0024</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>7.00</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>2.298</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>3.22</ci_lower_limit>
<ci_upper_limit>10.79</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O6</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0118</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>5.69</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>2.255</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>1.98</ci_lower_limit>
<ci_upper_limit>9.41</ci_upper_limit>
</analysis>
</analysis_list>
</outcome>
<outcome>
<type>Secondary</type>
<title>Bipolar VAS for "Overall Drug Liking"</title>
<description>100 mm visual analog scale at 24, 36, and 48 hours post-dose for the question "Overall, my liking for this drug is" where 0 = "definitely not", 50 = "neutral", and 100 = "definitely so". The data from the 24, 36, and 48 hours postdose measurements were combined into a single overall model-adjusted value for 24 to 48 hours post-treatment timeframe by estimation from a mixed model with treatment, period, treatment sequence, time, and treatment*time as fixed effects, subject nested within sequence as a random effect. The compound symmetric covariance matrix was employed. Data from all time points were included</description>
<time_frame>Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)</time_frame>
<population>Modified completer population</population>
<group_list>
<group group_id="O1">
<title>Placebo Single Dose</title>
<description>Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants will receive a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O5">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants will receive a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O6">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants will receive a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Bipolar VAS for "Overall Drug Liking"</title>
<description>100 mm visual analog scale at 24, 36, and 48 hours post-dose for the question "Overall, my liking for this drug is" where 0 = "definitely not", 50 = "neutral", and 100 = "definitely so". The data from the 24, 36, and 48 hours postdose measurements were combined into a single overall model-adjusted value for 24 to 48 hours post-treatment timeframe by estimation from a mixed model with treatment, period, treatment sequence, time, and treatment*time as fixed effects, subject nested within sequence as a random effect. The compound symmetric covariance matrix was employed. Data from all time points were included</description>
<population>Modified completer population</population>
<units>Score on a 100 mm scale</units>
<param>Least Squares Mean</param>
<dispersion>Standard Error</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="42"/>
<count group_id="O2" value="42"/>
<count group_id="O3" value="42"/>
<count group_id="O4" value="42"/>
<count group_id="O5" value="42"/>
<count group_id="O6" value="42"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="51.75" spread="2.895"/>
<measurement group_id="O2" value="72.06" spread="2.886"/>
<measurement group_id="O3" value="54.40" spread="2.909"/>
<measurement group_id="O4" value="58.25" spread="2.902"/>
<measurement group_id="O5" value="75.90" spread="2.907"/>
<measurement group_id="O6" value="79.94" spread="2.878"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<analysis_list>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O2</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>20.31</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>2.246</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>16.61</ci_lower_limit>
<ci_upper_limit>24.01</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O3</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.2439</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>2.65</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>2.271</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-1.09</ci_lower_limit>
<ci_upper_limit>6.39</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O4</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0044</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>6.50</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>2.276</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>2.75</ci_lower_limit>
<ci_upper_limit>10.25</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O5</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>24.15</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>2.284</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>20.39</ci_lower_limit>
<ci_upper_limit>27.91</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O6</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>28.19</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>2.240</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>24.50</ci_lower_limit>
<ci_upper_limit>31.88</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O3</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-17.7</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>2.266</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-21.4</ci_lower_limit>
<ci_upper_limit>-13.9</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O4</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-13.8</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>2.268</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-17.5</ci_lower_limit>
<ci_upper_limit>-10.1</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O5</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0907</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>3.84</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>2.267</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>0.11</ci_lower_limit>
<ci_upper_limit>7.57</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O6</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0004</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>7.88</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>2.225</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>4.22</ci_lower_limit>
<ci_upper_limit>11.55</ci_upper_limit>
</analysis>
</analysis_list>
</outcome>
<outcome>
<type>Secondary</type>
<title>Unipolar VAS for "Good Drug Effect"</title>
<description>100 mm visual analog scale for the question "At this moment, I can feel good drug effects" where 0 = "not at all" and 100 = "extremely"</description>
<time_frame>up to 48 hours after treatments</time_frame>
<population>Modified completer population</population>
<group_list>
<group group_id="O1">
<title>Placebo</title>
<description>Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O5">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O6">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Unipolar VAS for "Good Drug Effect"</title>
<description>100 mm visual analog scale for the question "At this moment, I can feel good drug effects" where 0 = "not at all" and 100 = "extremely"</description>
<population>Modified completer population</population>
<units>Score on a 100 mm scale</units>
<param>Least Squares Mean</param>
<dispersion>Standard Error</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="42"/>
<count group_id="O2" value="42"/>
<count group_id="O3" value="42"/>
<count group_id="O4" value="42"/>
<count group_id="O5" value="42"/>
<count group_id="O6" value="42"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="2.54" spread="2.123"/>
<measurement group_id="O2" value="27.91" spread="2.117"/>
<measurement group_id="O3" value="6.13" spread="2.117"/>
<measurement group_id="O4" value="8.73" spread="2.120"/>
<measurement group_id="O5" value="34.72" spread="2.119"/>
<measurement group_id="O6" value="32.71" spread="2.113"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<analysis_list>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O2</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>25.37</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>1.528</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>22.86</ci_lower_limit>
<ci_upper_limit>27.88</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O3</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0189</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>3.59</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>1.529</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>1.08</ci_lower_limit>
<ci_upper_limit>6.11</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O4</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>6.18</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>1.536</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>3.66</ci_lower_limit>
<ci_upper_limit>8.71</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O5</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>32.18</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>1.537</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>29.65</ci_lower_limit>
<ci_upper_limit>34.71</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O6</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>30.17</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>1.525</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>27.66</ci_lower_limit>
<ci_upper_limit>32.68</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O3</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-21.8</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>1.522</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-24.3</ci_lower_limit>
<ci_upper_limit>-19.3</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O4</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-19.2</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>1.530</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-21.7</ci_lower_limit>
<ci_upper_limit>-16.7</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O5</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>6.81</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>1.524</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>4.30</ci_lower_limit>
<ci_upper_limit>9.31</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O6</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0015</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>4.80</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>1.514</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>2.31</ci_lower_limit>
<ci_upper_limit>7.29</ci_upper_limit>
</analysis>
</analysis_list>
</outcome>
<outcome>
<type>Secondary</type>
<title>Unipolar VAS for "Bad Drug Effect"</title>
<description>100 mm visual analog scale for the question "At this moment, I can feel bad drug effects" where 0 = "not at all" and 100 = "extremely"</description>
<time_frame>up to 48 hours after treatments</time_frame>
<population>Modified completer population</population>
<group_list>
<group group_id="O1">
<title>Placebo</title>
<description>Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O5">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O6">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Unipolar VAS for "Bad Drug Effect"</title>
<description>100 mm visual analog scale for the question "At this moment, I can feel bad drug effects" where 0 = "not at all" and 100 = "extremely"</description>
<population>Modified completer population</population>
<units>Score on a 100 mm scale</units>
<param>Least Squares Mean</param>
<dispersion>Standard Error</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="42"/>
<count group_id="O2" value="42"/>
<count group_id="O3" value="42"/>
<count group_id="O4" value="42"/>
<count group_id="O5" value="42"/>
<count group_id="O6" value="42"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="0.19" spread="1.211"/>
<measurement group_id="O2" value="4.41" spread="1.209"/>
<measurement group_id="O3" value="0.82" spread="1.209"/>
<measurement group_id="O4" value="0.97" spread="1.210"/>
<measurement group_id="O5" value="4.10" spread="1.210"/>
<measurement group_id="O6" value="3.41" spread="1.207"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<analysis_list>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O2</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>4.23</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>0.743</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>3.01</ci_lower_limit>
<ci_upper_limit>5.45</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O3</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.3933</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>0.63</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>0.743</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-0.59</ci_lower_limit>
<ci_upper_limit>1.86</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O4</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.2916</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>0.79</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>0.747</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-0.44</ci_lower_limit>
<ci_upper_limit>2.02</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O5</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>3.92</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>0.748</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>2.69</ci_lower_limit>
<ci_upper_limit>5.15</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O6</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>3.22</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>0.742</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>2.00</ci_lower_limit>
<ci_upper_limit>4.44</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O3</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-3.59</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>0.740</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-4.81</ci_lower_limit>
<ci_upper_limit>-2.38</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O4</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-3.44</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>0.744</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-4.66</ci_lower_limit>
<ci_upper_limit>-2.22</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O5</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.6765</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-0.31</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>0.741</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-1.53</ci_lower_limit>
<ci_upper_limit>0.91</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O6</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.1712</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-1.01</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>0.737</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-2.22</ci_lower_limit>
<ci_upper_limit>0.20</ci_upper_limit>
</analysis>
</analysis_list>
</outcome>
<outcome>
<type>Secondary</type>
<title>Unipolar VAS for "Any Drug Effect"</title>
<description>100 mm visual analog scale for the question "At this moment, I can feel any drug effects" where 0 = "not at all" and 100 = "extremely"</description>
<time_frame>up to 48 hours after treatments</time_frame>
<population>Modified completer population</population>
<group_list>
<group group_id="O1">
<title>Placebo</title>
<description>Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O5">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O6">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Unipolar VAS for "Any Drug Effect"</title>
<description>100 mm visual analog scale for the question "At this moment, I can feel any drug effects" where 0 = "not at all" and 100 = "extremely"</description>
<population>Modified completer population</population>
<units>Score on a 100 mm scale</units>
<param>Least Squares Mean</param>
<dispersion>Standard Error</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="42"/>
<count group_id="O2" value="42"/>
<count group_id="O3" value="42"/>
<count group_id="O4" value="42"/>
<count group_id="O5" value="42"/>
<count group_id="O6" value="42"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="3.77" spread="2.167"/>
<measurement group_id="O2" value="28.46" spread="2.161"/>
<measurement group_id="O3" value="6.63" spread="2.162"/>
<measurement group_id="O4" value="7.88" spread="2.164"/>
<measurement group_id="O5" value="34.34" spread="2.163"/>
<measurement group_id="O6" value="33.76" spread="2.158"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<analysis_list>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O2</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>24.70</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>1.526</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>22.19</ci_lower_limit>
<ci_upper_limit>27.21</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O3</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0606</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>2.87</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>1.527</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>0.35</ci_lower_limit>
<ci_upper_limit>5.38</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O4</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0074</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>4.11</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>1.534</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>1.59</ci_lower_limit>
<ci_upper_limit>6.64</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O5</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>30.58</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>1.536</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>28.05</ci_lower_limit>
<ci_upper_limit>33.10</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O6</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>29.99</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>1.524</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>27.48</ci_lower_limit>
<ci_upper_limit>32.50</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O3</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-21.8</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>1.521</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-24.3</ci_lower_limit>
<ci_upper_limit>-19.3</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O4</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value><.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>-20.6</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>1.529</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>-23.1</ci_lower_limit>
<ci_upper_limit>-18.1</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O5</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0001</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>5.88</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>1.523</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>3.37</ci_lower_limit>
<ci_upper_limit>8.38</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O6</group_id>
</group_id_list>
<non_inferiority_type>Other</non_inferiority_type>
<p_value>0.0005</p_value>
<method>Mixed Models Analysis</method>
<param_type>Mean Difference (Final Values)</param_type>
<param_value>5.29</param_value>
<dispersion_type>Standard Error of the Mean</dispersion_type>
<dispersion_value>1.513</dispersion_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>2.80</ci_lower_limit>
<ci_upper_limit>7.78</ci_upper_limit>
</analysis>
</analysis_list>
</outcome>
<outcome>
<type>Secondary</type>
<title>Cmax of Gabapentin</title>
<description>Maximum plasma concentration of gabapentin</description>
<time_frame>Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest.</population>
<group_list>
<group group_id="O1">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Cmax of Gabapentin</title>
<description>Maximum plasma concentration of gabapentin</description>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest.</population>
<units>micrograms/milliliter</units>
<param>Mean</param>
<dispersion>Standard Deviation</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="51"/>
<count group_id="O2" value="52"/>
<count group_id="O3" value="52"/>
<count group_id="O4" value="52"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="4.16" spread="1.422"/>
<measurement group_id="O2" value="6.07" spread="1.951"/>
<measurement group_id="O3" value="4.17" spread="1.121"/>
<measurement group_id="O4" value="6.18" spread="1.443"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
<outcome>
<type>Secondary</type>
<title>Tmax of Gabapentin</title>
<description>Time when the maximum concentration of gabapentin is reached</description>
<time_frame>Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest</population>
<group_list>
<group group_id="O1">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Tmax of Gabapentin</title>
<description>Time when the maximum concentration of gabapentin is reached</description>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest</population>
<units>Hours</units>
<param>Median</param>
<dispersion>Full Range</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="51"/>
<count group_id="O2" value="52"/>
<count group_id="O3" value="52"/>
<count group_id="O4" value="52"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="3.13" lower_limit="1.2" upper_limit="6.1"/>
<measurement group_id="O2" value="3.13" lower_limit="1.6" upper_limit="6.1"/>
<measurement group_id="O3" value="3.13" lower_limit="1.2" upper_limit="8.1"/>
<measurement group_id="O4" value="3.13" lower_limit="1.2" upper_limit="8.2"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
<outcome>
<type>Secondary</type>
<title>AUCinf of Gabapentin</title>
<description>Area under the plasma concentration/time curve from time 0 extrapolated to infinity time of gabapentin</description>
<time_frame>Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest</population>
<group_list>
<group group_id="O1">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>AUCinf of Gabapentin</title>
<description>Area under the plasma concentration/time curve from time 0 extrapolated to infinity time of gabapentin</description>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest</population>
<units>micrograms*hour/milliliter</units>
<param>Mean</param>
<dispersion>Standard Deviation</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="51"/>
<count group_id="O2" value="52"/>
<count group_id="O3" value="52"/>
<count group_id="O4" value="52"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="41.42" spread="11.798"/>
<measurement group_id="O2" value="65.38" spread="18.854"/>
<measurement group_id="O3" value="48.58" spread="12.009"/>
<measurement group_id="O4" value="75.18" spread="18.431"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
<outcome>
<type>Secondary</type>
<title>AUClast of Gabapentin</title>
<description>Area under the plasma concentration/time profile from time 0 to the time of the last quantifiable concentration of gabapentin</description>
<time_frame>Up to 48 hours after treatment (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interes</population>
<group_list>
<group group_id="O1">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>AUClast of Gabapentin</title>
<description>Area under the plasma concentration/time profile from time 0 to the time of the last quantifiable concentration of gabapentin</description>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interes</population>
<units>micrograms*hour/milliliter</units>
<param>Mean</param>
<dispersion>Standard Deviation</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="51"/>
<count group_id="O2" value="52"/>
<count group_id="O3" value="52"/>
<count group_id="O4" value="52"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="39.76" spread="11.856"/>
<measurement group_id="O2" value="61.42" spread="19.900"/>
<measurement group_id="O3" value="47.31" spread="12.142"/>
<measurement group_id="O4" value="72.73" spread="17.781"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
<outcome>
<type>Secondary</type>
<title>Half-life (t½) of Gabapentin</title>
<description>Half-life (t½) of gabapentin</description>
<time_frame>Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest</population>
<group_list>
<group group_id="O1">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O2">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="O3">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O4">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Half-life (t½) of Gabapentin</title>
<description>Half-life (t½) of gabapentin</description>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest</population>
<units>Hours</units>
<param>Mean</param>
<dispersion>Standard Deviation</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="51"/>
<count group_id="O2" value="51"/>
<count group_id="O3" value="52"/>
<count group_id="O4" value="52"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="9.14" spread="10.846"/>
<measurement group_id="O2" value="10.62" spread="7.674"/>
<measurement group_id="O3" value="8.20" spread="3.551"/>
<measurement group_id="O4" value="9.19" spread="3.596"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
<outcome>
<type>Secondary</type>
<title>Cmax of Oxycodone</title>
<description>Maximum plasma concentration of Oxycodone</description>
<time_frame>Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest</population>
<group_list>
<group group_id="O1">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O2">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O3">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Cmax of Oxycodone</title>
<description>Maximum plasma concentration of Oxycodone</description>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest</population>
<units>nanograms/milliliter</units>
<param>Mean</param>
<dispersion>Standard Deviation</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="51"/>
<count group_id="O2" value="51"/>
<count group_id="O3" value="50"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="44.92" spread="17.336"/>
<measurement group_id="O2" value="43.82" spread="14.144"/>
<measurement group_id="O3" value="40.79" spread="14.809"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
<outcome>
<type>Secondary</type>
<title>Tmax of Oxycodone</title>
<description>Time when the maximum concentration of Oxycodone is reached</description>
<time_frame>Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest</population>
<group_list>
<group group_id="O1">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O2">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O3">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Tmax of Oxycodone</title>
<description>Time when the maximum concentration of Oxycodone is reached</description>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest</population>
<units>hours</units>
<param>Median</param>
<dispersion>Full Range</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="51"/>
<count group_id="O2" value="51"/>
<count group_id="O3" value="50"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="1.15" lower_limit="0.6" upper_limit="8.1"/>
<measurement group_id="O2" value="1.15" lower_limit="0.6" upper_limit="5.9"/>
<measurement group_id="O3" value="1.63" lower_limit="0.6" upper_limit="3.6"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
<outcome>
<type>Secondary</type>
<title>AUCinf of Oxycodone</title>
<description>Area under the plasma concentration/time curve from time 0 extrapolated to infinity time of Oxycodone</description>
<time_frame>Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest</population>
<group_list>
<group group_id="O1">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O2">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O3">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>AUCinf of Oxycodone</title>
<description>Area under the plasma concentration/time curve from time 0 extrapolated to infinity time of Oxycodone</description>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest</population>
<units>nanograms*hour/milliliter</units>
<param>Mean</param>
<dispersion>Standard Deviation</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="51"/>
<count group_id="O2" value="51"/>
<count group_id="O3" value="49"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="233.29" spread="64.369"/>
<measurement group_id="O2" value="228.40" spread="71.854"/>
<measurement group_id="O3" value="234.94" spread="77.115"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
<outcome>
<type>Secondary</type>
<title>AUClast of Oxycodone</title>
<description>Area under the plasma concentration/time profile from time 0 to the time of the last quantifiable concentration of Oxycodone</description>
<time_frame>Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest</population>
<group_list>
<group group_id="O1">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O2">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O3">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>AUClast of Oxycodone</title>
<description>Area under the plasma concentration/time profile from time 0 to the time of the last quantifiable concentration of Oxycodone</description>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest</population>
<units>nanograms*hour/milliliter</units>
<param>Mean</param>
<dispersion>Standard Deviation</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="51"/>
<count group_id="O2" value="51"/>
<count group_id="O3" value="50"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="229.31" spread="64.935"/>
<measurement group_id="O2" value="224.79" spread="71.748"/>
<measurement group_id="O3" value="234.65" spread="80.068"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
<outcome>
<type>Secondary</type>
<title>Half-life (t½) of Oxycodone</title>
<description>Half-life (t½) of Oxycodone</description>
<time_frame>Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)</time_frame>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest</population>
<group_list>
<group group_id="O1">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="O2">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="O3">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<measure>
<title>Half-life (t½) of Oxycodone</title>
<description>Half-life (t½) of Oxycodone</description>
<population>Pharmacokinetic population: all enrolled participants who received study medication and have pharmacokinetic data for the parameters of interest</population>
<units>hours</units>
<param>Median</param>
<dispersion>Full Range</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="51"/>
<count group_id="O2" value="51"/>
<count group_id="O3" value="49"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="4.12" lower_limit="2.6" upper_limit="6.2"/>
<measurement group_id="O2" value="3.84" lower_limit="2.2" upper_limit="6.1"/>
<measurement group_id="O3" value="3.90" lower_limit="2.4" upper_limit="10.7"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
</outcome_list>
<reported_events>
<time_frame>During the entire Treatment Phase of the study, which encompassed the time interval from admission of the subject to their first Treatment Period until 28 days after study drug dosing in their last (6th) Treatment Period, including the washout in between Treatment Periods. The total duration of the Treatment Phase for each subject was dependent on visit scheduling and whether the subject completed all 6 treatment periods, and it lasted up to approximately 13 weeks.</time_frame>
<desc>Adverse events that occur during the washout interval between treatment visits or during the follow up after the final study drug dose were counted under the previous treatment visit</desc>
<group_list>
<group group_id="E1">
<title>Placebo</title>
<description>Participants received a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="E2">
<title>Oxycodone HCl 20 mg Single Dose</title>
<description>Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin</description>
</group>
<group group_id="E3">
<title>Gabapentin 600 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="E4">
<title>Gabapentin 1200 mg Single Dose</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl</description>
</group>
<group group_id="E5">
<title>Gabapentin 600 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg</description>
</group>
<group group_id="E6">
<title>Gabapentin 1200 mg and Oxycodone HCl 20 mg</title>
<description>Participants received a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg</description>
</group>
</group_list>
<serious_events>
<category_list>
<category>
<title>Total</title>
<event_list>
<event>
<sub_title>Total, all-cause mortality</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
<counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
<counts group_id="E5" subjects_affected="0" subjects_at_risk="52"/>
<counts group_id="E6" subjects_affected="0" subjects_at_risk="52"/>
</event>
<event>
<sub_title>Total, serious adverse events</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
<counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
<counts group_id="E5" subjects_affected="0" subjects_at_risk="52"/>
<counts group_id="E6" subjects_affected="0" subjects_at_risk="52"/>
</event>
</event_list>
</category>
</category_list>
</serious_events>
<other_events>
<frequency_threshold>0</frequency_threshold>
<default_vocab>MedDRA (24.1)</default_vocab>
<default_assessment>Non-systematic Assessment</default_assessment>
<category_list>
<category>
<title>Total</title>
<event_list>
<event>
<sub_title>Total, other adverse events</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
<counts group_id="E2" subjects_affected="4" subjects_at_risk="52"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
<counts group_id="E4" subjects_affected="2" subjects_at_risk="52"/>
<counts group_id="E5" subjects_affected="4" subjects_at_risk="52"/>
<counts group_id="E6" subjects_affected="2" subjects_at_risk="52"/>
</event>
</event_list>
</category>
<category>
<title>Gastrointestinal disorders</title>
<event_list>
<event>
<sub_title>Nausea</sub_title>
<counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
<counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="52"/>
<counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
<counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
<counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="52"/>
<counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="52"/>
</event>
<event>
<sub_title>Vomiting</sub_title>
<counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
<counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="52"/>
<counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
<counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
<counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="52"/>
<counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="52"/>
</event>
</event_list>
</category>
<category>
<title>Injury, poisoning and procedural complications</title>
<event_list>
<event>
<sub_title>Muscle strain</sub_title>
<counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
<counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="52"/>
<counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
<counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
<counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="52"/>
<counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="52"/>
</event>
</event_list>
</category>
</category_list>
</other_events>
</reported_events>
<certain_agreements>
<pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
</certain_agreements>
<point_of_contact>
<name_or_title>Dik WH Ng</name_or_title>
<organization>Viatris</organization>
<phone>+44 (0)1304 626895</phone>
<email>dik.ng@viatris.com</email>
</point_of_contact>
</clinical_results>
</clinical_study>
|
This will be a randomized, double-blind, double-dummy, placebo- and active-controlled, 6
treatment, 6-period crossover single-dose, Williams square design study in healthy male
and/or female adult, non-drug-dependent recreational opioid users.
The study includes Screening, a Qualification Phase consisting of a Naloxone Challenge and
Drug Discrimination crossover study, a Treatment Phase and Follow-up. Following successful
completion of the Qualification Phase the participants will be enrolled in the Treatment
phase. The Treatment Phase is a randomized, double-blind, double dummy, placebo- and active
controlled, 6 treatment, 10-sequence, 6 period crossover, single-dose, Williams square design
study in healthy male and/or female adult, non drug-dependent recreational users. On Day 1 of
each of the Treatment Phase 6 periods, which will be separated by a washout of at least 14
days, participants will receive an oral dose of either gabapentin 600 mg or 1200 mg alone, or
concomitantly with a 20 mg dose of oxycodone HCl or 20 mg monotherapy of oxycodone HCl or a
placebo. Study treatments will be administered under fasted conditions (overnight fast and no
food until 4 hours after dosing). Water will be allowed without restriction until 1 hour
prior to dosing and 1 hour after dosing.
Inclusion Criteria:
1. Male and female participants must be 18 to 55 years of age, inclusive, at the time of
screening. Participants must meet reproductive criteria as outlined in the protocol.
2. Male and female participants who are overtly healthy. Healthy is defined as no
clinically relevant abnormalities identified by a detailed medical history, complete
physical examination, vital signs, 12-lead ECG, and/or clinical laboratory tests.
3. Participants must have drug abuse experience with opioids; ie, must have used opioids
for non-therapeutic purposes (ie, for psychoactive effects) on at least 10 occasions
within the last year and at least once in the 8 weeks before the Screening Visit
(Visit 1).
4. Participants must satisfactorily complete both the Naloxone Challenge and the Drug
Discrimination.
5. Participants who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, lifestyle considerations, and other study procedures.
6. Body mass index (BMI) of 17.5 to 34 kg/m2, inclusive; and a total body weight ≥50 kg
(110 lb).
7. Capable of giving signed informed consent as described in the protocol, which includes
compliance with the requirements and restrictions listed in the informed consent
document (ICD) and in this protocol.
Exclusion Criteria:
1. Current or past diagnosis of any type of drug dependence within the past year.
Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine)
will be assessed by the Investigator using the Diagnostic and Statistical Manual of
Mental Disorders-IV (DSM-IV) criteria performed at Screening. Current drug use will be
allowed if the candidate can produce a negative urine sample and are free of any
signs/symptoms of withdrawal. The candidate will be informed if they have a positive
breathalyzer test.
2. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).
3. Any condition possibly affecting drug absorption (eg, gastrectomy) excluding
cholecystectomy within 1 year prior to study.
4. Abnormal baseline EtCO2 <35mm Hg or >45 mm Hg.
5. Clinical or laboratory evidence of active hepatitis A infection or a history of human
immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C, and/or positive
testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody
(HBcAb), or hepatitis C antibody (HCVAb).
6. Participants with active suicidal ideation or suicidal behavior within 5 years prior
to Screening as determined through the use of the Columbia Suicide Severity Rating
Scale (C-SSRS) or active ideation identified at Screening or on Day 0.
7. Participants with any history of sleep apnea, myasthenia gravis or glaucoma.
8. Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the participant inappropriate for entry into
this study.
9. Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half lives (whichever is longer) prior to the first dose of investigational product.
(Refer to Section 6.5 for additional details).
10. Herbal supplements, herbal medications and hormone replacement therapy must be
discontinued at least 28 days prior to the first dose of study medication.
11. Previous administration with an investigational drug within 30 days (or as determined
by the local requirement) or 5 half lives (whichever is longer) preceding the first
dose of investigational product used in this study.
12. Positive urine drug screen (UDS) for substances of abuse at each admission in
Qualification and Treatment Phase, excluding tetrahydrocannabinol (THC). If a
participant presents with a positive UDS excluding THC at any admission or any visit,
the investigator, at his/her discretion, may reschedule a repeat of UDS until the UDS
is negative, excluding THC, before the participate is permitted to participate in any
phase of the study.
13. Unable to abstain from using THC during the Qualification and Treatment Phase of the
study.
14. Has participated in, is currently participating in, or is seeking treatment for
substance and/or alcohol related disorders (excluding nicotine and caffeine).
15. Has a positive alcohol breathalyzer or urine test at each admission to the study
center during Qualification and Treatment Phases. Positive results may be repeated
and/or participants re scheduled at the Investigator's discretions.
16. Participants are heavy smokers or users of other types of nicotine products (>20
cigarettes equivalents per day).
17. Participants are unable to abstain from smoking for at least 2 hours before and at
least 8 hours after study drug administration.
18. Screening sitting blood pressure (BP) >=140 mm Hg (systolic) or >=90 mm Hg
(diastolic), following at least 5 minutes rest. If BP is >=140 mm Hg (systolic) or
>=90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the
3 BP values should be used to determine the participant's eligibility. Repeated BP
tests should be spaced at least 5 minutes apart.
19. Baseline (screening) 12 lead electrocardiogram (ECG) that demonstrates clinically
relevant abnormalities that may affect participant safety or interpretation of study
results (eg, baseline corrected QT (QTc) interval as determined by the Fridericia
method (QTcF) >450 msec, complete left bundle branch block [LBBB], signs of an acute
or indeterminate age myocardial infarction, ST T interval changes suggestive of
myocardial ischemia, second or third degree atrioventricular [AV] block, or serious
bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450
msec, this interval should be rate corrected using the Fridericia method and the
resulting QTcF should be used for decision making and reporting. If QTcF exceeds 450
msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average
of the 3 QTcF or QRS values should be used to determine the participant's eligibility.
Computer interpreted ECGs should be overread by a physician experienced in reading
ECGs before excluding participants.
20. Participants with ANY of the following abnormalities in clinical laboratory tests at
screening, as assessed by the study specific laboratory and confirmed by a single
repeat test, if deemed necessary:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >=1.5 ×
upper limit of normal (ULN);
- Total bilirubin level >=1.5 × ULN; participants with a history of Gilbert's
syndrome may have direct bilirubin measured and would be eligible for this study
provided the direct bilirubin level is <= ULN.
21. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.
22. History of sensitivity to heparin or heparin induced thrombocytopenia.
23. Unwilling or unable to comply with the criteria in the Lifestyle Considerations
section of this protocol.
24. History of hypersensitivity to gabapentin or oxycodone or any of the components in the
formulation of the study products.
25. Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
Sponsor employees, including their family members, directly involved in the conduct of
the study.
|
NCT0531xxxx/NCT05319769.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319769</url>
</required_header>
<id_info>
<org_study_id>234/2022/Oss/AOUFe</org_study_id>
<nct_id>NCT05319769</nct_id>
</id_info>
<brief_title>Non Fluoroscopic APpROach iN atriaL Fibrillation Ablation procEdureS</brief_title>
<acronym>APRONLESS</acronym>
<official_title>Non Fluoroscopic APpROach iN atriaL Fibrillation Ablation procEdureS</official_title>
<sponsors>
<lead_sponsor>
<agency>University Hospital of Ferrara</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University Hospital of Ferrara</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
In electrophysiology, interventional procedures are often assisted by fluoroscopic guidance,
exposing both patients and healthcare professionals to a considerable dose of radiation.
Catheter ablation of atrial fibrillation has frequently involved the use of fluoroscopy: in
fact, it incorporates greater complexity due to the need to perform the transseptal puncture.

A visible introducer in the 3D electro-anatomical mapping system (which does not involve the
use of X-rays), has become an important tool for performing transseptal puncture: in
particular, it is positioned at level of the oval fossa of the right atrium (puncture site);
subsequently, the needle is introduced inside it; the intervention is guided both by
electroanatomical mapping and by the use of intracardiac echocardiography for the
identification of important anatomical landmarks.

The "zero rays" technique represents a valid alternative to fluoroscopic guidance, widely
used and validated over the years. In fact, X-ray exposure in an atrial fibrillation ablation
procedure can reach up to 60 mSv: the radiological risk makes it necessary to study safe and
effective alternative techniques.

In this retrospective, observational and monocentric study, 50 catheter ablation procedures
of atrial fibrillation will be examined, divided into two groups:

1. 25 patients who performed this procedure according to the classic approach, ie under
fluoroscopic guidance;

2. 25 patients who performed this procedure using an ablative approach that involved the
use of the introducer in combination with the 3D EAM system and intracardiac
echocardiography.

Clinical efficacy will be assessed through a cardiological checkup and 24-hour
electrocardiographic recording (ECG Holter) at 6 months.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Atrial fibrillation (AF) is the most common sustained adult tachyarrhythmia found in clinical
practice. The prevalence of this arrhythmia in the general population varies from 2 to 4% and
increases significantly in elderly patients and in carriers of diseases such as arterial
hypertension, heart failure, coronary and valvular disease, obesity, diabetes mellitus and
chronic kidney disease. In addition to being a marker of underlying heart or vascular
disease, FA in itself is accompanied by an increased incidence of ischemic stroke, heart
failure and dementia. The mechanisms underlying this arrhythmia are still debated, but seem
to involve electrical and structural alterations of the atrium that constitute a
morpho-functional substrate that facilitate its development.

Traditionally, five types of atrial fibrillation are distinguished, based on presentation,
duration and term:

1. Newly diagnosed AF: first finding of AF, regardless of the duration, presence and
severity of symptoms;

2. Paroxysmal AF: AF that resolves within seven days (spontaneously or through
cardioversion);

3. Persistent AF: AF that lasts more than seven days or is cardioverted after seven days;

4. Long lasting AF: AF that lasts more than a year continuously, when a rhythm control
strategy has been adopted.

5. Permanent AF: AF accepted by the patient (and by the attending physician) for which no
further attempt to control the rhythm is undertaken.

Treatment include heart rate and / or rhythm control strategies, prevention of cerebral
thromboembolism and reduction / elimination of symptoms, as well as control of major
cardiovascular risk factors. The decision about the implementation of therapeutic strategies
aimed at restoring and maintaining sinus rhythm must be shared between doctor and patient,
weighing on the one hand the effect on quality of life and symptoms, and on the other the
risk of toxic effects of drugs. used. When AF has been on for less than a year, an early
rhythm control strategy has been shown to reduce the composite outcome of cardiovascular
death, stroke, hospitalization for heart failure or acute coronary syndrome in the EAST-AFNET
4 clinical trial.

Trans catheter ablation is a well-established treatment for the reduction of AF relapses and
is proposed in cases of paroxysmal and persistent AF. It is a procedure that consists in the
antral circumferential disconnection of the pulmonary veins by radiofrequency, laser or
cryoblation. It is a safe and effective technique for maintaining sinus rhythm and for
improving symptoms. When antiarrhythmic drugs fail in rhythm control, the current ESC 2020
Guidelines place trans-catheter ablation in class I for paroxysmal and persistent AF with or
without major risk factors for recurrence, while as a first therapeutic approach it is in
class IIa for paroxysmal AF and IIb for persistent AF without major risk factors for relapse.

Advanced three-dimensional electro-anatomical mapping systems (3D EAM) have revolutionized
the transcatheter ablative approach, allowing a new approach to the study of complex
arrhythmias, such as FA. All the mapping systems, even if based on different principles,
allow a precise localization of the scaler catheter, starting from the vascular access up to
the heart chambers. While the catheter scans the different cardiac structures, the system
records information about the catheter's position and uses the spatial and electrical data to
create an accurate reproduction of the 3D geometry of the cardiac structures. All this has
led to a reduction in the use of fluoroscopy and, in particular for the ablation of AF, there
has been a reduction in radiation during these procedures even if a complete elimination has
not yet been possible.

Intracardiac echocardiography is an imaging technique capable of visualizing heart structures
in real time and with very high spatial resolution, as well as monitoring the position of the
catheter within the heart chambers and quickly identifying any procedural complications, such
as the formation of thrombus or pericardial effusion. A further advantage is represented by
the reduction of the scan times. For these reasons, intracardiac echocardiography has largely
replaced transesophageal echocardiography in many interventional procedures, including those
of electrophysiology. In fact, intracardiac echocardiography allows the integration of images
in real time with electro-anatomical mapping systems, allowing to map those structures that
are not viewable under fluoroscopy, such as the atrial septum.

A bi-directional, deflectable guide introducer capable of being visualized on the 3D mapping
system allows the visualization in real time, allowing to increase the efficiency during the
mapping and positioning of the scaler catheter, reducing, up to zero, the scan times. It also
has 2-degree bidirectional deflection capability, reaching up to 180 degrees in both
directions.

Furthermore, it is extremely performing during the atrial septal puncture procedures: when,
in fact, a dilator is introduced through introducer to perform the transseptal puncture, the
presence of a smooth interface between the dilator and the tip of introducer allows access
more easily to the left atrium, reducing the force required to advance the system through the
atrial septum by 33%.

The fluoroscopic approach is widely validated and has represented for years the gold standard
in electrophysiological study and ablation procedures. However, this approach exposes the
operator and the patient to a high dose of radiation: in fact, during an AF ablation
procedure, the radiological exposure can reach up to 60 mSv, thus increasing the absolute
risk of developing lifetime cancer by 0.08%. It is therefore very necessary to apply the
principles of ALARA (a slow as reasonably achievable) as established by the consent document
of the American College of Cardiology of 1998.

Recently the trans catheter ablation procedures of AF have undergone a major increase.
Considering, therefore, the wide diffusion of this technique and the high radiological
exposure linked to the transseptal puncture and the isolation of the pulmonary veins,
promoting an approach without radiological exposure becomes extremely crucial.

The rationale of this study is to evaluate the clinical and procedural features of an
ablative approach using the steerable introducer in combination with the 3D EAM system and
intracardiac echocardiography: the combination of these elements is potentially able to
significantly reduce, to zero, the scanning times and to reduce procedural times,
guaranteeing efficacy and safety. Complications will also be assessed at 30 days and the
effectiveness of the procedure at six months.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">June 1, 2020</start_date>
<completion_date type="Actual">December 31, 2021</completion_date>
<primary_completion_date type="Actual">June 30, 2021</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Control</observational_model>
<time_perspective>Retrospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Fluoroscopy time</measure>
<time_frame>Intraprocedure</time_frame>
<description>Time of X-ray exposure</description>
</primary_outcome>
<primary_outcome>
<measure>DAP</measure>
<time_frame>Intraprocedure</time_frame>
<description>Dose area product</description>
</primary_outcome>
<primary_outcome>
<measure>Procedural time</measure>
<time_frame>Intraprocedure</time_frame>
<description>Total procedure time</description>
</primary_outcome>
<secondary_outcome>
<measure>Time for PVI</measure>
<time_frame>Intraprocedure</time_frame>
<description>Pulmonary veins isolation time</description>
</secondary_outcome>
<secondary_outcome>
<measure>Complications</measure>
<time_frame>30 days</time_frame>
<description>Procedural complications, percardial effusion, groin hematoma, thromboembolism</description>
</secondary_outcome>
<secondary_outcome>
<measure>Absence of atrial fibrillation recurrence</measure>
<time_frame>6 months</time_frame>
<description>Freedom from new episodes of arrhythmias</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Actual">50</enrollment>
<condition>Atrial Fibrillation</condition>
<arm_group>
<arm_group_label>Zero fluoroscopy</arm_group_label>
<description>Zero fluoroscopy Patients undergoing AF ablation using the steerable introducer in combination with the 3D EAM system and intracardiac echocardiography.
Reconstruction of a bipolar map of the right atrium with a mapping catheter. Then, the interatrial septum is reconstructed and the oval fossa is defined. Transseptal puncture is performed using the steerable introducer (which can be viewed on the EAM) through which, a transseptal needle is introduced. The introducer is positioned at the fossa ovalis. The transseptal needle is advanced to perform the puncture of the septum. After accessing the left atrium, the mapping catheter is introduced iusing the introducer, with which all the structures of the left atrium are mapped. In addition, with intracardiac echocardiography, it is possible to identify important structures such as the pulmonary veins and the esophagus. The pulmonary veins are isolated by means of a catheter.</description>
</arm_group>
<arm_group>
<arm_group_label>Traditional approach</arm_group_label>
<description>Traditional approach Patients who have undergone atrial fibrillation ablation procedure using the traditional approach.
The procedure is based on 3D reconstruction using intracardiac ultrasound first and then electroanatomical mapping of the left atrium through a transseptal approach guided by integration of fluoroscopy and intracardiac ultrasound. The transseptal puncture is performed using a transseptal needle which is brought into place using a long introducer with a dilator. The fluoroscopic support is essential as the introducer is not viewable with 3D mapping systems. After accessing the left atrium, through the previously used introducer, a mapping catheter is taken to the left atrium for electro-anatomical reconstruction. Subsequently, the antral pulmonary veins are isolated by means of an ablator catheter with irrigated tip.</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Atrial fibrillation ablation</intervention_name>
<description>Pulmonary vein isolation</description>
<arm_group_label>Traditional approach</arm_group_label>
<arm_group_label>Zero fluoroscopy</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
Patients with atrial fibrillation (paroxysmal or persistent) treated with transcatheter
ablation
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Paroxysmal or persistent atrial fibrillation

- Atrial fibrillation ablation performed during study period

- Clinical follow-up and ECG-Holter recording during follow-up

Exclusion Criteria:

- Age < 18 years

- Pregnancy
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>100 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Matteo Bertini</name>
<address>
<city>Ferrara</city>
<zip>44124</zip>
<country>Italy</country>
</address>
</facility>
</location>
<location_countries>
<country>Italy</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>March 31, 2022</last_update_submitted>
<last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 8, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University Hospital of Ferrara</investigator_affiliation>
<investigator_full_name>Matteo Bertini</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<keyword>atrial fibrillation</keyword>
<keyword>ablation</keyword>
<keyword>radiofrequency</keyword>
<keyword>intracardiac echocardiography</keyword>
<keyword>zero fluoroscopy</keyword>
<keyword>arrhythmias</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Atrial Fibrillation</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
In electrophysiology, interventional procedures are often assisted by fluoroscopic guidance,
exposing both patients and healthcare professionals to a considerable dose of radiation.
Catheter ablation of atrial fibrillation has frequently involved the use of fluoroscopy: in
fact, it incorporates greater complexity due to the need to perform the transseptal puncture.
A visible introducer in the 3D electro-anatomical mapping system (which does not involve the
use of X-rays), has become an important tool for performing transseptal puncture: in
particular, it is positioned at level of the oval fossa of the right atrium (puncture site);
subsequently, the needle is introduced inside it; the intervention is guided both by
electroanatomical mapping and by the use of intracardiac echocardiography for the
identification of important anatomical landmarks.
The "zero rays" technique represents a valid alternative to fluoroscopic guidance, widely
used and validated over the years. In fact, X-ray exposure in an atrial fibrillation ablation
procedure can reach up to 60 mSv: the radiological risk makes it necessary to study safe and
effective alternative techniques.
In this retrospective, observational and monocentric study, 50 catheter ablation procedures
of atrial fibrillation will be examined, divided into two groups:
1. 25 patients who performed this procedure according to the classic approach, ie under
fluoroscopic guidance;
2. 25 patients who performed this procedure using an ablative approach that involved the
use of the introducer in combination with the 3D EAM system and intracardiac
echocardiography.
Clinical efficacy will be assessed through a cardiological checkup and 24-hour
electrocardiographic recording (ECG Holter) at 6 months.
Atrial fibrillation (AF) is the most common sustained adult tachyarrhythmia found in clinical
practice. The prevalence of this arrhythmia in the general population varies from 2 to 4% and
increases significantly in elderly patients and in carriers of diseases such as arterial
hypertension, heart failure, coronary and valvular disease, obesity, diabetes mellitus and
chronic kidney disease. In addition to being a marker of underlying heart or vascular
disease, FA in itself is accompanied by an increased incidence of ischemic stroke, heart
failure and dementia. The mechanisms underlying this arrhythmia are still debated, but seem
to involve electrical and structural alterations of the atrium that constitute a
morpho-functional substrate that facilitate its development.
Traditionally, five types of atrial fibrillation are distinguished, based on presentation,
duration and term:
1. Newly diagnosed AF: first finding of AF, regardless of the duration, presence and
severity of symptoms;
2. Paroxysmal AF: AF that resolves within seven days (spontaneously or through
cardioversion);
3. Persistent AF: AF that lasts more than seven days or is cardioverted after seven days;
4. Long lasting AF: AF that lasts more than a year continuously, when a rhythm control
strategy has been adopted.
5. Permanent AF: AF accepted by the patient (and by the attending physician) for which no
further attempt to control the rhythm is undertaken.
Treatment include heart rate and / or rhythm control strategies, prevention of cerebral
thromboembolism and reduction / elimination of symptoms, as well as control of major
cardiovascular risk factors. The decision about the implementation of therapeutic strategies
aimed at restoring and maintaining sinus rhythm must be shared between doctor and patient,
weighing on the one hand the effect on quality of life and symptoms, and on the other the
risk of toxic effects of drugs. used. When AF has been on for less than a year, an early
rhythm control strategy has been shown to reduce the composite outcome of cardiovascular
death, stroke, hospitalization for heart failure or acute coronary syndrome in the EAST-AFNET
4 clinical trial.
Trans catheter ablation is a well-established treatment for the reduction of AF relapses and
is proposed in cases of paroxysmal and persistent AF. It is a procedure that consists in the
antral circumferential disconnection of the pulmonary veins by radiofrequency, laser or
cryoblation. It is a safe and effective technique for maintaining sinus rhythm and for
improving symptoms. When antiarrhythmic drugs fail in rhythm control, the current ESC 2020
Guidelines place trans-catheter ablation in class I for paroxysmal and persistent AF with or
without major risk factors for recurrence, while as a first therapeutic approach it is in
class IIa for paroxysmal AF and IIb for persistent AF without major risk factors for relapse.
Advanced three-dimensional electro-anatomical mapping systems (3D EAM) have revolutionized
the transcatheter ablative approach, allowing a new approach to the study of complex
arrhythmias, such as FA. All the mapping systems, even if based on different principles,
allow a precise localization of the scaler catheter, starting from the vascular access up to
the heart chambers. While the catheter scans the different cardiac structures, the system
records information about the catheter's position and uses the spatial and electrical data to
create an accurate reproduction of the 3D geometry of the cardiac structures. All this has
led to a reduction in the use of fluoroscopy and, in particular for the ablation of AF, there
has been a reduction in radiation during these procedures even if a complete elimination has
not yet been possible.
Intracardiac echocardiography is an imaging technique capable of visualizing heart structures
in real time and with very high spatial resolution, as well as monitoring the position of the
catheter within the heart chambers and quickly identifying any procedural complications, such
as the formation of thrombus or pericardial effusion. A further advantage is represented by
the reduction of the scan times. For these reasons, intracardiac echocardiography has largely
replaced transesophageal echocardiography in many interventional procedures, including those
of electrophysiology. In fact, intracardiac echocardiography allows the integration of images
in real time with electro-anatomical mapping systems, allowing to map those structures that
are not viewable under fluoroscopy, such as the atrial septum.
A bi-directional, deflectable guide introducer capable of being visualized on the 3D mapping
system allows the visualization in real time, allowing to increase the efficiency during the
mapping and positioning of the scaler catheter, reducing, up to zero, the scan times. It also
has 2-degree bidirectional deflection capability, reaching up to 180 degrees in both
directions.
Furthermore, it is extremely performing during the atrial septal puncture procedures: when,
in fact, a dilator is introduced through introducer to perform the transseptal puncture, the
presence of a smooth interface between the dilator and the tip of introducer allows access
more easily to the left atrium, reducing the force required to advance the system through the
atrial septum by 33%.
The fluoroscopic approach is widely validated and has represented for years the gold standard
in electrophysiological study and ablation procedures. However, this approach exposes the
operator and the patient to a high dose of radiation: in fact, during an AF ablation
procedure, the radiological exposure can reach up to 60 mSv, thus increasing the absolute
risk of developing lifetime cancer by 0.08%. It is therefore very necessary to apply the
principles of ALARA (a slow as reasonably achievable) as established by the consent document
of the American College of Cardiology of 1998.
Recently the trans catheter ablation procedures of AF have undergone a major increase.
Considering, therefore, the wide diffusion of this technique and the high radiological
exposure linked to the transseptal puncture and the isolation of the pulmonary veins,
promoting an approach without radiological exposure becomes extremely crucial.
The rationale of this study is to evaluate the clinical and procedural features of an
ablative approach using the steerable introducer in combination with the 3D EAM system and
intracardiac echocardiography: the combination of these elements is potentially able to
significantly reduce, to zero, the scanning times and to reduce procedural times,
guaranteeing efficacy and safety. Complications will also be assessed at 30 days and the
effectiveness of the procedure at six months.
Patients with atrial fibrillation (paroxysmal or persistent) treated with transcatheter
ablation
Inclusion Criteria:
- Paroxysmal or persistent atrial fibrillation
- Atrial fibrillation ablation performed during study period
- Clinical follow-up and ECG-Holter recording during follow-up
Exclusion Criteria:
- Age < 18 years
- Pregnancy
|
NCT0531xxxx/NCT05319782.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319782</url>
</required_header>
<id_info>
<org_study_id>2021/663</org_study_id>
<nct_id>NCT05319782</nct_id>
</id_info>
<brief_title>Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences</brief_title>
<acronym>SAHARA</acronym>
<official_title>Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences</official_title>
<sponsors>
<lead_sponsor>
<agency>Centre Hospitalier Universitaire de Besancon</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Centre Hospitalier Universitaire de Besancon</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this study is to assess the long term urinary, sexual, cosmetic and
psycho-social outcomes of adult patients operated for hypospadias during childhood
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">May 10, 2023</start_date>
<completion_date type="Anticipated">May 2024</completion_date>
<primary_completion_date type="Anticipated">May 2024</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Other</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Proportion of adult patients with urethral stenosis following a repair surgery performed during childhood</measure>
<time_frame>Day 1</time_frame>
<description>Proportion of adult patients with urethral stenosis following a repair surgery performed during childhood, assessed with flowmetry (maximal urinary flow)</description>
</primary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">66</enrollment>
<condition>Hypospadias</condition>
<arm_group>
<arm_group_label>Experimental arm</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Urethral stenosis assesment</intervention_name>
<description>Auto-questionnaires + Clinical examination + Flow metry and post-mictional residue</description>
<arm_group_label>Experimental arm</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Patients operated for hypospadias during childhood (before the age of 15) at the
University Hospital of Besançon (France)

Exclusion Criteria:

- Patients with a non-operated hypospadias

- Opposition to participate

- Legal incapacity
</textblock>
</criteria>
<gender>Male</gender>
<gender_based>Yes</gender_based>
<minimum_age>18 Years</minimum_age>
<maximum_age>23 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Yann CHAUSSY, MD, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>CHU De Besançon</affiliation>
</overall_official>
<location>
<facility>
<name>CHU de Besançon</name>
<address>
<city>Besançon</city>
<zip>25000</zip>
<country>France</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Yann CHAUSSY, MD, PhD</last_name>
<phone>0033381219400</phone>
<email>ychaussy@chu-besancon.fr</email>
</contact>
<investigator>
<last_name>Yann CHAUSSY, MD, PhD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>France</country>
</location_countries>
<verification_date>May 2023</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>May 12, 2023</last_update_submitted>
<last_update_submitted_qc>May 12, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 15, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Hypospadias</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this study is to assess the long term urinary, sexual, cosmetic and
psycho-social outcomes of adult patients operated for hypospadias during childhood
Inclusion Criteria:
- Patients operated for hypospadias during childhood (before the age of 15) at the
University Hospital of Besançon (France)
Exclusion Criteria:
- Patients with a non-operated hypospadias
- Opposition to participate
- Legal incapacity
|
NCT0531xxxx/NCT05319795.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319795</url>
</required_header>
<id_info>
<org_study_id>CAPCR 21-5814</org_study_id>
<nct_id>NCT05319795</nct_id>
</id_info>
<brief_title>Effortful Swallow Maneuver for Swallowing Impairment in People With Parkinson Disease</brief_title>
<official_title>Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With Parkinson Disease</official_title>
<sponsors>
<lead_sponsor>
<agency>University Health Network, Toronto</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University Health Network, Toronto</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Context: Many people with Parkinson Disease (PwPD) experience swallowing difficulties,
particularly with food/liquid going down the wrong way or remaining in the throat after
swallowing. Prior studies suggest that exercise-based treatments targeting swallowing
strength may be effective in reducing these difficulties.

Research question: Does an exercise-based treatment involving the effortful swallow maneuver
improve swallowing function in PwPD?

Study plan: The investigators will study the effects of a four-week intensive swallowing
rehabilitation program in PwPD, over a 2-year period.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The investigators will study the effects of a four-week intensive swallowing rehabilitation
program in PwPD, over a 2 year period. The program will involve daily practice of the
effortful swallowing maneuver, with swallowing function assessed before and after the
treatment program using videofluoroscopic x-rays.

Expected outcomes: In other populations, the effortful swallow has shown to address two
mechanisms that are thought to underlie swallowing impairment in Parkinson Disease: slowness
in achieving airway protection and weakness in muscles responsible for transporting food
through the throat. The investigators expect that repeated practice of this maneuver by PwPD
will lead to improved airway protection and improved clearance of residue from the throat.
</textblock>
</detailed_description>
<overall_status>Enrolling by invitation</overall_status>
<start_date type="Actual">March 9, 2022</start_date>
<completion_date type="Anticipated">June 30, 2023</completion_date>
<primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<intervention_model_description>This is a prospective single arm case series treatment study involving a behavioral intervention (the Effortful Swallow Maneuver).</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
<masking_description>This is a single arm study. However, individuals responsible for rating the videofluoroscopy x-ray data to determine outcomes will be blinded to timepoint of evaluation.</masking_description>
</study_design_info>
<primary_outcome>
<measure>Change in Time-to-laryngeal-vestibule-closure</measure>
<time_frame>Post treatment (4 weeks) compared to pre-treatment baseline</time_frame>
<description>The time interval (in milliseconds) measured on a videofluoroscopic x-ray of swallowing between onset of the hyoid burst movement at the beginning of a swallow and achieving airway protection via closure of the laryngeal vestibule. The investigators will measure time-to-laryngeal-vestibule-closure across a series of 3 thin liquid swallows and 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst score per consistency will be recorded at each timepoint.</description>
</primary_outcome>
<primary_outcome>
<measure>Change in Penetration-Aspiration Scale Score</measure>
<time_frame>Post treatment (4 weeks) compared to pre-treatment baseline</time_frame>
<description>The Penetration-Aspiration Scale is an 8-point ordinal scale, measured on a videofluorosopic x-ray of swallowing, which documents the depth of any airway invasion events, and the subsequent response to airway invasion (Rosenbek et al., 1996). The investigators will measure penetration-aspiration across a series of 3 thin liquid swallows and 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst (i.e., highest) score per consistency will be recorded at each timepoint.</description>
</primary_outcome>
<primary_outcome>
<measure>Change in pharyngeal area at maximum constriction</measure>
<time_frame>Post treatment (4 weeks) compared to pre-treatment baseline</time_frame>
<description>A videofluoroscopic measure of the degree of pharyngeal constriction during swallowing (i.e. maximum obliteration of the space in the pharynx). The investigators will measure pharyngeal area at maximum constriction across a series of 3 thin liquid swallows and 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst (i.e., highest) score per consistency will be recorded at each timepoint.</description>
</primary_outcome>
<primary_outcome>
<measure>Change in total pharyngeal residue</measure>
<time_frame>Post treatment (4 weeks) compared to pre-treatment baseline</time_frame>
<description>A videofluoroscopic measure of the amount of residue left behind in the pharynx after a swallow. The investigators will measure pharyngeal residue across a series of 3 thin liquid swallows and 3 mildly thick liquid swallows in videofluoroscopy. The participant's worst (i.e., highest) score per consistency will be recorded at each timepoint.</description>
</primary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">12</enrollment>
<condition>Parkinson Disease</condition>
<condition>Dysphagia</condition>
<arm_group>
<arm_group_label>Effortful Swallow Maneuver</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Adults with a confirmed diagnosis of Parkinson Disease who have radiographically confirmed difficulties with timely airway protection and/or bolus clearance during swallowing. Individuals will complete a 4-week intervention program with two 30-minute sessions of Effortful Swallow (ES) practice daily, 5 days per week.</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Effortful Swallow Maneuver</intervention_name>
<description>Repeated practice of the Effortful Swallowing Maneuver generated by pushing the tongue with increased effort against the palate at the point of swallow initiation.</description>
<arm_group_label>Effortful Swallow Maneuver</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- At least 18 years old

- English-speaking

- Able to follow study instructions

- Neurologist confirmed diagnosis of PD

- Hoehn and Yahr scale score of 2 or 3

- Self-report of one or more swallowing or related symptoms:

1. Difficulty with secretion management

2. Coughing at the meal time

3. Choking on food

4. Respiratory infection in the past 6 months (other than COVID)

Exclusion Criteria:

- History of head and neck cancer

- Radical neck dissection (e.g. anterior cervical spine surgery) or neck/ oropharyngeal
surgery (not excluded - tonsillectomy, adenoidectomy)

- Past medical history of any neurological disease other than PD (e.g. multiple
sclerosis, amyotrophic lateral sclerosis, traumatic brain injury, stroke)

- Cognitive or receptive communication difficulties that preclude the participant's
ability to follow study instructions provided in English. This will be determined by
the participant's physician prior to referring them to the study.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Catriona M Steele, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>University Health Network, Toronto</affiliation>
</overall_official>
<location>
<facility>
<name>Toronto Rehabilitation Institute - University Health Network</name>
<address>
<city>Toronto</city>
<state>Ontario</state>
<zip>M5G 2A2</zip>
<country>Canada</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University Health Network</name>
<address>
<city>Toronto</city>
<state>Ontario</state>
<zip>M5G 2C4</zip>
<country>Canada</country>
</address>
</facility>
</location>
<location_countries>
<country>Canada</country>
</location_countries>
<reference>
<citation>Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.</citation>
<PMID>8721066</PMID>
</reference>
<verification_date>May 2022</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>May 16, 2022</last_update_submitted>
<last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">May 19, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University Health Network, Toronto</investigator_affiliation>
<investigator_full_name>Catriona Steele</investigator_full_name>
<investigator_title>Scientist</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Parkinson Disease</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<pending_results>
<submitted>June 5, 2023</submitted>
</pending_results>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Context: Many people with Parkinson Disease (PwPD) experience swallowing difficulties,
particularly with food/liquid going down the wrong way or remaining in the throat after
swallowing. Prior studies suggest that exercise-based treatments targeting swallowing
strength may be effective in reducing these difficulties.
Research question: Does an exercise-based treatment involving the effortful swallow maneuver
improve swallowing function in PwPD?
Study plan: The investigators will study the effects of a four-week intensive swallowing
rehabilitation program in PwPD, over a 2-year period.
The investigators will study the effects of a four-week intensive swallowing rehabilitation
program in PwPD, over a 2 year period. The program will involve daily practice of the
effortful swallowing maneuver, with swallowing function assessed before and after the
treatment program using videofluoroscopic x-rays.
Expected outcomes: In other populations, the effortful swallow has shown to address two
mechanisms that are thought to underlie swallowing impairment in Parkinson Disease: slowness
in achieving airway protection and weakness in muscles responsible for transporting food
through the throat. The investigators expect that repeated practice of this maneuver by PwPD
will lead to improved airway protection and improved clearance of residue from the throat.
Inclusion Criteria:
- At least 18 years old
- English-speaking
- Able to follow study instructions
- Neurologist confirmed diagnosis of PD
- Hoehn and Yahr scale score of 2 or 3
- Self-report of one or more swallowing or related symptoms:
1. Difficulty with secretion management
2. Coughing at the meal time
3. Choking on food
4. Respiratory infection in the past 6 months (other than COVID)
Exclusion Criteria:
- History of head and neck cancer
- Radical neck dissection (e.g. anterior cervical spine surgery) or neck/ oropharyngeal
surgery (not excluded - tonsillectomy, adenoidectomy)
- Past medical history of any neurological disease other than PD (e.g. multiple
sclerosis, amyotrophic lateral sclerosis, traumatic brain injury, stroke)
- Cognitive or receptive communication difficulties that preclude the participant's
ability to follow study instructions provided in English. This will be determined by
the participant's physician prior to referring them to the study.
|
NCT0531xxxx/NCT05319808.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319808</url>
</required_header>
<id_info>
<org_study_id>UI-123218</org_study_id>
<nct_id>NCT05319808</nct_id>
</id_info>
<brief_title>Rehabilitation for Whiplash Associated Disorders</brief_title>
<official_title>Rehabilitation for Whiplash Associated Disorders; a Randomized Clinical Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Iceland</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>K!M Rehabilitation</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Haefi Physiotherapy</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Healo</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Reykjavik University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Landspitali University Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>University of Iceland</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Individuals (n=180) with subacute (<1 month, >3 months) WAD grade I and II with medium to
high-risk symptoms of working age will be randomized into three groups with block
randomization in a prospective, assessor-blinded randomized controlled trial. Two primary
intervention groups (A and B) will receive manual therapy (MT) in the same out-patient
clinic. In addition, group A will receive a remote, novel, computer-based cervical
kinaesthetic exercise program starting at visit two, whereby quality and quantity of exercise
performance, as well as compliance (frequency and duration), will be registered into the
physical therapy clinic's system for evaluation. Group B will receive neck exercises (not
computer-based) provided by the corresponding physical therapist. Group A will continue
remote exercise therapy until 6 months post baseline measurements regardless of whether they
are still being treated in-clinic or discharged.

Hypothesis 1.a.: Internet-based neck-specific CKE combined with in-clinic manual therapy and
exercises will be superior to manual therapy and exercises alone at a physiotherapy clinic
(i.e., treatment A is superior to treatment B) for self-reported and measured (movement
performance) outcome measures.

Hypothesis 1.b.: Improvements in self-reported outcomes will positively correlate with
outcomes of movement performance testing, as will the pre- to post-intervention changes from
baseline to follow-up assessments.

The groups will be compared to a "treatment as usual" group (C). Objective measures include
measurements for motor control, proprioception, and cervical range of motion. Neck disability
and pain intensity, general health, self-perceived handicap, and physical, emotional and
functional difficulties due to dizziness will be measured using questionnaires. Short-term
effects will be measured at 10-12 weeks and long-term effects at 6- and 12-months post
baseline measurements.

Hypothesis 2.a.: Participants of groups A and B will improve significantly more than those in
group C for subjective and objective outcome measures.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
QUALITY ASSURANCE PLAN:

PhD student will monitor the data and guarantee high data quality. Data will be protected
according to the Act on Data Protection and the Processing of Personal data (Icelandic law)
and stored at the University Hospital or at a secure NeckCare database. Data will be
registered into Microsoft Excel and shared through a secure network with other researchers to
promote transparency.

DATA CHECKS:

Data will be checked for outliers.

SOURCE DATA VERIFICATION:

N/A

DATA DICTIONARY:

WAD: whiplash-associated disorders; MVC: motor vehicle collision; VR: virtual reality; NDI:
neck disability index; ROM: range of motion; PTs: physiotherapists; MT: manual therapy; CKE:
cervical kinaesthetic exercise; IT: information technology; IoT: internet of things; IMU:
inertial monitoring unit; VAS: visual analog scale; SF-36: short form 36 item health survey;
DHI: dizziness handicap inventory; CSI: central sensitisation inventory; CS: central
sensitization; ToT: time on target; CI: confidence interval; MCIC: minimal clinically
important changes.

STANDARD OPERATION PROCEDURES:

A total of 180 subjects (60 from each of the three groups) will be recruited through the
databases of The Emergency Department of Landspitali University Hospital, Reykjavik, Iceland
via phone call.

Subjective and objective outcome measures will be collected by a PhD student. In addition to
questionnaire and clinical outcome measures, the pharmaceutical database of the Directorate
of Health in Iceland will be accessed for data on subjects' drug use.

Data will be analysed by the PhD student using Microsoft Excel and R, a free software
environment for statistical computing and graphics.

The PhD student will be responsible for reporting adverse events and change management.

SAMPLE SIZE ASSESSMENT:

Sample size and power regarding group differences will be calculated based on the primary
outcome NDI. To detect a clinically relevant improvement of 8% in the NDI, 40 participants
are needed in each group for 80% power. For non-inferiority tests, the significance level
will be set to 5% (p > 0.05) which corresponds to the one-sided confidence interval (95% CI).
To ensure that enough people are in each group after dropouts, for prediction analyses and
the opportunity for subgroup analyses, 60 participants will be included in each group
(n=180).

PLAN FOR MISSING DATA:

If data will be found to be missing by any reason, each incident will be assessed by the PhD
student and her advisors. Imputation methods may be used, the subject involved may be asked
to come back in for a measurement or answer questionnaires again (depending on the time that
has passed from the measurement/questionnaires until data is discovered missing) or the
subject involved will be removed from the study.

STATISTICAL ANALYSIS PLAN:

Data analyses and statistics Database monitoring will be performed by the primary researcher
and statisticians involved, independent of sponsors and competing interests. Background data
will be assessed after all subjects have completed their baseline measurements.

Background data and association of self-reported and clinical measures Background data will
be evaluated with descriptive statistics and differences in baseline data determined using
t-tests and (M)ANOVA (mean and standard deviation) or non-parametric tests where appropriate.
Association of self-reported measurements and clinical measures will be assessed for
baseline, 10-12-week, 6-month and 12-month measurements using Pearson or Spearman correlation
depending on the distribution of the data. Subgroup analyses of CPS may possibly be
performed.

Effectiveness of therapy Analyses will be performed primarily on an intention-to-treat basis
(as individuals being randomized into the groups) and secondarily on a per protocol basis
(individuals who fulfilled the programme for at least 50%). Imputation methods may be used
when deemed to have additional value. Linear mixed models with time as a repeated factor will
be used to assess the effect of treatment for each outcome. Correlation over time, within the
PT and prognostic factors will be accounted for. Estimates of the effect of the intervention
will be obtained by constructing linear contrasts to compare the mean change in outcome for
each measurement (subjective and objective) to each time point between treatment groups and
between each treatment group compared to control group. The main dependent variable will be
score on NDI with independent fixed factors time (baseline, 10-12-week, 6-month, and
12-month) and group (A, B and C). If the non-inferiority of C to A or of C to B is concluded
based on the 95% CI, a test of the superiority of C to A or of C to B will be performed as
suggested by Lesaffre (see reference list). The variation in response to intervention
(heterogeneity of treatment effect) will be evaluated using regression analysis.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">May 27, 2022</start_date>
<completion_date type="Anticipated">April 30, 2024</completion_date>
<primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Two groups will receive physiotherapy. Both will receive a "hands-on" individualized treatment of manual therapy. The "hands-off" treatment differs between groups and goes as follows:
Group A will receive a novel, remote computer based cervical joint positioning exercise and cervical kinaesthesia exercise program with a 6-month follow-up.
Group B will receive a non-computer based exercise regime at the need of each individual (pragmatic approach). This group will not be followed up on their exercises post intervention but will be encouraged to continue doing their exercises. They will be asked during follow-up measurements if they have been doing their exercises.
The "treatment as usual" group (group C) will/will not receive treatment at his/her own choice and/or convenience and without any instructions from research staff to reflect general practice. In addition to follow-up assessments, data will be collected which asks about treatment modalities used.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Neck disability index (NDI)</measure>
<time_frame>5 minutes</time_frame>
<description>the NDI is a 10-item self-report questionnaire that has been shown to demonstrate good validity and reliability. Each section is scored on a 0 to 5 rating scale, higher score represents more neck pain related disability.</description>
</primary_outcome>
<primary_outcome>
<measure>Visual Analog Scale (VAS)</measure>
<time_frame>1 minutes</time_frame>
<description>Neck pain intensity during the past week prior to each measurement measured by a 100 mm visual analogue scale (VAS) with 0mm representing "no pain" and 100mm representing "worst pain imaginable</description>
</primary_outcome>
<primary_outcome>
<measure>Butterfly Test</measure>
<time_frame>5 minutes</time_frame>
<description>Procedure: The subject tracks an unpredictable path as accurately as possible using head movement to manipulate the on-screen cursor. There are different trajectories with increasing difficulty. The subject repeats each trajectory path 3 times.
Metrics: (1) Amplitude Accuracy (AA): the absolute distance (radius) in mm between the cursor that represents the head position and the target. (2) Time On Target (ToT): the percentage of time the cursor that represents the head position spends in a mathematically determined, invisible free zone around the target. (3) Smoothness of Movement Index (SMI): The index is calculated based on the third positional derivative with respect to time and is scaled between 0 and 5 with 0 being the best and 5 being the worst.</description>
</primary_outcome>
<primary_outcome>
<measure>Whole Cervical Range of Motion (ROM) Test</measure>
<time_frame>5 minutes</time_frame>
<description>Procedure: The subject turns their head using four different types of movements: flexion, extension, rotation (left/right) and lateral flexion (left/right) to measure the maximum range ROM. Each movement is repeated 3 times.
Metrics: An average degree value and standard deviation of the 3 measurements for each movement type.</description>
</primary_outcome>
<primary_outcome>
<measure>Head Neck Relocation Test (HNRT)</measure>
<time_frame>5 minutes</time_frame>
<description>Procedure: While blindfolded, the subject is asked to find their "neutral" position. The subject then turns their head to rotate left/right and up/down and attempts to return to the neutral/initial position following each movement, the subject informs the researcher by saying a simple "ok" when he believes he has reached the neutral position. The researcher marks this with one mouse click.
Metrics: (1) Accuracy Error measures the deviation in degrees from the initial position; (2) Constant Error measures under-/overshooting; and (3) Variable Error measures the precision of the head posture.</description>
</primary_outcome>
<secondary_outcome>
<measure>SF-36 Health Survey (SF-36) RAND version</measure>
<time_frame>10 minutes</time_frame>
<description>SF-36 is the most frequently recommended questionnaire to rate general mental health for patients with chronic musculoskeletal disorders. It's a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting, and the 36 items tap eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a 0 to 100 range where higher score defines a more favorable health state.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Dizziness Handicap Inventory (DHI)</measure>
<time_frame>5 minutes</time_frame>
<description>the DHI is a 25-item self-assessment inventory designed to evaluate the self-perceived handicapping effects imposed by dizziness. Each item is scored on a 0 to 4 rating scale, with higher score representing more self-perceived handicapping.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Central Sensitization Inventory (CSI)</measure>
<time_frame>5 minutes</time_frame>
<description>the CSI is a self-reported tool to assess symptoms of CS (central sensitization). The list includes 25 items about CS-related symptoms, scored on a five-point Likert scale from 0-4. Higher total scores reflect higher CS symptomology</description>
</secondary_outcome>
<other_outcome>
<measure>Background data, questionnaire</measure>
<time_frame>7 minutes</time_frame>
<description>Background data that will be collected will include age, sex, date of birth, information on when the accident occurred and how, first symptoms, former healthcare, education, occupational classification, income, and information on insurance claim status. Furthermore, during the 6-month and 12-month follow-up participants will also be asked to give information on if they have met with a health care practitioner for treatment other than those of this study</description>
</other_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Anticipated">180</enrollment>
<condition>Whiplash Injury of Cervical Spine</condition>
<arm_group>
<arm_group_label>Group A</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Telehealth using NeckCare equipment</description>
</arm_group>
<arm_group>
<arm_group_label>Group B</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Exercises without telehealth intervention</description>
</arm_group>
<arm_group>
<arm_group_label>Group C</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>No intervention provided by the researchers</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Manual therapy</intervention_name>
<description>Individualized treatment of manual therapy provided by MT PTs, graduates from Curtin University of Technology, Perth, Australia (2008)</description>
<arm_group_label>Group A</arm_group_label>
<arm_group_label>Group B</arm_group_label>
</intervention>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Telehealth exercises</intervention_name>
<description>A novel, remote computer based cervical joint positioning exercise and cervical kinaesthetic exercise (CKE) program. A technical consultant monitors the data from the remote exercises and inform the PTs if someone has not done their exercises in over 2 weeks during the study period so subjects can be encouraged with a friendly reminder.</description>
<arm_group_label>Group A</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Non-computer based exercises</intervention_name>
<description>Home-exercises in the need of each subject (pragmatic approach) taught by MT PTs, graduates from Curtin University of Technology, Perth, Australia (2008)</description>
<arm_group_label>Group B</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- subacute (>1 month, <3 months) neck problems corresponding to WAD grades I-II verified
by WhipPredict

- medium to high risk symptoms (NDI score >32% OR subject is >36 years old) OR VAS score
>4/10

- within daily reach of a computer/tablet/smartphone and Internet

- showed neck symptoms within the first week following the car collision (i.e. neck
pain, neck stiffness)

Exclusion Criteria:

- WAD grades III-IV

- considerable degree of known or suspected physical pathology (Myelopathy, Spinal
tumours, Spinal infection, Ongoing malignancy, Cervical spine surgery, Severe neck
problems within their medical history which resulted in sick leave for more than a
month in the year before the current whiplash injury, Other illness/injury that may
prevent full participation from being feasible, Lack of ability to either understand
or write Icelandic, Severe obesity (body mass index; BMI > 35), Pregnancy)

- unable to complete the assessment
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>63 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>K!M Rehabilitaion</name>
<address>
<city>Kópavogur</city>
<zip>203</zip>
<country>Iceland</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Harpa S Ragnarsdóttir, MSc</last_name>
<phone>+3548670350</phone>
<phone_ext>+354</phone_ext>
<email>harpasr@gmail.com</email>
</contact>
</location>
<location>
<facility>
<name>University of Iceland</name>
<address>
<city>Reykjavík</city>
<zip>102</zip>
<country>Iceland</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Kristín Briem, PhD</last_name>
<phone>5254096</phone>
<phone_ext>+354</phone_ext>
<email>kbriem@hi.is</email>
</contact>
<contact_backup>
<last_name>Guðný L Oddsdóttir, PhD</last_name>
<phone>5254091</phone>
<phone_ext>Ragnarsdóttir</phone_ext>
<email>glo@hi.is</email>
</contact_backup>
<investigator>
<last_name>Harpa S Ragnarsdóttir, MSc</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Hjalti M Björnsson, MD</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Landspítali University Hospital</name>
<address>
<city>Reykjavík</city>
<zip>108</zip>
<country>Iceland</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Hjalti M Björnsson, MD</last_name>
<phone>5431000</phone>
<phone_ext>354</phone_ext>
<email>hjaltimb@landspitali.is</email>
</contact>
</location>
<location>
<facility>
<name>Hæfi Physiotherapy</name>
<address>
<city>Reykjavík</city>
<zip>112</zip>
<country>Iceland</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Karólína Ólafsdóttir, MSc</last_name>
<phone>5111011</phone>
<phone_ext>+354</phone_ext>
<email>karolina@haefi.is</email>
</contact>
</location>
<location_countries>
<country>Iceland</country>
</location_countries>
<reference>
<citation>Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4.</citation>
<PMID>18537788</PMID>
</reference>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>June 30, 2022</last_update_submitted>
<last_update_submitted_qc>June 30, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">July 6, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Whiplash-Associated Disorders</keyword>
<keyword>Car-collision</keyword>
<keyword>Kinaesthesia</keyword>
<keyword>Telehealth</keyword>
<keyword>Motor Control</keyword>
<keyword>Treatment</keyword>
<keyword>Exercises</keyword>
<keyword>Manual Therapy</keyword>
<keyword>Objective measurements</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Whiplash Injuries</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Individuals (n=180) with subacute (<1 month, >3 months) WAD grade I and II with medium to
high-risk symptoms of working age will be randomized into three groups with block
randomization in a prospective, assessor-blinded randomized controlled trial. Two primary
intervention groups (A and B) will receive manual therapy (MT) in the same out-patient
clinic. In addition, group A will receive a remote, novel, computer-based cervical
kinaesthetic exercise program starting at visit two, whereby quality and quantity of exercise
performance, as well as compliance (frequency and duration), will be registered into the
physical therapy clinic's system for evaluation. Group B will receive neck exercises (not
computer-based) provided by the corresponding physical therapist. Group A will continue
remote exercise therapy until 6 months post baseline measurements regardless of whether they
are still being treated in-clinic or discharged.
Hypothesis 1.a.: Internet-based neck-specific CKE combined with in-clinic manual therapy and
exercises will be superior to manual therapy and exercises alone at a physiotherapy clinic
(i.e., treatment A is superior to treatment B) for self-reported and measured (movement
performance) outcome measures.
Hypothesis 1.b.: Improvements in self-reported outcomes will positively correlate with
outcomes of movement performance testing, as will the pre- to post-intervention changes from
baseline to follow-up assessments.
The groups will be compared to a "treatment as usual" group (C). Objective measures include
measurements for motor control, proprioception, and cervical range of motion. Neck disability
and pain intensity, general health, self-perceived handicap, and physical, emotional and
functional difficulties due to dizziness will be measured using questionnaires. Short-term
effects will be measured at 10-12 weeks and long-term effects at 6- and 12-months post
baseline measurements.
Hypothesis 2.a.: Participants of groups A and B will improve significantly more than those in
group C for subjective and objective outcome measures.
QUALITY ASSURANCE PLAN:
PhD student will monitor the data and guarantee high data quality. Data will be protected
according to the Act on Data Protection and the Processing of Personal data (Icelandic law)
and stored at the University Hospital or at a secure NeckCare database. Data will be
registered into Microsoft Excel and shared through a secure network with other researchers to
promote transparency.
DATA CHECKS:
Data will be checked for outliers.
SOURCE DATA VERIFICATION:
N/A
DATA DICTIONARY:
WAD: whiplash-associated disorders; MVC: motor vehicle collision; VR: virtual reality; NDI:
neck disability index; ROM: range of motion; PTs: physiotherapists; MT: manual therapy; CKE:
cervical kinaesthetic exercise; IT: information technology; IoT: internet of things; IMU:
inertial monitoring unit; VAS: visual analog scale; SF-36: short form 36 item health survey;
DHI: dizziness handicap inventory; CSI: central sensitisation inventory; CS: central
sensitization; ToT: time on target; CI: confidence interval; MCIC: minimal clinically
important changes.
STANDARD OPERATION PROCEDURES:
A total of 180 subjects (60 from each of the three groups) will be recruited through the
databases of The Emergency Department of Landspitali University Hospital, Reykjavik, Iceland
via phone call.
Subjective and objective outcome measures will be collected by a PhD student. In addition to
questionnaire and clinical outcome measures, the pharmaceutical database of the Directorate
of Health in Iceland will be accessed for data on subjects' drug use.
Data will be analysed by the PhD student using Microsoft Excel and R, a free software
environment for statistical computing and graphics.
The PhD student will be responsible for reporting adverse events and change management.
SAMPLE SIZE ASSESSMENT:
Sample size and power regarding group differences will be calculated based on the primary
outcome NDI. To detect a clinically relevant improvement of 8% in the NDI, 40 participants
are needed in each group for 80% power. For non-inferiority tests, the significance level
will be set to 5% (p > 0.05) which corresponds to the one-sided confidence interval (95% CI).
To ensure that enough people are in each group after dropouts, for prediction analyses and
the opportunity for subgroup analyses, 60 participants will be included in each group
(n=180).
PLAN FOR MISSING DATA:
If data will be found to be missing by any reason, each incident will be assessed by the PhD
student and her advisors. Imputation methods may be used, the subject involved may be asked
to come back in for a measurement or answer questionnaires again (depending on the time that
has passed from the measurement/questionnaires until data is discovered missing) or the
subject involved will be removed from the study.
STATISTICAL ANALYSIS PLAN:
Data analyses and statistics Database monitoring will be performed by the primary researcher
and statisticians involved, independent of sponsors and competing interests. Background data
will be assessed after all subjects have completed their baseline measurements.
Background data and association of self-reported and clinical measures Background data will
be evaluated with descriptive statistics and differences in baseline data determined using
t-tests and (M)ANOVA (mean and standard deviation) or non-parametric tests where appropriate.
Association of self-reported measurements and clinical measures will be assessed for
baseline, 10-12-week, 6-month and 12-month measurements using Pearson or Spearman correlation
depending on the distribution of the data. Subgroup analyses of CPS may possibly be
performed.
Effectiveness of therapy Analyses will be performed primarily on an intention-to-treat basis
(as individuals being randomized into the groups) and secondarily on a per protocol basis
(individuals who fulfilled the programme for at least 50%). Imputation methods may be used
when deemed to have additional value. Linear mixed models with time as a repeated factor will
be used to assess the effect of treatment for each outcome. Correlation over time, within the
PT and prognostic factors will be accounted for. Estimates of the effect of the intervention
will be obtained by constructing linear contrasts to compare the mean change in outcome for
each measurement (subjective and objective) to each time point between treatment groups and
between each treatment group compared to control group. The main dependent variable will be
score on NDI with independent fixed factors time (baseline, 10-12-week, 6-month, and
12-month) and group (A, B and C). If the non-inferiority of C to A or of C to B is concluded
based on the 95% CI, a test of the superiority of C to A or of C to B will be performed as
suggested by Lesaffre (see reference list). The variation in response to intervention
(heterogeneity of treatment effect) will be evaluated using regression analysis.
Inclusion Criteria:
- subacute (>1 month, <3 months) neck problems corresponding to WAD grades I-II verified
by WhipPredict
- medium to high risk symptoms (NDI score >32% OR subject is >36 years old) OR VAS score
>4/10
- within daily reach of a computer/tablet/smartphone and Internet
- showed neck symptoms within the first week following the car collision (i.e. neck
pain, neck stiffness)
Exclusion Criteria:
- WAD grades III-IV
- considerable degree of known or suspected physical pathology (Myelopathy, Spinal
tumours, Spinal infection, Ongoing malignancy, Cervical spine surgery, Severe neck
problems within their medical history which resulted in sick leave for more than a
month in the year before the current whiplash injury, Other illness/injury that may
prevent full participation from being feasible, Lack of ability to either understand
or write Icelandic, Severe obesity (body mass index; BMI > 35), Pregnancy)
- unable to complete the assessment
|
NCT0531xxxx/NCT05319821.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319821</url>
</required_header>
<id_info>
<org_study_id>STUDY22110036</org_study_id>
<secondary_id>R01CA268017</secondary_id>
<nct_id>NCT05319821</nct_id>
</id_info>
<brief_title>PA Moves Trial - PCP Participants</brief_title>
<official_title>Increasing Physical Activity in Rural Pennsylvanians: PCP Participants</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Pittsburgh</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Cancer Institute (NCI)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>University of Pittsburgh</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this voluntary research study is to determine the impact of an ECHO
intervention on the likelihood that rural primary care providers (PCP) will refer their
physically inactive patients to be more active.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
People living in rural areas are diagnosed and die from cancer at higher rates than people
living in cities. Physical activity has been shown to decrease the risk and occurrence of a
variety of cancers, including bladder, breast, colon, endometrial, gastric, kidney, and
prostate cancers. Being inactive can cause over 10% of breast and colon cancer cases.

Compared to people living in cities, people living in rural areas tend to be less physically
active. They're also more likely to be overweight/obese or have diabetes. Adults who are
overweight, obese, or diabetic often have changes in the way their bodies deal with insulin,
glucose metabolism, and inflammation. Physical activity is thought to reduce the risk of
cancer by improving these issues over time.

PCPs and their staff can identify a patient's need for more physical activity, but may not
have the time or resources to give advice or assistance. We have set up a telephone-based
physical activity coaching program, called the MoveLine, to give inactive patients advice and
assistance in becoming more physically active.

The purpose of this study is to determine if an ECHO intervention will impact the likelihood
that PCPs will refer patients to the MoveLine for physical activity coaching.

Approximately 32-48 providers will take part in this research study.
</textblock>
</detailed_description>
<overall_status>Enrolling by invitation</overall_status>
<start_date type="Actual">September 21, 2022</start_date>
<completion_date type="Anticipated">February 2028</completion_date>
<primary_completion_date type="Anticipated">January 2028</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Other</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Likelihood of patient referral</measure>
<time_frame>Through study completion, an average of 5 years</time_frame>
<description>Percentage of participating primary care providers referring their patients to a community-level, telephone-based physical activity counseling service assessed through the EMR of their participating patients</description>
</primary_outcome>
<secondary_outcome>
<measure>PAQ-M</measure>
<time_frame>Baseline intervention group vs. Baseline delayed intervention group</time_frame>
<description>The 11-question Morgenstern Physical Activity Questionnaire (PAQ-M) is a self-report of physical activity resulting from recreational activities, exercises, home or work activities, and chores.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Estimated average metabolic equivalents expended daily</measure>
<time_frame>1 week at baseline</time_frame>
<description>Daily metabolic equivalents collected using an accelerometer from Actigraph</description>
</secondary_outcome>
<secondary_outcome>
<measure>Estimated metabolic equivalents expended weekly</measure>
<time_frame>1 week at baseline</time_frame>
<description>Weekly metabolic equivalents collected using an accelerometer from Actigraph, expressed in hours/week</description>
</secondary_outcome>
<secondary_outcome>
<measure>Time in Sleep</measure>
<time_frame>1 week at baseline</time_frame>
<description>Weekly time in sleep collected using an accelerometer from Actigraph</description>
</secondary_outcome>
<secondary_outcome>
<measure>Sedentary Time</measure>
<time_frame>1 week at baseline</time_frame>
<description>Weekly sedentary time collected using an accelerometer from Actigraph</description>
</secondary_outcome>
<secondary_outcome>
<measure>Low physical activity</measure>
<time_frame>1 week at baseline</time_frame>
<description>Weekly low physical activity collected using an accelerometer from Actigraph</description>
</secondary_outcome>
<secondary_outcome>
<measure>Moderate physical activity</measure>
<time_frame>1 week at baseline</time_frame>
<description>Weekly moderate physical activity collected using an accelerometer from Actigraph</description>
</secondary_outcome>
<secondary_outcome>
<measure>Vigorous physical activity</measure>
<time_frame>1 week at baseline</time_frame>
<description>Weekly vigorous physical activity collected using an accelerometer from Actigraph</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">48</enrollment>
<condition>Behavior</condition>
<condition>Physical Activity</condition>
<arm_group>
<arm_group_label>Active Intervention</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>PCP participants in the practice cohort or the intervention group will receive the ECHO46 intervention via real-time, interactive videoconferencing through Zoom sessions held once weekly for 4 weeks (4 sessions total) at regularly scheduled times convenient to providers. Session topics will focus on training PCP participants to assess, advise, and refer patients to be more physically active, as well as provide evidence-based strategies they can use to supplement and sustain their communication efforts.</description>
</arm_group>
<arm_group>
<arm_group_label>Delayed Intervention</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>PCP participants will be offered the intervention in year 5.</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Receive ECHO training</intervention_name>
<description>Active Intervention</description>
<arm_group_label>Active Intervention</arm_group_label>
</intervention>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Offered ECHO training in year 5</intervention_name>
<description>Delayed Intervention</description>
<arm_group_label>Delayed Intervention</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Primary care providers or adjunct faculty from Primary Health Network (PHN) and Penn
State Health Family and Community Medicine (FCM) rural clinics

- Must be able to provide and understand informed consent

Exclusion Criteria:

- Primary care providers or adjunct faculty NOT from PHN or FCM rural clinics
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Kathryn Schmitz, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>University of Pittsburgh</affiliation>
</overall_official>
<location>
<facility>
<name>Milton S. Hershey Medical Center</name>
<address>
<city>Hershey</city>
<state>Pennsylvania</state>
<zip>17033</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>UPMC</name>
<address>
<city>Pittsburgh</city>
<state>Pennsylvania</state>
<zip>15219</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>May 2023</verification_date>
<study_first_submitted>March 10, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>May 8, 2023</last_update_submitted>
<last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 9, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of Pittsburgh</investigator_affiliation>
<investigator_full_name>Kathryn Schmitz</investigator_full_name>
<investigator_title>Professor</investigator_title>
</responsible_party>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this voluntary research study is to determine the impact of an ECHO
intervention on the likelihood that rural primary care providers (PCP) will refer their
physically inactive patients to be more active.
People living in rural areas are diagnosed and die from cancer at higher rates than people
living in cities. Physical activity has been shown to decrease the risk and occurrence of a
variety of cancers, including bladder, breast, colon, endometrial, gastric, kidney, and
prostate cancers. Being inactive can cause over 10% of breast and colon cancer cases.
Compared to people living in cities, people living in rural areas tend to be less physically
active. They're also more likely to be overweight/obese or have diabetes. Adults who are
overweight, obese, or diabetic often have changes in the way their bodies deal with insulin,
glucose metabolism, and inflammation. Physical activity is thought to reduce the risk of
cancer by improving these issues over time.
PCPs and their staff can identify a patient's need for more physical activity, but may not
have the time or resources to give advice or assistance. We have set up a telephone-based
physical activity coaching program, called the MoveLine, to give inactive patients advice and
assistance in becoming more physically active.
The purpose of this study is to determine if an ECHO intervention will impact the likelihood
that PCPs will refer patients to the MoveLine for physical activity coaching.
Approximately 32-48 providers will take part in this research study.
Inclusion Criteria:
- Primary care providers or adjunct faculty from Primary Health Network (PHN) and Penn
State Health Family and Community Medicine (FCM) rural clinics
- Must be able to provide and understand informed consent
Exclusion Criteria:
- Primary care providers or adjunct faculty NOT from PHN or FCM rural clinics
|
NCT0531xxxx/NCT05319834.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319834</url>
</required_header>
<id_info>
<org_study_id>3/2020/OBG</org_study_id>
<nct_id>NCT05319834</nct_id>
</id_info>
<brief_title>Comparative Study Between Vaginal Progesterone Alone or Combined With Aspirin in Prevention of Recurrent Preterm Birth</brief_title>
<acronym>prematurity</acronym>
<official_title>Comparative Study Between Vaginal Progesterone Alone or Combined With Aspirin in Prevention of Recurrent Preterm Birth</official_title>
<sponsors>
<lead_sponsor>
<agency>Menoufia University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Menoufia University</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
<is_us_export>No</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
This is a double blinded randomized placebo controlled clinical trial to detect the efficacy
and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent
PTB.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The included women will be randomly allocated to prophylactically receive either vaginal
progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at
a dose of 100mg once daily both at the same time (group1), or vaginal progesterone
(prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the
same size and shape of asprin tablet) also at the same time (group 2).
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">April 1, 2022</start_date>
<completion_date type="Anticipated">December 31, 2023</completion_date>
<primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date>
<phase>Phase 4</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>To detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.</intervention_model_description>
<primary_purpose>Prevention</primary_purpose>
<masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
<masking_description>All participants and investigators</masking_description>
</study_design_info>
<primary_outcome>
<measure>Number of participants who will deliver before 34 weeks gestation.</measure>
<time_frame>18 month</time_frame>
<description>Number of participants who have preterm delivery before 34 weeks gestation</description>
</primary_outcome>
<secondary_outcome>
<measure>The number of participants who have prolongation of pregnancy after 34 till 37 weeks gestation</measure>
<time_frame>18 months</time_frame>
<description>Number of participants who will deliver after 34w gestation and neonatal outcomes</description>
</secondary_outcome>
<secondary_outcome>
<measure>Neonatal outcomes</measure>
<time_frame>18 months</time_frame>
<description>Neonatal birth weight Admission to NICU Neonatal complications</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">254</enrollment>
<condition>Preterm Birth</condition>
<arm_group>
<arm_group_label>Progesterone with asprin</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>The included women will be randomly allocated to prophylactically receive either vaginal progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at a dose of 100mg once daily both at the same time (group1),</description>
</arm_group>
<arm_group>
<arm_group_label>Progesterone and placebo</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>vaginal progesterone (prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the same size and shape of asprin tablet) also at the same time (group 2).</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Aspirin tablet</intervention_name>
<description>group1: oral aspirin at a dose of 100mg once daily at the same time with progesterone</description>
<arm_group_label>Progesterone with asprin</arm_group_label>
<other_name>group 1 intervention</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Placebo</intervention_name>
<description>group 2: oral placebo once daily at the same time with progesterone</description>
<arm_group_label>Progesterone and placebo</arm_group_label>
<other_name>group 2 intervention</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Women of any age

2. Any parity

3. Healthy singleton pregnancy

4. History suggestive of one or more previous PTB

5. Current pregnancy (16-20) weeks gestation.

Exclusion Criteria:

1. Multifetal pregnancy.

2. History of ante partum PROM.

3. Cervical Incompetence or current cervical cerclage.

4. Known fetal anomaly.

5. Hypertension requiring medications.

6. History of Thrombo-embolic disorders.

7. Known allergy to progesterone or asprin.

8. Known liver disease.

9. Established preterm labor

10. Short cervix
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 22, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>March 31, 2022</last_update_submitted>
<last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 8, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Menoufia University</investigator_affiliation>
<investigator_full_name>Mohamed Maher</investigator_full_name>
<investigator_title>Professor</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Premature Birth</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Aspirin</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This is a double blinded randomized placebo controlled clinical trial to detect the efficacy
and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent
PTB.
The included women will be randomly allocated to prophylactically receive either vaginal
progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at
a dose of 100mg once daily both at the same time (group1), or vaginal progesterone
(prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the
same size and shape of asprin tablet) also at the same time (group 2).
Inclusion Criteria:
1. Women of any age
2. Any parity
3. Healthy singleton pregnancy
4. History suggestive of one or more previous PTB
5. Current pregnancy (16-20) weeks gestation.
Exclusion Criteria:
1. Multifetal pregnancy.
2. History of ante partum PROM.
3. Cervical Incompetence or current cervical cerclage.
4. Known fetal anomaly.
5. Hypertension requiring medications.
6. History of Thrombo-embolic disorders.
7. Known allergy to progesterone or asprin.
8. Known liver disease.
9. Established preterm labor
10. Short cervix
|
NCT0531xxxx/NCT05319847.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319847</url>
</required_header>
<id_info>
<org_study_id>20239Disco</org_study_id>
<nct_id>NCT05319847</nct_id>
</id_info>
<brief_title>An Exploratory Investigation of a Male Focused Skincare Supplement</brief_title>
<official_title>An Exploratory Investigation of a Male Focused Skincare Supplement</official_title>
<sponsors>
<lead_sponsor>
<agency>Let's Disco</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
<collaborator>
<agency>Citruslabs</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>Let's Disco</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Most skincare products on the market are topical and do not take a holistic approach to
understanding skin health. This trial will examine a dietary supplement designed to support
the gut microbiome and promote skin health from an internal perspective. Research has
previously supported the link between the gut microbiome and skin health and the supplement
tested in this trial will further the knowledge on the effectiveness of supporting gut health
to improve skin outcomes.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">April 15, 2022</start_date>
<completion_date type="Actual">June 30, 2022</completion_date>
<primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
<masking_description>Open Label, Single Group Design</masking_description>
</study_design_info>
<primary_outcome>
<measure>Adult Acne</measure>
<time_frame>12 week</time_frame>
<description>Change in overall frequency and intensity of adult acne (Likert Scale 0-5 with higher scores representing a reduction in the appearance of adult acne)</description>
</primary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">38</enrollment>
<condition>Acne</condition>
<condition>Skin Abnormalities</condition>
<arm_group>
<arm_group_label>Intervention arm</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Daily Skin Supplement - Fountain of Youth</description>
</arm_group>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Daily Skin Supplement - Fountain of Youth</intervention_name>
<description>Skincare supplement</description>
<arm_group_label>Intervention arm</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Male

- Between the ages of 18-55

- Frequently experience different forms of acne

- Frequently experience breakouts

- Must be in good health with no long term health conditions

- BMI must be under 40

- Must follow a consistent dietary regimen

- Must be willing to stop any oral supplementation targeting their skin while in the
trail

Exclusion Criteria:

- Anyone who does take prescription medication (oral or topical) targeting their skin
including reinoid, over the counter retinol, or retinal

- Not willing to stop any oral supplementation targeting their skin

- Severe chronic conditions, including oncological and psychiatric disorders

- Previous severe allergic reactions

- Unwilling the follow the study protocol
</textblock>
</criteria>
<gender>Male</gender>
<gender_based>Yes</gender_based>
<minimum_age>18 Years</minimum_age>
<maximum_age>55 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Citruslabs</name>
<address>
<city>Santa Monica</city>
<state>California</state>
<zip>90404</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>September 2022</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>September 22, 2022</last_update_submitted>
<last_update_submitted_qc>September 22, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">September 26, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Skin Abnormalities</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Most skincare products on the market are topical and do not take a holistic approach to
understanding skin health. This trial will examine a dietary supplement designed to support
the gut microbiome and promote skin health from an internal perspective. Research has
previously supported the link between the gut microbiome and skin health and the supplement
tested in this trial will further the knowledge on the effectiveness of supporting gut health
to improve skin outcomes.
Inclusion Criteria:
- Male
- Between the ages of 18-55
- Frequently experience different forms of acne
- Frequently experience breakouts
- Must be in good health with no long term health conditions
- BMI must be under 40
- Must follow a consistent dietary regimen
- Must be willing to stop any oral supplementation targeting their skin while in the
trail
Exclusion Criteria:
- Anyone who does take prescription medication (oral or topical) targeting their skin
including reinoid, over the counter retinol, or retinal
- Not willing to stop any oral supplementation targeting their skin
- Severe chronic conditions, including oncological and psychiatric disorders
- Previous severe allergic reactions
- Unwilling the follow the study protocol
|
NCT0531xxxx/NCT05319860.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319860</url>
</required_header>
<id_info>
<org_study_id>20201412</org_study_id>
<nct_id>NCT05319860</nct_id>
</id_info>
<brief_title>Aromatherapy for Chemotherapy-induced Nausea and Vomiting (CINV)</brief_title>
<official_title>Effects of Aromatherapy on Chemotherapy-Induced Nausea and Vomiting: A Control Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Miami</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>University of Miami</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
<is_us_export>No</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this study is to evaluate the use of aromatherapy to reduce nausea, vomiting,
and the use of anti-emetic in cancer survivors undergoing moderate to highly emetogenic
chemotherapy regimens.
</textblock>
</brief_summary>
<overall_status>Enrolling by invitation</overall_status>
<start_date type="Actual">August 1, 2022</start_date>
<completion_date type="Anticipated">August 1, 2024</completion_date>
<primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Supportive Care</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Change in severity of Chemotherapy-Induced Nausea and Vomiting (CINV)</measure>
<time_frame>Baseline, up to 12 weeks</time_frame>
<description>Assessed by the mean score of the Multi Association of Supportive Care in Cancer (MASCC) Antiemesis tool (MAT), which measures acute and delayed CINV across patients' chemotherapy regimens.
The MAT tool has a total score measured from zero to ten with the higher score indicating a higher level of nausea and vomiting.</description>
</primary_outcome>
<secondary_outcome>
<measure>Change in frequency of Antiemetic Medication</measure>
<time_frame>Baseline, up to 12 weeks</time_frame>
<description>Assessed by the mean score of antiemetics diary, which measures the usage frequency (date and time)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Type of antiemetic medications</measure>
<time_frame>Up to 12 weeks</time_frame>
<description>Participants will complete an Anti-Emetic Diary which will track their anti-emetic medications to combat nausea.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">150</enrollment>
<condition>Chemotherapy-induced Nausea and Vomiting</condition>
<arm_group>
<arm_group_label>Standard of Care With No Study Intervention</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Participants will receive standard medical care, consisting of antiemetic medicine at the first sign of Chemotherapy-Induced Nausea and Vomiting (CINV) on a schedule as prescribed by the healthcare provider.</description>
</arm_group>
<arm_group>
<arm_group_label>Standard of Care With Study Intervention</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive an aromatherapy inhaler for complementary in addition to their standard of care antiemetic medication for Chemotherapy-Induced Nausea and Vomiting (CINV).</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV)</intervention_name>
<description>Standard of care for CINV includes anti-nausea medication as needed after chemotherapy regimen given for up to 12 weeks.</description>
<arm_group_label>Standard of Care With No Study Intervention</arm_group_label>
<arm_group_label>Standard of Care With Study Intervention</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Aromatherapy Care</intervention_name>
<description>An aromatherapy inhaler provided for use as needed after chemotherapy regimen given for up to 12 weeks. One normal inhale is equal to one dose of aromatherapy. Participants can use the aromatherapy as often as needed.</description>
<arm_group_label>Standard of Care With Study Intervention</arm_group_label>
<other_name>Soothing Scents QueaseEase aromatherapy inhalers</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. 18 years of age or older

2. Able to read and speak English or Spanish

3. Able to and willing to give informed consent

4. Currently undergoing moderate and high emetogenic chemotherapy (adjuvant or
neoadjuvant)

5. Receiving three or more remaining cycles of chemotherapy

6. Symptoms of nausea or vomiting after the first chemotherapy infusion

Exclusion Criteria:

1. Unable or unwilling to give informed consent

2. Sensitivity to essential oils*

3. Olfactory disorders

4. Receiving chemotherapy for the first time

5. Undergoing low emetogenic chemotherapy regimens

6. Patients with hormone-sensitive cancers

7. Timely request of treating provider
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Debbie Anglade, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>University of Miami</affiliation>
</overall_official>
<location>
<facility>
<name>University of Miami</name>
<address>
<city>Miami</city>
<state>Florida</state>
<zip>33136</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>July 2023</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>March 31, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>July 10, 2023</last_update_submitted>
<last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">July 11, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of Miami</investigator_affiliation>
<investigator_full_name>Debbie Anglade, PhD, MSN, RN</investigator_full_name>
<investigator_title>Assistant Professor of Clinical</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Nausea</mesh_term>
<mesh_term>Vomiting</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this study is to evaluate the use of aromatherapy to reduce nausea, vomiting,
and the use of anti-emetic in cancer survivors undergoing moderate to highly emetogenic
chemotherapy regimens.
Inclusion Criteria:
1. 18 years of age or older
2. Able to read and speak English or Spanish
3. Able to and willing to give informed consent
4. Currently undergoing moderate and high emetogenic chemotherapy (adjuvant or
neoadjuvant)
5. Receiving three or more remaining cycles of chemotherapy
6. Symptoms of nausea or vomiting after the first chemotherapy infusion
Exclusion Criteria:
1. Unable or unwilling to give informed consent
2. Sensitivity to essential oils*
3. Olfactory disorders
4. Receiving chemotherapy for the first time
5. Undergoing low emetogenic chemotherapy regimens
6. Patients with hormone-sensitive cancers
7. Timely request of treating provider
|
NCT0531xxxx/NCT05319873.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319873</url>
</required_header>
<id_info>
<org_study_id>21-001819</org_study_id>
<secondary_id>NCI-2021-11707</secondary_id>
<nct_id>NCT05319873</nct_id>
</id_info>
<brief_title>Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer</brief_title>
<official_title>A Phase 1B Trial Evaluating the Safety of Ribociclib, Tucatinib, and Trastuzumab in Patients With Metastatic, HER2+ Breast Cancer and a Multicenter, Randomized, Open-Label, Phase 2 Study of Preoperative Treatment With Ribociclib,Ttrastuzumab, Tucatinib, and Fulvestrant Versus Docetaxel, Carboplatin,Ttrastuzumab, and Pertuzumab in HR+/HER2+ Breast Cancer and Ribociclib, Trastuzumab, and Tucatinib Versus Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab in Patients With HR-/HER2+ Breast Cancer</official_title>
<sponsors>
<lead_sponsor>
<agency>Jonsson Comprehensive Cancer Center</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Seagen Inc.</agency>
<agency_class>Industry</agency_class>
</collaborator>
<collaborator>
<agency>Novartis</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>Jonsson Comprehensive Cancer Center</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
<is_us_export>No</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
This phase Ib/II trial studies the side effects and best dose of ribociclib, tucatinib, and
trastuzumab for the treatment of HER2 positive breast cancer that has spread to other parts
of the body (metastatic), and then compares the effect of ribociclib, tucatinib, trastuzumab
with or without fulvestrant to docetaxel, carboplatin, trastuzumab, and pertuzumab (standard
of care) for the treatment of early stage breast cancer before surgery (neoadjuvant therapy).
Ribociclib and tucatinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Trastuzumab is a form of targeted therapy because it attaches itself
to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors.
When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are
blocked and the tumor cell may be marked for destruction by the body's immune system.
Pertuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to
grow and spread. Estrogen can cause the growth of breast tumor cells. Fulvestrant blocks the
use of estrogen by the tumor cells. Chemotherapy drugs, such as docetaxel and carboplatin,
work in different ways to stop the growth of tumor cells, either by killing the cells, by
stopping them from dividing, or by stopping them from spreading. Giving ribociclib,
tucatinib, and trastuzumab with or without fulvestrant before surgery may make the tumor
smaller and may reduce the amount of normal tissue that needs to be removed.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
PRIMARY OBJECTIVES:

I. To assess the safety of the combination of ribociclib, tucatinib, and trastuzumab in
patients with metastatic, HER2+ breast cancer. (Phase 1 Dose Escalation Trial) II. To
determine the recommended phase 2 dose of ribociclib when combined with tucatinib and
trastuzumab. (Phase 1 Dose Escalation Trial) III. To assess the pathologic complete response
(pCR). (Phase 2 Neoadjuvant Study)

SECONDARY OBJECTIVES:

I. To evaluate the pharmacokinetics of ribociclib and tucatinib when given in combination.
(Phase 1 Dose Escalation Trial) II. To assess the clinical objective response rate after 3
cycles via Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. (Phase 1 Dose
Escalation Trial) III. To assess the clinical objective response rate in the experimental
arms. (Phase 2 Neoadjuvant Study) IV. To assess quality of life by evaluating toxicity burden
using a quality of life (QOL)/patient-reported outcomes (PRO) questionnaire- the European
Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30
(EORTC QLQ-C30) instrument. (Phase 2 Neoadjuvant Study) V. To assess the molecular changes in
tumor biomarkers after 1 cycle of targeted therapy (anti-HER2, anti-estrogen, and CDK 4/6
directed therapy). (Phase 2 Neoadjuvant Study) VI. Pathological Assessment According to
Residual Cancer Burden (RCB) Index at surgery. (Phase 2 Neoadjuvant Study)

EXPLORATORY OBJECTIVE:

I. To investigate potential serum and tumor predictive biomarkers to predict response to
experimental therapy. (Phase 2 Neoadjuvant Study)

OUTLINE: This is a phase Ib, dose-escalation study of ribociclib followed by a phase II
study.

PHASE Ib: Patients receive ribociclib orally (PO) once daily (QD) on days 1-21, tucatinib PO
twice daily (BID) on days 1-28, and trastuzumab intravenously (IV) over 30-90 minutes every 7
days. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or
unacceptable toxicity.

PHASE II: Patients with hormone receptor (HR) positive status are randomized to Arm A or Arm
B. Patients with HR negative status are randomized to Arm B or Arm C.

ARM A: Patients receive ribociclib PO QD on days 1-21, tucatinib BID on days 1-28,
trastuzumab IV over 30-90 minutes every 7 days and fulvestrant subcutaneously (SC) on days 1
and 15 of cycle 1 and day 1 of every subsequent cycle. Cycles repeat every 28 days for up to
6 cycles in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive docetaxel IV over 1 hour on day 1, carboplatin IV on day 1,
trastuzumab IV over 30-90 minutes on day 1, and pertuzumab IV over 1 hour on day 1. Cycles
repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable
toxicity.

ARM C: Patients receive ribociclib PO QD on days 1-21, tucatinib BID on days 1-28, and
trastuzumab IV over 30-90 minutes every 7 days. Cycles repeat every 28 days for up to 6
cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed-up within 7 and 30 days.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">April 7, 2022</start_date>
<completion_date type="Anticipated">April 1, 2025</completion_date>
<primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
<phase>Phase 1/Phase 2</phase>
<study_type>Interventional</study_type>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Sequential Assignment</intervention_model>
<intervention_model_description>Phase Ib: Sequential assignment to increasing doses of ribociclib with fixed doses of tucatinib and trastuzumab.
Phase II: Randomized assignment to 3 parallel arms.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Maximum tolerated dose (MTD) (Phase Ib)</measure>
<time_frame>During the first cycle of treatment (1 cycle = 28 days)</time_frame>
<description>Defined as the highest dose level that does not lead to unacceptable toxicity in two or more patients in a dosing level.</description>
</primary_outcome>
<primary_outcome>
<measure>Pathologic complete response (pCR) (Phase II)</measure>
<time_frame>Up to 30 days after last treatment dose</time_frame>
<description>Defined as no invasive tumor in the breast or lymph nodes at the time of surgery. Response evaluable participants are defined as participants who are randomized and have receive at least one cycle of protocol therapy. The pCR rate is defined as percentage of randomized patients with a pCR in each of the treatment arms.The estimated pCR rate (and 95% confidence interval [CIs]) will be calculated for each experimental arm and compared to the corresponding control arm using the Cochran-Mantel-Haenszel x^2 test, with a two-sided significance level of 5%. Absolute differences in pCR rate between study arms will be calculated, along with 95% exact confidence intervals. This will be stratified according to hormone receptor (HR) status Multivariate logistic regression will be used to control for important baseline characteristics and odds ratios with corresponding CIs will be calculated.</description>
</primary_outcome>
<secondary_outcome>
<measure>Clinical objective response rate (ORR) (Phase IB and II)</measure>
<time_frame>Up to 30 days after last treatment dose</time_frame>
<description>ORR will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using caliper measurements. A responder is defined as any participant who exhibits a complete response (CR) or partial response (PR). The clinical response rate is estimated as the total number of CRs and PRs divided by the total number of participants randomized.The estimated ORR rate (and 95% CIs) will be calculated for each treatment arm and compared using the Cochran-Mantel-Haenszel x^2 test, with a two-sided significance level of 5%. Absolute differences in pCR rate between study arms will be calculated, along with 95% exact confidence intervals. This will be stratified according to HR status. Multivariate logistic regression will be used to control for important baseline characteristics and odds ratios with corresponding CIs will be calculated.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluate the pharmacokinetics of ribociclib and tucatinib when given in combination with tucatinib and trastuzumab. (Phase 1b): Area Under Curve (AUC)</measure>
<time_frame>Pre-infusion and 1, 2, 3, and 6 hours after the start of the infusion</time_frame>
<description>The pharmacokinetic (PK) parameter - area under the plasma concentration-time curve (AUC) will be determined for ribociclib and tucatinib in all Phase 1b participants.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluate the pharmacokinetics of ribociclib and tucatinib when given in combination with tucatinib and trastuzumab. (Phase 1b): Elimination half-life (t½)</measure>
<time_frame>Pre-infusion and 1, 2, 3, and 6 hours after the start of the infusion</time_frame>
<description>The pharmacokinetic (PK) parameter - Elimination half-life (t½) will be determined for for ribociclib and tucatinib in all Phase 1b participants.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluate the pharmacokinetics of ribociclib and tucatinib when given in combination with tucatinib and trastuzumab. (Phase 1b): Maximum plasma concentration (Cmax)</measure>
<time_frame>Pre-infusion and 1, 2, 3, and 6 hours after the start of the infusion</time_frame>
<description>Maximum plasma concentration (Cmax) will be determined for for ribociclib and tucatinib in all Phase 1b participants.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluate the pharmacokinetics of ribociclib and tucatinib when given in combination with tucatinib and trastuzumab. (Phase 1b): Minimum plasma concentration</measure>
<time_frame>Pre-infusion and 1, 2, 3, and 6 hours after the start of the infusion</time_frame>
<description>Minimum plasma concentration will be determined for ribociclib and tucatinib in all Phase 1b participants.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluate the pharmacokinetics of ribociclib and tucatinib when given in combination with tucatinib and trastuzumab. (Phase 1b): Time when Cmax occurs (Tmax)</measure>
<time_frame>Pre-infusion and 1, 2, 3, and 6 hours after the start of the infusion</time_frame>
<description>Time when Cmax occurs (Tmax) will be determined for ribociclib and tucatinib in all Phase 1b participants.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Evaluate the pharmacokinetics of ribociclib and tucatinib when given in combination with tucatinib and trastuzumab. (Phase 1b): Average plasma concentration at steady state (Cavg)</measure>
<time_frame>Pre-infusion and 1, 2, 3, and 6 hours after the start of the infusion</time_frame>
<description>Average plasma concentration at steady state (Cavg) will be determined for ribociclib and tucatinib in all Phase 1b participants.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Quality of life (QOL) (Phase II)</measure>
<time_frame>Up to 7 days after last treatment dose</time_frame>
<description>The EPRTC QLQ-C30 (European Organization for the Research and Treatment of Cancer- Quality of Life questionnaire) is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / Quality of Life (QoL) scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Measure the gene expression and/or biomarker changes that may be correlated with or predict biological, clinical, and pathologic response (Phase II)</measure>
<time_frame>Up to 30 days after last treatment dose</time_frame>
<description>Primary analysis of these molecular changes will include a linear model with treatment and hormone receptor status fixed effects. Separate analyses for change after 1 cycle and all cycles will be performed and compared to baseline levels. Serum and tumor biomarker analyses, including but not limited to on treatment tumor CD45 expression and germline IL6 promoter genotyping will be correlated with clinical outcomes and important clinical characteristics. Absolute change in Ki67 and cell cycle arrest rate (defined as a Ki67 of =< 2.7%) will be analyzed separately.</description>
</secondary_outcome>
<number_of_arms>4</number_of_arms>
<enrollment type="Anticipated">18</enrollment>
<condition>Anatomic Stage II Breast Cancer AJCC v8</condition>
<condition>Anatomic Stage IIA Breast Cancer AJCC v8</condition>
<condition>Anatomic Stage IIB Breast Cancer AJCC v8</condition>
<condition>Anatomic Stage III Breast Cancer AJCC v8</condition>
<condition>Anatomic Stage IIIA Breast Cancer AJCC v8</condition>
<condition>Anatomic Stage IIIB Breast Cancer AJCC v8</condition>
<condition>Anatomic Stage IIIC Breast Cancer AJCC v8</condition>
<condition>Anatomic Stage IV Breast Cancer AJCC v8</condition>
<condition>Invasive Breast Carcinoma</condition>
<condition>Locally Advanced HER2-Positive Breast Carcinoma</condition>
<condition>Metastatic HER2-Positive Breast Carcinoma</condition>
<condition>Prognostic Stage IB Breast Cancer AJCC v8</condition>
<condition>Prognostic Stage II Breast Cancer AJCC v8</condition>
<condition>Prognostic Stage IIA Breast Cancer AJCC v8</condition>
<condition>Prognostic Stage IIB Breast Cancer AJCC v8</condition>
<condition>Prognostic Stage III Breast Cancer AJCC v8</condition>
<condition>Prognostic Stage IIIA Breast Cancer AJCC v8</condition>
<condition>Prognostic Stage IIIB Breast Cancer AJCC v8</condition>
<condition>Prognostic Stage IIIC Breast Cancer AJCC v8</condition>
<condition>Prognostic Stage IV Breast Cancer AJCC v8</condition>
<arm_group>
<arm_group_label>Phase Ib (ribociclib, tucatinib, trastuzumab)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients receive ribociclib PO QD on days 1-21, tucatinib PO BID on days 1-28, and trastuzumab IV over 30-90 minutes every 7 days. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.</description>
</arm_group>
<arm_group>
<arm_group_label>Phase II, Arm C (ribociclib, tucatinib, trastuzumab)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients receive ribociclib PO QD on days 1-21, tucatinib BID on days 1-28, and trastuzumab IV over 30-90 minutes every 7 days. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.</description>
</arm_group>
<arm_group>
<arm_group_label>Phase II,Arm A(ribociclib,tucatinib, trastuzumab, fulvestrant)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients receive ribociclib PO QD on days 1-21, tucatinib BID on days 1-28, trastuzumab IV over 30-90 minutes every 7 days and fulvestrant subcutaneously (SC) on days 1 and 15 of cycle 1 and day 1 of every subsequent cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.</description>
</arm_group>
<arm_group>
<arm_group_label>Phase II,Arm B(docetaxel,carboplatin,trastuzumab,pertuzumab)</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Patients receive docetaxel IV over 1 hour on day 1, carboplatin IV on day 1, trastuzumab IV over 30-90 minutes on day 1, and pertuzumab IV over 1 hour on day 1. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Carboplatin</intervention_name>
<description>Given IV</description>
<arm_group_label>Phase II,Arm B(docetaxel,carboplatin,trastuzumab,pertuzumab)</arm_group_label>
<other_name>Blastocarb</other_name>
<other_name>Carboplat</other_name>
<other_name>Carboplatin Hexal</other_name>
<other_name>Carboplatino</other_name>
<other_name>Carboplatinum</other_name>
<other_name>Carbosin</other_name>
<other_name>Carbosol</other_name>
<other_name>Carbotec</other_name>
<other_name>CBDCA</other_name>
<other_name>Displata</other_name>
<other_name>Ercar</other_name>
<other_name>JM-8</other_name>
<other_name>Nealorin</other_name>
<other_name>Novoplatinum</other_name>
<other_name>Paraplatin</other_name>
<other_name>Paraplatin AQ</other_name>
<other_name>Paraplatine</other_name>
<other_name>Platinwas</other_name>
<other_name>Ribocarbo</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Docetaxel</intervention_name>
<description>Given IV</description>
<arm_group_label>Phase II,Arm B(docetaxel,carboplatin,trastuzumab,pertuzumab)</arm_group_label>
<other_name>Docecad</other_name>
<other_name>RP56976</other_name>
<other_name>Taxotere</other_name>
<other_name>Taxotere Injection Concentrate</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Fulvestrant</intervention_name>
<description>Given SC</description>
<arm_group_label>Phase II,Arm A(ribociclib,tucatinib, trastuzumab, fulvestrant)</arm_group_label>
<other_name>Faslodex</other_name>
<other_name>Faslodex(ICI 182,780)</other_name>
<other_name>ICI 182,780</other_name>
<other_name>ICI 182780</other_name>
<other_name>ZD9238</other_name>
</intervention>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>Pertuzumab</intervention_name>
<description>Given IV</description>
<arm_group_label>Phase II,Arm B(docetaxel,carboplatin,trastuzumab,pertuzumab)</arm_group_label>
<other_name>2C4</other_name>
<other_name>2C4 Antibody</other_name>
<other_name>HS627</other_name>
<other_name>MoAb 2C4</other_name>
<other_name>Monoclonal Antibody 2C4</other_name>
<other_name>Omnitarg</other_name>
<other_name>Perjeta</other_name>
<other_name>Pertuzumab Biosimilar HS627</other_name>
<other_name>rhuMAb2C4</other_name>
<other_name>RO4368451</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Quality-of-Life Assessment</intervention_name>
<description>Ancillary Studies</description>
<arm_group_label>Phase II, Arm C (ribociclib, tucatinib, trastuzumab)</arm_group_label>
<arm_group_label>Phase II,Arm B(docetaxel,carboplatin,trastuzumab,pertuzumab)</arm_group_label>
<arm_group_label>Phase Ib (ribociclib, tucatinib, trastuzumab)</arm_group_label>
<other_name>Quality of Life Assessment</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Ribociclib</intervention_name>
<description>Given PO</description>
<arm_group_label>Phase II, Arm C (ribociclib, tucatinib, trastuzumab)</arm_group_label>
<arm_group_label>Phase II,Arm A(ribociclib,tucatinib, trastuzumab, fulvestrant)</arm_group_label>
<arm_group_label>Phase Ib (ribociclib, tucatinib, trastuzumab)</arm_group_label>
<other_name>Kisqali</other_name>
<other_name>LEE-011</other_name>
<other_name>LEE011</other_name>
</intervention>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>Trastuzumab</intervention_name>
<description>Given IV</description>
<arm_group_label>Phase II, Arm C (ribociclib, tucatinib, trastuzumab)</arm_group_label>
<arm_group_label>Phase II,Arm A(ribociclib,tucatinib, trastuzumab, fulvestrant)</arm_group_label>
<arm_group_label>Phase II,Arm B(docetaxel,carboplatin,trastuzumab,pertuzumab)</arm_group_label>
<arm_group_label>Phase Ib (ribociclib, tucatinib, trastuzumab)</arm_group_label>
<other_name>ABP 980</other_name>
<other_name>ALT02</other_name>
<other_name>Anti-c-ERB-2</other_name>
<other_name>Anti-c-erbB2 Monoclonal Antibody</other_name>
<other_name>Anti-ERB-2</other_name>
<other_name>Anti-erbB-2</other_name>
<other_name>Anti-erbB2 Monoclonal Antibody</other_name>
<other_name>Anti-HER2/c-erbB2 Monoclonal Antibody</other_name>
<other_name>Anti-p185-HER2</other_name>
<other_name>c-erb-2 Monoclonal Antibody</other_name>
<other_name>HER2 Monoclonal Antibody</other_name>
<other_name>Herceptin</other_name>
<other_name>Herceptin Biosimilar PF-05280014</other_name>
<other_name>Herceptin Trastuzumab Biosimilar PF-05280014</other_name>
<other_name>Herzuma</other_name>
<other_name>Kanjinti</other_name>
<other_name>MoAb HER2</other_name>
<other_name>Monoclonal Antibody c-erb-2</other_name>
<other_name>Monoclonal Antibody HER2</other_name>
<other_name>Ogivri</other_name>
<other_name>Ontruzant</other_name>
<other_name>PF-05280014</other_name>
<other_name>rhuMAb HER2</other_name>
<other_name>RO0452317</other_name>
<other_name>SB3</other_name>
<other_name>Trastuzumab Biosimilar ABP 980</other_name>
<other_name>Trastuzumab Biosimilar ALT02</other_name>
<other_name>trastuzumab biosimilar EG12014</other_name>
<other_name>Trastuzumab Biosimilar HLX02</other_name>
<other_name>Trastuzumab Biosimilar PF-05280014</other_name>
<other_name>Trastuzumab Biosimilar SB3</other_name>
<other_name>Trastuzumab Biosimilar SIBP-01</other_name>
<other_name>Trastuzumab-anns</other_name>
<other_name>Trastuzumab-dkst</other_name>
<other_name>Trastuzumab-dttb</other_name>
<other_name>Trastuzumab-pkrb</other_name>
<other_name>Trastuzumab-qyyp</other_name>
<other_name>Trazimera</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Tucatinib</intervention_name>
<description>Given PO</description>
<arm_group_label>Phase II, Arm C (ribociclib, tucatinib, trastuzumab)</arm_group_label>
<arm_group_label>Phase II,Arm A(ribociclib,tucatinib, trastuzumab, fulvestrant)</arm_group_label>
<arm_group_label>Phase Ib (ribociclib, tucatinib, trastuzumab)</arm_group_label>
<other_name>ARRY-380</other_name>
<other_name>Irbinitinib</other_name>
<other_name>ONT-380</other_name>
<other_name>Tukysa</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- PHASE IB AND II: Patients over age of 18

- PHASE IB AND II: Available archival tissue for confirmatory central HER2 testing.
Results not required prior to enrollment.

- PHASE IB AND II: Left ventricular ejection fraction (LVEF) >= 50% based on
echocardiogram or multigated acquisition (MUGA).

- PHASE IB AND II: Platelet count >= 100,000/mm^3 (within 7 days before enrollment)

- For Phase Ib only: Phase Ib allows for red blood cell transfusion, filgrastim
(G-CSF), and hydration to meet eligibility requirements at the discretion of the
investigator

- PHASE IB AND II: Hemoglobin >= 9.0 g/dL (within 7 days before enrollment)

- For Phase Ib only: Phase Ib allows for red blood cell transfusion, G-CSF, and
hydration to meet eligibility requirements at the discretion of the investigator

- PHASE IB AND II: Absolute neutrophil count (ANC) >= 1500/mm^3 (within 7 days before
enrollment)

- For Phase Ib only: Phase Ib allows for red blood cell transfusion, G-CSF, and
hydration to meet eligibility requirements at the discretion of the investigator

- PHASE IB AND II: Creatinine clearance >= 30 mL/min as calculated using the
Cockcroft-Gault equation or Serum creatinine =< 1.5 × upper limit of normal (ULN)
(within 7 days before enrollment)

- For Phase Ib only: Phase Ib allows for red blood cell transfusion, G-CSF, and
hydration to meet eligibility requirements at the discretion of the investigator

- PHASE IB AND II: Alanine aminotransferase (ALT) < 2.5 × ULN, except for patients with
liver metastasis, who are only included if the ALT is < 5 × ULN (within 7 days before
enrollment)

- PHASE IB AND II: Aspartate aminotransferase (AST) < 2.5 × ULN, except for patients
with liver metastasis, who are only included if the AST is < 5 × ULN (within 7 days
before enrollment)

- PHASE IB AND II: Total bilirubin =< 1.5 x ULN. Participants with Gilbert's syndrome
with a total bilirubin =< 2.0 times ULN and direct bilirubin within normal limits are
permitted (within 7 days before enrollment)

- PHASE IB AND II: Serum Albumin >= 2.5 g/dL (within 7 days before enrollment)

- PHASE IB AND II: International normalized ratio (INR)/prothrombin time (PT) and
activated partial thromboplastin time (aPTT) =< 1.5 × ULN (within 7 days before
enrollment)

- PHASE IB AND II: Potassium within normal limits or corrected to within normal limits
prior to first dose

- PHASE IB AND II: Magnesium within normal limits or corrected to within normal limits
prior to first dose

- PHASE IB AND II: Total calcium (corrected for serum albumin) within normal limits or
corrected to within normal limits prior to first dose

- PHASE IB AND II: Willingness and ability to comply with scheduled visits, treatment
plans, laboratory tests, and other study procedures

- PHASE IB AND II: Patient can be premenopausal, perimenopausal, or post-menopausal at
the time of study entry.

- Premenopausal status is defined as either:

- Patient had last menstrual period within the last 12 months, OR

- If on tamoxifen or toremifene, plasma estradiol and follicle stimulating
hormone (FSH) are in the premenopausal ranges according to central/local
laboratory definition, OR

- In case of therapy-induced amenorrhea, plasma estradiol and/or FSH are in
the premenopausal ranges according to central/local laboratory definition

- Perimenopausal status is defined as neither premenopausal nor
postmenopausal

- Postmenopausal is defined as not meeting premenopausal status

- For pre-menopausal patients: Confirmed negative serum pregnancy test
(beta-hCG) before starting study treatment or patient has had a
hysterectomy. Male and female participants of reproductive/childbearing
potential must agree to use a highly effective form of contraception or
avoid intercourse during and upon completion of the study and for at
least 7 months for females and 4 months for males after the last dose
of study drug

- PHASE IB AND II: Male and female participants of reproductive/childbearing potential
must agree to use a highly effective form of contraception or avoid intercourse during
and upon completion of the study and for at least 7 months for females and 4 months
for males after the last dose of study drug. Highly effective contraception methods
include:

- Total abstinence (when this is in line with the preferred and usual lifestyle of
the patient). Periodic abstinence (e.g. calendar, ovulation, symptothermal,
post-ovulation methods) and withdrawal are not acceptable methods of
contraception

- Double barrier method of contraception. The following are considered adequate
barrier methods of contraception, must use 2: diaphragm, condom (by the partner),
sponge, or spermicide/spermicidal jelly.

- Female sterilization (have had surgical bilateral oophorectomy with or without
hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before
taking trial treatment. In case of oophorectomy alone, only when the reproductive
status of the woman has been confirmed by follow up hormone level assessment.

- Male partner sterilization (at least 6 months prior to randomization). For female
patients on the trial the vasectomized male partner should be the sole partner
for that patient. If vasectomy of the male partner is the highly effective method
of contraception chosen, the success of the vasectomy should be medically
confirmed according to local practice

- Placement of an intrauterine device (IUD)

- PHASE IB: Locally advanced/non-operable or metastatic HER2/neu amplified breast
cancer, defined as 3+ by immunohistochemistry (IHC), or IHC 2+ and fluorescence in
situ hybridization (FISH) + breast cancer

- PHASE IB: Received 1 or more prior lines of HER2 directed therapy in the metastatic
setting

- PHASE IB: Recommended by the patient's treating oncologist to receive a tucatinib
containing regimen as part of the next standard of care (SOC) line of therapy

- PHASE IB: Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- PHASE IB: Measurable or non-measurable disease per RECIST 1.1

- PHASE IB: Based on screening contrast brain magnetic resonance imaging (MRI), patients
must have one of the following:

- No evidence of brain metastases

- Untreated brain metastases not needing immediate local therapy. For patients with
untreated central nervous system (CNS) lesions > 2.0 cm on screening contrast
brain MRI, discussion with and approval from the medical monitor is required
prior to enrollment

- Previously treated brain metastases

- Brain metastases previously treated with local therapy may either be stable
since treatment or may have progressed since prior local CNS therapy,
provided that there is no clinical indication for immediate re-treatment
with local therapy in the opinion of the investigator

- Patients treated with CNS local therapy for newly identified lesions found
on contrast brain MRI performed during screening for this study may be
eligible to enroll if all of the following criteria are met:

- Time since whole-brain radiotherapy (WBRT) is >= 21 days prior to first
dose of treatment, time since stereotactic radiosurgery (SRS) is >= 7
days prior to first dose of treatment, or time since surgical resection
is >= 28 days

- Other sites of disease assessable by RECIST 1.1 are present

- Relevant records of any CNS treatment must be available to allow for
classification of target and non-target lesions

- PHASE II: Operable HER2/neu amplified invasive breast cancer, defined as 3+ by IHC, or
IHC 2+ and FISH +

- PHASE II: Known Ki67 status

- PHASE II: Previously untreated operable invasive carcinoma of the breast greater than
2.0 cm (cT2) in size based on imaging or physical exam or imaging. Patients with
clinical node negative disease or clinical node (cN1/cN2) positive are allowed
provided they are deemed to have operable disease at study entry

- PHASE II: Patients with clinically involved lymph nodes should not have evidence of
distant disease based on standard of care staging imaging prior to informed consent
form (ICF) signature

- PHASE II: Breast cancer suitable for mandatory baseline core biopsy

- PHASE II: No prior systemic therapy or radiotherapy for currently-diagnosed invasive
or non-invasive breast cancer

- PHASE II: Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

- PHASE IB AND II: Concurrent therapy with any other non-protocol anti-cancer therapy

- PHASE IB AND II: History of any other malignancy within the past 5 years, with the
exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix

- PHASE IB AND II: Proteinuria estimated by urine protein: creatinine ratio > 3.5 on a
random urine sample

- PHASE IB AND II: Uncontrolled arterial hypertension despite optimal medical management

- PHASE IB AND II: Patient has known active hepatitis B virus (HBV) or hepatitis C virus
(HCV), or Human immunodeficiency virus (HIV) infection (testing is not mandatory,
unless required by local regulation)

- PHASE IB AND II: Uncontrolled infection; active, clinically serious infections (>
Common Terminology Criteria for Adverse Events [CTCAE] grade 2)

- PHASE IB AND II: Clinically significant, uncontrolled heart disease and/or cardiac
repolarization abnormality, including any of the following:

- History of documented myocardial infarction (MI), angina pectoris, symptomatic
pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to
study entry

- Documented cardiomyopathy

- Left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated
acquisition (MUGA) scan or echocardiogram (ECHO)

- Long QT syndrome or family history of idiopathic sudden death or congenital long
QT syndrome, or any of the following:

- Risk factors for Torsades de Pointe (TdP) including uncorrected
hypocalcemia, hypokalemia or hypomagnesemia, history of cardiac failure, or
history of clinically significant/symptomatic bradycardia

- Concomitant medication(s) with a known risk to prolong the QT interval
and/or known to cause Torsades de Pointe that cannot be discontinued or
replaced by safe alternative medication (e.g., within 5 half-lives or 7 days
prior to starting study drug)

- Inability to determine the corrected QT using Fridericia's formula (QTcF)
interval

- Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia),
complete left bundle branch block, high-grade atrioventricular (AV) block
(e.g., bifascicular block, Mobitz type II and third degree AV block)

- Systolic blood pressure (SBP) > 160 or < 90 mmHg

- PHASE IB AND II: Congestive heart failure > New York Heart Association (NYHA) class 2

- PHASE IB AND II: History of baseline QT prolongation > 450 msec

- PHASE IB AND II: Unstable angina (angina symptoms at rest), new-onset angina (begun
within the last 3 months)

- PHASE IB AND II: Myocardial infarction less than 6 months before start of test drug

- PHASE IB AND II: Anti-arrhythmic therapy (beta blockers or digoxin are permitted)

- PHASE IB AND II: Arterial or venous thrombotic or embolic events such as
cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis
or pulmonary embolism within 3 months before the start of study medication.

- PHASE IB AND II: Participants receiving anticoagulation therapy are not allowed

- PHASE IB AND II: Patients with evidence or history of bleeding diathesis. Any
hemorrhage or bleeding event >= CTCAE Grade 3 within 4 weeks of start of study
medication

- PHASE IB AND II: Non-healing wound or ulcer

- PHASE IB AND II: History of, or current autoimmune disease (other than Hashimoto's
thyroiditis with normal thyroid stimulating hormone [TSH])

- PHASE IB AND II: Major surgical procedure or significant traumatic injury (as judged
by the investigator) within 28 days before start of study medication, open biopsy
within 7 days before start of study medication

- PHASE IB AND II: Unable to swallow pills or has significant gastrointestinal disease
which would preclude the adequate oral absorption of medications

- PHASE IB AND II: Patients with seizure disorder requiring medication

- PHASE IB AND II: Known hypersensitivity to any of the study drugs, study drug classes,
or excipients in the formulation

- PHASE IB AND II: Systemic continuous corticosteroid therapy at a daily dose higher
than 15 mg prednisone or equivalent is not allowed. Patients may be using topical or
inhaled corticosteroids. Previous corticosteroid therapy must be stopped or reduced to
the allowed dose at least 7 days prior to the first study drug administration. If a
patient is on chronic corticosteroid therapy, corticosteroids should be de-escalated
to the maximum allowed dose after the patient has signed the consent document

- PHASE IB AND II: History of having received an allogeneic bone marrow or organ
transplant

- PHASE IB AND II: Chronic oxygen therapy

- PHASE IB AND II: Use of a strong cytochrome P450 (CYP)2C8 inhibitor within 5
half-lives of the inhibitor or use of a strong CYP3A4 or CYP2C8 inducer within 5 days
prior to the first dose of study treatment

- PHASE IB: Early stage (curable) breast cancer

- PHASE IB: Based on screening brain MRI, patients must not have any of the following:

- Any untreated brain lesions > 2.0 cm in size, unless discussed with medical
monitor and approval for enrollment is given

- Ongoing use of systemic corticosteroids for control of symptoms of brain
metastases at a total daily dose of > 2 mg of dexamethasone (or equivalent).
However, patients on a chronic stable dose of =< 2 mg total daily of
dexamethasone (or equivalent) may be eligible with discussion and approval by the
medical monitor

- Any brain lesion thought to require immediate local therapy, including (but not
limited to) a lesion in an anatomic site where increase in size or possible
treatment-related edema may pose risk to patient (e.g. brain stem lesions).
Patients who undergo local treatment for such lesions identified by screening
contrast brain MRI may still be eligible for the study based on criteria
described under CNS inclusion criteria

- PHASE IB: Known or suspected leptomeningeal disease (LMD) as documented by the
investigator

- PHASE IN: Have poorly controlled (> 1/week) generalized or complex partial seizures,
or manifest neurologic progression due to brain metastases notwithstanding
CNS-directed therapy

- PHASE II: Metastatic breast cancer (local spread to axillary or internal mammary lymph
nodes is permitted)

- PHASE II: Current therapy with raloxifene, tamoxifen, aromatase inhibitor, or other
selective estrogen receptor modulator (SERM), gonadotrophin-releasing hormone (GNRH)
agonist/antagonist, either for osteoporosis or prevention of breast cancer. Subjects
must have discontinued therapies for at least 28 days prior to first baseline biopsy
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Nicholas P McAndrew</last_name>
<role>Principal Investigator</role>
<affiliation>UCLA / Jonsson Comprehensive Cancer Center</affiliation>
</overall_official>
<overall_contact>
<last_name>Monica Rocha</last_name>
<phone>310.998-4747</phone>
<phone_ext>20384</phone_ext>
<email>mprocha@mednet.ucla.edu</email>
</overall_contact>
<location>
<facility>
<name>UCLA / Jonsson Comprehensive Cancer Center</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90095</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Monica Rocha</last_name>
<phone>310-998-4747</phone>
<phone_ext>20384</phone_ext>
<email>mprocha@mednet.ucla.edu</email>
</contact>
<investigator>
<last_name>Nicholas P. McAndrew, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>June 2023</verification_date>
<study_first_submitted>March 18, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>June 6, 2023</last_update_submitted>
<last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">June 8, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Carcinoma</mesh_term>
<mesh_term>Breast Neoplasms</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Carboplatin</mesh_term>
<mesh_term>Docetaxel</mesh_term>
<mesh_term>Trastuzumab</mesh_term>
<mesh_term>Fulvestrant</mesh_term>
<mesh_term>Pertuzumab</mesh_term>
<mesh_term>Tucatinib</mesh_term>
<mesh_term>Trastuzumab biosimilar HLX02</mesh_term>
<mesh_term>Antineoplastic Agents, Immunological</mesh_term>
<mesh_term>Antibodies</mesh_term>
<mesh_term>Immunoglobulins</mesh_term>
<mesh_term>Antibodies, Monoclonal</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This phase Ib/II trial studies the side effects and best dose of ribociclib, tucatinib, and
trastuzumab for the treatment of HER2 positive breast cancer that has spread to other parts
of the body (metastatic), and then compares the effect of ribociclib, tucatinib, trastuzumab
with or without fulvestrant to docetaxel, carboplatin, trastuzumab, and pertuzumab (standard
of care) for the treatment of early stage breast cancer before surgery (neoadjuvant therapy).
Ribociclib and tucatinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Trastuzumab is a form of targeted therapy because it attaches itself
to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors.
When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are
blocked and the tumor cell may be marked for destruction by the body's immune system.
Pertuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to
grow and spread. Estrogen can cause the growth of breast tumor cells. Fulvestrant blocks the
use of estrogen by the tumor cells. Chemotherapy drugs, such as docetaxel and carboplatin,
work in different ways to stop the growth of tumor cells, either by killing the cells, by
stopping them from dividing, or by stopping them from spreading. Giving ribociclib,
tucatinib, and trastuzumab with or without fulvestrant before surgery may make the tumor
smaller and may reduce the amount of normal tissue that needs to be removed.
PRIMARY OBJECTIVES:
I. To assess the safety of the combination of ribociclib, tucatinib, and trastuzumab in
patients with metastatic, HER2+ breast cancer. (Phase 1 Dose Escalation Trial) II. To
determine the recommended phase 2 dose of ribociclib when combined with tucatinib and
trastuzumab. (Phase 1 Dose Escalation Trial) III. To assess the pathologic complete response
(pCR). (Phase 2 Neoadjuvant Study)
SECONDARY OBJECTIVES:
I. To evaluate the pharmacokinetics of ribociclib and tucatinib when given in combination.
(Phase 1 Dose Escalation Trial) II. To assess the clinical objective response rate after 3
cycles via Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. (Phase 1 Dose
Escalation Trial) III. To assess the clinical objective response rate in the experimental
arms. (Phase 2 Neoadjuvant Study) IV. To assess quality of life by evaluating toxicity burden
using a quality of life (QOL)/patient-reported outcomes (PRO) questionnaire- the European
Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30
(EORTC QLQ-C30) instrument. (Phase 2 Neoadjuvant Study) V. To assess the molecular changes in
tumor biomarkers after 1 cycle of targeted therapy (anti-HER2, anti-estrogen, and CDK 4/6
directed therapy). (Phase 2 Neoadjuvant Study) VI. Pathological Assessment According to
Residual Cancer Burden (RCB) Index at surgery. (Phase 2 Neoadjuvant Study)
EXPLORATORY OBJECTIVE:
I. To investigate potential serum and tumor predictive biomarkers to predict response to
experimental therapy. (Phase 2 Neoadjuvant Study)
OUTLINE: This is a phase Ib, dose-escalation study of ribociclib followed by a phase II
study.
PHASE Ib: Patients receive ribociclib orally (PO) once daily (QD) on days 1-21, tucatinib PO
twice daily (BID) on days 1-28, and trastuzumab intravenously (IV) over 30-90 minutes every 7
days. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or
unacceptable toxicity.
PHASE II: Patients with hormone receptor (HR) positive status are randomized to Arm A or Arm
B. Patients with HR negative status are randomized to Arm B or Arm C.
ARM A: Patients receive ribociclib PO QD on days 1-21, tucatinib BID on days 1-28,
trastuzumab IV over 30-90 minutes every 7 days and fulvestrant subcutaneously (SC) on days 1
and 15 of cycle 1 and day 1 of every subsequent cycle. Cycles repeat every 28 days for up to
6 cycles in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive docetaxel IV over 1 hour on day 1, carboplatin IV on day 1,
trastuzumab IV over 30-90 minutes on day 1, and pertuzumab IV over 1 hour on day 1. Cycles
repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable
toxicity.
ARM C: Patients receive ribociclib PO QD on days 1-21, tucatinib BID on days 1-28, and
trastuzumab IV over 30-90 minutes every 7 days. Cycles repeat every 28 days for up to 6
cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed-up within 7 and 30 days.
Inclusion Criteria:
- PHASE IB AND II: Patients over age of 18
- PHASE IB AND II: Available archival tissue for confirmatory central HER2 testing.
Results not required prior to enrollment.
- PHASE IB AND II: Left ventricular ejection fraction (LVEF) >= 50% based on
echocardiogram or multigated acquisition (MUGA).
- PHASE IB AND II: Platelet count >= 100,000/mm^3 (within 7 days before enrollment)
- For Phase Ib only: Phase Ib allows for red blood cell transfusion, filgrastim
(G-CSF), and hydration to meet eligibility requirements at the discretion of the
investigator
- PHASE IB AND II: Hemoglobin >= 9.0 g/dL (within 7 days before enrollment)
- For Phase Ib only: Phase Ib allows for red blood cell transfusion, G-CSF, and
hydration to meet eligibility requirements at the discretion of the investigator
- PHASE IB AND II: Absolute neutrophil count (ANC) >= 1500/mm^3 (within 7 days before
enrollment)
- For Phase Ib only: Phase Ib allows for red blood cell transfusion, G-CSF, and
hydration to meet eligibility requirements at the discretion of the investigator
- PHASE IB AND II: Creatinine clearance >= 30 mL/min as calculated using the
Cockcroft-Gault equation or Serum creatinine =< 1.5 × upper limit of normal (ULN)
(within 7 days before enrollment)
- For Phase Ib only: Phase Ib allows for red blood cell transfusion, G-CSF, and
hydration to meet eligibility requirements at the discretion of the investigator
- PHASE IB AND II: Alanine aminotransferase (ALT) < 2.5 × ULN, except for patients with
liver metastasis, who are only included if the ALT is < 5 × ULN (within 7 days before
enrollment)
- PHASE IB AND II: Aspartate aminotransferase (AST) < 2.5 × ULN, except for patients
with liver metastasis, who are only included if the AST is < 5 × ULN (within 7 days
before enrollment)
- PHASE IB AND II: Total bilirubin =< 1.5 x ULN. Participants with Gilbert's syndrome
with a total bilirubin =< 2.0 times ULN and direct bilirubin within normal limits are
permitted (within 7 days before enrollment)
- PHASE IB AND II: Serum Albumin >= 2.5 g/dL (within 7 days before enrollment)
- PHASE IB AND II: International normalized ratio (INR)/prothrombin time (PT) and
activated partial thromboplastin time (aPTT) =< 1.5 × ULN (within 7 days before
enrollment)
- PHASE IB AND II: Potassium within normal limits or corrected to within normal limits
prior to first dose
- PHASE IB AND II: Magnesium within normal limits or corrected to within normal limits
prior to first dose
- PHASE IB AND II: Total calcium (corrected for serum albumin) within normal limits or
corrected to within normal limits prior to first dose
- PHASE IB AND II: Willingness and ability to comply with scheduled visits, treatment
plans, laboratory tests, and other study procedures
- PHASE IB AND II: Patient can be premenopausal, perimenopausal, or post-menopausal at
the time of study entry.
- Premenopausal status is defined as either:
- Patient had last menstrual period within the last 12 months, OR
- If on tamoxifen or toremifene, plasma estradiol and follicle stimulating
hormone (FSH) are in the premenopausal ranges according to central/local
laboratory definition, OR
- In case of therapy-induced amenorrhea, plasma estradiol and/or FSH are in
the premenopausal ranges according to central/local laboratory definition
- Perimenopausal status is defined as neither premenopausal nor
postmenopausal
- Postmenopausal is defined as not meeting premenopausal status
- For pre-menopausal patients: Confirmed negative serum pregnancy test
(beta-hCG) before starting study treatment or patient has had a
hysterectomy. Male and female participants of reproductive/childbearing
potential must agree to use a highly effective form of contraception or
avoid intercourse during and upon completion of the study and for at
least 7 months for females and 4 months for males after the last dose
of study drug
- PHASE IB AND II: Male and female participants of reproductive/childbearing potential
must agree to use a highly effective form of contraception or avoid intercourse during
and upon completion of the study and for at least 7 months for females and 4 months
for males after the last dose of study drug. Highly effective contraception methods
include:
- Total abstinence (when this is in line with the preferred and usual lifestyle of
the patient). Periodic abstinence (e.g. calendar, ovulation, symptothermal,
post-ovulation methods) and withdrawal are not acceptable methods of
contraception
- Double barrier method of contraception. The following are considered adequate
barrier methods of contraception, must use 2: diaphragm, condom (by the partner),
sponge, or spermicide/spermicidal jelly.
- Female sterilization (have had surgical bilateral oophorectomy with or without
hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before
taking trial treatment. In case of oophorectomy alone, only when the reproductive
status of the woman has been confirmed by follow up hormone level assessment.
- Male partner sterilization (at least 6 months prior to randomization). For female
patients on the trial the vasectomized male partner should be the sole partner
for that patient. If vasectomy of the male partner is the highly effective method
of contraception chosen, the success of the vasectomy should be medically
confirmed according to local practice
- Placement of an intrauterine device (IUD)
- PHASE IB: Locally advanced/non-operable or metastatic HER2/neu amplified breast
cancer, defined as 3+ by immunohistochemistry (IHC), or IHC 2+ and fluorescence in
situ hybridization (FISH) + breast cancer
- PHASE IB: Received 1 or more prior lines of HER2 directed therapy in the metastatic
setting
- PHASE IB: Recommended by the patient's treating oncologist to receive a tucatinib
containing regimen as part of the next standard of care (SOC) line of therapy
- PHASE IB: Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- PHASE IB: Measurable or non-measurable disease per RECIST 1.1
- PHASE IB: Based on screening contrast brain magnetic resonance imaging (MRI), patients
must have one of the following:
- No evidence of brain metastases
- Untreated brain metastases not needing immediate local therapy. For patients with
untreated central nervous system (CNS) lesions > 2.0 cm on screening contrast
brain MRI, discussion with and approval from the medical monitor is required
prior to enrollment
- Previously treated brain metastases
- Brain metastases previously treated with local therapy may either be stable
since treatment or may have progressed since prior local CNS therapy,
provided that there is no clinical indication for immediate re-treatment
with local therapy in the opinion of the investigator
- Patients treated with CNS local therapy for newly identified lesions found
on contrast brain MRI performed during screening for this study may be
eligible to enroll if all of the following criteria are met:
- Time since whole-brain radiotherapy (WBRT) is >= 21 days prior to first
dose of treatment, time since stereotactic radiosurgery (SRS) is >= 7
days prior to first dose of treatment, or time since surgical resection
is >= 28 days
- Other sites of disease assessable by RECIST 1.1 are present
- Relevant records of any CNS treatment must be available to allow for
classification of target and non-target lesions
- PHASE II: Operable HER2/neu amplified invasive breast cancer, defined as 3+ by IHC, or
IHC 2+ and FISH +
- PHASE II: Known Ki67 status
- PHASE II: Previously untreated operable invasive carcinoma of the breast greater than
2.0 cm (cT2) in size based on imaging or physical exam or imaging. Patients with
clinical node negative disease or clinical node (cN1/cN2) positive are allowed
provided they are deemed to have operable disease at study entry
- PHASE II: Patients with clinically involved lymph nodes should not have evidence of
distant disease based on standard of care staging imaging prior to informed consent
form (ICF) signature
- PHASE II: Breast cancer suitable for mandatory baseline core biopsy
- PHASE II: No prior systemic therapy or radiotherapy for currently-diagnosed invasive
or non-invasive breast cancer
- PHASE II: Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion Criteria:
- PHASE IB AND II: Concurrent therapy with any other non-protocol anti-cancer therapy
- PHASE IB AND II: History of any other malignancy within the past 5 years, with the
exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix
- PHASE IB AND II: Proteinuria estimated by urine protein: creatinine ratio > 3.5 on a
random urine sample
- PHASE IB AND II: Uncontrolled arterial hypertension despite optimal medical management
- PHASE IB AND II: Patient has known active hepatitis B virus (HBV) or hepatitis C virus
(HCV), or Human immunodeficiency virus (HIV) infection (testing is not mandatory,
unless required by local regulation)
- PHASE IB AND II: Uncontrolled infection; active, clinically serious infections (>
Common Terminology Criteria for Adverse Events [CTCAE] grade 2)
- PHASE IB AND II: Clinically significant, uncontrolled heart disease and/or cardiac
repolarization abnormality, including any of the following:
- History of documented myocardial infarction (MI), angina pectoris, symptomatic
pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to
study entry
- Documented cardiomyopathy
- Left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated
acquisition (MUGA) scan or echocardiogram (ECHO)
- Long QT syndrome or family history of idiopathic sudden death or congenital long
QT syndrome, or any of the following:
- Risk factors for Torsades de Pointe (TdP) including uncorrected
hypocalcemia, hypokalemia or hypomagnesemia, history of cardiac failure, or
history of clinically significant/symptomatic bradycardia
- Concomitant medication(s) with a known risk to prolong the QT interval
and/or known to cause Torsades de Pointe that cannot be discontinued or
replaced by safe alternative medication (e.g., within 5 half-lives or 7 days
prior to starting study drug)
- Inability to determine the corrected QT using Fridericia's formula (QTcF)
interval
- Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia),
complete left bundle branch block, high-grade atrioventricular (AV) block
(e.g., bifascicular block, Mobitz type II and third degree AV block)
- Systolic blood pressure (SBP) > 160 or < 90 mmHg
- PHASE IB AND II: Congestive heart failure > New York Heart Association (NYHA) class 2
- PHASE IB AND II: History of baseline QT prolongation > 450 msec
- PHASE IB AND II: Unstable angina (angina symptoms at rest), new-onset angina (begun
within the last 3 months)
- PHASE IB AND II: Myocardial infarction less than 6 months before start of test drug
- PHASE IB AND II: Anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- PHASE IB AND II: Arterial or venous thrombotic or embolic events such as
cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis
or pulmonary embolism within 3 months before the start of study medication.
- PHASE IB AND II: Participants receiving anticoagulation therapy are not allowed
- PHASE IB AND II: Patients with evidence or history of bleeding diathesis. Any
hemorrhage or bleeding event >= CTCAE Grade 3 within 4 weeks of start of study
medication
- PHASE IB AND II: Non-healing wound or ulcer
- PHASE IB AND II: History of, or current autoimmune disease (other than Hashimoto's
thyroiditis with normal thyroid stimulating hormone [TSH])
- PHASE IB AND II: Major surgical procedure or significant traumatic injury (as judged
by the investigator) within 28 days before start of study medication, open biopsy
within 7 days before start of study medication
- PHASE IB AND II: Unable to swallow pills or has significant gastrointestinal disease
which would preclude the adequate oral absorption of medications
- PHASE IB AND II: Patients with seizure disorder requiring medication
- PHASE IB AND II: Known hypersensitivity to any of the study drugs, study drug classes,
or excipients in the formulation
- PHASE IB AND II: Systemic continuous corticosteroid therapy at a daily dose higher
than 15 mg prednisone or equivalent is not allowed. Patients may be using topical or
inhaled corticosteroids. Previous corticosteroid therapy must be stopped or reduced to
the allowed dose at least 7 days prior to the first study drug administration. If a
patient is on chronic corticosteroid therapy, corticosteroids should be de-escalated
to the maximum allowed dose after the patient has signed the consent document
- PHASE IB AND II: History of having received an allogeneic bone marrow or organ
transplant
- PHASE IB AND II: Chronic oxygen therapy
- PHASE IB AND II: Use of a strong cytochrome P450 (CYP)2C8 inhibitor within 5
half-lives of the inhibitor or use of a strong CYP3A4 or CYP2C8 inducer within 5 days
prior to the first dose of study treatment
- PHASE IB: Early stage (curable) breast cancer
- PHASE IB: Based on screening brain MRI, patients must not have any of the following:
- Any untreated brain lesions > 2.0 cm in size, unless discussed with medical
monitor and approval for enrollment is given
- Ongoing use of systemic corticosteroids for control of symptoms of brain
metastases at a total daily dose of > 2 mg of dexamethasone (or equivalent).
However, patients on a chronic stable dose of =< 2 mg total daily of
dexamethasone (or equivalent) may be eligible with discussion and approval by the
medical monitor
- Any brain lesion thought to require immediate local therapy, including (but not
limited to) a lesion in an anatomic site where increase in size or possible
treatment-related edema may pose risk to patient (e.g. brain stem lesions).
Patients who undergo local treatment for such lesions identified by screening
contrast brain MRI may still be eligible for the study based on criteria
described under CNS inclusion criteria
- PHASE IB: Known or suspected leptomeningeal disease (LMD) as documented by the
investigator
- PHASE IN: Have poorly controlled (> 1/week) generalized or complex partial seizures,
or manifest neurologic progression due to brain metastases notwithstanding
CNS-directed therapy
- PHASE II: Metastatic breast cancer (local spread to axillary or internal mammary lymph
nodes is permitted)
- PHASE II: Current therapy with raloxifene, tamoxifen, aromatase inhibitor, or other
selective estrogen receptor modulator (SERM), gonadotrophin-releasing hormone (GNRH)
agonist/antagonist, either for osteoporosis or prevention of breast cancer. Subjects
must have discontinued therapies for at least 28 days prior to first baseline biopsy
|
NCT0531xxxx/NCT05319886.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319886</url>
</required_header>
<id_info>
<org_study_id>LC202103001</org_study_id>
<nct_id>NCT05319886</nct_id>
</id_info>
<brief_title>Observational Study of the Efficacy and Safety of Anlotinib Combined With Penpulimab in Elderly Lung Cancer Patients</brief_title>
<acronym>AP</acronym>
<official_title>A Phase IV Observational Study Evaluating the Efficacy and Safety of Anlotinib in Combination With Penpulimab as First-line Treatment in Elderly Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)</official_title>
<sponsors>
<lead_sponsor>
<agency>The First Affiliated Hospital of Xinxiang Medical College</agency>
<agency_class>U.S. Fed</agency_class>
</lead_sponsor>
</sponsors>
<source>The First Affiliated Hospital of Xinxiang Medical College</source>
<oversight_info>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This prospective observational study will evaluate the efficacy and safety of anlotinib in
combination with Penpulimab in elderly patients with lung cancer. Data will be collected from
each patient at baseline and after 4-6 cycles of therapy.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This research study is a Phase IV clinical trial. Participants are being involved in the
portion of the study to observe the efficacy and safety of an observational intervention and
also tries to evaluate the disease control rate (such as Progression-Free-Survival, overall
survival, Objective Response Rate, Disease control rates, Duration of Response, Quality of
Life and Adverse events).

Anlotinib is a small molecule multi-target tyrosine kinase inhibitor, can effectively inhibit
VEGFR, PDGFR, FGFR, c-Kit and other kinases, with anti-tumor angiogenesis and tumor growth
inhibiting effects. Penpulimab injection is a new PD-1 monoclonal antibody drug, was approved
for marketing by the State Drug Administration (NMPA) of China for the indication: treatment
of adult patients with relapsed or refractory classic Hodgkin's lymphoma (r/r cHL) who have
undergone at least second-line systemic chemotherapy. By putting these two drugs together,
the investigators hope that it will have a greater effect on cancer growth in elderly
patients with lung cancer.

Efficacy evaluation was performed every 2 cycles during the follow-up study. Patients with
disease control (complete response (CR)+partial response (PR)+stable disease (SD)) and
tolerable adverse reactions continued to take the drug until the investigator considered that
the patient was not suitable to continue the drug or the efficacy was evaluated as disease
progression (PD). Safety evaluations were performed concurrently with the dosing period. No
other antitumor therapy can be administered until PD.

The purpose of this study is to:

- Test the efficacy of these two drugs Anlotinib and Penpulimab in elderly lung cancer;

- Determine the Progression-Free-Survival of the combination;

- Further evaluate the side effect profile for the combination of Anlotinib and Penpulimab
in elderly lung cancer patients.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">May 16, 2022</start_date>
<completion_date type="Anticipated">March 30, 2025</completion_date>
<primary_completion_date type="Anticipated">March 30, 2023</primary_completion_date>
<study_type>Observational [Patient Registry]</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<target_duration>2 Years</target_duration>
<primary_outcome>
<measure>Progression Free Survival</measure>
<time_frame>2 years</time_frame>
<description>The time from the start of treatment until objective tumor progression or death. For participants who don't show progression or die until the end of treatment, the date of last contact is taken as the censoring time.</description>
</primary_outcome>
<secondary_outcome>
<measure>Overall Survival</measure>
<time_frame>2 years</time_frame>
<description>Overall survival is the time elapsed between enrollment and death of any cause. For participants who don't die until the end of treatment, the overall survival data will be analyzed retrospectively based on their date of death after the end of study.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Objective Response Rate</measure>
<time_frame>2 years</time_frame>
<description>This refers to the percentage of patients with a certain amount of tumor shrinkage that is maintained for a certain period of time, including CR and PR.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Disease control rates</measure>
<time_frame>2 years</time_frame>
<description>Includes the number of cases of CR, PR, and SD with confirmed disease as a percentage of patients evaluable for efficacy.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Duration of Response</measure>
<time_frame>2 years</time_frame>
<description>Time between the start of the first evaluation of the tumor as CR or PR and the first evaluation of PD or death from any cause</description>
</secondary_outcome>
<secondary_outcome>
<measure>Adverse events</measure>
<time_frame>2 years</time_frame>
<description>An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.</description>
</secondary_outcome>
<number_of_groups>1</number_of_groups>
<enrollment type="Anticipated">40</enrollment>
<condition>Lung Cancer</condition>
<condition>Lung Carcinoma</condition>
<condition>Non Small Cell Lung Cancer</condition>
<condition>Non-small Cell Carcinoma</condition>
<condition>Lung Neoplasm</condition>
<arm_group>
<arm_group_label>Anlotinib and Penpulimab</arm_group_label>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Anlotinib and Penpulimab</intervention_name>
<description>Anlotinib 12mg, po, qd, with 2 weeks off for 1 week. Penpulimab 200mg, ivgtt, q3w. Efficacy was evaluated every 2 cycles. Efficacy evaluation was performed every 2 cycles during the follow-up study. Patients with disease control (CR+PR+SD) and tolerable adverse reactions continued to take the drug until the investigator considered that the patient was not suitable to continue the drug or the efficacy was evaluated as PD. Safety evaluations were performed concurrently with the dosing period. No other antitumor therapy can be administered until PD.</description>
<arm_group_label>Anlotinib and Penpulimab</arm_group_label>
<other_name>AL3818 and AK105</other_name>
</intervention>
<eligibility>
<study_pop>
<textblock>
At least 65 years old with locally advanced, recurrent or metastatic stage IIIB-IV
non-small cell lung cancer.
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- At least 65 years old;

- Non-small cell lung cancer with locally advanced, recurrent or metastasis, which
confirmed by histologically or cytologically (except sputum cytology) and evaluated as
IIIB-IV stage, who are unresectable or unable to undergo radical radiotherapy or
refuse radical radiotherapy. (If multiple tumor components are mixed, it should be
classified according to their predominant cell type);

- Participants are required to have one measurable disease per RECIST 1.1;

- Unsuitable or unwilling to receive radical treatment methods (such as radical
chemoradiotherapy and/or surgery) and have not received prior systemic therapy;

- ECOG performance status of 0 to 2; The expected survival is more than 3 months;

- Adequate organ and marrow function defined as follows:

- Hemoglobin (HB) ≥90 g/L (no blood transfusion within 28 days);

- Absolute neutrophil count (ANC) ≥1.5×109/L;

- Platelet count (PLT) ≥ 100×109/L;

- Aspartate Transaminase (AST) ≤ 1.5 x upper limit of normal (ULN);

- Alaninetransaminase (ALT) ≤ 1.5 x ULN (ALT and AST ≤ 5 x ULN if liver metastases
are present);

- Alkaline phosphatase (ALP) ≤ 1.5 x ULN;

- Albumin (ALB) ≥ 30g/L;

- Creatinine ≤1.5 x ULN or Creatinine Clearance (CCr) ≥ 60 ml/min;

- International normalized ratio (INR) ≤ 1.5 x ULN;

- Partial thromboplastin time (APTT) ≤ 1.5 x ULN;

- Prothrombin time (PT) ≤ 1.5 x ULN ;

- Thyrotropic hormone (TSH) ≤ ULN (When TSH value is abnormal, T3 and T4 levels is
normal, which can be enrolled);

- Urine protein < (++), or 24-hour urine protein amount < 1.0 g ;

- Patients must have adequate cardiac function, defined as:

Left ventricular ejection fraction (LVEF) > 50% as determined by cardiac echocardiogram.

-Patients enrolled in this study voluntarily and signed an informed consent with a good
compliance.

Exclusion Criteria:

- Participants who have active infection;

- Patients with known immunodeficiency diseases (e.g. psoriasis, active arthritis,
immune nephropathy, HIV, etc);

- Participants with no measurable disease;

- Patients with cancerous meningitis and spinal cord compression;

- Participants with active central nervous system (CNS) metastases (clinically stable
and maintained for at least 2 weeks after adequate treatment of CNS metastases and do
not require treatment such as glucocorticoids and dehydrating drugs are eligible for
enrollment);

- Previously treated with chemotherapy drugs (except neoadjuvant therapy) / targeted
drugs / immunotherapy;

- Participants who were confirmed severe abnormalities of gastrointestinal function
(e.g. inability to take oral medications, uncontrollable nausea or vomiting, history
of major gastrointestinal resection, untreated recurrent diarrhea, untreated gastric
disease requiring long-term acid-suppressing PPI-like medications, Crohn's disease,
ulcerative colitis);

- Patients with central squamous lung cancer on imaging;

- Patients who had an arterial/venous thrombotic event within 6 months, such as
cerebrovascular accident (temporary ischemic attack is excluded), deep vein thrombosis
and pulmonary embolism;

- Patients whose imaging shows that the tumor has invaded a significant vessel or have a
high risk of fatal hemorrhage due to tumor invasion of a significant vessel during the
follow-up study judged by the investigator; or who have bleeding tendencies (e.g.,
active peptic ulcer) or receiving thrombolytic or anticoagulant therapy such as
warfarin, heparin, or their analogs;

- Patients who had antineoplastic therapy against other malignancies, including
radiotherapy, chemotherapy, immunotherapy and herbal medicine (except previously
eradicated malignancies without recurrent metastases for ≥ 5 years);

- Patients with uncontrollable pleural effusion, pericardial effusion or ascites
requiring repeated drainage (except patients who do not require drainage of effusion
or whose effusion does not increase significantly after 3 days of cessation of
drainage);

- Patients who have used immunosuppressive drugs within 4 weeks prior to the study
treatment, except for topical glucocorticoids by nasal spray, inhalation or other
routes or physiologic doses of systemic glucocorticoids (no more than 10 mg/day of
prednisone or equivalent doses of other glucocorticoids);

- Patients who have known or suspected active autoimmune disease (congenital or
acquired), such as interstitial pneumonia, uveitis, enterocolitis, hepatitis,
pituitary inflammation, vasculitis, nephritis, thyroiditis, etc. (Patients with
vitiligo or asthma that has completely resolved in childhood and does not require any
intervention in adulthood may be enrolled; Patients with type I diabetes with good
insulin control may be enrolled);

- Patients who have known allogeneic organ transplantation (except corneal
transplantation) or allogeneic hematopoietic stem cell transplantation;

- Anticipants who have hypersensitivity to any component of anlotinib and monoclonal
antibodies;

- Anticipants who have active interstitial lung disease requiring treatment;

- Anticipants who have a history of psychotropic substance abuse and are unable to
abstain or have a psychiatric disorder;

- Anticipants who have participated in another anti-tumor clinical trial within four
weeks;

- Anticipants who administered anti-infective vaccines (e.g., influenza virus vaccine,
human papillomavirus vaccine) within 4 weeks prior to study therapy; During the
treatment period, in addition to inactive vaccines, other vaccines are prohibited;

- Anticipants who have undergone major surgery (except for diagnostic purposes) within 4
weeks (28 days) prior to the administration of the study;

- Patients who are not suitable for enrollment in the judgment of the investigator.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>65 Years</minimum_age>
<maximum_age>N/A</maximum_age>
</eligibility>
<overall_contact>
<last_name>Yinghua Ji, Master</last_name>
<phone>13663030446</phone>
<email>54234317@qq.com</email>
</overall_contact>
<overall_contact_backup>
<last_name>Yana Zhang, Doctor</last_name>
<phone>15093230340</phone>
<email>Drzhangyana@hotmail.com</email>
</overall_contact_backup>
<location>
<facility>
<name>The First Affiliated Hospital of Xinxiang Medical College</name>
<address>
<city>Xinxiang</city>
<state>Henan</state>
<zip>453100</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Yinghua Ji, Master</last_name>
<phone>13663030446</phone>
<email>54234317@qq.com</email>
</contact>
<contact_backup>
<last_name>Yana Zhang, Doctor</last_name>
<phone>15093230340</phone>
<email>Drzhangyana@hotmail.com</email>
</contact_backup>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>May 2022</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<last_update_submitted>May 16, 2022</last_update_submitted>
<last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">May 20, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Anlotinib</keyword>
<keyword>Penpulimab</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Carcinoma</mesh_term>
<mesh_term>Lung Neoplasms</mesh_term>
<mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This prospective observational study will evaluate the efficacy and safety of anlotinib in
combination with Penpulimab in elderly patients with lung cancer. Data will be collected from
each patient at baseline and after 4-6 cycles of therapy.
This research study is a Phase IV clinical trial. Participants are being involved in the
portion of the study to observe the efficacy and safety of an observational intervention and
also tries to evaluate the disease control rate (such as Progression-Free-Survival, overall
survival, Objective Response Rate, Disease control rates, Duration of Response, Quality of
Life and Adverse events).
Anlotinib is a small molecule multi-target tyrosine kinase inhibitor, can effectively inhibit
VEGFR, PDGFR, FGFR, c-Kit and other kinases, with anti-tumor angiogenesis and tumor growth
inhibiting effects. Penpulimab injection is a new PD-1 monoclonal antibody drug, was approved
for marketing by the State Drug Administration (NMPA) of China for the indication: treatment
of adult patients with relapsed or refractory classic Hodgkin's lymphoma (r/r cHL) who have
undergone at least second-line systemic chemotherapy. By putting these two drugs together,
the investigators hope that it will have a greater effect on cancer growth in elderly
patients with lung cancer.
Efficacy evaluation was performed every 2 cycles during the follow-up study. Patients with
disease control (complete response (CR)+partial response (PR)+stable disease (SD)) and
tolerable adverse reactions continued to take the drug until the investigator considered that
the patient was not suitable to continue the drug or the efficacy was evaluated as disease
progression (PD). Safety evaluations were performed concurrently with the dosing period. No
other antitumor therapy can be administered until PD.
The purpose of this study is to:
- Test the efficacy of these two drugs Anlotinib and Penpulimab in elderly lung cancer;
- Determine the Progression-Free-Survival of the combination;
- Further evaluate the side effect profile for the combination of Anlotinib and Penpulimab
in elderly lung cancer patients.
At least 65 years old with locally advanced, recurrent or metastatic stage IIIB-IV
non-small cell lung cancer.
Inclusion Criteria:
- At least 65 years old;
- Non-small cell lung cancer with locally advanced, recurrent or metastasis, which
confirmed by histologically or cytologically (except sputum cytology) and evaluated as
IIIB-IV stage, who are unresectable or unable to undergo radical radiotherapy or
refuse radical radiotherapy. (If multiple tumor components are mixed, it should be
classified according to their predominant cell type);
- Participants are required to have one measurable disease per RECIST 1.1;
- Unsuitable or unwilling to receive radical treatment methods (such as radical
chemoradiotherapy and/or surgery) and have not received prior systemic therapy;
- ECOG performance status of 0 to 2; The expected survival is more than 3 months;
- Adequate organ and marrow function defined as follows:
- Hemoglobin (HB) ≥90 g/L (no blood transfusion within 28 days);
- Absolute neutrophil count (ANC) ≥1.5×109/L;
- Platelet count (PLT) ≥ 100×109/L;
- Aspartate Transaminase (AST) ≤ 1.5 x upper limit of normal (ULN);
- Alaninetransaminase (ALT) ≤ 1.5 x ULN (ALT and AST ≤ 5 x ULN if liver metastases
are present);
- Alkaline phosphatase (ALP) ≤ 1.5 x ULN;
- Albumin (ALB) ≥ 30g/L;
- Creatinine ≤1.5 x ULN or Creatinine Clearance (CCr) ≥ 60 ml/min;
- International normalized ratio (INR) ≤ 1.5 x ULN;
- Partial thromboplastin time (APTT) ≤ 1.5 x ULN;
- Prothrombin time (PT) ≤ 1.5 x ULN ;
- Thyrotropic hormone (TSH) ≤ ULN (When TSH value is abnormal, T3 and T4 levels is
normal, which can be enrolled);
- Urine protein < (++), or 24-hour urine protein amount < 1.0 g ;
- Patients must have adequate cardiac function, defined as:
Left ventricular ejection fraction (LVEF) > 50% as determined by cardiac echocardiogram.
-Patients enrolled in this study voluntarily and signed an informed consent with a good
compliance.
Exclusion Criteria:
- Participants who have active infection;
- Patients with known immunodeficiency diseases (e.g. psoriasis, active arthritis,
immune nephropathy, HIV, etc);
- Participants with no measurable disease;
- Patients with cancerous meningitis and spinal cord compression;
- Participants with active central nervous system (CNS) metastases (clinically stable
and maintained for at least 2 weeks after adequate treatment of CNS metastases and do
not require treatment such as glucocorticoids and dehydrating drugs are eligible for
enrollment);
- Previously treated with chemotherapy drugs (except neoadjuvant therapy) / targeted
drugs / immunotherapy;
- Participants who were confirmed severe abnormalities of gastrointestinal function
(e.g. inability to take oral medications, uncontrollable nausea or vomiting, history
of major gastrointestinal resection, untreated recurrent diarrhea, untreated gastric
disease requiring long-term acid-suppressing PPI-like medications, Crohn's disease,
ulcerative colitis);
- Patients with central squamous lung cancer on imaging;
- Patients who had an arterial/venous thrombotic event within 6 months, such as
cerebrovascular accident (temporary ischemic attack is excluded), deep vein thrombosis
and pulmonary embolism;
- Patients whose imaging shows that the tumor has invaded a significant vessel or have a
high risk of fatal hemorrhage due to tumor invasion of a significant vessel during the
follow-up study judged by the investigator; or who have bleeding tendencies (e.g.,
active peptic ulcer) or receiving thrombolytic or anticoagulant therapy such as
warfarin, heparin, or their analogs;
- Patients who had antineoplastic therapy against other malignancies, including
radiotherapy, chemotherapy, immunotherapy and herbal medicine (except previously
eradicated malignancies without recurrent metastases for ≥ 5 years);
- Patients with uncontrollable pleural effusion, pericardial effusion or ascites
requiring repeated drainage (except patients who do not require drainage of effusion
or whose effusion does not increase significantly after 3 days of cessation of
drainage);
- Patients who have used immunosuppressive drugs within 4 weeks prior to the study
treatment, except for topical glucocorticoids by nasal spray, inhalation or other
routes or physiologic doses of systemic glucocorticoids (no more than 10 mg/day of
prednisone or equivalent doses of other glucocorticoids);
- Patients who have known or suspected active autoimmune disease (congenital or
acquired), such as interstitial pneumonia, uveitis, enterocolitis, hepatitis,
pituitary inflammation, vasculitis, nephritis, thyroiditis, etc. (Patients with
vitiligo or asthma that has completely resolved in childhood and does not require any
intervention in adulthood may be enrolled; Patients with type I diabetes with good
insulin control may be enrolled);
- Patients who have known allogeneic organ transplantation (except corneal
transplantation) or allogeneic hematopoietic stem cell transplantation;
- Anticipants who have hypersensitivity to any component of anlotinib and monoclonal
antibodies;
- Anticipants who have active interstitial lung disease requiring treatment;
- Anticipants who have a history of psychotropic substance abuse and are unable to
abstain or have a psychiatric disorder;
- Anticipants who have participated in another anti-tumor clinical trial within four
weeks;
- Anticipants who administered anti-infective vaccines (e.g., influenza virus vaccine,
human papillomavirus vaccine) within 4 weeks prior to study therapy; During the
treatment period, in addition to inactive vaccines, other vaccines are prohibited;
- Anticipants who have undergone major surgery (except for diagnostic purposes) within 4
weeks (28 days) prior to the administration of the study;
- Patients who are not suitable for enrollment in the judgment of the investigator.
|
NCT0531xxxx/NCT05319899.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319899</url>
</required_header>
<id_info>
<org_study_id>WTX101-101</org_study_id>
<secondary_id>CA12887</secondary_id>
<nct_id>NCT05319899</nct_id>
</id_info>
<brief_title>A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults</brief_title>
<official_title>A Phase 1, Single-Center, Randomized, 3-Period Crossover Study to Evaluate the Relative Bioavailability of WTX101 in Healthy Subjects After Single Dose Administration of a Non-Coated Formulation With and Without a Proton Pump Inhibitor and With a Proton Pump Inhibitor With and Without Food</official_title>
<sponsors>
<lead_sponsor>
<agency>Alexion</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Alexion</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover
study evaluating the PK of single doses of WTX101 in healthy participants based on the
measurement of plasma total Molybdenum.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">January 20, 2014</start_date>
<completion_date type="Actual">March 24, 2014</completion_date>
<primary_completion_date type="Actual">March 24, 2014</primary_completion_date>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Crossover Assignment</intervention_model>
<intervention_model_description>This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study.</intervention_model_description>
<primary_purpose>Basic Science</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo)</measure>
<time_frame>Predose (0 hour) up to 192 hours postdose</time_frame>
<description>AUC0-t was calculated by the linear trapezoidal method.</description>
</primary_outcome>
<primary_outcome>
<measure>Maximum Measured Plasma Concentration (Cmax) of Total Mo</measure>
<time_frame>Predose (0 hour) up to 192 hours postdose</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</measure>
<time_frame>Day 1 through 14 days following final dose (up to Day 43)</time_frame>
<description>An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with the study drug and which did not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A TEAE was defined as an AE that started or worsened at the time of or after study drug administration. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.</description>
</primary_outcome>
<number_of_arms>6</number_of_arms>
<enrollment type="Actual">18</enrollment>
<condition>Healthy</condition>
<arm_group>
<arm_group_label>Sequence 1: ABC</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment A): ALXN1840 following an overnight fast. Period 2 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</arm_group>
<arm_group>
<arm_group_label>Sequence 2: ACB</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment A): ALXN1840 following an overnight fast. Period 2 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</arm_group>
<arm_group>
<arm_group_label>Sequence 3: BAC</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 2 (Treatment A): ALXN1840 following an overnight fast. Period 3 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</arm_group>
<arm_group>
<arm_group_label>Sequence 4: BCA</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 2 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment A): ALXN1840 following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</arm_group>
<arm_group>
<arm_group_label>Sequence 5: CAB</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment A): ALXN1840 following an overnight fast. Period 3 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</arm_group>
<arm_group>
<arm_group_label>Sequence 6: CBA</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment A): ALXN1840 following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>ALXN1840</intervention_name>
<description>ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.</description>
<arm_group_label>Sequence 1: ABC</arm_group_label>
<arm_group_label>Sequence 2: ACB</arm_group_label>
<arm_group_label>Sequence 3: BAC</arm_group_label>
<arm_group_label>Sequence 4: BCA</arm_group_label>
<arm_group_label>Sequence 5: CAB</arm_group_label>
<arm_group_label>Sequence 6: CBA</arm_group_label>
<other_name>WTX101 (formerly)</other_name>
<other_name>Bis-choline tetrathiomolybdate</other_name>
<other_name>Tiomolibdate choline</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Omeprazole</intervention_name>
<description>Omeprazole (20 milligrams) was administered orally as a delayed-release capsule in the morning of Days -5 to -1 and at Hour -1 on Day 1.</description>
<arm_group_label>Sequence 1: ABC</arm_group_label>
<arm_group_label>Sequence 2: ACB</arm_group_label>
<arm_group_label>Sequence 3: BAC</arm_group_label>
<arm_group_label>Sequence 4: BCA</arm_group_label>
<arm_group_label>Sequence 5: CAB</arm_group_label>
<arm_group_label>Sequence 6: CBA</arm_group_label>
<other_name>Prilosec</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Non-smoker

- Medically healthy with no clinically significant laboratory profiles, vital signs, or
electrocardiograms.

- Body mass index ≥ 18 and ≤ 32.0 kilograms/meter squared.

- Willing and able to adhere to contraception requirements.

Exclusion Criteria:

- Participant was mentally or legally incapacitated

- History or presence of clinically significant medical or psychiatric condition or
disease.

- History of any illness that might have interfered with drug absorption.

- History or presence of hypersensitivity or idiosyncratic reaction to the study
medications, study medication excipients.

- History or presence of alcoholism or drug abuse.

- Female participants who were pregnant or lactating.

- Positive results at screening for human immunodeficiency virus, hepatitis B surface
antigen, or hepatitis C virus.

- Serum ceruloplasmin and copper values outside of the normal range at screening.

- On a diet incompatible with the on-study diet within the 28 days prior to the first
ALXN1840 dose and throughout the study; unable to consume the contents of a high-fat
breakfast.

- Participation in a previous clinical trial with ALXN1840.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>19 Years</minimum_age>
<maximum_age>55 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Clinical Trial Site</name>
<address>
<city>Lincoln</city>
<state>Nebraska</state>
<zip>68502</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>September 2022</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<results_first_submitted>September 14, 2022</results_first_submitted>
<results_first_submitted_qc>September 14, 2022</results_first_submitted_qc>
<results_first_posted type="Actual">August 1, 2023</results_first_posted>
<last_update_submitted>September 14, 2022</last_update_submitted>
<last_update_submitted_qc>September 14, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">August 1, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>ALXN1840</keyword>
<keyword>WTX101</keyword>
<keyword>Omeprazole</keyword>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Tetrathiomolybdate</mesh_term>
<mesh_term>Choline</mesh_term>
<mesh_term>Omeprazole</mesh_term>
</intervention_browse>
<clinical_results>
<participant_flow>
<pre_assignment_details>Participants were randomized to one of 6 treatment sequences.</pre_assignment_details>
<group_list>
<group group_id="P1">
<title>Treatment Sequence 1: ABC</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment A): ALXN1840 60 milligrams (mg) (2 x 30 mg capsules) on Day 1 following an overnight fast. Period 2 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) once daily (QD) in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="P2">
<title>Treatment Sequence 2: ACB</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast. Period 2 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="P3">
<title>Treatment Sequence 3: BAC</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast. Period 2 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast. Period 3 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="P4">
<title>Treatment Sequence 4: BCA</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast.
Period 2 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="P5">
<title>Treatment Sequence 5: CAB</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast. Period 3 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="P6">
<title>Treatment Sequence 6: CBA</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
</group_list>
<period_list>
<period>
<title>Overall Study</title>
<milestone_list>
<milestone>
<title>STARTED</title>
<participants_list>
<participants group_id="P1" count="3"/>
<participants group_id="P2" count="3"/>
<participants group_id="P3" count="3"/>
<participants group_id="P4" count="3"/>
<participants group_id="P5" count="3"/>
<participants group_id="P6" count="3"/>
</participants_list>
</milestone>
<milestone>
<title>Received at Least 1 Dose of Study Drug</title>
<participants_list>
<participants group_id="P1" count="3"/>
<participants group_id="P2" count="3"/>
<participants group_id="P3" count="3"/>
<participants group_id="P4" count="3"/>
<participants group_id="P5" count="3"/>
<participants group_id="P6" count="3"/>
</participants_list>
</milestone>
<milestone>
<title>COMPLETED</title>
<participants_list>
<participants group_id="P1" count="3"/>
<participants group_id="P2" count="3"/>
<participants group_id="P3" count="3"/>
<participants group_id="P4" count="3"/>
<participants group_id="P5" count="3"/>
<participants group_id="P6" count="3"/>
</participants_list>
</milestone>
<milestone>
<title>NOT COMPLETED</title>
<participants_list>
<participants group_id="P1" count="0"/>
<participants group_id="P2" count="0"/>
<participants group_id="P3" count="0"/>
<participants group_id="P4" count="0"/>
<participants group_id="P5" count="0"/>
<participants group_id="P6" count="0"/>
</participants_list>
</milestone>
</milestone_list>
</period>
</period_list>
</participant_flow>
<baseline>
<population>All enrolled participants.</population>
<group_list>
<group group_id="B1">
<title>Treatment Sequence 1: ABC</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast. Period 2 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="B2">
<title>Treatment Sequence 2: ACB</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast. Period 2 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="B3">
<title>Treatment Sequence 3: BAC</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast. Period 2 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast. Period 3 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="B4">
<title>Treatment Sequence 4: BCA</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast. Period 2 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="B5">
<title>Treatment Sequence 5: CAB</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast. Period 3 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="B6">
<title>Treatment Sequence 6: CBA</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment B): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment A): ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="B7">
<title>Total</title>
<description>Total of all reporting groups</description>
</group>
</group_list>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Overall</scope>
<count_list>
<count group_id="B1" value="3"/>
<count group_id="B2" value="3"/>
<count group_id="B3" value="3"/>
<count group_id="B4" value="3"/>
<count group_id="B5" value="3"/>
<count group_id="B6" value="3"/>
<count group_id="B7" value="18"/>
</count_list>
</analyzed>
</analyzed_list>
<measure_list>
<measure>
<title>Age</title>
<units>years</units>
<param>Mean</param>
<dispersion>Standard Deviation</dispersion>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="B1" value="30.7" spread="4.16"/>
<measurement group_id="B2" value="31.3" spread="10.21"/>
<measurement group_id="B3" value="25.7" spread="2.52"/>
<measurement group_id="B4" value="36.0" spread="14.11"/>
<measurement group_id="B5" value="35.0" spread="17.69"/>
<measurement group_id="B6" value="40.0" spread="12.53"/>
<measurement group_id="B7" value="33.1" spread="10.75"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<measure>
<title>Sex: Female, Male</title>
<units>Participants</units>
<param>Count of Participants</param>
<class_list>
<class>
<category_list>
<category>
<title>Female</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
<measurement group_id="B2" value="1"/>
<measurement group_id="B3" value="3"/>
<measurement group_id="B4" value="2"/>
<measurement group_id="B5" value="2"/>
<measurement group_id="B6" value="1"/>
<measurement group_id="B7" value="9"/>
</measurement_list>
</category>
<category>
<title>Male</title>
<measurement_list>
<measurement group_id="B1" value="3"/>
<measurement group_id="B2" value="2"/>
<measurement group_id="B3" value="0"/>
<measurement group_id="B4" value="1"/>
<measurement group_id="B5" value="1"/>
<measurement group_id="B6" value="2"/>
<measurement group_id="B7" value="9"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</measure_list>
</baseline>
<outcome_list>
<outcome>
<type>Primary</type>
<title>Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo)</title>
<description>AUC0-t was calculated by the linear trapezoidal method.</description>
<time_frame>Predose (0 hour) up to 192 hours postdose</time_frame>
<population>Pharmacokinetic (PK) analysis population included all participants who completed at least 2 periods of the study and had sufficient data for the determination of PK parameters.</population>
<group_list>
<group group_id="O1">
<title>Treatment A: ALXN1840 (Fasted)</title>
<description>ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast.</description>
</group>
<group group_id="O2">
<title>Treatment B: Omeprazole + ALXN1840 (Fasted)</title>
<description>Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast.</description>
</group>
<group group_id="O3">
<title>Treatment C: Omeprazole + ALXN1840 (Fed)</title>
<description>Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.</description>
</group>
</group_list>
<measure>
<title>Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo)</title>
<description>AUC0-t was calculated by the linear trapezoidal method.</description>
<population>Pharmacokinetic (PK) analysis population included all participants who completed at least 2 periods of the study and had sufficient data for the determination of PK parameters.</population>
<units>hours*ng/mL</units>
<param>Mean</param>
<dispersion>Standard Deviation</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="18"/>
<count group_id="O2" value="18"/>
<count group_id="O3" value="18"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="14531" spread="6886"/>
<measurement group_id="O2" value="18537" spread="4303"/>
<measurement group_id="O3" value="14536" spread="3663"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<analysis_list>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O2</group_id>
</group_id_list>
<groups_desc>Analysis was performed using analysis of variance (ANOVA).</groups_desc>
<non_inferiority_type>Other</non_inferiority_type>
<param_type>Geometric Mean Ratio (%)</param_type>
<param_value>140.63</param_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>118.94</ci_lower_limit>
<ci_upper_limit>166.26</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O3</group_id>
</group_id_list>
<groups_desc>Analysis was performed using ANOVA.</groups_desc>
<non_inferiority_type>Other</non_inferiority_type>
<param_type>Geometric Mean Ratio (%)</param_type>
<param_value>77.65</param_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>65.67</ci_lower_limit>
<ci_upper_limit>91.80</ci_upper_limit>
</analysis>
</analysis_list>
</outcome>
<outcome>
<type>Primary</type>
<title>Maximum Measured Plasma Concentration (Cmax) of Total Mo</title>
<time_frame>Predose (0 hour) up to 192 hours postdose</time_frame>
<population>PK analysis population included all participants who completed at least 2 periods of the study and had sufficient data for the determination of PK parameters.</population>
<group_list>
<group group_id="O1">
<title>Treatment A: ALXN1840 (Fasted)</title>
<description>ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast.</description>
</group>
<group group_id="O2">
<title>Treatment B: Omeprazole + ALXN1840 (Fasted)</title>
<description>Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast.</description>
</group>
<group group_id="O3">
<title>Treatment C: Omeprazole + ALXN1840 (Fed)</title>
<description>Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.</description>
</group>
</group_list>
<measure>
<title>Maximum Measured Plasma Concentration (Cmax) of Total Mo</title>
<population>PK analysis population included all participants who completed at least 2 periods of the study and had sufficient data for the determination of PK parameters.</population>
<units>ng/mL</units>
<param>Mean</param>
<dispersion>Standard Deviation</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="18"/>
<count group_id="O2" value="18"/>
<count group_id="O3" value="18"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="330" spread="124"/>
<measurement group_id="O2" value="401" spread="78.3"/>
<measurement group_id="O3" value="385" spread="71.3"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<analysis_list>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O2</group_id>
</group_id_list>
<groups_desc>Analysis was performed using ANOVA.</groups_desc>
<non_inferiority_type>Other</non_inferiority_type>
<param_type>Geometric Mean Ratio (%)</param_type>
<param_value>128.23</param_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>112.99</ci_lower_limit>
<ci_upper_limit>145.52</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O2</group_id>
<group_id>O3</group_id>
</group_id_list>
<groups_desc>Analysis was performed using ANOVA.</groups_desc>
<non_inferiority_type>Other</non_inferiority_type>
<param_type>Geometric Mean Ratio (%)</param_type>
<param_value>95.94</param_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>84.54</ci_lower_limit>
<ci_upper_limit>108.88</ci_upper_limit>
</analysis>
</analysis_list>
</outcome>
<outcome>
<type>Primary</type>
<title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
<description>An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with the study drug and which did not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A TEAE was defined as an AE that started or worsened at the time of or after study drug administration. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.</description>
<time_frame>Day 1 through 14 days following final dose (up to Day 43)</time_frame>
<population>All enrolled participants who received at least 1 dose of study drug.</population>
<group_list>
<group group_id="O1">
<title>Treatment A: ALXN1840 (Fasted)</title>
<description>ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast.</description>
</group>
<group group_id="O2">
<title>Treatment B: Omeprazole + ALXN1840 (Fasted)</title>
<description>Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast.</description>
</group>
<group group_id="O3">
<title>Treatment C: Omeprazole + ALXN1840 (Fed)</title>
<description>Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.</description>
</group>
</group_list>
<measure>
<title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
<description>An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with the study drug and which did not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A TEAE was defined as an AE that started or worsened at the time of or after study drug administration. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.</description>
<population>All enrolled participants who received at least 1 dose of study drug.</population>
<units>Participants</units>
<param>Count of Participants</param>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="18"/>
<count group_id="O2" value="18"/>
<count group_id="O3" value="18"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="6"/>
<measurement group_id="O2" value="5"/>
<measurement group_id="O3" value="6"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
</outcome_list>
<reported_events>
<time_frame>Day 1 through 14 days following final dose (up to Day 43)</time_frame>
<desc>All enrolled participants who received at least 1 dose of study drug.</desc>
<group_list>
<group group_id="E1">
<title>Treatment A: ALXN1840 (Fasted)</title>
<description>ALXN1840 60 mg (2 x 30 mg capsules) on Day 1 following an overnight fast.</description>
</group>
<group group_id="E2">
<title>Treatment B: Omeprazole + ALXN1840 (Fasted)</title>
<description>Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, following an overnight fast.</description>
</group>
<group group_id="E3">
<title>Treatment C: Omeprazole + ALXN1840 (Fed)</title>
<description>Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg capsules) at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast.</description>
</group>
</group_list>
<serious_events>
<category_list>
<category>
<title>Total</title>
<event_list>
<event>
<sub_title>Total, serious adverse events</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
</event_list>
</category>
</category_list>
</serious_events>
<other_events>
<frequency_threshold>0</frequency_threshold>
<default_vocab>MedDRA 16.1</default_vocab>
<default_assessment>Systematic Assessment</default_assessment>
<category_list>
<category>
<title>Total</title>
<event_list>
<event>
<sub_title>Total, other adverse events</sub_title>
<counts group_id="E1" subjects_affected="6" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="5" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="6" subjects_at_risk="18"/>
</event>
</event_list>
</category>
<category>
<title>Eye disorders</title>
<event_list>
<event>
<sub_title>Eyelid oedema</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
</event_list>
</category>
<category>
<title>Gastrointestinal disorders</title>
<event_list>
<event>
<sub_title>Abdominal pain lower</sub_title>
<counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
<event>
<sub_title>Dyspepsia</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
</event>
</event_list>
</category>
<category>
<title>Infections and infestations</title>
<event_list>
<event>
<sub_title>Gastroenteritis</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
<event>
<sub_title>Rhinitis</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
</event_list>
</category>
<category>
<title>Injury, poisoning and procedural complications</title>
<event_list>
<event>
<sub_title>Superficial injury of eye</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
</event>
</event_list>
</category>
<category>
<title>Investigations</title>
<event_list>
<event>
<sub_title>Haematocrit decreased</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
</event>
<event>
<sub_title>Haemoglobin decreased</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
</event>
</event_list>
</category>
<category>
<title>Musculoskeletal and connective tissue disorders</title>
<event_list>
<event>
<sub_title>Back pain</sub_title>
<counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
<event>
<sub_title>Myalgia</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
</event_list>
</category>
<category>
<title>Nervous system disorders</title>
<event_list>
<event>
<sub_title>Headache</sub_title>
<counts group_id="E1" subjects_affected="3" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
</event>
<event>
<sub_title>Sinus headache</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
</event>
</event_list>
</category>
<category>
<title>Renal and urinary disorders</title>
<event_list>
<event>
<sub_title>Pollakiuria</sub_title>
<counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
</event_list>
</category>
<category>
<title>Respiratory, thoracic and mediastinal disorders</title>
<event_list>
<event>
<sub_title>Cough</sub_title>
<counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
<event>
<sub_title>Epistaxis</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
<event>
<sub_title>Oropharyngeal pain</sub_title>
<counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
<event>
<sub_title>Respiratory tract congestion</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
<event>
<sub_title>Sinus congestion</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="3" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
<event>
<sub_title>Sneezing</sub_title>
<counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
</event_list>
</category>
<category>
<title>Skin and subcutaneous tissue disorders</title>
<event_list>
<event>
<sub_title>Dermatitis contact</sub_title>
<counts group_id="E1" subjects_affected="3" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
</event>
<event>
<sub_title>Dry skin</sub_title>
<counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
</event_list>
</category>
</category_list>
</other_events>
</reported_events>
<certain_agreements>
<pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
<restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
</certain_agreements>
<point_of_contact>
<name_or_title>Alexion Pharmaceuticals Inc.</name_or_title>
<organization>Alexion Pharmaceuticals Inc.</organization>
<phone>+1 855-752-2356</phone>
<email>clinicaltrials@alexion.com</email>
</point_of_contact>
</clinical_results>
</clinical_study>
|
This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover
study evaluating the PK of single doses of WTX101 in healthy participants based on the
measurement of plasma total Molybdenum.
Inclusion Criteria:
- Non-smoker
- Medically healthy with no clinically significant laboratory profiles, vital signs, or
electrocardiograms.
- Body mass index ≥ 18 and ≤ 32.0 kilograms/meter squared.
- Willing and able to adhere to contraception requirements.
Exclusion Criteria:
- Participant was mentally or legally incapacitated
- History or presence of clinically significant medical or psychiatric condition or
disease.
- History of any illness that might have interfered with drug absorption.
- History or presence of hypersensitivity or idiosyncratic reaction to the study
medications, study medication excipients.
- History or presence of alcoholism or drug abuse.
- Female participants who were pregnant or lactating.
- Positive results at screening for human immunodeficiency virus, hepatitis B surface
antigen, or hepatitis C virus.
- Serum ceruloplasmin and copper values outside of the normal range at screening.
- On a diet incompatible with the on-study diet within the 28 days prior to the first
ALXN1840 dose and throughout the study; unable to consume the contents of a high-fat
breakfast.
- Participation in a previous clinical trial with ALXN1840.
|
NCT0531xxxx/NCT05319912.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319912</url>
</required_header>
<id_info>
<org_study_id>WTX101-102</org_study_id>
<secondary_id>CA13895</secondary_id>
<nct_id>NCT05319912</nct_id>
</id_info>
<brief_title>A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults</brief_title>
<official_title>A Phase 1, Single-Center, Randomized, 3-Period Crossover Study in Healthy Volunteers to Evaluate the Absorption of WTX101 After Single Dose Administration of an Enteric Coated Formulation With and Without Food and a Non-Coated Formulation Coadministered With a Proton Pump Inhibitor Without Food</official_title>
<sponsors>
<lead_sponsor>
<agency>Alexion</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Alexion</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover
study evaluating the PK of single doses of WTX101 in healthy participants based on the
measurement of plasma total Mo concentration.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">April 7, 2014</start_date>
<completion_date type="Actual">May 29, 2014</completion_date>
<primary_completion_date type="Actual">May 29, 2014</primary_completion_date>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Crossover Assignment</intervention_model>
<primary_purpose>Basic Science</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo)</measure>
<time_frame>Predose (0 hour) up to 192 hours postdose</time_frame>
<description>AUC0-t was calculated by the linear trapezoidal method.</description>
</primary_outcome>
<primary_outcome>
<measure>Maximum Measured Plasma Concentration (Cmax) of Total Mo</measure>
<time_frame>Predose (0 hour) up to 192 hours postdose</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</measure>
<time_frame>Day 1 through 14 days following final dose (up to Day 43)</time_frame>
<description>An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with the study drug and which did not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A TEAE was defined as an AE that started or worsened at the time of or after study drug administration. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.</description>
</primary_outcome>
<number_of_arms>6</number_of_arms>
<enrollment type="Actual">18</enrollment>
<condition>Healthy</condition>
<arm_group>
<arm_group_label>Sequence 1: ABC</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment A): ALXN1840 tablets following an overnight fast. Period 2 (Treatment B): ALXN1840 tablets after the start of a high-fat breakfast, preceded by an overnight fast. Period 3 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 non-coated capsules at Hour 0 on Day 1.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</arm_group>
<arm_group>
<arm_group_label>Sequence 2: ACB</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment A): ALXN1840 tablets following an overnight fast. Period 2 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 non-coated capsules at Hour 0 on Day 1. Period 3 (Treatment B): ALXN1840 tablets after the start of a high-fat breakfast, preceded by an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</arm_group>
<arm_group>
<arm_group_label>Sequence 3: BAC</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment B): ALXN1840 tablets after the start of a high-fat breakfast, preceded by an overnight fast. Period 2 (Treatment A): ALXN1840 tablets following an overnight fast. Period 3 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 non-coated capsules at Hour 0 on Day 1.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</arm_group>
<arm_group>
<arm_group_label>Sequence 4: BCA</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment B): ALXN1840 tablets after the start of a high-fat breakfast, preceded by an overnight fast. Period 2 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 non-coated capsules at Hour 0 on Day 1. Period 3 (Treatment A): ALXN1840 tablets following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</arm_group>
<arm_group>
<arm_group_label>Sequence 5: CAB</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 non-coated capsules at Hour 0 on Day 1. Period 2 (Treatment A): ALXN1840 tablets following an overnight fast. Period 3 (Treatment B): ALXN1840 tablets after the start of a high-fat breakfast, preceded by an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</arm_group>
<arm_group>
<arm_group_label>Sequence 6: CBA</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 non-coated capsules at Hour 0 on Day 1. Period 2 (Treatment B): ALXN1840 tablets after the start of a high-fat breakfast, preceded by an overnight fast. Period 3 (Treatment A): ALXN1840 tablets following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>ALXN1840 Enteric-coated Tablet</intervention_name>
<description>ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1.</description>
<arm_group_label>Sequence 1: ABC</arm_group_label>
<arm_group_label>Sequence 2: ACB</arm_group_label>
<arm_group_label>Sequence 3: BAC</arm_group_label>
<arm_group_label>Sequence 4: BCA</arm_group_label>
<arm_group_label>Sequence 5: CAB</arm_group_label>
<arm_group_label>Sequence 6: CBA</arm_group_label>
<other_name>WTX101 (formerly)</other_name>
<other_name>Bis-choline tetrathiomolybdate</other_name>
<other_name>Tiomolibdate choline</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>ALXN1840 Non-coated Capsule</intervention_name>
<description>ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.</description>
<arm_group_label>Sequence 1: ABC</arm_group_label>
<arm_group_label>Sequence 2: ACB</arm_group_label>
<arm_group_label>Sequence 3: BAC</arm_group_label>
<arm_group_label>Sequence 4: BCA</arm_group_label>
<arm_group_label>Sequence 5: CAB</arm_group_label>
<arm_group_label>Sequence 6: CBA</arm_group_label>
<other_name>WTX101 (formerly)</other_name>
<other_name>Bis-choline tetrathiomolybdate</other_name>
<other_name>Tiomolibdate choline</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Omeprazole</intervention_name>
<description>Omeprazole (20 milligrams) was administered orally as a delayed-release capsule in the morning of Days -5 to -1 and at Hour -1 on Day 1.</description>
<arm_group_label>Sequence 1: ABC</arm_group_label>
<arm_group_label>Sequence 2: ACB</arm_group_label>
<arm_group_label>Sequence 3: BAC</arm_group_label>
<arm_group_label>Sequence 4: BCA</arm_group_label>
<arm_group_label>Sequence 5: CAB</arm_group_label>
<arm_group_label>Sequence 6: CBA</arm_group_label>
<other_name>Prilosec</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Non-smoker

- Medically healthy with no clinically significant laboratory profiles, vital signs, or
electrocardiograms.

- Body mass index ≥ 18 and ≤ 32.0 kilograms/meter squared.

- Willing and able to adhere to contraception requirements.

Exclusion Criteria:

- Participant was mentally or legally incapacitated

- History or presence of clinically significant medical or psychiatric condition or
disease.

- History of any illness that might have interfered with drug absorption.

- History or presence of hypersensitivity or idiosyncratic reaction to the study
medications, study medication excipients.

- History or presence of alcoholism or drug abuse.

- Female participants who were pregnant or lactating.

- Positive results at screening for human immunodeficiency virus, hepatitis B surface
antigen, or hepatitis C virus.

- Serum ceruloplasmin and copper values outside of the normal range at screening.

- On a diet incompatible with the on-study diet within the 28 days prior to the first
ALXN1840 dose and throughout the study; unable to consume the contents of a high-fat
breakfast.

- Participation in a previous clinical trial with ALXN1840.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>19 Years</minimum_age>
<maximum_age>55 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Clinical Trial Site</name>
<address>
<city>Lincoln</city>
<state>Nebraska</state>
<zip>68502</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>September 2022</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 8, 2022</study_first_posted>
<results_first_submitted>September 15, 2022</results_first_submitted>
<results_first_submitted_qc>September 15, 2022</results_first_submitted_qc>
<results_first_posted type="Actual">August 2, 2023</results_first_posted>
<last_update_submitted>September 15, 2022</last_update_submitted>
<last_update_submitted_qc>September 15, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">August 2, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>ALXN1840</keyword>
<keyword>WTX101</keyword>
<keyword>Omeprazole</keyword>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Molybdenum</mesh_term>
<mesh_term>Tetrathiomolybdate</mesh_term>
<mesh_term>Choline</mesh_term>
<mesh_term>Omeprazole</mesh_term>
</intervention_browse>
<provided_document_section>
<provided_document>
<document_type>Study Protocol</document_type>
<document_has_protocol>Yes</document_has_protocol>
<document_has_icf>No</document_has_icf>
<document_has_sap>No</document_has_sap>
<document_date>February 24, 2014</document_date>
<document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT05319912/Prot_000.pdf</document_url>
</provided_document>
<provided_document>
<document_type>Statistical Analysis Plan</document_type>
<document_has_protocol>No</document_has_protocol>
<document_has_icf>No</document_has_icf>
<document_has_sap>Yes</document_has_sap>
<document_date>May 22, 2014</document_date>
<document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT05319912/SAP_001.pdf</document_url>
</provided_document>
</provided_document_section>
<clinical_results>
<participant_flow>
<pre_assignment_details>Participants were randomized to one of 6 treatment sequences.</pre_assignment_details>
<group_list>
<group group_id="P1">
<title>Treatment Sequence 1: ABC</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment A): ALXN1840 60 milligrams (mg) (2 x 30 mg enteric-coated [EC] tablets) at Hour 0 on Day 1 following an overnight fast. Period 2 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast. Period 3 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) once daily (QD) in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="P2">
<title>Treatment Sequence 2: ACB</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1 following an overnight fast. Period 2 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. Period 3 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="P3">
<title>Treatment Sequence 3: BAC</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast. Period 2 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1 following an overnight fast. Period 3 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="P4">
<title>Treatment Sequence 4: BCA</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast. Period 2 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. Period 3 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1 following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="P5">
<title>Treatment Sequence 5: CAB</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. Period 2 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1 following an overnight fast. Period 3 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="P6">
<title>Treatment Sequence 6: CBA</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. Period 2 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast. Period 3 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1 following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
</group_list>
<period_list>
<period>
<title>Overall Study</title>
<milestone_list>
<milestone>
<title>STARTED</title>
<participants_list>
<participants group_id="P1" count="3"/>
<participants group_id="P2" count="3"/>
<participants group_id="P3" count="3"/>
<participants group_id="P4" count="3"/>
<participants group_id="P5" count="3"/>
<participants group_id="P6" count="3"/>
</participants_list>
</milestone>
<milestone>
<title>Received at Least 1 Dose of Study Drug</title>
<participants_list>
<participants group_id="P1" count="3"/>
<participants group_id="P2" count="3"/>
<participants group_id="P3" count="3"/>
<participants group_id="P4" count="3"/>
<participants group_id="P5" count="3"/>
<participants group_id="P6" count="3"/>
</participants_list>
</milestone>
<milestone>
<title>COMPLETED</title>
<participants_list>
<participants group_id="P1" count="3"/>
<participants group_id="P2" count="3"/>
<participants group_id="P3" count="3"/>
<participants group_id="P4" count="3"/>
<participants group_id="P5" count="3"/>
<participants group_id="P6" count="3"/>
</participants_list>
</milestone>
<milestone>
<title>NOT COMPLETED</title>
<participants_list>
<participants group_id="P1" count="0"/>
<participants group_id="P2" count="0"/>
<participants group_id="P3" count="0"/>
<participants group_id="P4" count="0"/>
<participants group_id="P5" count="0"/>
<participants group_id="P6" count="0"/>
</participants_list>
</milestone>
</milestone_list>
</period>
</period_list>
</participant_flow>
<baseline>
<population>All enrolled participants.</population>
<group_list>
<group group_id="B1">
<title>Treatment Sequence 1: ABC</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1 following an overnight fast. Period 2 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast. Period 3 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="B2">
<title>Treatment Sequence 2: ACB</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1 following an overnight fast. Period 2 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. Period 3 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="B3">
<title>Treatment Sequence 3: BAC</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast. Period 2 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1 following an overnight fast. Period 3 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="B4">
<title>Treatment Sequence 4: BCA</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast. Period 2 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. Period 3 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1 following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="B5">
<title>Treatment Sequence 5: CAB</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. Period 2 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1 following an overnight fast. Period 3 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="B6">
<title>Treatment Sequence 6: CBA</title>
<description>Participants received each treatment on 1 occasion:
Period 1 (Treatment C): Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1. Period 2 (Treatment B): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast. Period 3 (Treatment A): ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1 following an overnight fast.
There was a washout period of at least 14 days between each ALXN1840 dosing.</description>
</group>
<group group_id="B7">
<title>Total</title>
<description>Total of all reporting groups</description>
</group>
</group_list>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Overall</scope>
<count_list>
<count group_id="B1" value="3"/>
<count group_id="B2" value="3"/>
<count group_id="B3" value="3"/>
<count group_id="B4" value="3"/>
<count group_id="B5" value="3"/>
<count group_id="B6" value="3"/>
<count group_id="B7" value="18"/>
</count_list>
</analyzed>
</analyzed_list>
<measure_list>
<measure>
<title>Age</title>
<units>years</units>
<param>Mean</param>
<dispersion>Standard Deviation</dispersion>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="B1" value="42.3" spread="15.95"/>
<measurement group_id="B2" value="33.7" spread="16.07"/>
<measurement group_id="B3" value="25.7" spread="3.06"/>
<measurement group_id="B4" value="38.0" spread="13.00"/>
<measurement group_id="B5" value="40.7" spread="11.37"/>
<measurement group_id="B6" value="31.7" spread="10.97"/>
<measurement group_id="B7" value="35.3" spread="12.04"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<measure>
<title>Sex: Female, Male</title>
<units>Participants</units>
<param>Count of Participants</param>
<class_list>
<class>
<category_list>
<category>
<title>Female</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
<measurement group_id="B2" value="0"/>
<measurement group_id="B3" value="0"/>
<measurement group_id="B4" value="2"/>
<measurement group_id="B5" value="3"/>
<measurement group_id="B6" value="1"/>
<measurement group_id="B7" value="6"/>
</measurement_list>
</category>
<category>
<title>Male</title>
<measurement_list>
<measurement group_id="B1" value="3"/>
<measurement group_id="B2" value="3"/>
<measurement group_id="B3" value="3"/>
<measurement group_id="B4" value="1"/>
<measurement group_id="B5" value="0"/>
<measurement group_id="B6" value="2"/>
<measurement group_id="B7" value="12"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</measure_list>
</baseline>
<outcome_list>
<outcome>
<type>Primary</type>
<title>Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo)</title>
<description>AUC0-t was calculated by the linear trapezoidal method.</description>
<time_frame>Predose (0 hour) up to 192 hours postdose</time_frame>
<population>Pharmacokinetic (PK) analysis population included all enrolled participants who completed the study and had sufficient data for the determination of PK parameters.</population>
<group_list>
<group group_id="O1">
<title>Treatment A: ALXN1840 (Fasted)</title>
<description>ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1 following an overnight fast.</description>
</group>
<group group_id="O2">
<title>Treatment B: ALXN1840 (Fed)</title>
<description>ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast.</description>
</group>
<group group_id="O3">
<title>Treatment C: Omeprazole + ALXN1840 (Fasted)</title>
<description>Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1.</description>
</group>
</group_list>
<measure>
<title>Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo)</title>
<description>AUC0-t was calculated by the linear trapezoidal method.</description>
<population>Pharmacokinetic (PK) analysis population included all enrolled participants who completed the study and had sufficient data for the determination of PK parameters.</population>
<units>hours*ng/mL</units>
<param>Mean</param>
<dispersion>Standard Deviation</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="18"/>
<count group_id="O2" value="17"/>
<count group_id="O3" value="18"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="16026" spread="5635"/>
<measurement group_id="O2" value="5740" spread="4681"/>
<measurement group_id="O3" value="19809" spread="3509"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<analysis_list>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O3</group_id>
</group_id_list>
<groups_desc>Analysis was performed using analysis of variance (ANOVA).</groups_desc>
<non_inferiority_type>Other</non_inferiority_type>
<param_type>Geometric Mean Ratio (%)</param_type>
<param_value>75.81</param_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>52.23</ci_lower_limit>
<ci_upper_limit>110.02</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O2</group_id>
</group_id_list>
<groups_desc>Analysis was performed using ANOVA.</groups_desc>
<non_inferiority_type>Other</non_inferiority_type>
<param_type>Geometric Mean Ratio (%)</param_type>
<param_value>25.20</param_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>17.21</ci_lower_limit>
<ci_upper_limit>36.89</ci_upper_limit>
</analysis>
</analysis_list>
</outcome>
<outcome>
<type>Primary</type>
<title>Maximum Measured Plasma Concentration (Cmax) of Total Mo</title>
<time_frame>Predose (0 hour) up to 192 hours postdose</time_frame>
<population>PK analysis population included all enrolled participants who completed the study and had sufficient data for the determination of PK parameters.</population>
<group_list>
<group group_id="O1">
<title>Treatment A: ALXN1840 (Fasted)</title>
<description>ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1 following an overnight fast.</description>
</group>
<group group_id="O2">
<title>Treatment B: ALXN1840 (Fed)</title>
<description>ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast.</description>
</group>
<group group_id="O3">
<title>Treatment C: Omeprazole + ALXN1840 (Fasted)</title>
<description>Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1.</description>
</group>
</group_list>
<measure>
<title>Maximum Measured Plasma Concentration (Cmax) of Total Mo</title>
<population>PK analysis population included all enrolled participants who completed the study and had sufficient data for the determination of PK parameters.</population>
<units>ng/mL</units>
<param>Mean</param>
<dispersion>Standard Deviation</dispersion>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="18"/>
<count group_id="O2" value="17"/>
<count group_id="O3" value="18"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="376" spread="98.0"/>
<measurement group_id="O2" value="187" spread="118"/>
<measurement group_id="O3" value="442" spread="69.6"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<analysis_list>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O3</group_id>
</group_id_list>
<groups_desc>Analysis was performed using ANOVA.</groups_desc>
<non_inferiority_type>Other</non_inferiority_type>
<param_type>Geometric Mean Ratio (%)</param_type>
<param_value>82.65</param_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>63.91</ci_lower_limit>
<ci_upper_limit>106.90</ci_upper_limit>
</analysis>
<analysis>
<group_id_list>
<group_id>O1</group_id>
<group_id>O2</group_id>
</group_id_list>
<groups_desc>Analysis was performed using ANOVA.</groups_desc>
<non_inferiority_type>Other</non_inferiority_type>
<param_type>Geometric Mean Ratio (%)</param_type>
<param_value>40.49</param_value>
<ci_percent>90</ci_percent>
<ci_n_sides>2-Sided</ci_n_sides>
<ci_lower_limit>31.12</ci_lower_limit>
<ci_upper_limit>52.68</ci_upper_limit>
</analysis>
</analysis_list>
</outcome>
<outcome>
<type>Primary</type>
<title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
<description>An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with the study drug and which did not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A TEAE was defined as an AE that started or worsened at the time of or after study drug administration. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.</description>
<time_frame>Day 1 through 14 days following final dose (up to Day 43)</time_frame>
<population>All enrolled participants who received at least 1 dose of study drug.</population>
<group_list>
<group group_id="O1">
<title>Treatment A: ALXN1840 (Fasted)</title>
<description>ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1 following an overnight fast.</description>
</group>
<group group_id="O2">
<title>Treatment B: ALXN1840 (Fed)</title>
<description>ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast.</description>
</group>
<group group_id="O3">
<title>Treatment C: Omeprazole + ALXN1840 (Fasted)</title>
<description>Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1.</description>
</group>
</group_list>
<measure>
<title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
<description>An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with the study drug and which did not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A TEAE was defined as an AE that started or worsened at the time of or after study drug administration. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.</description>
<population>All enrolled participants who received at least 1 dose of study drug.</population>
<units>Participants</units>
<param>Count of Participants</param>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="18"/>
<count group_id="O2" value="18"/>
<count group_id="O3" value="18"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="4"/>
<measurement group_id="O2" value="2"/>
<measurement group_id="O3" value="6"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
</outcome_list>
<reported_events>
<time_frame>Day 1 through 14 days following final dose (up to Day 43)</time_frame>
<desc>All enrolled participants who received at least 1 dose of study drug.</desc>
<group_list>
<group group_id="E1">
<title>Treatment A: ALXN1840 (Fasted)</title>
<description>ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1 following an overnight fast.</description>
</group>
<group group_id="E2">
<title>Treatment B: ALXN1840 (Fed)</title>
<description>ALXN1840 60 mg (2 x 30 mg EC tablets) at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast, preceded by an overnight fast.</description>
</group>
<group group_id="E3">
<title>Treatment C: Omeprazole + ALXN1840 (Fasted)</title>
<description>Omeprazole 20 mg (1 x 20 mg delayed-release capsule) QD in the morning of Days -5 to -1 following an overnight fast, omeprazole 20 mg delayed-release capsule at Hour -1 on Day 1 following an overnight fast, and ALXN1840 60 mg (2 x 30 mg non-coated capsules) at Hour 0 on Day 1.</description>
</group>
</group_list>
<serious_events>
<category_list>
<category>
<title>Total</title>
<event_list>
<event>
<sub_title>Total, serious adverse events</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
</event_list>
</category>
</category_list>
</serious_events>
<other_events>
<frequency_threshold>0</frequency_threshold>
<default_vocab>MedDRA 16.1</default_vocab>
<default_assessment>Systematic Assessment</default_assessment>
<category_list>
<category>
<title>Total</title>
<event_list>
<event>
<sub_title>Total, other adverse events</sub_title>
<counts group_id="E1" subjects_affected="4" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="2" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="6" subjects_at_risk="18"/>
</event>
</event_list>
</category>
<category>
<title>Eye disorders</title>
<event_list>
<event>
<sub_title>Eye haemorrhage</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
</event>
</event_list>
</category>
<category>
<title>Gastrointestinal disorders</title>
<event_list>
<event>
<sub_title>Abdominal distension</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
</event>
<event>
<sub_title>Diarrhoea</sub_title>
<counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
<event>
<sub_title>Nausea</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
</event_list>
</category>
<category>
<title>Infections and infestations</title>
<event_list>
<event>
<sub_title>Upper respiratory tract infection</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
</event>
</event_list>
</category>
<category>
<title>Injury, poisoning and procedural complications</title>
<event_list>
<event>
<sub_title>Contusion</sub_title>
<counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
<event>
<sub_title>Laceration</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
</event>
</event_list>
</category>
<category>
<title>Nervous system disorders</title>
<event_list>
<event>
<sub_title>Headache</sub_title>
<counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
</event>
<event>
<sub_title>Somnolence</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
</event>
</event_list>
</category>
<category>
<title>Respiratory, thoracic and mediastinal disorders</title>
<event_list>
<event>
<sub_title>Dysphonia</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
</event>
<event>
<sub_title>Nasal congestion</sub_title>
<counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
<event>
<sub_title>Nasal dryness</sub_title>
<counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
</event>
<event>
<sub_title>Rhinorrhoea</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
<counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
</event>
</event_list>
</category>
</category_list>
</other_events>
</reported_events>
<certain_agreements>
<pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
<restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
</certain_agreements>
<point_of_contact>
<name_or_title>Alexion Pharmaceuticals Inc.</name_or_title>
<organization>Alexion Pharmaceuticals Inc.</organization>
<phone>+1 855-752-2356</phone>
<email>clinicaltrials@alexion.com</email>
</point_of_contact>
</clinical_results>
</clinical_study>
|
This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover
study evaluating the PK of single doses of WTX101 in healthy participants based on the
measurement of plasma total Mo concentration.
Inclusion Criteria:
- Non-smoker
- Medically healthy with no clinically significant laboratory profiles, vital signs, or
electrocardiograms.
- Body mass index ≥ 18 and ≤ 32.0 kilograms/meter squared.
- Willing and able to adhere to contraception requirements.
Exclusion Criteria:
- Participant was mentally or legally incapacitated
- History or presence of clinically significant medical or psychiatric condition or
disease.
- History of any illness that might have interfered with drug absorption.
- History or presence of hypersensitivity or idiosyncratic reaction to the study
medications, study medication excipients.
- History or presence of alcoholism or drug abuse.
- Female participants who were pregnant or lactating.
- Positive results at screening for human immunodeficiency virus, hepatitis B surface
antigen, or hepatitis C virus.
- Serum ceruloplasmin and copper values outside of the normal range at screening.
- On a diet incompatible with the on-study diet within the 28 days prior to the first
ALXN1840 dose and throughout the study; unable to consume the contents of a high-fat
breakfast.
- Participation in a previous clinical trial with ALXN1840.
|
NCT0531xxxx/NCT05319925.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319925</url>
</required_header>
<id_info>
<org_study_id>S-177/2021</org_study_id>
<secondary_id>70113978</secondary_id>
<nct_id>NCT05319925</nct_id>
</id_info>
<brief_title>Financial Effects of a Tumor Disease - Development and Validation of a Patient Reported Outcome Measure in Germany</brief_title>
<acronym>FIAT</acronym>
<official_title>Financial Effects of a Tumor Disease</official_title>
<sponsors>
<lead_sponsor>
<agency>University Hospital Heidelberg</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Chair of Methods in Empirical Social Research, Institute of Sociology, Technische Universität Dresden</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Health Economics and Health Care Management, Bielefeld University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Haematology and Oncology, University of Jena</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>University Hospital Heidelberg</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This study aims to develop and to validate a standardised German-language instrument for
measuring experienced financial effects of a cancer diagnosis and therapy in a
cross-sectional bi-centre study. Obtained data will make the patient-related description of
financial difficulties more comprehensible, communicable and addressable in the future, e.g.
by offering targeted advisory aids or considering financial effects in health technology
assessments.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Methods and analysis:

Phase 1: Construct definition and item generation

Preliminary study:

The preliminary study aims to identify dimensions, topics and risk factors that are relevant
for the assessment of financial effects through qualitative interviews with patients, focus
group discussions with potential users of a new instrument (social services,
HTA-institutions, payers) and a systematic literature review.

Preliminary questionnaire:

In order to derive a pre-final questionnaire, the aim of this part of the study is to define
the construct of financial effects and to generate a list of appropriate indicators for
measuring financial effects based on the results available from the literature. The pre-final
questionnaire will be peer-reviewed by the interdisciplinary project team (oncology/medical
ethics, health economics, methods of empirical social research).

Phase 2: Questionnaire Piloting and Validation

Cognitive pre-test:

A cognitive pre-test of the pre-final questionnaire is conducted to examine comprehension of
questions and response option and identify any potential problems respondents would have to
understand the questions and to respond to them. The results are used in order to further
optimize the first draft of the questionnaire.

Quantitative evaluation and validation:

Quantitative evaluation and validation of the developed questionnaire will be performed based
on two studies on the target population by determining the distribution parameters of the
indicators and their measurement characteristics. In the first study, the pre-final
questionnaire will be tested and after adjustment, the final version will be applied in study
2. Participants of the first study (n=100) will be surveyed again within the second study
(n=400 participants), while data of the additional participants (n=300) in study 2 will be
measured at a single time point.

For validation purposes, additional scales measuring similar and unrelated constructs, as
well as criteria (external concepts affected by financial effects) will be included in the
questionnaire. Validity will be assessed by subsequent examining of different relationships
between the developed instrument and predefined third variables and criteria. Factorial
validity will be examined by factor analyses. Furthermore reliability and test-fairness of
the instrument will be assessed through further psychometric testing.

Phase 3: Further applicability of the questionnaire To formulate well-founded recommendations
for the use of the instrument, a pilot screening program for social services is evaluated
through qualitative interviews with representatives of social services and patients regarding
practicability of the instrument. A synthesis of all project results will translate into
overall recommendations within the clinical and regulatory context.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">June 1, 2022</start_date>
<completion_date type="Anticipated">October 31, 2023</completion_date>
<primary_completion_date type="Anticipated">May 31, 2023</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Other</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Validation of FIAT questionnaire (pre-version): Distribution analysis</measure>
<time_frame>4 months</time_frame>
<description>Distribution analyses (correspondence to the normal distribution; skew and excess with evidence for possible ceiling and floor effects)</description>
</primary_outcome>
<primary_outcome>
<measure>Validation of FIAT questionnaire (pre-version): Factorial validity</measure>
<time_frame>4 months</time_frame>
<description>Exploratory Factor Analysis (EFA) will be used to analyse the factorial structure of the instrument to investigate which theoretically defined properties of the construct can adequately covered and differentiated with help of single indicators (items and questions).</description>
</primary_outcome>
<primary_outcome>
<measure>Validation of FIAT questionnaire (pre-version): Reliability</measure>
<time_frame>4 months</time_frame>
<description>Preliminary assessment of reliability with Guttmans-Lambda</description>
</primary_outcome>
<primary_outcome>
<measure>Validation of FIAT questionnaire (final version): Distribution analysis</measure>
<time_frame>5 months</time_frame>
<description>Distribution analyses (correspondence to the normal distribution; skew and excess with evidence for possible ceiling and floor effects)</description>
</primary_outcome>
<primary_outcome>
<measure>Validation of FIAT questionnaire (final version): Factorial validity</measure>
<time_frame>5 months</time_frame>
<description>Exploratory Factor Analysis (EFA) and Confirmatory Factor Analysis (CFA) will be used.</description>
</primary_outcome>
<primary_outcome>
<measure>Validation of FIAT questionnaire (pre-version and final version): Test-retest-reliability</measure>
<time_frame>5 months</time_frame>
<description>Correlations between the measurements between the first and second survey will be obtained to evaluate test-retest-reliability.</description>
</primary_outcome>
<primary_outcome>
<measure>Validation of FIAT questionnaire (final version): Test-fairness</measure>
<time_frame>5 months</time_frame>
<description>Test fairness will be evaluated by means of Multi-Group Confirmatory Factor Analysis (MG-CFA).</description>
</primary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Anticipated">400</enrollment>
<condition>Cancer</condition>
<arm_group>
<arm_group_label>Study 1</arm_group_label>
<description>Initial examination of the developed questionnaire in the first 100 participants to identify problematic questions and to optimise the instrument.
To evaluate test-retest reliability, collected data of the first 100 patients will be used as baseline value and re-assessed in Study 2.</description>
</arm_group>
<arm_group>
<arm_group_label>Study 2</arm_group_label>
<description>Second examination in 300 additional participants and re-assessment in participants from Study 1 (n=400) to validate modified questionnaire in its final form.
To evaluate test-retest reliability, data of Study 1 is compared against Study 2 of the same participant sample (n=100).</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Patient reported outcome measure</intervention_name>
<description>Newly developed patient-reported instrument to measure financial effects of a cancer diagnosis and therapy of cancer patients in Germany</description>
<arm_group_label>Study 1</arm_group_label>
<arm_group_label>Study 2</arm_group_label>
<other_name>FIAT questionnaire</other_name>
</intervention>
<eligibility>
<study_pop>
<textblock>
Patients with all types of cancer who have undergone at least two months of cancer related
therapy with an ECOG Status < 2, who are treated at the day care unit and ambulances of the
NCT Heidelberg or conservative day care unit and oncological ward B100, Jena University
Hospital.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Any type of historically or cytological confirmed solid cancer or haematological
malignancy with an ECOG-Status <2 and at least two month of cancer related therapy

- Patients are treated at the day care unit or ambulances of the NCT Heidelberg or
oncological ward B100 at Jena University Hospital

Exclusion Criteria:

- Patients younger than 18 years old

- Patients who refuse or withdraw from informed consent

- No sufficient level of German language
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Eva C Winkler, Prof. Dr. Dr.</last_name>
<role>Principal Investigator</role>
<affiliation>National Center for Tumor Diseases, University Hospital Heidelberg</affiliation>
</overall_official>
<overall_contact>
<last_name>Eva C. Winkler, Prof. Dr. Dr.</last_name>
<phone>004962215637216</phone>
<email>eva.winkler@med.uni-heidelberg.de</email>
</overall_contact>
<location>
<facility>
<name>National Center for Tumor Diseases, University Hospital Heidelberg</name>
<address>
<city>Heidelberg</city>
<country>Germany</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Andrea Züger, lic. phil.</last_name>
<phone>0049 6221 56-35727</phone>
</contact>
<investigator>
<last_name>Eva C. Winkler, Prof. Dr .Dr.</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Wolfgang Greiner, Prof. Dr.</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Natalja Menold, Prof. Dr.</last_name>
<role>Principal Investigator</role>
</investigator>
<investigator>
<last_name>Thomas Ernst, Prof. Dr.</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Bastian Surmann, MSc</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Viktoria Mathies, MSc</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Katja Mehlis, Dr.</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Sophie Pauge, MSc</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Luise Richter, Dipl.-Soz.</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Andrea Züger, lic.phil.</last_name>
<role>Sub-Investigator</role>
</investigator>
</location>
<location_countries>
<country>Germany</country>
</location_countries>
<link>
<url>https://www.nct-heidelberg.de/forschung/nct-core-services/nct-epoc/research/fiat.html</url>
<description>project description</description>
</link>
<reference>
<citation>Pauge S, Surmann B, Mehlis K, Zueger A, Richter L, Menold N, Greiner W, Winkler EC. Patient-Reported Financial Distress in Cancer: A Systematic Review of Risk Factors in Universal Healthcare Systems. Cancers (Basel). 2021 Oct 7;13(19):5015. doi: 10.3390/cancers13195015.</citation>
<PMID>34638499</PMID>
</reference>
<verification_date>April 2023</verification_date>
<study_first_submitted>February 8, 2022</study_first_submitted>
<study_first_submitted_qc>April 6, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>April 20, 2023</last_update_submitted>
<last_update_submitted_qc>April 20, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">April 21, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University Hospital Heidelberg</investigator_affiliation>
<investigator_full_name>Eva Winkler, MD</investigator_full_name>
<investigator_title>Prof. Dr. Dr.</investigator_title>
</responsible_party>
<keyword>Financial Toxicity</keyword>
<keyword>Financial Effects</keyword>
<keyword>Patient-reported Outcome</keyword>
<keyword>Cancer</keyword>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This study aims to develop and to validate a standardised German-language instrument for
measuring experienced financial effects of a cancer diagnosis and therapy in a
cross-sectional bi-centre study. Obtained data will make the patient-related description of
financial difficulties more comprehensible, communicable and addressable in the future, e.g.
by offering targeted advisory aids or considering financial effects in health technology
assessments.
Methods and analysis:
Phase 1: Construct definition and item generation
Preliminary study:
The preliminary study aims to identify dimensions, topics and risk factors that are relevant
for the assessment of financial effects through qualitative interviews with patients, focus
group discussions with potential users of a new instrument (social services,
HTA-institutions, payers) and a systematic literature review.
Preliminary questionnaire:
In order to derive a pre-final questionnaire, the aim of this part of the study is to define
the construct of financial effects and to generate a list of appropriate indicators for
measuring financial effects based on the results available from the literature. The pre-final
questionnaire will be peer-reviewed by the interdisciplinary project team (oncology/medical
ethics, health economics, methods of empirical social research).
Phase 2: Questionnaire Piloting and Validation
Cognitive pre-test:
A cognitive pre-test of the pre-final questionnaire is conducted to examine comprehension of
questions and response option and identify any potential problems respondents would have to
understand the questions and to respond to them. The results are used in order to further
optimize the first draft of the questionnaire.
Quantitative evaluation and validation:
Quantitative evaluation and validation of the developed questionnaire will be performed based
on two studies on the target population by determining the distribution parameters of the
indicators and their measurement characteristics. In the first study, the pre-final
questionnaire will be tested and after adjustment, the final version will be applied in study
2. Participants of the first study (n=100) will be surveyed again within the second study
(n=400 participants), while data of the additional participants (n=300) in study 2 will be
measured at a single time point.
For validation purposes, additional scales measuring similar and unrelated constructs, as
well as criteria (external concepts affected by financial effects) will be included in the
questionnaire. Validity will be assessed by subsequent examining of different relationships
between the developed instrument and predefined third variables and criteria. Factorial
validity will be examined by factor analyses. Furthermore reliability and test-fairness of
the instrument will be assessed through further psychometric testing.
Phase 3: Further applicability of the questionnaire To formulate well-founded recommendations
for the use of the instrument, a pilot screening program for social services is evaluated
through qualitative interviews with representatives of social services and patients regarding
practicability of the instrument. A synthesis of all project results will translate into
overall recommendations within the clinical and regulatory context.
Patients with all types of cancer who have undergone at least two months of cancer related
therapy with an ECOG Status < 2, who are treated at the day care unit and ambulances of the
NCT Heidelberg or conservative day care unit and oncological ward B100, Jena University
Hospital.
Inclusion Criteria:
- Any type of historically or cytological confirmed solid cancer or haematological
malignancy with an ECOG-Status <2 and at least two month of cancer related therapy
- Patients are treated at the day care unit or ambulances of the NCT Heidelberg or
oncological ward B100 at Jena University Hospital
Exclusion Criteria:
- Patients younger than 18 years old
- Patients who refuse or withdraw from informed consent
- No sufficient level of German language
|
NCT0531xxxx/NCT05319938.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319938</url>
</required_header>
<id_info>
<org_study_id>HD-1726</org_study_id>
<nct_id>NCT05319938</nct_id>
</id_info>
<brief_title>Growth Factors in the Treatment of the Multiple Gingival Recessions</brief_title>
<official_title>Clinical Evaluation of Treatment With Micro-surgical Management of Type I Multiple Gingival Recessions Using Coronally Advanced Flap With Either Advanced Platelet-Rich Fibrin or Concentrated Growth Factor: A Comparative Analysis</official_title>
<sponsors>
<lead_sponsor>
<agency>Bulent Ecevit University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Bulent Ecevit University</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this study was to compare and evaluate the clinical effects of Concentrated
Growth Factor (CGF) and Advanced Platelet-Rich Fibrin (A-PRF) applied together with Coronally
Advanced Flap (CAF) technique using a microsurgical approach in the treatment of Type I
multiple gingival recessions (GR).
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">December 1, 2018</start_date>
<completion_date type="Actual">December 1, 2020</completion_date>
<primary_completion_date type="Actual">December 1, 2020</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Single (Participant)</masking>
</study_design_info>
<primary_outcome>
<measure>Complete and mean root coverage</measure>
<time_frame>Change from baseline at 6 months of the percent of complete and mean root coverage</time_frame>
<description>Percentages of root coverage and complete root coverage were calculated according to the following standard formulae.
Percentage of root coverage: [(preop. vertical gingival recession (VGR)- postop.VGR)\ preop. VGR] x 100 Percentage of complete root coverage: [(teeth with complete root coverage) \ (all treated teeth)] x 100.</description>
</primary_outcome>
<secondary_outcome>
<measure>Gingival thickness</measure>
<time_frame>Change from baseline at 6 months of the gingival thickness</time_frame>
<description>The gingival thickness was evaluated midbuccally in the attached gingival (GT-MB), halfway between the mucogingival junction and free gingival groove and at the base of the interdental papilla. GT was measured by using a periodontal probe with a rubber stopper under local anesthesia, and then the thickness was assessed by transferring to an electronic digital caliper.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Keratinized gingiva width (WKG)</measure>
<time_frame>Change from baseline at 6 months of keratinized gingiva width</time_frame>
<description>The WKG was determined by subtracting the VGR from the CEJ- MGJ (mucogingival junction).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Patient esthetic score (PES)</measure>
<time_frame>Change from baseline at 6 months of the patient esthetic score</time_frame>
<description>Patient esthetic score (PES) to evaluate esthetic appearance (color, appearance, and form of the selected site),
PES: bad-unlikely esthetics (score 0) → perfect esthetics (score 10)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Patient comfort score (PCS)</measure>
<time_frame>Change from baseline at 6 months of the patient comfort score</time_frame>
<description>Patient comfort score (PCS) for the pain, edema and other experiences regarding operating technique, instruments, and microscopic view, etc.
PCS: unbearable discomfort (score 0) → no-discomfort (score 10).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Hypersensitivity score (HS)</measure>
<time_frame>Change from baseline at 6 months of the hypersensitivity score</time_frame>
<description>"Hypersensitivity" score was recorded after blasting air (60 psi, 22°C) derived from a dental syringe that was heading for the root surface for 1 s. The syringe was held at 90° angle, 2-3 mm from the root surface. Neighboring teeth were shielded during testing with the dentist's gloved fingers; then the patient has enquired again to score the discomfort level.
HS: no pain (score 0) → worst pain imaginable (score 10)</description>
</secondary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Actual">20</enrollment>
<condition>Growth Factors, Combined Defect of</condition>
<condition>Gingival Recession</condition>
<arm_group>
<arm_group_label>CAF only</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Only Coronally Advanced Flap technique</description>
</arm_group>
<arm_group>
<arm_group_label>CAF+CGF</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Concentrated Growth Factor (CGF) applied together with Coronally Advanced Flap (CAF) technique</description>
</arm_group>
<arm_group>
<arm_group_label>CAF+A-PRF</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Advanced Platelet-Rich Fibrin (A-PRF) applied together with Coronally Advanced Flap (CAF) technique</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>CAF only</intervention_name>
<description>After local anesthesia, initially, sulcular incisions were made on the buccal aspect of the teeth and two vertical incisions were made. A trapezoidal flap was elevated with a split-full-split approach in the coronal-apical direction. The anatomic inter-dental papillae adjacent to the involved tooth were de-epithelialized. Plaque, calculus, and soft tooth structures on exposed root surfaces were removed with curettes. No further mechanical or chemical root conditioning materials were performed. The flap was coronally placed over the membranes to completely cover the CEJ and sutured with 6.0 propylene suture.</description>
<arm_group_label>CAF only</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>CAF+CGF</intervention_name>
<description>After local anesthesia, initially, sulcular incisions were made on the buccal aspect of the teeth and two vertical incisions were made. A trapezoidal flap was elevated with a split-full-split approach in the coronal-apical direction. The anatomic inter-dental papillae adjacent to the involved tooth were de-epithelialized. Plaque, calculus, and soft tooth structures on exposed root surfaces were removed with curettes. No further mechanical or chemical root conditioning materials were performed. The flap was coronally placed over the membranes to completely cover the CEJ and sutured with 6.0 propylene suture.
Blood samples were collected into 10 ml glass-coated plastic tubes without anticoagulant solutions. These tubes were placed into CGF centrifuge machine and centrifuged immediately . CGF membrane were placed over the defect. The flap was coronally placed over the membranes to completely cover the CEJ and sutured with 6.0 propylene suture.</description>
<arm_group_label>CAF+CGF</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>CAF+A-PRF</intervention_name>
<description>After local anesthesia, initially, sulcular incisions were made on the buccal aspect of the teeth and two vertical incisions were made. A trapezoidal flap was elevated with a split-full-split approach in the coronal-apical direction. The anatomic inter-dental papillae adjacent to the involved tooth were de-epithelialized. Plaque, calculus, and soft tooth structures on exposed root surfaces were removed with curettes. No further mechanical or chemical root conditioning materials were performed. The flap was coronally placed over the membranes to completely cover the CEJ and sutured with 6.0 propylene suture.
Blood samples were collected into 10 ml glass-coated plastic tubes without anticoagulant solutions. These tubes were placed into A-PRF centrifuge machine and centrifuged immediately. A-PRF membrane were placed over the defect. The flap was coronally placed over the membranes to completely cover the CEJ and sutured with 6.0 propylene suture.</description>
<arm_group_label>CAF+A-PRF</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Systematically and periodontally healthy non-smokers

- Presence of Cairo Recession type I gingival recession with ≥ 2 mm gingival recession
depth, probing depth <3 mm and gingival thickness (GT) ≥ 0.8 mm on both sides of the
maxillary arch

- Width of keratinized gingiva ≥ 2mm

- Presence of identifiable cemento-enamel junction

- Full-mouth plaque index (PI) < 20 %

- Gingival index (GI) scores =1

- Presence of tooth vitality

- Absence of caries, restorations and furcation involvement in the treated area

Exclusion Criteria:

- Patients who had systemic problems that wound contraindicate for periodontal surgery

- Usage of medications known to interfere with healing and to cause gingival enlargement

- Recession defects associated with demineralization, deep abrasion, previous surgery in
the defects area within the past 1 year

- Pregnant or lactating females

- Drug and alcohol abuse
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>25 Years</minimum_age>
<maximum_age>55 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Figen Öngöz Dede</name>
<address>
<city>Ordu</city>
<zip>52100</zip>
<country>Turkey</country>
</address>
</facility>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 11, 2022</study_first_submitted>
<study_first_submitted_qc>April 7, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>April 7, 2022</last_update_submitted>
<last_update_submitted_qc>April 7, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 11, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Bulent Ecevit University</investigator_affiliation>
<investigator_full_name>Figen Öngöz Dede</investigator_full_name>
<investigator_title>Clinical Association Professor</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Gingival Recession</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this study was to compare and evaluate the clinical effects of Concentrated
Growth Factor (CGF) and Advanced Platelet-Rich Fibrin (A-PRF) applied together with Coronally
Advanced Flap (CAF) technique using a microsurgical approach in the treatment of Type I
multiple gingival recessions (GR).
Inclusion Criteria:
- Systematically and periodontally healthy non-smokers
- Presence of Cairo Recession type I gingival recession with ≥ 2 mm gingival recession
depth, probing depth <3 mm and gingival thickness (GT) ≥ 0.8 mm on both sides of the
maxillary arch
- Width of keratinized gingiva ≥ 2mm
- Presence of identifiable cemento-enamel junction
- Full-mouth plaque index (PI) < 20 %
- Gingival index (GI) scores =1
- Presence of tooth vitality
- Absence of caries, restorations and furcation involvement in the treated area
Exclusion Criteria:
- Patients who had systemic problems that wound contraindicate for periodontal surgery
- Usage of medications known to interfere with healing and to cause gingival enlargement
- Recession defects associated with demineralization, deep abrasion, previous surgery in
the defects area within the past 1 year
- Pregnant or lactating females
- Drug and alcohol abuse
|
NCT0531xxxx/NCT05319951.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319951</url>
</required_header>
<id_info>
<org_study_id>Different liquids intake</org_study_id>
<nct_id>NCT05319951</nct_id>
</id_info>
<brief_title>Effect of Different Liquids Intake in Vasovagal Reaction After Whole Blood Donation</brief_title>
<official_title>Effect of Different Liquids Intake in Vasovagal Reaction After Whole Blood Donation</official_title>
<sponsors>
<lead_sponsor>
<agency>Guangzhou Blood Center</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Guangzhou Blood Center</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
we compared the effect of 3 different kinds of liquids (water, Oral Rehydration Salt 3 and
white granulated sugar water) intake in Vasovagal Reaction After Whole Blood Donation
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Vasovagal reaction is the most common type of blood donation reaction. The main cause of this
reaction is the decrease of blood volume. Therefore, fluid supplement before blood donation
has been proved to be effective in preventing the vagal reaction after blood donation. It was
proved that isotonic (sugar & salt) drink intake before blood donation had a significant
effect on reducing vasovagal reaction.

However, in 2002, WHO recommended the new reduced osmolarity rehydration formula with better
taste. Oral Rehydration Salt 3 has been produced according to WHO formula with standard
ingredient and easy to prepare. In addition, in Guangdong culture, sugar water is regarded as
a tonic, more easily accepted. So, the aim of our study was to compare the effects of 500 ml
water with Oral Rehydration Salt 3, white granulated sugar and conventional recommended water
intake prior to blood donation on blood donation reaction after whole blood donation, in
order to understand the effect of different liquid supplement on blood donation reaction and
the willingness of blood donation again.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">January 20, 2021</start_date>
<completion_date type="Actual">December 31, 2021</completion_date>
<primary_completion_date type="Actual">November 26, 2021</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Health Services Research</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>vasovagal reaction rate</measure>
<time_frame>1-3days</time_frame>
<description>vasovagal reaction rate in three groups</description>
</primary_outcome>
<secondary_outcome>
<measure>rate of willingness to donate blood again</measure>
<time_frame>3days</time_frame>
<description>rate of willingness to donate blood again in three groups</description>
</secondary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Actual">6250</enrollment>
<condition>Blood Donation</condition>
<arm_group>
<arm_group_label>Oral Rehydration Salts Power (iii)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Dissolve 2 packs of Oral Rehydration Salts Power (iii) (5.125g/pack) in 500ml water and let the subjects drink it up in 20 minutes prior to donation.</description>
</arm_group>
<arm_group>
<arm_group_label>water with white granulated sugar</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Dissolve 2 packs of Taikoo white granulated sugar (5g/pack) in 500ml water and let the subjects drink it up in 20 minutes prior to donation.</description>
</arm_group>
<arm_group>
<arm_group_label>recommended water intake</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>Recommend the subjects to drink up 500ml water in 20 minutes prior to donation.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Oral Rehydration Salts power (iii)</intervention_name>
<description>Dissolve 2 packs of Oral Rehydration Salts Power (iii) (5.125g/pack) in 500ml water and let the subjects drink it up in 20 minutes prior to donation.</description>
<arm_group_label>Oral Rehydration Salts Power (iii)</arm_group_label>
<other_name>Sichuan Emeishan Pharmaceutical Co., Ltd. 20210402 5100621103491</other_name>
</intervention>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>water with white granulated sugar</intervention_name>
<description>Dissolve 2 packs of Taikoo white granulated sugar (5g/pack) in 500ml water and let the subjects drink it up in 20 minutes prior to donation.</description>
<arm_group_label>water with white granulated sugar</arm_group_label>
</intervention>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>water</intervention_name>
<description>Recommend the subjects to drink up 500ml water in 20 minutes prior to donation.</description>
<arm_group_label>recommended water intake</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:All blood donors donated whole blood in Guangzhou Blood Center during
study.

-

Exclusion Criteria:Blood donors who were deferral by blood screening result and other
situations.

-
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>60 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Guiyun Xie, MPH</last_name>
<role>Study Chair</role>
<affiliation>Guangzhou Blood Center</affiliation>
</overall_official>
<overall_official>
<last_name>Jinyan Chen, MPH</last_name>
<role>Principal Investigator</role>
<affiliation>Guangzhou Blood Center</affiliation>
</overall_official>
<overall_official>
<last_name>Shijie Li</last_name>
<role>Study Director</role>
<affiliation>Guangzhou Blood Center</affiliation>
</overall_official>
<location>
<facility>
<name>Guangzhou Blood Center</name>
<address>
<city>Guangzhou</city>
<state>Guangdong</state>
<zip>510095</zip>
<country>China</country>
</address>
</facility>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>September 2022</verification_date>
<study_first_submitted>December 1, 2020</study_first_submitted>
<study_first_submitted_qc>April 7, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>September 30, 2022</last_update_submitted>
<last_update_submitted_qc>September 30, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">October 3, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Syncope, Vasovagal</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
we compared the effect of 3 different kinds of liquids (water, Oral Rehydration Salt 3 and
white granulated sugar water) intake in Vasovagal Reaction After Whole Blood Donation
Vasovagal reaction is the most common type of blood donation reaction. The main cause of this
reaction is the decrease of blood volume. Therefore, fluid supplement before blood donation
has been proved to be effective in preventing the vagal reaction after blood donation. It was
proved that isotonic (sugar & salt) drink intake before blood donation had a significant
effect on reducing vasovagal reaction.
However, in 2002, WHO recommended the new reduced osmolarity rehydration formula with better
taste. Oral Rehydration Salt 3 has been produced according to WHO formula with standard
ingredient and easy to prepare. In addition, in Guangdong culture, sugar water is regarded as
a tonic, more easily accepted. So, the aim of our study was to compare the effects of 500 ml
water with Oral Rehydration Salt 3, white granulated sugar and conventional recommended water
intake prior to blood donation on blood donation reaction after whole blood donation, in
order to understand the effect of different liquid supplement on blood donation reaction and
the willingness of blood donation again.
Inclusion Criteria:All blood donors donated whole blood in Guangzhou Blood Center during
study.
-
Exclusion Criteria:Blood donors who were deferral by blood screening result and other
situations.
-
|
NCT0531xxxx/NCT05319964.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319964</url>
</required_header>
<id_info>
<org_study_id>E2_AGTTKO</org_study_id>
<nct_id>NCT05319964</nct_id>
</id_info>
<brief_title>Anti-gravity Treadmill Training in Patients With Knee Osteoarthritis</brief_title>
<official_title>Anti-gravity Treadmill Training in Patients With Knee Osteoarthritis</official_title>
<sponsors>
<lead_sponsor>
<agency>Hitit University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Hitit University</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The aim of this study was to compare the effects of anti-gravity treadmill training and
traditional treadmill training treatments combined with strengthening exercises on patients'
pain levels, quality of life, distal femoral cartilage thickness, and functional capacity in
patients with moderate and severe knee OA. In addition, it was aimed to compare the
compliance of the patients to aerobic exercise.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Patients with moderate to severe OA have persistent pain that significantly affects their
functional status, activity participation, and quality of life. As with mild OA,
non-pharmacological interventions that focus on education, exercise, and weight management
are first-line treatments for patients with moderate to severe knee OA.

Exercise is recommended for all patients with moderate to severe knee OA to reduce pain and
protect the joint. A meta-analysis showed that exercise has beneficial effects on pain, even
in patients with severe disease and awaiting total knee replacement.

The aim of this study was to compare the effects of anti-gravity treadmill training and
traditional treadmill training treatments combined with strengthening exercises on patients'
pain levels, quality of life, distal femoral cartilage thickness, and functional capacity in
patients with moderate and severe knee OA. In addition, it was aimed to compare the
compliance of the patients to aerobic exercise.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">April 5, 2022</start_date>
<completion_date type="Anticipated">January 2023</completion_date>
<primary_completion_date type="Anticipated">January 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Single (Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Visual Analogue Scale for Pain (VAS-pain)</measure>
<time_frame>Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 weeks</time_frame>
<description>Pain intensity will be evaluated with a visual analog scale (0-10mm) that has proven validity and reliability to measure musculoskeletal pain.</description>
</primary_outcome>
<secondary_outcome>
<measure>WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Score</measure>
<time_frame>Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 weeks</time_frame>
<description>It measures knee pain, stiffness, and physical function. Scores for each subscale are summed with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. The sum of the scores of the three subscales gives the WOMAC score. High scores are associated with more pain, stiffness, and dysfunction, while low scores indicate well-being.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Short Form Health Survey 36 (SF-36)</measure>
<time_frame>Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 weeks</time_frame>
<description>SF-36 includes 36 items used to assess the quality of life of patients with chronic pain. It measures eight different domains that address physical function, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation, and mental health. The score for each domain ranges from 0 (worse quality of life) to 100 (best quality of life).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Six-minute walk test (6MWT)</measure>
<time_frame>Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 weeks</time_frame>
<description>The 6 Minute Walk Test is a submaximal exercise test that usually corresponds to 80% of a person's maximum heart rate and is used to evaluate functional capacity and treatment response.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Femoral cartilage thickness measurement with ultrasound</measure>
<time_frame>Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 weeks</time_frame>
<description>Distal femoral cartilage thickness will be evaluated by the same investigator, blinded to the patient treatment groups, using an ultrasound device with a 7.5-12 MHz linear transducer (LOGIQ 7 Pro; GE Yokogawa Medical System, Tokyo, Japan) available in our clinic.</description>
</secondary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Anticipated">30</enrollment>
<condition>Knee Osteoarthritis</condition>
<arm_group>
<arm_group_label>anti-gravity treadmill</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients in all three study groups will receive hot pack, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound 3 days a week for 8 weeks.
Participants were provided 30 minutes 30% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 3 days a week, for 8 weeks</description>
</arm_group>
<arm_group>
<arm_group_label>conventional treadmill</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Patients in all three study groups will receive hot pack, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, 3 days a week for 8 weeks.
The moderate-intensity aerobic exercise program will be performed for 30 minutes at an intensity of 65-80% of the maximum heart rate, consisting of a 5-minute warm-up and cool-down period.</description>
</arm_group>
<arm_group>
<arm_group_label>Control</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>Patients in all three study groups will receive hot pack, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound 3 days a week for 8 weeks</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Anti-gravity treadmill</intervention_name>
<description>Patients in all three study groups will receive hot pack, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, 3 days a week for 8 weeks.
Participants were provided 30 minutes 30% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 3 days a week, for 8 weeks</description>
<arm_group_label>anti-gravity treadmill</arm_group_label>
</intervention>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Conventional treadmill</intervention_name>
<description>Patients in all three study groups will receive hot pack, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound 3 days a week for 8 weeks.
The moderate-intensity aerobic exercise program will be performed for 30 minutes at an intensity of 65-80% of the maximum heart rate, consisting of a 5-minute warm-up and cool-down period.</description>
<arm_group_label>conventional treadmill</arm_group_label>
</intervention>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Control</intervention_name>
<description>Patients in all three study groups will receive hot pack, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound 3 days a week for 8 weeks.</description>
<arm_group_label>Control</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Female patients ≥ 50 and ≤ 75 years old

- Patients with a diagnosis of knee OA in at least one knee according to the
classification criteria of the American College of Rheumatology

- Patients with Kellgren-Lawrence (K-L) knee OA staging II to IV

- Patients reporting knee pain on most days of the past month

- Patients with stable medical and psychological status

- Patients willing to participate in the study

Exclusion Criteria:

Patients with serious cardiovascular, pulmonary, neurological disease or other
musculoskeletal problems (inflammatory rheumatic disease, active synovitis, severe low back
pain, hip/knee joint replacement or other hip/knee-related trauma, fracture, or surgery)
that impair walking

- Patients with a history of corticosteroid injection to the knee in the last 3 months

- Patients who have received opioid analgesics or systemic corticosteroids in the last 3
months

- Patients who have undergone any exercise program or physical therapy program for the
lower extremities in the last 3 months

- Patients with severe vision, hearing and language problems

- Patients with a body mass index ≥35 kg /m²
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>50 Years</minimum_age>
<maximum_age>75 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Gaziler Physical Therapy and Rehabilitation Education and Research Hospital</name>
<address>
<city>Ankara</city>
<country>Turkey</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Tuğba Atan</last_name>
<phone>+90312 291 10 00</phone>
<email>tubaatan@gmail.com</email>
</contact>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<verification_date>January 2023</verification_date>
<study_first_submitted>March 28, 2022</study_first_submitted>
<study_first_submitted_qc>April 7, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>January 27, 2023</last_update_submitted>
<last_update_submitted_qc>January 27, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">January 30, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Hitit University</investigator_affiliation>
<investigator_full_name>Tuğba Atan, MD</investigator_full_name>
<investigator_title>Assoc. Prof</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Osteoarthritis</mesh_term>
<mesh_term>Osteoarthritis, Knee</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The aim of this study was to compare the effects of anti-gravity treadmill training and
traditional treadmill training treatments combined with strengthening exercises on patients'
pain levels, quality of life, distal femoral cartilage thickness, and functional capacity in
patients with moderate and severe knee OA. In addition, it was aimed to compare the
compliance of the patients to aerobic exercise.
Patients with moderate to severe OA have persistent pain that significantly affects their
functional status, activity participation, and quality of life. As with mild OA,
non-pharmacological interventions that focus on education, exercise, and weight management
are first-line treatments for patients with moderate to severe knee OA.
Exercise is recommended for all patients with moderate to severe knee OA to reduce pain and
protect the joint. A meta-analysis showed that exercise has beneficial effects on pain, even
in patients with severe disease and awaiting total knee replacement.
The aim of this study was to compare the effects of anti-gravity treadmill training and
traditional treadmill training treatments combined with strengthening exercises on patients'
pain levels, quality of life, distal femoral cartilage thickness, and functional capacity in
patients with moderate and severe knee OA. In addition, it was aimed to compare the
compliance of the patients to aerobic exercise.
Inclusion Criteria:
- Female patients ≥ 50 and ≤ 75 years old
- Patients with a diagnosis of knee OA in at least one knee according to the
classification criteria of the American College of Rheumatology
- Patients with Kellgren-Lawrence (K-L) knee OA staging II to IV
- Patients reporting knee pain on most days of the past month
- Patients with stable medical and psychological status
- Patients willing to participate in the study
Exclusion Criteria:
Patients with serious cardiovascular, pulmonary, neurological disease or other
musculoskeletal problems (inflammatory rheumatic disease, active synovitis, severe low back
pain, hip/knee joint replacement or other hip/knee-related trauma, fracture, or surgery)
that impair walking
- Patients with a history of corticosteroid injection to the knee in the last 3 months
- Patients who have received opioid analgesics or systemic corticosteroids in the last 3
months
- Patients who have undergone any exercise program or physical therapy program for the
lower extremities in the last 3 months
- Patients with severe vision, hearing and language problems
- Patients with a body mass index ≥35 kg /m²
|
NCT0531xxxx/NCT05319977.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319977</url>
</required_header>
<id_info>
<org_study_id>0217974</org_study_id>
<nct_id>NCT05319977</nct_id>
</id_info>
<brief_title>Maternal Alcohol Reduction Intervention in South Africa [MaRISA]</brief_title>
<official_title>Mobile Behavioral Intervention to Reduce Maternal Drinking in South Africa</official_title>
<sponsors>
<lead_sponsor>
<agency>RTI International</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Medical Research Council, South Africa</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>RTI International</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This application proposes to develop and test a technology-based behavioral intervention to
address maternal alcohol use in South Africa (SA). SA reports the highest per capita rates of
alcohol consumption in the world and has one of the world's highest rates of lifelong
disorders called fetal alcohol spectrum disorders (FASD). Prenatal alcohol use is often
associated with exposure to gender-based violence, and an increase in gender-based violence
due to the uncertainty and economic impact of COVID-19 is of a major concern. Recent evidence
also showed that alcohol use during lactation significantly compromises child development in
children exposed to alcohol through breastfeeding, and the adverse effect of postpartum
alcohol use while breastfeeding was independent of prenatal alcohol exposure. Average
breastfeeding duration in SA is beyond 1 year, and over 40% of mothers with and without a
history of prenatal drinking report alcohol use while breastfeeding. A community-based
behavioral intervention involving case management helps reduce prenatal alcohol use but is
labor intensive, challenging the feasibility of widespread implementation in economically
disadvantaged communities especially during the COVID-19 pandemic with limited social
contact. An efficacious behavioral intervention to reduce alcohol use during pregnancy and
lactation needs to be developed that is acceptable and feasible in economically disadvantaged
communities, for women with transportation difficulties, or during the COVID-19 pandemic with
limited social contact. The proposed intervention will incorporate mobile breathalyzer
technology, contingent financial incentives, and text-based health promotion and referrals on
gender-based violence, maternal infant health, and psychosocial issues including the impact
of COVID-19 in the context of maternal alcohol use. Specific aims are (1) to develop and
pretest a technology-based behavioral intervention to help women abstain from alcohol use
during pregnancy and lactation via formative qualitative research with women who are pregnant
or breastfeeding with a recent history of alcohol use, clinic and community stakeholders, and
an established Community Collaborative Board in Cape Metropole, SA, and (2) to examine the
acceptability and feasibility of the intervention on alcohol use during pregnancy and
lactation by pilot testing the mobile technology-based platform with 60 women who are
pregnant or postpartum. Acceptability will be assessed at follow-ups, and feasibility will
include recruitment capability, process measures, and intervention outcomes. With the
evidence of acceptability and feasibility of the proposed intervention, a large randomized
clinical trial will become essential to establish efficacy of the intervention. The potential
settings that can remotely incorporate the proposed behavioral intervention include primary
care clinics, substance use treatment programs, and publicly funded programs for
maternal/infant populations in SA, the United States, and other countries.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">March 5, 2021</start_date>
<completion_date type="Actual">February 28, 2023</completion_date>
<primary_completion_date type="Actual">February 28, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Urine Ethylglucuronide (EtG) Testing</measure>
<time_frame>Baseline</time_frame>
<description>Dichotomous positive results of alcohol use by urinalysis will be considered positive for recent drinking.</description>
</primary_outcome>
<primary_outcome>
<measure>Urine Ethylglucuronide (EtG) Testing</measure>
<time_frame>6 weeks</time_frame>
<description>Dichotomous positive results of alcohol use by urinalysis will be considered positive for recent drinking.</description>
</primary_outcome>
<primary_outcome>
<measure>Urine Ethylglucuronide (EtG) Testing</measure>
<time_frame>3 months</time_frame>
<description>Dichotomous positive results of alcohol use by urinalysis will be considered positive for recent drinking.</description>
</primary_outcome>
<primary_outcome>
<measure>Self-reported recent drinking with timeline followback</measure>
<time_frame>Baseline</time_frame>
<description>Self-reported use of daily alcohol by the number of standard drinks based on the definition in South Africa (e.g., 12 g per standard drink) and craving levels on a scale of 1 to 10 ["not at all" to "extreme"]).</description>
</primary_outcome>
<primary_outcome>
<measure>Self-reported recent drinking with timeline followback</measure>
<time_frame>6 weeks</time_frame>
<description>Self-reported use of daily alcohol by the number of standard drinks based on the definition in South Africa (e.g., 12 g per standard drink) and craving levels on a scale of 1 to 10 ["not at all" to "extreme"]).</description>
</primary_outcome>
<primary_outcome>
<measure>Self-reported recent drinking with timeline followback</measure>
<time_frame>3 months</time_frame>
<description>Self-reported use of daily alcohol by the number of standard drinks based on the definition in South Africa (e.g., 12 g per standard drink) and craving levels on a scale of 1 to 10 ["not at all" to "extreme"]).</description>
</primary_outcome>
<primary_outcome>
<measure>The Treatment Acceptability/Adherence Scale (TAAS)</measure>
<time_frame>Baseline</time_frame>
<description>10-item self-report questionnaire with a 7-point Likert-type scale (1 = Disagree strongly; 7 = Agree strongly). The score ranges from 10 to 70, with higher scores indicating greater acceptability of treatment and greater anticipated adherence</description>
</primary_outcome>
<primary_outcome>
<measure>The Treatment Acceptability/Adherence Scale (TAAS)</measure>
<time_frame>6 weeks</time_frame>
<description>10-item self-report questionnaire with a 7-point Likert-type scale (1 = Disagree strongly; 7 = Agree strongly). The score ranges from 10 to 70, with higher scores indicating greater acceptability of treatment and greater anticipated adherence</description>
</primary_outcome>
<primary_outcome>
<measure>The Treatment Acceptability/Adherence Scale (TAAS)</measure>
<time_frame>3 months</time_frame>
<description>10-item self-report questionnaire with a 7-point Likert-type scale (1 = Disagree strongly; 7 = Agree strongly). The score ranges from 10 to 70, with higher scores indicating greater acceptability of treatment and greater anticipated adherence</description>
</primary_outcome>
<secondary_outcome>
<measure>Infant weight (g)</measure>
<time_frame>At a postpartum timepoint during the study period of 3 months</time_frame>
<description>The measure will be based on medical records and postpartum assessment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Infant height (cm)</measure>
<time_frame>At a postpartum timepoint during the study period of 3 months</time_frame>
<description>The measure will be based on medical records and postpartum assessment.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Infant head circumference (cm)</measure>
<time_frame>At a postpartum timepoint during the study period of 3 months</time_frame>
<description>The measure will be based on medical records.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Gestational weeks at birth</measure>
<time_frame>At a postpartum timepoint during the study period of 3 months</time_frame>
<description>The measure will be based on medical records.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">60</enrollment>
<condition>Maternal; Alcohol Use, Affecting Fetus</condition>
<arm_group>
<arm_group_label>Mobile incentive-based intervention</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Contingent incentives on abstinence from alcohol; Text-based health promotion support</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Mobile incentive-based intervention</intervention_name>
<description>a technology-based behavioral intervention to address maternal alcohol use with mobile breathalyzer technology or/and urinalysis for biochemical verification of alcohol use, contingent financial incentives on alcohol abstinence, and text-based health promotion.</description>
<arm_group_label>Mobile incentive-based intervention</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Pregnant (≤28 ges wks) or postpartum (≤3 mos)

- Have reported alcohol use during the current pregnancy or lactation

- Positive for prenatal alcohol use by urinalysis

- Have their own mobile phone

- Intend to breastfeed for 6 months

- Voluntarily consent

Exclusion Criteria:

- Participated in focus group discussions or pretesting will not be eligible for pilot
testing

- Serious medical problems threatening their current pregnancy or current suicidal
thoughts or attempts in the past month
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>South African Medical Research Council</name>
<address>
<city>Cape Town</city>
<country>South Africa</country>
</address>
</facility>
</location>
<location_countries>
<country>South Africa</country>
</location_countries>
<verification_date>August 2023</verification_date>
<study_first_submitted>March 15, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>August 10, 2023</last_update_submitted>
<last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">August 14, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>RTI International</investigator_affiliation>
<investigator_full_name>Yukiko Washio</investigator_full_name>
<investigator_title>Senior Research Psychologist</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Alcohol Drinking</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>After the main findings are published, we welcome other researchers who want to analyze the data in other ways.</ipd_description>
<ipd_info_type>Study Protocol</ipd_info_type>
<ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
<ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This application proposes to develop and test a technology-based behavioral intervention to
address maternal alcohol use in South Africa (SA). SA reports the highest per capita rates of
alcohol consumption in the world and has one of the world's highest rates of lifelong
disorders called fetal alcohol spectrum disorders (FASD). Prenatal alcohol use is often
associated with exposure to gender-based violence, and an increase in gender-based violence
due to the uncertainty and economic impact of COVID-19 is of a major concern. Recent evidence
also showed that alcohol use during lactation significantly compromises child development in
children exposed to alcohol through breastfeeding, and the adverse effect of postpartum
alcohol use while breastfeeding was independent of prenatal alcohol exposure. Average
breastfeeding duration in SA is beyond 1 year, and over 40% of mothers with and without a
history of prenatal drinking report alcohol use while breastfeeding. A community-based
behavioral intervention involving case management helps reduce prenatal alcohol use but is
labor intensive, challenging the feasibility of widespread implementation in economically
disadvantaged communities especially during the COVID-19 pandemic with limited social
contact. An efficacious behavioral intervention to reduce alcohol use during pregnancy and
lactation needs to be developed that is acceptable and feasible in economically disadvantaged
communities, for women with transportation difficulties, or during the COVID-19 pandemic with
limited social contact. The proposed intervention will incorporate mobile breathalyzer
technology, contingent financial incentives, and text-based health promotion and referrals on
gender-based violence, maternal infant health, and psychosocial issues including the impact
of COVID-19 in the context of maternal alcohol use. Specific aims are (1) to develop and
pretest a technology-based behavioral intervention to help women abstain from alcohol use
during pregnancy and lactation via formative qualitative research with women who are pregnant
or breastfeeding with a recent history of alcohol use, clinic and community stakeholders, and
an established Community Collaborative Board in Cape Metropole, SA, and (2) to examine the
acceptability and feasibility of the intervention on alcohol use during pregnancy and
lactation by pilot testing the mobile technology-based platform with 60 women who are
pregnant or postpartum. Acceptability will be assessed at follow-ups, and feasibility will
include recruitment capability, process measures, and intervention outcomes. With the
evidence of acceptability and feasibility of the proposed intervention, a large randomized
clinical trial will become essential to establish efficacy of the intervention. The potential
settings that can remotely incorporate the proposed behavioral intervention include primary
care clinics, substance use treatment programs, and publicly funded programs for
maternal/infant populations in SA, the United States, and other countries.
Inclusion Criteria:
- Pregnant (≤28 ges wks) or postpartum (≤3 mos)
- Have reported alcohol use during the current pregnancy or lactation
- Positive for prenatal alcohol use by urinalysis
- Have their own mobile phone
- Intend to breastfeed for 6 months
- Voluntarily consent
Exclusion Criteria:
- Participated in focus group discussions or pretesting will not be eligible for pilot
testing
- Serious medical problems threatening their current pregnancy or current suicidal
thoughts or attempts in the past month
|
NCT0531xxxx/NCT05319990.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05319990</url>
</required_header>
<id_info>
<org_study_id>22-0250</org_study_id>
<nct_id>NCT05319990</nct_id>
</id_info>
<brief_title>Pathogenesis of Kidney Disease in Type 1 Diabetes: a Modern Kidney Biopsy Cohort (The PANDA Study)</brief_title>
<acronym>PANDA</acronym>
<official_title>Pathogenesis of Kidney Disease in Type 1 Diabetes: a Modern Kidney Biopsy Cohort (The PANDA Study)</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Colorado, Denver</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>University of Colorado, Denver</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Diabetic kidney disease (DKD) occurs in up to 40% of people with type 1 diabetes (T1D), often
leading to kidney failure and markedly magnifying risks of cardiovascular disease and
premature death. Landmark T1D kidney biopsy studies identified the classic pathological
lesions of DKD, which have been attributed largely to hyperglycemia. Recent advances in
continuous glucose monitoring (CGM) and automated insulin delivery have facilitated improved
glycemic control, but the residual risk of DKD continues to be high. In addition, obesity and
insulin resistance (IR) have accompanied intensive glycemic therapy and may promote
mitochondrial dysfunction and inflammation. Deciphering the molecular underpinnings of DKD in
modern-day T1D and identifying modifiable risk factors could lead to more effective and
targeted therapies to prevent DKD.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The overall goal of this project is to characterize the molecular, morphometric, and
metabolic features of DKD over the modern clinical course of T1D. The investigators
hypothesize that perturbed kidney energetics and hypoxia are central metabolic pathways in
the development of DKD. Kidney hypoxia stems from a mismatch between increased renal energy
demand (e.g., increased glomerular filtration rate [GFR] and tubular reabsorption of sodium)
and impaired substrate metabolism (e.g., IR and mitochondrial dysfunction) and results in
activation of the hypoxia-inducible factor (HIF) system. Although upregulation of HIF1α
confers favorable short-term effects, sustained activation promotes cellular injury.
Supporting these hypotheses, data from our group and others have shown that obesity, IR, and
The investigators also found that youth with T1D exhibit kidney hypoxia by MRI that strongly
associates with IR and mitochondrial dysfunction. Moreover, our preliminary single-cell RNA
sequencing (scRNA-seq) data from kidney biopsies demonstrate upregulated tubular expression
of HIF1α in adults with T1D vs. healthy controls. The investigators propose to build a unique
new longitudinal kidney biopsy cohort (N=100) spanning the critical duration of T1D over
which DKD initiates and progresses (5-30 years). Participants will be enrolled from our
existing CROCODILE study (adding longitudinal follow-up to completed kidney biopsies and
baseline data and biosample acquisition) and from new enrollment at the University of
Colorado and University of Washington. Normative kidney biopsy data will be provided from our
existing cohort of healthy controls (N=20) and the Kidney Precision Medicine Project (KPMP).
The investigators will implement state-of-the-art molecular (scRNA-seq) and morphometric
interrogation of kidney tissue and rigorous metabolic phenotyping to include kidney magnetic
resonance imaging (MRI), direct measurements of glycemia (continuous glucose monitoring),
intraabdominal fat (dual-energy X-ray absorptiometry), estimation of insulin sensitivity by a
T1D-validated equation, and (in a subset) GFR (iohexol clearance) and renal plasma flow
(p-aminohippurate clearance). Participants will be followed longitudinally for DKD outcomes.
A subset of 20 participants will undergo repeat kidney biopsies and associated procedures 3
years after baseline kidney biopsy.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 9, 2022</start_date>
<completion_date type="Anticipated">December 31, 2027</completion_date>
<primary_completion_date type="Anticipated">June 30, 2027</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Renal Oxygenation</measure>
<time_frame>30 min</time_frame>
<description>Blood oxygen level dependent (BOLD) MRI</description>
</primary_outcome>
<primary_outcome>
<measure>Renal Perfusion</measure>
<time_frame>30 min</time_frame>
<description>Arterial Spin Labeling (ASL) MRI</description>
</primary_outcome>
<primary_outcome>
<measure>Insulin Sensitivity</measure>
<time_frame>4.5 hours</time_frame>
<description>Hyperinsulinemic-Euglycemic Clamp</description>
</primary_outcome>
<secondary_outcome>
<measure>Glomerular Filtration Rate (GFR)</measure>
<time_frame>3 hours</time_frame>
<description>Iohexol Clearance Study</description>
</secondary_outcome>
<secondary_outcome>
<measure>Effective Renal Plasma Flow (ERPF)</measure>
<time_frame>2.5 hours</time_frame>
<description>PAH Clearance Study</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Anticipated">100</enrollment>
<condition>Type 1 Diabetes</condition>
<condition>Diabetic Kidney Disease</condition>
<condition>Diabetes Complications</condition>
<condition>Diabetic Nephropathies</condition>
<condition>Autoimmune Diabetes</condition>
<arm_group>
<arm_group_label>PANDA, T1D</arm_group_label>
<description>New participants with T1D will be enrolled at the University of Colorado and University of Washington.</description>
</arm_group>
<arm_group>
<arm_group_label>PANDA Sub Study, Former CROCODILE Participants</arm_group_label>
<description>Participants will be enrolled from the existing CROCODILE study (COMIRB # 19-1282), adding longitudinal follow-up to completed kidney biopsies and baseline data and biosample acquisition.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Aminohippurate Sodium Inj 20% Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)</intervention_name>
<description>PAH (Basic Pharma, Geleen, Netherlands) has been used to measure ERPF in human research for 7 decades, and is very well tolerated and generally recognized as safe with low toxicity.</description>
<arm_group_label>PANDA Sub Study, Former CROCODILE Participants</arm_group_label>
<other_name>Sodium 4-amino hippurate (PAH) inj 20% 2g/10mL</other_name>
<other_name>Para-aminohippurate</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Iohexol Inj 300 MG/ML Diagnostic aid/agent used to measure glomerular filtration rate (GFR)</intervention_name>
<description>Iohexol (Omnipaque 300, GE Healthcare, Chicago, IL) is a nonionic, low osmolar contrast agent with a history of extensive use in Radiology practice (for contrast x-rays) that shares many qualities of an ideal GFR marker, like inulin, such as not being absorbed, metabolized, or secreted by the kidney.</description>
<arm_group_label>PANDA Sub Study, Former CROCODILE Participants</arm_group_label>
<other_name>omnipaque 300</other_name>
</intervention>
<biospec_retention>Samples With DNA</biospec_retention>
<biospec_descr>
<textblock>
During the study, the investigators will collect blood, urine, and tissue samples for
assessment of kidney function and kidney injury markers.
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
The investigators propose to address the specific aims of this study in a cross-sectional
project with 70 newly enrolled adults with T1D and 30 former CROCODILE participants (COMIRB
#19-1282).
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Age ≥ 18 years at enrollment (rationale: this study focuses on determinants of early
DKD over the course of T1D in adults)

- T1D duration >5 and ≤ 30 years (rationale: DKD in T1D rarely manifests prior to 5
years of disease duration; longstanding T1D above > 30 years subject to survivorship
bias)

- HbA1c <11% (rationale: HbA1c ≥ 11% exceeds the average HbA1c at most academic center
and would limiting the generalizability of our study findings)

Exclusion Criteria:

- T2D and monogenic diabetes (rationale: our study focuses on T1D)

- Recent diabetic ketoacidosis, i.e., <1 month (rationale: safety and insulin resistance
and tubular dysfunction of DKA can confound study findings)

- eGFR < 30 ml/min/1.73m2 or dialysis treatment (rationale: to reduce the likelihood of
identifying secondary pathways that are not specific to kidney injury from T1D)

- Kidney transplant recipients (rationale: molecular confounding from immunosuppression)

- Kidney biopsy contraindications (rationale: safety - kidney biopsy):

- Evidence of bleeding disorder or complications from bleeding

- Use of aspirin, Nonsteroidal anti-inflammatory drugs (NSAIDS) or other blood
thinner that cannot be safely stopped for a sufficient time before and after the
biopsy to avoid additional risk of bleeding.

- INR > 1.4

- Hemoglobin (Hgb) < 10 mg/dL (Colorado) [altitude]

- Hemoglobin (Hgb) < 9 mg/dL (Washington)

- Platelet count < 100,000 / µL

- Uncontrolled or difficult to control hypertension (> 150/90 mmHg at the day of
biopsy)

- Single kidney (either by history, documented by prior imaging or ultrasound
performed prior to the biopsy)

- Kidney size: One or both kidneys < 8 cm

- Hydronephrosis or other important renal ultrasound findings such as significant
stone disease

- Any evidence of a current urinary tract infection as indicated on day of biopsy

- Clinical evidence of non-diabetic renal disease

- Positive urine pregnancy test or pregnancy
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Susan P Gross, MS</last_name>
<phone>720-777-6143</phone>
<email>susan.p.gross@cuanschutz.edu</email>
</overall_contact>
<overall_contact_backup>
<last_name>Petter M Bjornstad, MD</last_name>
<phone>720-777-4659</phone>
<email>petter.m.bjornstad@cuanschutz.edu</email>
</overall_contact_backup>
<location>
<facility>
<name>Children's Hospital Colorado</name>
<address>
<city>Aurora</city>
<state>Colorado</state>
<zip>80045</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Susan P Gross, MS</last_name>
<phone>720-777-6143</phone>
<email>susan.p.gross@cuanschutz.edu</email>
</contact>
<contact_backup>
<last_name>Petter M Bjornstad, MD</last_name>
<phone>720-777-4659</phone>
<email>petter.m.bjornstad@cuanschutz.edu</email>
</contact_backup>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>February 2023</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>February 8, 2023</last_update_submitted>
<last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">February 9, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Kidney Diseases</mesh_term>
<mesh_term>Diabetic Nephropathies</mesh_term>
<mesh_term>Diabetes Mellitus</mesh_term>
<mesh_term>Diabetes Mellitus, Type 1</mesh_term>
<mesh_term>Diabetes Complications</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Diabetic kidney disease (DKD) occurs in up to 40% of people with type 1 diabetes (T1D), often
leading to kidney failure and markedly magnifying risks of cardiovascular disease and
premature death. Landmark T1D kidney biopsy studies identified the classic pathological
lesions of DKD, which have been attributed largely to hyperglycemia. Recent advances in
continuous glucose monitoring (CGM) and automated insulin delivery have facilitated improved
glycemic control, but the residual risk of DKD continues to be high. In addition, obesity and
insulin resistance (IR) have accompanied intensive glycemic therapy and may promote
mitochondrial dysfunction and inflammation. Deciphering the molecular underpinnings of DKD in
modern-day T1D and identifying modifiable risk factors could lead to more effective and
targeted therapies to prevent DKD.
The overall goal of this project is to characterize the molecular, morphometric, and
metabolic features of DKD over the modern clinical course of T1D. The investigators
hypothesize that perturbed kidney energetics and hypoxia are central metabolic pathways in
the development of DKD. Kidney hypoxia stems from a mismatch between increased renal energy
demand (e.g., increased glomerular filtration rate [GFR] and tubular reabsorption of sodium)
and impaired substrate metabolism (e.g., IR and mitochondrial dysfunction) and results in
activation of the hypoxia-inducible factor (HIF) system. Although upregulation of HIF1α
confers favorable short-term effects, sustained activation promotes cellular injury.
Supporting these hypotheses, data from our group and others have shown that obesity, IR, and
The investigators also found that youth with T1D exhibit kidney hypoxia by MRI that strongly
associates with IR and mitochondrial dysfunction. Moreover, our preliminary single-cell RNA
sequencing (scRNA-seq) data from kidney biopsies demonstrate upregulated tubular expression
of HIF1α in adults with T1D vs. healthy controls. The investigators propose to build a unique
new longitudinal kidney biopsy cohort (N=100) spanning the critical duration of T1D over
which DKD initiates and progresses (5-30 years). Participants will be enrolled from our
existing CROCODILE study (adding longitudinal follow-up to completed kidney biopsies and
baseline data and biosample acquisition) and from new enrollment at the University of
Colorado and University of Washington. Normative kidney biopsy data will be provided from our
existing cohort of healthy controls (N=20) and the Kidney Precision Medicine Project (KPMP).
The investigators will implement state-of-the-art molecular (scRNA-seq) and morphometric
interrogation of kidney tissue and rigorous metabolic phenotyping to include kidney magnetic
resonance imaging (MRI), direct measurements of glycemia (continuous glucose monitoring),
intraabdominal fat (dual-energy X-ray absorptiometry), estimation of insulin sensitivity by a
T1D-validated equation, and (in a subset) GFR (iohexol clearance) and renal plasma flow
(p-aminohippurate clearance). Participants will be followed longitudinally for DKD outcomes.
A subset of 20 participants will undergo repeat kidney biopsies and associated procedures 3
years after baseline kidney biopsy.
During the study, the investigators will collect blood, urine, and tissue samples for
assessment of kidney function and kidney injury markers.
The investigators propose to address the specific aims of this study in a cross-sectional
project with 70 newly enrolled adults with T1D and 30 former CROCODILE participants (COMIRB
#19-1282).
Inclusion Criteria:
- Age ≥ 18 years at enrollment (rationale: this study focuses on determinants of early
DKD over the course of T1D in adults)
- T1D duration >5 and ≤ 30 years (rationale: DKD in T1D rarely manifests prior to 5
years of disease duration; longstanding T1D above > 30 years subject to survivorship
bias)
- HbA1c <11% (rationale: HbA1c ≥ 11% exceeds the average HbA1c at most academic center
and would limiting the generalizability of our study findings)
Exclusion Criteria:
- T2D and monogenic diabetes (rationale: our study focuses on T1D)
- Recent diabetic ketoacidosis, i.e., <1 month (rationale: safety and insulin resistance
and tubular dysfunction of DKA can confound study findings)
- eGFR < 30 ml/min/1.73m2 or dialysis treatment (rationale: to reduce the likelihood of
identifying secondary pathways that are not specific to kidney injury from T1D)
- Kidney transplant recipients (rationale: molecular confounding from immunosuppression)
- Kidney biopsy contraindications (rationale: safety - kidney biopsy):
- Evidence of bleeding disorder or complications from bleeding
- Use of aspirin, Nonsteroidal anti-inflammatory drugs (NSAIDS) or other blood
thinner that cannot be safely stopped for a sufficient time before and after the
biopsy to avoid additional risk of bleeding.
- INR > 1.4
- Hemoglobin (Hgb) < 10 mg/dL (Colorado) [altitude]
- Hemoglobin (Hgb) < 9 mg/dL (Washington)
- Platelet count < 100,000 / µL
- Uncontrolled or difficult to control hypertension (> 150/90 mmHg at the day of
biopsy)
- Single kidney (either by history, documented by prior imaging or ultrasound
performed prior to the biopsy)
- Kidney size: One or both kidneys < 8 cm
- Hydronephrosis or other important renal ultrasound findings such as significant
stone disease
- Any evidence of a current urinary tract infection as indicated on day of biopsy
- Clinical evidence of non-diabetic renal disease
- Positive urine pregnancy test or pregnancy
|
NCT0532xxxx/NCT05320003.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320003</url>
</required_header>
<id_info>
<org_study_id>IstanbulUC-ShahlaALIMADATLI</org_study_id>
<nct_id>NCT05320003</nct_id>
</id_info>
<brief_title>Assessment of Balance in Patients With Pes Planus</brief_title>
<official_title>Assessment of Balance in Patients With Pes Planus Aged 50-65, Clinically and With Static Posturography</official_title>
<sponsors>
<lead_sponsor>
<agency>Istanbul University - Cerrahpasa (IUC)</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Istanbul University - Cerrahpasa (IUC)</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Introduction: Pes planus is a foot deformity with increased contact of the foot with the
ground as a result of the decrease or disappearance of the medial longitudinal arch of the
foot. The arch of the foot creates an adaptive and flexible support for the whole body, and
biomechanical changes in the foot can affect the whole body posture and balance. The results
of the studies evaluating balance and plantar pressure analysis in adults with pes planus
seem contradictory. The aim of this study is to evaluate fall risk and plantar pressure in
adults with pes planus aged 50 -65 years
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Materials and Methods: 34 cases with pes planus will be included in the study. Medial
longitudinal arch height of all cases will be evaluated by physical examination . Affected
foot, presence of "too many toes" sign will be observed. With the fingertip rise test, it
will be checked whether the pes planus is flexible or rigid.

Inky foot analysis and plantar pressure analysis will be performed in cases. Chippaux-Smirak
index and Staheli arch index of all cases will be evaluated for the diagnosis of pes
planus.The risk of falling will be calculated by evaluation of the balance with clinically
and with posturography.

Results: Statistical analyzes in the study will be made with the NCSS (Number Cruncher
Statistical System) 2007 Statistical Software (Utah, USA) package program.

In addition to descriptive statistical methods (mean, standard deviation) in the evaluation
of the data, the distribution of the variables will be examined with the Shapiro - Wilk
normality test, one-way analysis of variance in the comparison of the normally distributed
variables, Tukey multiple comparison test in the comparison of subgroups, independent t test
in the comparison of the paired groups, Chi-square test will be used in comparisons of
qualitative data. Results will be evaluated at the level of significance p<0.05.

Discussion: The results will be discussed according to the recent literature. In the
literature, there are conflicting results about the balance and gait of adults with pes
planus. In several studies in the literature, it has been found that the risk of falling is
increased in elderly individuals with pes planus. The study can contribute to the literature
in this perspective.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">April 6, 2022</start_date>
<completion_date type="Anticipated">May 15, 2022</completion_date>
<primary_completion_date type="Anticipated">April 15, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Diagnostic</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Fall risk</measure>
<time_frame>10 minutes</time_frame>
<description>Balance - the body's ability to remain stable against internal and external factors.Clinical, Functional and computer aided methods are frequently used to evaluate balance. The risk of falling will be evaluated with the computerized static posturography device [Tetrax® Interactive Postural Balance System (Sunlight Medical, Israel)]</description>
</primary_outcome>
<primary_outcome>
<measure>Fall risc</measure>
<time_frame>5 minutes</time_frame>
<description>Balance - the body's ability to remain stable against internal and external factors.Clinical, Functional and computer aided methods are frequently used to evaluate balance. The risk of falling will be evaluated with the timed up to go test.</description>
</primary_outcome>
<secondary_outcome>
<measure>Plantar Pressure Analysis</measure>
<time_frame>10 minutes</time_frame>
<description>Static foot pressure measurement will be performed with (Emed, Novel GmBH,Germany)
device in all cases.Peak pressure (Kpa), maximum force (N) and total foot area (cm²) values will be obtained.The correlation of these parameters with the risk of falling will be examined.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">40</enrollment>
<condition>Pes Planus</condition>
<condition>Fall Risk</condition>
<arm_group>
<arm_group_label>Adults with pes planus</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>Detailed clinical examination of cases with pes planus will be performed. Inky foot analysis of both feet will be performed to confirm the diagnosis of pes planus in the subjects included in the study. Staheli arch index and Chippaux-Smirak Index will be calculated for each foot based on the footprints obtained. According to the Staheli Arc Index 1 and above, according to the Chippaux-Smirak Index 0.45 and above will be considered as pes planus, static foot pressure measurement will be performed with a pedobarography device in all cases. Peak pressure, maximum force and total foot area values will be obtained. Balance assessment of the patients will be performed with a computerized static posturography device. Individuals will be graded according to the fall index results, as low, medium and high risk. It will be determined whether there is a fall risk with the Timed Up and Go Test, which is one of the clinical balance tests.</description>
</arm_group>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>Inky foot analysis</intervention_name>
<description>Inky foot analysis to confirm the diagnosis of pes planus</description>
<arm_group_label>Adults with pes planus</arm_group_label>
<other_name>Fall risk assessment with static posturography</other_name>
</intervention>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>Evaluation of plantar pressure with pedobarography</intervention_name>
<description>Evaluation of plantar pressure distribution by pedobarography in individuals with pes planus</description>
<arm_group_label>Adults with pes planus</arm_group_label>
</intervention>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>Balance assessment with computerized posturography</intervention_name>
<description>Evaluation of fall risk with computerized posturography</description>
<arm_group_label>Adults with pes planus</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Patients aged 50 years and above with pes planus according to Staheli Arch Index and
Chippaux- Smirak Index

Exclusion Criteria:

- Congenital anomalies of the foot

- Prior lower extremity surgery Inflammatory arthritis

- Neuromuscular diseases

- Diseases that interfere with lower extremity circulation

- Presence of orthostatic hypotension

- Untreated visual impairment

- Neurological and vestibular diseases

- Use of drugs that can cause balance disorders (Antipsychotics, Pregabalin, etc.)
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>50 Years</minimum_age>
<maximum_age>65 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Shahla Alimadatli</last_name>
<role>Principal Investigator</role>
<affiliation>Istanbul University - Cerrahpasa (IUC)</affiliation>
</overall_official>
<overall_contact>
<last_name>Shahla ALIMADATLI</last_name>
<phone>+905378677287</phone>
<email>dr.shahla628@gmail.com</email>
</overall_contact>
<overall_contact_backup>
<last_name>Fevziye Merih SARIDOGAN</last_name>
<phone>+905326621700</phone>
<email>merihsa@gmail.com</email>
</overall_contact_backup>
<reference>
<citation>Michaudet C, Edenfield KM, Nicolette GW, Carek PJ. Foot and Ankle Conditions: Pes Planus. FP Essent. 2018 Feb;465:18-23.</citation>
<PMID>29381041</PMID>
</reference>
<reference>
<citation>Cote KP, Brunet ME, Gansneder BM, Shultz SJ. Effects of Pronated and Supinated Foot Postures on Static and Dynamic Postural Stability. J Athl Train. 2005 Mar;40(1):41-46.</citation>
<PMID>15902323</PMID>
</reference>
<reference>
<citation>Knapp PW, Constant D. Posterior Tibial Tendon Dysfunction. 2023 May 23. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK542160/</citation>
<PMID>31194317</PMID>
</reference>
<reference>
<citation>Mosca VS. Flexible flatfoot in children and adolescents. J Child Orthop. 2010 Apr;4(2):107-21. doi: 10.1007/s11832-010-0239-9. Epub 2010 Feb 18.</citation>
<PMID>21455468</PMID>
</reference>
<reference>
<citation>Forriol F, Pascual J. Footprint analysis between three and seventeen years of age. Foot Ankle. 1990 Oct;11(2):101-4. doi: 10.1177/107110079001100208.</citation>
<PMID>2265808</PMID>
</reference>
<reference>
<citation>Staheli LT, Chew DE, Corbett M. The longitudinal arch. A survey of eight hundred and eighty-two feet in normal children and adults. J Bone Joint Surg Am. 1987 Mar;69(3):426-8.</citation>
<PMID>3818704</PMID>
</reference>
<reference>
<citation>Awale A, Hagedorn TJ, Dufour AB, Menz HB, Casey VA, Hannan MT. Foot Function, Foot Pain, and Falls in Older Adults: The Framingham Foot Study. Gerontology. 2017;63(4):318-324. doi: 10.1159/000475710. Epub 2017 May 9.</citation>
<PMID>28482340</PMID>
</reference>
<reference>
<citation>Neri SGR, Harvey LA, Tiedemann A, Gadelha AB, Lima RM. Obesity and falls in older women: Mediating effects of muscle quality, foot loads and postural control. Gait Posture. 2020 Mar;77:138-143. doi: 10.1016/j.gaitpost.2020.01.025. Epub 2020 Feb 1.</citation>
<PMID>32036318</PMID>
</reference>
<reference>
<citation>Skopljak A, Muftic M, Sukalo A, Masic I, Zunic L. Pedobarography in diagnosis and clinical application. Acta Inform Med. 2014 Dec;22(6):374-8. doi: 10.5455/aim.2014.22.374-378. Epub 2014 Dec 19.</citation>
<PMID>25684844</PMID>
</reference>
<reference>
<citation>Akkaya N, Doganlar N, Celik E, Aysse SE, Akkaya S, Gungor HR, Sahin F. TEST-RETEST RELIABILITY OF TETRAX(R) STATIC POSTUROGRAPHY SYSTEM IN YOUNG ADULTS WITH LOW PHYSICAL ACTIVITY LEVEL. Int J Sports Phys Ther. 2015 Nov;10(6):893-900.</citation>
<PMID>26618068</PMID>
</reference>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 15, 2022</study_first_submitted>
<study_first_submitted_qc>April 6, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>April 6, 2022</last_update_submitted>
<last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 11, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
<investigator_full_name>Shahla ALIMADATLI</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<keyword>Pes planus</keyword>
<keyword>Ink foot analysis</keyword>
<keyword>Pedobarography</keyword>
<keyword>Computed posturography</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Flatfoot</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Introduction: Pes planus is a foot deformity with increased contact of the foot with the
ground as a result of the decrease or disappearance of the medial longitudinal arch of the
foot. The arch of the foot creates an adaptive and flexible support for the whole body, and
biomechanical changes in the foot can affect the whole body posture and balance. The results
of the studies evaluating balance and plantar pressure analysis in adults with pes planus
seem contradictory. The aim of this study is to evaluate fall risk and plantar pressure in
adults with pes planus aged 50 -65 years
Materials and Methods: 34 cases with pes planus will be included in the study. Medial
longitudinal arch height of all cases will be evaluated by physical examination . Affected
foot, presence of "too many toes" sign will be observed. With the fingertip rise test, it
will be checked whether the pes planus is flexible or rigid.
Inky foot analysis and plantar pressure analysis will be performed in cases. Chippaux-Smirak
index and Staheli arch index of all cases will be evaluated for the diagnosis of pes
planus.The risk of falling will be calculated by evaluation of the balance with clinically
and with posturography.
Results: Statistical analyzes in the study will be made with the NCSS (Number Cruncher
Statistical System) 2007 Statistical Software (Utah, USA) package program.
In addition to descriptive statistical methods (mean, standard deviation) in the evaluation
of the data, the distribution of the variables will be examined with the Shapiro - Wilk
normality test, one-way analysis of variance in the comparison of the normally distributed
variables, Tukey multiple comparison test in the comparison of subgroups, independent t test
in the comparison of the paired groups, Chi-square test will be used in comparisons of
qualitative data. Results will be evaluated at the level of significance p<0.05.
Discussion: The results will be discussed according to the recent literature. In the
literature, there are conflicting results about the balance and gait of adults with pes
planus. In several studies in the literature, it has been found that the risk of falling is
increased in elderly individuals with pes planus. The study can contribute to the literature
in this perspective.
Inclusion Criteria:
- Patients aged 50 years and above with pes planus according to Staheli Arch Index and
Chippaux- Smirak Index
Exclusion Criteria:
- Congenital anomalies of the foot
- Prior lower extremity surgery Inflammatory arthritis
- Neuromuscular diseases
- Diseases that interfere with lower extremity circulation
- Presence of orthostatic hypotension
- Untreated visual impairment
- Neurological and vestibular diseases
- Use of drugs that can cause balance disorders (Antipsychotics, Pregabalin, etc.)
|
NCT0532xxxx/NCT05320016.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320016</url>
</required_header>
<id_info>
<org_study_id>B-2109-708-309</org_study_id>
<nct_id>NCT05320016</nct_id>
</id_info>
<brief_title>Effects of Remimazolam on Quality of Recovery After Ambulatory Surgery</brief_title>
<official_title>Effects of Remimazolam Combined With Remifentanil on Quality of Recovery After Ambulatory Hysteroscopic Surgery: a Prospective, Observational Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Seoul National University Bundang Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Seoul National University Bundang Hospital</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Remimazolam is a novel ultra-short acting benzodiazepine with rapid onset of effects, short
maintenance and faster recovery time. Due to its recent development, few studies have
investigated the effect of remimazolam on postoperative recovery mainly focusing on
physiologic endpoints, recovery time and possible adverse events. Although these parameters
are crucial and need evaluation, the investigators ignore quality of recovery from
participant's perspective. For this purpose, various measurment tools have been developed for
psychometric evaluation of QoR score.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
To date, there has not been a study investigating the impact of remimazolam on quality of
recovery (QoR). This study evaluates the effect of remimazolam on QoR of participants
undergoing general anesthesia using remimazolam-remifentanil total intravenous anesthesia
(TIVA) for hysteroscopy as day surgery basis. Herein, the investigators used the translated
Korean version of the 15-item Quality of Recovery-15 (QoR-15K) questionnaire, which was
previously validated in Korean surgical participants.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">November 1, 2021</start_date>
<completion_date type="Actual">December 31, 2021</completion_date>
<primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Only</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Quality of recovery</measure>
<time_frame>24 hours after ambulatory hysteroscopic surgery</time_frame>
<description>the translated Korean version of 15-item Quality of Recovery scale (QoR-15K)</description>
</primary_outcome>
<enrollment type="Actual">38</enrollment>
<condition>Day Surgery</condition>
<condition>Patient Outcome Assessment</condition>
<condition>Quality of Recovery</condition>
<condition>Remimazolam</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Remimazolam</intervention_name>
<description>Effects of remimazolam on quality of recovery scores after ambulatory hysteroscopic surgery</description>
<other_name>the translated Korean version of 15-item Quality of Recovery scale (QoR-15K)</other_name>
</intervention>
<eligibility>
<study_pop>
<textblock>
Adult woman scheduled for ambulatory gynecological surgery under general anesthesia
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Adult woman scheduled for ambulatory gynecological surgery under general anesthesia

- American Society of Anesthesiology grade 1 or 2

Exclusion Criteria:

- Underlying diseases: liver, kidney, brain nervous system, glaucoma

- Patients with BMI greater than 30 and less than 18.5

- Patients diagnosed with sleep apnea

- Alcohol or drug dependent patients

- Patients with severe or acute respiratory failure

- Lactose intolerance

- Dextran 40 hypersensitivity

- Patients in shock or coma
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>19 Years</minimum_age>
<maximum_age>75 Years</maximum_age>
</eligibility>
<overall_official>
<last_name>Sang-Hwan Do</last_name>
<role>Principal Investigator</role>
<affiliation>Seoul National University Bundang Hospital</affiliation>
</overall_official>
<location>
<facility>
<name>Seoul National University Bundang Hospital</name>
<address>
<city>Seongnam-si</city>
<state>Gyunggi-do</state>
<zip>13620</zip>
<country>Korea, Republic of</country>
</address>
</facility>
</location>
<location_countries>
<country>Korea, Republic of</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>April 6, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>April 6, 2022</last_update_submitted>
<last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 11, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Remimazolam is a novel ultra-short acting benzodiazepine with rapid onset of effects, short
maintenance and faster recovery time. Due to its recent development, few studies have
investigated the effect of remimazolam on postoperative recovery mainly focusing on
physiologic endpoints, recovery time and possible adverse events. Although these parameters
are crucial and need evaluation, the investigators ignore quality of recovery from
participant's perspective. For this purpose, various measurment tools have been developed for
psychometric evaluation of QoR score.
To date, there has not been a study investigating the impact of remimazolam on quality of
recovery (QoR). This study evaluates the effect of remimazolam on QoR of participants
undergoing general anesthesia using remimazolam-remifentanil total intravenous anesthesia
(TIVA) for hysteroscopy as day surgery basis. Herein, the investigators used the translated
Korean version of the 15-item Quality of Recovery-15 (QoR-15K) questionnaire, which was
previously validated in Korean surgical participants.
Adult woman scheduled for ambulatory gynecological surgery under general anesthesia
Inclusion Criteria:
- Adult woman scheduled for ambulatory gynecological surgery under general anesthesia
- American Society of Anesthesiology grade 1 or 2
Exclusion Criteria:
- Underlying diseases: liver, kidney, brain nervous system, glaucoma
- Patients with BMI greater than 30 and less than 18.5
- Patients diagnosed with sleep apnea
- Alcohol or drug dependent patients
- Patients with severe or acute respiratory failure
- Lactose intolerance
- Dextran 40 hypersensitivity
- Patients in shock or coma
|
NCT0532xxxx/NCT05320029.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320029</url>
</required_header>
<id_info>
<org_study_id>20256031708</org_study_id>
<nct_id>NCT05320029</nct_id>
</id_info>
<brief_title>Clinical Trial of Efficacy and Safety of Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal Tissue Cutting and Anastomosis</brief_title>
<official_title>Clinical Trial of Efficacy and Safety of Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal Tissue Cutting and Anastomosis</official_title>
<sponsors>
<lead_sponsor>
<agency>Fengh Medical Co., Ltd.</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
<collaborator>
<agency>First People's Hospital of Yangzhou</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Affiliated Hospital of Jiangsu University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>People's Hospital of Quzhou</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>The Central Hospital of Lishui City</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Shanghai Tong Ren Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Fengh Medical Co., Ltd.</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
To evaluate whether the anastomosis success rate of the main effectiveness evaluation indexes
is not inferior to the similar products produced by Johnson & Johnson when the Fengh
Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal
Tissue Cutting and Anastomosis
</textblock>
</brief_summary>
<detailed_description>
<textblock>
In this clinical trial, prospective, multi-center, stratified group randomization, incomplete
blind setting, parallel positive control and non-inferiority test were used to evaluate the
Disposable Powered Articulating Endoscopic Linear Cutter Stapler manufactured by Jiangsu
Fengh Medical Co., Ltd. when used for gastrointestinal tissue cutting and anastomosis. To
determine whether there is any difference in the incidence of adverse events, serious adverse
events, device defects and other safety evaluation indicators compared with similar products
produced by Johnson & Johnson.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">August 30, 2018</start_date>
<completion_date type="Actual">January 20, 2022</completion_date>
<primary_completion_date type="Actual">February 11, 2020</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Patients randomized to the trial group and the control group will not cross use the product</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
<masking_description>A test method in which subjects are not told whether they are a trial device or a control device in order to control intentional or unintentional bias in the course of a clinical trial and in the interpretation of results</masking_description>
</study_design_info>
<primary_outcome>
<measure>Anastomosis success rate</measure>
<time_frame>During surgery</time_frame>
<description>By comparing the anastomotic success rate of the two staplers, we can judge the safety and effectiveness of the wind and stapler.</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">164</enrollment>
<condition>Gastrointestinal Neoplasm</condition>
<arm_group>
<arm_group_label>Disposable Powered Articulating Endoscopic Linear Cutter Stapler</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>Echelon Flex POWERED Articulating Endoscopic Linear Cutters</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Gastrointestinal tumor surgery</intervention_name>
<description>Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment</description>
<arm_group_label>Disposable Powered Articulating Endoscopic Linear Cutter Stapler</arm_group_label>
<arm_group_label>Echelon Flex POWERED Articulating Endoscopic Linear Cutters</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. The subjects are 18 ~ 75 years old, regardless of gender:

2. Subjects need to use a linear stapler for gastrointestinal tissue cutting and
anastomosis:

3. The subject or his legal representative can understand the purpose of the study and
show sufficient compliance with the study protocol And sign informed consent.

Exclusion Criteria:

1. The subject plans to perform emergency gastrointestinal surgery:

2. Subjects with moderate malnutrition (BML < 17kg / m2) and severe anemia (HB < 60g /
L):

3. Subject BMI 228kg / m2;

4. Subject platelet (PLT) < 60x 109 / L or international normalized ratio (INR) > 1.5;

5. Subject forced expiratory volume per second (FEV1) / expected value ≤ 50%, or forced
expiratory volume per second (FEV1) / forced vital capacity (FCV) < 60%;

6. Subject's cardiac ejection fraction ≤ 50%;

7. Have important organ failure or other serious diseases (e.g. preoperative subject
aspartate amino acid) Transferase (AST), or alanine aminotransferase (ALT), or serum
creatinine (SER) exceeds normal values

Upper limit 3 times and above: subjects with fasting blood glucose value > 10.0mmol/l
before operation:

8. The subjects were pregnant or lactating women; Page 16 of 53 Version No.: 1.1/version
date 20190125 Clinical trial on the efficacy and safety of linear cutting stapler and
components for disposable electric endoscopy for cutting and anastomosis of
gastrointestinal tissue

9. Subjects participated in clinical trials of other drugs or devices within 3 months
before the trial;

10. Other conditions that the researchers judged not suitable for inclusion.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>75 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Disposable Powered Articulating Endoscopic Linear Cutter Stapler</name>
<address>
<city>Jiangyin</city>
<state>Jiangsu</state>
<zip>214437</zip>
<country>China</country>
</address>
</facility>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>July 2022</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>April 8, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>July 25, 2022</last_update_submitted>
<last_update_submitted_qc>July 25, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">July 27, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Gastrointestinal Neoplasms</mesh_term>
<mesh_term>Digestive System Neoplasms</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
<ipd_description>Participants can only see the results of CT, blood routine, coagulation function, fasting blood glucose, fecal occult blood test, cardiac ultrasound, pulmonary function and gastrointestinal angiography, and the other results are not shared</ipd_description>
</patient_data>
<pending_results>
<submitted>February 13, 2023</submitted>
</pending_results>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
To evaluate whether the anastomosis success rate of the main effectiveness evaluation indexes
is not inferior to the similar products produced by Johnson & Johnson when the Fengh
Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal
Tissue Cutting and Anastomosis
In this clinical trial, prospective, multi-center, stratified group randomization, incomplete
blind setting, parallel positive control and non-inferiority test were used to evaluate the
Disposable Powered Articulating Endoscopic Linear Cutter Stapler manufactured by Jiangsu
Fengh Medical Co., Ltd. when used for gastrointestinal tissue cutting and anastomosis. To
determine whether there is any difference in the incidence of adverse events, serious adverse
events, device defects and other safety evaluation indicators compared with similar products
produced by Johnson & Johnson.
Inclusion Criteria:
1. The subjects are 18 ~ 75 years old, regardless of gender:
2. Subjects need to use a linear stapler for gastrointestinal tissue cutting and
anastomosis:
3. The subject or his legal representative can understand the purpose of the study and
show sufficient compliance with the study protocol And sign informed consent.
Exclusion Criteria:
1. The subject plans to perform emergency gastrointestinal surgery:
2. Subjects with moderate malnutrition (BML < 17kg / m2) and severe anemia (HB < 60g /
L):
3. Subject BMI 228kg / m2;
4. Subject platelet (PLT) < 60x 109 / L or international normalized ratio (INR) > 1.5;
5. Subject forced expiratory volume per second (FEV1) / expected value ≤ 50%, or forced
expiratory volume per second (FEV1) / forced vital capacity (FCV) < 60%;
6. Subject's cardiac ejection fraction ≤ 50%;
7. Have important organ failure or other serious diseases (e.g. preoperative subject
aspartate amino acid) Transferase (AST), or alanine aminotransferase (ALT), or serum
creatinine (SER) exceeds normal values
Upper limit 3 times and above: subjects with fasting blood glucose value > 10.0mmol/l
before operation:
8. The subjects were pregnant or lactating women; Page 16 of 53 Version No.: 1.1/version
date 20190125 Clinical trial on the efficacy and safety of linear cutting stapler and
components for disposable electric endoscopy for cutting and anastomosis of
gastrointestinal tissue
9. Subjects participated in clinical trials of other drugs or devices within 3 months
before the trial;
10. Other conditions that the researchers judged not suitable for inclusion.
|
NCT0532xxxx/NCT05320042.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320042</url>
</required_header>
<id_info>
<org_study_id>ROC2-21-013</org_study_id>
<nct_id>NCT05320042</nct_id>
</id_info>
<brief_title>1-Week Dispensing Evaluation of Kalifilcon A Toric Contact Lenses Compared to Ultra for Astigmatism</brief_title>
<official_title>1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Ultra for Astigmatism Contact Lenses</official_title>
<sponsors>
<lead_sponsor>
<agency>Bausch & Lomb Incorporated</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Bausch & Lomb Incorporated</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>Yes</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory,
randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated
measures, dispensing study. All subjects will be seen for a Screening/Baseline Visit at which
informed consent will be obtained and eligibility will be assessed.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">February 14, 2022</start_date>
<completion_date type="Actual">May 10, 2022</completion_date>
<primary_completion_date type="Actual">May 10, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Crossover Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Participant, Care Provider)</masking>
</study_design_info>
<primary_outcome>
<measure>Visual Acuity</measure>
<time_frame>One week</time_frame>
<description>Mean Binocular logMAR Visual Acuity</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">28</enrollment>
<condition>Myopia</condition>
<condition>Astigmatism</condition>
<arm_group>
<arm_group_label>kalifilcon A Daily Disposable Toric</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>kalifilcon A Daily Disposable Toric</description>
</arm_group>
<arm_group>
<arm_group_label>Ultra for Astigmatism Contact Lenses</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Ultra for Astigmatism Contact Lenses</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>kalifilcon A Daily Disposable Toric</intervention_name>
<description>kalifilcon A Daily Disposable Toric</description>
<arm_group_label>kalifilcon A Daily Disposable Toric</arm_group_label>
</intervention>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Ultra for Astigmatism Contact Lenses</intervention_name>
<description>Ultra for Astigmatism Contact Lenses</description>
<arm_group_label>Ultra for Astigmatism Contact Lenses</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have
the capacity to read, understand and provide written voluntary informed consent.

2. Have physiologically normal anterior segments not exhibiting clinically significant
biomicroscopy findings.

3. Have no active ocular disease or allergic conjunctivitis.

4. Not be using any topical ocular medications.

5. Be willing and able to follow instructions.

6. Have signed a statement of informed consent.

Exclusion Criteria:

1. Participating in a conflicting study.

2. Considered by the Investigator to not be a suitable candidate for participation.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Robert Steffen</last_name>
<role>Study Director</role>
<affiliation>Bausch & Lomb Incorporated</affiliation>
</overall_official>
<location>
<facility>
<name>Bausch site 1</name>
<address>
<city>Rochester</city>
<state>New York</state>
<zip>14609</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>November 2022</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>November 16, 2022</last_update_submitted>
<last_update_submitted_qc>November 16, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">November 17, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Astigmatism</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<pending_results>
<submitted>August 31, 2023</submitted>
</pending_results>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory,
randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated
measures, dispensing study. All subjects will be seen for a Screening/Baseline Visit at which
informed consent will be obtained and eligibility will be assessed.
Inclusion Criteria:
1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have
the capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant
biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.
Exclusion Criteria:
1. Participating in a conflicting study.
2. Considered by the Investigator to not be a suitable candidate for participation.
|
NCT0532xxxx/NCT05320055.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320055</url>
</required_header>
<id_info>
<org_study_id>IPOM vs TARUP</org_study_id>
<nct_id>NCT05320055</nct_id>
</id_info>
<brief_title>Pain and Readmission After Lap IPOM vs. Robotic Ventral Hernia Repair</brief_title>
<official_title>Less Postoperative Pain and Length of Stay After Robotic-assisted Laparoscopic Transabdominal Repair With Retro Rectus Mesh Placement (rTARUP) Compared With Laparoscopic Intraperitoneal Onlay Mesh Repair (IPOM) for Small and Medium-sized Ventral Hernias</official_title>
<sponsors>
<lead_sponsor>
<agency>Bispebjerg Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Bispebjerg Hospital</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Comparison of results after rTARUP and lap IPOM in patients with small- and medium-sized
ventral hernia. Retrospective cohort study of consecutive patients undergoing rTARUP or IPOM
repair for small or medium-sized primary ventral and incisional hernias. The primary outcome
was the postoperative need for transverse abdominis plane (TAP) block or epidural catheter,
secondary outcomes were 30-day complications, and length of stay. All patients underwent
elective surgery and were followed for 30 days postoperatively.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Single-center retrospective cohort study of consecutive patients undergoing rTARUP or IPOM
repair for small or medium-sized primary ventral and incisional hernias. The primary outcome
was the postoperative need for transverse abdominis plane (TAP) block or epidural catheter,
secondary outcomes were 30-day complications, and length of stay. All patients underwent
elective surgery and were followed for 30 days postoperatively.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">March 1, 2021</start_date>
<completion_date type="Actual">October 1, 2021</completion_date>
<primary_completion_date type="Actual">September 1, 2021</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Retrospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>epidural blockade or TAP block</measure>
<time_frame>0-1 postoperative day</time_frame>
<description>postoperative pain requiring epidural or TAP block</description>
</primary_outcome>
<secondary_outcome>
<measure>readmissison</measure>
<time_frame>30 days</time_frame>
<description>if the patients get readmitted during the follow-up</description>
</secondary_outcome>
<secondary_outcome>
<measure>complications</measure>
<time_frame>30 days</time_frame>
<description>if the patients get any medical or surgical complication during the follow-up</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Actual">59</enrollment>
<condition>Hernia, Ventral</condition>
<arm_group>
<arm_group_label>IPOM</arm_group_label>
<description>receiving laparoscopic intraperitoneal onlay mesh repair</description>
</arm_group>
<arm_group>
<arm_group_label>rTARUP</arm_group_label>
<description>recieving robotic assited retromuscular repair</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>robotic repair</intervention_name>
<description>robotic assisted retromuscular hernia repair</description>
<arm_group_label>IPOM</arm_group_label>
<arm_group_label>rTARUP</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
Study population is all patients referred from primary sector and eligible for laparoscopic
primary ventral or incisional hernia repair
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- all patients undergoing elective minimally invasive repair for small or medium-sized
primary ventral or incisional hernia repairs at one academic hernia center with an
unrestricted patient referral.

Consecutive patients undergoing IPOM (December 1st, 2017 - December 1st, 2018) and
rTARUPrRetrorectus (March 1st, 2021 - June 1st, 2021).

Exclusion Criteria:

- open repairs
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>80 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Mette Willaume, phd</last_name>
<role>Principal Investigator</role>
<affiliation>University of Copenhagen, Bispebjerg Hospital</affiliation>
</overall_official>
<location>
<facility>
<name>Bispebjerg Hospital</name>
<address>
<city>Copenhagen</city>
<zip>1650</zip>
<country>Denmark</country>
</address>
</facility>
</location>
<location_countries>
<country>Denmark</country>
</location_countries>
<verification_date>August 2023</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>August 4, 2023</last_update_submitted>
<last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">August 7, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
<investigator_full_name>Mette Willaume</investigator_full_name>
<investigator_title>Staff specialist, MD, PhD</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Hernia</mesh_term>
<mesh_term>Hernia, Ventral</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Comparison of results after rTARUP and lap IPOM in patients with small- and medium-sized
ventral hernia. Retrospective cohort study of consecutive patients undergoing rTARUP or IPOM
repair for small or medium-sized primary ventral and incisional hernias. The primary outcome
was the postoperative need for transverse abdominis plane (TAP) block or epidural catheter,
secondary outcomes were 30-day complications, and length of stay. All patients underwent
elective surgery and were followed for 30 days postoperatively.
Single-center retrospective cohort study of consecutive patients undergoing rTARUP or IPOM
repair for small or medium-sized primary ventral and incisional hernias. The primary outcome
was the postoperative need for transverse abdominis plane (TAP) block or epidural catheter,
secondary outcomes were 30-day complications, and length of stay. All patients underwent
elective surgery and were followed for 30 days postoperatively.
Study population is all patients referred from primary sector and eligible for laparoscopic
primary ventral or incisional hernia repair
Inclusion Criteria:
- all patients undergoing elective minimally invasive repair for small or medium-sized
primary ventral or incisional hernia repairs at one academic hernia center with an
unrestricted patient referral.
Consecutive patients undergoing IPOM (December 1st, 2017 - December 1st, 2018) and
rTARUPrRetrorectus (March 1st, 2021 - June 1st, 2021).
Exclusion Criteria:
- open repairs
|
NCT0532xxxx/NCT05320068.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320068</url>
</required_header>
<id_info>
<org_study_id>PREVAN-ICD</org_study_id>
<nct_id>NCT05320068</nct_id>
</id_info>
<brief_title>Oral Vancomycin vs Placebo in the Prevention of Recurrence of Clostridioides Difficile's Infection</brief_title>
<acronym>PREVAN</acronym>
<official_title>Phase III,Randomized,Double-blinded Clinical Trial to Evaluate the Effectiveness and Safety of Oral Vancomycin Vs Placebo in the Prevention of Recurrence of C.Difficile Infection in Patients Under Treatment With Systemic Antibiotic Therapy</official_title>
<sponsors>
<lead_sponsor>
<agency>Julia Orígüen</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Instituto de Salud Carlos III</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Hospital Universitario 12 de Octubre</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
A phase III randomized clinical trial in proportion 2:1 in favor of oral vancomycin
(experimental treatment), multicentric, national, double-blinded, controlled with placebo.
The main objective is to evaluate the effectiveness of treatment with oral vancomycin to
reduce the incidence of Clostridioides difficile infection (CDI) in patients who suffered
previous CDI and who need further hospitalization and treatment with systemic antibiotic
therapy in the 90 days after the first CDI.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
As secondary objectives the investigators intend to:

- Evaluate the effectiveness of the treatment with oral vancomycin as part of the
prophylaxis arsenal to prevent ICD in patients with previous ICD episodes stratified by
the number of previous recurrences.

- Compare the severity of recurrences in both study groups.

- Compare the effectiveness of the treatment with oral vancomycin depending on the type of
systemic antibiotic therapy prescribed.

- Evaluate the tolerance and the safety of the treatment with oral vancomycin in terms of
secondary effects and difficulty in therapeutic compliance.

- Evaluate if the treatment with oral vancomycin has an effect in diminishing the severity
of ICD recurrences.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">August 2, 2022</start_date>
<completion_date type="Anticipated">July 2024</completion_date>
<primary_completion_date type="Anticipated">January 2024</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>Proportion 2:1 in favour to the intervention arm</intervention_model_description>
<primary_purpose>Prevention</primary_purpose>
<masking>Triple (Participant, Care Provider, Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Effectiveness of treatment with oral vancomycin in the prevention of Clostridioides difficile</measure>
<time_frame>60 days after the beginning of the intervention</time_frame>
<description>Absolute difference in the rate of C. difficile infection recurrences with vancomycin Vs placebo.</description>
</primary_outcome>
<secondary_outcome>
<measure>Effectiveness of treatment with oral vancomycin according to the number of previous recurrences</measure>
<time_frame>60 days after the beginning of the intervention</time_frame>
<description>The absolute difference in the rate of C. difficile infection recurrences with vancomycin vs placebo stratified by index CDI episode (first episode or recurrence)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Effectiveness of treatment with oral vancomycin in diminishing the severity of the recurrence</measure>
<time_frame>60 days after the beginning of the intervention</time_frame>
<description>The absolute difference in the rate of severe C. difficile infection recurrences with vancomycin vs placebo</description>
</secondary_outcome>
<secondary_outcome>
<measure>Effectiveness of treatment with oral vancomycin depending on antibiotic therapy</measure>
<time_frame>60 days after the beginning of the intervention</time_frame>
<description>The absolute difference in the rate of C. difficile infection recurrences with vancomycin vs placebo stratified by the type of systemic antibiotic therapy prescribed.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Tolerance and safety of treatment with oral vancomycin</measure>
<time_frame>60 days after the beginning of the intervention</time_frame>
<description>Rate of major adverse events and drug-related adverse events.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">108</enrollment>
<condition>Clostridioides Difficile Infection</condition>
<arm_group>
<arm_group_label>Intervention group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>A group of patients will be treated with a blinded capsule that contains 125mg of vancomycin every 6 hours for 10 days.</description>
</arm_group>
<arm_group>
<arm_group_label>Placebo group</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>A group of patients will be treated with a blinded capsule that contains a placebo every 6 hours for 10 days.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Oral Vancomycin</intervention_name>
<description>A blinded capsule that contains 125mg of vancomycin every 6 hours during 10 days.</description>
<arm_group_label>Intervention group</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Placebo</intervention_name>
<description>A blinded capsule that contains no vancomycin every 6 hours during 10 days.</description>
<arm_group_label>Placebo group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Age equal or superior to 18 years

- Previous history of Clostridioides difficile infection in the 90 days before the study
enrolment

- Need for hospitalization and need of antibiotic therapy

- Signature of informed consent

Exclusion Criteria:

- Woman of childbearing age, pregnant woman, or breastfeeding woman

- Hypersensitivity to vancomycin

- Inability to comply with study protocol

- Critically ill condition or life expectancy less than 30 days

- Patients with diagnosed inflammatory bowel disease or with any conditions that produce
chronic diarrhea

- Fulfilment of the criteria for diarrhea or diagnosis of CDI at the time of assessment
for eligibility or in the previous 3 days

- Therapy with oral vancomycin or any other agent with activity against C. difficile for
>48 hours in the previous 3 days;.

- Prophylaxis with oral vancomycin or any other agent with activity against C. difficile
within the 70 days before the assessment for eligibility

- Systemic antibiotic therapy for 72 hours or more before the recruitment

- Ongoing enrolment in another RCT evaluating the effectiveness of other drugs

- Estimated use of systemic antibiotic therapy for more than 4 weeks
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>RAFAEL SAN-JUAN</last_name>
<role>Study Chair</role>
<affiliation>HOSPITAL 12 DE OCTUBRE</affiliation>
</overall_official>
<overall_contact>
<last_name>RAFAEL SAN-JUAN, M.D</last_name>
<phone>0034609488076</phone>
<email>rafael.san@salud.madrid.org</email>
</overall_contact>
<location>
<facility>
<name>Rafael San Juan</name>
<address>
<city>Madrid</city>
<zip>28032</zip>
<country>Spain</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>RAFAEL SAN-JUAN, MD.PhD.</last_name>
<phone>609488076</phone>
<phone_ext>4843</phone_ext>
<email>rafasjg@yahoo.es</email>
</contact>
<contact_backup>
<last_name>José María Aguado, MD. PhD.</last_name>
<phone>0034913908000</phone>
<phone_ext>4632</phone_ext>
<email>jaguadog1@gmail.com</email>
</contact_backup>
</location>
<location_countries>
<country>Spain</country>
</location_countries>
<reference>
<citation>Magill SS, Edwards JR, Bamberg W, Beldavs ZG, Dumyati G, Kainer MA, Lynfield R, Maloney M, McAllister-Hollod L, Nadle J, Ray SM, Thompson DL, Wilson LE, Fridkin SK; Emerging Infections Program Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Team. Multistate point-prevalence survey of health care-associated infections. N Engl J Med. 2014 Mar 27;370(13):1198-208. doi: 10.1056/NEJMoa1306801. Erratum In: N Engl J Med. 2022 Jun 16;386(24):2348.</citation>
<PMID>24670166</PMID>
</reference>
<reference>
<citation>Rauseo AM, Olsen MA, Reske KA, Dubberke ER. Strategies to prevent adverse outcomes following Clostridioides difficile infection in the elderly. Expert Rev Anti Infect Ther. 2020 Mar;18(3):203-217. doi: 10.1080/14787210.2020.1717950. Epub 2020 Jan 27.</citation>
<PMID>31976779</PMID>
</reference>
<reference>
<citation>Asensio A, Monge D. [Epidemiology of Clostridium difficile infection in Spain]. Enferm Infecc Microbiol Clin. 2012 Jun;30(6):333-7. doi: 10.1016/j.eimc.2011.09.010. Epub 2011 Dec 2. Spanish.</citation>
<PMID>22136747</PMID>
</reference>
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<citation>Asensio A, Vaque-Rafart J, Calbo-Torrecillas F, Gestal-Otero JJ, Lopez-Fernandez F, Trilla-Garcia A, Canton R; EPINE Working Group. Increasing rates in Clostridium difficile infection (CDI) among hospitalised patients, Spain 1999-2007. Euro Surveill. 2008 Jul 31;13(31):18943.</citation>
<PMID>18761902</PMID>
</reference>
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<citation>McDonald LC, Owings M, Jernigan DB. Clostridium difficile infection in patients discharged from US short-stay hospitals, 1996-2003. Emerg Infect Dis. 2006 Mar;12(3):409-15. doi: 10.3201/eid1205.051064.</citation>
<PMID>16704777</PMID>
</reference>
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<citation>Eyre DW, Walker AS, Wyllie D, Dingle KE, Griffiths D, Finney J, O'Connor L, Vaughan A, Crook DW, Wilcox MH, Peto TE; Infections in Oxfordshire Research Database. Predictors of first recurrence of Clostridium difficile infection: implications for initial management. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S77-87. doi: 10.1093/cid/cis356.</citation>
<PMID>22752869</PMID>
</reference>
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<citation>Rodriguez-Pardo D, Almirante B, Bartolome RM, Pomar V, Mirelis B, Navarro F, Soriano A, Sorli L, Martinez-Montauti J, Molins MT, Lung M, Vila J, Pahissa A; Barcelona Clostridium difficile Study Group. Epidemiology of Clostridium difficile infection and risk factors for unfavorable clinical outcomes: results of a hospital-based study in Barcelona, Spain. J Clin Microbiol. 2013 May;51(5):1465-73. doi: 10.1128/JCM.03352-12. Epub 2013 Feb 27.</citation>
<PMID>23447638</PMID>
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<citation>Kelly CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012 Dec;18 Suppl 6:21-7. doi: 10.1111/1469-0691.12046.</citation>
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<citation>Leav BA, Blair B, Leney M, Knauber M, Reilly C, Lowy I, Gerding DN, Kelly CP, Katchar K, Baxter R, Ambrosino D, Molrine D. Serum anti-toxin B antibody correlates with protection from recurrent Clostridium difficile infection (CDI). Vaccine. 2010 Jan 22;28(4):965-9. doi: 10.1016/j.vaccine.2009.10.144. Epub 2009 Nov 24.</citation>
<PMID>19941990</PMID>
</reference>
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<citation>Pepin J, Alary ME, Valiquette L, Raiche E, Ruel J, Fulop K, Godin D, Bourassa C. Increasing risk of relapse after treatment of Clostridium difficile colitis in Quebec, Canada. Clin Infect Dis. 2005 Jun 1;40(11):1591-7. doi: 10.1086/430315. Epub 2005 Apr 25.</citation>
<PMID>15889355</PMID>
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<citation>Hu MY, Katchar K, Kyne L, Maroo S, Tummala S, Dreisbach V, Xu H, Leffler DA, Kelly CP. Prospective derivation and validation of a clinical prediction rule for recurrent Clostridium difficile infection. Gastroenterology. 2009 Apr;136(4):1206-14. doi: 10.1053/j.gastro.2008.12.038. Epub 2008 Dec 13.</citation>
<PMID>19162027</PMID>
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<citation>Deshpande A, Pasupuleti V, Thota P, Pant C, Rolston DD, Hernandez AV, Donskey CJ, Fraser TG. Risk factors for recurrent Clostridium difficile infection: a systematic review and meta-analysis. Infect Control Hosp Epidemiol. 2015 Apr;36(4):452-60. doi: 10.1017/ice.2014.88. Epub 2015 Jan 28.</citation>
<PMID>25626326</PMID>
</reference>
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<citation>Cadena J, Thompson GR 3rd, Patterson JE, Nakashima B, Owens A, Echevarria K, Mortensen EM. Clinical predictors and risk factors for relapsing Clostridium difficile infection. Am J Med Sci. 2010 Apr;339(4):350-5. doi: 10.1097/MAJ.0b013e3181d3cdaa.</citation>
<PMID>20224312</PMID>
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<citation>Ghantoji SS, Sail K, Lairson DR, DuPont HL, Garey KW. Economic healthcare costs of Clostridium difficile infection: a systematic review. J Hosp Infect. 2010 Apr;74(4):309-18. doi: 10.1016/j.jhin.2009.10.016. Epub 2010 Feb 12.</citation>
<PMID>20153547</PMID>
</reference>
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<citation>Larrainzar-Coghen T, Rodriguez-Pardo D, Puig-Asensio M, Rodriguez V, Ferrer C, Bartolome R, Pigrau C, Fernandez-Hidalgo N, Pumarola T, Almirante B. First recurrence of Clostridium difficile infection: clinical relevance, risk factors, and prognosis. Eur J Clin Microbiol Infect Dis. 2016 Mar;35(3):371-8. doi: 10.1007/s10096-015-2549-9. Epub 2016 Jan 11.</citation>
<PMID>26753991</PMID>
</reference>
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<citation>Carpenter BP, Hennessey EK, Bryant AM, Khoury JA, Crannage AJ. Identification of Factors Impacting Recurrent Clostridium difficile Infection and Development of a Risk Evaluation Tool. J Pharm Pharm Sci. 2016 Jul-Sep;19(3):349-356. doi: 10.18433/J32S41.</citation>
<PMID>27806252</PMID>
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<citation>Zilberberg MD, Reske K, Olsen M, Yan Y, Dubberke ER. Risk factors for recurrent Clostridium difficile infection (CDI) hospitalization among hospitalized patients with an initial CDI episode: a retrospective cohort study. BMC Infect Dis. 2014 Jun 4;14:306. doi: 10.1186/1471-2334-14-306.</citation>
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</reference>
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<citation>Aldape MJ, Rice SN, Field KP, Bryant AE, Stevens DL. Sub-lethal doses of surotomycin and vancomycin have similar effects on Clostridium difficile virulence factor production in vitro. J Med Microbiol. 2018 Dec;67(12):1689-1697. doi: 10.1099/jmm.0.000852. Epub 2018 Oct 11.</citation>
<PMID>30307842</PMID>
</reference>
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</reference>
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<PMID>22321770</PMID>
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<PMID>24799326</PMID>
</reference>
<reference>
<citation>Louie TJ, Miller MA, Mullane KM, Weiss K, Lentnek A, Golan Y, Gorbach S, Sears P, Shue YK; OPT-80-003 Clinical Study Group. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011 Feb 3;364(5):422-31. doi: 10.1056/NEJMoa0910812.</citation>
<PMID>21288078</PMID>
</reference>
<reference>
<citation>Weiss K, Allgren RL, Sellers S. Safety analysis of fidaxomicin in comparison with oral vancomycin for Clostridium difficile infections. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S110-5. doi: 10.1093/cid/cis390.</citation>
<PMID>22752858</PMID>
</reference>
<reference>
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<PMID>3110198</PMID>
</reference>
<verification_date>April 2023</verification_date>
<study_first_submitted>March 22, 2022</study_first_submitted>
<study_first_submitted_qc>April 8, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>April 20, 2023</last_update_submitted>
<last_update_submitted_qc>April 20, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">April 24, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>Hospital Universitario 12 de Octubre</investigator_affiliation>
<investigator_full_name>Julia Orígüen</investigator_full_name>
<investigator_title>Julia Origüen Sabater, MD, PhD, Principal Investigator.</investigator_title>
</responsible_party>
<keyword>Vancomycin oral capsules</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Infections</mesh_term>
<mesh_term>Communicable Diseases</mesh_term>
<mesh_term>Clostridium Infections</mesh_term>
<mesh_term>Recurrence</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Vancomycin</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>All IPD that underlie results in a publication will be shared</ipd_description>
<ipd_info_type>Study Protocol</ipd_info_type>
<ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
<ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
<ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
<ipd_time_frame>Data generated by the research will be made available as soon as possible, wherever legally and ethically possible. It is Planned to share data starting 9 months after publication, and data will be available for 24 months thereafter.</ipd_time_frame>
<ipd_access_criteria>IPD will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Proposals should be directed to rafael.san@salud.madrid.org. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
A phase III randomized clinical trial in proportion 2:1 in favor of oral vancomycin
(experimental treatment), multicentric, national, double-blinded, controlled with placebo.
The main objective is to evaluate the effectiveness of treatment with oral vancomycin to
reduce the incidence of Clostridioides difficile infection (CDI) in patients who suffered
previous CDI and who need further hospitalization and treatment with systemic antibiotic
therapy in the 90 days after the first CDI.
As secondary objectives the investigators intend to:
- Evaluate the effectiveness of the treatment with oral vancomycin as part of the
prophylaxis arsenal to prevent ICD in patients with previous ICD episodes stratified by
the number of previous recurrences.
- Compare the severity of recurrences in both study groups.
- Compare the effectiveness of the treatment with oral vancomycin depending on the type of
systemic antibiotic therapy prescribed.
- Evaluate the tolerance and the safety of the treatment with oral vancomycin in terms of
secondary effects and difficulty in therapeutic compliance.
- Evaluate if the treatment with oral vancomycin has an effect in diminishing the severity
of ICD recurrences.
Inclusion Criteria:
- Age equal or superior to 18 years
- Previous history of Clostridioides difficile infection in the 90 days before the study
enrolment
- Need for hospitalization and need of antibiotic therapy
- Signature of informed consent
Exclusion Criteria:
- Woman of childbearing age, pregnant woman, or breastfeeding woman
- Hypersensitivity to vancomycin
- Inability to comply with study protocol
- Critically ill condition or life expectancy less than 30 days
- Patients with diagnosed inflammatory bowel disease or with any conditions that produce
chronic diarrhea
- Fulfilment of the criteria for diarrhea or diagnosis of CDI at the time of assessment
for eligibility or in the previous 3 days
- Therapy with oral vancomycin or any other agent with activity against C. difficile for
>48 hours in the previous 3 days;.
- Prophylaxis with oral vancomycin or any other agent with activity against C. difficile
within the 70 days before the assessment for eligibility
- Systemic antibiotic therapy for 72 hours or more before the recruitment
- Ongoing enrolment in another RCT evaluating the effectiveness of other drugs
- Estimated use of systemic antibiotic therapy for more than 4 weeks
|
NCT0532xxxx/NCT05320081.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320081</url>
</required_header>
<id_info>
<org_study_id>MA-ML-Ⅱ-001</org_study_id>
<nct_id>NCT05320081</nct_id>
</id_info>
<brief_title>Camrelizumab Combined With CD30 CAR-T in the Treatment of Relapsed/Refractory CD30+ Lymphoma</brief_title>
<official_title>Camrelizumab Combined With CD30 CAR-T in the Treatment of Relapsed/Refractory CD30+ Lymphoma: a Single-arm, Open-label Clinical Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Huazhong University of Science and Technology</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>The First Affiliated Hospital of Nanchang University</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Huazhong University of Science and Technology</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The is a phase II, single-arm, open-label clinical study assessing the efficacy and safety of
Camrelizumab combined with CD30 CAR-T in the treatment of r/r CD30+ lymphoma. Plan to recruit
30 subjects with r/r CD30+ lymphoma。
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This study intends to combine CD30 CAR-T (provided by Wuhan Bio-Raid Biotechnology Co., Ltd)
and Camrelizumab (provided by Jiangsu Hengrui Pharmaceutical Co., Ltd.) to treat r/r CD30+
lymphoma, to observe the safety and effectiveness of the combined treatment, and to study the
effect of PD-1 antibody on the pharmacokinetics and pharmacodynamics of CAR-T. Obtain a
better treatment plan and provide a new strategy for the treatment of clinically r/r CD30+
lymphoma.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">November 30, 2021</start_date>
<completion_date type="Anticipated">June 30, 2024</completion_date>
<primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>overall response rate</measure>
<time_frame>up to 3 months after CAR-T cell infusion</time_frame>
<description>including complete remission (CR) or partial remission (PR)</description>
</primary_outcome>
<primary_outcome>
<measure>Number of participants with treatment-related adverse events as assessed by CTCAE v5.0</measure>
<time_frame>up to 90 days</time_frame>
<description>To evaluate the safety of camrelizumab combined with CD30 CAR-T in the treatment of relapsed/refractory CD30+ lymphoma.</description>
</primary_outcome>
<secondary_outcome>
<measure>overall survival (OS)</measure>
<time_frame>24 months</time_frame>
<description>The time from the day of enrollment to death due to any cause. If it is unclear whether the subject has died, OS refers to the duration from the day of enrollment to the date of the last follow-up.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Duration of remission (DOR)</measure>
<time_frame>24 months</time_frame>
<description>Defined as the time between the initial appearance of complete or partial remission for a subject in objective remission to the appearance of disease recurrence or death from any cause (whichever occurs first).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Progression-free Survival (PFS)</measure>
<time_frame>24 months</time_frame>
<description>The time from the start of the trial to the day of PD or to death due to any reason. If the subject's disease status is unclear, PFS refers to the duration from the day of enrollment to the date of the last follow-up.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Time to Remission (TTR).</measure>
<time_frame>12 months</time_frame>
<description>The time from the first day of medication to the first assessment of PR or CR, whichever comes first. Only applicable to subjects with CR or PR.</description>
</secondary_outcome>
<other_outcome>
<measure>The copy number of CD30 CAR-T cells</measure>
<time_frame>12 months</time_frame>
<description>The copy number of CD30 CAR-T cells amplified (copies/mcgDNA) in peripheral blood after administration;</description>
</other_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">30</enrollment>
<condition>Lymphoma</condition>
<condition>Relapse/Recurrence</condition>
<arm_group>
<arm_group_label>Camrelizumab combined with CD30 CAR-T</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>This study have only one arm that is Camrelizumab combined with CD30 CAR-T experimental arm.</description>
</arm_group>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>CD30 CAR-T</intervention_name>
<description>Subjects need to complete a series of checks before reinfusion of CD30 CAR-T cells as baseline information for subjects after non-myeloablative pretreatment. The subject was reinfused with CD30 CAR-T cells (10±3)×10^6/kg on the 0th day of the first dosing cycle (the investigator decided the specific reinfusion dose based on the subject's own/disease conditions and preparation conditions in vitro ), concurrent oxygen inhalation and monitoring (ECG, blood pressure and blood oxygen monitoring). The reinfusion was completed in about 30 minutes, and the tube was flushed with saline.
Note: CAR-T cell infusion and reinfusion dose are based on the subject's condition.</description>
<arm_group_label>Camrelizumab combined with CD30 CAR-T</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Camrelizumab</intervention_name>
<description>Received Camrelizumab treatment on the 15th day after CAR-T cell reinfusion, and then received Camrelizumab treatment every 2 weeks.</description>
<arm_group_label>Camrelizumab combined with CD30 CAR-T</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- age≥18 years and ≤70 years，female and male；

- ECOG performance status 0-2；

- Histological or flow cytometry confirmed CD30+ lymphoma [according to WHO2008
diagnostic standard]

- Patients with CD30+ lymphoma relapsed after ≥2 lines of systemic treatment (the
disease progresses after treatment remission) or refractory ( failed to obtain CR
after previous systemic treatment)；

- The patient did not receive any chemotherapy, radiotherapy, immunotherapy (such as
immunosuppressive drugs) and other anti-cancer treatments within 4 weeks before
enrollment, and the treatment-related toxicity has recovered to ≤ Grade 1 (except for
alopecia) 4 weeks before enrollment；

- At least 1 evaluable or measurable lesion can be measured according to the LYRIC 2016
evaluation criteria for malignant lymphoma ；

- Sufficient organ and bone marrow function, no serious abnormalities neither in
hematopoietic function nor in heart, lung, liver, and kidney functions, and no immune
deficiencies;

1. The absolute value of neutrophils is ≥1.5×109/L (for patients with bone marrow
invasion ≥1.0×109/L);

2. Platelets ≥75×109/L (patients with bone marrow invasion ≥50×109/L);

3. Hemoglobin ≥9 g/dL;

4. Serum creatinine ≤ 1.5× the upper limit of normal (ULN), or creatinine clearance
≥40 mL/min (estimated based on the Cockcroft-Gault formula);

5. Serum total bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN ( liver invasion);.

6. f) Aspartate aminotransferase、Alanine Aminotransferase (ALT) ≤2.5 × ULN or ≤5 ×
ULN ( liver invasion);

7. Coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN;
Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN
(the PT and APTT should be within the expected range of anticoagulant therapy at
the time of screening if the subject is receiving anticoagulant therapy,).

8. Thyroid-stimulating hormone (TSH) or free thyroxine (FT4) or free
triiodothyronine (FT3) are within ±10% of the normal value.

9. Left ventricular ejection fraction (LVEF) ≥ 50%, no serious malignant arrhythmia;

- The estimated survival time ≥6 months;

- Sufficient understanding and voluntarily to sign the informed consent form;

- Patients with fertility must be willing to be able to use reliable contraceptive
measures during the clinical study and within 12 months after the last administration

Exclusion Criteria:

- Lymphoma associated hemophagocytic syndrome;

- Patients diagnosed as primary cutaneous anaplastic large cell lymphoma （ALCL）
(patients can be enrolled if ALCL is transformed from other organ involvement);

- Patients with malignant T cells involving bone marrow or peripheral blood;

- Suffered from other malignant tumors in the past 5 years, except for for skin basal
cell carcinoma, skin squamous cell carcinoma, breast carcinoma in situ and cervical
carcinoma in situ undergoing the radical treatment

- Received CAR-T therapy or other genetically modified cell therapy before screening

- Received other treatments that affect the collection of T cells for when enrolled or
within 4 weeks before enrollment;

- Suffer from active autoimmune diseases that require systemic treatment in the past two
years (hormone replacement therapy is not considered as systemic treatment, such as
type I diabetes, hypothyroidism that requires only thyroxine replacement therapy,
patients with low adrenal function or hypopituitarism who need only physiological
doses of glucocorticoid replacement therapy);

- Patients with uncontrolled infectious diseases, active viral hepatitis, tuberculosis,
and HIV-infected ;

- Known to be allergic to ampicillin, antibodies, cytokines, anti-PD-1/PD-L1 antibodies
or pharmaceutical excipients; or have severe allergic reactions to other monoclonal
antibodies;

- Previous use of immunosuppressive drugs within 14 days before the first use of the
drug, excluding nasal sprays and inhaled corticosteroids or physiological doses of
systemic steroid hormones (ie not more than 10 mg/day prednisolone or equivalent
physiological doses of other corticosteroids);

- long-term use of systemic hormones (dose equivalent to >10mg prednisone/day) or any
other form of immunosuppressive therapy is required. Subjects using inhaled or topical
corticosteroids can be enrolled;

- Suffer from uncontrolled comorbidities, including but not limited to symptomatic
congestive heart failure, uncontrolled hypertension, unstable angina, active peptic
ulcer or bleeding disorders.

- With history of interstitial lung disease or non-infectious pneumonia. Subjects who
have previously had drug-induced or radioactive non-infectious pneumonia but
asymptomatic are allowed to enroll.

- Patients have other conditions that are not suitable for enrollment according to the
judgment of the investigator.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>70 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Jianfeng Zhou</last_name>
<role>Principal Investigator</role>
<affiliation>Huazhong University of Science and Technology</affiliation>
</overall_official>
<overall_contact>
<last_name>Jianfeng Zhou, MD, PhD</last_name>
<phone>86-13627284963</phone>
<email>jfzhou@tjh.tjmu.edu.cn</email>
</overall_contact>
<overall_contact_backup>
<last_name>Xiaoxi Zhou, MD, PhD</last_name>
<phone>86-027-83662686</phone>
<email>cello316@tjh.tjmu.edu.cn</email>
</overall_contact_backup>
<location>
<facility>
<name>Department of Hematology Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
<address>
<city>Wuhan</city>
<state>Hubei</state>
<zip>430030</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Jianfeng Zhou, PhD</last_name>
<phone>86-13627284963</phone>
<email>jfzhou@tjh.tjmu.edu.cn</email>
</contact>
</location>
<location>
<facility>
<name>The First Affiliated Hospital of Nanchang University</name>
<address>
<city>Nanchang</city>
<state>Jiangxi</state>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Fei Li, PhD</last_name>
<phone>13970038386</phone>
<email>yx021021@sina.com</email>
</contact>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>November 24, 2021</study_first_submitted>
<study_first_submitted_qc>April 8, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>April 8, 2022</last_update_submitted>
<last_update_submitted_qc>April 8, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 11, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
<investigator_full_name>Jianfeng Zhou</investigator_full_name>
<investigator_title>Director of the Division of Hematology</investigator_title>
</responsible_party>
<keyword>CD30 positive</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Lymphoma</mesh_term>
<mesh_term>Recurrence</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The is a phase II, single-arm, open-label clinical study assessing the efficacy and safety of
Camrelizumab combined with CD30 CAR-T in the treatment of r/r CD30+ lymphoma. Plan to recruit
30 subjects with r/r CD30+ lymphoma。
This study intends to combine CD30 CAR-T (provided by Wuhan Bio-Raid Biotechnology Co., Ltd)
and Camrelizumab (provided by Jiangsu Hengrui Pharmaceutical Co., Ltd.) to treat r/r CD30+
lymphoma, to observe the safety and effectiveness of the combined treatment, and to study the
effect of PD-1 antibody on the pharmacokinetics and pharmacodynamics of CAR-T. Obtain a
better treatment plan and provide a new strategy for the treatment of clinically r/r CD30+
lymphoma.
Inclusion Criteria:
- age≥18 years and ≤70 years，female and male；
- ECOG performance status 0-2；
- Histological or flow cytometry confirmed CD30+ lymphoma [according to WHO2008
diagnostic standard]
- Patients with CD30+ lymphoma relapsed after ≥2 lines of systemic treatment (the
disease progresses after treatment remission) or refractory ( failed to obtain CR
after previous systemic treatment)；
- The patient did not receive any chemotherapy, radiotherapy, immunotherapy (such as
immunosuppressive drugs) and other anti-cancer treatments within 4 weeks before
enrollment, and the treatment-related toxicity has recovered to ≤ Grade 1 (except for
alopecia) 4 weeks before enrollment；
- At least 1 evaluable or measurable lesion can be measured according to the LYRIC 2016
evaluation criteria for malignant lymphoma ；
- Sufficient organ and bone marrow function, no serious abnormalities neither in
hematopoietic function nor in heart, lung, liver, and kidney functions, and no immune
deficiencies;
1. The absolute value of neutrophils is ≥1.5×109/L (for patients with bone marrow
invasion ≥1.0×109/L);
2. Platelets ≥75×109/L (patients with bone marrow invasion ≥50×109/L);
3. Hemoglobin ≥9 g/dL;
4. Serum creatinine ≤ 1.5× the upper limit of normal (ULN), or creatinine clearance
≥40 mL/min (estimated based on the Cockcroft-Gault formula);
5. Serum total bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN ( liver invasion);.
6. f) Aspartate aminotransferase、Alanine Aminotransferase (ALT) ≤2.5 × ULN or ≤5 ×
ULN ( liver invasion);
7. Coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN;
Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN
(the PT and APTT should be within the expected range of anticoagulant therapy at
the time of screening if the subject is receiving anticoagulant therapy,).
8. Thyroid-stimulating hormone (TSH) or free thyroxine (FT4) or free
triiodothyronine (FT3) are within ±10% of the normal value.
9. Left ventricular ejection fraction (LVEF) ≥ 50%, no serious malignant arrhythmia;
- The estimated survival time ≥6 months;
- Sufficient understanding and voluntarily to sign the informed consent form;
- Patients with fertility must be willing to be able to use reliable contraceptive
measures during the clinical study and within 12 months after the last administration
Exclusion Criteria:
- Lymphoma associated hemophagocytic syndrome;
- Patients diagnosed as primary cutaneous anaplastic large cell lymphoma （ALCL）
(patients can be enrolled if ALCL is transformed from other organ involvement);
- Patients with malignant T cells involving bone marrow or peripheral blood;
- Suffered from other malignant tumors in the past 5 years, except for for skin basal
cell carcinoma, skin squamous cell carcinoma, breast carcinoma in situ and cervical
carcinoma in situ undergoing the radical treatment
- Received CAR-T therapy or other genetically modified cell therapy before screening
- Received other treatments that affect the collection of T cells for when enrolled or
within 4 weeks before enrollment;
- Suffer from active autoimmune diseases that require systemic treatment in the past two
years (hormone replacement therapy is not considered as systemic treatment, such as
type I diabetes, hypothyroidism that requires only thyroxine replacement therapy,
patients with low adrenal function or hypopituitarism who need only physiological
doses of glucocorticoid replacement therapy);
- Patients with uncontrolled infectious diseases, active viral hepatitis, tuberculosis,
and HIV-infected ;
- Known to be allergic to ampicillin, antibodies, cytokines, anti-PD-1/PD-L1 antibodies
or pharmaceutical excipients; or have severe allergic reactions to other monoclonal
antibodies;
- Previous use of immunosuppressive drugs within 14 days before the first use of the
drug, excluding nasal sprays and inhaled corticosteroids or physiological doses of
systemic steroid hormones (ie not more than 10 mg/day prednisolone or equivalent
physiological doses of other corticosteroids);
- long-term use of systemic hormones (dose equivalent to >10mg prednisone/day) or any
other form of immunosuppressive therapy is required. Subjects using inhaled or topical
corticosteroids can be enrolled;
- Suffer from uncontrolled comorbidities, including but not limited to symptomatic
congestive heart failure, uncontrolled hypertension, unstable angina, active peptic
ulcer or bleeding disorders.
- With history of interstitial lung disease or non-infectious pneumonia. Subjects who
have previously had drug-induced or radioactive non-infectious pneumonia but
asymptomatic are allowed to enroll.
- Patients have other conditions that are not suitable for enrollment according to the
judgment of the investigator.
|
NCT0532xxxx/NCT05320094.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320094</url>
</required_header>
<id_info>
<org_study_id>CV027-043</org_study_id>
<nct_id>NCT05320094</nct_id>
</id_info>
<brief_title>A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants</brief_title>
<official_title>An Open-label Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Pharmacokinetics of Mavacamten in Healthy Participants</official_title>
<sponsors>
<lead_sponsor>
<agency>Bristol-Myers Squibb</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Bristol-Myers Squibb</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this study is to evaluate the effects of co-administration of activated
charcoal with sorbitol on the single-dose drug levels of mavacamten in healthy participants.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">April 15, 2022</start_date>
<completion_date type="Actual">September 11, 2022</completion_date>
<primary_completion_date type="Actual">September 11, 2022</primary_completion_date>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))</measure>
<time_frame>Up to 2 months</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T))</measure>
<time_frame>Up to 2 months</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Maximum observed plasma concentration (Cmax)</measure>
<time_frame>Up to 1 month</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>Number of participants with adverse events (AEs)</measure>
<time_frame>Up to 3 months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Number of participants with serious adverse events (SAEs)</measure>
<time_frame>Up to 3 months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Number of participants with vital sign abnormalities exceeding predefined thresholds</measure>
<time_frame>Up to 3 months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Number of participants with electrocardiogram (ECG) abnormalities</measure>
<time_frame>Up to 3 Months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Number of participants with physical exam abnormalities</measure>
<time_frame>Up to 3 months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Number of participants with clinical laboratory evaluation abnormalities</measure>
<time_frame>Up to 3 months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Time of maximum observed plasma concentration (Tmax)</measure>
<time_frame>Up to 1 month</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Apparent terminal plasma half-life (T-HALF)</measure>
<time_frame>Up to 2 months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Concentration at 24 hours (C24)</measure>
<time_frame>Up to 1 month</time_frame>
</secondary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Actual">45</enrollment>
<condition>Healthy Participants</condition>
<arm_group>
<arm_group_label>Mavacamten</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>Mavacamten and activated charcoal with sorbitol - Dose A</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>Mavacamten and activated charcoal with sorbitol - Dose B</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Mavacamten</intervention_name>
<description>Specified dose on specified days</description>
<arm_group_label>Mavacamten</arm_group_label>
<arm_group_label>Mavacamten and activated charcoal with sorbitol - Dose A</arm_group_label>
<arm_group_label>Mavacamten and activated charcoal with sorbitol - Dose B</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Activated Charcoal with Sorbitol</intervention_name>
<description>Specified dose on specified days</description>
<arm_group_label>Mavacamten and activated charcoal with sorbitol - Dose A</arm_group_label>
<arm_group_label>Mavacamten and activated charcoal with sorbitol - Dose B</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Body mass index between 18 and 30 kg/m^2, inclusive, at the Screening Visit

- Healthy, as determined by physical examination, vital signs, electrocardiograms
(ECGs), and clinical laboratory assessments

Exclusion Criteria:

- Current or recent (within 3 months of study intervention administration)
gastrointestinal disease

- History of sorbitol or fructose intolerance or inability to tolerate activated
charcoal

- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)

Other protocol-defined inclusion/exclusion criteria apply
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>60 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Bristol-Myers Squibb</last_name>
<role>Study Director</role>
<affiliation>Bristol-Myers Squibb</affiliation>
</overall_official>
<location>
<facility>
<name>Local Institution - 0001</name>
<address>
<city>Dallas</city>
<state>Texas</state>
<zip>75247-4989</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
<description>BMS Clinical Trial Information</description>
</link>
<link>
<url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
<description>BMS Clinical Trial Patient Recruiting</description>
</link>
<link>
<url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
<description>FDA Safety Alerts and Recalls</description>
</link>
<verification_date>October 2022</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>November 4, 2022</last_update_submitted>
<last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">November 8, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Mavacamten</keyword>
<keyword>Sorbitol</keyword>
<keyword>Activated Charcoal</keyword>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Sorbitol</mesh_term>
<mesh_term>Charcoal</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purpose of this study is to evaluate the effects of co-administration of activated
charcoal with sorbitol on the single-dose drug levels of mavacamten in healthy participants.
Inclusion Criteria:
- Body mass index between 18 and 30 kg/m^2, inclusive, at the Screening Visit
- Healthy, as determined by physical examination, vital signs, electrocardiograms
(ECGs), and clinical laboratory assessments
Exclusion Criteria:
- Current or recent (within 3 months of study intervention administration)
gastrointestinal disease
- History of sorbitol or fructose intolerance or inability to tolerate activated
charcoal
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
Other protocol-defined inclusion/exclusion criteria apply
|
NCT0532xxxx/NCT05320107.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320107</url>
</required_header>
<id_info>
<org_study_id>PSY-NIL-0010</org_study_id>
<nct_id>NCT05320107</nct_id>
</id_info>
<brief_title>The Effect of Ketamine on Aesthetics and Role for Antidepressant Effects</brief_title>
<official_title>Unraveling the Aesthetic Mind in Anhedonia, Insights From Pharmacological Imaging of the Human Brain: A Single-blind, Randomized, Placebo-controlled Cross-over Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Medical University of Vienna</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Medical University of Vienna</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
<is_us_export>No</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
The aim of this study is to assess the impact of ketamine on aesthetic perception and
processing. This study assesses the role of these effects in facilitating ketamine's
antidepressant properties, with a focus on anhedonia. To address this aim, 25 patients with
major depressive disorder and 35 healthy controls will be assessed twice with magnetic
resonance imaging, once after administration of intravenous ketamine (subanesthetic dose) and
once after administration of placebo.This study has a single-center, placebo-controlled,
cross-over study design. During MRI, structural, resting state, and functional imaging will
be performed. Functional imaging will comprise aesthetic processing, reward, and sexual
arousal paradigms. In addition, various neuropsychological scales assessing depressive
symptoms, anhedonia, and aesthetic processing will be performed. Eligibility for
participation will be assessed during a screening visit, a follow up visit will end study
participation.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">June 1, 2022</start_date>
<completion_date type="Anticipated">February 28, 2025</completion_date>
<primary_completion_date type="Anticipated">February 28, 2025</primary_completion_date>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Crossover Assignment</intervention_model>
<primary_purpose>Basic Science</primary_purpose>
<masking>Single (Participant)</masking>
</study_design_info>
<primary_outcome>
<measure>BOLD signal assessed with fMRI during aesthetic paradigm</measure>
<time_frame>Change from baseline to up to 4 weeks</time_frame>
<description>Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during an aesthetic processing task</description>
</primary_outcome>
<primary_outcome>
<measure>BOLD signal assessed with fMRI during reward paradigm</measure>
<time_frame>Change from baseline to up to 4 weeks</time_frame>
<description>Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during a reward processing task</description>
</primary_outcome>
<primary_outcome>
<measure>BOLD signal assessed with fMRI during sexual arousal paradigm</measure>
<time_frame>Change from baseline to up to 4 weeks</time_frame>
<description>Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during a sexual arousal paradigm</description>
</primary_outcome>
<primary_outcome>
<measure>Levels of pleasantness assessed during aesthetic fMRI task</measure>
<time_frame>Change from baseline to up to 4 weeks</time_frame>
<description>Level of pleasantness (Numbered scale) of aesthetic stimuli during aesthetic paradigm task</description>
</primary_outcome>
<primary_outcome>
<measure>Number of of chills assessed during aesthetic fMRI task</measure>
<time_frame>Change from baseline to up to 4 weeks</time_frame>
<description>Number of chills in response to aesthetic stimuli during aesthetic paradigm task</description>
</primary_outcome>
<primary_outcome>
<measure>BOLD signal assessed with fMRI during resting state</measure>
<time_frame>Change from baseline to up to 4 weeks</time_frame>
<description>Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during resting state</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">60</enrollment>
<condition>Major Depressive Disorder</condition>
<arm_group>
<arm_group_label>Ketamine first, then placebo</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>0.5mg/kg bodyweight (or 0.25mg/kg bodyweight) ketamine, will be determined in pilot study, then placebo</description>
</arm_group>
<arm_group>
<arm_group_label>Placebo frist, then ketamine</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>0.9% NaCl, then ketamine</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Ketamine</intervention_name>
<description>0.5mg/kg bodyweight (or 0.25mg/kg bodyweight) ketamine, will be determined in pilot study</description>
<arm_group_label>Ketamine first, then placebo</arm_group_label>
<arm_group_label>Placebo frist, then ketamine</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Placebo</intervention_name>
<description>0.9% NaCl</description>
<arm_group_label>Ketamine first, then placebo</arm_group_label>
<arm_group_label>Placebo frist, then ketamine</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- General health based on medical history and physical examination

- Psychiatric health based on structured clinical interview for DSM-5 (SCID) for healthy
controls

- Major depressive episode (first or recurrent) based on structured clinical interview
for DSM-5 and ICD-10 for patients

- Age 18 to 55 years

- Right-handedness (due to potential lateralization effects of lefthanded subjects)

- Willingness and competence to sign the informed consent form

Exclusion Criteria:

- Current or history of neurological disease

- Current medical illness requiring treatment

- Psychiatric diagnosis for healthy individuals

- Psychiatric comorbidity with the exception of anxiety disorders for depressed
individuals

- Pregnancy or current breastfeeding

- Current or former substance abuse

- Previous ketamine use in lifetime

- Any contraindication for MRI (e.g., MR incompatible implants, etc.) including dental
implants causing signal artifacts

- Failure to comply with the study protocol or to follow the instruction of the
investigating team
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>55 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Rupert Lanzenberger, MD</last_name>
<phone>0043 1 40400</phone>
<phone_ext>35760</phone_ext>
<email>rupert.lanzenberger@meduniwien.ac.at</email>
</overall_contact>
<location>
<facility>
<name>Medical University of Vienna</name>
<address>
<city>Vienna</city>
<zip>1090</zip>
<country>Austria</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Rupert Lanzenberger, MD</last_name>
</contact>
</location>
<location_countries>
<country>Austria</country>
</location_countries>
<verification_date>July 2022</verification_date>
<study_first_submitted>February 26, 2022</study_first_submitted>
<study_first_submitted_qc>April 8, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>July 14, 2022</last_update_submitted>
<last_update_submitted_qc>July 14, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">July 15, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Medical University of Vienna</investigator_affiliation>
<investigator_full_name>Rupert Lanzenberger</investigator_full_name>
<investigator_title>Principle Investigator</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Depressive Disorder</mesh_term>
<mesh_term>Depressive Disorder, Major</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Ketamine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The aim of this study is to assess the impact of ketamine on aesthetic perception and
processing. This study assesses the role of these effects in facilitating ketamine's
antidepressant properties, with a focus on anhedonia. To address this aim, 25 patients with
major depressive disorder and 35 healthy controls will be assessed twice with magnetic
resonance imaging, once after administration of intravenous ketamine (subanesthetic dose) and
once after administration of placebo.This study has a single-center, placebo-controlled,
cross-over study design. During MRI, structural, resting state, and functional imaging will
be performed. Functional imaging will comprise aesthetic processing, reward, and sexual
arousal paradigms. In addition, various neuropsychological scales assessing depressive
symptoms, anhedonia, and aesthetic processing will be performed. Eligibility for
participation will be assessed during a screening visit, a follow up visit will end study
participation.
Inclusion Criteria:
- General health based on medical history and physical examination
- Psychiatric health based on structured clinical interview for DSM-5 (SCID) for healthy
controls
- Major depressive episode (first or recurrent) based on structured clinical interview
for DSM-5 and ICD-10 for patients
- Age 18 to 55 years
- Right-handedness (due to potential lateralization effects of lefthanded subjects)
- Willingness and competence to sign the informed consent form
Exclusion Criteria:
- Current or history of neurological disease
- Current medical illness requiring treatment
- Psychiatric diagnosis for healthy individuals
- Psychiatric comorbidity with the exception of anxiety disorders for depressed
individuals
- Pregnancy or current breastfeeding
- Current or former substance abuse
- Previous ketamine use in lifetime
- Any contraindication for MRI (e.g., MR incompatible implants, etc.) including dental
implants causing signal artifacts
- Failure to comply with the study protocol or to follow the instruction of the
investigating team
|
NCT0532xxxx/NCT05320120.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320120</url>
</required_header>
<id_info>
<org_study_id>PSY-NIL-0011</org_study_id>
<nct_id>NCT05320120</nct_id>
</id_info>
<brief_title>Investigation of Intranasal Ketamine Related Changes in Attentional Brain Networks With Functional and Structural MRI</brief_title>
<official_title>Investigation of Intranasal Ketamine Related Changes in Attentional Brain Networks With Functional and Structural MRI: a Placebo Controlled, Randomized, Cross-over Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Rupert Lanzenberger</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Medical University of Vienna</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Subanesthetic ketamine is currently used as a rapid-acting antidepressant. It is an
antagonist of the N-methyl-d-aspartate (NMDA) receptor, but former results indicate that its
action also depends on the noradrenaline system and the locus coeruleus (LC).

Based on this known impact of ketamine on the sympathetic nervous system the aim of this
study is to investigate the effects of intranasal esketamine on LC related attentional brain
networks in task based functional MRI, to relate those attention network changes to
behavioural measures and to predict ketamine related attention network changes by brain
structure.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">June 1, 2022</start_date>
<completion_date type="Anticipated">April 22, 2024</completion_date>
<primary_completion_date type="Anticipated">April 22, 2024</primary_completion_date>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Crossover Assignment</intervention_model>
<primary_purpose>Basic Science</primary_purpose>
<masking>Double (Participant, Care Provider)</masking>
</study_design_info>
<primary_outcome>
<measure>BOLD response assessed with fMRI to arousal task</measure>
<time_frame>up to two weeks</time_frame>
<description>Blood oxygen level (BOLD) response assessed with functional magnetic resonance imaging (fMRI) during an arousal task</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">33</enrollment>
<condition>Ketamine Treatment</condition>
<arm_group>
<arm_group_label>first 56mg esketamine (2x Spravato® 28 mg nasal spray), then placebo</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>first placebo (0.9% saline solution nasal spray), then ketamine</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>56mg esketamine (2x Spravato® 28 mg nasal spray)</intervention_name>
<description>56mg esketamine (2x Spravato® 28 mg nasal spray)</description>
<arm_group_label>first 56mg esketamine (2x Spravato® 28 mg nasal spray), then placebo</arm_group_label>
<arm_group_label>first placebo (0.9% saline solution nasal spray), then ketamine</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>0.9% saline solution nasal spray</intervention_name>
<description>0.9% saline solution nasal spray</description>
<arm_group_label>first 56mg esketamine (2x Spravato® 28 mg nasal spray), then placebo</arm_group_label>
<arm_group_label>first placebo (0.9% saline solution nasal spray), then ketamine</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- General health (no serious internal or neurologic pre-existing conditions) based on
medical history, physical examination and structured clinical interview for DSM-IV
(SCID)

- Age 18 to 55 years

- Right-handedness (due to potential lateralization effects of left-handed subjects)

- Willingness and competence to sign the informed consent form

Exclusion Criteria:

- Current or history of psychiatric or neurological disease

- Current medical illness requiring treatment

- Current or former substance abuse

- Pregnancy or current breastfeeding

- Diagnosis of an Axis-1 psychotic disorder in a first-degree relative

- Known aneurysmal vascular disease based on medical history (including intracranial,
thoracic, or abdominal aorta, or peripheral arterial vessels), history of
intracerebral haemorrhage, recent (within 6weeks) cardiovascular event, including
myocardial infarction (MI)

- Significant pulmonary insufficiency, including COPD; sleep apnoea with morbid obesity
(BMI ≥35), uncontrolled brady- or tachyarrhythmias that lead to haemodynamic
instability; history of an MI, haemodynamically significant valvular heart disease or
heart failure (NYHA Class III-IV)

- Hyperthyroidism that has not been sufficiently treated

- History of brain injury, hypertensive encephalopathy, intrathecal therapy with
ventricular shunts, or any other condition associated with increased intracranial
pressure

- Child-Pugh class C (severe) hepatic impairment

- Any contraindication for MRI (e.g., MR incompatible implants, etc.) including dental
implants causing signal artifacts

- Failure to comply with the study protocol or to follow the instruction of the
investigating team
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>55 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Department of Psychiatry and Psychotherapy</name>
<address>
<city>Vienna</city>
<zip>1090</zip>
<country>Austria</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Rupert Lanzenberger, Assoc. Prof. PD MD</last_name>
<phone>+43-1-40400-35760</phone>
<email>rupert.lanzenberger@meduniwien.ac.at</email>
</contact>
</location>
<location_countries>
<country>Austria</country>
</location_countries>
<verification_date>July 2022</verification_date>
<study_first_submitted>February 28, 2022</study_first_submitted>
<study_first_submitted_qc>April 8, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>July 14, 2022</last_update_submitted>
<last_update_submitted_qc>July 14, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">July 18, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>Medical University of Vienna</investigator_affiliation>
<investigator_full_name>Rupert Lanzenberger</investigator_full_name>
<investigator_title>Prof. Dr. Rupert Lanzenberger</investigator_title>
</responsible_party>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Esketamine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Subanesthetic ketamine is currently used as a rapid-acting antidepressant. It is an
antagonist of the N-methyl-d-aspartate (NMDA) receptor, but former results indicate that its
action also depends on the noradrenaline system and the locus coeruleus (LC).
Based on this known impact of ketamine on the sympathetic nervous system the aim of this
study is to investigate the effects of intranasal esketamine on LC related attentional brain
networks in task based functional MRI, to relate those attention network changes to
behavioural measures and to predict ketamine related attention network changes by brain
structure.
Inclusion Criteria:
- General health (no serious internal or neurologic pre-existing conditions) based on
medical history, physical examination and structured clinical interview for DSM-IV
(SCID)
- Age 18 to 55 years
- Right-handedness (due to potential lateralization effects of left-handed subjects)
- Willingness and competence to sign the informed consent form
Exclusion Criteria:
- Current or history of psychiatric or neurological disease
- Current medical illness requiring treatment
- Current or former substance abuse
- Pregnancy or current breastfeeding
- Diagnosis of an Axis-1 psychotic disorder in a first-degree relative
- Known aneurysmal vascular disease based on medical history (including intracranial,
thoracic, or abdominal aorta, or peripheral arterial vessels), history of
intracerebral haemorrhage, recent (within 6weeks) cardiovascular event, including
myocardial infarction (MI)
- Significant pulmonary insufficiency, including COPD; sleep apnoea with morbid obesity
(BMI ≥35), uncontrolled brady- or tachyarrhythmias that lead to haemodynamic
instability; history of an MI, haemodynamically significant valvular heart disease or
heart failure (NYHA Class III-IV)
- Hyperthyroidism that has not been sufficiently treated
- History of brain injury, hypertensive encephalopathy, intrathecal therapy with
ventricular shunts, or any other condition associated with increased intracranial
pressure
- Child-Pugh class C (severe) hepatic impairment
- Any contraindication for MRI (e.g., MR incompatible implants, etc.) including dental
implants causing signal artifacts
- Failure to comply with the study protocol or to follow the instruction of the
investigating team
|
NCT0532xxxx/NCT05320133.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320133</url>
</required_header>
<id_info>
<org_study_id>2021CR36</org_study_id>
<nct_id>NCT05320133</nct_id>
</id_info>
<brief_title>Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection</brief_title>
<official_title>The Effect and Safety of Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection, a Randomized Pilot Study</official_title>
<sponsors>
<lead_sponsor>
<agency>Peking University First Hospital</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Peking University First Hospital</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This study is to evaluate the efficacy and safety of the Jinghua Weikang Capsule (a Chinese
patent medicine for peptic ulcer and gastritis) containing quadruple therapy (Jinghua Weikang
Caplsule plus triple therpy) for eradicating Helicobacter pylori in IgA nephropathy.
</textblock>
</brief_summary>
<overall_status>Enrolling by invitation</overall_status>
<start_date type="Actual">June 20, 2022</start_date>
<completion_date type="Anticipated">December 31, 2024</completion_date>
<primary_completion_date type="Anticipated">November 30, 2024</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Helicobacter pylori eradicaion rate</measure>
<time_frame>The forth week after the treatment.</time_frame>
<description>The Helicobacter pylori infection status was measured by 13-carbon breath test.</description>
</primary_outcome>
<secondary_outcome>
<measure>Blood creatinine level</measure>
<time_frame>Baseline, the third and sixth month after the treatment, respectively.</time_frame>
<description>The change of average blood creatinine level between two groups.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Blood urea nitrogen level</measure>
<time_frame>Baseline, the third and sixth month after the treatment, respectively.</time_frame>
<description>The change of average blood urea nitrogen level between two groups.</description>
</secondary_outcome>
<secondary_outcome>
<measure>eGFR</measure>
<time_frame>Baseline, the third and sixth month after the treatment, respectively.</time_frame>
<description>The change of average eGFR level between two groups.</description>
</secondary_outcome>
<secondary_outcome>
<measure>24hrs urine protein level</measure>
<time_frame>Baseline, the third and sixth month after the treatment, respectively.</time_frame>
<description>The change of average24hrs urine protein level between two groups.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Blood presure</measure>
<time_frame>Baseline, the third and sixth month after the treatment, respectively.</time_frame>
<description>The change of average blood presure level between two groups.</description>
</secondary_outcome>
<secondary_outcome>
<measure>IgA level</measure>
<time_frame>Baseline, the third and sixth month after the treatment, respectively.</time_frame>
<description>The change of average IgA level level between two groups.</description>
</secondary_outcome>
<secondary_outcome>
<measure>IgA1 level</measure>
<time_frame>Baseline, the third and sixth month after the treatment, respectively.</time_frame>
<description>The change of average IgA1 level between two groups.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Gd-IgA1 level</measure>
<time_frame>Baseline, the third and sixth month after the treatment, respectively.</time_frame>
<description>The change of average Gd-IgA1 level level between two groups.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">80</enrollment>
<condition>Helicobacter Pylori Infection</condition>
<arm_group>
<arm_group_label>JWC group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Jinghua Weikang Capsule containing quadruple therapy.</description>
</arm_group>
<arm_group>
<arm_group_label>Control group</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Bismuth-containing quadruple therapy.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>JWC containing quadruple therapy</intervention_name>
<description>Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and Jinghua Weikang Capsule 240mg twice daily for 14 days.</description>
<arm_group_label>JWC group</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Bismuth-containing quadruple therapy</intervention_name>
<description>Subjects will receive the rabeprazole 10mg, moxycillin 1.0g, clarithromycin 500mg and bismuth potassium citrate 220mg twice daily for 14 days.</description>
<arm_group_label>Control group</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- IgA nephropathy diagnosed by renal biopsy;

- Current Helicobacter pylori infection;

- Age 18-65.

Exclusion Criteria:

- ①eGFR<90ml/（min·1.73m2）-

- History of Helicobacter pylori treatment

- Present taking hormones or immunosuppressants

- Malignant tumor and high-grade intraepithelial neoplasia and severe dysplasia of
gastric mucosa

- Allergy history to medicines used in the study

- History of gastric surgery

- Uncontrolled chronic diseases such as diabetes, cardiovascular and cerebrovascular
diseases, respiratory diseases, mental disorders and other researchers are considered
to affect treatment and assessment

- Combined with other primary or secondary nephropathy except for IgAN

- Combined with acute renal injury

- Female patients with pregnancy, lactation and planned pregnancy.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>65 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>HUI YE</last_name>
<role>Principal Investigator</role>
<affiliation>Peking University First Hospital</affiliation>
</overall_official>
<location>
<facility>
<name>Peking University First Hospital</name>
<address>
<city>Beijing</city>
<state>Beijing</state>
<zip>100034</zip>
<country>China</country>
</address>
</facility>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>October 2022</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>April 8, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>October 17, 2022</last_update_submitted>
<last_update_submitted_qc>October 17, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">October 18, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Helicobacter pylori</keyword>
<keyword>IgA nephropathy</keyword>
<keyword>Jinghua Weikang Caplsule</keyword>
<keyword>Bismuth-containing quadruple therapy</keyword>
<keyword>Eradication</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Infections</mesh_term>
<mesh_term>Communicable Diseases</mesh_term>
<mesh_term>Helicobacter Infections</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Bismuth</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>IPD will be shared on https://clinicaltrials.gov.</ipd_description>
<ipd_info_type>Study Protocol</ipd_info_type>
<ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
<ipd_time_frame>The data will be uploaded within 6 month after Dec 31, 2024.</ipd_time_frame>
<ipd_access_criteria>The user of ClinicalTrials.gov PRS could access the data.</ipd_access_criteria>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This study is to evaluate the efficacy and safety of the Jinghua Weikang Capsule (a Chinese
patent medicine for peptic ulcer and gastritis) containing quadruple therapy (Jinghua Weikang
Caplsule plus triple therpy) for eradicating Helicobacter pylori in IgA nephropathy.
Inclusion Criteria:
- IgA nephropathy diagnosed by renal biopsy;
- Current Helicobacter pylori infection;
- Age 18-65.
Exclusion Criteria:
- ①eGFR<90ml/（min·1.73m2）-
- History of Helicobacter pylori treatment
- Present taking hormones or immunosuppressants
- Malignant tumor and high-grade intraepithelial neoplasia and severe dysplasia of
gastric mucosa
- Allergy history to medicines used in the study
- History of gastric surgery
- Uncontrolled chronic diseases such as diabetes, cardiovascular and cerebrovascular
diseases, respiratory diseases, mental disorders and other researchers are considered
to affect treatment and assessment
- Combined with other primary or secondary nephropathy except for IgAN
- Combined with acute renal injury
- Female patients with pregnancy, lactation and planned pregnancy.
|
NCT0532xxxx/NCT05320146.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320146</url>
</required_header>
<id_info>
<org_study_id>CORT118335-861 - Sub Study</org_study_id>
<nct_id>NCT05320146</nct_id>
</id_info>
<brief_title>A Sub Study of the Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)</brief_title>
<official_title>A Phase 1b, Open-Label Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Adult Patients With Presumed Nonalcoholic Steatohepatitis (NASH)</official_title>
<sponsors>
<lead_sponsor>
<agency>Corcept Therapeutics</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Corcept Therapeutics</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This optional sub study is a part of the phase 1b, Open-Label Study is to assess the safety,
efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This optional sub study is a part of the phase 1b, Open-Label Study is to assess the safety,
efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH).

All patients who participated in the current study (CORT118335-861) or the Corcept Phase 2a
NASH study (CORT118335-860), and who received at least one dose of miricorilant will be
eligible for participation in an observational follow-up study; this includes patients who
either terminated early or are study completers.
</textblock>
</detailed_description>
<overall_status>Active, not recruiting</overall_status>
<start_date type="Actual">March 4, 2022</start_date>
<completion_date type="Anticipated">August 2024</completion_date>
<primary_completion_date type="Anticipated">August 2024</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Change in liver-fat content assessed by MRI-PDFF after the last dose of study drug.</measure>
<time_frame>Baseline Day 1 up to Month 12</time_frame>
</primary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Actual">22</enrollment>
<condition>Nonalcoholic Steatohepatitis (NASH)</condition>
<arm_group>
<arm_group_label>CORT118335-860 Participants</arm_group_label>
<description>This group will include patients who participated in CORT118335-860 study and received at least one dose of miricorilant.</description>
</arm_group>
<arm_group>
<arm_group_label>CORT118335-861 Participants</arm_group_label>
<description>This group will include patients who participated in CORT118335-861 study and received at least one dose of miricorilant.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>MRI-PDFF</intervention_name>
<description>Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a MRI-based diagnostic imaging biomarker of the liver.</description>
<arm_group_label>CORT118335-860 Participants</arm_group_label>
<arm_group_label>CORT118335-861 Participants</arm_group_label>
</intervention>
<biospec_retention>Samples With DNA</biospec_retention>
<biospec_descr>
<textblock>
Whole blood and Serum samples will be retained.
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
Patients that have previously enrolled in CORT118335-860 or in CORT118335-861 and have
received at least one dose of miricorilant.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Have participated in either Study CORT118335-861 (current study) or Study
CORT118335-860 (Corcept Phase 2a NASH study) and received at least one dose of
miricorilant; this includes patients who terminated early from the study or completed
the study.

- Have not participated in any other clinical trial following study completion in either
Study CORT118335-861 or Study CORT118335-860.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>75 Years</maximum_age>
</eligibility>
<overall_official>
<last_name>Kavita Juneja, MD</last_name>
<role>Study Director</role>
<affiliation>Corcept Therapeutics</affiliation>
</overall_official>
<location>
<facility>
<name>Site 207</name>
<address>
<city>Chandler</city>
<state>Arizona</state>
<zip>85224</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Site 209</name>
<address>
<city>Tucson</city>
<state>Arizona</state>
<zip>85712</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Site 214</name>
<address>
<city>Panorama City</city>
<state>California</state>
<zip>91402</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Site 233</name>
<address>
<city>Santa Ana</city>
<state>California</state>
<zip>92704</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Site 210</name>
<address>
<city>Sarasota</city>
<state>Florida</state>
<zip>34240</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Site 211</name>
<address>
<city>Austin</city>
<state>Texas</state>
<zip>78757</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Site 213</name>
<address>
<city>Edinburg</city>
<state>Texas</state>
<zip>78539</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>305</name>
<address>
<city>Houston</city>
<state>Texas</state>
<zip>77079</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Site 212</name>
<address>
<city>San Antonio</city>
<state>Texas</state>
<zip>78229</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>226</name>
<address>
<city>Seattle</city>
<state>Washington</state>
<zip>98105</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>https://clinicaltrials.gov/ct2/show/NCT03823703</url>
<description>Clinical Trial public posting for CORT113885-860</description>
</link>
<link>
<url>https://clinicaltrials.gov/ct2/show/NCT05117489</url>
<description>Clinical Trial public posting for CORT118335-861</description>
</link>
<verification_date>August 2023</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>August 30, 2023</last_update_submitted>
<last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">September 1, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Nonalcoholic Steatohepatitis</keyword>
<keyword>NASH</keyword>
<keyword>Nonalcoholic Fatty Liver Disease</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Fatty Liver</mesh_term>
<mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This optional sub study is a part of the phase 1b, Open-Label Study is to assess the safety,
efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)
This optional sub study is a part of the phase 1b, Open-Label Study is to assess the safety,
efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH).
All patients who participated in the current study (CORT118335-861) or the Corcept Phase 2a
NASH study (CORT118335-860), and who received at least one dose of miricorilant will be
eligible for participation in an observational follow-up study; this includes patients who
either terminated early or are study completers.
Whole blood and Serum samples will be retained.
Patients that have previously enrolled in CORT118335-860 or in CORT118335-861 and have
received at least one dose of miricorilant.
Inclusion Criteria:
- Have participated in either Study CORT118335-861 (current study) or Study
CORT118335-860 (Corcept Phase 2a NASH study) and received at least one dose of
miricorilant; this includes patients who terminated early from the study or completed
the study.
- Have not participated in any other clinical trial following study completion in either
Study CORT118335-861 or Study CORT118335-860.
|
NCT0532xxxx/NCT05320159.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320159</url>
</required_header>
<id_info>
<org_study_id>CAIN457AUS28</org_study_id>
<nct_id>NCT05320159</nct_id>
</id_info>
<brief_title>Treatment Effectiveness Among Psoriasis Patients Treated With Cosentyx (Secukinumab)</brief_title>
<official_title>Characteristics, Treatment Patterns, and Treatment Satisfaction Among Psoriasis Patients Treated With Cosentyx (Secukinumab)</official_title>
<sponsors>
<lead_sponsor>
<agency>Novartis Pharmaceuticals</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Novartis</source>
<brief_summary>
<textblock>
This was a retrospective cohort study utilizing data from Modernizing Medicine Data Services'
(MMDS) electronic medical records (EMR)-based dermatology database to evaluate secukinumab
patient characteristics, treatment patterns, and outcomes.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This was a retrospective cohort study utilizing data from Modernizing Medicine Data Services'
(MMDS) electronic medical records (EMR)-based dermatology database to evaluate secukinumab
patient characteristics, treatment patterns, and outcomes. Psoriasis (PsO) patients
initiating secukinumab were identified and indexed to the first secukinumab use using the
most recent data at study initiation (data period: March 1, 2018 to August 31, 2019) and with
a subsequent data refresh (data period: March 1, 2017 - July 31, 2020).
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">February 3, 2021</start_date>
<completion_date type="Actual">March 31, 2021</completion_date>
<primary_completion_date type="Actual">March 31, 2021</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Retrospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Treatment satisfaction level at Baseline</measure>
<time_frame>Baseline</time_frame>
<description>Patient reported satisfaction with treatment effectiveness was captured on a 5-point scale - "I believe this treatment is effective in clearing my skin of psoriasis." (1 = strongly agree, 2 = somewhat agree, 3 = Neither agree nor disagree, 4 = Somewhat disagree, 5 = Strongly disagree; n, %) in the EMR data system.
For this analysis, the responses were classified into three groups:
Satisfied with treatment effectiveness (1 = strongly agree, 2 = somewhat agree)
Dissatisfied with treatment effectiveness ( 4 = Somewhat disagree, 5 = Strongly disagree)
Neither satisfied nor dissatisfied with treatment effectiveness (3 = Neither agree nor disagree)</description>
</primary_outcome>
<primary_outcome>
<measure>Treatment satisfaction level at 6 months post-index</measure>
<time_frame>6 months after initiating treatment with secukinumab (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)</time_frame>
<description>Patient reported satisfaction with treatment effectiveness was captured on a 5-point scale - "I believe this treatment is effective in clearing my skin of psoriasis." (1 = strongly agree, 2 = somewhat agree, 3 = Neither agree nor disagree, 4 = Somewhat disagree, 5 = Strongly disagree; n, %) in the EMR data system.
For this analysis, the responses were classified into three groups:
Satisfied with treatment effectiveness (1 = strongly agree, 2 = somewhat agree)
Dissatisfied with treatment effectiveness ( 4 = Somewhat disagree, 5 = Strongly disagree)
Neither satisfied nor dissatisfied with treatment effectiveness (3 = Neither agree nor disagree)</description>
</primary_outcome>
<secondary_outcome>
<measure>Age</measure>
<time_frame>Baseline (March 1, 2017 - March 1, 2018)</time_frame>
<description>Age information was reported</description>
</secondary_outcome>
<secondary_outcome>
<measure>Gender</measure>
<time_frame>Baseline (March 1, 2017 - March 1, 2018)</time_frame>
<description>Gender information was reported</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of patients at various regions</measure>
<time_frame>Baseline (March 1, 2017 - March 1, 2018)</time_frame>
<description>Patient regions: Northeast, Midwest, South, West, Unknown</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of patients with different race</measure>
<time_frame>Baseline (March 1, 2017 - March 1, 2018)</time_frame>
<description>Race: White, Hispanic, African American, Asian, other/unknown</description>
</secondary_outcome>
<secondary_outcome>
<measure>Weight</measure>
<time_frame>Baseline (March 1, 2017 - March 1, 2018)</time_frame>
<description>Weight of patients was reported</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of patients at Index year</measure>
<time_frame>Study Period: March 1, 2017 - July 31, 2020</time_frame>
<description>Number of patients at each index year were reported</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of patients with plaque psoriasis subtype</measure>
<time_frame>Baseline (March 1, 2017 - March 1, 2018)</time_frame>
<description>Plaque psoriasis subtype was categorized as: generalized plaque psoriasis, localized plaque psoriasis, localized scalp psoriasis, inverse psoriasis, palmoplantar psoriasis, guttate psoriasis, nail psoriasis, psoriasis vulgaris, ostraceous psoriasis, or plaque psoriasis with unknown subtype during the 12 month pre-index period (including index date)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of patients with Plaque location</measure>
<time_frame>Baseline (March 1, 2017 - March 1, 2018)</time_frame>
<description>Plaque location was categorized as recorded in EMR, including hand, arm, leg, trunk, scalp, head and neck, other/unknown</description>
</secondary_outcome>
<secondary_outcome>
<measure>Comorbidities of interest</measure>
<time_frame>Baseline (March 1, 2017 - March 1, 2018)</time_frame>
<description>Comorbidities of interest during the 12 months pre-index were reported</description>
</secondary_outcome>
<secondary_outcome>
<measure>Physician global assessment (PGA)</measure>
<time_frame>Baseline and 6 months post index including index date (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)</time_frame>
<description>PGA is scored on a 6-point scale from 0-5: 0 = clear, 1 = minimal, 2 = mild, 3 =moderate, 4 = marked, and 5 = severe</description>
</secondary_outcome>
<secondary_outcome>
<measure>Total body surface area (TBSA)</measure>
<time_frame>Baseline and 6 months post index including index date (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)</time_frame>
<description>Total body surface area (BSA) was expressed as the percentage of body surface involved; BSA values of <3%, 3-10%, and >10% (reported as n, %) will be considered as mild, moderate, or severe, respectively.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Psoriasis-related therapy</measure>
<time_frame>6 months post index including index date (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)</time_frame>
<description>The following categories were included:
Biologics
Methotrexate
Corticosteroids (oral/injection)
Topical therapy
Phototherapy and Psoralen plus ultraviolet A photochemotherapy (PUVA)
NSAID/salicylates
Other systemic plaque psoriasis therapy (Acitretin)
Apremilast (PDE4 inhibitor)</description>
</secondary_outcome>
<number_of_groups>5</number_of_groups>
<enrollment type="Actual">17743</enrollment>
<condition>Psoriasis</condition>
<arm_group>
<arm_group_label>Overall cohort: Secukinumab</arm_group_label>
<description>Included all the patients treated with secukinumab</description>
</arm_group>
<arm_group>
<arm_group_label>Bio-naive</arm_group_label>
<description>Included PsO patients initiating treatment with secukinumab. Bio-naïve was defined as no observed treatment (i.e., injection, prescription or patient reported history) with any of the following biologic drugs of interest anytime pre-index: secukinumab, certolizumab, etanercept, adalimumab, infliximab, golimumab, ustekinumab, ixekizumab, brodalumab, abatacept, and guselkumab and risankizumab during all available history</description>
</arm_group>
<arm_group>
<arm_group_label>Bio-experienced</arm_group_label>
<description>Included PsO patients initiating treatment with secukinumab. Patients had pre-index use of one or more of the biologic drugs of interest during all available history</description>
</arm_group>
<arm_group>
<arm_group_label>Systemic-naive</arm_group_label>
<description>Included PsO patients initiating treatment with secukinumab. Systemic-naïve was defined as no observed treatment (i.e., injection, prescription or patient reported history) with any of the biologic treatments or with any of the following systemic (i.e., oral or injectable - no topical forms) drugs of interest pre-index: methotrexate, corticosteroids, acitretin or apremilast.</description>
</arm_group>
<arm_group>
<arm_group_label>Systemic-experienced</arm_group_label>
<description>Included PsO patients initiating treatment with secukinumab. Systemic-experienced patients had pre-index use of one or more of the systemic drugs of interest.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Secukinumab</intervention_name>
<description>Included all the patients treated with secukinumab</description>
<arm_group_label>Bio-experienced</arm_group_label>
<arm_group_label>Bio-naive</arm_group_label>
<arm_group_label>Overall cohort: Secukinumab</arm_group_label>
<arm_group_label>Systemic-experienced</arm_group_label>
<arm_group_label>Systemic-naive</arm_group_label>
<other_name>Cosentyx</other_name>
</intervention>
<eligibility>
<study_pop>
<textblock>
Psoriasis patients treated with Cosentyx (secukinumab)
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- ≥1 orders/administrations for secukinumab within the index window (March 1, 2018 to
August 31,2019 for the base analysis; March 1, 2018 to January 31, 2020 for the
refresh analysis). The date of the first order or administration was be the index date

- Patients in the MMDS database with a diagnosis of PsO on or prior to the 1st
secukinumab order/administration

- ≥18 years of age as of the index date

- To ensure capturing continuous patient activities in the EMR dataset, patients must
have at least one more visit (any visit regardless of diagnosis) in addition to the
index visit within the first 6 months after secukinumab initiation

- Patients must have at least one visit (any visit regardless of diagnosis) within the
12 months pre-index period

Exclusion Criteria:

- Evidence of secukinumab use in the 12-month pre-index period

- Data quality issues (missing age, gender, prescription order information)
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>100 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Novartis Pharmaceuticals</last_name>
<role>Study Director</role>
<affiliation>Novartis Pharmaceuticals</affiliation>
</overall_official>
<location>
<facility>
<name>Novartis Investigative Site</name>
<address>
<city>East Hanover</city>
<state>New Jersey</state>
<zip>07936-1080</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17921</url>
<description>Results for CAIN457AUS28 from the Novartis Clinical Trials Results Database</description>
</link>
<verification_date>June 2022</verification_date>
<study_first_submitted>March 30, 2022</study_first_submitted>
<study_first_submitted_qc>April 8, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>June 29, 2022</last_update_submitted>
<last_update_submitted_qc>June 29, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">July 1, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Psoriasis</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This was a retrospective cohort study utilizing data from Modernizing Medicine Data Services'
(MMDS) electronic medical records (EMR)-based dermatology database to evaluate secukinumab
patient characteristics, treatment patterns, and outcomes.
This was a retrospective cohort study utilizing data from Modernizing Medicine Data Services'
(MMDS) electronic medical records (EMR)-based dermatology database to evaluate secukinumab
patient characteristics, treatment patterns, and outcomes. Psoriasis (PsO) patients
initiating secukinumab were identified and indexed to the first secukinumab use using the
most recent data at study initiation (data period: March 1, 2018 to August 31, 2019) and with
a subsequent data refresh (data period: March 1, 2017 - July 31, 2020).
Psoriasis patients treated with Cosentyx (secukinumab)
Inclusion Criteria:
- ≥1 orders/administrations for secukinumab within the index window (March 1, 2018 to
August 31,2019 for the base analysis; March 1, 2018 to January 31, 2020 for the
refresh analysis). The date of the first order or administration was be the index date
- Patients in the MMDS database with a diagnosis of PsO on or prior to the 1st
secukinumab order/administration
- ≥18 years of age as of the index date
- To ensure capturing continuous patient activities in the EMR dataset, patients must
have at least one more visit (any visit regardless of diagnosis) in addition to the
index visit within the first 6 months after secukinumab initiation
- Patients must have at least one visit (any visit regardless of diagnosis) within the
12 months pre-index period
Exclusion Criteria:
- Evidence of secukinumab use in the 12-month pre-index period
- Data quality issues (missing age, gender, prescription order information)
|
NCT0532xxxx/NCT05320172.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320172</url>
</required_header>
<id_info>
<org_study_id>PRP ED in corneal diseases</org_study_id>
<nct_id>NCT05320172</nct_id>
</id_info>
<brief_title>Platelet Rich Plasma in Corneal Surface Diseases</brief_title>
<official_title>Effect of Platelet Rich Plasma Eye Drops in Corneal Surface Diseases</official_title>
<sponsors>
<lead_sponsor>
<agency>Assiut University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Assiut University</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The Aim of the study is to evaluate the efficacy of platelet rich plasma eye drops in the
management of different corneal surface disorders.

PRP is a blood sample with a concentrated platelet count, and numerous growth factors that
are associated with conjunctival and corneal wound healing process. which is an important
advantage over other products. PRP eye drops recently are proving to be an effective and
potent therapeutic approach to promote corneal wound re-epithelization and promote ocular
surface regeneration in different pathological conditions.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
There are many conditions in which the ocular surface is severely affected as
keratoconjunctivitis sicca, persistent epithelial corneal defect, recurrent corneal erosion,
neurotrophic keratopathy, post laser in-situ keratomileusis (LASIK) ocular surface syndrome
(OSS), dormant corneal ulcer, graft-versus-host disease, ocular cicatricial pemphigoid, and
neurotrophic changes. If corneal wound healing does not occur promptly, it can lead to visual
loss, severe scarring, infection and even corneal perforation, the treatment of ocular
surface disorders has a multifactorial approach and conventional therapy is often not enough
to solve the problem.

Platelet-rich plasma (PRP) is defined as a portion of the plasma fraction of autologous blood
having a platelet concentration above baseline. They use a PRP device, concentrate platelets
using a double centrifugation technique and activate PRP just when they are ready to use it.
The final concentration is at least 1.000.000 platelets/ microliter. Therefore, it is an
autologous concentration of platelets and growth factors.

An important reservoir of proteins and growth factors precipitating in haemostasis, tissue
regeneration, immune response, and wound healing. Alpha granules of the platelets include
over 30 biologically active substances such as platelet-derived growth factor, transforming
growth factor b1 and b2 and insulin-like growth factor 1, vascular endothelial growth factor,
epidermal cell growth factor, fibroblast growth factor 2, and insulin-like growth factor.

Eye platelet-rich plasma has a lubricating effect and has been effective in regenerating the
ocular surface in cases of micropunctate keratitis, decreasing inflammation in patients
suffering from dry eye and stimulating wound-healing processes in dormant corneal ulcers.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">June 2023</start_date>
<completion_date type="Anticipated">June 2024</completion_date>
<primary_completion_date type="Anticipated">June 2024</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<intervention_model_description>Fifty milliliters of whole blood will be placed in five 10-ml vacutainer tubes containing anticoagulant-citrate-dextrose solution (1.4 ml) and centrifuged at 200g for 11 min. The upper two layers of the centrifuged blood, the plasma and buffy coat layer will be separated in a sterile manner and diluted to 20 % (v/v) with a sterile saline solution. The final preparation is divided into 5-ml bottles wrapped in aluminum foil for protection from ultraviolet light. The patients are instructed to store these bottles at -20 °C until required. The bottles being used will be maintained under refrigerated conditions at 4 °C.</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Evaluation of the efficacy of platelet rich plasma eye drops in the management of persistent corneal epithelial defects, and dry eye disease by observation of change in size of defect over different periods of time.</measure>
<time_frame>At 48 hours, one week and one month.</time_frame>
<description>To evaluate the effect of platelet-rich plasma (PRP) eye drops in management of different ocular surface pathologies, the therapeutic response will be evaluated with clinical examination and follow up.
Main outcome measurements include the change in size of defect by fluorescein staining on slit lamp biomicroscopy.
The largest linear dimension of the epithelial defect and its largest possible perpendicular within the confines of the epithelial defect are measured in millimeters using a slit lamp.</description>
</primary_outcome>
<primary_outcome>
<measure>Evaluation of the efficacy of platelet rich plasma eye drops in the management of persistent corneal epithelial defects, and dry eye disease by observation of change in visual acuity.</measure>
<time_frame>At 48 hours, one week and one month.</time_frame>
<description>To evaluate the effect of platelet-rich plasma (PRP) eye drops in management of different ocular surface pathologies, the therapeutic response will be evaluated with clinical examination and follow up.
Main outcome measurements include the change in visual acuity measured by Snellen visual acuity (VA) testing.</description>
</primary_outcome>
<primary_outcome>
<measure>Evaluation of the efficacy of platelet rich plasma eye drops in the management of persistent corneal epithelial defects, and dry eye disease by observation of change in height of tear meniscus,</measure>
<time_frame>At 48 hours, one week and one month.</time_frame>
<description>To evaluate the effect of platelet-rich plasma (PRP) eye drops in management of different ocular surface pathologies, the therapeutic response will be evaluated with clinical examination and follow up.
Main outcome measurements include the change in height of tear meniscus measured by slit lamp biomicroscopy.</description>
</primary_outcome>
<secondary_outcome>
<measure>Evaluation of the efficacy of platelet rich plasma eye drops in the relief symptoms caused by persistent corneal epithelial defects, and dry eye disease by observation of change in ocular symptoms.</measure>
<time_frame>At 48 hours, one week and one month.</time_frame>
<description>Secondary outcome measurements include the change and improvement of subjective symptoms during treatment; particularly pain. assessed by visual analog score for pain.</description>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Anticipated">70</enrollment>
<condition>Persistent Corneal Epithelial Defects</condition>
<condition>Dry Eye</condition>
<arm_group>
<arm_group_label>Treatment group</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants with persistent epithelial defects will be treated with autologous platelet rich plasma eye drops.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Autologous platelet rich plasma eye drops</intervention_name>
<description>Fifty milliliters of patient's own whole blood will be placed in five 10-ml vacutainer tubes containing anticoagulant-citrate-dextrose solution (1.4 ml) and centrifuged at 200g for 11 min. The upper two layers of the centrifuged blood, the plasma and buffy coat layer will be separated in a sterile manner and diluted to 20 % (v/v) with a sterile saline solution. The final preparation is divided into 5-ml bottles wrapped in aluminum foil for protection from ultraviolet light. The patients are instructed to store these bottles at -20 °C until required. The bottles being used will be maintained under refrigerated conditions at 4 °C.</description>
<arm_group_label>Treatment group</arm_group_label>
<other_name>PRP eye drops</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Persistent epithelial defects (Exposure keratopathy, Post infectious keratitis).

2. Dry eye disease.

Exclusion Criteria:

1. Active ocular infection or inflammation.

2. Patients will be withdrawn if allergic or adverse side effects develop.

3. Pregnancy or breast feeding.

4. The use of systemic antiplatelet or anticoagulant.

5. Uncontrolled systemic diseases

6. Non-compliance with the study protocol.

7. Positive HIV, HBV, HCB or Syphilis.

8. Anemia (less than 10 g/dl of HGB, platelet count less than 105/ul).
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>99 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Mohamed S Abdelrahman, MD</last_name>
<role>Study Chair</role>
<affiliation>Professor of ophthalmology, Faculty of medicine, Assiut University</affiliation>
</overall_official>
<overall_official>
<last_name>Mahmoud F Rateb, MD</last_name>
<role>Study Chair</role>
<affiliation>Assistant professor of ophthalmology, Faculty of medicine, Assiut University</affiliation>
</overall_official>
<overall_official>
<last_name>Mohamed G Saleh, MD</last_name>
<role>Study Director</role>
<affiliation>Lecturer of ophthalmology, Faculty of medicine, Assiut university</affiliation>
</overall_official>
<overall_contact>
<last_name>Ahmed A Abdelnasser</last_name>
<phone>01099427763</phone>
<phone_ext>+2</phone_ext>
<email>ahmedazzam200@gmail.com</email>
</overall_contact>
<link>
<url>https://www.ophed.com/system/files/2015/07/Eye%20platelet-rich%20plasma%20in%20the%20treatment%20of%20ocular%20surface%20disorders.pdf?fbclid=IwAR3A7EUT-g_PraOMio5VqndyDA0i5h1SRQa35gKFtP7r4xqvX1hxr1YrP1g</url>
<description>Eye platelet-rich plasma in the treatment of ocular surface disorders</description>
</link>
<link>
<url>https://journals.lww.com/implantdent/Fulltext/2001/10000/Platelet_Rich_Plasma__PRP___What_Is_PRP_and_What.2.aspx</url>
<description>Platelet-Rich Plasma (PRP): What Is PRP and What Is Not PRP? Marx, Robert E. DDS</description>
</link>
<link>
<url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5693817/</url>
<description>Treatment of Dry Eye Disease with Autologous Platelet-Rich Plasma</description>
</link>
<results_reference>
<citation>Kim KM, Shin YT, Kim HK. Effect of autologous platelet-rich plasma on persistent corneal epithelial defect after infectious keratitis. Jpn J Ophthalmol. 2012 Nov;56(6):544-50. doi: 10.1007/s10384-012-0175-y. Epub 2012 Sep 13.</citation>
<PMID>22972393</PMID>
</results_reference>
<results_reference>
<citation>Noble BA, Loh RS, MacLennan S, Pesudovs K, Reynolds A, Bridges LR, Burr J, Stewart O, Quereshi S. Comparison of autologous serum eye drops with conventional therapy in a randomised controlled crossover trial for ocular surface disease. Br J Ophthalmol. 2004 May;88(5):647-52. doi: 10.1136/bjo.2003.026211.</citation>
<PMID>15090417</PMID>
</results_reference>
<results_reference>
<citation>Alio JL, Arnalich-Montiel F, Rodriguez AE. The role of "eye platelet rich plasma" (E-PRP) for wound healing in ophthalmology. Curr Pharm Biotechnol. 2012 Jun;13(7):1257-65. doi: 10.2174/138920112800624355.</citation>
<PMID>21740369</PMID>
</results_reference>
<results_reference>
<citation>Alio JL, Abad M, Artola A, Rodriguez-Prats JL, Pastor S, Ruiz-Colecha J. Use of autologous platelet-rich plasma in the treatment of dormant corneal ulcers. Ophthalmology. 2007 Jul;114(7):1286-1293.e1. doi: 10.1016/j.ophtha.2006.10.044. Epub 2007 Feb 26.</citation>
<PMID>17324465</PMID>
</results_reference>
<results_reference>
<citation>Nurden AT. Platelets, inflammation and tissue regeneration. Thromb Haemost. 2011 May;105 Suppl 1:S13-33. doi: 10.1160/THS10-11-0720. Epub 2011 Apr 11.</citation>
<PMID>21479340</PMID>
</results_reference>
<results_reference>
<citation>Lee JH, Kim MJ, Ha SW, Kim HK. Autologous Platelet-rich Plasma Eye Drops in the Treatment of Recurrent Corneal Erosions. Korean J Ophthalmol. 2016 Apr;30(2):101-7. doi: 10.3341/kjo.2016.30.2.101. Epub 2016 Mar 25.</citation>
<PMID>27051257</PMID>
</results_reference>
<results_reference>
<citation>Wu TE, Chen CJ, Hu CC, Cheng CK. Easy-to-prepare autologous platelet-rich plasma in the treatment of refractory corneal ulcers. Taiwan J Ophthalmol. 2015 Jul-Sep;5(3):132-135. doi: 10.1016/j.tjo.2014.09.001. Epub 2014 Nov 20.</citation>
<PMID>29018685</PMID>
</results_reference>
<verification_date>February 2023</verification_date>
<study_first_submitted>November 16, 2021</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>February 24, 2023</last_update_submitted>
<last_update_submitted_qc>February 24, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">February 27, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Assiut University</investigator_affiliation>
<investigator_full_name>Ahmed Abdelnasser Mohamed Abdelnasser</investigator_full_name>
<investigator_title>Ophthalmology Resident, Assiut University Hospital</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Dry Eye Syndromes</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Ophthalmic Solutions</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The Aim of the study is to evaluate the efficacy of platelet rich plasma eye drops in the
management of different corneal surface disorders.
PRP is a blood sample with a concentrated platelet count, and numerous growth factors that
are associated with conjunctival and corneal wound healing process. which is an important
advantage over other products. PRP eye drops recently are proving to be an effective and
potent therapeutic approach to promote corneal wound re-epithelization and promote ocular
surface regeneration in different pathological conditions.
There are many conditions in which the ocular surface is severely affected as
keratoconjunctivitis sicca, persistent epithelial corneal defect, recurrent corneal erosion,
neurotrophic keratopathy, post laser in-situ keratomileusis (LASIK) ocular surface syndrome
(OSS), dormant corneal ulcer, graft-versus-host disease, ocular cicatricial pemphigoid, and
neurotrophic changes. If corneal wound healing does not occur promptly, it can lead to visual
loss, severe scarring, infection and even corneal perforation, the treatment of ocular
surface disorders has a multifactorial approach and conventional therapy is often not enough
to solve the problem.
Platelet-rich plasma (PRP) is defined as a portion of the plasma fraction of autologous blood
having a platelet concentration above baseline. They use a PRP device, concentrate platelets
using a double centrifugation technique and activate PRP just when they are ready to use it.
The final concentration is at least 1.000.000 platelets/ microliter. Therefore, it is an
autologous concentration of platelets and growth factors.
An important reservoir of proteins and growth factors precipitating in haemostasis, tissue
regeneration, immune response, and wound healing. Alpha granules of the platelets include
over 30 biologically active substances such as platelet-derived growth factor, transforming
growth factor b1 and b2 and insulin-like growth factor 1, vascular endothelial growth factor,
epidermal cell growth factor, fibroblast growth factor 2, and insulin-like growth factor.
Eye platelet-rich plasma has a lubricating effect and has been effective in regenerating the
ocular surface in cases of micropunctate keratitis, decreasing inflammation in patients
suffering from dry eye and stimulating wound-healing processes in dormant corneal ulcers.
Inclusion Criteria:
1. Persistent epithelial defects (Exposure keratopathy, Post infectious keratitis).
2. Dry eye disease.
Exclusion Criteria:
1. Active ocular infection or inflammation.
2. Patients will be withdrawn if allergic or adverse side effects develop.
3. Pregnancy or breast feeding.
4. The use of systemic antiplatelet or anticoagulant.
5. Uncontrolled systemic diseases
6. Non-compliance with the study protocol.
7. Positive HIV, HBV, HCB or Syphilis.
8. Anemia (less than 10 g/dl of HGB, platelet count less than 105/ul).
|
NCT0532xxxx/NCT05320185.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320185</url>
</required_header>
<id_info>
<org_study_id>RuiXin-CoronaryAI</org_study_id>
<nct_id>NCT05320185</nct_id>
</id_info>
<brief_title>Evaluation on the Effectiveness and Safety of RuiXin-CoronaryAI for Diagnosis of Coronary Artery Stenosis</brief_title>
<official_title>Evaluation on the Effectiveness and Safety of AI-based Coronary CT Angiographic Analysis Software (RuiXin-CoronaryAI) for Diagnosis of Coronary Artery Stenosis</official_title>
<sponsors>
<lead_sponsor>
<agency>Shenzhen Raysight Intelligent Medical Technology Co., Ltd.</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
<collaborator>
<agency>Tongji Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Beijing Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Shenzhen Raysight Intelligent Medical Technology Co., Ltd.</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
With the emergence of advanced technology to date in the artificial intelligence (AI),
computer aided diagnosis has gradually gained its popularity in the field of healthcare.
Particularly, in the clinical practice of coronary artery disease diagnosis, the application
of AI could be of great implication in alleviating the shortage of medical sources. To
evaluate the effectiveness and safety of the AI-based coronary CT angiographic analysis
software (RuiXin-CoronaryAI) for diagnosis of coronary artery stenosis, a retrospective,
multi-center, cross-over designed, blinded, sensitivity superiority and specificity
non-inferiority clinical trial will be conducted.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Patients ≥18 years old with suspected or known coronary artery disease who underwent CCTA
will be included. CCTA images of subjects should be of good quality up to the DICOM 3.0
standards, obtained by CT scan with ≥64-slices. The subjects with unqualified CTA will be
excluded. CCTA images will be analyzed in three methods (3 groups). Control group: CCTA
images will be visually evaluated by physicians. Experiment group: CCTA images will be
evaluated by physicians using RuiXin-CoronaryAI. Reference group: CCTA images will be
visually evaluated by cardiologists with at least 10 years experiences, and the conclusions
they offer will be used as golden standard. Primary outcomes are diagnostic sensitivity and
specificity of RuiXin-CoronaryAI and coronary CTA for diagnosis of ischemia on a per-vessel
basis. The effectiveness of RuiXin-CoronaryAI for diagnosis of coronary artery stenosis will
be conducted by testing superiority of diagnostic sensitivity and non-inferiority of
specificity.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">July 28, 2021</start_date>
<completion_date type="Anticipated">December 30, 2022</completion_date>
<primary_completion_date type="Actual">July 30, 2022</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Retrospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Per-vessel diagnostic sensitivity of RuiXin-CoronaryAI for diagnosis of coronary artery stenosis</measure>
<time_frame>1 day; Incident time for CTA examination was dependent on the length of time on the CT scaner. RuiXin-CoronaryAI examination was done remotely at Raysight's processing center in Shenzhen with a turnaround time of 24 hours from CT scan.</time_frame>
<description>Outcome measures were comparing RuiXin-CoronaryAI to CTA on a per-vessel basis</description>
</primary_outcome>
<primary_outcome>
<measure>Per-vessel diagnostic specificity of RuiXin-CoronaryAI for diagnosis of coronary artery stenosis</measure>
<time_frame>1 day; Incident time for CTA examination was dependent on the length of time on the CT scaner. RuiXin-CoronaryAI examination was done remotely at Raysight's processing center in Shenzhen with a turnaround time of 24 hours from CT scan.</time_frame>
<description>Outcome measures were comparing RuiXin-CoronaryAI to CTA on a per-vessel basis</description>
</primary_outcome>
<secondary_outcome>
<measure>Per-patient diagnostic sensitivity of RuiXin-CoronaryAI for diagnosis of coronary artery stenosis</measure>
<time_frame>1 day; Incident time for CTA examination was dependent on the length of time on the CT scaner. RuiXin-CoronaryAI examination was done remotely at Raysight's processing center in Shenzhen with a turnaround time of 24 hours from CT scan.</time_frame>
<description>Outcome measures were comparing RuiXin-CoronaryAI to CTA on a per-patient basis</description>
</secondary_outcome>
<secondary_outcome>
<measure>Per-patient diagnostic specificity of RuiXin-CoronaryAI for diagnosis of coronary artery stenosis</measure>
<time_frame>1 day; Incident time for CTA examination was dependent on the length of time on the CT scaner. RuiXin-CoronaryAI examination was done remotely at Raysight's processing center in Shenzhen with a turnaround time of 24 hours from CT scan.</time_frame>
<description>Outcome measures were comparing RuiXin-CoronaryAI to CTA on a per-patient basis</description>
</secondary_outcome>
<number_of_groups>3</number_of_groups>
<enrollment type="Anticipated">615</enrollment>
<condition>Coronary Artery Disease</condition>
<condition>Artificial Intelligence</condition>
<condition>Coronary Artery Stenosis</condition>
<condition>CT Angiography</condition>
<arm_group>
<arm_group_label>Control group</arm_group_label>
<description>CCTA images will be visually evaluated by physicians.</description>
</arm_group>
<arm_group>
<arm_group_label>Experiment group</arm_group_label>
<description>CCTA images will be evaluated by physicians using RuiXin-CoronaryAI.</description>
</arm_group>
<arm_group>
<arm_group_label>Reference group</arm_group_label>
<description>CCTA images will be visually evaluated by cardiologists with at least 10 years experiences, and the conclusions they offer will be used as golden standard.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>RuiXin-CoronaryAI software</intervention_name>
<description>RuiXin-CoronaryAI, based on Computed Tomography Angiography (CTA) and was independently designed by RaysightMed Inc., which has been already authorized by National Medical Products Administration (NMPA).</description>
<arm_group_label>Experiment group</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
Patients ≥18 years old with suspected or known coronary artery disease who underwent CCTA
examination.
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

1. layer thickness of CCTA images should be less than 1mm, image quality should be up to
DICOM 3.0 standards;

2. vessels should be clearly developed, contrast medium ought to be well filled, the
average of CT value of aortic root cavity should be between 325-600HU in CCTA image;

3. remodeling of vessels should be intact, including coronary artery and branches,
without missed or inaccurate slices;

4. CCTA image should be obtained from single- or dual-source computed tomography (CT)
scanners with a minimum of 64 detector rows.

Exclusion Criteria:

1. CCTA image is of poor quality due to motion artifact, severe calcification, metal
coverage, noise, poor contrast medium injection and other variables influencing the
diagnosis of stenosis;

2. previous percutaneous coronary intervention (PCI) or coronary artery bypass grafting
(CABG);

3. anomalous origin of coronary artery;

4. other non-atherosclerosis-related coronary diseases like coronary artery fistula,
aneurysm, coronary artery ectasia, arteritis coronaria, etc.;

5. repeated enrollment;

6. other conditions not suitable for enrollment.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Liming Xia</last_name>
<role>Study Director</role>
<affiliation>Tongji Hospital</affiliation>
</overall_official>
<overall_contact>
<last_name>Liming Xia</last_name>
<phone>13607176908</phone>
<email>lmxia@tjh.tjmu.edu.cn</email>
</overall_contact>
<overall_contact_backup>
<last_name>Lihui Li</last_name>
<phone>13636480344</phone>
<email>lihui.li@raysightmed.com</email>
</overall_contact_backup>
<location>
<facility>
<name>Beijing Hospital</name>
<address>
<city>Beijing</city>
<state>Beijing</state>
<zip>100730</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Min Chen</last_name>
</contact>
</location>
<location>
<facility>
<name>Sun Yat-sen Memorial Hospital</name>
<address>
<city>Guangzhou</city>
<state>Guangdong</state>
<zip>510120</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Jun Shen</last_name>
</contact>
</location>
<location>
<facility>
<name>Tongji Hospital</name>
<address>
<city>Wuhan</city>
<state>Hubei</state>
<zip>430030</zip>
<country>China</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Liming Xia</last_name>
<phone>13607176908</phone>
<email>lmxia@tjh.tjmu.edu.cn</email>
</contact>
</location>
<location_countries>
<country>China</country>
</location_countries>
<verification_date>March 2022</verification_date>
<study_first_submitted>March 16, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>September 19, 2022</last_update_submitted>
<last_update_submitted_qc>September 19, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">September 21, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Coronary Artery Disease</mesh_term>
<mesh_term>Coronary Stenosis</mesh_term>
<mesh_term>Constriction, Pathologic</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
With the emergence of advanced technology to date in the artificial intelligence (AI),
computer aided diagnosis has gradually gained its popularity in the field of healthcare.
Particularly, in the clinical practice of coronary artery disease diagnosis, the application
of AI could be of great implication in alleviating the shortage of medical sources. To
evaluate the effectiveness and safety of the AI-based coronary CT angiographic analysis
software (RuiXin-CoronaryAI) for diagnosis of coronary artery stenosis, a retrospective,
multi-center, cross-over designed, blinded, sensitivity superiority and specificity
non-inferiority clinical trial will be conducted.
Patients ≥18 years old with suspected or known coronary artery disease who underwent CCTA
will be included. CCTA images of subjects should be of good quality up to the DICOM 3.0
standards, obtained by CT scan with ≥64-slices. The subjects with unqualified CTA will be
excluded. CCTA images will be analyzed in three methods (3 groups). Control group: CCTA
images will be visually evaluated by physicians. Experiment group: CCTA images will be
evaluated by physicians using RuiXin-CoronaryAI. Reference group: CCTA images will be
visually evaluated by cardiologists with at least 10 years experiences, and the conclusions
they offer will be used as golden standard. Primary outcomes are diagnostic sensitivity and
specificity of RuiXin-CoronaryAI and coronary CTA for diagnosis of ischemia on a per-vessel
basis. The effectiveness of RuiXin-CoronaryAI for diagnosis of coronary artery stenosis will
be conducted by testing superiority of diagnostic sensitivity and non-inferiority of
specificity.
Patients ≥18 years old with suspected or known coronary artery disease who underwent CCTA
examination.
Inclusion Criteria:
1. layer thickness of CCTA images should be less than 1mm, image quality should be up to
DICOM 3.0 standards;
2. vessels should be clearly developed, contrast medium ought to be well filled, the
average of CT value of aortic root cavity should be between 325-600HU in CCTA image;
3. remodeling of vessels should be intact, including coronary artery and branches,
without missed or inaccurate slices;
4. CCTA image should be obtained from single- or dual-source computed tomography (CT)
scanners with a minimum of 64 detector rows.
Exclusion Criteria:
1. CCTA image is of poor quality due to motion artifact, severe calcification, metal
coverage, noise, poor contrast medium injection and other variables influencing the
diagnosis of stenosis;
2. previous percutaneous coronary intervention (PCI) or coronary artery bypass grafting
(CABG);
3. anomalous origin of coronary artery;
4. other non-atherosclerosis-related coronary diseases like coronary artery fistula,
aneurysm, coronary artery ectasia, arteritis coronaria, etc.;
5. repeated enrollment;
6. other conditions not suitable for enrollment.
|
NCT0532xxxx/NCT05320198.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320198</url>
</required_header>
<id_info>
<org_study_id>DISC-0974-102</org_study_id>
<nct_id>NCT05320198</nct_id>
</id_info>
<brief_title>Study of DISC-0974 in Participants With Myelofibrosis and Anemia</brief_title>
<official_title>A Phase 1b/2a Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DISC-0974 in Participants With Myelofibrosis and Anemia</official_title>
<sponsors>
<lead_sponsor>
<agency>Disc Medicine, Inc</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>Disc Medicine, Inc</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
This phase 1b/2a open-label study will assess the safety, tolerability, pharmacokinetics and
pharmacodynamics of DISC-0974 as well as categorize the effects on anemia response in
subjects with myelofibrosis and anemia.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">June 6, 2022</start_date>
<completion_date type="Anticipated">October 2024</completion_date>
<primary_completion_date type="Anticipated">October 2024</primary_completion_date>
<phase>Phase 1/Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Sequential Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Incidence of treatment-emergent adverse events (Phase 1b only)</measure>
<time_frame>up to 225 days</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Incidence of clinically abnormal vital signs (Phase 1b only)</measure>
<time_frame>up to 225 days</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Incidence of clinically abnormal physical exam (Phase 1b only)</measure>
<time_frame>up to 225 days</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Incidence of clinically abnormal electrocardiograms (Phase 1b only)</measure>
<time_frame>up to 225 days</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Incidence of abnormal laboratory test results (Phase 1b only)</measure>
<time_frame>up to 225 days</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Anemia response, defined per IWG-MRT criteria (Phase 2a only)</measure>
<time_frame>up to 225 days</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>Anemia response defined per IWG-MRT criteria (Phase 1b only)</measure>
<time_frame>up to 225 days</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Change from baseline in concentration of iron laboratory parameters (Phase 1b and 2a)</measure>
<time_frame>up to 225 days</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Change from baseline in concentration of hematologic laboratory parameters (Phase 1b and 2a)</measure>
<time_frame>up to 225 days</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Rate of RBC transfusion per participant month during treatment period (Phase 1b and 2a)</measure>
<time_frame>up to 225 days</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Transfusion response defined per IWG-MRT criteria (Phase 1b and 2a)</measure>
<time_frame>up to 225 days</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Mean change in Hgb (Phase 1b and 2a)</measure>
<time_frame>up to 225 days</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of treatment-emergent adverse events (Phase 2a only)</measure>
<time_frame>up to 225 days</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of clinically abnormal vital signs (Phase 2a only)</measure>
<time_frame>up to 225 days</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of clinically abnormal physical exam (Phase 2a only)</measure>
<time_frame>up to 225 days</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of clinically abnormal electrocardiogram (Phase 2a only)</measure>
<time_frame>up to 225 days</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of abnormal laboratory test results (Phase 2a only)</measure>
<time_frame>up to 225 days</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Cmax-Maximum drug concentration measured in plasma (Phase 1b and 2a)</measure>
<time_frame>up to 225 days</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Tmax-Time of maximum drug concentration (Phase 1b and 2a)</measure>
<time_frame>up to 225 days</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>AUC-Area under the drug concentration time curve (Phase 1b and 2a)</measure>
<time_frame>up to 225 days</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>T½ - Elimination half life of the drug (Phase 1b and 2a)</measure>
<time_frame>up to 225 days</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>CL/F-Apparent drug clearance (Phase 1b and 2a)</measure>
<time_frame>up to 225 days</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Vd/F-Apparent volume of distribution of the drug (Phase 1b and 2a)</measure>
<time_frame>up to 225 days</time_frame>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">56</enrollment>
<condition>Myelofibrosis; Anemia</condition>
<condition>Anemia</condition>
<condition>Myelofibrosis</condition>
<condition>Myelofibrosis Due to and Following Polycythemia Vera</condition>
<condition>Primary Myelofibrosis</condition>
<condition>Post-essential Thrombocythemia Myelofibrosis</condition>
<arm_group>
<arm_group_label>Phase 1b: Dose Escalation</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>In the Phase 1b (dose-escalation) portion of the study, DISC-0974 will be administered subcutaneously every 4 weeks.</description>
</arm_group>
<arm_group>
<arm_group_label>Phase 2a: Expansion</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>In the Phase 2a (expansion) portion of the study, DISC-0974 will be administered subcutaneously every 4 weeks.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>DISC-0974</intervention_name>
<description>DISC-0974 is administered subcutaneously.</description>
<arm_group_label>Phase 1b: Dose Escalation</arm_group_label>
<arm_group_label>Phase 2a: Expansion</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Age 18 years or older at the time of signing the informed consent (ICF).

2. For Phase 1b: Dynamic International Prognostic Scoring System (DIPSS) score of 3 to 4
(intermediate-2 risk) or ≥ 5 (high-risk) primary MF, post-PV MF, and/or post-ET MF, as
confirmed in the most recent local bone marrow biopsy report, according to World
Health Organization (WHO) 2016 criteria.

3. Washout of at least 28 days prior to Screening of the following treatments: androgens,
erythropoietin, cladribine, immunomodulators (lenalidomide, thalidomide), interferon
alpha-2a or any other MF-directed therapy. Systemic corticosteroids are permitted for
non-hematological conditions if stable or decreasing dose for ≥ 28 days prior to
Screening and receiving an equivalent to ≤ 10 mg prednisone for the 28 days
immediately prior to Screening.

4. Anemia: For Phase 1b: Hemoglobin (Hgb) < 10 g/dL on ≥ 3 assessments over 84 days prior
to Screening, without RBC transfusion, or Hgb < 10 g/dL and receiving RBC transfusions
periodically but not meeting criteria for TD participant as defined for the TD cohort.
The baseline Hgb value for these participants is the lowest Hgb level during the 84
days prior to Screening, or RBC transfusion dependence, defined as an RBC transfusion
frequency of ≥ 6 units packed RBCs (PRBC) over the 84 days immediately prior to
Screening. There must not be any consecutive 42-day period without an RBC transfusion
in the 84-day period, and the last transfusion must be within 28 days prior to
Screening. For Phase 2a: RBC transfusion dependence, defined as an RBC transfusion
frequency of ≥ 6 units PRBC over the 84 days immediately prior to Screening. There
must not be any consecutive 42-day period without an RBC transfusion in the 84-day
period, and the last transfusion must be within 28 days prior to Screening.

5. Stable dose of JAK inhibitor and/or hydroxyurea, or, if taking any other treatment for
MF, stable for at least 28 days prior to Screening.

6. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2.

7. Infusion of hematopoietic stem cell transplant not anticipated within 8 months after
Screening.

8. Transferrin saturation <75% (local lab acceptable).

9. Liver iron concentration by MRI < 7 mg/g dry weight within 3 months of eligibility
confirmation.

10. Serum ferritin ≥ 30 μg/L at Screening.

11. Platelet count ≥ 25,000/μL and < 1,000,000/μL; neutrophils ≥ 1,000/μL; and total white
blood cell (WBC) count < 50,000/μL at Screening.

12. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2 by the Chronic Kidney
Disease-Epidemiology Collaboration (CKD-EPI) formula.

13. Aspartate aminotransferase (AST) and alanine transaminase (ALT) < 3.0 x upper limit of
normal (ULN) at Screening.

14. Direct bilirubin < 2x ULN at Screening. Higher levels are acceptable if these can be
attributed by the Investigator to ineffective erythropoiesis.

Exclusion Criteria:

Medical History:

1. Hereditary hemochromatosis

2. Hemoglobinopathy or intrinsic RBC defect associated with anemia

3. Total splenectomy

4. Hematopoietic cell transplant within the past 10 years

5. Current anemia from iron deficiency, vitamin B12 or folate deficiency, infection, or
bleeding

6. Active immune-mediated hemolytic anemia

7. Symptomatic bleeding, unrelated to surgery, in a critical area or organ and/or
bleeding causing a decrease in Hgb of ≥ 2 g/dL or leading to transfusion of ≥ 2 units
of RBCs in the 6 months prior to Screening

8. Major surgery within 8 weeks prior to Screening or incomplete recovery from any
previous surgery

9. Malignancy within the past 3 years, other than primary MF, post-ET, or post-PV MF. The
following history or concurrent conditions are allowed:

1. basal or squamous cell carcinoma

2. carcinoma in situ of the cervix or the breast

3. histologic finding of prostate cancer (T1a or T1b using the tumor, nodes,
metastasis [TNM] clinical staging system)

A history of completed treatment (medical or surgical) of stage 1-2 cancers may be
permitted with prior Sponsor agreement.

10. Stroke, deep vein thrombosis, or pulmonary or arterial embolism within 6 months prior
to Screening

11. Known allergic reaction to any study drug excipient, or anaphylaxis to any food or
drug

12. A history of anti-drug antibody formation

13. Inadequately controlled heart disease (New York Heart Association Classification 3 or
4) and/or known to have left ventricular ejection fraction < 35%

14. Active Hepatitis B or C, or human immunodeficiency virus (HIV) with detectable viral
load

15. Uncontrolled fungal, bacterial, or viral infection (ongoing signs/symptoms related to
the infection, without improvement despite appropriate treatment)

Treatment History:

16. Concurrent or planned treatment with momelotinib during the study period

17. Iron chelation therapy in the 28 days prior to Screening

18. Change in anticoagulant therapy regimen within 8 weeks prior to Screening

Laboratory Exclusions:

19. Peripheral blood myeloblasts ≥ 10% of WBC differential at most recent evaluation prior
to Screening

20. Positive direct antiglobulin test in conjunction with a reactive RBC eluate at
Screening
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Will Savage, MD PhD</last_name>
<role>Study Director</role>
<affiliation>Disc Medicine</affiliation>
</overall_official>
<overall_contact>
<last_name>Disc Medicine Clinical Trials</last_name>
<phone>(617) 674 9274</phone>
<email>clinicaltrials@discmedicine.com</email>
</overall_contact>
<location>
<facility>
<name>Mayo Clinic Jacksonville</name>
<address>
<city>Jacksonville</city>
<state>Florida</state>
<zip>32224</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Tiffany Brown</last_name>
<phone>904-953-4564</phone>
<email>brown.tiffany@mayo.edu</email>
</contact>
<investigator>
<last_name>James Foran, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>University of Michigan</name>
<address>
<city>Ann Arbor</city>
<state>Michigan</state>
<zip>48109</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Linda Kemp</last_name>
<phone>734-232-4312</phone>
<email>lfarhat@med.umich.edu</email>
</contact>
<investigator>
<last_name>Moshe Talpaz, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Mayo Clinic Rochester</name>
<address>
<city>Rochester</city>
<state>Minnesota</state>
<zip>55905</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Ashya Burgress</last_name>
<email>Burgess.Ashya@mayo.edu</email>
</contact>
<investigator>
<last_name>Naseema Gangat, MBBS</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Washington University St.Louis</name>
<address>
<city>Saint Louis</city>
<state>Missouri</state>
<zip>63110</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Nicole Gaudin</last_name>
<email>nrgaudin@wustl.edu</email>
</contact>
<investigator>
<last_name>Amy Zhou, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Atrium Health Wake Forest Baptist</name>
<address>
<city>Winston-Salem</city>
<state>North Carolina</state>
<zip>27157</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Libyadda Mosley</last_name>
<email>limosley@wakehealth.edu</email>
</contact>
<investigator>
<last_name>Anne Wofford, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Gabrail Cancer Center Research</name>
<address>
<city>Canton</city>
<state>Ohio</state>
<zip>44718</zip>
<country>United States</country>
</address>
</facility>
<status>Active, not recruiting</status>
</location>
<location>
<facility>
<name>Oregon Health and Science University</name>
<address>
<city>Portland</city>
<state>Oregon</state>
<zip>97239</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Colin Hammons</last_name>
<email>hammonsc@ohsu.edu</email>
</contact>
<contact_backup>
<last_name>Keshara Bandara</last_name>
<email>bandara@ohsu.edu</email>
</contact_backup>
<investigator>
<last_name>Ronan Swords, MD, PhD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Sargon Research - Pennsylvania Cancer Specialists and Research Center</name>
<address>
<city>Gettysburg</city>
<state>Pennsylvania</state>
<zip>17325</zip>
<country>United States</country>
</address>
</facility>
<status>Active, not recruiting</status>
</location>
<location>
<facility>
<name>University of Pennsylvania</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19104</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Thomas Greenwood</last_name>
<phone>267-854-6712</phone>
<email>thomas.greenwood@pennmedicine.upenn.edu</email>
</contact>
<investigator>
<last_name>Elizabeth Hexner, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>MD Anderson</name>
<address>
<city>Houston</city>
<state>Texas</state>
<zip>77030</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Romany Gergis</last_name>
<phone>346-725-5139</phone>
<email>rgergis@mdanderson.org</email>
</contact>
<investigator>
<last_name>Prithviraj Bose, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>University of Washington</name>
<address>
<city>Seattle</city>
<state>Washington</state>
<zip>98109</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Kayla Pankey</last_name>
<phone>206-602-1172</phone>
<email>kpankey@seattlecca.org</email>
</contact>
<investigator>
<last_name>Anna Halpern, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>August 2023</verification_date>
<study_first_submitted>March 15, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>August 1, 2023</last_update_submitted>
<last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">August 2, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Myeloproliferative Neoplasm</keyword>
<keyword>Myeloproliferative Disorders</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Polycythemia Vera</mesh_term>
<mesh_term>Anemia</mesh_term>
<mesh_term>Primary Myelofibrosis</mesh_term>
<mesh_term>Polycythemia</mesh_term>
<mesh_term>Thrombocytosis</mesh_term>
<mesh_term>Thrombocythemia, Essential</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This phase 1b/2a open-label study will assess the safety, tolerability, pharmacokinetics and
pharmacodynamics of DISC-0974 as well as categorize the effects on anemia response in
subjects with myelofibrosis and anemia.
Inclusion Criteria:
1. Age 18 years or older at the time of signing the informed consent (ICF).
2. For Phase 1b: Dynamic International Prognostic Scoring System (DIPSS) score of 3 to 4
(intermediate-2 risk) or ≥ 5 (high-risk) primary MF, post-PV MF, and/or post-ET MF, as
confirmed in the most recent local bone marrow biopsy report, according to World
Health Organization (WHO) 2016 criteria.
3. Washout of at least 28 days prior to Screening of the following treatments: androgens,
erythropoietin, cladribine, immunomodulators (lenalidomide, thalidomide), interferon
alpha-2a or any other MF-directed therapy. Systemic corticosteroids are permitted for
non-hematological conditions if stable or decreasing dose for ≥ 28 days prior to
Screening and receiving an equivalent to ≤ 10 mg prednisone for the 28 days
immediately prior to Screening.
4. Anemia: For Phase 1b: Hemoglobin (Hgb) < 10 g/dL on ≥ 3 assessments over 84 days prior
to Screening, without RBC transfusion, or Hgb < 10 g/dL and receiving RBC transfusions
periodically but not meeting criteria for TD participant as defined for the TD cohort.
The baseline Hgb value for these participants is the lowest Hgb level during the 84
days prior to Screening, or RBC transfusion dependence, defined as an RBC transfusion
frequency of ≥ 6 units packed RBCs (PRBC) over the 84 days immediately prior to
Screening. There must not be any consecutive 42-day period without an RBC transfusion
in the 84-day period, and the last transfusion must be within 28 days prior to
Screening. For Phase 2a: RBC transfusion dependence, defined as an RBC transfusion
frequency of ≥ 6 units PRBC over the 84 days immediately prior to Screening. There
must not be any consecutive 42-day period without an RBC transfusion in the 84-day
period, and the last transfusion must be within 28 days prior to Screening.
5. Stable dose of JAK inhibitor and/or hydroxyurea, or, if taking any other treatment for
MF, stable for at least 28 days prior to Screening.
6. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2.
7. Infusion of hematopoietic stem cell transplant not anticipated within 8 months after
Screening.
8. Transferrin saturation <75% (local lab acceptable).
9. Liver iron concentration by MRI < 7 mg/g dry weight within 3 months of eligibility
confirmation.
10. Serum ferritin ≥ 30 μg/L at Screening.
11. Platelet count ≥ 25,000/μL and < 1,000,000/μL; neutrophils ≥ 1,000/μL; and total white
blood cell (WBC) count < 50,000/μL at Screening.
12. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2 by the Chronic Kidney
Disease-Epidemiology Collaboration (CKD-EPI) formula.
13. Aspartate aminotransferase (AST) and alanine transaminase (ALT) < 3.0 x upper limit of
normal (ULN) at Screening.
14. Direct bilirubin < 2x ULN at Screening. Higher levels are acceptable if these can be
attributed by the Investigator to ineffective erythropoiesis.
Exclusion Criteria:
Medical History:
1. Hereditary hemochromatosis
2. Hemoglobinopathy or intrinsic RBC defect associated with anemia
3. Total splenectomy
4. Hematopoietic cell transplant within the past 10 years
5. Current anemia from iron deficiency, vitamin B12 or folate deficiency, infection, or
bleeding
6. Active immune-mediated hemolytic anemia
7. Symptomatic bleeding, unrelated to surgery, in a critical area or organ and/or
bleeding causing a decrease in Hgb of ≥ 2 g/dL or leading to transfusion of ≥ 2 units
of RBCs in the 6 months prior to Screening
8. Major surgery within 8 weeks prior to Screening or incomplete recovery from any
previous surgery
9. Malignancy within the past 3 years, other than primary MF, post-ET, or post-PV MF. The
following history or concurrent conditions are allowed:
1. basal or squamous cell carcinoma
2. carcinoma in situ of the cervix or the breast
3. histologic finding of prostate cancer (T1a or T1b using the tumor, nodes,
metastasis [TNM] clinical staging system)
A history of completed treatment (medical or surgical) of stage 1-2 cancers may be
permitted with prior Sponsor agreement.
10. Stroke, deep vein thrombosis, or pulmonary or arterial embolism within 6 months prior
to Screening
11. Known allergic reaction to any study drug excipient, or anaphylaxis to any food or
drug
12. A history of anti-drug antibody formation
13. Inadequately controlled heart disease (New York Heart Association Classification 3 or
4) and/or known to have left ventricular ejection fraction < 35%
14. Active Hepatitis B or C, or human immunodeficiency virus (HIV) with detectable viral
load
15. Uncontrolled fungal, bacterial, or viral infection (ongoing signs/symptoms related to
the infection, without improvement despite appropriate treatment)
Treatment History:
16. Concurrent or planned treatment with momelotinib during the study period
17. Iron chelation therapy in the 28 days prior to Screening
18. Change in anticoagulant therapy regimen within 8 weeks prior to Screening
Laboratory Exclusions:
19. Peripheral blood myeloblasts ≥ 10% of WBC differential at most recent evaluation prior
to Screening
20. Positive direct antiglobulin test in conjunction with a reactive RBC eluate at
Screening
|
NCT0532xxxx/NCT05320211.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320211</url>
</required_header>
<id_info>
<org_study_id>10310012110002</org_study_id>
<nct_id>NCT05320211</nct_id>
</id_info>
<brief_title>Three-dimensional Printed Hand Orthoses</brief_title>
<official_title>Three-dimensional Printed Orthoses for Improving Daily Functioning in Chronic Hand Conditions</official_title>
<sponsors>
<lead_sponsor>
<agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>ZonMw: The Netherlands Organisation for Health Research and Development</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
In persons with chronic hand conditions, orthoses are often prescribed to improve daily-life
functioning. In most cases, orthoses are custom manufactured based on a plaster hand model,
which is a time-consuming and labor-intensive process. It has been demonstrated that the
production time to custom manufacture hand orthoses can be greatly reduced by using
three-dimensional (3D) scanning and printing, offering a promising cost-effective alternative
to conventional costum manufactured hand orthoses. However, before setting up a
cost-effectiveness study in persons with chronic hand conditions, insight into the
effectiveness of 3D-printed orthoses on performance of activities of daily living (ADL) is
needed, as well as insight into potential cost reductions. To date, this information is
largely unknown. The aims of this feasibility study are 1) to collect data on the preliminary
effectiveness of 3D-printed orthoses on performance of ADL, satisfaction with the orthosis
and quality of life compared to conventional orthoses in persons with chronic hand
conditions, and 2) to compare the production time and costs of 3D-printed orthoses with
conventional orthoses.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">April 12, 2022</start_date>
<completion_date type="Actual">February 28, 2023</completion_date>
<primary_completion_date type="Actual">February 28, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<intervention_model_description>within-subjects design</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Change from baseline in performance of ADL on the custom short form of the Dutch-Flemish Patient-Reported Outcomes Measurement Information System - Upper extremity (DF-PROMIS-UE) at 4 months post-intervention.</measure>
<time_frame>2 weeks pre-intervention; baseline; 1 month post-intervention; 4 months post-intervention</time_frame>
<description>The short form DF-PROMIS-UE contains 25 items from the DF-PROMIS-UE 46-item bank. Patients will rate how easily they can perform each activity on a 5-point scale, ranging from "without any difficulty" (score 4 or 5) to "unable to do" (score 1). For each activity, the question was added whether participants use their orthosis for that specific activity. The total score will be expressed as a T-score, which is a standardized score, with 50 representing the average score of the US general population and 10 being its standard deviation (SD). Note. For this study, the reliability of the DF-PROMIS-UE in persons with chronic hand conditions will be determined.</description>
</primary_outcome>
<secondary_outcome>
<measure>Change from baseline in performance of ADL, overall hand function, pain, work, performance, aesthetics, and satisfaction on the Michigan Hand Questionnaire-Dutch Language version (MHQ-DLV) at 4 months post-intervention.</measure>
<time_frame>2 weeks pre-intervention; baseline; 1 month post-intervention; 4 months post-intervention</time_frame>
<description>MHQ-DVL domain items are scored from 0 - 100, in which 100 is the best possible ability, while for pain a score of 0 indicates no pain. The total MHQ-DLV score is calculated as the mean of all 6 domains (after converting pain from a "best score of 0" scale to a "best score of 100" scale). Note. For this study, the reliability of the MHQ-DLV in persons with chronic hand conditions will be determined.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from baseline in satisfaction assessed with the Dutch version of the Client Satisfaction with Device (CSD) module of the Orthotics and Prosthetics User's Survey (OPUS) at 4 months post-intervention.</measure>
<time_frame>2 weeks pre-intervention; baseline; 1 month post-intervention; 4 months post-intervention</time_frame>
<description>The CSD contains 9 items rated on a 5-point Likert scale ranging from 0 ('strongly disagree') to 4 ('strongly agree), with a total score ranging from 0-36. Since the CSD is not yet available in Dutch, the investigators will translate it into the Dutch language and assess its content validity, structural validity, and reliability in Dutch orthotic users.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from baseline in satisfaction assessed with the Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST) at 4 months post-intervention</measure>
<time_frame>Baseline; 1 month post-intervention; 4 months post-intervention</time_frame>
<description>The D-QUEST assesses satisfaction with aspects related to the device and provided services. For this study, only the device-part of the D-QUEST will be used, which comprises 8 questions about certain characteristics of the orthotic device, all scored on a 5-point scale (from 'not satisfied at all' to 'very satisfied'), with a total score ranging from 8-40 (with 40 being the best possible satisfaction score).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in quality of life on the 5-dimension 5-level EuroQol (EQ-5D-5L) at 4 months post-intervention.</measure>
<time_frame>Baseline; 1 month post-intervention, 4 months post-intervention</time_frame>
<description>The EQ-5D-5L contains five questions about mobility, self-care, usual activities, pain/discomfort, and anxiety and depression scored on a 5-point scale indicating the degree of problems with each dimension and one question about experienced health scored on a 0-100 visual analogue scale.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Production time of the orthosis (in minutes).</measure>
<time_frame>From start of the intervention up to delivery of the orthosis</time_frame>
<description>For each step in manufacturing the orthosis until final delivery, time will be recorded (with a stopwatch).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Production costs of the orthosis (in euro).</measure>
<time_frame>From start of the intervention up to delivery of the orthosis</time_frame>
<description>Costs of the conventional orthoses will be retrospectively inventoried from the administration records of OIM. Costs related to the manufacturing of the 3D-printed orthoses will be prospectively assessed.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from baseline in personal goals at 4 month post-intervention.</measure>
<time_frame>Baseline; 1 month post-intervention, 4 months post-intervention</time_frame>
<description>An in-house usability questionnaire will be used to inventory information on personal goals of the orthosis, and whether this goal has been achieved (scored on a 10-point-scale, ranging from 1: not achieved at all to 10: very well achieved).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from baseline in orthosis use at 4 month post-intervention.</measure>
<time_frame>Baseline; 1 month post-intervention, 4 months post-intervention</time_frame>
<description>An in-house usability questionnaire will be used to inventory how often the orthosis is used, classified in 5 categories; ranging from never until 6-7 days a week.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Patient and therapist experiences with the 3D orthosis</measure>
<time_frame>1 month post-treatment</time_frame>
<description>Experiences of patients and health care providers with respect to the time window of the 3D intervention and satisfaction with the treatment process will be assessed with an in-house questionnaire, with items scored on a 5-point Likert scale.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Number of visits for fabrication of the 3D orthosis</measure>
<time_frame>From start of the intervention up to delivery of the orthosis</time_frame>
<description>The total number of visits for fabricating the 3D orthosis will be obtained from the administration records of OIM</description>
</secondary_outcome>
<other_outcome>
<measure>Adverse events</measure>
<time_frame>up to 4 months post intervention</time_frame>
<description>The following adverse events reported by the participant or observed by the investigator or orthotist will be recorded; pressure sores, abrasions, pain due to the orthosis, and material damage of the orthosis.</description>
</other_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">21</enrollment>
<condition>Hand Injuries and Disorders</condition>
<arm_group>
<arm_group_label>3D-printed hand orthoses</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>3D-printed hand orthosis</intervention_name>
<description>3D-printed hand orthoses (intervention) will be compared with custom-fabricated conventional orthoses (control condition at baseline)</description>
<arm_group_label>3D-printed hand orthoses</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Having a chronic hand-wrist condition due to an injury, or a musculoskeletal disorder,
neuromuscular disorder, or neurological disorder;

2. Minimum age of 18 years;

3. Currently wearing a conventional custom manufactured hand orthosis (including a
wrist-orthosis, wrist/thumb orthosis or thumb orthosis) for permanent use;

4. Indicated for a new hand orthosis.

Exclusion Criteria:

1. Already wearing a 3D-printed orthosis

2. Wearing a silver wrist-orthosis, wrist/thumb orthosis or thumb orthosis

3. Wearing an orthosis prescribed for a dysfunctional hand;

4. Wearing a broken orthosis;

5. Wearing the orthosis only at night;

6. Worsening of disease;

7. Insufficient mastery of the Dutch language.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Prof. dr. Frans Nollet, MD PhD</last_name>
<role>Study Director</role>
<affiliation>Amsterdam UMC, location AMC</affiliation>
</overall_official>
<location>
<facility>
<name>Department of rehabilitation medicine Amsterdam UMC, location AMC</name>
<address>
<city>Amsterdam</city>
<zip>1105AZ</zip>
<country>Netherlands</country>
</address>
</facility>
</location>
<location_countries>
<country>Netherlands</country>
</location_countries>
<reference>
<citation>Oud TAM, Lazzari E, Gijsbers HJH, Gobbo M, Nollet F, Brehm MA. Effectiveness of 3D-printed orthoses for traumatic and chronic hand conditions: A scoping review. PLoS One. 2021 Nov 18;16(11):e0260271. doi: 10.1371/journal.pone.0260271. eCollection 2021.</citation>
<PMID>34793566</PMID>
</reference>
<reference>
<citation>Oud T, Kerkum Y, de Groot P, Gijsbers H, Nollet F, Brehm MA. Production Time and User Satisfaction of 3-Dimensional Printed Orthoses For Chronic Hand Conditions Compared With Conventional Orthoses: A Prospective Case Series. J Rehabil Med Clin Commun. 2021 Feb 12;4:1000048. doi: 10.2340/20030711-1000048. eCollection 2021.</citation>
<PMID>33884150</PMID>
</reference>
<verification_date>March 2023</verification_date>
<study_first_submitted>March 24, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>March 30, 2023</last_update_submitted>
<last_update_submitted_qc>March 30, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">March 31, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
<investigator_full_name>Merel Brehm</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<keyword>feasibility</keyword>
<keyword>hand</keyword>
<keyword>orthotic device</keyword>
<keyword>printing; three-dimensional</keyword>
<keyword>activities, daily living</keyword>
<keyword>satisfaction</keyword>
<keyword>production time</keyword>
<keyword>costs</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Hand Injuries</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
<ipd_description>Anonymized individual participant data (IPD) and meta data will be made available to third parties via Figshare. Other anonymized IPD and documents will be made available on request including data analysis codes such as SPSS syntaxes or R scripts.</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
In persons with chronic hand conditions, orthoses are often prescribed to improve daily-life
functioning. In most cases, orthoses are custom manufactured based on a plaster hand model,
which is a time-consuming and labor-intensive process. It has been demonstrated that the
production time to custom manufacture hand orthoses can be greatly reduced by using
three-dimensional (3D) scanning and printing, offering a promising cost-effective alternative
to conventional costum manufactured hand orthoses. However, before setting up a
cost-effectiveness study in persons with chronic hand conditions, insight into the
effectiveness of 3D-printed orthoses on performance of activities of daily living (ADL) is
needed, as well as insight into potential cost reductions. To date, this information is
largely unknown. The aims of this feasibility study are 1) to collect data on the preliminary
effectiveness of 3D-printed orthoses on performance of ADL, satisfaction with the orthosis
and quality of life compared to conventional orthoses in persons with chronic hand
conditions, and 2) to compare the production time and costs of 3D-printed orthoses with
conventional orthoses.
Inclusion Criteria:
1. Having a chronic hand-wrist condition due to an injury, or a musculoskeletal disorder,
neuromuscular disorder, or neurological disorder;
2. Minimum age of 18 years;
3. Currently wearing a conventional custom manufactured hand orthosis (including a
wrist-orthosis, wrist/thumb orthosis or thumb orthosis) for permanent use;
4. Indicated for a new hand orthosis.
Exclusion Criteria:
1. Already wearing a 3D-printed orthosis
2. Wearing a silver wrist-orthosis, wrist/thumb orthosis or thumb orthosis
3. Wearing an orthosis prescribed for a dysfunctional hand;
4. Wearing a broken orthosis;
5. Wearing the orthosis only at night;
6. Worsening of disease;
7. Insufficient mastery of the Dutch language.
|
NCT0532xxxx/NCT05320224.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320224</url>
</required_header>
<id_info>
<org_study_id>POMI_Phase_II_2022_3005</org_study_id>
<nct_id>NCT05320224</nct_id>
</id_info>
<brief_title>Feasibility & Acceptability of a Patient-Oriented Music Intervention to Reduce Pain in the Intensive Care: A Pilot Trial</brief_title>
<acronym>POMI_PhaseII</acronym>
<official_title>Feasibility and Acceptability of a Patient-Oriented Music Intervention to Reduce Acute Pain in the Adult Intensive Care Unit: A Randomized Crossover Pilot Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>McGill University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>McGill University</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Introduction Many patients experience pain in the intensive care unit (ICU) despite receiving
pain medication. Research has shown that music can help manage pain. Music interventions that
have been studied so far have not been based on patient preferences, recommended tempo and
duration, nor used music streaming. It is important that a music intervention take into
consideration the expertise of ICU patients, family members and nurses/orderlies.

Study objectives This study aims to evaluate the feasibility and acceptability of a new
patient-oriented music intervention (POMI) to reduce pain in ICU patients. In addition, the
aim is to evaluate the feasibility of conducting a crossover randomized controlled trial
(RCT) to test the interventions in the adult ICU. A secondary objective will be to examine
the preliminary efficacy of the POMI.

Methodology/Study Design A single-blind 2x2 crossover pilot RCT will be used to evaluate the
feasibility, acceptability, and preliminary efficacy of the POMI. Patients will undergo a
sequence of two intervention periods: the POMI and the Active Control intervention (ACI;
headphones/pillow without music). Patients will be randomly assigned to Sequence 1 or
Sequence 2, where patients in Sequence 1 receive the POMI during the first intervention
period, followed by the ACI in the second intervention period; and patients in Sequence 2
receive the ACI first, followed be the POMI (with a 4-hour washout period).

Before the turning procedure, music will be stopped, and the headphones will be removed. For
patients able to self-report, the music (or control period without music) will be delivered
either via headphones or a music pillow, depending on their individual preference. For
patients unable to self-report, music (or control period without music) will be delivered via
the music pillow.

Twenty-four patients (12 patients able to self-report their pain and 12 patients unable to
self-report) will be recruited. The 12 patients able to self-report will be asked about their
music preferences and to complete an acceptability questionnaire (AQ). For the 12 patients
unable to self-report, 12 family members will be recruited to answer questions on the
patient's music preferences and to complete an AQ. In addition, 12 nurses/orderlies (involved
in the turning procedure for a patient participant) will be recruited and asked to complete
an AQ.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">March 15, 2022</start_date>
<completion_date type="Anticipated">September 10, 2022</completion_date>
<primary_completion_date type="Anticipated">September 10, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Crossover Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Participant, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Acceptability questionnaire, adapted from the validated Treatment Acceptability and Preferences questionnaire, 0-20 rating scores</measure>
<time_frame>60 minutes</time_frame>
<description>The acceptability questionnaire is adapted from the validated Treatment Acceptability and Preferences (TAP) questionnaire. The TAP and is comprised of four items: suitability, appropriateness, effectiveness and willingness to comply, each of which is rated on a 5-point scale ranging from 0 (not at all) to 4 (very much) for a total score ranging from 0 to 20, with higher scores indicating higher acceptability. The total scale score is obtained by calculating the mean of all the items' scores. The TAP can capture the complex nature of participants' preferences and yet be simple enough for use in the ICU setting. One item has been added to the questionnaire to determine the risks of side effects of the POMI, an additional important aspect in assessing the acceptability of the intervention.</description>
</primary_outcome>
<primary_outcome>
<measure>Feasibility of intervention delivery</measure>
<time_frame>up to 60 minutes</time_frame>
<description>The items for the assessment of the feasibility of intervention include time spent creating the individualized playlist, the presence or absence of any issue with headphone or pillow use, the presence or absence of any issue with music delivery, the presence or absence of skipping one or more song from the generated playlist, the presence or absence of any environmental noise, any POMI interruptions, whether the ICU adult patient participant received the full duration of the POMI, the dose (duration in minutes) of the music actually delivered, and the content of the music delivered (details of the music pieces played).</description>
</primary_outcome>
<secondary_outcome>
<measure>Change from Baseline Pain intensity on the 11-point Numeric Rating Scale (NRS) at 30 minutes</measure>
<time_frame>Baseline and 30 minutes</time_frame>
<description>The Faces Pain Thermometer (FPT) is a 0-10 NRS with faces in a thermometer format allowing the measurement of self-reported pain intensity by patients. The FPT is advantageous for use in ICU adult patients not only for its concomitant use of faces with 0-10 number, but also for being presented vertically, facilitating the interpretation of the scale in adults of all ages. The FPT is reported to have acceptable test-retest reliability (Pearson's r, 0.63), high content validation (content validity indices, 0.73-1.00), high convergent validation with the descriptive pain scale (kappa coefficients ranging from 0.63-0.79) as well as discriminative validation, with significantly higher pain scores during nociceptive/painful events compared to non-nociceptive/non-painful events</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline Pain intensity on the 11-point Numeric Rating Scale (NRS) at Bed Turning</measure>
<time_frame>From baseline to bed turning, up to 90 minutes</time_frame>
<description>The Faces Pain Thermometer (FPT) is a 0-10 NRS with faces in a thermometer format allowing the measurement of self-reported pain intensity by patients. The FPT is advantageous for use in ICU adult patients not only for its concomitant use of faces with 0-10 number, but also for being presented vertically, facilitating the interpretation of the scale in adults of all ages. The FPT is reported to have acceptable test-retest reliability (Pearson's r, 0.63), high content validation (content validity indices, 0.73-1.00), high convergent validation with the descriptive pain scale (kappa coefficients ranging from 0.63-0.79) as well as discriminative validation, with significantly higher pain scores during nociceptive/painful events compared to non-nociceptive/non-painful events</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Bed Turning Pain intensity on the 11-point Numeric Rating Scale (NRS) at 30 minutes</measure>
<time_frame>From bed turning (up to 90 minutes post baseline) to 30 minutes post bed turning</time_frame>
<description>The Faces Pain Thermometer (FPT) is a 0-10 NRS with faces in a thermometer format allowing the measurement of self-reported pain intensity by patients. The FPT is advantageous for use in ICU adult patients not only for its concomitant use of faces with 0-10 number, but also for being presented vertically, facilitating the interpretation of the scale in adults of all ages. The FPT is reported to have acceptable test-retest reliability (Pearson's r, 0.63), high content validation (content validity indices, 0.73-1.00), high convergent validation with the descriptive pain scale (kappa coefficients ranging from 0.63-0.79) as well as discriminative validation, with significantly higher pain scores during nociceptive/painful events compared to non-nociceptive/non-painful events</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline Pain distress on the 11-point Numeric Rating Scale (NRS) at 30 minutes</measure>
<time_frame>Baseline and 30 minutes</time_frame>
<description>Evaluation of the affective dimension of pain will be conducted using the validated a 0-10 pain distress score, derived from the NRS, ranging from no distress (0) to very distressing (10). In a study conducted with 3851 patients across 28 countries across 192 adult ICUs, higher degrees of pain distress were associated with turning procedures (relative risk = 1.18) and turning procedures predicted greater pain distress than pain intensity (odds ratio = 0.626).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline Pain distress on the 11-point Numeric Rating Scale (NRS) at Bed Turning</measure>
<time_frame>From baseline to bed turning, up to 90 minutes</time_frame>
<description>Evaluation of the affective dimension of pain will be conducted using the validated a 0-10 pain distress score, derived from the NRS, ranging from no distress (0) to very distressing (10). In a study conducted with 3851 patients across 28 countries across 192 adult ICUs, higher degrees of pain distress were associated with turning procedures (relative risk = 1.18) and turning procedures predicted greater pain distress than pain intensity (odds ratio = 0.626).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Bed Turning Pain distress on the 11-point Numeric Rating Scale (NRS) at 30 minutes</measure>
<time_frame>From bed turning (up to 90 minutes post baseline) to 30 minutes post bed turning</time_frame>
<description>Evaluation of the affective dimension of pain will be conducted using the validated a 0-10 pain distress score, derived from the NRS, ranging from no distress (0) to very distressing (10). In a study conducted with 3851 patients across 28 countries across 192 adult ICUs, higher degrees of pain distress were associated with turning procedures (relative risk = 1.18) and turning procedures predicted greater pain distress than pain intensity (odds ratio = 0.626).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline Critical-Care Pain Observation Tool (CPOT) at 30 minutes</measure>
<time_frame>Baseline and 30 minutes</time_frame>
<description>Evaluation of pain using the CPOT yields a score between zero and eight with scores above 2 representing the presence of pain. More specifically, the CPOT includes 4 items that can each be scored from 0-2: facial expression, body movements, muscle tension and vocalization/ventilator compliance. The CPOT has been validated in 47 studies with 3966 ICU patients unable to self-report across 21 different countries. Interrater reliability was examined in 30 studies, as determined by intra-class correlation and/or weighted kappa values above 0.60. Discriminative validation has been consistently supported with significantly higher CPOT scores during nociceptive/painful events compared to rest periods of rest or non-nociceptive/non-painful events, as evaluated by all studies that measured it (n = 43).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Baseline Critical-Care Pain Observation Tool (CPOT) at Bed Turning</measure>
<time_frame>From baseline to bed turning, up to 90 minutes</time_frame>
<description>Evaluation of pain using the CPOT yields a score between zero and eight with scores above 2 representing the presence of pain. More specifically, the CPOT includes 4 items that can each be scored from 0-2: facial expression, body movements, muscle tension and vocalization/ventilator compliance. The CPOT has been validated in 47 studies with 3966 ICU patients unable to self-report across 21 different countries. Interrater reliability was examined in 30 studies, as determined by intra-class correlation and/or weighted kappa values above 0.60. Discriminative validation has been consistently supported with significantly higher CPOT scores during nociceptive/painful events compared to rest periods of rest or non-nociceptive/non-painful events, as evaluated by all studies that measured it (n = 43).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change from Bed Turning Critical-Care Pain Observation Tool (CPOT) at 30 minutes</measure>
<time_frame>From bed turning (up to 90 minutes post baseline) to 30 minutes post bed turning</time_frame>
<description>Evaluation of pain using the CPOT yields a score between zero and eight with scores above 2 representing the presence of pain. More specifically, the CPOT includes 4 items that can each be scored from 0-2: facial expression, body movements, muscle tension and vocalization/ventilator compliance. The CPOT has been validated in 47 studies with 3966 ICU patients unable to self-report across 21 different countries. Interrater reliability was examined in 30 studies, as determined by intra-class correlation and/or weighted kappa values above 0.60. Discriminative validation has been consistently supported with significantly higher CPOT scores during nociceptive/painful events compared to rest periods of rest or non-nociceptive/non-painful events, as evaluated by all studies that measured it (n = 43).</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">48</enrollment>
<condition>Pain, Acute</condition>
<condition>Distress, Emotional</condition>
<condition>Critical Illness</condition>
<arm_group>
<arm_group_label>Patient-Oriented Music Intervention (POMI) followed by No Music - Sequence AB</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>Patient participants will first receive 20-30 minutes of the patient-oriented music intervention (POMI) first, followed by no music, with a minimal washout period of four hours</description>
</arm_group>
<arm_group>
<arm_group_label>No Music followed by Patient-Oriented Music Intervention (POMI) - Sequence BA</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>Patient participants will first receive no music first, followed by 20-30 minutes of the patient-oriented music intervention (POMI), with a minimal washout period of four hours</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Patient-Oriented Music Intervention (POMI)</intervention_name>
<description>The brief name given to this intervention is POMI (Patient-Oriented Music Intervention). In POMI, music is delivered to adult patients either via headphones (Bose) or by music pillow (MusiCure). Adults admitted to the intensive care unit (ICU) will choose the mode of delivery. ICU adult patients who are unable to self-report will hear music via music pillow. Individualized playlists will be created based on the patient music preferences, as self-reported. For patients unable to self-report, a person significant to the patient such as a family member will be asked about the patient music preferences. Questions about preferences will include music genre, track, artist, instrumentalness, acousticness, energy, and valence, as defined by the streaming service Spotify. A POMI web-based tool (https://pomi.glitch.me) will use these preferences to create personalized playlists on Spotify, with a tempo restriction of 60-80 bpm. Music will play for at least 20 minutes, via smart device (iPad).</description>
<arm_group_label>No Music followed by Patient-Oriented Music Intervention (POMI) - Sequence BA</arm_group_label>
<arm_group_label>Patient-Oriented Music Intervention (POMI) followed by No Music - Sequence AB</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion criteria:

- ≥ 18 years old (all patients)

- Admitted to ICU (all patients)

- Able to self-report (patients able to self-report)

- Able to listen to music as per patient (patients able to self-report)

- Significant person is present at bedside (patients unable to self-report)

- Considers self to have knowledge of the patient's music preferences (significant
persons)

- Is qualified to consent to any care required by the state of health for the incapable
ICU adult patient (significant persons)

- Is present during turning procedure at the time of the POMI project data collection
(nurses/orderlies)

Exclusion criteria:

- Cannot be turned (all patients)

- Does not speak/understand French or English (all participants)

- RASS -5 (all patients)

- Under effects of neuromuscular blocking agents (all patients)
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Céline Gélinas, RN, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>McGill University</affiliation>
</overall_official>
<overall_contact>
<last_name>Melissa Richard-Lalonde, Phd(c)</last_name>
<phone>514-340-8222</phone>
<phone_ext>23641</phone_ext>
<email>melissa.richard-lalonde@mail.mcgill.ca</email>
</overall_contact>
<location>
<facility>
<name>Jewish General Hospital</name>
<address>
<city>Montréal</city>
<state>Quebec</state>
<zip>H3T1E2</zip>
<country>Canada</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Melissa Richard-Lalonde</last_name>
<phone>514-340-8222</phone>
<phone_ext>23641</phone_ext>
<email>melissa.richard-lalonde@mail.mcgill.ca</email>
</contact>
</location>
<location_countries>
<country>Canada</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 10, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>April 1, 2022</last_update_submitted>
<last_update_submitted_qc>April 1, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 11, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>McGill University</investigator_affiliation>
<investigator_full_name>Céline Gélinas</investigator_full_name>
<investigator_title>Full Professor, Senior Researcher</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Critical Illness</mesh_term>
<mesh_term>Acute Pain</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Introduction Many patients experience pain in the intensive care unit (ICU) despite receiving
pain medication. Research has shown that music can help manage pain. Music interventions that
have been studied so far have not been based on patient preferences, recommended tempo and
duration, nor used music streaming. It is important that a music intervention take into
consideration the expertise of ICU patients, family members and nurses/orderlies.
Study objectives This study aims to evaluate the feasibility and acceptability of a new
patient-oriented music intervention (POMI) to reduce pain in ICU patients. In addition, the
aim is to evaluate the feasibility of conducting a crossover randomized controlled trial
(RCT) to test the interventions in the adult ICU. A secondary objective will be to examine
the preliminary efficacy of the POMI.
Methodology/Study Design A single-blind 2x2 crossover pilot RCT will be used to evaluate the
feasibility, acceptability, and preliminary efficacy of the POMI. Patients will undergo a
sequence of two intervention periods: the POMI and the Active Control intervention (ACI;
headphones/pillow without music). Patients will be randomly assigned to Sequence 1 or
Sequence 2, where patients in Sequence 1 receive the POMI during the first intervention
period, followed by the ACI in the second intervention period; and patients in Sequence 2
receive the ACI first, followed be the POMI (with a 4-hour washout period).
Before the turning procedure, music will be stopped, and the headphones will be removed. For
patients able to self-report, the music (or control period without music) will be delivered
either via headphones or a music pillow, depending on their individual preference. For
patients unable to self-report, music (or control period without music) will be delivered via
the music pillow.
Twenty-four patients (12 patients able to self-report their pain and 12 patients unable to
self-report) will be recruited. The 12 patients able to self-report will be asked about their
music preferences and to complete an acceptability questionnaire (AQ). For the 12 patients
unable to self-report, 12 family members will be recruited to answer questions on the
patient's music preferences and to complete an AQ. In addition, 12 nurses/orderlies (involved
in the turning procedure for a patient participant) will be recruited and asked to complete
an AQ.
Inclusion criteria:
- ≥ 18 years old (all patients)
- Admitted to ICU (all patients)
- Able to self-report (patients able to self-report)
- Able to listen to music as per patient (patients able to self-report)
- Significant person is present at bedside (patients unable to self-report)
- Considers self to have knowledge of the patient's music preferences (significant
persons)
- Is qualified to consent to any care required by the state of health for the incapable
ICU adult patient (significant persons)
- Is present during turning procedure at the time of the POMI project data collection
(nurses/orderlies)
Exclusion criteria:
- Cannot be turned (all patients)
- Does not speak/understand French or English (all participants)
- RASS -5 (all patients)
- Under effects of neuromuscular blocking agents (all patients)
|
NCT0532xxxx/NCT05320237.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320237</url>
</required_header>
<id_info>
<org_study_id>22/VRMS/115</org_study_id>
<nct_id>NCT05320237</nct_id>
</id_info>
<brief_title>Immersive Virtual Reality for Upper Limb Rehabilitation in Multiple Sclerosis</brief_title>
<official_title>Upper Limb Rehabilitation Using Immersive Virtual Reality for People With Multiple Sclerosis; a Feasibility Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Glasgow Caledonian University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>MS Society, UK</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>NHS Lanarkshire</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Glasgow Caledonian University</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Virtual reality (VR) has reported benefits of engagement, immersion, and motivation in
rehabilitation and has been proposed to be a solution for long-term engaging rehabilitation
methods. However, the use of VR within the multiple sclerosis (MS) population is not widely
investigated, and even less with regards to upper limb function. The main aim of this study
is to assess the feasibility of using the Oculus Quest VR headset and games for improving
upper limb function within the MS population. Recruited people with MS will be randomly
assigned to either an eight week intervention using VR games that have been designed by
co-production with people with MS and MS-specialists; or to a control group of usual care.
All participants will undertake testing at baseline, four weeks and eight weeks for multiple
outcomes measures related to upper limb and motor function. After completion of the
intervention, participants who undertook VR intervention will complete a survey regarding the
usability of the games, and some individuals will be invited to interviews to express their
experience of using VR and any suggestions for improvement for potential future trials.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The aim of this study is to investigate the feasibility of an eight-week intervention of
co-produced virtual reality (VR) games delivered using the Oculus Quest for improving the
upper limb function of people with MS. This study is also a randomised controlled trial with
two arms, one group will undergo the intervention using VR and the other will be a control
group.

This study aims to recruit up to 30 people with MS who have some degree of self-reported
upper limb mobility difficulties from MS clinics in NHS Lanarkshire and MS Revive, a third
sector in Glasgow. Participants will be randomly allocated to a group: an eight week
intervention study using VR and exercise games or a control group of usual care. All groups
will have assessments at baseline, week 4 and week 8. However, only the VR intervention group
will undertake the USE questionnaire and only a select number of participants in the VR group
will participate in the semi-structured interviews.

The VR intervention group will involve participants travelling to a research site twice a
week for eight weeks and each session will be approximately 30 minutes. This 30-minute
intervention will include participating in game play and the participant using the game's
interface (e.g. navigating through menus, selecting which games to play). The games for the
intervention will involve facilitating and replicating upper limb movements: pushing buttons
for the interface; individual finger movement; grasp and release and one game includes
holding a controller for elbow flexion and extension (see table). The intervention group will
undergo exercises in a fully immersive VR environment using the Oculus Quest VR headsets. For
health and safety reasons participants will complete their programme whilst seated.

The control group will not receive a specific exercise programme but will be asked to
continue with their usual care, which could generally include any ongoing physiotherapy or
occupational therapy support or none whatsoever. Any ongoing physiotherapy or occupational
therapy (NHS or non-NHS) will be recorded, detailing the exercises and frequency. After
completion of the week 8 assessment, participants within the control group will be offered
the opportunity to take part in a 30-minute session trialling the VR games.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">June 26, 2022</start_date>
<completion_date type="Actual">April 28, 2023</completion_date>
<primary_completion_date type="Actual">April 28, 2023</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Recruitment Rates</measure>
<time_frame>First 5 months of study.</time_frame>
<description>Recording the number of participants: identified and approached; number of participants that meet eligibility criteria or are excluded and record reasons for exclusion; number of participants that agree to take part in the study.</description>
</primary_outcome>
<primary_outcome>
<measure>Number of intervention sessions completed by participants</measure>
<time_frame>Through the intervention period of 6 months.</time_frame>
<description>Measured by recording the amount of VR sessions completed and the duration of these for each participant.</description>
</primary_outcome>
<primary_outcome>
<measure>Recording the number of drop out rates from participants</measure>
<time_frame>Through the intervention period of 6 months.</time_frame>
<description>Measured by recording the amount of participants from both groups dropping out of the study.</description>
</primary_outcome>
<primary_outcome>
<measure>Acceptance of being assigned to the control arm</measure>
<time_frame>Week 8 of intervention.</time_frame>
<description>Asking participants in the control arm if they accept being in this group rather than the intervention group.</description>
</primary_outcome>
<primary_outcome>
<measure>Reporting adverse effects from intervention.</measure>
<time_frame>Through the intervention period of 6 months.</time_frame>
<description>Recording the number and type of adverse effects experienced by the participants from the intervention, either during or immediately following the VR intervention.</description>
</primary_outcome>
<primary_outcome>
<measure>Rate of completion of secondary outcomes</measure>
<time_frame>Through the intervention period of 6 months.</time_frame>
<description>Recording if participants are able to complete the upper limb related outcomes.</description>
</primary_outcome>
<secondary_outcome>
<measure>Nine Hole Peg Test</measure>
<time_frame>Baseline, Week 4, Week 8</time_frame>
<description>Measurement of hand dexterity.</description>
</secondary_outcome>
<secondary_outcome>
<measure>ABLIHAND questionnaire</measure>
<time_frame>Baseline, Week 4, Week 8</time_frame>
<description>Self-reported questionnaire regarding their ability to perform activities of daily living that requires upper limb function. It has a maximum score of 46 and the lower the score, the poorer the functional ability.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Hand grip strength via Jamar dynamometer</measure>
<time_frame>Baseline, Week 4, Week 8</time_frame>
<description>Measurement of hand grip strength.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Action Research Arm Test (ARAT)</measure>
<time_frame>Baseline, Week 4, Week 8</time_frame>
<description>Measurement of ability of handling objects and other general upper limb movements.</description>
</secondary_outcome>
<secondary_outcome>
<measure>The spasticity-related quality of life tool (SQoL-6D)</measure>
<time_frame>Baseline, Week 4, Week 8</time_frame>
<description>Self-reported questionnaire regarding how spasticity of their upper limb affects their quality of life. There are 7 domains and the participant has to tick which statement they believe is most appropriate to their spasticity within the last 7 days.</description>
</secondary_outcome>
<secondary_outcome>
<measure>USE questionnaire</measure>
<time_frame>Week 8</time_frame>
<description>Questionnaire regarding the user's opinion on the usefulness, satisfaction and ease of use of the developed software. There are 30 questions using a 7-point Likert scale the participant must rate how strongly they agree or disagree with the statements regarding the software.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Semi-structured interviews</measure>
<time_frame>Week 9</time_frame>
<description>Interviews to explore the participant's experience with the virtual reality intervention, any issues encountered and suggested improvements for future studies using the games or virtual reality.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">19</enrollment>
<condition>Multiple Sclerosis</condition>
<arm_group>
<arm_group_label>Virtual Reality Intervention</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Eight weeks of two 30 minute sessions using virtual reality with the upper limb exercise games.</description>
</arm_group>
<arm_group>
<arm_group_label>Control Group</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>Participants will be asked to continue with their usual care independent of this study.</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Immersive Virtual Reality Intervention</intervention_name>
<description>Eight week intervention with two sessions a week. Each session will be 30 minutes in duration and will involve participants partaking in VR and such games include targeting individual finger movement (playing piano); grasp and release and one game (catching falling stars) includes holding a controller for elbow flexion and extension (Whack-a-mole).</description>
<arm_group_label>Virtual Reality Intervention</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Confirmed diagnosis of multiple sclerosis.

- Degree of self-reported hand or upper limb impairment which interferes with some
activities of daily living (ADL) (e.g. dressing, eating, grooming).

- Objective upper limb impairment, in at least one hand, as determined by a Nine Hole
Peg Test (see Section Outcome Measures) of 2 standard deviations of more above the
published normative values depending on age and sex.

- Must be able to travel to a research site.

Exclusion Criteria:

- If they have had a relapse in the last three months

- Subjective cognitive problems resulting in them being unable to use the equipment or
participate in virtual reality.

- Visual problems such that they cannot see the visual display within the headset (this
does not include participants who have glasses that are enough to correct eyesight
issues)

- Have a current eye infection.

- Have any significant co-existing neurological or orthopaedic conditions affecting the
upper limb.

- Are unable to understand verbal or written explanations of the study or are unable to
speak or understand English.

- Individuals who are currently enrolled in any clinical trials will be excluded, but
those who have previously taken part in research and other trials will be eligible.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Amy Webster</name>
<address>
<city>Glasgow</city>
<state>Scotland</state>
<zip>G4 0BA</zip>
<country>United Kingdom</country>
</address>
</facility>
</location>
<location_countries>
<country>United Kingdom</country>
</location_countries>
<verification_date>September 2023</verification_date>
<study_first_submitted>March 10, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>September 11, 2023</last_update_submitted>
<last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">September 13, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Multiple Sclerosis</keyword>
<keyword>Rehabilitation</keyword>
<keyword>Virtual reality</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Multiple Sclerosis</mesh_term>
<mesh_term>Sclerosis</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
<ipd_description>There is no plan to share participant data to anyone outside the research team, however the results of this study will be reported and planned publication after the study is completed with anonymised data.</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Virtual reality (VR) has reported benefits of engagement, immersion, and motivation in
rehabilitation and has been proposed to be a solution for long-term engaging rehabilitation
methods. However, the use of VR within the multiple sclerosis (MS) population is not widely
investigated, and even less with regards to upper limb function. The main aim of this study
is to assess the feasibility of using the Oculus Quest VR headset and games for improving
upper limb function within the MS population. Recruited people with MS will be randomly
assigned to either an eight week intervention using VR games that have been designed by
co-production with people with MS and MS-specialists; or to a control group of usual care.
All participants will undertake testing at baseline, four weeks and eight weeks for multiple
outcomes measures related to upper limb and motor function. After completion of the
intervention, participants who undertook VR intervention will complete a survey regarding the
usability of the games, and some individuals will be invited to interviews to express their
experience of using VR and any suggestions for improvement for potential future trials.
The aim of this study is to investigate the feasibility of an eight-week intervention of
co-produced virtual reality (VR) games delivered using the Oculus Quest for improving the
upper limb function of people with MS. This study is also a randomised controlled trial with
two arms, one group will undergo the intervention using VR and the other will be a control
group.
This study aims to recruit up to 30 people with MS who have some degree of self-reported
upper limb mobility difficulties from MS clinics in NHS Lanarkshire and MS Revive, a third
sector in Glasgow. Participants will be randomly allocated to a group: an eight week
intervention study using VR and exercise games or a control group of usual care. All groups
will have assessments at baseline, week 4 and week 8. However, only the VR intervention group
will undertake the USE questionnaire and only a select number of participants in the VR group
will participate in the semi-structured interviews.
The VR intervention group will involve participants travelling to a research site twice a
week for eight weeks and each session will be approximately 30 minutes. This 30-minute
intervention will include participating in game play and the participant using the game's
interface (e.g. navigating through menus, selecting which games to play). The games for the
intervention will involve facilitating and replicating upper limb movements: pushing buttons
for the interface; individual finger movement; grasp and release and one game includes
holding a controller for elbow flexion and extension (see table). The intervention group will
undergo exercises in a fully immersive VR environment using the Oculus Quest VR headsets. For
health and safety reasons participants will complete their programme whilst seated.
The control group will not receive a specific exercise programme but will be asked to
continue with their usual care, which could generally include any ongoing physiotherapy or
occupational therapy support or none whatsoever. Any ongoing physiotherapy or occupational
therapy (NHS or non-NHS) will be recorded, detailing the exercises and frequency. After
completion of the week 8 assessment, participants within the control group will be offered
the opportunity to take part in a 30-minute session trialling the VR games.
Inclusion Criteria:
- Confirmed diagnosis of multiple sclerosis.
- Degree of self-reported hand or upper limb impairment which interferes with some
activities of daily living (ADL) (e.g. dressing, eating, grooming).
- Objective upper limb impairment, in at least one hand, as determined by a Nine Hole
Peg Test (see Section Outcome Measures) of 2 standard deviations of more above the
published normative values depending on age and sex.
- Must be able to travel to a research site.
Exclusion Criteria:
- If they have had a relapse in the last three months
- Subjective cognitive problems resulting in them being unable to use the equipment or
participate in virtual reality.
- Visual problems such that they cannot see the visual display within the headset (this
does not include participants who have glasses that are enough to correct eyesight
issues)
- Have a current eye infection.
- Have any significant co-existing neurological or orthopaedic conditions affecting the
upper limb.
- Are unable to understand verbal or written explanations of the study or are unable to
speak or understand English.
- Individuals who are currently enrolled in any clinical trials will be excluded, but
those who have previously taken part in research and other trials will be eligible.
|
NCT0532xxxx/NCT05320250.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320250</url>
</required_header>
<id_info>
<org_study_id>FDG_Saliva_Parkinson_RaSPiD</org_study_id>
<nct_id>NCT05320250</nct_id>
</id_info>
<brief_title>Saliva and Extracellular Vesicles for Parkinson's Disease</brief_title>
<acronym>RaSPiD</acronym>
<official_title>Raman Spectroscopy Analysis of Saliva and Salivary Extracellular Vesicles as New Biomarkers for Parkinson's Disease and Atypical Parkinsonisms.</official_title>
<sponsors>
<lead_sponsor>
<agency>Fondazione Don Carlo Gnocchi Onlus</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>University of Cagliari</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Campus Bio-Medico University</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Fondazione Don Carlo Gnocchi Onlus</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Rehabilitation is crucial in the treatment of people with Parkinson's disease (PD) as it can
ameliorate motor and non-motor impairments, improving their clinical profile and quality of
life. Considering the complex biological processes occurring in PD brain, the identification
of accessible and measurable biomarkers to monitor the events induced by intensive
rehabilitation would help in i)testing rehabilitation effectiveness, ii)improving the design
of clinical trials and iii)personalizing the rehabilitation strategies by the prediction of
patients' responsiveness. The objective of this project is the validation of Raman analysis
of saliva and salivary extracellular vesicles (EV) for the differential diagnosis of
Parkinson's disease (PD) and atypical Parkinsonism. The proposed diagnostic method can be
integrated in the preliminary assessment and monitoring of the patient by providing a quickly
and repeatable measurable biomarker. In the end, this will bring tothe personalization of the
rehabilitation path and provide an indication on the outcome of the rehabilitation treatment.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms such
as bradykinesia, tremor, rigidity and postural instability. An accurate rehabilitation
program designed considering the specific characteristics of the patient allows you to
maximize the effect of drug therapy, improve the patient's quality of life, while also
limiting secondary complications related to the progression of the disease. At the time of
diagnosis, however, it is particularly important to be able to quickly identify individuals
with idiopathic Parkinson's and distinguish them from those who have an atypical form of
Parkinsonism, such as Progressive Supranuclear Palsy (PSP), Multiple System Atrophy (MSA),
Corticobasal Degeneration (CBD) and Dementia with Lewy bodies (DLB). Atypical Parkinsonisms
are in fact progressive diseases that share some signs and symptoms with PD, however these
patients do not respond as effectively to drug therapy since the cellular and degenerative
mechanisms that characterize them are very different. For these reasons, their early
identification is particularly important to identify the best pharmacological and
rehabilitative path for each patient.

To ensure a more accurate patient profiling that takes into account the individual complex
clinical picture, the discovery of a biomarker that can be periodically measured in an easily
accessible biofluid would allow for better patient stratification, monitoring of the course
of the disease and careful study of the effects of the pharmacological and rehabilitation
program as well as its personalization, with a view to precision medicine designed, defined
and built on the patient.

The Laboratory of Nanomedicine and Clinical Biophotonics (LABION) of Fondazione Don Gnocchi
has been working for years on using innovative methods such as Raman spectroscopy to identify
biomarkers of neurodegenerative diseases in easily accessible biological fluids, such as
blood and saliva. Raman Spectroscopy (RS) allows to obtain a specific and complete
characterization of a specific fluid in a rapid, sensitive and non-destructive way, without
particular procedures for the preparation of the sample to be analyzed. In RS the entire
spectrum obtained from the sample is used as a highly specific "fingerprint" for the selected
sample (eg saliva, blood, serum, cerebrospinal fluid) which represents the diagnostic
biomarker. The Raman analysis of saliva has already demonstrated the possibility of profiling
patients with progressive pathologies with good accuracy and, specifically, of distinguishing
subjects suffering from amyotrophic lateral sclerosis compared to subjects with other types
of neurodegenerative diseases.

At the same time, LABION has verified the possibility of characterizing by Raman
spectroscopy, the extracellular vesicles (EV) circulating in the blood of patients with PD.
Since 2017, LABION has been working on the biochemical study of circulating EVs in the serum
of PD patients by analyzing the EVs in spectroscopy and the ability of RS to identify a
specific biochemical profile of blood vesicles that correlates with clinical scales has been
demonstrated. UPDRS III and Hoehn and Yahr. The analysis of the EVs present in the saliva of
patients with PD could help to understand the origin of biochemical alterations in the saliva
as well as identify even more specific markers.

Raman spectroscopy is therefore proposed as a useful method for the rapid and comprehensive
biochemical characterization of saliva and the vesicular component present within it, without
the use of staining and labeling procedures.

The objective of this project is the validation of a specific Raman molecular signature for
the different experimental groups, which can lead to the determination of a biomarker useful
for the differential diagnosis of people with PD compared to subjects with atypical
Parkinsonism, through the analysis of a biological fluid that is not invasive, thus filling
the current lack of a measurable biomarker for rapid differential diagnosis and for
monitoring the evolution of the diseases.

The rapid identification and differential diagnosis of subjects with Parkinson's disease and
atypical parkinsonisms will allow to promptly identify the optimal pharmacological and
rehabilitative therapy for each subject, leading to a significant improvement in the quality
of life for the patient and, in the future, an increased probability slowing the progression
of the disease.

SAMPLE COLLECTION: Saliva collection from all the selected subjects will be performed
following the Salivette (SARSTEDT) manufacturer's instructions. Saliva will be obtained from
all subjects after an appropriate lag time from feeding and teeth brushing. Pre-analytical
parameters (i.e. storage temperature and time between collection and processing), dietary and
smoking habit will be properly recorded. Briefly, the swab will be placed in the mouth and
chewed for 60 seconds to stimulate salivation. Then the swab will be centrifuged for 2
minutes at 1,000 g to remove cells fragments and food debris. Collected samples will be
stored at -80° C.

SAMPLE PROCESSING: For the Raman analysis, a drop of each sample will be casted on an
aluminium foil in order to achieve the Surface Enhanced Raman Scattering (SERS).

EV ISOLATION: different isolation methods will be tested for effective EV isolation. Purified
EVs will be then concentrated and analysed by means of standard techniques and by Raman
spectroscopy following a previously optimized protocol for blood EVs. The experimetal
settings will be adapted to the salivary EVs, considering variations in substrate,
acquisition time, etc.

DATA COLLECTION: Salivary and EV spectra will be acquired using an Aramis Raman microscope
(Horiba Jobin-Yvon, France) equipped with a laser light source operating at 785 nm and 532
nm. The instrument will be calibrated before each analysis using the reference band of
silicon at 520.7 cm-1. Raman spectra will be acquired in the region between 400 and 1600 cm-1
for saliva, 500-1800 nad 2600-3200 cm-1 for EVs using a 50x objective. The software package
LabSpec 6 (Horiba Jobin-Yvon, France) will be used for the acquisition of spectra.

DATA PROCESSING: All the acquired spectra will be baseline corrected and normalized by unit
vector using the dedicated software LabSpec 6. The contribution of the substrate will be
removed from each spectra, if necessary. The statistical analysis to validate the method,
will be performed using a multivariate analysis approach. Principal Component analysis (PCA)
will be performed in order to reduce data dimensions and to evidence major trends. The first
20 resultant Principal Components (PCs) will be used in a classification model, Linear
Discriminant Analysis (LDA), to discriminate the data maximizing the variance between the
selected groups. The smallest number of PCs will be selected to prevent data overfitting.
Leave-one-out cross-validation and confusion matrix test will be used to evaluate the method
sensitivity, precision and accuracy of the LDA model. Mann-Whitney will be performed on PCs
scores to verify the differences statistically relevant between the analysed groups.
Correlation and partial correlation analysis will be performed using the Spearman's test,
assuming as valid correlation only the coefficients with a p-value lower than 0.05. The
statistical analysis will be performed using Origin2018 (OriginLab, USA).

ROC Curve will be calculated to assess thediagnostic potential of the method.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">December 15, 2021</start_date>
<completion_date type="Anticipated">June 15, 2023</completion_date>
<primary_completion_date type="Anticipated">January 31, 2023</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Control</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Salivary Raman fingerprint of PD and atypical parkinsonism</measure>
<time_frame>15/12/2021 - 28/02/2023</time_frame>
<description>Raman spectroscopy analysis of the saliva of patients with PD and atypical Parkinsonisms for the validation of the diagnostic power of the method</description>
</primary_outcome>
<primary_outcome>
<measure>Salivary Raman fingerprint of PD patients after rehabilitation</measure>
<time_frame>15/12/2021 - 28/02/2023</time_frame>
<description>Raman spectroscopy analysis of the saliva of patients with PD and atypical Parkinsonisms for the validation of the diagnostic power of the method</description>
</primary_outcome>
<primary_outcome>
<measure>Salivary Extracellular vesicles characterization</measure>
<time_frame>01/03/2022 - 31/03/2023</time_frame>
<description>Isolation and characterization with standard technoques and by Raman spectroscopy of salivary extracellular vesicles</description>
</primary_outcome>
<secondary_outcome>
<measure>Correlation of Raman data with clinical assessments</measure>
<time_frame>01/10/2022 - 15/06/2023</time_frame>
<description>Data analysis, correlation study and data interpretation</description>
</secondary_outcome>
<number_of_groups>4</number_of_groups>
<enrollment type="Anticipated">180</enrollment>
<condition>Parkinson's Disease and Parkinsonism</condition>
<arm_group>
<arm_group_label>Parkinson's disease</arm_group_label>
<description>60 patients. People with Parkinson's disease (pwPD) will be recruited for the study at Fondazione Don Gnocchi.
PwPD will be assigned to a rehabilitation program that will last for 6 consecutive weeks. Two possible rehabilitation plans are included:
Rehabilitation treatment at the IRCCS S. Maria Nascente: 30 sessions / 5 days a week including motor rehabilitation, cognitive rehabilitation and speech therapy rehabilitation.
Self-treatment program consisting of stretching and active mobilization exercises at home. Before starting the program, the subjects will undergo an educational and training session with the physiotherapist to learn the correct way of carrying out the proposed exercises.</description>
</arm_group>
<arm_group>
<arm_group_label>Atypical Parkinsonism</arm_group_label>
<description>Progressive supranuclear palsy: 20 patients; Corticobasal syndrome: 20 patients; Multisystemic atrophy: 20 patients.</description>
</arm_group>
<arm_group>
<arm_group_label>REM sleep Behavior Disorder</arm_group_label>
<description>30 patients</description>
</arm_group>
<arm_group>
<arm_group_label>Healthy controls</arm_group_label>
<description>30 patients</description>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Single saliva collection</intervention_name>
<description>1 ml of saliva will be collected with Salivette swabs.</description>
<arm_group_label>Atypical Parkinsonism</arm_group_label>
<arm_group_label>Healthy controls</arm_group_label>
<arm_group_label>REM sleep Behavior Disorder</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Saliva collection, longitudinal</intervention_name>
<description>1 ml of saliva will be collected with Salivette swabs. Subjects diagnosed with PD will undergo assessments and saliva sampling before starting rehabilitation treatment (T0), at the end of treatment (T1) and 3 months after the end of treatment (T2).</description>
<arm_group_label>Parkinson's disease</arm_group_label>
</intervention>
<biospec_retention>Samples With DNA</biospec_retention>
<biospec_descr>
<textblock>
Saliva containing DNA. DNA will not be analysed separatly
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
PD patients will be recrutied at the Neurology Rehabilitation Unit of IRCCS S. Maria
Nascente of Fondazione Don Gnocchi under the responsibility of Dr. Mario Meloni, before and
after the rehabilitation treatment.

Subjects with PSP, CBS and AMS will be recruited at Campus Bio-Medico University (Rome) and
at Gaetano Pini Orthopedic Institute-ASST Pini-CTO (Milan).

Subjects with RBD will be recruited at the University of Cagliari - Neurology Complex
Operating Unit - Sleep Center.
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

For Pakinson's disease: diagnosis following "MDS clinical diagnostic criteria for
Parkinson's disease" (Postuma et al. Movement Disorders vol. 30 1591-1601, 2015), with
Hoehn&Yahr between 1 and 3.

The diagnosis of Progressive Supranuclear Palsy will be made according to the criteria of
the Movement Disorders Society (Höglinger et al. Mov. Disord. 32, 853-864, 2017). The
diagnosis of Corticobasal Syndrome will be made according to the 2013 Armstrong criteria
(Armstrong et al. Neurology 80, 496-503, 2013).

The diagnosis of multiple system atrophy will be made according to the Gilman criteria of
The diagnosis of Behavior Disorder in REM phase will be made according to the criteria of
the "International Classification of Sleep Disorders, Third Edition (ICSD-3)".

Exclusion Criteria:

For all the experimental groups considered and for healthy controls, subjects with
concomitant chronic and / or inflammatory diseases of the oral cavity, other systemic
diseases (eg anemia, cardiovascular or respiratory diseases), oncological or infectious
diseases will be excluded.

Vascular parkinsonisms, monogenic parkinsonisms will also be excluded as well as iatrogenic
parkinsonisms, parkinsonisms secondary to exposure to known neurotoxins; parkinsonisms
secondary to tumor lesions; parkinsonisms due to normotensive hydrocephalus; subjects with
a form of dementia, severe speech disorders and other psychiatric and / or neurological
pathologies.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>50 Years</minimum_age>
<maximum_age>85 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Alice Gualerzi, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Fondazione Don Carlo Gnocchi</affiliation>
</overall_official>
<overall_contact>
<last_name>Alice Gualerzi, PhD</last_name>
<phone>+390240308533</phone>
<email>agualerzi@dongnocchi.it</email>
</overall_contact>
<overall_contact_backup>
<last_name>Marzia Bedoni, PhD</last_name>
<phone>+390240308874</phone>
<email>mbedoni@dongnocchi.it</email>
</overall_contact_backup>
<location>
<facility>
<name>Azienda Ospedaliero - Universitaria di Cagliari</name>
<address>
<city>Cagliari</city>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Monica Puligheddu, MD</last_name>
</contact>
<investigator>
<last_name>Mario Meloni, MD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi ONLUS</name>
<address>
<city>Milano</city>
<zip>20148</zip>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Alice Gualerzi, PhD</last_name>
<phone>0240308533</phone>
<phone_ext>+39</phone_ext>
<email>agualerzi@dongnocchi.it</email>
</contact>
<contact_backup>
<last_name>Marzia Bedoni, PhD</last_name>
<phone>0240308874</phone>
<phone_ext>+39</phone_ext>
<email>labion@dongnocchi.it</email>
</contact_backup>
<investigator>
<last_name>Silvia Picciolini, PhD</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Francesca Saibene, MD</last_name>
<role>Sub-Investigator</role>
</investigator>
<investigator>
<last_name>Alice Gualerzi, PhD</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location>
<facility>
<name>Università Campus Bio-Medico</name>
<address>
<city>Roma</city>
<country>Italy</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Massimo Marano, MD</last_name>
</contact>
</location>
<location_countries>
<country>Italy</country>
</location_countries>
<reference>
<citation>Carlomagno C, Bertazioli D, Gualerzi A, Picciolini S, Andrico M, Roda F, Meloni M, Banfi PI, Verde F, Ticozzi N, Silani V, Messina E, Bedoni M. Identification of the Raman Salivary Fingerprint of Parkinson's Disease Through the Spectroscopic- Computational Combinatory Approach. Front Neurosci. 2021 Oct 26;15:704963. doi: 10.3389/fnins.2021.704963. eCollection 2021.</citation>
<PMID>34764849</PMID>
</reference>
<reference>
<citation>Gualerzi A, Picciolini S, Carlomagno C, Terenzi F, Ramat S, Sorbi S, Bedoni M. Raman profiling of circulating extracellular vesicles for the stratification of Parkinson's patients. Nanomedicine. 2019 Nov;22:102097. doi: 10.1016/j.nano.2019.102097. Epub 2019 Oct 21.</citation>
<PMID>31648040</PMID>
</reference>
<verification_date>February 2022</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>January 16, 2023</last_update_submitted>
<last_update_submitted_qc>January 16, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">January 18, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>saliva</keyword>
<keyword>Raman spectroscopy</keyword>
<keyword>extracellular vesicles</keyword>
<keyword>rehabilitation biomarkers</keyword>
<keyword>diagnosis</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Parkinson Disease</mesh_term>
<mesh_term>Parkinsonian Disorders</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Rehabilitation is crucial in the treatment of people with Parkinson's disease (PD) as it can
ameliorate motor and non-motor impairments, improving their clinical profile and quality of
life. Considering the complex biological processes occurring in PD brain, the identification
of accessible and measurable biomarkers to monitor the events induced by intensive
rehabilitation would help in i)testing rehabilitation effectiveness, ii)improving the design
of clinical trials and iii)personalizing the rehabilitation strategies by the prediction of
patients' responsiveness. The objective of this project is the validation of Raman analysis
of saliva and salivary extracellular vesicles (EV) for the differential diagnosis of
Parkinson's disease (PD) and atypical Parkinsonism. The proposed diagnostic method can be
integrated in the preliminary assessment and monitoring of the patient by providing a quickly
and repeatable measurable biomarker. In the end, this will bring tothe personalization of the
rehabilitation path and provide an indication on the outcome of the rehabilitation treatment.
Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms such
as bradykinesia, tremor, rigidity and postural instability. An accurate rehabilitation
program designed considering the specific characteristics of the patient allows you to
maximize the effect of drug therapy, improve the patient's quality of life, while also
limiting secondary complications related to the progression of the disease. At the time of
diagnosis, however, it is particularly important to be able to quickly identify individuals
with idiopathic Parkinson's and distinguish them from those who have an atypical form of
Parkinsonism, such as Progressive Supranuclear Palsy (PSP), Multiple System Atrophy (MSA),
Corticobasal Degeneration (CBD) and Dementia with Lewy bodies (DLB). Atypical Parkinsonisms
are in fact progressive diseases that share some signs and symptoms with PD, however these
patients do not respond as effectively to drug therapy since the cellular and degenerative
mechanisms that characterize them are very different. For these reasons, their early
identification is particularly important to identify the best pharmacological and
rehabilitative path for each patient.
To ensure a more accurate patient profiling that takes into account the individual complex
clinical picture, the discovery of a biomarker that can be periodically measured in an easily
accessible biofluid would allow for better patient stratification, monitoring of the course
of the disease and careful study of the effects of the pharmacological and rehabilitation
program as well as its personalization, with a view to precision medicine designed, defined
and built on the patient.
The Laboratory of Nanomedicine and Clinical Biophotonics (LABION) of Fondazione Don Gnocchi
has been working for years on using innovative methods such as Raman spectroscopy to identify
biomarkers of neurodegenerative diseases in easily accessible biological fluids, such as
blood and saliva. Raman Spectroscopy (RS) allows to obtain a specific and complete
characterization of a specific fluid in a rapid, sensitive and non-destructive way, without
particular procedures for the preparation of the sample to be analyzed. In RS the entire
spectrum obtained from the sample is used as a highly specific "fingerprint" for the selected
sample (eg saliva, blood, serum, cerebrospinal fluid) which represents the diagnostic
biomarker. The Raman analysis of saliva has already demonstrated the possibility of profiling
patients with progressive pathologies with good accuracy and, specifically, of distinguishing
subjects suffering from amyotrophic lateral sclerosis compared to subjects with other types
of neurodegenerative diseases.
At the same time, LABION has verified the possibility of characterizing by Raman
spectroscopy, the extracellular vesicles (EV) circulating in the blood of patients with PD.
Since 2017, LABION has been working on the biochemical study of circulating EVs in the serum
of PD patients by analyzing the EVs in spectroscopy and the ability of RS to identify a
specific biochemical profile of blood vesicles that correlates with clinical scales has been
demonstrated. UPDRS III and Hoehn and Yahr. The analysis of the EVs present in the saliva of
patients with PD could help to understand the origin of biochemical alterations in the saliva
as well as identify even more specific markers.
Raman spectroscopy is therefore proposed as a useful method for the rapid and comprehensive
biochemical characterization of saliva and the vesicular component present within it, without
the use of staining and labeling procedures.
The objective of this project is the validation of a specific Raman molecular signature for
the different experimental groups, which can lead to the determination of a biomarker useful
for the differential diagnosis of people with PD compared to subjects with atypical
Parkinsonism, through the analysis of a biological fluid that is not invasive, thus filling
the current lack of a measurable biomarker for rapid differential diagnosis and for
monitoring the evolution of the diseases.
The rapid identification and differential diagnosis of subjects with Parkinson's disease and
atypical parkinsonisms will allow to promptly identify the optimal pharmacological and
rehabilitative therapy for each subject, leading to a significant improvement in the quality
of life for the patient and, in the future, an increased probability slowing the progression
of the disease.
SAMPLE COLLECTION: Saliva collection from all the selected subjects will be performed
following the Salivette (SARSTEDT) manufacturer's instructions. Saliva will be obtained from
all subjects after an appropriate lag time from feeding and teeth brushing. Pre-analytical
parameters (i.e. storage temperature and time between collection and processing), dietary and
smoking habit will be properly recorded. Briefly, the swab will be placed in the mouth and
chewed for 60 seconds to stimulate salivation. Then the swab will be centrifuged for 2
minutes at 1,000 g to remove cells fragments and food debris. Collected samples will be
stored at -80° C.
SAMPLE PROCESSING: For the Raman analysis, a drop of each sample will be casted on an
aluminium foil in order to achieve the Surface Enhanced Raman Scattering (SERS).
EV ISOLATION: different isolation methods will be tested for effective EV isolation. Purified
EVs will be then concentrated and analysed by means of standard techniques and by Raman
spectroscopy following a previously optimized protocol for blood EVs. The experimetal
settings will be adapted to the salivary EVs, considering variations in substrate,
acquisition time, etc.
DATA COLLECTION: Salivary and EV spectra will be acquired using an Aramis Raman microscope
(Horiba Jobin-Yvon, France) equipped with a laser light source operating at 785 nm and 532
nm. The instrument will be calibrated before each analysis using the reference band of
silicon at 520.7 cm-1. Raman spectra will be acquired in the region between 400 and 1600 cm-1
for saliva, 500-1800 nad 2600-3200 cm-1 for EVs using a 50x objective. The software package
LabSpec 6 (Horiba Jobin-Yvon, France) will be used for the acquisition of spectra.
DATA PROCESSING: All the acquired spectra will be baseline corrected and normalized by unit
vector using the dedicated software LabSpec 6. The contribution of the substrate will be
removed from each spectra, if necessary. The statistical analysis to validate the method,
will be performed using a multivariate analysis approach. Principal Component analysis (PCA)
will be performed in order to reduce data dimensions and to evidence major trends. The first
20 resultant Principal Components (PCs) will be used in a classification model, Linear
Discriminant Analysis (LDA), to discriminate the data maximizing the variance between the
selected groups. The smallest number of PCs will be selected to prevent data overfitting.
Leave-one-out cross-validation and confusion matrix test will be used to evaluate the method
sensitivity, precision and accuracy of the LDA model. Mann-Whitney will be performed on PCs
scores to verify the differences statistically relevant between the analysed groups.
Correlation and partial correlation analysis will be performed using the Spearman's test,
assuming as valid correlation only the coefficients with a p-value lower than 0.05. The
statistical analysis will be performed using Origin2018 (OriginLab, USA).
ROC Curve will be calculated to assess thediagnostic potential of the method.
Saliva containing DNA. DNA will not be analysed separatly
PD patients will be recrutied at the Neurology Rehabilitation Unit of IRCCS S. Maria
Nascente of Fondazione Don Gnocchi under the responsibility of Dr. Mario Meloni, before and
after the rehabilitation treatment.
Subjects with PSP, CBS and AMS will be recruited at Campus Bio-Medico University (Rome) and
at Gaetano Pini Orthopedic Institute-ASST Pini-CTO (Milan).
Subjects with RBD will be recruited at the University of Cagliari - Neurology Complex
Operating Unit - Sleep Center.
Inclusion Criteria:
For Pakinson's disease: diagnosis following "MDS clinical diagnostic criteria for
Parkinson's disease" (Postuma et al. Movement Disorders vol. 30 1591-1601, 2015), with
Hoehn&Yahr between 1 and 3.
The diagnosis of Progressive Supranuclear Palsy will be made according to the criteria of
the Movement Disorders Society (Höglinger et al. Mov. Disord. 32, 853-864, 2017). The
diagnosis of Corticobasal Syndrome will be made according to the 2013 Armstrong criteria
(Armstrong et al. Neurology 80, 496-503, 2013).
The diagnosis of multiple system atrophy will be made according to the Gilman criteria of
The diagnosis of Behavior Disorder in REM phase will be made according to the criteria of
the "International Classification of Sleep Disorders, Third Edition (ICSD-3)".
Exclusion Criteria:
For all the experimental groups considered and for healthy controls, subjects with
concomitant chronic and / or inflammatory diseases of the oral cavity, other systemic
diseases (eg anemia, cardiovascular or respiratory diseases), oncological or infectious
diseases will be excluded.
Vascular parkinsonisms, monogenic parkinsonisms will also be excluded as well as iatrogenic
parkinsonisms, parkinsonisms secondary to exposure to known neurotoxins; parkinsonisms
secondary to tumor lesions; parkinsonisms due to normotensive hydrocephalus; subjects with
a form of dementia, severe speech disorders and other psychiatric and / or neurological
pathologies.
|
NCT0532xxxx/NCT05320263.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320263</url>
</required_header>
<id_info>
<org_study_id>2018_0105</org_study_id>
<nct_id>NCT05320263</nct_id>
</id_info>
<brief_title>Contact Aspiration Versus Stent Retriever for Recanalisation of Acute Stroke Patients With Basilar Artery Occlusion: The Posterior Circulation ASTER Randomized Trial Protocol</brief_title>
<acronym>pc-ASTER</acronym>
<official_title>Contact Aspiration Versus Stent Retriever for Recanalisation of Acute Stroke Patients With Basilar Artery Occlusion: The Posterior Circulation ASTER Randomized Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Hopital Foch</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Hopital Foch</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Acute ischemic stroke (AIS) patients with basilar artery occlusion (BAO) present a
devastating, life-threatening prognosis.

Urgent recanalization with endovascular mechanical thrombectomy is routinely performed in
patients with BAO although the level of evidence is lower than that in anterior circulation
occlusions (randomization in this population versus medical treatment alone having been
impossible in recent studies). Recently, a large retrospective study supports the interest of
thrombectomy in this population .

Speed and grade of the recanalisation have a major impact on clinical outcome. Favorable
outcome at 90 days is strongly associated with the successful recanalization status at the
end of the endovascular procedure (OR=4.57, 95%CI=1.24-16.87, P=0.023).

First pass effect has been shown to be a strong marker of efficacy of endovascular procedure
with significant correlation with clinical outcome.

Thrombectomy with Stent retrievers dramatically changed the prognosis of anterior circulation
large vessel occlusion strokes and currently used in BAO patients (posterior circulation).
Contact aspiration (CA) is currently used in anterior large vessel occlusions (COMPASS trial,
Lancet 2019), with similar rates of recanalization and favorable outcomes (Boulanger M,
2019), as well as in BAO patients .

However, the benefit of CA compared to SR for the treatment of BAO remains under debate with
the superiority of first line CA compared to SR or no difference. Available data are based on
retrospective studies with no data from RCT.

In this context, a randomized controlled trial is needed to assess the benefit of CA versus
SR.
</textblock>
</brief_summary>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">November 19, 2022</start_date>
<completion_date type="Anticipated">July 2027</completion_date>
<primary_completion_date type="Anticipated">July 2026</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<intervention_model_description>It is planned to include a total of 480 patients (240 per am) to show with a 80% power an 12% increase in FPE rate at end of MT with contact aspiration technique, assuming 23 % of FPE in control arm, 5% of spontaneous recanalization and considering one interim futility analysis</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Rate of first pass effect (FPE) defined by complete reperfusion after first device pass</measure>
<time_frame>24 hours</time_frame>
<description>The definition of FPE: single pass/use of the device, (2) complete revascularization of the large vessel occlusion and its downstream territory (mTICI 3), and (3) no use of rescue therapy</description>
</primary_outcome>
<secondary_outcome>
<measure>Rate of complete reperfusion after first-line thrombectomy strategy and at the end of endovascular procedure</measure>
<time_frame>24 hours</time_frame>
<description>mTICI (modified Thrombolysis In Cerebral Infarction ) score equals to 3 after the first line thrombectomy and at the end of endovascular.
mTICI score is evaluated between 0-3 : 0 a complete obstruction of the artery and 3 indicates a complete reperfusion</description>
</secondary_outcome>
<secondary_outcome>
<measure>Rate of successful reperfusion (mTICI 2b/2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure</measure>
<time_frame>24 hours</time_frame>
<description>mTICI score is evaluated between 0 to 3. Rate of patients with mTICI score equals to 2b/2c/3 after first-line thrombectomy strategy and at the end of endovascular procedure will be evaluated.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Rate of near to complete reperfusion (mTICI 2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure</measure>
<time_frame>24 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Rate of Arterial Occlusive Lesion (AOL) recanalization score III after first-line thrombectomy strategy and at the end of endovascular procedure</measure>
<time_frame>24 hours</time_frame>
<description>AOL recanalization score is evaluated between 0 to 3 :
0 indicates no recanalization of the primary occlusive lesion
3 indicates complete recanalization of the primary occlusive lesion with any distal flow</description>
</secondary_outcome>
<secondary_outcome>
<measure>Groin puncture time to successful reperfusion time (evaluated in minutes)</measure>
<time_frame>360 minutes</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Modified Rankin Score (mRS) at 3 and 12 months</measure>
<time_frame>12 months</time_frame>
<description>mRS is evaluated between 0 to 6. A score of 0 indicates that there is no disability and a score of 6 indicates death.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Rate of good functional outcome at 90-day and at one year defined by a mRS 0-3 or equal to pre-stroke mRS (Modified Rankin Score)</measure>
<time_frame>12 months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Quality of life at 90 days and 12 months assessed by EuroQol 5D-5L scale</measure>
<time_frame>12 months</time_frame>
<description>EuroQol 5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.</description>
</secondary_outcome>
<secondary_outcome>
<measure>All cause of mortality at 90-day and 12 months</measure>
<time_frame>12 months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>24-hours change in NIHSS (National Institutes of Health Stroke Scale) from baseline defined as the difference between NIHSS score at 24 hours and NIHSS score at admission.</measure>
<time_frame>24 hours</time_frame>
<description>NIHSS (National Institutes of Health Stroke Scale) score is evaluated between 0-42 0 is normal and 42 maximal gravity</description>
</secondary_outcome>
<secondary_outcome>
<measure>Subgroups analysis : Age (≤70 vs. >70 years)</measure>
<time_frame>24 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Subgroups analysis :Baseline NIHSS≥10 vs NIHSS<10 (18)</measure>
<time_frame>24 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Subgroups analysis : Volume of infarct area assessed by pc-ASPECTS (≤7 vs. >7)</measure>
<time_frame>24 hours</time_frame>
<description>A pc-ASPECTS score of 10 indicates absence of visible ischemic changes in the posterior circulation, and pc-ASPECTS score of 0 indicates ischemic changes in the midbrain, pons, and bilateral thalami, posterior circulation territories, and cerebellar hemispheres</description>
</secondary_outcome>
<secondary_outcome>
<measure>Subgroups analysis : Time from admission of patient in hospital to randomization (≤ 300 vs. > 300 minutes)</measure>
<time_frame>360 minutes</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Subgroups analysis: Baseline site of thrombi on vascular imaging (Top of the basilar artery vs other adjudicated by the core lab)</measure>
<time_frame>24 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Subgroups analysis: Prior use of IV alteplase (yes vs. no)</measure>
<time_frame>24 hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Subgroups analysis : Collateral status (good versus poor, as adjudicated by the core lab on initial angiogram) with a 0-3 scale</measure>
<time_frame>24 hours</time_frame>
<description>Collateral circulation is estimated by angiography with a 0-3 scale. The collateral status will be categorized as poor collaterals (scores 0-1) and good collaterals (scores 2-3)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of any intracerebral hemorrhage (ICH), parenchymal hematoma (PH), symptomatic ICH on brain imaging (Magnetic resonance imaging MRI or CT (computed tomography) scan) at 24±12h after thrombectomy (according to ECASS3 classification)</measure>
<time_frame>24 hours</time_frame>
<description>ECASS III (European Cooperative Acute Stroke Study) classification :
Hemorrhage infarction type 1 (HI1)
Hemorrhage infarction type 2 (HI2)
Parenchymal hematoma type 1 (PH1)
Parenchymal hematoma type 2 (PH2)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Incidence of procedure-related complications defined as arterial perforation, arterial dissection, embolization in a new territory (ENT) and subarachnoid haemorrhage</measure>
<time_frame>hours</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Cost-effectiveness analysis at 12 months</measure>
<time_frame>12 months</time_frame>
<description>Incremental cost-effectiveness ratio (ICER, cost per quality-adjusted life year [QALY]), of Contact Aspiration (CA) first-line thrombectomy compared to standard first-line SR thrombectomy in treatment of AIS due to BAO, from a collective perspective and with a 12-months' time horizon.</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Anticipated">480</enrollment>
<condition>Basilar Artery Occlusion</condition>
<arm_group>
<arm_group_label>contact aspiration first line thrombectomy</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patient randomized in this arm will have the first arm thrombectomy by contact aspiration</description>
</arm_group>
<arm_group>
<arm_group_label>Stent retriever first line thrombectomy</arm_group_label>
<arm_group_type>Sham Comparator</arm_group_type>
<description>Patient randomized in this arm will have the first arm thrombectomy by Stent retriever</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Contact aspiration Thrombectomy</intervention_name>
<description>The contact aspiration approach is performed, as in standard care, using a long sheath positioned in the distal cervical vasculature using an exchange technique.
A large bore balloon guide catheter as to be placed into the cervical ICA. The microcatheter is then advanced close to the thrombus and the large-bore aspiration catheter is advanced as close to the proximal aspect of the thrombus as possible. A control superselective angiogram may be used to document the extent of occlusion and thrombus. After a 3 min waiting period, the large-bore aspiration catheter is connected to a continuous aspiration from the dedicated aspiration pump while simultaneously advancing the aspiration catheter up to the face of the thrombus. through the long sheath positioned in the cervical vasculature.</description>
<arm_group_label>contact aspiration first line thrombectomy</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Stent retriever thrombectomy</intervention_name>
<description>The technique used should be in accordance with the device IFU. A large bore access guide catheter possible is recommended. A suitable delivery microcatheter is navigated over a microwire across the occlusion. A control superselective angiogram may be used to document the extent of occlusion and thrombus. The stent is left in place according to the internal practice of each participating center before the withdrawal. Any CE-marked stent retriever device is then deployed across the occlusion. A minimum of 3 attempts with SR should be performed. A revascularization score will be recorded after each device attempt.</description>
<arm_group_label>Stent retriever first line thrombectomy</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

Age ≥ 18 years

- AIS with BAO on non-invasive imaging (CT or MRI)

- Eligible for thrombectomy : groin puncture undergone within 24 hours of first symptoms
or of last time the patient was seen normal

- Being covered by a national health insurance

- Informed consent obtained from the patients/his proxy or following an emergency
procedure

Exclusion Criteria:

- Known or suspected pre-existing (chronic) large vessel stenosis / occlusion in the
symptomatic territory (basilar artery)

- Severe contrast medium allergy or absolute contraindication to use of iodinated
products

- Clinical history, past imaging or clinical judgment suggesting intracranial stenosis
of the basilar artery

- Pregnancy (urine or serum beta HCG test for women of child-bearing potential)

- Person deprived of liberty

- Patient benefiting from a legal protection (guardianship or curatorship)
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Arturo CONSOLI</last_name>
<role>Principal Investigator</role>
<affiliation>Study principal investigator</affiliation>
</overall_official>
<overall_official>
<last_name>Benjamin GORY</last_name>
<role>Study Chair</role>
<affiliation>Scientific director</affiliation>
</overall_official>
<overall_contact>
<last_name>Arturo CONSOLI</last_name>
<phone>0033146251955</phone>
<email>a.consoli@hopital-foch.com</email>
</overall_contact>
<overall_contact_backup>
<last_name>Bertrand LAPERGUE</last_name>
<phone>0033146255973</phone>
<email>b.lapergue@hopital-foch.com</email>
</overall_contact_backup>
<location>
<facility>
<name>Chu Bordeaux</name>
<address>
<city>Bordeaux</city>
<country>France</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Gaultier MARNAT</last_name>
<email>Gaultier.marnart@chu-bordeaux.fr</email>
</contact>
</location>
<location>
<facility>
<name>CHU Caen</name>
<address>
<city>Caen</city>
<country>France</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Charlotte BARBIER</last_name>
<email>barbier-ch@chu-caen.fr</email>
</contact>
</location>
<location>
<facility>
<name>CHU Limoges</name>
<address>
<city>Limoges</city>
<country>France</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Charbel MOUNAYER</last_name>
<email>charbel.mounayer@chu-limoges.fr</email>
</contact>
</location>
<location>
<facility>
<name>CHU Montpellier</name>
<address>
<city>Montpellier</city>
<country>France</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Vincent COSTALAT</last_name>
<email>vincent.costalat@chu-montpellier.fr</email>
</contact>
</location>
<location>
<facility>
<name>Chru Nancy</name>
<address>
<city>Nancy</city>
<country>France</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Benjamin GORY</last_name>
<email>b.gory@chu-nancy.fr</email>
</contact>
</location>
<location>
<facility>
<name>Chu Nantes</name>
<address>
<city>Nantes</city>
<country>France</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Hubert DESAL</last_name>
<email>hubert.desal@chu-nantes.fr</email>
</contact>
</location>
<location>
<facility>
<name>APHP - Pitié Salpêtrière</name>
<address>
<city>Paris</city>
<country>France</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Frédéric CLARENCON</last_name>
<email>frederic.clarencon@aphp.fr</email>
</contact>
</location>
<location>
<facility>
<name>Fondation Adolphe de Rothschild</name>
<address>
<city>Paris</city>
<country>France</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Michel PIOTIN</last_name>
<email>mpiotin@for.paris</email>
</contact>
</location>
<location>
<facility>
<name>CHU de Reims</name>
<address>
<city>Reims</city>
<country>France</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Sébastien SOIZE</last_name>
<email>ssoize@chu-reims.fr</email>
</contact>
</location>
<location>
<facility>
<name>CHU Rennes</name>
<address>
<city>Rennes</city>
<country>France</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Jean-Christophe FERRE</last_name>
<email>jean-christophe.ferre@chu-rennes.fr</email>
</contact>
</location>
<location>
<facility>
<name>Hôpital FOCH</name>
<address>
<city>Suresnes</city>
<country>France</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Arturo CONSOLI</last_name>
<phone>0033146251955</phone>
<email>a.consoli@hopital-foch.com</email>
</contact>
</location>
<location>
<facility>
<name>CHU de Tours</name>
<address>
<city>Tours</city>
<country>France</country>
</address>
</facility>
<status>Not yet recruiting</status>
<contact>
<last_name>Grégoire BOULOUIS</last_name>
<email>g.boulouis@chu-tours.fr</email>
</contact>
</location>
<location_countries>
<country>France</country>
</location_countries>
<verification_date>February 2023</verification_date>
<study_first_submitted>February 14, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>February 27, 2023</last_update_submitted>
<last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">March 1, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Stroke</keyword>
<keyword>Basilar artery occlusion</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Stroke</mesh_term>
<mesh_term>Arterial Occlusive Diseases</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Acute ischemic stroke (AIS) patients with basilar artery occlusion (BAO) present a
devastating, life-threatening prognosis.
Urgent recanalization with endovascular mechanical thrombectomy is routinely performed in
patients with BAO although the level of evidence is lower than that in anterior circulation
occlusions (randomization in this population versus medical treatment alone having been
impossible in recent studies). Recently, a large retrospective study supports the interest of
thrombectomy in this population .
Speed and grade of the recanalisation have a major impact on clinical outcome. Favorable
outcome at 90 days is strongly associated with the successful recanalization status at the
end of the endovascular procedure (OR=4.57, 95%CI=1.24-16.87, P=0.023).
First pass effect has been shown to be a strong marker of efficacy of endovascular procedure
with significant correlation with clinical outcome.
Thrombectomy with Stent retrievers dramatically changed the prognosis of anterior circulation
large vessel occlusion strokes and currently used in BAO patients (posterior circulation).
Contact aspiration (CA) is currently used in anterior large vessel occlusions (COMPASS trial,
Lancet 2019), with similar rates of recanalization and favorable outcomes (Boulanger M,
2019), as well as in BAO patients .
However, the benefit of CA compared to SR for the treatment of BAO remains under debate with
the superiority of first line CA compared to SR or no difference. Available data are based on
retrospective studies with no data from RCT.
In this context, a randomized controlled trial is needed to assess the benefit of CA versus
SR.
Inclusion Criteria:
Age ≥ 18 years
- AIS with BAO on non-invasive imaging (CT or MRI)
- Eligible for thrombectomy : groin puncture undergone within 24 hours of first symptoms
or of last time the patient was seen normal
- Being covered by a national health insurance
- Informed consent obtained from the patients/his proxy or following an emergency
procedure
Exclusion Criteria:
- Known or suspected pre-existing (chronic) large vessel stenosis / occlusion in the
symptomatic territory (basilar artery)
- Severe contrast medium allergy or absolute contraindication to use of iodinated
products
- Clinical history, past imaging or clinical judgment suggesting intracranial stenosis
of the basilar artery
- Pregnancy (urine or serum beta HCG test for women of child-bearing potential)
- Person deprived of liberty
- Patient benefiting from a legal protection (guardianship or curatorship)
|
NCT0532xxxx/NCT05320276.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320276</url>
</required_header>
<id_info>
<org_study_id>ESCAPE</org_study_id>
<nct_id>NCT05320276</nct_id>
</id_info>
<brief_title>Predictors of Non-accESs to therapeutiC EducAtion Programs Among Patients With Type 2 Diabetes, and/or Asthma, and/or Chronic Heart Failure in an Emergency Setting</brief_title>
<acronym>ESCAPE</acronym>
<official_title>Redictors of Non-accESs to therapeutiC EducAtion Programs Among Patients With Type 2 Diabetes, and/or Asthma, and/or Chronic Heart Failure in an Emergency Setting</official_title>
<sponsors>
<lead_sponsor>
<agency>Fondation Hôpital Saint-Joseph</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Fondation Hôpital Saint-Joseph</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Chronic diseases are frequent and potentially severe. Type II diabetes, asthma and heart
failure affect 3.3 million, 4 million and 1 million people respectively in France. They are
sources of avoidable mortality as well as disabilities leading to a loss of years of full
health life (DALYS). Cumulatively, they were responsible for the loss of more than 1 million
DALYS in 2019 in France. National and international recommendations also include TVE in the
management of these three diseases.

This severity can be reduced by better management underpinned by therapeutic education. By
improving their knowledge of the disease, it allows a better adherence of patients to the
care project, the achievement of clinical and biological objectives, a decrease in the number
of emergency room visits and unscheduled hospitalizations, and an improvement in the quality
of life during the course of three frequent chronic diseases such as type 2 diabetes, asthma
and heart failure.

However, participation in a therapeutic education program remains highly variable depending
on many parameters. Lack of information seems to play a major role in this context.

In the Ile de France region, the density of available TEP programs is high, particularly in
Paris. The three chronic diseases that are managed by an advanced practice nurse with a PCS
mention have the largest number of TVE programs in Paris: type 2 diabetes (32, and 6 for
diabetic foot), asthma and heart failure.

In an urban area with a good supply of TVE facilities, how can investigators explain the lack
of integration of these facilities into the care pathway? Among the diverse patient
population consulting an emergency department suffering from type II diabetes, asthma or
heart failure, investigators wish to determine the proportion of patients who have not been
offered TVE during their care.

Investigators will then try to identify demographic, socioeconomic, and medical factors
statistically associated with the absence of FTE proposal.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">February 28, 2022</start_date>
<completion_date type="Actual">April 26, 2023</completion_date>
<primary_completion_date type="Actual">April 15, 2022</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Cross-Sectional</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Frequency of patients with chronic diseases seen in the emergency department who have not been offered an educational program</measure>
<time_frame>Day 1</time_frame>
<description>This outcome corresponds to the number of patients who have not been offered participation in a therapeutic education program during their course of care since the diagnosis of their chronic disease.</description>
</primary_outcome>
<secondary_outcome>
<measure>Patient Characteristics Associated with Not Offering a Therapeutic Education Program During the Course of Care</measure>
<time_frame>Day 1</time_frame>
<description>This outcome corresponds to the demographic, social, economic and medical characteristics statistically associated with the absence of a therapeutic education proposal.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Identification of reasons for refusal to participate</measure>
<time_frame>Day 1</time_frame>
<description>This outcome corresponds to the reason for declining to participate in an TEP program for patients who have been offered one.</description>
</secondary_outcome>
<enrollment type="Actual">297</enrollment>
<condition>Therapeutic Education Program</condition>
<condition>Emergencies</condition>
<condition>Diabetes</condition>
<condition>Asthma</condition>
<condition>Heart Failure</condition>
<eligibility>
<study_pop>
<textblock>
Patients visit the emergency department for any reason between 12/15/2021 and 3/30/2022 and
have at least one of the following chronic conditions: type 2 diabetes, asthma or heart
failure.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Patient whose age is ≥ 18 years

- Patient consulting the GHPSJ emergency department for any reason

- Patient with a chronic disease among type 2 diabetes and/or asthma and/or heart
failure

- Francophone patient

Exclusion Criteria:

- Diagnosis of the chronic disease in the context of its current management in the
emergency room

- Patient being followed outside of Ile de France for the chronic disease studied

- Patient with dementia or cognitive disorders

- Patient under guardianship or curatorship

- Patient deprived of liberty

- Patient under legal protection

- Patient opposing the use of his data for this research
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Camille GERLIER, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Groupe Hopsitalier Paris Saint-Joseph</affiliation>
</overall_official>
<location>
<facility>
<name>Groupe Hospitalier Paris Saint-Joseph</name>
<address>
<city>Paris</city>
<zip>75014</zip>
<country>France</country>
</address>
</facility>
</location>
<location_countries>
<country>France</country>
</location_countries>
<link>
<url>https://www.em-consulte.com/article/1196953/competences-attendues-de-l-infirmiere-de-pratique-</url>
<description>Related Info</description>
</link>
<reference>
<citation>Odgers-Jewell K, Ball LE, Kelly JT, Isenring EA, Reidlinger DP, Thomas R. Effectiveness of group-based self-management education for individuals with Type 2 diabetes: a systematic review with meta-analyses and meta-regression. Diabet Med. 2017 Aug;34(8):1027-1039. doi: 10.1111/dme.13340. Epub 2017 Mar 20.</citation>
<PMID>28226200</PMID>
</reference>
<reference>
<citation>McGhan SL, Cicutto LC, Befus AD. Advances in development and evaluation of asthma education programs. Curr Opin Pulm Med. 2005 Jan;11(1):61-8. doi: 10.1097/01.mcp.0000146783.18716.31.</citation>
<PMID>15591890</PMID>
</reference>
<reference>
<citation>Rice H, Say R, Betihavas V. The effect of nurse-led education on hospitalisation, readmission, quality of life and cost in adults with heart failure. A systematic review. Patient Educ Couns. 2018 Mar;101(3):363-374. doi: 10.1016/j.pec.2017.10.002. Epub 2017 Oct 5.</citation>
<PMID>29102442</PMID>
</reference>
<verification_date>April 2023</verification_date>
<study_first_submitted>March 31, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>April 26, 2023</last_update_submitted>
<last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">April 27, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Asthma</mesh_term>
<mesh_term>Heart Failure</mesh_term>
<mesh_term>Diabetes Mellitus</mesh_term>
<mesh_term>Emergencies</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Chronic diseases are frequent and potentially severe. Type II diabetes, asthma and heart
failure affect 3.3 million, 4 million and 1 million people respectively in France. They are
sources of avoidable mortality as well as disabilities leading to a loss of years of full
health life (DALYS). Cumulatively, they were responsible for the loss of more than 1 million
DALYS in 2019 in France. National and international recommendations also include TVE in the
management of these three diseases.
This severity can be reduced by better management underpinned by therapeutic education. By
improving their knowledge of the disease, it allows a better adherence of patients to the
care project, the achievement of clinical and biological objectives, a decrease in the number
of emergency room visits and unscheduled hospitalizations, and an improvement in the quality
of life during the course of three frequent chronic diseases such as type 2 diabetes, asthma
and heart failure.
However, participation in a therapeutic education program remains highly variable depending
on many parameters. Lack of information seems to play a major role in this context.
In the Ile de France region, the density of available TEP programs is high, particularly in
Paris. The three chronic diseases that are managed by an advanced practice nurse with a PCS
mention have the largest number of TVE programs in Paris: type 2 diabetes (32, and 6 for
diabetic foot), asthma and heart failure.
In an urban area with a good supply of TVE facilities, how can investigators explain the lack
of integration of these facilities into the care pathway? Among the diverse patient
population consulting an emergency department suffering from type II diabetes, asthma or
heart failure, investigators wish to determine the proportion of patients who have not been
offered TVE during their care.
Investigators will then try to identify demographic, socioeconomic, and medical factors
statistically associated with the absence of FTE proposal.
Patients visit the emergency department for any reason between 12/15/2021 and 3/30/2022 and
have at least one of the following chronic conditions: type 2 diabetes, asthma or heart
failure.
Inclusion Criteria:
- Patient whose age is ≥ 18 years
- Patient consulting the GHPSJ emergency department for any reason
- Patient with a chronic disease among type 2 diabetes and/or asthma and/or heart
failure
- Francophone patient
Exclusion Criteria:
- Diagnosis of the chronic disease in the context of its current management in the
emergency room
- Patient being followed outside of Ile de France for the chronic disease studied
- Patient with dementia or cognitive disorders
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
- Patient opposing the use of his data for this research
|
NCT0532xxxx/NCT05320289.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320289</url>
</required_header>
<id_info>
<org_study_id>ULTRA-US</org_study_id>
<nct_id>NCT05320289</nct_id>
</id_info>
<brief_title>Feasibility Study of the AblaCare System in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With Infertility Due to Polycystic Ovary Syndrome</brief_title>
<acronym>ULTRA-US</acronym>
<official_title>Feasibility Study of the AblaCare System in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With Infertility Due to Polycystic Ovary Syndrome</official_title>
<sponsors>
<lead_sponsor>
<agency>May Health</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>May Health</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>Yes</is_fda_regulated_device>
<is_unapproved_device>Yes</is_unapproved_device>
</oversight_info>
<brief_summary>
<textblock>
The objective of the study is to provide preliminary evidence for the safety and
effectiveness of the AblaCare System in transvaginal ablation of ovarian tissue under
ultrasound visualization in women with infertility due to polycystic ovary syndrome (PCOS)
who have not responded to first-line ovulation induction treatment or are contraindicated for
or decline such treatment.
</textblock>
</brief_summary>
<overall_status>Active, not recruiting</overall_status>
<start_date type="Actual">May 12, 2022</start_date>
<completion_date type="Anticipated">November 15, 2023</completion_date>
<primary_completion_date type="Actual">November 15, 2022</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Device Feasibility</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Occurrence of at least one (1) ovulation between treatment and 3-month visit.</measure>
<time_frame>3 months</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>Occurrence of at least one (1) ovulation between treatment and the 6-month visit with or without 1st line medication 3 months or more post-procedure</measure>
<time_frame>6 months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Successful completion of a complete ovarian tissue ablation procedure, which is defined as achievement of the desired number of ablations within each ovary under ultrasound visualization.</measure>
<time_frame>During procedure</time_frame>
</secondary_outcome>
<other_outcome>
<measure>Pain level after procedure completion measured by a Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst pain)</measure>
<time_frame>Immediately after procedure completion, at 7-day and at 30-day follow up</time_frame>
</other_outcome>
<other_outcome>
<measure>Pain medication taken during procedure and after procedure</measure>
<time_frame>During procedure, at 7-day and at 30-day follow up</time_frame>
</other_outcome>
<other_outcome>
<measure>Documented ovulation</measure>
<time_frame>Between week 2 and week 24 post-procedure</time_frame>
</other_outcome>
<other_outcome>
<measure>Documented pregnancy</measure>
<time_frame>Between week 2 and week 24 post-procedure, at any point during the study</time_frame>
</other_outcome>
<other_outcome>
<measure>Menstruation occurrences</measure>
<time_frame>From 3-month prior to baseline examination, at 7-day, 30-day, 3-, 6-, 9-, and 12-month follow up</time_frame>
</other_outcome>
<other_outcome>
<measure>Fertility treatment taken</measure>
<time_frame>Up to 12 months</time_frame>
</other_outcome>
<other_outcome>
<measure>Intercourse activity frequency</measure>
<time_frame>At 7- and 30-day, 3-, 6-, 9- and 12-month follow up</time_frame>
</other_outcome>
<other_outcome>
<measure>Number of ablations performed per ovary and estimated achieved ablation % of total ovary volume</measure>
<time_frame>At procedure</time_frame>
</other_outcome>
<other_outcome>
<measure>Time required to complete procedure, defined as time from first insertion of the ultrasound probe and AblaCare NCAD to the completion of the final ablation</measure>
<time_frame>At procedure</time_frame>
</other_outcome>
<other_outcome>
<measure>Device performance of the AblaCare System, defined as a successful completion of a full ovarian tissue ablation procedure without device deficiency related to one component of the AblaCare system</measure>
<time_frame>At procedure</time_frame>
</other_outcome>
<other_outcome>
<measure>Ovarian volume in mL</measure>
<time_frame>At baseline, 3-week, 3-month and 6-month follow up</time_frame>
</other_outcome>
<other_outcome>
<measure>Ovarian antral follicle count per ovary</measure>
<time_frame>At baseline, 3-week, 3-month and 6-month follow up</time_frame>
</other_outcome>
<other_outcome>
<measure>Ovary morphology: either defined as PCOS or not</measure>
<time_frame>At baseline, 3-week, 3-month and 6-month follow up</time_frame>
</other_outcome>
<other_outcome>
<measure>AMH in pmol/l</measure>
<time_frame>At baseline, 3-month and 6-month follow up</time_frame>
</other_outcome>
<other_outcome>
<measure>Testosterone in nmol/l</measure>
<time_frame>At baseline, 3-month and 6-month follow up</time_frame>
</other_outcome>
<other_outcome>
<measure>Androstenedione in nmol/l</measure>
<time_frame>At baseline, 3-month and 6-month follow up</time_frame>
</other_outcome>
<other_outcome>
<measure>LH in IU/l</measure>
<time_frame>At baseline, 3-month and 6-month follow up</time_frame>
</other_outcome>
<other_outcome>
<measure>FSH in IU/l</measure>
<time_frame>At baseline, 3-month and 6-month follow up</time_frame>
</other_outcome>
<other_outcome>
<measure>Free Androgen Index calculated as the ratio of total Testosterone in nmol/l divided by SHBG in nmol/l and multiplied by 100</measure>
<time_frame>At baseline, 3-month and 6-month follow up</time_frame>
</other_outcome>
<other_outcome>
<measure>Sex Hormone-Binding Globulin (SHBG) in nmol/l</measure>
<time_frame>At baseline, 3-month and 6-month follow up</time_frame>
</other_outcome>
<other_outcome>
<measure>Menstrual cycle pattern reported as regular, oligomenorrhea or amenorrhea</measure>
<time_frame>From 3-month prior to baseline examination, at 7-day, 30-day, 3-, 6-, 9-, and 12-month follow up</time_frame>
</other_outcome>
<other_outcome>
<measure>Hirsutism evaluation</measure>
<time_frame>At baseline, 3-month and 6-month follow up</time_frame>
</other_outcome>
<other_outcome>
<measure>Acne evaluation</measure>
<time_frame>At baseline, 3-month and 6-month follow up</time_frame>
</other_outcome>
<other_outcome>
<measure>BMI</measure>
<time_frame>At baseline, 3-month and 6-month follow up</time_frame>
</other_outcome>
<other_outcome>
<measure>Quality of life measure by the health-related Quality-of-Life Questionnaire for Women with PCOS at baseline</measure>
<time_frame>At baseline, 3-month and 6-month follow up</time_frame>
</other_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">5</enrollment>
<condition>Polycystic Ovary Syndrome</condition>
<condition>Infertility, Female</condition>
<arm_group>
<arm_group_label>AblaCare Procedure</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>AblaCare Procedure performed with use of the AblaCare Kit intended for transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>AblaCare System</intervention_name>
<description>The intervention includes the short-term use of the AblaCare System, which is comprised of three elements: (1) the AblaCare Needle-Catheter Ablation Device (NCAD) (the Device) a 16G echogenic needle including a bipolar temperature-controlled RF ablation catheter which is clipped and secure onto a vaginal ultrasound probe; (2) the AblaCare Adapter which is clipped onto the ultrasound probe; and (3) the AblaCare Generator: a bipolar radiofrequency (RF) ablation platform utilizing the single use AblaCare NCAD for ovarian tissue ablation.
Once th patient is under conscious sedation, the physician guides the AblaCare system transvaginally with the use of a transvaginal ultrasound. Once the AblaCare device is safely and securely positioned, the physician will deliver radio frequency energy inside the ovary in order to ablate the tissue.</description>
<arm_group_label>AblaCare Procedure</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Age: ≥ 18 to ≤ 40 years

2. Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria:
Infertility associated with chronic anovulation or oligomenorrhea, AND EITHER:

2.1. Ultrasonographic evidence of PCOS (ovarian volume ≥ 10ml and/or ovarian antral
follicle count per ovary ≥ 20) OR 2.2. Evidence of hyperandrogenaemia: either clinical
(hirsutism defined as mFG level ≥ 4-6 depending on ethnicity) or biochemical (raised
serum concentration of androgens (testosterone ≥ 2.5nmol/l, or FAI > 4)

3. At least one ovary with ovarian volume ≥ 10ml

4. Ovarian accessibility: determined by ability to bring transvaginal ultrasound
transducer into close proximity to ovaries

5. Failure to respond to first-line pharmacological treatment or is contraindicated for
or decline such treatment.

6. At least one patent fallopian tube and normal uterine cavity as determined by
sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3
years

7. Willing to comply with Clinical Investigation Plan-specified follow-up evaluation

8. Ability to understand study requirements and has sufficient fluency in one of the
IRB-approved written translation of the Patient Information and Informed consent form

9. Signed informed consent

10. Normal sperm parameters based on WHO 2010 criteria (concentration ≥ 15 million/mL,
total motility ≥ 40%, normal morphology ≥ 4%) within the last year

11. Ability to have regular vaginal intercourse during the study

12. No previous sterilization procedures (vasectomy, tubal ligation) that have been
reversed

Exclusion Criteria:

1. Current pregnancy

2. Marked obesity, BMI > 40

3. Marked hyperandrogenism (FAI > 15)

4. Patient is currently participating in another investigational drug or device study
that clinically interferes with the endpoints of this study

5. Patient not willing to stop all concomitant first-line oral medications at least 6
weeks prior to study procedure and until the 3-month endpoint is reached, and all
other forms of ovulation-induction treatment until the 6-month endpoint is reached

6. Lack of capacity to give informed consent

7. Lack of capacity to follow Clinical Investigation Plan and study requirements
including all study follow-up visits

8. Previous ovarian surgery: laparoscopic ovarian drilling, endometriosis surgery,
ovarian cysts surgery

9. Patient with known or suspected periovarian adhesions

10. Transvaginal ultrasound transducer cannot be brought into proximity of both ovaries
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>40 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>University of Oklahoma</name>
<address>
<city>Oklahoma City</city>
<state>Oklahoma</state>
<zip>73104</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>February 2023</verification_date>
<study_first_submitted>March 18, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>February 6, 2023</last_update_submitted>
<last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">February 8, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>PCOS</keyword>
<keyword>Infertility related to PCOS</keyword>
<keyword>Ovulation restoration</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Polycystic Ovary Syndrome</mesh_term>
<mesh_term>Infertility</mesh_term>
<mesh_term>Infertility, Female</mesh_term>
<mesh_term>Syndrome</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The objective of the study is to provide preliminary evidence for the safety and
effectiveness of the AblaCare System in transvaginal ablation of ovarian tissue under
ultrasound visualization in women with infertility due to polycystic ovary syndrome (PCOS)
who have not responded to first-line ovulation induction treatment or are contraindicated for
or decline such treatment.
Inclusion Criteria:
1. Age: ≥ 18 to ≤ 40 years
2. Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria:
Infertility associated with chronic anovulation or oligomenorrhea, AND EITHER:
2.1. Ultrasonographic evidence of PCOS (ovarian volume ≥ 10ml and/or ovarian antral
follicle count per ovary ≥ 20) OR 2.2. Evidence of hyperandrogenaemia: either clinical
(hirsutism defined as mFG level ≥ 4-6 depending on ethnicity) or biochemical (raised
serum concentration of androgens (testosterone ≥ 2.5nmol/l, or FAI > 4)
3. At least one ovary with ovarian volume ≥ 10ml
4. Ovarian accessibility: determined by ability to bring transvaginal ultrasound
transducer into close proximity to ovaries
5. Failure to respond to first-line pharmacological treatment or is contraindicated for
or decline such treatment.
6. At least one patent fallopian tube and normal uterine cavity as determined by
sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3
years
7. Willing to comply with Clinical Investigation Plan-specified follow-up evaluation
8. Ability to understand study requirements and has sufficient fluency in one of the
IRB-approved written translation of the Patient Information and Informed consent form
9. Signed informed consent
10. Normal sperm parameters based on WHO 2010 criteria (concentration ≥ 15 million/mL,
total motility ≥ 40%, normal morphology ≥ 4%) within the last year
11. Ability to have regular vaginal intercourse during the study
12. No previous sterilization procedures (vasectomy, tubal ligation) that have been
reversed
Exclusion Criteria:
1. Current pregnancy
2. Marked obesity, BMI > 40
3. Marked hyperandrogenism (FAI > 15)
4. Patient is currently participating in another investigational drug or device study
that clinically interferes with the endpoints of this study
5. Patient not willing to stop all concomitant first-line oral medications at least 6
weeks prior to study procedure and until the 3-month endpoint is reached, and all
other forms of ovulation-induction treatment until the 6-month endpoint is reached
6. Lack of capacity to give informed consent
7. Lack of capacity to follow Clinical Investigation Plan and study requirements
including all study follow-up visits
8. Previous ovarian surgery: laparoscopic ovarian drilling, endometriosis surgery,
ovarian cysts surgery
9. Patient with known or suspected periovarian adhesions
10. Transvaginal ultrasound transducer cannot be brought into proximity of both ovaries
|
NCT0532xxxx/NCT05320302.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320302</url>
</required_header>
<id_info>
<org_study_id>19874A</org_study_id>
<secondary_id>2021-005082-40</secondary_id>
<nct_id>NCT05320302</nct_id>
</id_info>
<brief_title>A Brain Imaging PET Study of [11C]-Lu AF88370 in Healthy Adult Male Participants</brief_title>
<official_title>Interventional, Open-Label, Positron Emission Tomography (PET) Study With [11C]-Lu AF88370 Investigating Blood-Brain Barrier Penetration of Lu AF88370 in Healthy Men</official_title>
<sponsors>
<lead_sponsor>
<agency>H. Lundbeck A/S</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>H. Lundbeck A/S</source>
<oversight_info>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The main goals of the study are to assess uptake and distribution of Lu AF88370 in the brain
when given at tracer levels (microdose) in healthy young men.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date type="Actual">March 31, 2022</start_date>
<completion_date type="Actual">June 20, 2022</completion_date>
<primary_completion_date type="Actual">June 15, 2022</primary_completion_date>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Whole Brain Total Distribution Volume (VT) of [11C]-Lu AF88370</measure>
<time_frame>Day 1</time_frame>
</primary_outcome>
<primary_outcome>
<measure>VT of [11C]-Lu AF88370 in Regions of Interest (ROI)</measure>
<time_frame>Day 1</time_frame>
</primary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">6</enrollment>
<condition>Healthy Participants</condition>
<arm_group>
<arm_group_label>[11C]-Lu AF88370</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants will receive [11C]-Lu AF88370 via an intravenous cannula on Day 1.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>[11C]-Lu AF88370</intervention_name>
<description>PET ligand in a single intravenous bolus injection</description>
<arm_group_label>[11C]-Lu AF88370</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- The participant has a body mass index (BMI) ≥18.5 and ≤30.0 kilograms (kg)/square
meter (m^2) at the Screening Visit.

- The participant is, in the opinion of the investigator, generally healthy based on
medical history, a physical and neurological examination, vital signs, an ECG, and the
results of the clinical chemistry, hematology, urinalysis, serology, and other
laboratory tests.

Exclusion Criteria:

- The participant has taken disallowed medication <1 week prior to the first dose of
study drug or <5 half-lives prior to the Screening Visit for any medication taken.

- The participant has received a COVID-19 vaccination within the last 30 days before
receiving first dose of study drug.

- The participant has had surgery or trauma with significant blood loss <6 months prior
to the first dose of the study drug.

- The participant is exposed to significant levels of ionising radiation at work.

Note: Other inclusion and exclusion criteria may apply.
</textblock>
</criteria>
<gender>Male</gender>
<minimum_age>20 Years</minimum_age>
<maximum_age>55 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Email contact via H. Lundbeck A/S</last_name>
<role>Study Director</role>
<affiliation>H. Lundbeck A/S</affiliation>
</overall_official>
<location>
<facility>
<name>Invicro</name>
<address>
<city>London</city>
<zip>W12 0NN</zip>
<country>United Kingdom</country>
</address>
</facility>
</location>
<location_countries>
<country>United Kingdom</country>
</location_countries>
<verification_date>July 2022</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>July 12, 2022</last_update_submitted>
<last_update_submitted_qc>July 12, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">July 14, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The main goals of the study are to assess uptake and distribution of Lu AF88370 in the brain
when given at tracer levels (microdose) in healthy young men.
Inclusion Criteria:
- The participant has a body mass index (BMI) ≥18.5 and ≤30.0 kilograms (kg)/square
meter (m^2) at the Screening Visit.
- The participant is, in the opinion of the investigator, generally healthy based on
medical history, a physical and neurological examination, vital signs, an ECG, and the
results of the clinical chemistry, hematology, urinalysis, serology, and other
laboratory tests.
Exclusion Criteria:
- The participant has taken disallowed medication <1 week prior to the first dose of
study drug or <5 half-lives prior to the Screening Visit for any medication taken.
- The participant has received a COVID-19 vaccination within the last 30 days before
receiving first dose of study drug.
- The participant has had surgery or trauma with significant blood loss <6 months prior
to the first dose of the study drug.
- The participant is exposed to significant levels of ionising radiation at work.
Note: Other inclusion and exclusion criteria may apply.
|
NCT0532xxxx/NCT05320315.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320315</url>
</required_header>
<id_info>
<org_study_id>ISD-FT-355-01-2020</org_study_id>
<nct_id>NCT05320315</nct_id>
</id_info>
<brief_title>Protective Effect Assessment of Foto Ultra Isdin Solar Allergy Fusion Fluid on the UVA Induced PLE</brief_title>
<official_title>Protective Effect Assessment Foto Ultra Isdin Solar Allergy Fusion Fluid (Isdin, s.a.) on the Ultraviolet A Induced Polymorphic Light Eruption</official_title>
<sponsors>
<lead_sponsor>
<agency>Centre de Pharmacologie Clinique Applique a la Dermatologie</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Centre de Pharmacologie Clinique Applique a la Dermatologie</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The primary objective of this Clinical Investigation was to assess the protective efficacy of
a medical device (FOTO ULTRA ISDIN® SOLAR ALLERGY FUSION FLUID) against the polymorphic light
eruption induced by the UVA.

The secondary objective of this Clinical Investigation was to assess the local safety and the
overall tolerability of the test MD on the basis of AE/SAE reporting.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This was a PMCF investigation for a MD CE marked and used in its intended purpose with
additional procedure non-invasive or non-burdensome.

This was a monocentric, single-blind, randomized, and controlled study performed with
intra-individual comparisons. It is a type 2 Interventional study with minimal risks and
constraints.

At least Fifteen (15) subjects with a known history of typical PLE on the chest after intense
sun exposure were included in the study. The subjects were recruited via the CPCAD Subject
Database or from those who spontaneously come to the CPCAD.

At Day 1, the tested MD was applied (2mg/cm²) on on side (10x15cm area) of the chest of each
subject. The other side was not treated. Then, 15 minutes after application, both sides were
irradiated with 40L/cm² of UVA. Same procedure was used from Day 2 to Day 5 with inceased UVA
dose at Day 3 and Day 4 (50J/cm²) and Day 5 (60J/cm²).

UVA exposures have to be stopped once a PLE reaction was induced. Assessments (clinical,
colorimetrical and photographs) were performed each day. Last assessments were perfomed at
Day 8.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">February 25, 2021</start_date>
<completion_date type="Actual">June 8, 2021</completion_date>
<primary_completion_date type="Actual">June 8, 2021</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<intervention_model_description>Monocentric, single-blind, randomized, controlled, study with intra-individual comparisons</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
<masking_description>The study was Investigator evaluator blinded. The products were dispensed according to the randomization list by a responsible designated person other than the Investigator evaluator and/or evaluators. The randomization list was masked to the Investigator evaluator during the whole study.</masking_description>
</study_design_info>
<primary_outcome>
<measure>Cumulative number of subjects who don't develop a positive PLE reaction</measure>
<time_frame>Day 8</time_frame>
<description>Cumulative number of subjects who don't develop a positive PLE reaction (at Day 8)</description>
</primary_outcome>
<secondary_outcome>
<measure>Cumulative number of subjects who don't develop a positive PLE reaction by day</measure>
<time_frame>from Day 1 to Day 8</time_frame>
<description>Cumulative number of subjects who don't develop a positive PLE reaction by day</description>
</secondary_outcome>
<secondary_outcome>
<measure>PLE severity score</measure>
<time_frame>from Day 1 to Day 8</time_frame>
<description>Scale of severity of polymorphous light eruption, 0 (no PLE) to 3 (severe PLE)</description>
</secondary_outcome>
<other_outcome>
<measure>Colorimetry component a*</measure>
<time_frame>from Day 1 to Day 8</time_frame>
<description>component a* related to erythema</description>
</other_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">15</enrollment>
<condition>Polymorphic Light Eruption</condition>
<arm_group>
<arm_group_label>ACTIVE and UNTREATED</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>This was an intraindividual comparison study. Active (DM sunscreen) treated zone and Untreated zone are compared</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Foto Ultra ISDIN® Solar Allergy Fusion Fluid</intervention_name>
<description>The tested MD is a very high protection sunscreen</description>
<arm_group_label>ACTIVE and UNTREATED</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Healthy volunteers of both sexes aged >18 years with a known history of typical PLE on
the chest after intense sun exposure and a last PLE outbreak since at least eight
months,

2. Subject with Phototype I to IV according to the Fitzpatrick classification (1988)
(14),

3. Subject in good health having normal results for the physical examination and medical
antecedents compatible with the study requirements,

4. subject of non-childbearing potential (tubal ligation, hysterectomy, bilateral
ovariectomy), or, subject of childbearing potential who has been, in the opinion of
the Investigator, using an approved method of birth control (e.g. oral contraception
pill or patch, intra-uterine devices, contraceptive implants or vaginal rings,
condoms, bilateral tubal ligation) for at least 1 month prior to first visit. Subject
must agree to continue adequate contraception during the entire study period and for 1
month after the end of the study,

5. Subject who, in the Investigator's opinion, will comply with the requirements of the
protocol (e.g., follow protocol instructions, maintain regular contact to allow
evaluation during the study),

6. Subject agreeing to avoid exposure to UV radiation (tanning beds, phototherapy, and
sunlight) on the whole body for at least six months before the screening visit and for
the whole duration of the study,

7. Subject agreeing to not apply cosmetic, medical or aesthetic treatments out of the
study protocol on the chest during the whole study duration,

8. Healthy subject registered with Social Security in accordance with French law on
interventional research. (Law 2004-806 and its implementing decree n°2006-477 of 26
April 2006).

Exclusion Criteria:

1. Female subject who is pregnant, parturient or breast feeding,

2. Subject of childbearing potential having a positive urinary pregnancy test at Day 1,

3. Subject has a PLE outbreak in the past eight months,

4. Subject has a medical condition or is taking medication that could put him or her at
undue risk,

5. Subject has a pathology that is unstable or risks interfering with the study,

6. Subject is currently receiving treatment that may interfere with interpretation of the
study results,

7. Subject has known or suspected allergies or sensitivities to any of the components of
the study product,

8. Subjects with an underlying pathology, or with a surgical, physical or medical status
which, according to the investigator, could interfere with the interpretation of the
study results such as:

1. Dermatological active pathologies (e.g. acne, psoriasis, eczema, urticaria...) in
particular on the tested area (the chest) or suspicion/antecedents of allergies
to cosmetics,

2. All systemic or local uncontrolled pathologies,

3. S kin anomalies (scars, excessive hair, tattooing…) on the chest,

9. Subjects having been exposed to ultraviolet radiation (UV), natural (sun) or
artificial (tanning salon), in the 6 months before the initial visit or who plans such
an exposure during the study,

10. Subjects having taken a systemic treatment, able to induce an abnormal response to UV,
for more than 5 days during the month preceding inclusion (steroids, non-steroidal
anti-inflammatories such as aspirin, insulin, antihistamines, anti-hypertensives,
antibiotics such as quinolones, tetracyclines, thiazides and fluoroquinolones, and all
other photosensitising treatments) or all treatments capable of inducing an abnormal
response to UV (vitamin A derivatives, psoralen, aminolevulinic acid derivatives…) or
planning to take these treatments during the study,

11. Subjects having applied a local treatment on the chest for more than 2 days during the
2 weeks preceding inclusion (steroids, non-steroidal anti-inflammatories,
antihistamines, antibiotics) and all other cosmetic products in the previous 24 hours,

12. Protected subject as defined in the Articles of the CSP: Article 1121-7: person
deprived of liberty by a judicial or administrative decision, or subject to
psychiatric care or person admitted to a health or social institution for purposes
other than the research. Article 1121-8: adult person subject to a legal protection
measure or unable to express his/her consent.

13. Subject unable to communicate or cooperate with the Investigator due to poor mental
development, language problems or impaired cerebral function,

14. Subject currently participating in another clinical study related to pharmaceuticals
or MDs or being in an exclusion period of another clinical study,

15. Subject who has received (or who will receive) more than 4500 euros as indemnity for
participating in clinical studies within the previous 12 months.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>CPCAD</name>
<address>
<city>Nice</city>
<state>Cpcad</state>
<zip>06202</zip>
<country>France</country>
</address>
</facility>
</location>
<location_countries>
<country>France</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>September 17, 2021</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>April 1, 2022</last_update_submitted>
<last_update_submitted_qc>April 1, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 11, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Exanthema</mesh_term>
<mesh_term>Dermatitis, Contact</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
<ipd_description>No plan to make individual participant data (IPD) available to other researchers</ipd_description>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The primary objective of this Clinical Investigation was to assess the protective efficacy of
a medical device (FOTO ULTRA ISDIN® SOLAR ALLERGY FUSION FLUID) against the polymorphic light
eruption induced by the UVA.
The secondary objective of this Clinical Investigation was to assess the local safety and the
overall tolerability of the test MD on the basis of AE/SAE reporting.
This was a PMCF investigation for a MD CE marked and used in its intended purpose with
additional procedure non-invasive or non-burdensome.
This was a monocentric, single-blind, randomized, and controlled study performed with
intra-individual comparisons. It is a type 2 Interventional study with minimal risks and
constraints.
At least Fifteen (15) subjects with a known history of typical PLE on the chest after intense
sun exposure were included in the study. The subjects were recruited via the CPCAD Subject
Database or from those who spontaneously come to the CPCAD.
At Day 1, the tested MD was applied (2mg/cm²) on on side (10x15cm area) of the chest of each
subject. The other side was not treated. Then, 15 minutes after application, both sides were
irradiated with 40L/cm² of UVA. Same procedure was used from Day 2 to Day 5 with inceased UVA
dose at Day 3 and Day 4 (50J/cm²) and Day 5 (60J/cm²).
UVA exposures have to be stopped once a PLE reaction was induced. Assessments (clinical,
colorimetrical and photographs) were performed each day. Last assessments were perfomed at
Day 8.
Inclusion Criteria:
1. Healthy volunteers of both sexes aged >18 years with a known history of typical PLE on
the chest after intense sun exposure and a last PLE outbreak since at least eight
months,
2. Subject with Phototype I to IV according to the Fitzpatrick classification (1988)
(14),
3. Subject in good health having normal results for the physical examination and medical
antecedents compatible with the study requirements,
4. subject of non-childbearing potential (tubal ligation, hysterectomy, bilateral
ovariectomy), or, subject of childbearing potential who has been, in the opinion of
the Investigator, using an approved method of birth control (e.g. oral contraception
pill or patch, intra-uterine devices, contraceptive implants or vaginal rings,
condoms, bilateral tubal ligation) for at least 1 month prior to first visit. Subject
must agree to continue adequate contraception during the entire study period and for 1
month after the end of the study,
5. Subject who, in the Investigator's opinion, will comply with the requirements of the
protocol (e.g., follow protocol instructions, maintain regular contact to allow
evaluation during the study),
6. Subject agreeing to avoid exposure to UV radiation (tanning beds, phototherapy, and
sunlight) on the whole body for at least six months before the screening visit and for
the whole duration of the study,
7. Subject agreeing to not apply cosmetic, medical or aesthetic treatments out of the
study protocol on the chest during the whole study duration,
8. Healthy subject registered with Social Security in accordance with French law on
interventional research. (Law 2004-806 and its implementing decree n°2006-477 of 26
April 2006).
Exclusion Criteria:
1. Female subject who is pregnant, parturient or breast feeding,
2. Subject of childbearing potential having a positive urinary pregnancy test at Day 1,
3. Subject has a PLE outbreak in the past eight months,
4. Subject has a medical condition or is taking medication that could put him or her at
undue risk,
5. Subject has a pathology that is unstable or risks interfering with the study,
6. Subject is currently receiving treatment that may interfere with interpretation of the
study results,
7. Subject has known or suspected allergies or sensitivities to any of the components of
the study product,
8. Subjects with an underlying pathology, or with a surgical, physical or medical status
which, according to the investigator, could interfere with the interpretation of the
study results such as:
1. Dermatological active pathologies (e.g. acne, psoriasis, eczema, urticaria...) in
particular on the tested area (the chest) or suspicion/antecedents of allergies
to cosmetics,
2. All systemic or local uncontrolled pathologies,
3. S kin anomalies (scars, excessive hair, tattooing…) on the chest,
9. Subjects having been exposed to ultraviolet radiation (UV), natural (sun) or
artificial (tanning salon), in the 6 months before the initial visit or who plans such
an exposure during the study,
10. Subjects having taken a systemic treatment, able to induce an abnormal response to UV,
for more than 5 days during the month preceding inclusion (steroids, non-steroidal
anti-inflammatories such as aspirin, insulin, antihistamines, anti-hypertensives,
antibiotics such as quinolones, tetracyclines, thiazides and fluoroquinolones, and all
other photosensitising treatments) or all treatments capable of inducing an abnormal
response to UV (vitamin A derivatives, psoralen, aminolevulinic acid derivatives…) or
planning to take these treatments during the study,
11. Subjects having applied a local treatment on the chest for more than 2 days during the
2 weeks preceding inclusion (steroids, non-steroidal anti-inflammatories,
antihistamines, antibiotics) and all other cosmetic products in the previous 24 hours,
12. Protected subject as defined in the Articles of the CSP: Article 1121-7: person
deprived of liberty by a judicial or administrative decision, or subject to
psychiatric care or person admitted to a health or social institution for purposes
other than the research. Article 1121-8: adult person subject to a legal protection
measure or unable to express his/her consent.
13. Subject unable to communicate or cooperate with the Investigator due to poor mental
development, language problems or impaired cerebral function,
14. Subject currently participating in another clinical study related to pharmaceuticals
or MDs or being in an exclusion period of another clinical study,
15. Subject who has received (or who will receive) more than 4500 euros as indemnity for
participating in clinical studies within the previous 12 months.
|
NCT0532xxxx/NCT05320328.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320328</url>
</required_header>
<id_info>
<org_study_id>RFA</org_study_id>
<nct_id>NCT05320328</nct_id>
</id_info>
<brief_title>RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION</brief_title>
<acronym>MBOP</acronym>
<official_title>SAFETY AND EFFICACY OF INTRA DUCTAL RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION: PROSPECTIVE OBSERVATIONAL STUDY</official_title>
<sponsors>
<lead_sponsor>
<agency>Asian Institute of Gastroenterology, India</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Asian Institute of Gastroenterology, India</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
Endoscopic retrograde cholangio pancreatography procedure will performed as per local
standard procedure.After common bile duct cannulation,cholangiography will be performed (to
confirm the stricture) followed by biliary sphincterotomy. All biliary strictures(Bismuth
Type I/II/III/IV) will be enrolled for the study.

Patient opting for Uncovered self expandable metallic stent / Plastic stent will undergo
biliary stent placement and considered under control arm Patient opting for radio frequency
ablation + Uncovered SEMS/Plastic stent will undergo radio frequency ablation and biliary
stent placement and considered under Study arm The RFA probe will be inserted into the bile
duct alongwith the guidewire. Keeping the electrode overlapping the stricture, RFA will be
performed using a power of 10W for 120 seconds. The electrode will be kept at the ablation
site for an additional 1 minute to allow the RFA probe to cool before removal to prevent
thermal injury of normal tissue and/or endoscope accessory channel. If the stricture is more
than 3 cm, step-by-step RFA will be performed from the superior to inferior aspect. After RFA
application, an uncovered SEMS/Plastic stent will be placed.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Placement of self expandable metallic stent is the standard of care in the palliative
management of patients with malignant biliary strictures . Relieves biliary obstruction and
jaundice.

Self expandable metallic stent provide efficient drainage and have superior patency rates
compared with the plastic stents Endoscopic radio frequency ablation combined with stent
placement can significantly prolong survival and the stent patency period without increasing
the incidence of adverse events in patients with extra hepatic cholangiocarcinoma patient.

Compared to plastic/ metal stent placement alone the addition of radio frequency ablation to
stent placement would have better outcomes.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date type="Actual">June 10, 2021</start_date>
<completion_date type="Anticipated">December 10, 2022</completion_date>
<primary_completion_date type="Anticipated">June 10, 2022</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Control</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Prospectively evaluate the safety and efficacy of combining intraductal Radio frequency ablation with biliary metal/ plastic stent placement for patients with malignant biliary obstruction.</measure>
<time_frame>12 months</time_frame>
<description>satety of radio frequency ablation assessed by complications/adverse effects post procedure and efficacy of the procedure will be assessed by stent patency at the end of one month</description>
</primary_outcome>
<secondary_outcome>
<measure>Stent patency at 1 year</measure>
<time_frame>12 months</time_frame>
<description>Stent patency will be estimated by bio chemical parameters (Total bilirubin, Alkaline phosphatase) or ultra sound abdomen scan</description>
</secondary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Anticipated">50</enrollment>
<condition>Bile Duct Neoplasms</condition>
<condition>Gall Bladder Carcinoma</condition>
<arm_group>
<arm_group_label>1</arm_group_label>
<description>The study group (A) will receive radio frequency ablation followed by uncovered Self expandable metal stent/Plastic stent placement (one or more)at same procedure.</description>
</arm_group>
<arm_group>
<arm_group_label>2</arm_group_label>
<description>The control group (B) will receive uncovered Self expandable metal stent / Plastic stent (one or more) placement.</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Radio frequency ablation</intervention_name>
<description>Radiofrequency ablation (RFA) uses heat to kill cancer cells. High-frequency electrical currents are passed through a special needle or probe called a needle electrode. The electrical current from the probe heats a small area containing cancer cells to high temperatures, killing the cancer cells. The area around the tumour is also usually treated because it may contain cancer cells.</description>
<arm_group_label>1</arm_group_label>
<other_name>RFA</other_name>
</intervention>
<eligibility>
<study_pop>
<textblock>
50 Subjects
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

1. Age 18-75 years

2. Malignant biliary obstruction confirmed using computed tomography (CT) or abdominal
magnetic resonance imaging(MRI), with pathological confirmation whenever possible;

3. Clinical jaundice, a serum bilirubin level greater than 5 mg/dL, and/or cholangitis;

4. ECOG performance status score≤2

5. Un resectability or refusal to be surgically treated.

6. Eligible patients were those with biliary obstruction due to cancer of the
gallbladder, or bile ducts; who were considered unsuitable for surgery because of
distant metastases, vascular invasion, or severe disability due to age or associated
diseases.

7. Non-resectability was established through the consensus opinion of a multidisciplinary
tumor board.

8. Written informed consent signed by the patient.

Exclusion Criteria:
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>75 Years</maximum_age>
</eligibility>
<overall_contact>
<last_name>Sai Dr Kumar, MBBS MD</last_name>
<phone>9121792373</phone>
<email>saiaig21@gmail.com</email>
</overall_contact>
<overall_contact_backup>
<last_name>Rajesh Mr Goud, M.Pharma, MBA, PDCR</last_name>
<phone>9705053550</phone>
<email>rajeshgoud761@gmail.com</email>
</overall_contact_backup>
<location>
<facility>
<name>Asian Institute of Gastroenterology</name>
<address>
<city>Hyderabad</city>
<state>Telangana</state>
<zip>500082</zip>
<country>India</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Rajesh Goud, M.Pharma MBA</last_name>
<phone>23378888</phone>
<phone_ext>040</phone_ext>
<email>rajeshgoud761@gmail.com</email>
</contact>
</location>
<location_countries>
<country>India</country>
</location_countries>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 23, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>April 1, 2022</last_update_submitted>
<last_update_submitted_qc>April 1, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 11, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Asian Institute of Gastroenterology, India</investigator_affiliation>
<investigator_full_name>Mohan Ramchandani</investigator_full_name>
<investigator_title>Doctor</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Urinary Bladder Neoplasms</mesh_term>
<mesh_term>Bile Duct Neoplasms</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
Endoscopic retrograde cholangio pancreatography procedure will performed as per local
standard procedure.After common bile duct cannulation,cholangiography will be performed (to
confirm the stricture) followed by biliary sphincterotomy. All biliary strictures(Bismuth
Type I/II/III/IV) will be enrolled for the study.
Patient opting for Uncovered self expandable metallic stent / Plastic stent will undergo
biliary stent placement and considered under control arm Patient opting for radio frequency
ablation + Uncovered SEMS/Plastic stent will undergo radio frequency ablation and biliary
stent placement and considered under Study arm The RFA probe will be inserted into the bile
duct alongwith the guidewire. Keeping the electrode overlapping the stricture, RFA will be
performed using a power of 10W for 120 seconds. The electrode will be kept at the ablation
site for an additional 1 minute to allow the RFA probe to cool before removal to prevent
thermal injury of normal tissue and/or endoscope accessory channel. If the stricture is more
than 3 cm, step-by-step RFA will be performed from the superior to inferior aspect. After RFA
application, an uncovered SEMS/Plastic stent will be placed.
Placement of self expandable metallic stent is the standard of care in the palliative
management of patients with malignant biliary strictures . Relieves biliary obstruction and
jaundice.
Self expandable metallic stent provide efficient drainage and have superior patency rates
compared with the plastic stents Endoscopic radio frequency ablation combined with stent
placement can significantly prolong survival and the stent patency period without increasing
the incidence of adverse events in patients with extra hepatic cholangiocarcinoma patient.
Compared to plastic/ metal stent placement alone the addition of radio frequency ablation to
stent placement would have better outcomes.
50 Subjects
Inclusion Criteria:
1. Age 18-75 years
2. Malignant biliary obstruction confirmed using computed tomography (CT) or abdominal
magnetic resonance imaging(MRI), with pathological confirmation whenever possible;
3. Clinical jaundice, a serum bilirubin level greater than 5 mg/dL, and/or cholangitis;
4. ECOG performance status score≤2
5. Un resectability or refusal to be surgically treated.
6. Eligible patients were those with biliary obstruction due to cancer of the
gallbladder, or bile ducts; who were considered unsuitable for surgery because of
distant metastases, vascular invasion, or severe disability due to age or associated
diseases.
7. Non-resectability was established through the consensus opinion of a multidisciplinary
tumor board.
8. Written informed consent signed by the patient.
Exclusion Criteria:
|
NCT0532xxxx/NCT05320341.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320341</url>
</required_header>
<id_info>
<org_study_id>MH.2.5</org_study_id>
<nct_id>NCT05320341</nct_id>
</id_info>
<brief_title>TIVA Versus Inhalational Anesthesia and Tissue Oxygenation in Cardiac Surgery</brief_title>
<official_title>The Effects of Total Intravenous and Inhalation Anesthesia Maintenance on Tissue Oxygenation in Coronary Artery Bypass Graft Surgery</official_title>
<sponsors>
<lead_sponsor>
<agency>Ankara City Hospital Bilkent</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Ankara City Hospital Bilkent</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The aim of this study was to evaluate the effect of total intravenous anesthesia (TIVA) and
inhalational anesthesia techniques on tissue oxygenation in cardiac surgery. The primary
objective of this study was to compare the effects of midazolam-based TIVA and
sevoflurane-based (SEVO) inhalation anesthesia maintenance on intraoperative central and
regional tissue oxygenation parameters.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
A pressing issue in anesthesiology involves developing an understanding of the non-anesthetic
effects of the medications typically used in intravenous and inhalation anesthesia methods.
Few studies describe the effects of both intravenous and inhalational anesthetics on regional
tissue perfusion is described under stable anesthetic conditions. There is the issue of
whether inhalational anesthetics compromise regional tissue perfusion even though systemic
parameters are within normal ranges. It is still debated how these effects may be different
under pathophysiological conditions, such as cardiac surgery.

Maintaining tissue perfusion and oxygenation is the cornerstone of therapy for patients with
cardiac disease. An imbalance in oxygen delivery and tissue oxygen consumption leads to
anaerobic metabolism, cellular injury, and organ dysfunction, and is associated with poor
outcomes. Consequently, monitoring tissue oxygen delivery and consumption status is of
paramount importance in cardiac surgery patients. Routinely used monitors in intraoperative
settings such as pulse oximetry, blood pressures, hemoglobin saturation levels, lactate,
acid-base status, and central venous oxygen saturation levels all reflect tissue metabolism.
Near-infrared spectroscopy (NIRS) is a non-invasive optical technique that can be used to
continuously monitor tissue oxygen delivery and oxygen consumption status. Cerebral
autoregulation can blunt the effect of impaired systemic oxygen delivery. Thus, cerebral NIRS
may be a good predictor of neurological outcomes, but skeletal muscle NIRS serves as a
follow-up indicator of many other postoperative complications due to impaired perfusion and
oxygenation. Therefore, both cerebral and somatic monitoring may contribute to a more
complete evaluation of hemodynamic competence. Obtaining the cerebral and somatic oxygenation
levels are valuable to help in clinical management during cardiopulmonary bypass (CPB) and
cardiac surgery as a whole.

The aim of this study was to evaluate the effect of total intravenous anesthesia (TIVA) and
inhalational anesthesia techniques on tissue oxygenation in cardiac surgery. For this
purpose, the effects of midazolam-based TIVA or sevoflurane-based inhalation anesthesia
maintenance on intraoperative central and somatic tissue oxygenation parameters were compared
in patients undergoing cardiac surgery.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">February 1, 2019</start_date>
<completion_date type="Actual">March 1, 2021</completion_date>
<primary_completion_date type="Actual">November 1, 2020</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Control</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Hemodynamic parameters</measure>
<time_frame>5 minutes after anesthesia induction</time_frame>
<description>mean arterial pressure in mmHg was recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Hemodynamic parameters</measure>
<time_frame>5 minutes after anesthesia induction</time_frame>
<description>heart rate (beat per minute) were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Hemodynamic parameters</measure>
<time_frame>After cardiopulmonary bypass cannulation, an average of 5 minutes</time_frame>
<description>mean arterial pressure (mmHg) was recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Hemodynamic parameters</measure>
<time_frame>After cardiopulmonary bypass cannulation, an average of 5 minutes</time_frame>
<description>heart rate (beat per minute) was recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Hemodynamic parameters</measure>
<time_frame>10th minute of cardiopulmonary bypass</time_frame>
<description>mean arterial pressure (mmHg) was recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Hemodynamic parameters</measure>
<time_frame>10th minute of cardiopulmonary bypass</time_frame>
<description>heart rate (beat per minute) was recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Hemodynamic parameters</measure>
<time_frame>10 minutes after cross clamp removal</time_frame>
<description>mean arterial pressure (mmHg) was recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Hemodynamic parameters</measure>
<time_frame>10 minutes after cross clamp removal</time_frame>
<description>heart rate (beat per minute) was recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Hemodynamic parameters</measure>
<time_frame>10 minutes after CPB completion</time_frame>
<description>mean arterial pressure (mmHg) was recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Hemodynamic parameters</measure>
<time_frame>10 minutes after CPB completion</time_frame>
<description>heart rate (beat per minute ) was recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Hemodynamic parameters</measure>
<time_frame>upon sternum closing</time_frame>
<description>mean arterial pressure (mmHg) was recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Hemodynamic parameters</measure>
<time_frame>upon sternum closing</time_frame>
<description>heart rate (beat per minute) was recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>5 minutes after anesthesia induction</time_frame>
<description>pH levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>5 minutes after anesthesia induction</time_frame>
<description>central venous saturation (%) levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>5 minutes after anesthesia induction</time_frame>
<description>lactate levels (mmol/L) were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>5 minutes after anesthesia induction</time_frame>
<description>Hemoglobin (g/dL) levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>After cardiopulmonary bypass cannulation, an average of 5 minutes</time_frame>
<description>pH levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>After cardiopulmonary bypass cannulation, an average of 5 minutes</time_frame>
<description>central venous saturation (%) levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>After cardiopulmonary bypass cannulation, an average of 5 minutes</time_frame>
<description>lactate (mmol/L) levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>After cardiopulmonary bypass cannulation, an average of 5 minutes</time_frame>
<description>hemoglobin (g/dL)levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>10th minute of cardiopulmonary bypass</time_frame>
<description>pH levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>10th minute of cardiopulmonary bypass</time_frame>
<description>central venous saturation (%) levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>10th minute of cardiopulmonary bypass</time_frame>
<description>lactate (mmol/L) levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>10th minute of cardiopulmonary bypass</time_frame>
<description>hemoglobin (g/dL) levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>10 minutes after cross clamp removal</time_frame>
<description>pH levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>10 minutes after cross clamp removal</time_frame>
<description>central venous saturation (%) levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>10 minutes after cross clamp removal</time_frame>
<description>lactate (mmol/L) levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>10 minutes after cross clamp removal</time_frame>
<description>hemoglobin (g/dL) levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>10 minutes after CPB completion</time_frame>
<description>pH levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>10 minutes after CPB completion</time_frame>
<description>central venous saturation (%) levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>10 minutes after CPB completion</time_frame>
<description>lactate (mmol/L) levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>10 minutes after CPB completion</time_frame>
<description>hemoglobin (g/dL) levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>upon sternum closing</time_frame>
<description>pH levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>upon sternum closing</time_frame>
<description>central venous saturation (%) levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>upon sternum closing</time_frame>
<description>lactate (mmol/L) levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>Arterial gas sampling</measure>
<time_frame>upon sternum closing</time_frame>
<description>hemoglobin (g/dL) levels were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>NIRS</measure>
<time_frame>5 minutes after anesthesia induction</time_frame>
<description>cerebral (rSO2) values were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>NIRS</measure>
<time_frame>5 minutes after anesthesia induction</time_frame>
<description>somatic (rSO2) values were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>NIRS</measure>
<time_frame>After cardiopulmonary bypass cannulation, an average of 5 minutes</time_frame>
<description>cerebral (rSO2) values were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>NIRS</measure>
<time_frame>After cardiopulmonary bypass cannulation, an average of 5 minutes</time_frame>
<description>somatic(rSO2) values were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>NIRS</measure>
<time_frame>10th minute of cardiopulmonary bypass</time_frame>
<description>cerebral (rSO2) values were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>NIRS</measure>
<time_frame>10th minute of cardiopulmonary bypass</time_frame>
<description>somatic (rSO2) values were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>NIRS</measure>
<time_frame>10 minutes after cross clamp removal</time_frame>
<description>cerebral (rSO2) were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>NIRS</measure>
<time_frame>10 minutes after cross clamp removal</time_frame>
<description>somatic (rSO2) were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>NIRS</measure>
<time_frame>10 minutes after CPB completion</time_frame>
<description>cerebral(rSO2)values were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>NIRS</measure>
<time_frame>10 minutes after CPB completion</time_frame>
<description>somatic (rSO2) values were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>NIRS</measure>
<time_frame>upon sternum closing</time_frame>
<description>cerebral(rSO2)values were recorded</description>
</primary_outcome>
<primary_outcome>
<measure>NIRS</measure>
<time_frame>upon sternum closing</time_frame>
<description>somatic (rSO2) values were recorded</description>
</primary_outcome>
<number_of_groups>2</number_of_groups>
<enrollment type="Actual">104</enrollment>
<condition>Cardiac Anesthesia</condition>
<arm_group>
<arm_group_label>TIVA group</arm_group_label>
<description>During the anesthesia maintenance of the TIVA group, 3 μg.kg-1 fentanyl, 0.01-0.05 mg.kg-1 midazolam, and 0.2 mg.kg-1 rocuronium bromide were applied throughout the operation to keep BIS between 40 and 60, approximately once every 45 minutes.</description>
</arm_group>
<arm_group>
<arm_group_label>SEVO group</arm_group_label>
<description>During the anesthesia maintenance of the SEVO group, 2-3% sevoflurane (1-2 MAC), 3 μg.kg-1 fentanyl and 0.2 mg.kg-1 rocuronium bromide were applied throughout the operation to keep BIS between 40-60.</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>TIVA</intervention_name>
<description>During the anesthesia maintenance of the TIVA group, 3 μg.kg-1 fentanyl, 0.01-0.05 mg.kg-1 midazolam, and 0.2 mg.kg-1 rocuronium bromide were applied throughout the operation to keep BIS between 40 and 60, approximately once every 45 minutes.</description>
<arm_group_label>TIVA group</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>SEVO</intervention_name>
<description>During the anesthesia maintenance of the SEVO group, 2-3% sevoflurane (1-2 MAC), 3 μg.kg-1 fentanyl and 0.2 mg.kg-1 rocuronium bromide were applied throughout the operation to keep BIS between 40-60.</description>
<arm_group_label>SEVO group</arm_group_label>
</intervention>
<eligibility>
<study_pop>
<textblock>
adult patients who undergoing coronary surgeries with cardiopulmonary bypass
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- coronary surgeries with CPB

Exclusion Criteria:

- emergency surgeries,

- operations

- ejection fraction under 40%

- coronary surgeries in conjunction with other procedures

- cerebrovascular accident

- neurological disorders

- hematologic disorder

- chronic alcohol use
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Ankara City Hospital</name>
<address>
<city>Ankara</city>
<state>Select State/Province</state>
<zip>06800</zip>
<country>Turkey</country>
</address>
</facility>
</location>
<location_countries>
<country>Turkey</country>
</location_countries>
<results_reference>
<citation>Turek Z, Sykora R, Matejovic M, Cerny V. Anesthesia and the microcirculation. Semin Cardiothorac Vasc Anesth. 2009 Dec;13(4):249-58. doi: 10.1177/1089253209353134. Epub 2009 Dec 2.</citation>
<PMID>19959497</PMID>
</results_reference>
<results_reference>
<citation>Bickler P, Feiner J, Rollins M, Meng L. Tissue Oximetry and Clinical Outcomes. Anesth Analg. 2017 Jan;124(1):72-82. doi: 10.1213/ANE.0000000000001348.</citation>
<PMID>27308951</PMID>
</results_reference>
<results_reference>
<citation>De Backer D, Dubois MJ, Schmartz D, Koch M, Ducart A, Barvais L, Vincent JL. Microcirculatory alterations in cardiac surgery: effects of cardiopulmonary bypass and anesthesia. Ann Thorac Surg. 2009 Nov;88(5):1396-403. doi: 10.1016/j.athoracsur.2009.07.002.</citation>
<PMID>19853081</PMID>
</results_reference>
<verification_date>April 2022</verification_date>
<study_first_submitted>March 23, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>April 1, 2022</last_update_submitted>
<last_update_submitted_qc>April 1, 2022</last_update_submitted_qc>
<last_update_posted type="Actual">April 11, 2022</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Ankara City Hospital Bilkent</investigator_affiliation>
<investigator_full_name>Eda Balci</investigator_full_name>
<investigator_title>Medical Doctor</investigator_title>
</responsible_party>
<keyword>tissue oxygenation</keyword>
<keyword>total intravenous anesthesia</keyword>
<keyword>inhalational anesthesia</keyword>
<keyword>cardiac surgery</keyword>
<keyword>NIRS</keyword>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The aim of this study was to evaluate the effect of total intravenous anesthesia (TIVA) and
inhalational anesthesia techniques on tissue oxygenation in cardiac surgery. The primary
objective of this study was to compare the effects of midazolam-based TIVA and
sevoflurane-based (SEVO) inhalation anesthesia maintenance on intraoperative central and
regional tissue oxygenation parameters.
A pressing issue in anesthesiology involves developing an understanding of the non-anesthetic
effects of the medications typically used in intravenous and inhalation anesthesia methods.
Few studies describe the effects of both intravenous and inhalational anesthetics on regional
tissue perfusion is described under stable anesthetic conditions. There is the issue of
whether inhalational anesthetics compromise regional tissue perfusion even though systemic
parameters are within normal ranges. It is still debated how these effects may be different
under pathophysiological conditions, such as cardiac surgery.
Maintaining tissue perfusion and oxygenation is the cornerstone of therapy for patients with
cardiac disease. An imbalance in oxygen delivery and tissue oxygen consumption leads to
anaerobic metabolism, cellular injury, and organ dysfunction, and is associated with poor
outcomes. Consequently, monitoring tissue oxygen delivery and consumption status is of
paramount importance in cardiac surgery patients. Routinely used monitors in intraoperative
settings such as pulse oximetry, blood pressures, hemoglobin saturation levels, lactate,
acid-base status, and central venous oxygen saturation levels all reflect tissue metabolism.
Near-infrared spectroscopy (NIRS) is a non-invasive optical technique that can be used to
continuously monitor tissue oxygen delivery and oxygen consumption status. Cerebral
autoregulation can blunt the effect of impaired systemic oxygen delivery. Thus, cerebral NIRS
may be a good predictor of neurological outcomes, but skeletal muscle NIRS serves as a
follow-up indicator of many other postoperative complications due to impaired perfusion and
oxygenation. Therefore, both cerebral and somatic monitoring may contribute to a more
complete evaluation of hemodynamic competence. Obtaining the cerebral and somatic oxygenation
levels are valuable to help in clinical management during cardiopulmonary bypass (CPB) and
cardiac surgery as a whole.
The aim of this study was to evaluate the effect of total intravenous anesthesia (TIVA) and
inhalational anesthesia techniques on tissue oxygenation in cardiac surgery. For this
purpose, the effects of midazolam-based TIVA or sevoflurane-based inhalation anesthesia
maintenance on intraoperative central and somatic tissue oxygenation parameters were compared
in patients undergoing cardiac surgery.
adult patients who undergoing coronary surgeries with cardiopulmonary bypass
Inclusion Criteria:
- coronary surgeries with CPB
Exclusion Criteria:
- emergency surgeries,
- operations
- ejection fraction under 40%
- coronary surgeries in conjunction with other procedures
- cerebrovascular accident
- neurological disorders
- hematologic disorder
- chronic alcohol use
|
NCT0532xxxx/NCT05320354.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320354</url>
</required_header>
<id_info>
<org_study_id>22-072</org_study_id>
<nct_id>NCT05320354</nct_id>
</id_info>
<brief_title>Diagnosis and Bacterial Identification of Periprosthetic Joint Infection With Microbial-ID</brief_title>
<acronym>MID</acronym>
<official_title>Diagnosis and Bacterial Identification of Periprosthetic Joint Infection With Microbial-ID</official_title>
<sponsors>
<lead_sponsor>
<agency>UMC Utrecht</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Zimmer Biomet</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>UMC Utrecht</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The primary objective of this study is to demonstrate the validity of the Microbial- ID test
to aid in diagnosis of periprosthetic joint infection (PJI) in terms of sensitivity and
specificity.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
In the diagnosis of periprosthetic joint infection (PJI) there is no golden standard test.
Multiple definitions for the diagnosis of PJI exist, such as the European Bone and Joint
Infection Society (EBJIS)1, Musculoskeletal Infection Society (MSIS)2, and the Infectious
Diseases Society of America (IDSA)3. One of the criteria that defines PJI is that there are
at least two positive periprosthetic cultures with phenotypically identical organisms.
Although these two positive bacterial cultures can certainly be considered proof of PJI, many
other criteria are also used, such as a sinus tract, white blood count (WBC), elevated
C-reactive protein and/or erythrocyte sedimentation rate (ESR), elevated percentage of
neutrophils, and positive alpha defensin. Even when all these criteria are negative, a PJI
cannot be excluded. Zimmer Biomet developed the Synovasure® Microbial-ID test that enables
early and faster identification of microbial species through detection of microbial antigens
responsible for infection.

This is an international multicenter, non-randomized, prospective, non-intervention clinical
investigation.The primary objective of this study is to demonstrate the validity of the
Microbial-ID test to aid in diagnosis of PJI in terms of sensitivity and specificity. The
study population is adult patients with a potentially infected joint implant, who will
undergo an articular puncture and/or surgery with harvesting of synovial fluid. In addition
to the standard of care procedure for patients with a suspected PJI, the MID-test will be
performed using the residual synovial fluid. Individual test results of the MID-test are not
reported back to the participating sites in order to not interfere with the sites' standard
of care approach.

Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: Patients do not benefit from participating in this study. A separate diagnostic
tool will run in parallel but this procedure will not interfere with the patient's current
path of diagnostic work up nor will it have an effect on their treatment plan. The results
will help the investigators to get more insight in the reliability of the MID-test to detect
microbial antigens responsible for the PJI. There are no known disadvantages for the patients
taking part in this research.
</textblock>
</detailed_description>
<overall_status>Enrolling by invitation</overall_status>
<start_date type="Actual">April 25, 2022</start_date>
<completion_date type="Anticipated">December 1, 2025</completion_date>
<primary_completion_date type="Anticipated">December 1, 2025</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Other</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>Sensitivity of the MID-test</measure>
<time_frame>after 3 weeks</time_frame>
<description>Sensitivity of the MID-test based upon the number of subjects with a positive MID-test AND ≥1 positive microbiology culture(s) for the same bacterial species (true positives) and the number of subjects with a negative MID-test AND ≥1 positive microbiology culture(s) for one of the four bacterial species the MID-test is testing for (false negatives).</description>
</primary_outcome>
<primary_outcome>
<measure>Specificity of the MID-test</measure>
<time_frame>after 3 weeks</time_frame>
<description>Specificity of the MID-test based upon the number of subjects with a negative MIDtest AND only negative microbiology cultures (true negatives) and the number subjects with a positive MID-test AND only negative microbiology cultures (false positives).</description>
</primary_outcome>
<secondary_outcome>
<measure>Comparison of MID-test and the MB culture(s) regarding the time-to-result.</measure>
<time_frame>after 3 weeks</time_frame>
<description>Comparison of the time-to-result (elapsing hours between harvesting and test result) of the MID-test and the microbiology culture(s).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Rate of identification of bacterial species by the MID-test and the corresponding MB culture(s).</measure>
<time_frame>after 3 weeks</time_frame>
<description>Rate of identification of bacterial species by the MID-test and the corresponding microbiology culture(s).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Proportion of agreement between the MID-test and the diagnosis of PJI according to the EBJIS definition.</measure>
<time_frame>after 3 weeks</time_frame>
<description>Proportion of agreement between the MID-test and the diagnosis of PJI according to the EBJIS definition as assessed by a blinded investigator.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Rate of "false positives" in the reported low-grade PJIs at ≥1-year follow-up.</measure>
<time_frame>after 1 year</time_frame>
<description>Rate of "false positives" (MID test (+) and MB culture (-) at F0) in the reported low-grade (MB (-) and clinical signs (+)) PJIs at ≥1-year follow-up.</description>
</secondary_outcome>
<number_of_groups>1</number_of_groups>
<enrollment type="Anticipated">200</enrollment>
<condition>Periprosthetic Joint Infection</condition>
<condition>PJI</condition>
<arm_group>
<arm_group_label>Patients suspected of PJI</arm_group_label>
<description>Adult patients, both male and female, scheduled for a puncture or surgery of their prosthetic joint due to suspected PJI.</description>
</arm_group>
<intervention>
<intervention_type>Diagnostic Test</intervention_type>
<intervention_name>Microbial ID test</intervention_name>
<description>In addition to the standard of care procedure for patients suspected for a periprosthetic joint infection, the MID-test will be performed using the residual synovial fluid. Individual test results of the MID-test are not reported back to the participating sites in order to not interfere with the sites' standard of care approach.</description>
<arm_group_label>Patients suspected of PJI</arm_group_label>
<other_name>Synovasure® Microbial Identification Test</other_name>
<other_name>Synovasure® Microbial ID P. acnes Test.</other_name>
</intervention>
<eligibility>
<study_pop>
<textblock>
Adult patients with a potentially infected joint implant, who will undergo an articular
puncture and/or surgery with harvesting of synovial fluid.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Patient has complaints (pain, stiffness) about the prosthetic joint And has clinical
features for joint infection at physical examination (swelling, redness, warm, sinus
tract) AND has an elevated serum CRP (>10 mg/L)

- Patient is scheduled for a puncture AND/OR surgery, with harvesting of synovial fluid

- Patient ≥ 18 years of age

- Patient is competent, able, and willing to provide written informed consent

Exclusion Criteria:

- Treatment with antibiotics ≤2 weeks prior to puncture and/or surgery;

- Other obvious reason(s) for implant dysfunction, such as: fracture, an implant
breakage, a malposition, and/or a tumour.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Harrie Weinans, Prof, MD</last_name>
<role>Principal Investigator</role>
<affiliation>H.H.Weinans@umcutrecht.nl</affiliation>
</overall_official>
<location>
<facility>
<name>Charité Universitätsmedizin Berlin</name>
<address>
<city>Berlin</city>
<country>Germany</country>
</address>
</facility>
</location>
<location>
<facility>
<name>UMC Utrecht</name>
<address>
<city>Utrecht</city>
<zip>3584CX</zip>
<country>Netherlands</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Hospitalar do Porto,</name>
<address>
<city>Porto</city>
<country>Portugal</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Valdoltra Orthopeadic Hospital,</name>
<address>
<city>Valdoltra</city>
<country>Slovenia</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Hospital Clinic Barcelona</name>
<address>
<city>Barcelona</city>
<country>Spain</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Universitätsspital Basel,</name>
<address>
<city>Basel</city>
<country>Switzerland</country>
</address>
</facility>
</location>
<location_countries>
<country>Germany</country>
<country>Netherlands</country>
<country>Portugal</country>
<country>Slovenia</country>
<country>Spain</country>
<country>Switzerland</country>
</location_countries>
<verification_date>February 2023</verification_date>
<study_first_submitted>April 1, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>February 22, 2023</last_update_submitted>
<last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">February 23, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>UMC Utrecht</investigator_affiliation>
<investigator_full_name>Harrie Weinans</investigator_full_name>
<investigator_title>Prof. Dr.</investigator_title>
</responsible_party>
<keyword>Microbial-ID test</keyword>
<keyword>Periprosthetic joint infection</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Infections</mesh_term>
<mesh_term>Communicable Diseases</mesh_term>
<mesh_term>Arthritis, Infectious</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>Undecided</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The primary objective of this study is to demonstrate the validity of the Microbial- ID test
to aid in diagnosis of periprosthetic joint infection (PJI) in terms of sensitivity and
specificity.
In the diagnosis of periprosthetic joint infection (PJI) there is no golden standard test.
Multiple definitions for the diagnosis of PJI exist, such as the European Bone and Joint
Infection Society (EBJIS)1, Musculoskeletal Infection Society (MSIS)2, and the Infectious
Diseases Society of America (IDSA)3. One of the criteria that defines PJI is that there are
at least two positive periprosthetic cultures with phenotypically identical organisms.
Although these two positive bacterial cultures can certainly be considered proof of PJI, many
other criteria are also used, such as a sinus tract, white blood count (WBC), elevated
C-reactive protein and/or erythrocyte sedimentation rate (ESR), elevated percentage of
neutrophils, and positive alpha defensin. Even when all these criteria are negative, a PJI
cannot be excluded. Zimmer Biomet developed the Synovasure® Microbial-ID test that enables
early and faster identification of microbial species through detection of microbial antigens
responsible for infection.
This is an international multicenter, non-randomized, prospective, non-intervention clinical
investigation.The primary objective of this study is to demonstrate the validity of the
Microbial-ID test to aid in diagnosis of PJI in terms of sensitivity and specificity. The
study population is adult patients with a potentially infected joint implant, who will
undergo an articular puncture and/or surgery with harvesting of synovial fluid. In addition
to the standard of care procedure for patients with a suspected PJI, the MID-test will be
performed using the residual synovial fluid. Individual test results of the MID-test are not
reported back to the participating sites in order to not interfere with the sites' standard
of care approach.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: Patients do not benefit from participating in this study. A separate diagnostic
tool will run in parallel but this procedure will not interfere with the patient's current
path of diagnostic work up nor will it have an effect on their treatment plan. The results
will help the investigators to get more insight in the reliability of the MID-test to detect
microbial antigens responsible for the PJI. There are no known disadvantages for the patients
taking part in this research.
Adult patients with a potentially infected joint implant, who will undergo an articular
puncture and/or surgery with harvesting of synovial fluid.
Inclusion Criteria:
- Patient has complaints (pain, stiffness) about the prosthetic joint And has clinical
features for joint infection at physical examination (swelling, redness, warm, sinus
tract) AND has an elevated serum CRP (>10 mg/L)
- Patient is scheduled for a puncture AND/OR surgery, with harvesting of synovial fluid
- Patient ≥ 18 years of age
- Patient is competent, able, and willing to provide written informed consent
Exclusion Criteria:
- Treatment with antibiotics ≤2 weeks prior to puncture and/or surgery;
- Other obvious reason(s) for implant dysfunction, such as: fracture, an implant
breakage, a malposition, and/or a tumour.
|
NCT0532xxxx/NCT05320367.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320367</url>
</required_header>
<id_info>
<org_study_id>21.361</org_study_id>
<nct_id>NCT05320367</nct_id>
</id_info>
<brief_title>A Study of Inhaled Cannabidiol in Healthy Occasional Cannabis Users</brief_title>
<official_title>A Randomized, Triple Blinded Cross-over Placebo Controlled Study of Effects of Inhaled Cannabidiol in Healthy Occasional Cannabis Users</official_title>
<sponsors>
<lead_sponsor>
<agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Centre hospitalier de l'Université de Montréal (CHUM)</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
<is_fda_regulated_drug>No</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
</oversight_info>
<brief_summary>
<textblock>
The purposes of this study are 1) to determine if the administration of different low doses
of CBD (5 mg, 17 mg, 50 mg and 100 mg) result in detectable subjective pleasant drug effect
compared to placebo and 2) to qualitatively explore whether low dose CBD is associated with
effects that are not detected with the available research tools.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Cannabis contains over 100 cannabinoids, the two most prominent being
Δ-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). A growing body of evidence exists
surrounding the effects of both THC and CBD, however, less is known about the specific
effects of CBD concentrations alone. Most existing data regarding the effects of CBD come
from studies where this compound is administered in high doses in a therapeutic context, and
where the subject can be administered either CBD, THC or both together. These contexts are
not representative of the current use by many consumers. Indeed, several available products
contain CBD at much lower doses. The overall objective of this study is to evaluate the acute
behavioral and biological effects of low doses of CBD (between 5-100mg) and placebo in
occasional cannabis users. Potential outcomes not detected with usual assessment tools
designed to evaluate THC-induced effects will also be explored.
</textblock>
</detailed_description>
<overall_status>Not yet recruiting</overall_status>
<start_date type="Anticipated">November 2023</start_date>
<completion_date type="Anticipated">November 2025</completion_date>
<primary_completion_date type="Anticipated">November 2024</primary_completion_date>
<phase>Phase 1/Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Crossover Assignment</intervention_model>
<intervention_model_description>In this crossover design, participants will be administered both dosages of CBD and placebo during participation in the study. Participant will be randomly assigned to one of ten pre-determined sequences with a CBD or placebo product at 5 dosages (0 mg, 5 mg, 17 mg, 50 mg and 100 mg). Participants will be randomized based on a completely balanced 5 by 5 latin square</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Pleasant drug effect</measure>
<time_frame>T1(10 minutes after inhalation)</time_frame>
<description>Pleasant drug effect will be assessed using a single item, visual analog scale, administered following administration of the study product at each study visit. It is rated on a continuous scale ranging from 0 (not at all) to 100 (extremely).</description>
</primary_outcome>
<primary_outcome>
<measure>Pleasant drug effect</measure>
<time_frame>T2 (60 minutes after inhalation)</time_frame>
<description>Pleasant drug effect will be assessed using a single item, visual analog scale, administered following administration of the study product at each study visit. It is rated on a continuous scale ranging from 0 (not at all) to 100 (extremely).</description>
</primary_outcome>
<primary_outcome>
<measure>Pleasant drug effect</measure>
<time_frame>T3 (120 minutes after inhalation)</time_frame>
<description>Pleasant drug effect will be assessed using a single item, visual analog scale, administered following administration of the study product at each study visit. It is rated on a continuous scale ranging from 0 (not at all) to 100 (extremely).</description>
</primary_outcome>
<secondary_outcome>
<measure>Drug Effects associated with cannabis administration</measure>
<time_frame>T1 (10 minutes after inhalation)</time_frame>
<description>Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis administration and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Drug Effects associated with cannabis administration</measure>
<time_frame>T2 (60 minutes after inhalation)</time_frame>
<description>Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis administration and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Drug Effects associated with cannabis administration</measure>
<time_frame>T3 (120 minutes after inhalation)</time_frame>
<description>Drug Effects Questionnaire (twenty-three-item) will be use to assess participant's physical signs, symptoms associated with cannabis administration and desire to use cannabis. The Drug Effects Questionnaire uses visual analogue scale, ranging from 0 (not at all) to 100 (extremely).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in dissociation</measure>
<time_frame>Baseline and after inhalation at (10 minutes, 60 minutes)</time_frame>
<description>Dissociation will be assessed using the Clinician Administered Dissociative States Scale (CADSS) administered at Baseline (T0) and following administration of the study product (T1- 10 minutes, T2-60 minutes) at each study visit. The CADSS, a 28-items validated instrument, includes 5 observer items and 23 participant self-report items rated on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). Minimum score :0 not at all; Maximum score 72 extremely dissociate.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Cannabis-Specific Subjective Effects</measure>
<time_frame>T3 (120 minutes after inhalation)</time_frame>
<description>Subjective effects of cannabis will be assessed using both the positive and negative subscales of the Cannabis Experience Questionnaire administered following administration study product. Each item is rated on a 5-point scale, ranging from 1 (not at all) to 5 (severely).The positive subscale includes16 items related to euphoric experiences (maximum 90 and minimum 16). The negative subscale includes 25 items related to paranoid-dysphoric experiences (Maximum 125 and minimum 25).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in Affect</measure>
<time_frame>Baseline and after inhalation at (10 minutes, 60 minutes, 120 minutes)</time_frame>
<description>Affect will be measured using the Positive and Negative Affect Schedule administered at Baseline (T0) and following administration of the study product at each study visit. The Positive and Negative Affect Schedule is a 20-item validated questionnaire divided into subscales of positive (10 items) and negative affect (10 items). Each item is rated on a 5-point scale ranging from 1 (not at all) to 5 (extremely). For each subscale minimum is 10 and maximum 50.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in Anxiety Symptoms</measure>
<time_frame>Baseline and after inhalation at (10 minutes, 60 minutes and 120 minutes)</time_frame>
<description>Symptoms of anxiety will be assessed using the States-Trait-Anxiety-Inventory, a 20-item validated self-report scale that measures the severity of anxiety in adults.. Each symptom is rated on a 4-point scale ranging from 1 (not at all) to 4 (very much).</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in Safety</measure>
<time_frame>Baseline and after inhalation at (10 minutes, 60 minutes, 120 minutes)</time_frame>
<description>Adverse events will be collected prior to administration of the study product (T0) and following administration of the study product (T1, T2 and T3)</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change on cognition</measure>
<time_frame>Baseline and after inhalation at T2 (60 minutes).</time_frame>
<description>The Cambridge Neuropsychological Test Automated Battery tests will be used for the rapid assessment of multiple cognitive components.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Visit Intoxication Assessment</measure>
<time_frame>End of the visit, approximatively 180 minutes after inhalation</time_frame>
<description>Signs of intoxication will be assess using the modified Standardized Field Sobriety Test.</description>
</secondary_outcome>
<other_outcome>
<measure>Change in plasma concentration of CBD</measure>
<time_frame>Baseline and after inhalation at ( 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes)</time_frame>
<description>Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after inhalation.</description>
</other_outcome>
<other_outcome>
<measure>Change in plasma concentration of 7-Hydroxycannabidiol</measure>
<time_frame>Baseline and after inhalation at ( 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes)</time_frame>
<description>Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after inhalation.</description>
</other_outcome>
<other_outcome>
<measure>Change in plasma concentration of 7-Carboxy-Cannabidiol</measure>
<time_frame>Baseline and after inhalation at ( 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes)</time_frame>
<description>Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after inhalation.</description>
</other_outcome>
<other_outcome>
<measure>Change in plasma concentration of Anandamide</measure>
<time_frame>Baseline and after inhalation at ( 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes)</time_frame>
<description>Plasma levels of CBD will be determined by high performance liquid chromatography-tandem mass spectrometry at baseline and after inhalation.</description>
</other_outcome>
<number_of_arms>5</number_of_arms>
<enrollment type="Anticipated">80</enrollment>
<condition>Cannabis</condition>
<arm_group>
<arm_group_label>CBD (Group 1)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Group will receive four CBD doses (5 mg, 17 mg, 50 mg and 100 mg), and placebo (0 mg).
Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit.
The order in which the study products will be administered depend on the randomization sequence</description>
</arm_group>
<arm_group>
<arm_group_label>CBD (Group 2)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Group will receive four CBD doses (5 mg, 17 mg, 50 mg and 100 mg), and placebo (0 mg).
Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit.
The order in which the study products will be administered depend on the randomization sequence</description>
</arm_group>
<arm_group>
<arm_group_label>CBD (Group 3)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Group will receive four CBD doses (5 mg, 17 mg, 50 mg and 100 mg), and placebo (0 mg).
Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit.
The order in which the study products will be administered depend on the randomization sequence.</description>
</arm_group>
<arm_group>
<arm_group_label>CBD (Group 4)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Group will receive four CBD doses (5 mg, 17 mg, 50 mg and 100 mg), and placebo (0 mg).
Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit.
The order in which the study products will be administered depend on the randomization sequence.</description>
</arm_group>
<arm_group>
<arm_group_label>CBD (Group 5)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Group will receive four CBD doses (5 mg, 17 mg, 50 mg and 100 mg), and placebo (0 mg).
Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit.
The order in which the study products will be administered depend on the randomization sequence.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Cannabis, placebo</intervention_name>
<description>Eligible participant will be randomize 1:1:1:1:1 to receive placebo, CBD (5mg, 17mg, 50mg and 100mg). Only one research product will be inhaled for each visit. The sequence will depend on the assigned randomization group.</description>
<arm_group_label>CBD (Group 1)</arm_group_label>
<arm_group_label>CBD (Group 2)</arm_group_label>
<arm_group_label>CBD (Group 3)</arm_group_label>
<arm_group_label>CBD (Group 4)</arm_group_label>
<arm_group_label>CBD (Group 5)</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

1. Between 21 and 65 years of age, inclusively;

2. Have used cannabis at least once in lifetime AND have used cannabis three days or less
in the 28 days prior to enrollment;

3. Be able to provide a signed informed consent;

4. Willing to comply with study procedures and requirements as per protocol;

5. Have a forced expiratory volume in first second (FEV) sup 90 %;

6. Able to communicate and understand English or French language;

7. For female participants:

a. Without childbearing potential, defined as: i. postmenopausal (12 months of
spontaneous amenorrhea and ≥ 45 years of age); or ii. Documented surgically sterilized
(i.e., tubal ligation, hysterectomy, or bilateral oophorectomy); or

b. With childbearing potential: i. Must have negative pregnancy test result at
screening and at subsequent visits.

ii. AND have no pregnancy plan while on the trial iii. AND must agree to use a medically
accepted method of birth control throughout the study.

Exclusion Criteria:

1. Any disabling medical condition, as assessed by medical history, physical exam, vital
signs and/or laboratory assessments that, in the opinion of the study physician,
precludes safe participation in the study or the ability to provide fully informed
consent;

2. Severe psychiatric condition (history of schizophrenia, schizoaffective disorder or
bipolar disorder; current acute psychosis, mania or current suicidality based on the
Mini International Neuropsychiatric Interview);

3. Any other disabling, unstable or acute mental condition that, in the opinion of the
study physician, precludes safe participation in the study or ability to provide fully
informed consent;

4. Current substance use disorder (except nicotine) according to Structured Clinical
Interview for the Diagnostic and Statistical Manual of Mental Disorders-5 (SCID-V );

5. Currently pregnant, breastfeeding or planning to become pregnant either at screening
or while enrolled in the study;

6. Pending legal action or other reason that, in the opinion of the study physician,
might prevent study completion;

7. Use of medication within 7 days of experimental sessions, which, in the opinion of the
Investigator, may interact with cannabis.

8. Participation in clinical trials or undergoing other investigational procedure
involving cannabis or cannabinoids administration within 30 days prior to
randomization
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>21 Years</minimum_age>
<maximum_age>65 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Didier Jutras-Aswad, MD,MS</last_name>
<role>Principal Investigator</role>
<affiliation>Centre hospitalier de l'Université de Montréal (CHUM)</affiliation>
</overall_official>
<overall_contact>
<last_name>Pamela Lachance, PhD</last_name>
<phone>514-890-8000</phone>
<phone_ext>30938</phone_ext>
<email>pamela.lachance-touchette.chum@ssss.gouv.qc.ca</email>
</overall_contact>
<overall_contact_backup>
<last_name>Didier Jutras-Aswad, MD,MS</last_name>
<phone>514-890-8000</phone>
<phone_ext>35703</phone_ext>
<email>didier.jutras-aswad@umontreal.ca</email>
</overall_contact_backup>
<verification_date>May 2023</verification_date>
<study_first_submitted>March 20, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>May 15, 2023</last_update_submitted>
<last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">May 16, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Marijuana Abuse</mesh_term>
</condition_browse>
<patient_data>
<sharing_ipd>No</sharing_ipd>
</patient_data>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
The purposes of this study are 1) to determine if the administration of different low doses
of CBD (5 mg, 17 mg, 50 mg and 100 mg) result in detectable subjective pleasant drug effect
compared to placebo and 2) to qualitatively explore whether low dose CBD is associated with
effects that are not detected with the available research tools.
Cannabis contains over 100 cannabinoids, the two most prominent being
Δ-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). A growing body of evidence exists
surrounding the effects of both THC and CBD, however, less is known about the specific
effects of CBD concentrations alone. Most existing data regarding the effects of CBD come
from studies where this compound is administered in high doses in a therapeutic context, and
where the subject can be administered either CBD, THC or both together. These contexts are
not representative of the current use by many consumers. Indeed, several available products
contain CBD at much lower doses. The overall objective of this study is to evaluate the acute
behavioral and biological effects of low doses of CBD (between 5-100mg) and placebo in
occasional cannabis users. Potential outcomes not detected with usual assessment tools
designed to evaluate THC-induced effects will also be explored.
Inclusion Criteria:
1. Between 21 and 65 years of age, inclusively;
2. Have used cannabis at least once in lifetime AND have used cannabis three days or less
in the 28 days prior to enrollment;
3. Be able to provide a signed informed consent;
4. Willing to comply with study procedures and requirements as per protocol;
5. Have a forced expiratory volume in first second (FEV) sup 90 %;
6. Able to communicate and understand English or French language;
7. For female participants:
a. Without childbearing potential, defined as: i. postmenopausal (12 months of
spontaneous amenorrhea and ≥ 45 years of age); or ii. Documented surgically sterilized
(i.e., tubal ligation, hysterectomy, or bilateral oophorectomy); or
b. With childbearing potential: i. Must have negative pregnancy test result at
screening and at subsequent visits.
ii. AND have no pregnancy plan while on the trial iii. AND must agree to use a medically
accepted method of birth control throughout the study.
Exclusion Criteria:
1. Any disabling medical condition, as assessed by medical history, physical exam, vital
signs and/or laboratory assessments that, in the opinion of the study physician,
precludes safe participation in the study or the ability to provide fully informed
consent;
2. Severe psychiatric condition (history of schizophrenia, schizoaffective disorder or
bipolar disorder; current acute psychosis, mania or current suicidality based on the
Mini International Neuropsychiatric Interview);
3. Any other disabling, unstable or acute mental condition that, in the opinion of the
study physician, precludes safe participation in the study or ability to provide fully
informed consent;
4. Current substance use disorder (except nicotine) according to Structured Clinical
Interview for the Diagnostic and Statistical Manual of Mental Disorders-5 (SCID-V );
5. Currently pregnant, breastfeeding or planning to become pregnant either at screening
or while enrolled in the study;
6. Pending legal action or other reason that, in the opinion of the study physician,
might prevent study completion;
7. Use of medication within 7 days of experimental sessions, which, in the opinion of the
Investigator, may interact with cannabis.
8. Participation in clinical trials or undergoing other investigational procedure
involving cannabis or cannabinoids administration within 30 days prior to
randomization
|
NCT0532xxxx/NCT05320380.xml | <clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT05320380</url>
</required_header>
<id_info>
<org_study_id>APAL2020B</org_study_id>
<secondary_id>NCI-2022-02157</secondary_id>
<secondary_id>APAL2020B</secondary_id>
<secondary_id>APAL2020B</secondary_id>
<secondary_id>U10CA180886</secondary_id>
<nct_id>NCT05320380</nct_id>
</id_info>
<brief_title>A Study of the Drug IMGN632 in Children With Leukemia That Has Come Back After Treatment or is Difficult to Treat</brief_title>
<official_title>A PedAL/EuPAL Phase 1/2 Trial of IMGN632 in Pediatric Patients With Relapsed or Refractory Leukemia</official_title>
<sponsors>
<lead_sponsor>
<agency>Children's Oncology Group</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>ImmunoGen, Inc.</agency>
<agency_class>Industry</agency_class>
</collaborator>
<collaborator>
<agency>National Cancer Institute (NCI)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>Children's Oncology Group</source>
<oversight_info>
<has_dmc>No</has_dmc>
<is_fda_regulated_drug>Yes</is_fda_regulated_drug>
<is_fda_regulated_device>No</is_fda_regulated_device>
<is_us_export>Yes</is_us_export>
</oversight_info>
<brief_summary>
<textblock>
This phase I/II trial finds the highest safe dose of IMGN632 that can be given with other
chemotherapy without causing severe side effects, studies what kind of side effects IMGN632
may cause, and determines whether IMGN632 is a beneficial treatment for leukemia in children
that has come back after treatment or is difficult to treat. IMGN632 is a monoclonal antibody
linked to a chemotherapy drug. IMGN632 is a form of targeted therapy because it attaches to
specific molecules (receptors) on the surface of cancer cells, known as CD123 receptors, and
delivers the chemotherapy drug to kill them. Giving IMGN632 with other chemotherapy may cause
the leukemia to stop growing or to shrink for a period of time.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
PRIMARY OBJECTIVES:

I. To determine the recommended phase 2 dose (RP2D) of anti-CD123 ADC IMGN632 (IMGN632)
monotherapy in pediatric patients with second or greater relapse of CD123 positive leukemia
or CD123 positive leukemia refractory to relapse therapy. (Cohort 1 [Monotherapy Phase 1])
II. To assess the flow-based overall response rate (complete remission [CR]/CR with
incomplete blood count recovery [CRi]/CR with partial recovery of platelet count [CRp]) in
patients with acute myeloid leukemia (AML) treated with IMGN632. (Cohort 1 [Monotherapy Phase
1]) III. To determine the safety, feasibility, and RP2D of IMGN632 in combination with
liposome-encapsulated daunorubicin-cytarabine (DAUNOrubicin and cytarabine liposome) in
pediatric patients with first relapse of CD123 positive AML. (Cohort 2 [Combination Therapy
Dose Finding]) IV. To compare the minimal residual disease (MRD) negative flow-based overall
response rate (CR/CRi/CRp) in pediatric patients with first relapse of CD123 positive AML
randomized to two cycles of therapy including DAUNOrubicin and cytarabine liposome followed
by fludarabine phosphate (fludarabine)/cytarabine with or without IMGN632. (Cohort 3
[Randomized Phase 2])

SECONDARY OBJECTIVE:

I. To characterize the pharmacokinetics of IMGN632 in a pediatric population. (Cohort 1
[Monotherapy Phase 1])

EXPLORATORY OBJECTIVES:

I. To describe the anti-leukemic activity (morphologic and flow-based CR/CRp/CRi after up to
two cycles, rates of MRD negative response after up to 2 cycles, event free survival [EFS]
and overall survival [OS]) of IMGN632 in patients with multiply relapsed or refractory
relapsed pediatric leukemia including AML, B-cell acute lymphoblastic leukemia [ALL], T-cell
ALL and mixed phenotype acute leukemia (MPAL). (Cohort 1) II. To describe the EFS, OS,
cumulative incidence of relapse, and rate of subsequent stem cell transplant for patients
with first relapse of AML randomized to treatment with up to two cycles of chemotherapy with
or without IMGN632. (Cohort 3) III. To determine if CD123 expression on leukemic blasts
(assessed by flow cytometry) correlates with clinical response to IMGN632. (All Cohorts) IV.
To determine the cumulative incidence of left ventricular systolic dysfunction (LVSD),
defined as an absolute decline in EF by >= 10% to an ejection fraction (EF) value of < 50%,
or an absolute decline in shortening fraction (SF) by >= 4% to an SF value of < 25%, within 1
year of initiation of DAUNOrubicin and cytarabine liposome based therapy for relapsed
pediatric AML.

V. To describe safety (adverse events) in pediatric leukemia patients treated with IMGN632
including long-term safety events related to treatment for up to 5 years. (All Cohorts)

OUTLINE: This is a phase I, dose-escalation study of IMGN632 followed by a phase II study. In
phase I, patients with second or greater relapse or refractory relapsed disease of AML,
B-ALL, T-ALL or MPAL with CD123 expression are assigned to Cohort I, while patients with
CD123 positive AML in first relapse are assigned to Cohort II. In phase II, patients with
first relapse of CD123 positive AML are assigned to Cohort III.

COHORT 1: Patients receive IMGN632 intravenously (IV) on days 1 and 22. Treatment repeats
every 42 days for up to 6 cycles in the absence of disease progression or unacceptable
toxicity.

COHORT 2:

CYCLE 1: Patients receive IMGN632 IV on days 1 and 22 and liposome-encapsulated
daunorubicin-cytarabine (CPX-351) IV over 90 minutes on days 1, 3, and 5 in the absence of
disease progression or unacceptable toxicity. Patients with CNS1 also receive intrathecal
triple therapy (ITT) consisting of methotrexate intrathecally (IT), hydrocortisone or
prednisolone IT, and cytarabine IT on day 0 of cycle 1 (NOTE: Patients who received IT
cytarabine or ITT at time of diagnostic lumbar puncture [LP] do not need to repeat ITT on day
0 if given within 7 days of starting protocol therapy). Patients with CNS2 receive ITT once
weekly (QW) until the cerebrospinal fluid (CSF) is clear for a maximum of 6 ITT treatments in
the absence of disease progression or unacceptable toxicity.

CYCLE 2: Patients receive ITT on day 0, IMGN632 IV on days 1 and 22, fludarabine IV over 30
minutes once daily (QD) on days 1-5, and cytarabine IV over 1-3 hours QD on days 1-5 in the
absence of disease progression or unacceptable toxicity.

COHORT 3: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5 of cycle 1 in the
absence of disease progression or unacceptable toxicity. Patients then receive fludarabine IV
over 30 minutes QD on days 1-5 of cycle 2 and cytarabine IV over 1-3 hours QD on days 1-5 of
cycle 2 in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5 of cycle 1 and IMGN632
IV on days 1 and 22 of cycle 1 in the absence of disease progression or unacceptable
toxicity. Patients then receive fludarabine IV over 30 minutes QD on days 1-5 of cycle 2,
cytarabine IV over 1-3 hours QD on days 1-5 of cycle 2, and IMGN632 IV on days 1 and 22 of
cycle 2 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for the first year,
twice a year for year two and yearly visits until five years from enrollment.
</textblock>
</detailed_description>
<overall_status>Withdrawn</overall_status>
<why_stopped>
Withdrawn per CS0150757
</why_stopped>
<start_date type="Anticipated">August 1, 2023</start_date>
<completion_date type="Anticipated">September 1, 2023</completion_date>
<primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
<phase>Phase 1/Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Sequential Assignment</intervention_model>
<intervention_model_description>Phase I non-randomized study followed by a phase II randomized study</intervention_model_description>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Recommended phase 2 dose (RP2D) of IMGN632 monotherapy (Cohort 1)</measure>
<time_frame>During cycle 1 (Each cycle = 42 days)</time_frame>
<description>Dose limiting toxicities (DLTs) during cycle 1 will be evaluated using a rolling 6 design.</description>
</primary_outcome>
<primary_outcome>
<measure>Flow-based overall response rate (ORR) (Cohort 1)</measure>
<time_frame>During cycle 1 (Each cycle = 42 days)</time_frame>
<description>ORR defined as complete remission (CR)/CR with incomplete blood count recovery (CRi)/CR with partial recovery of platelet count (CRp).</description>
</primary_outcome>
<primary_outcome>
<measure>RP2D of combination therapy (Cohort 2)</measure>
<time_frame>During cycle 1 (Each cycle = 42 days)</time_frame>
<description>Dose limiting toxicities (DLTs) during cycle 1 combination of DAUNOrubicin and cytarabine liposome and IMGN632 will be evaluated using a rolling 6 design.</description>
</primary_outcome>
<primary_outcome>
<measure>Minimal residual disease (MRD) negative flow-based ORR (Cohort 3)</measure>
<time_frame>Up to two cycles of IMGN632 with chemotherapy (Each cycle = 42 days)</time_frame>
<description>Eligible patients will be assessed for MRD negative responses at the end of each cycle of therapy and compared for those receiving therapy including DAUNOrubicin and cytarabine liposome with or without IMGN632. Responders versus non-responders will be classified based on response after up to 2 cycles with a response definition of < 0.01% abnormal blasts by central flow cytometry in a cellular bone marrow. Fisher's Exact test will be used to compare the MRD negative response rate after up to 2 cycles (DAUNOrubicin and cytarabine liposome treatment) followed by fludarabine/cytarabine in pediatric patients with first relapse of acute myeloid leukemia randomized to treatment with or without IMGN632.</description>
</primary_outcome>
<secondary_outcome>
<measure>Area under the plasma concentration versus time curve (AUC) of IMGN632</measure>
<time_frame>Cycles 1 & 2</time_frame>
<description>Non-compartmental methods will be used to estimate the area under the plasma concentration versus time curve (AUC) of IMGN632.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Maximum serum concentration (Cmax) of IMGN632</measure>
<time_frame>Cycles 1 & 2</time_frame>
<description>Non-compartmental methods will be used to estimate the maximum serum concentration (Cmax) of IMGN632.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Volume of distribution at steady state (Vss) of IMGN632</measure>
<time_frame>Cycles 1 & 2</time_frame>
<description>Non-compartmental methods will be used to estimate the volume of distribution at steady state (Vss) of IMGN632.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Half-life (t1/2) of IMGN632</measure>
<time_frame>Cycles 1 & 2</time_frame>
<description>Non-compartmental methods will be used to estimate the half-life (t1/2) of IMGN632.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Clearance (CL) of IMGN632</measure>
<time_frame>Cycles 1 & 2</time_frame>
<description>Non-compartmental methods will be used to estimate the clearance (CL) of IMGN632.</description>
</secondary_outcome>
<secondary_outcome>
<measure>Time to reach maximum serum concentration (Tmax) of IMGN632</measure>
<time_frame>Cycles 1 & 2</time_frame>
<description>Non-compartmental methods will be used to estimate the time to reach maximum serum concentration (Tmax) of IMGN632.</description>
</secondary_outcome>
<other_outcome>
<measure>Morphologic and flow-based CR/CRp/CRi of IMGN632 monotherapy (Cohort 1)</measure>
<time_frame>Up to 2 cycles (Each cycle = 42 days)</time_frame>
<description>Patients enrolled onto the monotherapy Phase 1 arm will be grouped by disease type (acute myeloid leukemia [AML], B-cell acute lymphoblastic leukemia [ALL], early thymic precursor [ETP] T-cell ALL and mixed phenotype acute leukemia [MPAL]) and the anti-leukemic activity of IMGN632 monotherapy will be described.</description>
</other_outcome>
<other_outcome>
<measure>Rates of MRD negative response of IMGN632 monotherapy (Cohort 1)</measure>
<time_frame>Up to 2 cycles (Each cycle = 42 days)</time_frame>
<description>Patients enrolled onto the monotherapy Phase 1 arm will be grouped by disease type (AML, B-cell ALL, ETP T-cell ALL and MPAL) and the anti-leukemic activity of IMGN632 monotherapy will be described.</description>
</other_outcome>
<other_outcome>
<measure>Event-free survival (EFS) of IMGN632 monotherapy (Cohort 1)</measure>
<time_frame>Up to 5 years</time_frame>
<description>Patients enrolled onto the monotherapy Phase 1 arm will be grouped by disease type (AML, B-cell ALL, ETP T-cell ALL and MPAL) and the anti-leukemic activity of IMGN632 monotherapy will be described.</description>
</other_outcome>
<other_outcome>
<measure>Overall survival (OS) of IMGN632 monotherapy (Cohort 1)</measure>
<time_frame>Up to 5 years</time_frame>
<description>Patients enrolled onto the monotherapy Phase 1 arm will be grouped by disease type (AML, B-cell ALL, ETP T-cell ALL and MPAL) and the anti-leukemic activity of IMGN632 monotherapy will be described.</description>
</other_outcome>
<other_outcome>
<measure>EFS for patients with first relapse of AML (Cohort 3)</measure>
<time_frame>Up to 5 years</time_frame>
</other_outcome>
<other_outcome>
<measure>OS for patients with first relapse of AML (Cohort 3)</measure>
<time_frame>Up to 5 years</time_frame>
</other_outcome>
<other_outcome>
<measure>Cumulative incidence of relapse for patients with first relapse of AML (Cohort 3)</measure>
<time_frame>Up to 5 years</time_frame>
</other_outcome>
<other_outcome>
<measure>Use of stem cell transplant after protocol therapy (Cohort 3)</measure>
<time_frame>Up to 5 years</time_frame>
<description>Will be collected and the rate of subsequent stem cell transplant will be described by treatment arm. This will include data regarding the conditioning regimen used, stem cell donor source and transplant related toxicities such as veno-occlusive disease.</description>
</other_outcome>
<other_outcome>
<measure>Incidence of adverse events (Cohort 3)</measure>
<time_frame>Up to 5 years</time_frame>
<description>Will be summarized by treatment arm for patients with first relapse of AML treated during the randomized Phase 2.</description>
</other_outcome>
<other_outcome>
<measure>CD123 expression</measure>
<time_frame>Up to 5 years</time_frame>
<description>CD123 expression on leukemic blasts will be analyzed at Hematologics, Inc. (Seattle, Washington [WA]) by multi-dimensional flow cytometry (MDF) utilizing a "difference from normal" flow cytometric technique. CD123 mean fluorescent intensity (MFI) will be quantified and converted to molecules per cell (MPC) using CD4 MFI on T cells as a reference. CD123 MPC will be assessed on bone marrow (or peripheral blood samples if bone marrow not available) at initial diagnosis and after cycle 1 of treatment for patients with first relapse of AML treated on the randomized phase 2 portion of this study. Outcomes, including OS, EFS, and MRD negative CR after cycle 1, will be correlated with CD123 MPC and compared between the groups of patients who did and did not receive the investigational therapy IMGN632 using Cox and logistic regression models.</description>
</other_outcome>
<other_outcome>
<measure>Cumulative incidence of left ventricular systolic dysfunction (LVSD)</measure>
<time_frame>Up to 1 year post AML relapse</time_frame>
<description>Will be estimated with subsequent relapse and death considered competing events. Cox regression will be used to estimate adjusted hazard ratio (HR) comparing EFS and OS in patients with LVSD relative to patients with no LVSD. LVSD will be treated as a time-varying exposure introduced on the first occurrence during/ following salvage therapy. HRs will be determined separately for infection-associated or not infection-associated events. Exploratory analyses will be performed to assess the differential impact of infection vs. non-infection associated LVSD on survival.</description>
</other_outcome>
<other_outcome>
<measure>Incidence of adverse events (All Cohorts)</measure>
<time_frame>Up to 5 years</time_frame>
<description>Will be described by summarizing adverse events reported for patients on protocol therapy. Long-term safety will include assessment and summary of the following: all toxicities reported (including any death that can be attributed possibly, probably, or definitely to protocol therapy and is not due to cancer recurrence and any secondary malignancy that can be attributed possibly, probably, or definitely to protocol therapy), all Grade 5 events regardless of attribution, all grades of sinusoidal obstructive syndrome (SOS)/veno-occlusive disease (VOD) and Grade 3 or greater of the cardiac toxicities ventricular arrhythmia and left ventricular systolic dysfunction.</description>
</other_outcome>
<number_of_arms>4</number_of_arms>
<enrollment type="Actual">0</enrollment>
<condition>Recurrent Acute Myeloid Leukemia</condition>
<condition>Recurrent B Acute Lymphoblastic Leukemia</condition>
<condition>Recurrent Mixed Phenotype Acute Leukemia</condition>
<condition>Recurrent T Acute Lymphoblastic Leukemia</condition>
<condition>Refractory Acute Myeloid Leukemia</condition>
<condition>Refractory B Acute Lymphoblastic Leukemia</condition>
<condition>Refractory Mixed Phenotype Acute Leukemia</condition>
<condition>Refractory T Acute Lymphoblastic Leukemia</condition>
<arm_group>
<arm_group_label>Cohort 1 (IMGN632)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients receive IMGN632 IV on days 1 and 22. Treatment repeats every 42 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.</description>
</arm_group>
<arm_group>
<arm_group_label>Cohort 2 (IMGN632, CPX-351, ITT, fludarabine, cytarabine)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>CYCLE 1: Patients receive IMGN632 IV on days 1 and 22 and CPX-351 IV over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. Patients with CNS1 also receive ITT consisting of methotrexate IT, hydrocortisone or prednisolone IT, and cytarabine IT on day 0 of cycle 1 (NOTE: Patients who received IT cytarabine or ITT at time of diagnostic LP do not need to repeat ITT on day 0 if given within 7 days of starting protocol therapy). Patients with CNS2 receive ITT QW until the CSF is clear for a maximum of 6 ITT treatments in the absence of disease progression or unacceptable toxicity.
CYCLE 2: Patients receive ITT on day 0, IMGN632 IV on days 1 and 22, fludarabine IV over 30 minutes QD on days 1-5, and cytarabine IV over 1-3 hours QD on days 1-5 in the absence of disease progression or unacceptable toxicity.</description>
</arm_group>
<arm_group>
<arm_group_label>Cohort 3, Arm A (CPX-351, fludarabine, cytarabine)</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5 of cycle 1 in the absence of disease progression or unacceptable toxicity. Patients then receive fludarabine IV over 30 minutes QD on days 1-5 of cycle 2 and cytarabine IV over 1-3 hours QD on days 1-5 of cycle 2 in the absence of disease progression or unacceptable toxicity.</description>
</arm_group>
<arm_group>
<arm_group_label>Cohort 3, Arm B (CPX-351, fludarabine, cytarabine, IMGN632)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5 of cycle 1 and IMGN632 IV on days 1 and 22 of cycle 1 in the absence of disease progression or unacceptable toxicity. Patients then receive fludarabine IV over 30 minutes QD on days 1-5 of cycle 2, cytarabine IV over 1-3 hours QD on days 1-5 of cycle 2, and IMGN632 IV on days 1 and 22 of cycle 2 in the absence of disease progression or unacceptable toxicity.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Anti-CD123 ADC IMGN632</intervention_name>
<description>Given IV</description>
<arm_group_label>Cohort 1 (IMGN632)</arm_group_label>
<arm_group_label>Cohort 2 (IMGN632, CPX-351, ITT, fludarabine, cytarabine)</arm_group_label>
<arm_group_label>Cohort 3, Arm B (CPX-351, fludarabine, cytarabine, IMGN632)</arm_group_label>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Bone Marrow Aspiration and Biopsy</intervention_name>
<description>Undergo bone marrow aspiration/biopsy</description>
<arm_group_label>Cohort 2 (IMGN632, CPX-351, ITT, fludarabine, cytarabine)</arm_group_label>
<arm_group_label>Cohort 3, Arm B (CPX-351, fludarabine, cytarabine, IMGN632)</arm_group_label>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Cytarabine</intervention_name>
<description>Given IT and IV</description>
<arm_group_label>Cohort 2 (IMGN632, CPX-351, ITT, fludarabine, cytarabine)</arm_group_label>
<arm_group_label>Cohort 3, Arm A (CPX-351, fludarabine, cytarabine)</arm_group_label>
<arm_group_label>Cohort 3, Arm B (CPX-351, fludarabine, cytarabine, IMGN632)</arm_group_label>
<other_name>.beta.-Cytosine arabinoside</other_name>
<other_name>1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone</other_name>
<other_name>1-.beta.-D-Arabinofuranosylcytosine</other_name>
<other_name>1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone</other_name>
<other_name>1-Beta-D-arabinofuranosylcytosine</other_name>
<other_name>1.beta.-D-Arabinofuranosylcytosine</other_name>
<other_name>2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-</other_name>
<other_name>2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-</other_name>
<other_name>Alexan</other_name>
<other_name>Ara-C</other_name>
<other_name>ARA-cell</other_name>
<other_name>Arabine</other_name>
<other_name>Arabinofuranosylcytosine</other_name>
<other_name>Arabinosylcytosine</other_name>
<other_name>Aracytidine</other_name>
<other_name>Aracytin</other_name>
<other_name>Aracytine</other_name>
<other_name>Beta-Cytosine Arabinoside</other_name>
<other_name>CHX-3311</other_name>
<other_name>Cytarabinum</other_name>
<other_name>Cytarbel</other_name>
<other_name>Cytosar</other_name>
<other_name>Cytosine Arabinoside</other_name>
<other_name>Cytosine-.beta.-arabinoside</other_name>
<other_name>Cytosine-beta-arabinoside</other_name>
<other_name>Erpalfa</other_name>
<other_name>Starasid</other_name>
<other_name>Tarabine PFS</other_name>
<other_name>U 19920</other_name>
<other_name>U-19920</other_name>
<other_name>Udicil</other_name>
<other_name>WR-28453</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Fludarabine Phosphate</intervention_name>
<description>Given IV</description>
<arm_group_label>Cohort 2 (IMGN632, CPX-351, ITT, fludarabine, cytarabine)</arm_group_label>
<arm_group_label>Cohort 3, Arm A (CPX-351, fludarabine, cytarabine)</arm_group_label>
<arm_group_label>Cohort 3, Arm B (CPX-351, fludarabine, cytarabine, IMGN632)</arm_group_label>
<other_name>2-F-ara-AMP</other_name>
<other_name>9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-</other_name>
<other_name>Beneflur</other_name>
<other_name>Fludara</other_name>
<other_name>SH T 586</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Hydrocortisone Sodium Succinate</intervention_name>
<description>Given IT</description>
<arm_group_label>Cohort 2 (IMGN632, CPX-351, ITT, fludarabine, cytarabine)</arm_group_label>
<other_name>(11beta)-21-(3-Carboxy-1-oxopropyl)-11,17-dihydroxypregn-4-ene-3,20-dione, Monosodium Salt</other_name>
<other_name>A-Hydrocort</other_name>
<other_name>Buccalsone</other_name>
<other_name>Corlan</other_name>
<other_name>Cortisol Sodium Succinate</other_name>
<other_name>Cortop</other_name>
<other_name>Efcortelan</other_name>
<other_name>Emergent-EZ</other_name>
<other_name>Flebocortid</other_name>
<other_name>Hidroc Clora</other_name>
<other_name>Hycorace</other_name>
<other_name>Hydro-Adreson</other_name>
<other_name>Hydrocort</other_name>
<other_name>Hydrocortisone 21-Sodium Succinate</other_name>
<other_name>Hydrocortisone Na Succinate</other_name>
<other_name>Kinogen</other_name>
<other_name>Nordicort</other_name>
<other_name>Nositrol</other_name>
<other_name>Sinsurrene</other_name>
<other_name>Sodium hydrocortisone succinate</other_name>
<other_name>Solu-Cortef</other_name>
<other_name>Solu-Glyc</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Liposome-encapsulated Daunorubicin-Cytarabine</intervention_name>
<description>Given IV</description>
<arm_group_label>Cohort 2 (IMGN632, CPX-351, ITT, fludarabine, cytarabine)</arm_group_label>
<arm_group_label>Cohort 3, Arm A (CPX-351, fludarabine, cytarabine)</arm_group_label>
<arm_group_label>Cohort 3, Arm B (CPX-351, fludarabine, cytarabine, IMGN632)</arm_group_label>
<other_name>CPX-351</other_name>
<other_name>Cytarabine-Daunorubicin Liposome for Injection</other_name>
<other_name>Daunorubicin and Cytarabine (Liposomal)</other_name>
<other_name>Liposomal AraC-Daunorubicin CPX-351</other_name>
<other_name>Liposomal Cytarabine-Daunorubicin</other_name>
<other_name>Liposome-encapsulated Combination of Daunorubicin and Cytarabine</other_name>
<other_name>Vyxeos</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Methotrexate</intervention_name>
<description>Given IT</description>
<arm_group_label>Cohort 2 (IMGN632, CPX-351, ITT, fludarabine, cytarabine)</arm_group_label>
<other_name>Abitrexate</other_name>
<other_name>Alpha-Methopterin</other_name>
<other_name>Amethopterin</other_name>
<other_name>Brimexate</other_name>
<other_name>CL 14377</other_name>
<other_name>CL-14377</other_name>
<other_name>Emtexate</other_name>
<other_name>Emthexat</other_name>
<other_name>Emthexate</other_name>
<other_name>Farmitrexat</other_name>
<other_name>Fauldexato</other_name>
<other_name>Folex</other_name>
<other_name>Folex PFS</other_name>
<other_name>Lantarel</other_name>
<other_name>Ledertrexate</other_name>
<other_name>Lumexon</other_name>
<other_name>Maxtrex</other_name>
<other_name>Medsatrexate</other_name>
<other_name>Metex</other_name>
<other_name>Methoblastin</other_name>
<other_name>Methotrexate LPF</other_name>
<other_name>Methotrexate Methylaminopterin</other_name>
<other_name>Methotrexatum</other_name>
<other_name>Metotrexato</other_name>
<other_name>Metrotex</other_name>
<other_name>Mexate</other_name>
<other_name>Mexate-AQ</other_name>
<other_name>MTX</other_name>
<other_name>Novatrex</other_name>
<other_name>Rheumatrex</other_name>
<other_name>Texate</other_name>
<other_name>Tremetex</other_name>
<other_name>Trexeron</other_name>
<other_name>Trixilem</other_name>
<other_name>WR-19039</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Prednisolone</intervention_name>
<description>Given IT</description>
<arm_group_label>Cohort 2 (IMGN632, CPX-351, ITT, fludarabine, cytarabine)</arm_group_label>
<other_name>(11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione</other_name>
<other_name>.delta.1-Hydrocortisone</other_name>
<other_name>Adnisolone</other_name>
<other_name>Aprednislon</other_name>
<other_name>Capsoid</other_name>
<other_name>Cortalone</other_name>
<other_name>Cortisolone</other_name>
<other_name>Dacortin H</other_name>
<other_name>Decaprednil</other_name>
<other_name>Decortin H</other_name>
<other_name>Delta(1)Hydrocortisone</other_name>
<other_name>Delta- Cortef</other_name>
<other_name>Delta-Cortef</other_name>
<other_name>Delta-Diona</other_name>
<other_name>Delta-F</other_name>
<other_name>Delta-Phoricol</other_name>
<other_name>Delta1-dehydro-hydrocortisone</other_name>
<other_name>Deltacortril</other_name>
<other_name>Deltahydrocortisone</other_name>
<other_name>Deltasolone</other_name>
<other_name>Deltidrosol</other_name>
<other_name>Dhasolone</other_name>
<other_name>Di-Adreson-F</other_name>
<other_name>Dontisolon D</other_name>
<other_name>Estilsona</other_name>
<other_name>Fisopred</other_name>
<other_name>Frisolona</other_name>
<other_name>Gupisone</other_name>
<other_name>Hostacortin H</other_name>
<other_name>Hydeltra</other_name>
<other_name>Hydeltrasol</other_name>
<other_name>Klismacort</other_name>
<other_name>Kuhlprednon</other_name>
<other_name>Lenisolone</other_name>
<other_name>Lepi-Cortinolo</other_name>
<other_name>Linola-H N</other_name>
<other_name>Linola-H-Fett N</other_name>
<other_name>Longiprednil</other_name>
<other_name>Metacortandralone</other_name>
<other_name>Meti Derm</other_name>
<other_name>Meticortelone</other_name>
<other_name>Opredsone</other_name>
<other_name>Panafcortelone</other_name>
<other_name>Precortisyl</other_name>
<other_name>Pred-Clysma</other_name>
<other_name>Predeltilone</other_name>
<other_name>Predni-Coelin</other_name>
<other_name>Predni-Helvacort</other_name>
<other_name>Prednicortelone</other_name>
<other_name>Prednisolonum</other_name>
<other_name>Prelone</other_name>
<other_name>Prenilone</other_name>
<other_name>Sterane</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Patients from Children's Oncology Group (COG) sites must be enrolled on APAL2020SC

- Patients must be >= 12 months and less than 22 years of age at the time of study
enrollment

- Patient's weight at time of enrollment must be >= 10 kg

- Patients must meet the eligibility in the appropriate Cohort for their diagnosis and
disease status

- Cohort 1 (Phase 1 Monotherapy):

- Patients must meet all the following criteria:

- Patient must have bone marrow sample showing >= 5% leukemic blasts by
flow cytometry

- Patient must have been diagnosed with AML, B-ALL, T-ALL, or mixed
phenotype acute leukemia (MPAL) meeting one of the following disease
criteria:

- Second or greater relapse OR

- Disease that is refractory to relapse therapy

- Refractory to relapse therapy is defined as persistent
disease after at least one cycle of induction chemotherapy to
treat the relapse disease

- Patient must have leukemic blasts that are CD123-positive by flow
cytometry as determined either by the treating institution or through
reference laboratory testing.

- Cohort 2 (Combination Dose Finding) and Cohort 3 (Randomized Phase 2
Combination):

- Patients must meet all the following criteria:

- Patient must have AML in first relapse with a bone marrow sample
showing >= 1% leukemic blasts by flow cytometry

- Patient must have leukemic blasts that are CD123-positive by flow
cytometry as determined either by the treating institution or through
reference laboratory testing

- For Cohort 3 only: Patient's AML is not treatment related

- Central nervous system (CNS) disease - All Cohorts

- Patients may have status of CNS1, CNS2, CNS3 disease without clinical signs
or neurologic symptoms suggestive of CNS leukemia, such as facial nerve
palsy, brain/eye involvement or hypothalamic syndrome

- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1 or 2 (>= 50% Lansky or Karnofsky score). Use Karnofsky for
patients > 16 years of age and Lansky for patients =< 16 years of age. Patients who
are unable to walk because of paralysis, but who are up in a wheelchair, will be
considered ambulatory for the purpose of assessing the performance score

- Patients must have fully recovered from the acute toxic effects of all prior
anti-cancer therapy and must meet the following minimum duration from prior
anti-cancer directed therapy prior to enrollment. Please refer to the table of
myelosuppressive/Anticancer Agents on the COG website:
https://www.cogmembers.org/uploadedFiles/Site/Disc/DVL/Documents/TableOfMyelosuppressi
veAnti-CancerAgents.pdf. For agents not listed, the duration of this interval must be
discussed with the study chair and the study-assigned Research Coordinator prior to
enrollment.

- Cytotoxic chemotherapy: Must not have received within 14 days of entry onto this
study, except for hydroxyurea or corticosteroids

- NOTE: Cytoreduction with hydroxyurea or corticosteroids must be discontinued
prior to the start of protocol therapy. Use of steroids for other purposes
such as premedication to prevent allergic reaction or during anesthesia is
allowed

- Intrathecal cytotoxic therapy

- No waiting period is required for patients having received any combination
of intrathecal cytarabine, methotrexate, and/or hydrocortisone

- Antibodies: >= 21 days must have elapsed from infusion of last dose of an
antibody-drug conjugate. For unmodified antibodies or T cell engaging antibodies,
2 half-lives must have elapsed before enrollment. Any toxicity related to prior
antibody therapy must be recovered to Grade =< 1

- Interleukins, interferons and cytokines (other than hematopoietic growth
factors): >= 21 days after the completion of interleukins, interferon or
cytokines (other than hematopoietic growth factors)

- Hematopoietic growth factors: >= 14 days after the last dose of a long-acting
growth factor (e.g., pegfilgrastim) or 7 days for short acting growth factor

- Radiation therapy (RT):

- 14 days have elapsed for local palliative RT (small port);

- >= 84 days must have elapsed if prior craniospinal RT or if >= 50% radiation
of pelvis;

- >= 42 days must have elapsed if other substantial bone marrow (BM) radiation

- For combination therapy arms: Patients must have received =< 13.6 Gy prior
radiation to the mediastinum

- Stem cell infusions:

- >= 84 days since allogeneic (non-autologous) bone marrow or stem cell
transplant (with or without total body irradiation [TBI]) or boost infusion
(any stem cell product; not including donor lymphocyte infusion [DLI])

- No evidence of graft versus host disease (GVHD)

- Patients must be off medications to treat or prevent either
graft-versus-host disease post bone marrow transplant or organ rejection
post-transplant for at least 14 days prior to start of protocol treatment

- Cellular therapy: >= 42 days after the completion of DLI (donor lymphocyte
infusion) or any type of cellular therapy (e.g., modified T cells, natural killer
[NK] cells, dendritic cells, etc.)

- Ejection fraction (EF) of >= 55% or if EF unavailable, shortening fraction (SF) >= 28%
by echocardiogram (within 21 days prior to enrollment and start of protocol therapy
[repeat if necessary]) AND

- Corrected QTc interval < 500 msec (within 7 days prior to enrollment)

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows (within 7 days
prior to enrollment):

- 1 to < 2 years (age); 0.6 mg/dL (male) 0.6 mg/dL (female)

- 2 to < 6 years (age); 0.8 mg/dL (male) 0.8 mg/dL (female)

- 6 to < 10 years (age); 1 mg/dL (male) 1 mg/dL (female)

- 10 to < 13 years (age); 1.2 mg/dL (male) 1.2 mg/dL (female)

- 13 to < 16 years (age); 1.5 mg/dL (male) 1.4 mg/dL (female)

- >= 16 years (age); 1.7 mg/dL (male) 1.4 mg/dL (female)

- Direct bilirubin < 2 mg/dL (< 34 umol/L), (within 7 days prior to enrollment) AND

- Serum glutamate pyruvate transaminase SGPT (alanine aminotransferase [ALT]) =< 135 U/L
(within 7 days prior to enrollment)

- If liver abnormality is due to leukemia infiltrate, the patient will remain
eligible

Exclusion Criteria:

- Plans to administer any type of non-protocol prescribed anti-cancer therapy while on
protocol directed therapy. For Cohort 1, additional intrathecal therapy is allowed per
treating physician's discretion

- Strong inducers or inhibitors of CYP2D6 or CYP3A4 are prohibited for 7 days prior to
the 1st dose of IMGN632 to the end of the treatment for both the Phase 1 Monotherapy
Dose Finding and pharmacokinetic (PK) and the Combination Dose Finding components of
the study. For patients not enrolled in a dose finding portion of the study,
concomitant therapy with strong inducers or inhibitors of CYP2D6 or CYP3A4 is STRONGLY
discouraged but not prohibited if clinically indicated

- Patients with acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia
(JMML)

- Patients with Down syndrome

- Patients with isolated extramedullary disease or those with minimal bone marrow
disease not meeting the definition of relapsed or relapse refractory as defined above

- Patients with a prior history of Grade 4 VOD/SOS (veno-occlusive disease/sinusoidal
obstructive syndrome) or any history of Grade 3 VOD/SOS that, at the discretion of the
treating physician, places the patient at unacceptably high risk for future severe
VOD/SOS

- Patients who are currently receiving another investigational drug

- Patients receiving medications for treatment of left ventricular systolic dysfunction

- Patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known
congenital bone marrow failure syndrome

- Patients with known prior allergy to any of the medications used in protocol therapy

- Patients with documented active, uncontrolled infection at the time of study entry

- Patients with history of Wilson's disease or other copper-related disorder

- Pregnancy and breastfeeding:

- Female patients who are pregnant since fetal toxicities and teratogenic effects
have been noted for several of the study drugs. A pregnancy test is required for
female patients of childbearing potential

- Lactating females who plan to breastfeed their infants

- Sexually active patients of reproductive potential (male and female) who have not
agreed to use an effective contraceptive method or abstinence for the duration of
their study participation and for 12 weeks after the last dose of IMGN632 or 6
months after last dose of DAUNOrubicin and cytarabine liposome, whichever is
longer

- Regulatory requirements

- All patients and/or their parents or legal guardians must sign a written informed
consent

- All institutional, Food and Drug Administration (FDA), and National Cancer
Institute (NCI) requirements for human studies must be met
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>12 Months</minimum_age>
<maximum_age>22 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Matthew A Kutny</last_name>
<role>Principal Investigator</role>
<affiliation>Children's Oncology Group</affiliation>
</overall_official>
<verification_date>February 2023</verification_date>
<study_first_submitted>March 22, 2022</study_first_submitted>
<study_first_submitted_qc>April 1, 2022</study_first_submitted_qc>
<study_first_posted type="Actual">April 11, 2022</study_first_posted>
<last_update_submitted>August 29, 2023</last_update_submitted>
<last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">September 1, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Leukemia</mesh_term>
<mesh_term>Leukemia, Myeloid</mesh_term>
<mesh_term>Leukemia, Myeloid, Acute</mesh_term>
<mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
<mesh_term>Leukemia, Lymphoid</mesh_term>
<mesh_term>Precursor T-Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
<mesh_term>Recurrence</mesh_term>
<mesh_term>Acute Disease</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cytarabine</mesh_term>
<mesh_term>Prednisolone</mesh_term>
<mesh_term>Methylprednisolone Acetate</mesh_term>
<mesh_term>Methylprednisolone</mesh_term>
<mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
<mesh_term>Prednisolone acetate</mesh_term>
<mesh_term>Hydrocortisone</mesh_term>
<mesh_term>Hydrocortisone 17-butyrate 21-propionate</mesh_term>
<mesh_term>Hydrocortisone acetate</mesh_term>
<mesh_term>Hydrocortisone hemisuccinate</mesh_term>
<mesh_term>Cortisone</mesh_term>
<mesh_term>Methotrexate</mesh_term>
<mesh_term>Fludarabine phosphate</mesh_term>
<mesh_term>Fludarabine</mesh_term>
<mesh_term>Daunorubicin</mesh_term>
<mesh_term>Prednisolone hemisuccinate</mesh_term>
<mesh_term>Prednisolone phosphate</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
This phase I/II trial finds the highest safe dose of IMGN632 that can be given with other
chemotherapy without causing severe side effects, studies what kind of side effects IMGN632
may cause, and determines whether IMGN632 is a beneficial treatment for leukemia in children
that has come back after treatment or is difficult to treat. IMGN632 is a monoclonal antibody
linked to a chemotherapy drug. IMGN632 is a form of targeted therapy because it attaches to
specific molecules (receptors) on the surface of cancer cells, known as CD123 receptors, and
delivers the chemotherapy drug to kill them. Giving IMGN632 with other chemotherapy may cause
the leukemia to stop growing or to shrink for a period of time.
PRIMARY OBJECTIVES:
I. To determine the recommended phase 2 dose (RP2D) of anti-CD123 ADC IMGN632 (IMGN632)
monotherapy in pediatric patients with second or greater relapse of CD123 positive leukemia
or CD123 positive leukemia refractory to relapse therapy. (Cohort 1 [Monotherapy Phase 1])
II. To assess the flow-based overall response rate (complete remission [CR]/CR with
incomplete blood count recovery [CRi]/CR with partial recovery of platelet count [CRp]) in
patients with acute myeloid leukemia (AML) treated with IMGN632. (Cohort 1 [Monotherapy Phase
1]) III. To determine the safety, feasibility, and RP2D of IMGN632 in combination with
liposome-encapsulated daunorubicin-cytarabine (DAUNOrubicin and cytarabine liposome) in
pediatric patients with first relapse of CD123 positive AML. (Cohort 2 [Combination Therapy
Dose Finding]) IV. To compare the minimal residual disease (MRD) negative flow-based overall
response rate (CR/CRi/CRp) in pediatric patients with first relapse of CD123 positive AML
randomized to two cycles of therapy including DAUNOrubicin and cytarabine liposome followed
by fludarabine phosphate (fludarabine)/cytarabine with or without IMGN632. (Cohort 3
[Randomized Phase 2])
SECONDARY OBJECTIVE:
I. To characterize the pharmacokinetics of IMGN632 in a pediatric population. (Cohort 1
[Monotherapy Phase 1])
EXPLORATORY OBJECTIVES:
I. To describe the anti-leukemic activity (morphologic and flow-based CR/CRp/CRi after up to
two cycles, rates of MRD negative response after up to 2 cycles, event free survival [EFS]
and overall survival [OS]) of IMGN632 in patients with multiply relapsed or refractory
relapsed pediatric leukemia including AML, B-cell acute lymphoblastic leukemia [ALL], T-cell
ALL and mixed phenotype acute leukemia (MPAL). (Cohort 1) II. To describe the EFS, OS,
cumulative incidence of relapse, and rate of subsequent stem cell transplant for patients
with first relapse of AML randomized to treatment with up to two cycles of chemotherapy with
or without IMGN632. (Cohort 3) III. To determine if CD123 expression on leukemic blasts
(assessed by flow cytometry) correlates with clinical response to IMGN632. (All Cohorts) IV.
To determine the cumulative incidence of left ventricular systolic dysfunction (LVSD),
defined as an absolute decline in EF by >= 10% to an ejection fraction (EF) value of < 50%,
or an absolute decline in shortening fraction (SF) by >= 4% to an SF value of < 25%, within 1
year of initiation of DAUNOrubicin and cytarabine liposome based therapy for relapsed
pediatric AML.
V. To describe safety (adverse events) in pediatric leukemia patients treated with IMGN632
including long-term safety events related to treatment for up to 5 years. (All Cohorts)
OUTLINE: This is a phase I, dose-escalation study of IMGN632 followed by a phase II study. In
phase I, patients with second or greater relapse or refractory relapsed disease of AML,
B-ALL, T-ALL or MPAL with CD123 expression are assigned to Cohort I, while patients with
CD123 positive AML in first relapse are assigned to Cohort II. In phase II, patients with
first relapse of CD123 positive AML are assigned to Cohort III.
COHORT 1: Patients receive IMGN632 intravenously (IV) on days 1 and 22. Treatment repeats
every 42 days for up to 6 cycles in the absence of disease progression or unacceptable
toxicity.
COHORT 2:
CYCLE 1: Patients receive IMGN632 IV on days 1 and 22 and liposome-encapsulated
daunorubicin-cytarabine (CPX-351) IV over 90 minutes on days 1, 3, and 5 in the absence of
disease progression or unacceptable toxicity. Patients with CNS1 also receive intrathecal
triple therapy (ITT) consisting of methotrexate intrathecally (IT), hydrocortisone or
prednisolone IT, and cytarabine IT on day 0 of cycle 1 (NOTE: Patients who received IT
cytarabine or ITT at time of diagnostic lumbar puncture [LP] do not need to repeat ITT on day
0 if given within 7 days of starting protocol therapy). Patients with CNS2 receive ITT once
weekly (QW) until the cerebrospinal fluid (CSF) is clear for a maximum of 6 ITT treatments in
the absence of disease progression or unacceptable toxicity.
CYCLE 2: Patients receive ITT on day 0, IMGN632 IV on days 1 and 22, fludarabine IV over 30
minutes once daily (QD) on days 1-5, and cytarabine IV over 1-3 hours QD on days 1-5 in the
absence of disease progression or unacceptable toxicity.
COHORT 3: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5 of cycle 1 in the
absence of disease progression or unacceptable toxicity. Patients then receive fludarabine IV
over 30 minutes QD on days 1-5 of cycle 2 and cytarabine IV over 1-3 hours QD on days 1-5 of
cycle 2 in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5 of cycle 1 and IMGN632
IV on days 1 and 22 of cycle 1 in the absence of disease progression or unacceptable
toxicity. Patients then receive fludarabine IV over 30 minutes QD on days 1-5 of cycle 2,
cytarabine IV over 1-3 hours QD on days 1-5 of cycle 2, and IMGN632 IV on days 1 and 22 of
cycle 2 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for the first year,
twice a year for year two and yearly visits until five years from enrollment.
Inclusion Criteria:
- Patients from Children's Oncology Group (COG) sites must be enrolled on APAL2020SC
- Patients must be >= 12 months and less than 22 years of age at the time of study
enrollment
- Patient's weight at time of enrollment must be >= 10 kg
- Patients must meet the eligibility in the appropriate Cohort for their diagnosis and
disease status
- Cohort 1 (Phase 1 Monotherapy):
- Patients must meet all the following criteria:
- Patient must have bone marrow sample showing >= 5% leukemic blasts by
flow cytometry
- Patient must have been diagnosed with AML, B-ALL, T-ALL, or mixed
phenotype acute leukemia (MPAL) meeting one of the following disease
criteria:
- Second or greater relapse OR
- Disease that is refractory to relapse therapy
- Refractory to relapse therapy is defined as persistent
disease after at least one cycle of induction chemotherapy to
treat the relapse disease
- Patient must have leukemic blasts that are CD123-positive by flow
cytometry as determined either by the treating institution or through
reference laboratory testing.
- Cohort 2 (Combination Dose Finding) and Cohort 3 (Randomized Phase 2
Combination):
- Patients must meet all the following criteria:
- Patient must have AML in first relapse with a bone marrow sample
showing >= 1% leukemic blasts by flow cytometry
- Patient must have leukemic blasts that are CD123-positive by flow
cytometry as determined either by the treating institution or through
reference laboratory testing
- For Cohort 3 only: Patient's AML is not treatment related
- Central nervous system (CNS) disease - All Cohorts
- Patients may have status of CNS1, CNS2, CNS3 disease without clinical signs
or neurologic symptoms suggestive of CNS leukemia, such as facial nerve
palsy, brain/eye involvement or hypothalamic syndrome
- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1 or 2 (>= 50% Lansky or Karnofsky score). Use Karnofsky for
patients > 16 years of age and Lansky for patients =< 16 years of age. Patients who
are unable to walk because of paralysis, but who are up in a wheelchair, will be
considered ambulatory for the purpose of assessing the performance score
- Patients must have fully recovered from the acute toxic effects of all prior
anti-cancer therapy and must meet the following minimum duration from prior
anti-cancer directed therapy prior to enrollment. Please refer to the table of
myelosuppressive/Anticancer Agents on the COG website:
https://www.cogmembers.org/uploadedFiles/Site/Disc/DVL/Documents/TableOfMyelosuppressi
veAnti-CancerAgents.pdf. For agents not listed, the duration of this interval must be
discussed with the study chair and the study-assigned Research Coordinator prior to
enrollment.
- Cytotoxic chemotherapy: Must not have received within 14 days of entry onto this
study, except for hydroxyurea or corticosteroids
- NOTE: Cytoreduction with hydroxyurea or corticosteroids must be discontinued
prior to the start of protocol therapy. Use of steroids for other purposes
such as premedication to prevent allergic reaction or during anesthesia is
allowed
- Intrathecal cytotoxic therapy
- No waiting period is required for patients having received any combination
of intrathecal cytarabine, methotrexate, and/or hydrocortisone
- Antibodies: >= 21 days must have elapsed from infusion of last dose of an
antibody-drug conjugate. For unmodified antibodies or T cell engaging antibodies,
2 half-lives must have elapsed before enrollment. Any toxicity related to prior
antibody therapy must be recovered to Grade =< 1
- Interleukins, interferons and cytokines (other than hematopoietic growth
factors): >= 21 days after the completion of interleukins, interferon or
cytokines (other than hematopoietic growth factors)
- Hematopoietic growth factors: >= 14 days after the last dose of a long-acting
growth factor (e.g., pegfilgrastim) or 7 days for short acting growth factor
- Radiation therapy (RT):
- 14 days have elapsed for local palliative RT (small port);
- >= 84 days must have elapsed if prior craniospinal RT or if >= 50% radiation
of pelvis;
- >= 42 days must have elapsed if other substantial bone marrow (BM) radiation
- For combination therapy arms: Patients must have received =< 13.6 Gy prior
radiation to the mediastinum
- Stem cell infusions:
- >= 84 days since allogeneic (non-autologous) bone marrow or stem cell
transplant (with or without total body irradiation [TBI]) or boost infusion
(any stem cell product; not including donor lymphocyte infusion [DLI])
- No evidence of graft versus host disease (GVHD)
- Patients must be off medications to treat or prevent either
graft-versus-host disease post bone marrow transplant or organ rejection
post-transplant for at least 14 days prior to start of protocol treatment
- Cellular therapy: >= 42 days after the completion of DLI (donor lymphocyte
infusion) or any type of cellular therapy (e.g., modified T cells, natural killer
[NK] cells, dendritic cells, etc.)
- Ejection fraction (EF) of >= 55% or if EF unavailable, shortening fraction (SF) >= 28%
by echocardiogram (within 21 days prior to enrollment and start of protocol therapy
[repeat if necessary]) AND
- Corrected QTc interval < 500 msec (within 7 days prior to enrollment)
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows (within 7 days
prior to enrollment):
- 1 to < 2 years (age); 0.6 mg/dL (male) 0.6 mg/dL (female)
- 2 to < 6 years (age); 0.8 mg/dL (male) 0.8 mg/dL (female)
- 6 to < 10 years (age); 1 mg/dL (male) 1 mg/dL (female)
- 10 to < 13 years (age); 1.2 mg/dL (male) 1.2 mg/dL (female)
- 13 to < 16 years (age); 1.5 mg/dL (male) 1.4 mg/dL (female)
- >= 16 years (age); 1.7 mg/dL (male) 1.4 mg/dL (female)
- Direct bilirubin < 2 mg/dL (< 34 umol/L), (within 7 days prior to enrollment) AND
- Serum glutamate pyruvate transaminase SGPT (alanine aminotransferase [ALT]) =< 135 U/L
(within 7 days prior to enrollment)
- If liver abnormality is due to leukemia infiltrate, the patient will remain
eligible
Exclusion Criteria:
- Plans to administer any type of non-protocol prescribed anti-cancer therapy while on
protocol directed therapy. For Cohort 1, additional intrathecal therapy is allowed per
treating physician's discretion
- Strong inducers or inhibitors of CYP2D6 or CYP3A4 are prohibited for 7 days prior to
the 1st dose of IMGN632 to the end of the treatment for both the Phase 1 Monotherapy
Dose Finding and pharmacokinetic (PK) and the Combination Dose Finding components of
the study. For patients not enrolled in a dose finding portion of the study,
concomitant therapy with strong inducers or inhibitors of CYP2D6 or CYP3A4 is STRONGLY
discouraged but not prohibited if clinically indicated
- Patients with acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia
(JMML)
- Patients with Down syndrome
- Patients with isolated extramedullary disease or those with minimal bone marrow
disease not meeting the definition of relapsed or relapse refractory as defined above
- Patients with a prior history of Grade 4 VOD/SOS (veno-occlusive disease/sinusoidal
obstructive syndrome) or any history of Grade 3 VOD/SOS that, at the discretion of the
treating physician, places the patient at unacceptably high risk for future severe
VOD/SOS
- Patients who are currently receiving another investigational drug
- Patients receiving medications for treatment of left ventricular systolic dysfunction
- Patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known
congenital bone marrow failure syndrome
- Patients with known prior allergy to any of the medications used in protocol therapy
- Patients with documented active, uncontrolled infection at the time of study entry
- Patients with history of Wilson's disease or other copper-related disorder
- Pregnancy and breastfeeding:
- Female patients who are pregnant since fetal toxicities and teratogenic effects
have been noted for several of the study drugs. A pregnancy test is required for
female patients of childbearing potential
- Lactating females who plan to breastfeed their infants
- Sexually active patients of reproductive potential (male and female) who have not
agreed to use an effective contraceptive method or abstinence for the duration of
their study participation and for 12 weeks after the last dose of IMGN632 or 6
months after last dose of DAUNOrubicin and cytarabine liposome, whichever is
longer
- Regulatory requirements
- All patients and/or their parents or legal guardians must sign a written informed
consent
- All institutional, Food and Drug Administration (FDA), and National Cancer
Institute (NCI) requirements for human studies must be met
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